SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT TO SECTION 13 AND 15(D) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 29, 1996
THERMOGENESIS CORP.
_____________________________________________________________________________
(Exact Name of Registrant as Specified in its Charter)
DELAWARE 0-16375 94-3018487
(State or other (Commission (IRS Employer
jurisdiction) file number) Identification No.)
11431 SUNRISE GOLD CIRCLE, SUITE A RANCHO CORDOVA, CA 95742
(Address of Principal Executive Office) (Zip Code)
Registrant's telephone number, including area code: (916) 858-5100
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Item 5. Other
(a) Approval of One-For-Two Stock Consolidation.
On May 29, 1996, the stockholders of THERMOGENESIS CORP. (the
"Company") approved a proposal authorizing a one-for-two consolidation
(reverse stock split) of the Company's common stock. By resolution of the
board of directors, the Company has established the close of business (5:00
p.m. Pacific Standard Time) on June 14, 1996 as the record date for
effecting the stock consolidation. Accordingly, shares of common stock
held by all stockholders of record on the close of business at the
Company's office on June 14, 1996 will, following that time, hold one share
of "new" common stock for each two shares of "old" common stock.
(b) Asahi Distribution and Manufacturing License Agreement
On May 30, 1996, the Company entered into a Distribution and
Manufacturing License Agreement ("Agreement") with Asahi Medical Co., Ltd.
of Japan relating to the Company's device and system for the rapid
harvesting of cryoprecipitate from human plasma ("System").
Cryoprecipitate is made up of concentrated clotting proteins, including
fibrinogen, and can be used by a surgeon to control bleeding and seal
tissues during surgery. The System consists of the Company's (1)
thermodynamic device for controlling the temperature of the plasma, (2) a
sterile container (bag set) used for the collection of plasma and
harvesting of cryoprecipitate, and (3) disposable applicators. Asahi
Medical Co., Ltd., a division of Asahi Chemical, is a leading international
supplier of artificial kidneys, blood purification systems and leukocyte
removal systems.
Pursuant to the terms of the agreement, the Company will receive, no
later than June 15, 1996, a non-refundable license fee in the amount of
$400,000. The Agreement provides that Asahi will purchase the
thermodynamic device and the disposable applicators manufactured by the
Company, and Asahi will manufacture the sterile disposable container used
in the System. Asahi will distribute the System in Japan and will also pay
the Company quarterly royalty payments in the amount of ten percent (10%)
of net sales arising from Asahi's distribution of an Auto-Cryo Kit, which
consists of the disposable applicators and the disposable sterile bag used
in the System. Although the company anticipates that Asahi will begin
manufacture and distribution of the system in the early part of 1997,
approval for reimbursement of the system by the Japanese Ministry of Health
is a condition. Accordingly, with the exception of the one time license
fee, the Company will not receive additional revenues until such time as
Asahi begins selling the system.
Asahi's rights to manufacture and distribute the System are limited to
the Japanese market. Pursuant to the terms of the Agreement, Asahi will
manufacture the disposable sterile plasma container used in the system and
will distribute the device and applicators that comprise the System. The
thermodynamic device and the disposable applicators will be manufactured by
the Company and sold to Asahi at prices to be determined by the Company
from time to time. The Company also retained the right to purchase the
disposable plasma container used in the System from Asahi at a price ten
percent (10%) over Asahi's actual cost for manufacturing.
The introduction of the System in Japan by Asahi is subject to certain
delays beyond the Company's control, and there are no assurances that the
Japanese market will accept the System. The Company's expectation of
revenues from the Agreement are subject to risks and uncertainties
including, but not limited to, the impact of competitive products, product
demand, and other risks detailed from time to time in the Company's filings
with the Securities and Exchange Commission.
Item 7(c). Exhibits.
1. Amended and Restated Certificate of Incorporation.
2.Distribution and Manufacturing License Agreement by and between
THERMOGENESIS CORP. and Asahi Medical Co., Ltd entered into and effective
as of the 30th Day of May, 1996.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
THERMOGENESIS CORP.
Dated: June 4, 1996 By: S/ PHILIP H. COELHO
Philip H. Coelho, President
and Chief Executive Officer
AMENDED AND RESTATED CERTIFICATE OF INCORPORATION
OF
THERMOGENESIS CORP.
ThermoGenesis Corp., a corporation organized and existing under the laws
of the State of Delaware, hereby certifies as follows:
1. This corporation was originally incorporated under the name of
Refrigeration Systems International, Inc. on July 3, 1986 upon filing its
certificate of incorporation with the Secretary of State of the State of
Delaware.
2. Pursuant to Sections 242 and 245 of the General Corporation Law of
the State of Delaware, this Amended and Restated Certificate of Incorporation
restates and integrates and further amends the provisions of the Fourth
Article of the Certificate ofIncorporation of this corporation to reflect the
one-for-two consolidation of common stock as approved by the stockholders
pursuant to Section 242.
3. The text of the Restated Certificate of Incorporation as heretofore
amended or supplemented is hereby restated and further amended to read in its
entirety as follows:
FIRST: The name of the corporation (hereinafter called the
"Corporation") is
ThermoGenesis Corp.
SECOND: The address, including street, number, city and county, of the
registered office of the Corporation in the State of Delaware is 1013 Centre
Road, Wilmington, DE 19805, County of Newcastle; and the name of the registered
agent of the Corporation in the State of Delaware at such address is The
Prentice-Hall Corporation System, Inc.
THIRD: The purpose of the Corporation is to engage in any lawful act or
activity for which corporations may be organized under the General Corporation
Law of the State of Delaware.
FOURTH: The total number of shares of stock which the Corporation shall
have authority to issue is Fifty-Two Million (52,000,000) consisting of Two
Million (2,000,000) shares of Preferred Stock, par value $.001 per share, and
Fifty Million (50,000,000) shares of Common Stock, par value $.001 per share.
Effective at 5:00 p.m. (Pacific Standard Time) on June 14, 1996, each two
(2) issued and outstanding shares of common stock of this Corporation shall be
combined into one (1) share of validly issued, fully paid and non-assessable
common stock, par value $.001. Each person as of [the date this amendment is
filed] holding of record any issued and outstanding shares of common stock
shall receive upon surrender to the Company's transfer agent a stock
certificate or certificates to evidence and represent the number of shares of
post-consolidation common stock to which such shareholder is entitled after
giving effect to the consolidation; provided, however, that all fractional
shares resulting therefrom shall be paid in cash.
The Preferred Stock may be issued, from time to time, in one or more
series, with such designations, preferences and relative, participating,
optional or other rights, qualifications, limitations or restrictions thereof
as shall be stated and expressed in the resolution or resolutions providing for
the issue of such series adopted by the Board of Directors from time to time,
pursuant to the authority herein given, a copy of which resolution or
resolutions shall have been set forth in a Certificate made, executed,
acknowledged, filed and recorded in the manner required by the laws of the
State of Delaware in order to make the same effective. Each series shall
consist of such number of shares as shall be stated and expressed in such
resolution or resolutions providing for the issuance of the stock of such
series. All shares of any one series of Preferred Stock shall be alike in
every particular.
FIFTH: The Corporation is to have perpetual existence.
SIXTH: Whenever a compromise or arrangement is proposed between this
Corporation and its creditors or any class of them and/or between this
Corporation and its stockholders or any class of them, any court of equitable
jurisdiction within the State of Delaware may, on the application in a summary
way of this Corporation or of any creditor or stockholder thereof or on the
application of any receiver or receivers appointed for this Corporation under
the provisions of Section 291 of Title 8 of the Delaware Code or on the
application of trustees in dissolution or of any receiver or receivers
appointed for this Corporation under the provisions of Section 279 of Title 8
of the Delaware Code order a meeting of the creditors or class of creditors,
and/or of the stockholders or class of stockholders of this Corporation, as the
case may be, to be summoned in such manner as the said court directs. If a
majority in number representing three-fourths (3/4) in value of the creditors
or class of creditors, and/or of the stockholders or class of stockholders of
this Corporation, as the case may be, agree to any compromise or arrangement
and to any reorganization of this Corporation as consequence of such compromise
or arrangement, the said compromise or arrangement and the said reorganization
shall, if sanctioned by the court to which the said application has been made,
be binding on all the creditors or class of creditors, and/or on all the
stockholders or class of stockholders, of this Corporation, as the case may be,
and also on this Corporation.
SEVENTH: For the management of the business and for the conduct of the
affairs of the Corporation, and in further definition, limitation and
regulation of the powers of the corporation and of its directors and of its
stockholder or any class thereof, as the case may be, it is further provided:
1. The management of the business and the conduct of the affairs of the
Corporation shall be vested in its Board of Directors. The number of directors
which shall constitute the entire Board of Directors shall be fixed by, or in
the manner provided in, the Bylaws, which number has been set initially at not
less than three nor more than nine, with the specific number set by the Board
of Direcctors from time to time, and provided further that the number of
directors constituting the entire Board shall be six until otherwise fixed by a
majority of the entire Board of Directors. The phrase "entire Board of
Directors" and the phrase "total number of directors" shall be deemed to have
the same meaning, to wit, the total number of directors which the Corporation
would have if there were no vacancies. No election of directors need be by
written ballot.
2. After the original or other Bylaws of the Corporation have been
adopted, amended, or repealed, as the case may be, in accordance with the
provisions of Section 109 of the General Corporation Law of the State of
Delaware and, after the Corporation has received any payment for any of its
stock, the power to adopt, amend, or repeal the Bylaws of the Corporation may
be exercised by the Board of Directors of the Corporation; provided, however,
that any provision for the classification of directors of the Corporation for
staggered terms pursuant to the provisions of subsection (d) of section 141 of
the General Corporation Law of the State of Delaware shall be set forth in the
initial Bylaws or in Bylaws adopted by the stockholders entitled to vote of the
Corporation unless provisions for such classification shall be set forth in
this certificate of incorporation.
3. Whenever the Corporation shall be authorized to issue only one class
of stock, each outstanding share shall entitle the holder thereof to notice of,
and the right to vote at, any meeting of stockholders. Whenever the
Corporation shall be authorized to issue more than one class of stock, no
outstanding share of any class of stock which is denied voting power under the
provisions of this Certificate of Incorporation shall entitle the holder
thereof to the right to vote at any meeting of stockholders except as the
provisions of paragraph (b)(2) of Section 242 of the General Corporation Law of
the State of Delaware shall otherwise require; provided, that no share of any
such class which is otherwise denied voting power shall entitle the holder
thereof to vote upon the increase or decrease in the number of authorized
shares of said class.
EIGHTH: The personal liability of the directors of the Corporation is
hereby eliminated to the fullest extent permitted by subsection (7) of
subsection (b) of Section 102 of the General Corporation Law of the State of
Delaware, as the same may be amended and supplemented.
NINTH: The Corporation shall, to the fullest extent permitted by
Section 145 of the General Corporation Law of the State of Delaware, as the
same may be amended and supplemented, indemnify any and all persons whom it
shall have power to indemnify under said section from and against any and all
of the expenses, liabilities or other matters referred to in or covered by said
section, and the indemnification provided for herein shall not be deemed
exclusive of any other rights to which those indemnified may be entitled under
any Bylaw, agreement, vote of stockholders or disinterested directors or
otherwise, both as to action in his official capacity and as to action in
another capacity while holding such office, and shall continue as to a person
who has ceased to be a director, officer, employee or agent and shall inure to
the benefit of the heirs, executors and administrators of such a person.
TENTH: From time to time any of the provisions of this certificate of
incorporation may be amended, altered or repealed, and other provisions
authorized by the laws of the State of Delaware at the time in force may be
added or inserted in the manner and at the time prescribed by said laws, and
all rights at any time conferred upon the stockholders of the Corporation by
this certificate of incorporation are granted subject to the provisions of this
Article ELEVENTH.
DATED: May ____, 1996
___________________________________
Philip H. Coelho, President
and Chief Executive Officer
ATTEST:
__________________________________
Charles de B. Griffiths, Secretary
DISTRIBUTION AND MANUFACTURING LICENSE AGREEMENT
This Distribution and Manufacturing License Agreement ("Agreement") is
entered into as of the ____________ day of __________, 19___, by and
between ASAHI MEDICAL CO., LTD., a JAPANESE corporation ("ASAHI") with an
office and place of business at THE IMPERIAL TOWER, 1-1, UCHISAIWAICHO 1-
CHOME, CHIYODA-KU, TOKYO 100, JAPAN, and THERMOGENESIS CORPORATION, a
DELAWARE corporation, ("THERMO") with an office and place of business at
11431 SUNRISE GOLD CIRCLE, SUITE A, RANCHO CORDOVA, CALIFORNIA, 95742.
W I T N E S S E T H:
WHEREAS, THERMO represents that it owns certain intellectual property
rights covering certain inventions relating to the design and manufacture
of a freezing and thawing "SYSTEM" for the rapid harvesting of
cryoprecipitate from human plasma and has the right to grant the license
herein contained;
WHEREAS, THERMO represents that it has filed Application for Letters
Patent of the United States, Serial No. 07789293 - "DEVICE" FOR
FRACTIONATING CONSTITUENT COMPONENTS OF A SUBSTANCE USING CRYOPRECIPITATION
and Serial No. 08005989 -- FIBRINOGEN PROCESSING APPARATUS METHOD AND
"CONTAINER", covering said inventions (The "Patent Applications") and is
preparing additional patent application, all of which either have been
and/or will be filed in Japan; and
WHEREAS, ASAHI desires to obtain, and THERMO is willing to grant, the
manufacturing and distribution rights for the sterile plastic disposable
processing "CONTAINERS" and the distribution rights to the thermodynamic
"DEVICE" respecting said inventions;
NOW, THEREFORE, in consideration of the foregoing and for the other
good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the parties, intending to be legally bound, hereby
agree as follows:
1. DEFINITIONS. As used in this Agreement, the following terms
shall have the meanings hereinafter set forth:
a. "SYSTEM" shall mean the CryoStat-1 freezing and thawing
thermodynamic device and the CP-1 sterile plastic disposable processing
container for the rapid harvesting of cryoprecipitate from human plasma
that embodies the Intellectual Property Rights of THERMO;
b. "CONTAINER" shall mean the CP-1 clear, plastic, sterile
disposable container, within which the plasma is located during the
freeze/thaw cycle caused by the thermodynamic "DEVICE";
c. "DEVICE" shall mean the CryoStat-1 thermodynamic machine on
which the container will be placed which will precisely control and alter
the temperature of the container and its contents in order to achieve the
separation and collection of the cryoprecipitate;
d."APPLICATORS" shall mean the CryoSpray or CryoLine applicators
for applying the cryoprecipitate, with or without thrombin, to the wound
site.
e."AUTO-CRYO KIT" shall mean the disposable kit which will be
reimbursed by the Japanese Ministry of Health and Welfare ("MHW") and will
include any drug fee and any material fee which shall include the
container, chemicals and applicators.
f."INTELLECTUAL PROPERTY RIGHTS" means the Patent Applications,
the Licensed Patents and the Know-How;
g."KNOW-HOW" shall mean all technical information, secret processes,
formulae, designs and data relating to the manufacture of the SYSTEM
presently owned by THERMO or acquired by it during the term of this
Agreement;
h. "LICENSED PATENTS" shall mean (i) the Patent Applications
and any Letters Patent filed in Japan (including any reissues or extensions
thereof) that may issue on any of the Patent Applications and any other
Application that at any time while this agreement is in effect shall be
filed in Japan as a substitute for, or a division, continuation-in-part of,
any of the Patent Applications or with respect to any improvements of the
inventions disclosed in any of the Patent Applications and any Letters
Patent issued thereon and (ii) any Letters Patent (including any
extensions thereof or Patents of Addition relating thereto) filed in Japan
that are owned or controlled by THERMO or in which it has any interest, in
which case to the extent of such interest, at any time while this Agreement
is in effect; and
i. "NET SELLING PRICE" with respect to the AUTO-CRYO KIT sold
by ASAHI or its sublicensees hereunder shall be determined by deducting
from the gross amount billed, therefore: (i) transportation and insurance
charges or allowances, if any included in such price; (ii) discounts
allowed, and commissions paid in lieu of trade discounts (other than
commissions paid to seller's employee) in amounts customary in the trade;
(iii) credits and allowances, if any, given or made on account of the
return or rejection of AUTO-CRYO KIT previously delivered or retroactive
price reductions; (iv) the purchase price paid by ASAHI to THERMO for the
APPLICATORS, CONTAINER and any component thereof.
2. GRANT OF MANUFACTURING & DISTRIBUTION LICENSE. Subject to the
terms and conditions hereafter set forth, THERMO hereby grants to ASAHI the
following rights with respect to the AUTO-CRYO KIT:
a. GRANT OF RIGHTS. THERMO grants to ASAHI the right and license,
with rights to grant sublicenses as provided below, to manufacture or have
manufactured, the AUTO-CRYO KIT in Japan (with the exception of the
APPLICATORS) and the unrestricted right to market and distribute the
DEVICE, AUTO-CRYO KIT and APPLICATORS in Japan.
b. SCOPE; TERRITORY. The rights granted herein for manufacture
and distribution are exclusive and limited to the geographical country of
Japan. At any time following execution of this Agreement, ASAHI may
propose to THERMO an agreement (consistent with the terms herein, subject
to negotiated pricing) for additional territories that would comprise the
Asian Pacific Rim countries. Notwithstanding the foregoing, THERMO
further grants to ASAHI a first right of refusal (the "Option") to acquire
similar rights in other countries comprising Asian Pacific Rim countries,
upon similar terms as provided in this Agreement, subject to negotiation
and execution of a definitive agreement, or upon such other terms that are
offered by a third party to THERMO for such rights. If ASAHI elects not to
enter into such an agreement within sixty (60) days after it is offered by
THERMO, such Option for the offered country will lapse, and THERMO will be
free to grant such rights to any third party, upon such terms as THERMO
deems appropriate in its sole discretion.
c. TECHNICAL SUPPORT. THERMO shall make available to ASAHI,
without charge, all technical and other information in its possession at
any time during the term of this Agreement relating to the manufacture of
the AUTO-CRYO KIT, including specifications and quality control information
(with the exception of the APPLICATORS) and shall from time to time make
available to ASAHI the services of such personnel of THERMO as THERMO deems
necessary, or as reasonably request by ASAHI, during the period from the
date of MHW approval to the date 12 months thereafter in order to assist
ASAHI in its efforts to manufacture or have manufactured the AUTO-CRYO KIT.
When THERMO personnel are in Japan at the request of ASAHI, the living
and travel expenses within Japan will be paid by ASAHI and the travel
expenses from the U.S. to Japan, and back to the U.S., will be paid by
THERMO. After the 12 month period, THERMO will make available technical
and support assistance, as may be requested by ASAHI, pursuant to THERMO'S
then standard rates and charges.
d. PARTS, SUPPLY AND SUPPORT. THERMO shall use its best efforts
to maintain parts and supplies for repair and maintenance of DEVICE and
APPLICATORS. THERMO shall use its best efforts to maintain sufficient
inventory of parts and supplies for repair and maintenance of DEVICE and
APPLICATORS for a period of ten years following termination of this
Agreement; provided, however, that ASAHI shall pay THERMO fifty percent
(50%) of actual inventory cost for all such parts and supplies stocked
following termination, unless ASAHI waives this requirement of parts
inventory at the time of termination. To the extent parts and supplies
maintained in inventory are not later purchased by ASAHI in an amount equal
to the fifty percent (50%) maintenance fee, such fee shall be retained by
THERMO to reflect lossses based on inventory maintenance.
e. ADVERTISING MATERIALS; CLINICAL DATA AND TEST MATERIALS.
THERMO shall provide to ASAHI sales, marketing and technical assistance and
AUTO-CRYO KIT, DEVICE and APPLICATOR training and support that THERMO deems
appropriate to enable ASAHI to Localize (as defined below) the AUTO-CRYO
KIT, DEVICE and APPLICATORS and to sell and provide AUTO-CRYO KIT
maintenance. THERMO shall provide ASAHI with a reasonable amount of sales
literature, advertising materials and point of purchase (i.e., AUTO-CRYO
KIT display) materials as may be necessary or appropriate to allow ASAHI to
complete Localization and promote and enhance the sales of AUTO-CRYO KIT,
DEVICE and APPLICATORS. THERMO shall also provide to ASAHI, when and as
available, all test data, clinical trial studies (including FDA application
data), and related information available to THERMO without additional
effort or cost on THERMO's part, in order to assist ASAHI obtain required
governmental approvals.
f. SUB-LICENSES. ASAHI shall notify THERMO of its intent to enter
into any sub-licensing arrangement, consistent with the terms of this
Agreement, and THERMO shall have the right to attend and participate in any
substantive negotiations with respect to such arrangement. All sub-license
agreements must be approved by an officer of THERMO prior to execution or
effect, which approval shall not be unreasonably withheld. Any sub-license
entered into without compliance with the foregoing approval requirements
shall be deemed outside the rights granted under this Agreement and will be
treated as void by THERMO.
g. IMPROVEMENTS. During the term of this Agreement, THERMO shall
provide ASAHI with access to improved DEVICE, APPLICATORS, CONTAINER and/or
AUTO-CRYO KIT (hereinafter individually or collectively referred to as
"Improved Product") if and when available. If ASAHI informs of its
intention of obtaining regulatory approval (if necessary) and promotion of
the Improved Product it will be considered to be DEVICE, APPLICATORS,
CONTAINER or AUTO-CRYO KIT stipulated in Article 1 of this Agreement and to
be subject to this Agreement.
<PAGE>
3. COMPENSATION AND ROYALTY; PAYMENTS.
a. LICENSE AND DISTRIBUTION FEE. ASAHI shall, within 30 days from
execution of this Agreement or June 15, 1996, whichever first occurs, pay a
non-refundable manufacturing and distribution license fee to THERMO of
$400,000 US by wire transfer.
b. PURCHASE OF DEVICES, APPLICATORS AND CONTAINERS. ASAHI shall
purchase the CryoStat -1 DEVICE and CryoLine and CryoSpray APPLICATORS from
THERMO for distribution in Japan at pricing as shown in Exhibit A.
c. CURRENCY ADJUSTMENT TO EXHIBIT A. All payments due or payable
under this Agreement shall in United States Dollars ("USD") based on the
exchange rate on the date payment is due. Notwithstanding the foregoing,
if the exchange rate rises or falls by more than fifteen percent (15%) from
the exchange rate on the date this Agreement is signed, and such rise or
fall continues in excess of fifteen percent (15%) for more than ten (10)
days, then the parties will meet to negotiate a new price for items listed
in Exhibit A.
d. ROYALTY PAYMENTS. In addition to the aforesaid payment, ASAHI shall pay
to THERMO royalties quarterly on the total sales of the AUTO-CRYO KIT equal
to the following percentages of the "NET SELLING PRICE":
ROYALTY PERCENTAGE
10%
THERMO and ASAHI agree to negotiate a sliding scale for royalty payments
based on product sales volume during each royalty period; THERMO and ASAHI
will meet to negotiate the proposed amendment within the thirty (30) day
period following extension of the Agreement for an additional five (5)
years or when ASAHI'S AUTO-CRYO KIT sales exceed 50,000 kits/year,
whichever comes earlier.
e. WRITTEN REPORTS OF ROYALTY. Within thirty (30) days after
the end of each calendar quarter during the term of this Agreement,
commencing with the quarter in which the first commercial sale of the
SYSTEM is made, ASAHI shall submit a written report to THERMO setting forth
for such quarter the number and location of DEVICES and AUTO-CRYO KITS
sold, the aggregate NET SELLING PRICE thereof and the amount of royalty
payable with respect thereof. Each such quarterly report shall be
accompanied by a wire transfer covering the royalty payable for such
quarter, which shall be received by THERMO at the time the report is
transmitted.
f. MAINTENANCE OF RECORDS. ASAHI shall keep, and shall cause
its sublicensees to keep, full and true books of account and other records
in sufficient detail so that the royalties payable to THERMO hereunder can
be properly ascertained. At the request of THERMO, ASAHI shall permit, and
shall cause its sublicensees to permit, a certified public accountant
selected by THERMO to have access to such books and records as may be
necessary to determine, in respect of any quarterly period ending not more
than 18 months prior to such request, the correctness of any report or
payment under this Agreement. Any such examination shall not be entitled
to disclose to THERMO any information relating to the business of ASAHI or
any sublicensee except that which should properly be contained in any
report hereunder.
g. RETENTION OF RECORDS; ACCESS TO INFORMATION. ASAHI shall furnish any
information which THERMO may reasonably request from time to time to verify
record maintenance. All records and documents related to the Licensed
Patents and any royalty due on account of such products shall be kept and
maintained by ASAHI for a period of three years following each royalty
payment as provided for in this Article 3.
h. TAXES. Any tax levied under any Japanese Tax Laws that is
required to be deducted from any royalty or other consideration payable to
THERMO hereunder shall be paid by ASAHI for the account of THERMO. Any
tax so paid shall be deducted by ASAHI from the royalties or consideration
payable to THERMO hereunder and ASAHI shall provide THERMO with the
original copy or certified copy of the official Japanese Government receipt
sufficient to enable THERMO to support a claim for credit, in respect of
any such taxes so withheld and paid, against United States income taxes.
4. LOCALIZATION DUTIES OF ASAHI. ASAHI shall provide and coordinate
all services necessary to cause the AUTO-CRYO KIT to be appropriately
packaged and prepared for sale and marketing throughout Japan in accordance
with the language and customs of Japan ("Localized"). Localization shall
include, but not be limited to, (i) the appropriate language translations
for all materials related to the AUTO-CRYO KIT (ii) the modification of the
appearance of packaging materials and (iii) any modifications necessary to
comply with Japanese laws and regulations. ASAHI shall not make any claims
with respect to the AUTO-CRYO KIT or other THERMO products inconsistent or
greater than those set forth in the THERMO marketing guidelines
("Guidelines"). ASAHI shall comply with all Guidelines established by
THERMO and as modified by THERMO from time to time. ASAHI shall not modify
any portion, part or component of the AUTO-CRYO KIT without the prior
written approval of an officer of THERMO. ASAHI may not modify the trade
names or logos of THERMO or its AUTO-CRYO KIT and THERMO may instruct ASAHI
from time to time regarding various other aspects of the AUTO-CRYO KIT that
may not be altered. Subject to the foregoing, ASAHI shall provide the
Localization services set forth in subparagraphs (a) and (b) below:
a. AUTO-CRYO KIT SPECIFIC MATERIAL. ASAHI shall prepare and
submit to THERMO recommendations and suggestions for all modifications
necessary or appropriate to Localize the following AUTO-CRYO KIT specific
material: (i) The outside packaging materials for the AUTO-CRYO KIT;
(ii) all instruction manuals for the AUTO-CRYO KIT; (iii) all start-up
cards, warranty and registration cards, and labels regarding the AUTO-CRYO
KIT; and (iv) any promotional material that may be included in promoting
the AUTO-CRYO KIT from time to time.
b. PREPARATION OF LOCALIZED MATERIALS. ASAHI shall be responsible
for all costs related to the translation and Localization of the materials
described above. ASAHI shall follow the direction of THERMO's in
coordinating the Localization process. All modifications proposed by ASAHI
must comply with the Guidelines. ASAHI shall timely submit mock-ups and
proofs of all proposed Localization materials for approval by THERMO. All
original art work provided to THERMO by ASAHI shall be on media of a type
and format agreed upon by the parties and accompanied by samples of the
finished AUTO-CRYO KIT materials. ASAHI agrees that all films and
materials produced are and shall remain the exclusive property of THERMO.
5. EVALUATION UNITS. Upon the request of a hospital or prospective
end-user for the AUTO-CRYO KIT, or proposed sub-distributor, for an
evaluation unit of a THERMO AUTO-CRYO KIT, ASAHI promptly shall notify
THERMO's sales department of such request in order to allow THERMO to
consider the request and, if approved by THERMO, to deliver the evaluation
unit on a timely basis. ASAHI shall pay the actual cost for such
evaluation unit, based on THERMO's manufacturing cost only, without mark-up
or profit. Any such evaluation unit will not be treated as a sale, for
purposes of compensation and royalty, and no royalty payment on account of
any evaluation unit will be paid by ASAHI. The evaulation unit will be
delivered to ASAHI by THERMO upon such terms as THERMO may determine, in
its sole discretion.
6. WARRANTY AND LIABILITY. The warranty for THERMO's DEVICE,
CONTAINER, APPLICATORS and AUTO-CRYO KIT, purchased under this Agreement
shall be as provided below:
a. SPECIFIC WARRANTIES. THERMO warrants that:
1) TITLE. The title to the DEVICE, CONTAINER, APPLICATORS and
AUTO-CRYO KIT, when conveyed to ASAHI, shall be good and their transfer
rightful except in circumstances where (a) ASAHI has reason to know that
THERMO does not claim title, or (b) an agreement between the parties
otherwise provides; and they shall be delivered free from any security
interest or other lien or encumbrance except as otherwise expressly agreed
upon by ASAHI;
2) WORKMANSHIP. The DEVICE, CONTAINER, APPLICATORS and AUTO-CRYO
KIT shall, upon the tender of delivery, be free from defects in (a) the
composition or substance of materials and (b) in THERMO's workmanship or in
materials arising from THERMO's workmanship;
3) CONFORMITY. THERMO shall provide ASAHI with written
specifications (the "Product Specifications"). THERMO warrants that the
DEVICE, CONTAINER, APPLICATORS and AUTO-CRYO KIT manufactured by THERMO
shall, upon tender of delivery, conform to all applicable specifications
and drawings which are a part of any contractual documents which
incorporate this clause and to any express representations or descriptions
contained in such contractual documents. THERMO warrants that the System,
when operated in accordance with the design specifications and engineering
specifications established by THERMO from time to time, will harvest the
fibrinogen rich cryoprecipitate through freezing and thawing plasma from a
plasma donor during the thirty (30) days following installation of the
System, normal wear and tear of operating the System excepted.
Notwithstanding the foregoing, THERMO does not warrant the result of
various possible uses or purpose for the system, or warrant that the System
is fit or intended for any particular use or intended purpose.
b. NOTICE; BREACH OF WARRANTY; REMEDY. Upon notice from ASAHI to
THERMO of a breach of the Warranty in Article 6 (a)(1), above THERMO shall
promptly secure removal of any encumbrance on the title. Except as set
forth below, ASAHI's remedy for a breach of the warranties set forth in
Article 6 (a)(2) and 6 (a)(3) above, and THERMO's obligation and liability
therefor, are expressly limited to the repair, rework or replacement of any
non-conforming materials, or parts, or components thereof, not including,
however, any costs occasioned by the removal or reinstallation of such
materials, parts or components. At THERMO's request, ASAHI shall return
any such non-conforming DEVICE, CONTAINER, APPLICATORS and/or AUTO-CRYO KIT
to THERMO at its manufacturing facility in Rancho Cordova, CA, USA, at
THERMO's expense. Replacement or repaired or reworked supplies shall be
returned to ASAHI at THERMO's expense. THERMO's obligation hereunder is
limited to defects becoming apparent within the period of twelve (12)
months from the date of delivery or installation of the DEVICE, CONTAINER,
APPLICATORS and AUTO-CRYO KIT and is conditioned upon receipt by THERMO,
promptly after such defect becomes apparent, but in no event later than
fifteen (15) days following expiration of such period, of written
notification stating such particulars as may reasonably be necessary to
notify THERMO of the nature of the asserted non-conformance. DEVICE,
CONTAINER, APPLICATORS and AUTO-CRYO KIT or parts or components thereof
repaired, reworked, or furnished in replacement pursuant to this
subparagraph shall, upon installation or delivery to ASAHI, also be subject
to the provisions of this clause to the same extent as DEVICE, CONTAINER,
APPLICATORS and AUTO-CRYO KIT initially delivered or installed.
c. SOLE REMEDY. These warranties and ASAHI's remedies thereunder
are solely for the benefit of the ASAHI and shall not, without the written
consent of THERMO, be extended or construed to extend to any other person
whatsoever. This paragraph sets forth the entire agreement of the parties
with respect to warranties for the DEVICE, CONTAINER, APPLICATORS and AUTO-
CRYO KIT and the remedy for their breach.
d. AGREEMENT ON WARRANTIES. THERMO and ASAHI agree that Article 6
has been the subject of discussion and is fully understood by the parties,
and that the express warranties, the limitation of ASAHI's remedies, the
exclusion of and waiver by ASAHI of all other warranties, remedies and
damages, all as set forth in this paragraph, are in consideration of the
price of the DEVICE, CONTAINER, APPLICATORS and AUTO-CRYO KIT and the other
mutual agreements of the parties set forth in any contractual documents
which incorporate this clause; provided, however, that this provision shall
not apply in case of product liability and the provision for
indemnification found in Article 11.
e. EXCLUSIVITY OF WARRANTIES. THERMO'S WARRANTIES, AS SET FORTH
IN THIS CLAUSE, ARE EXCLUSIVE AND ARE IN LIEU OF AND ASAHI HEREBY WAIVES
ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION,
ANY IMPLIED WARRANTIES OR MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR
PURPOSE.
f. LIMITATION ON OBLIGATIONS OF THERMO; RELEASE BY ASAHI. The obligations
and liabilities undertaken in subparagraph b) above are expressly agreed to
be the sole obligations and liabilities of THERMO in the event of a breach
of the express warranties other than the warranty of title made by THERMO
in subparagraph a) above. ASAHI waives, releases and renounces all other
rights, claims, and remedies against THERMO with respect to direct damage
and with respect to loss of use or other secondary or consequential damage,
however, occasioned.
g. LIMITATION ON LIABILITY. In no event shall THERMO's liability
under this Article 6 exceed, in the aggregate, the amount of $300,000 U.S.
(three hundred thousand U.S. dollars), which amount shall be the maximum
amount of THERMO's liability.
7. DEFECT RETURNS AND CREDITS. Upon receipt of a request from a
purchaser and end-user for a return, ASAHI shall obtain all appropriate
information and submit to THERMO in writing a request for a returned AUTO-
CRYO KIT, DEVICE, or APPLICATOR authorization ("RAN") number. The RAN
request shall describe the AUTO-CRYO KIT, DEVICE or APPLICATOR, the reason
for the return and date of purchase of the AUTO-CRYO KIT, DEVICE or
APPLICATOR to be returned. Upon receipt from THERMO of an RAN number,
ASAHI shall provide the purchaser/end-user with the RAN number and instruct
them to ship the AUTO-CRYO KIT to (i) ASAHI's warehouse or (ii) to THERMO,
as determined by THERMO when a RAN number is assigned and issued. ASAHI's
warehouse shall be adequately insured against theft, damage or loss of
THERMO's materials and products stored therein. THERMO shall be listed as
a named insured on such insurance policies. ASAHI shall properly maintain
the warehouse and shall provide security. The cost of such warehouse shall
be borne by ASAHI. Upon receipt of the AUTO-CRYO KIT, DEVICE, or
APPLICATOR, ASAHI shall inspect the item and report to THERMO any
discrepancies, identifying the RAN number.
a. ACCOMMODATION. ASAHI shall assist THERMO in accommodating all
AUTO-CRYO KITS, DEVICES and APPLICATORS returned by purchasers/end-users
for repair or replacement for noncompliance with specifications or
warranties, repackaging or for any other reason.
b.INSPECTION AND TESTING. At ASAHI's cost, ASAHI also shall
perform a detailed inspection and verification test of the AUTO-CRYO KIT,
DEVICE or APPLICATOR as set forth in THERMO's instructions for the AUTO-
CRYO KIT, DEVICE or APPLICATOR inspections guidelines provided to ASAHI by
THERMO (as modified from time to time). Following inspection, ASAHI shall
report to THERMO the results of such inspection. If any AUTO-CRYO KIT,
DEVICE or APPLICATOR is categorized as defective, a replacement unit in
accordance with THERMO's replacement policies as then in effect will be
shipped. If the defective unit can be fixed at ASAHI's warehouse by
replacement of a part, ASAHI shall replace the defective part or request
from THERMO the necessary replacement part and then replace the part,
repackage the unit, as necessary in accordance with packaging policies and
procedures, notify THERMO and store the unit in ASAHI's warehouse pending
THERMO's instructions that the unit may be distributed. If a previously
distributed unit requires replacement pursuant to THERMO's replacement
policies then in effect, ASAHI shall return the unit to THERMO for repair
at THERMO's expense, and THERMO will return the repaired unit or a
replacement unit in the case of the DEVICE or APPLICATOR. If the unit does
not require repair or replacement, ASAHI shall repackage the unit, notify
THERMO and store the unit in ASAHI's warehouse pending THERMO's shipping
instructions. Upon receipt of shipping instructions, ASAHI shall ship the
unit and components to the location specified and provide THERMO with
copies of all shipping documents.
c.WARRANTY AND SERVICE RETURNS BY END-USERS. Upon receipt of a
returned AUTO-CRYO KIT, DEVICE, or APPLICATOR from a purchaser or an end
user for warranty repair or replacement, ASAHI shall issue an RAC number to
the end user. ASAHI shall forthwith inspect and test the returned AUTO-
CRYO KIT received and determine whether each AUTO-CRYO KIT requires repair
or replacement, and submit a report of the inspection and test results to
THERMO. Certain basic repairs identified by THERMO FROM TIME TO TIME shall
be completed by ASAHI and ASAHI shall maintain adequate supplies to
complete such basic repairs. At THERMO's request, based on disclosed
problems, malfunctioning AUTO-CRYO KITS, DEVICES and APPLICATORS shall be
returned to THERMO, at THERMO's expense, or destroyed if so instructed by
THERMO. ASAHI shall promptly ship a replacement AUTO-CRYO KIT, DEVICE or
APPLICATOR to the end user, at ASAHI's expense. ASAHI shall repackage and
store in its warehouse all returned AUTO-CRYO KITS that are not defective
or that ASAHI repairs as provided above. ASAHI shall maintain adequate
inventory at its warehouse to replace such AUTO-CRYO KITS returned by
purchasers or end users.
8. PROSECUTION AND MAINTENANCE OF LICENSED PATENTS. To the extent it
has not done so, THERMO, through its own patent attorney and at its own
cost and expense, shall cause to be filed and prosecuted the existing
PATENT APPLICATIONS and all future PATENT APPLICATIONS which lend
protection to the SYSTEM in Japan. THERMO agrees to exercise all
reasonable efforts to cause such Applications to be prosecuted and all
Licensed Patents issued in respect thereof to be maintained in such manner
that the best possible patent protection may be obtained thereon. In the
event that THERMO fails to take action in Japan pursuant to ASAHI's
reasonable request, ASAHI may, on behalf and in the name of THERMO but at
ASAHI's own cost and expense and through patent attorneys designated by it,
cause to be filed and/or prosecute Applications for Letters Patent, and
cause to be maintained all Licensed Patents, in Japan, in which case ASAHI
shall be entitled to take as a credit against any royalty payments that are
or become due as a result of sales of AUTO-CRYO KITS or DEVICES in Japan
amounts equal to the reasonable out-of-pocket expenses and cost incurred by
ASAHI in connection with the filing, prosecution and/or maintenance of any
Application or Licensed Patent in Japan.
9. PATENT INDEMNIFICATION. THERMO agrees to defend any and all actions
and suits alleging that the AUTO-CRYO KIT AND THE SYSTEM embodying the
Intellectual Property Rights infringe any patent issued OR PUBLISHED to any
third party prior to the date of this Agreement that may at any time be
brought against ASAHI or its sublicensees or any of its or their customers
and to pay all costs and expenses incurred and to satisfy all judgments and
decrees against the defendant or defendants in such actions or suits and to
hold ASAHI harmless and its sublicensees and its and their customers
harmless from all loss, damage, expense and liability on account of any
such infringement; provided that THERMO shall have prompt notice of the
commencement of any such action or suit and full opportunity to defend the
same. ASAHI or its sublicensees or its or their customers, as the case may
be, shall be entitled at their expense to participate in the defense of any
such action or suit through counsel selected by them.
10. INFRINGEMENT OF LICENSED PATENTS. In the event that either party
shall become aware that any Licensed Patent is being infringed by a third
party, such party shall notify the other of the facts in respect thereof.
Should THERMO bring suit against such infringer, such suit will be at
THERMO's own expense. Any award for damages and costs recovered by THERMO
as a result of such suit shall be divided between ASAHI and THERMO in
proportion to their expenses incurred after deducting therefrom costs and
expenses incurred by ASAHI and THERMO in connection therewith. In any such
suit, ASAHI shall have the right to be represented by counsel of its own
selection at its own expense. In the event ASAHI deems that a patent
herein licensed is being or has been infringed by a third party and THERMO
does not file suit or resolve the matter within a period of 90 days after
notice from ASAHI, then and in such event ASAHI shall have the right to
join THERMO in the event THERMO is determined to be an indispensable party.
In any such suit brought by ASAHI, THERMO shall have the right to be
represented by counsel of its selection at its expense. ASAHI may register
the license granted herein with the Japanese Patent Office in order that
ASAHI may enforce its rights granted hereunder against any infringer of the
THERMO patents, subject to the terms of this Agreement, the cost of which
registration shall be paid by ASAHI. THERMO shall cooperate with ASAHI'S
efforts to register the license and ASAHI will take the necessary
procedures to cancel the registration upon termination of the Agreement,
which cancellation shall also be made at ASAHI'S expense.
11. INDEMNIFICATION.
a. INDEMNIFICATION BY THERMO. THERMO agrees to reimburse and
indemnify ASAHI from and within THERMO's product liability insurance policy
only for all liabilities which arise from the sale or use of the System and
which are caused solely or in part by a breach of THERMO's warranties for
the Device and/or Applicator stated in Article 6(a)(2) and 6(a)(3) of this
Agreement. Each party shall work to minimise damages that may arise under
this Article, in accordance with the terms of this Agreement; provided,
however, that THERMO's reimbursement and indemnification shall be
proportional to its breach in comparison to liability attributed to or
arising from acts or conduct of ASAHI. If any court or tribunal of
competent jurisdiction does not make any finding of apportionment or
contribution, then such determination shall be mutally agreed upon by ASAHI
and THERMO, or submitted to mutual binding arbitration as provided in
Article 26 of this Agreement.
b. INDEMNIFICATION BY ASAHI. ASAHI agrees to indemnify and hold
harmless THERMO, each of its officers, directors, agents and employees,
against losses, claims, damages or liabilities, joint or several, to which
THERMO or its officers, directors, agents and employees may become subject
to insofar as such losses, claims, damages or liabilities (or any action or
claim in respect thereof) arise out of, or are based upon, any act or
omission of ASAHI in the manufacture, marketing, distribution or use of the
SYSTEM and any component thereof; provided, however, that ASAHI's
reimbursement and indemnification shall be proportional to its acts,
conduct or omissions in comparison to any fault or liability attributed to
or arising from acts or conduct of THERMO. If any court or tribunal of
competent jurisdiction does not make any finding of apportionment or
contribution, then such determination shall be mutally agreed upon by ASAHI
and THERMO, or submitted to mutual binding arbitration as provided in
Article 27 of this Agreement.
c.NOTICE OF INDEMNIFIABLE EVENT. Promptly after receipt by an
indemnified party under this Article 11 of the commencement of any action
or threat of action, such indemnified party shall, if a claim with respect
to such action or threat of action is to be made against an indemnifying
party under this Article 11, notify the indemnifying party of the action or
claim. Upon the receipt of such notice, the indemnifying party shall
assume the defense of the action or claim, including employment of counsel
and payment of expenses; provided, however, that the indemnifying party
shall not be liable for the settlement or compromise of any claim or action
if it has not first consented to such settlement or compromise. The
indemnified party may, at its election and cost, join in the defense of
such action. Notwithstanding the foregoing, if both parties are named as
defendants in any action actually commenced or immediately threatened, the
parties shall cooperate in coordination of any defense, including selection
of counsel, and all costs of counsel shall be paid jointly until such time
as a finding of contribution or attribution of fault, if any, is made.
<PAGE>
d. PRODUCT LIABILITY INSURANCE. Each party shall be responsible
for maintaining product liability insurance coverage. Upon written
request, the parties shall provide to each other a specimen copy of all
such insurance maintained in connection with the manufacture, marketing,
distribution and use of the SYSTEM and any component part thereof.
e. RECALLS. In the event that one party knows or has reason to
know of problems with the DEVICE, APPLICATOR OR CONTAINER which may require
ASAHI or THERMO to recall such product from the market for any reaon, such
party shall notify the other party immediately and prior to effecting any
such recall, except as may be mandated by any governmental or regulatory
order. The parties shall cooperate and work together to effect any
required recall to minimize damage, including adverse publicity. The
parties shall cooperate, at their own expense, in effecting any such
recall, subject to credit for return and defective products as provided for
in this Agreement, and shall agree to adjust or share such costs after the
recall is completed or submit the matter to arbitration as provided for in
Article 27 of this Agreement.
12. REGULATORY APPROVALS.
a. ASAHI shall be responsible for, and shall bear the cost of
obtaining requisite government approvals to manufacture and market
SYSTEMS in Japan. THERMO shall provide assistance as provided above.
b. ASAHI agrees that it shall conform to the good manufacturing
practice and performance standards and other requirements of the Japanese
Authorities that are applicable to the manufacture and distribution of
products covered by this Agreement in Japan. ASAHI will deliver to THERMO
the following information and corroborative data on their manufacturing and
testing of the AUTO-CRYO KIT:
<circle>Materials used in the AUTO-CRYO KIT
<circle>Biocompatibility testing that is in compliance
with Tripartite Guidance
<circle>Labeling
<circle>Intended Use
<circle>Characterization of the Cryoprecipitate
<circle>Sterilization Data
13. ASAHI MARKETING EFFORT. ASAHI agrees to proceed with diligence and
use its reasonable efforts to develop manufacturing capability for the
AUTO-CRYO KIT and to commercialize and market the SYSTEM in Japan. In this
connection, ASAHI agrees that, within 90 days from the execution of this
contract, ASAHI will present to THERMO a comprehensive marketing plan
incorporating the elements set forth in Exhibit A and Exhibit B annexed
hereto but with such modifications that ASAHI deems are appropriate in
light of the circumstances and consistent with the undertaking contained in
the preceding sentence. Such marketing plan shall identify the marketing
strategies and resources committed to the development of the Japanese
market for the SYSTEM. ASAHI also agrees that it will:
a. Advise THERMO on a quarterly basis of the progress toward
established sales goals and next period goals for the SYSTEM. THERMO
agrees that this information is confidential to ASAHI and that THERMO and
its employees will not disclose it to others.
b. Designate a domestic marketing manager, employed by ASAHI,
who will assume responsibility for the SYSTEM and the implementation of the
marketing plan therefore.
c. Prepare sales and technical literature and other information
for product promotion and surgeon use of the SYSTEM in patient
applications. THERMO shall assist in assuring technical accuracy of all
such information. THERMO will provide, to the extent available,
accumulated materials relative to its products, competitor*s products, and
plasma component technology in general.
14. SELL BACK OF THE AUTO-CRYO KIT. ASAHI agrees, upon terms and
other standard conditions to be agreed upon by the parties, to sell the
AUTO-CRYO KIT or any component of the kit to THERMO at a price which is
equivalent to ASAHI'S purchasing price from its vendor plus ten percent
(10%).
15. TERM AND TERMINATION.
a. This Agreement, unless terminated or canceled as otherwise
provided herein, shall remain in full force and effect for an initial term
from the effective date hereof to the date five (5) years after the
availability date of the System to ASAHI. ASAHI shall have the option to
renew this Agreement for successive five-year terms upon written notice to
THERMO mailed at least 90 days prior to the expiration of the initial term
and each subsequent renewal term; provided, however, that ASAHI shall have
no right to renew this Agreement in the event that either party hereto has
exercised a right of termination or cancellation hereunder.
b. THERMO shall have the right to terminate the Agreement in
the event that ASAHI's total sales fall more than 25% less than the sales
projections in Exhibit B, or that ASAHI fails to fulfill its obligations in
Sections 3, 13 and 14 of this Agreement. For the purpose of the sales
projection in Exhibit B, Year 1 is defined as a year from the date of
reimbursement approval on the AUTO-CRYO KIT by the MHW. The sales
projection for Years 2 through 5 shall be reviewed and agreed upon by the
parties within six (6) months prior to the end of each subsequent year.
c. ASAHI may terminate this Agreement upon the failure of
THERMO to fulfill its obligations under Sections 2, 4, 5 and 6 of this
Agreement.
d. In the event that ASAHI shall at any time fail to make
payments, render reports, or otherwise abide by the conditions herein
provided, THERMO shall have the right to notify ASAHI of such default and
that THERMO intends to terminate this Agreement unless such default is
corrected. unless such default shall be corrected by ASAHI within 90 days
from the receipt by it of such notice, then, and in such event, this
Agreement and the license and right granted by it shall thereupon
automatically terminate.
e. In the event that ASAHI shall go into liquidation, or seek
the benefit of any bankruptcy or insolvency act, or a receiver or trustee
is appointed for the property or estate of ASAHI, or ASAHI makes an
assignment for the benefit of creditors, and whether any of the aforesaid
events be the outcome of the voluntary act of ASAHI or otherwise, this
Agreement and the license and rights granted hereby thereby automatically
terminate.
f. In the event that THERMO shall go into liquidation, or seek the benefit
of any bankruptcy or insolvency act, or a receiver or trustee is appointed
for the property or estate of THERMO, or THERMO makes an assignment for the
benefit of creditors, and whether any of the aforesaid events be the
outcome of the voluntary act of THERMO or otherwise, this Agreement and the
license and rights granted hereby thereby may be terminated by ASAHI.
g. The termination of this Agreement for any reason shall be
without prejudice to THERMO's right to receive all payments accrued and
unpaid at the effective date of such termination pursuant to the provisions
of Article 3 hereof as to periods prior to termination and to the remedy of
either party hereto in respect of any previous breach of any of the
covenants herein contained.
h. Upon termination of this Agreement, ASAHI shall have no
right to manufacture or have manufactured and market the SYSTEMS except
that ASAHI may dispose of inventory on hand. The termination of this
Agreement for any reason shall not, however, terminate or affect any
sublicense therefore granted by ASAHI pursuant to the provisions of Article
2 hereof (except to the extent any such sublicense shall have been granted
on terms providing for its termination with any termination of ASAHI's
rights hereunder) and ASAHI shall, upon termination of this Agreement,
assign to THERMO all of ASAHI's rights and obligations in and under such
sublicenses and THERMO shall assume the same.
16. EFFECT OF TERMINATION. Upon termination of this Agreement for any
reason, all royalty obligations shall cease to accrue except for the
disposition of the inventory in hand, and the parties understand and agree
to the following:
a. ASAHI shall immediately discontinue all activities relating to the
System, Container, Device, Applicators, Auto-Cryo Kit and the Licensed
Patents, except that those activities pertaining to sublicenses granted by
ASAHI under this Agreement may continue in effect upon THERMO'S written
consent.
b. The provisions of Sections 8, 9, 14, 15, 17 and 18 shall survive any such
termination.
c. All monies owed by ASAHI to THERMO shall become immediately due and
payable notwithstanding any credit terms that may previously have been made
available, and Licensee's obligation to make such payments shall survive
the termination of this Agreement.
17. NON-CIRCUMVENTION OF RIGHTS. ASAHI acknowledges THERMO's
proprietary ownership in the SYSTEM, AUTO-CRYO KIT, LICENSED PATENTS,
INTELLECTUAL PROPERTY RIGHTS, and KNOW HOW, and represents and warrants
that it will not take any action that will circumvent such ownership, or
lessen the worth of such ownership. ASAHI further represents, warrants,
and agrees that is shall not take any action, directly or indirectly, which
would challenge the validity of the Licensed Patents or THERMO's ownership
therein.
18. TITLE, PROPRIETARY RIGHTS, TRADE SECRETS AND COPYRIGHTS. The SYSTEM,
AUTO-CRYO KIT, DEVICE, LICENSED PATENTS, and KNOW HOW, including any
copyright, patent, and other intellectual rights therein, are and shall at
all times remain the property of THERMO, including any derivative products
developed or conceived by ASAHI during the term of this Agreement. ASAHI
agrees to deliver all derivative works, if any, to THERMO as soon as
practicable, and further agrees to execute such additional documentation as
may reasonably be required to insure ownership remains with THERMO.
19. UNFORESEEN OCCURRENCES. Neither party to this Agreement shall be
liable for any delay or failure of performance that is the result of any
happening or event that could not reasonably have been avoided or that is
otherwise beyond its control. Such happenings or events shall include, but
not be limited to: fire, flood, explosion, action of the elements,
inability to obtain or shortage of material, equipment or transportation,
governmental orders, regulations, restrictions, priorities or rationing,
acts of God, accidents and strikes, lockouts or other labor trouble or
shortage.
20. CONFIDENTIALITY. During the term of this Agreement, including
any renewals under Article 15(a) and for a period of five (5) years
thereafter or for ten (10) years after the effective date hereof, whichever
is longer, each party agrees that the technology constituting the
Intellectual Property Rights and any information that comes into its
possession as a result of this Agreement about the business of the other
that is not generally available to the public shall be kept confidential
except to the extent necessary for the commercialization of the SYSTEMS.
Public disclosure of the existence of this Agreement shall be determined by
the legal disclosure requirements of the securities laws governing either
THERMO or ASAHI.
21. NOTICES. All notices and consents hereunder shall be in writing
and shall be deemed to have been properly given and to be effective on the
date of delivery if delivered in person, by one-day courier service or by
facsimile transmission (provided a copy is sent by one-day courier service)
to the respective address of facsimile number provided below or to such
other address or facsimile number as either party shall designate by
written notice to the other in such manner:
If to ASAHI: If to THERMO:
Mr. Kunio Ohno Philip H. Coelho
Asahi Medical Co., Ltd. ThermoGenesis Corporation
The Imperial Tower 11431 - A Sunrise Gold Circle
1-1, Uchisaiwaicho 1-Chome Rancho Cordova, CA 95742-6511
Chiyoda-ku, Tokyo 100, Japan Phone: (916) 638-8357
Phone: 03-3507-2610 Fax: (916) 635-5802
Fax: 03-3507-2492
22. SUCCESSORS AND ASSIGNS. This Agreement shall be binding upon and
inure to the benefit of the parties hereto and their respective successors
and assignees; provided, however, that neither of the parties hereto may
assign or transfer its rights or obligations hereunder without the prior
written consent of the other party hereto.
23. ENTIRE AGREEMENT. This Agreement supersedes all prior
agreements, understandings, representations, and statements, if any,
regarding the subject matter contained herein, whether oral or written
(with the exception of the confidential disclosure agreement signed by
ASAHI and THERMO on April 17, 1996 (Exhibit C) and no amendment of this
Agreement shall be valid and binding upon the parties unless made in
writing and signed on behalf of each of such parties by their respective
authorized officers.
24. GOVERNING LAW. This Agreement shall be construed and interpreted
in accordance with the laws of the State of California.
25. SEVERABILITY OF PROVISIONS. If any provision or provisions of
this Agreement shall be held to be illegal, invalid or unenforceable, the
validity, legality and enforceability of the remaining provisions shall not
in any way be affected or impaired thereby.
26. WAIVER OF DEFAULT. The waiver of any default under this
Agreement by either party shall not constitute a waiver of any rights for
any subsequent default.
27. FORUM AND JURISDICTION OF DISPUTES. In the event of any dispute
arising in connection with this Agreement, the parties will endeavor to
negotiate a mutually satisfactory solution. If such solution cannot be
reached, the dispute shall, at either party's advance written demand, be
finally settled by arbitration in accordance with the rules of Conciliation
and Arbitration of the International Chamber of Commerce. THERMO and ASAHI
shall each appoint one arbitrator and these two arbitrators shall appoint
the third. If the two arbitrators cannot agree on the third arbitrator, he
shall then be appointed in accordance with such Rules. The arbitration
shall take place: i) in Sacramento, California, if the arbitration is
demanded by ASAHI; or ii) in Tokyo, Japan, if the arbitration is demanded
by THERMO. The arbitration shall be held in the English language.
IN WITNESS WHEREOF, the parties have executed this agreement as of the
day and year first above written.
ASAHI THERMO
By: ___________________________ By: ___________________________
Title: ___________________________ Title: ___________________________
Date: ___________________________ Date: ___________________________
<PAGE>
EXHIBIT A
DISTRIBUTOR PRICING
ITEM PRICE US QTY.
CRYOSTAT-1 $18,000 1-11
$16,000 12-24
$15,000 25+
CRYOSPRAY APPLICATOR TBA TBA
CRYOLINE APPLICATOR TBA TBA
<PAGE>
EXHIBIT B
ASAHI SALES PROJECTIONS
TERM SALES
YEAR 1 TO BE NEGOTIATED
YEAR 2 "
YEAR 3 "
YEAR 4 "
YEAR 5 "
<PAGE>
EXHIBIT C
CONFIDENTIAL NON-DISCLOSURE AGREEMENT
