AMENDMENT TO DISTRIBUTION AND MANUFACTURING LICENSE AGREEMENT
This Amendment (the "Amendment") to the Distribution and Manufacturing License
Agreement (the "Agreement") entered into on May 29, 1996 by and between
THERMOGENESIS CORP., a Delaware corporation ("THERMO") and Asahi Medical Co.,
Ltd., a Japanese corporation ("ASAHI") is effective this 21st day of June 1999
("Effective Date").
The second and third paragraphs of Witnesseth of the Agreement shall be amended
as follows:
WHEREAS, THERMO represents that is has filed Application for Letters Patent of
United States as set forth in the Agreement and subsequent thereto for
Fibrinogen Processing Apparatus Method and Container, and Apparatus and Method
of Preparation of Stable, Long Term Thrombin from Plasma and Thrombin Formed
Thereby, all of which are listed on the "confidential" schedule attached to this
Amendment, covering said inventions and is preparing an additional patent
application for Method of Preparation of Stable, Long Term Thrombin from Plasma
and Thrombin thereby (the "Patent Applications"), 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 disposable
processing"Containers" and the distribution rights to the thermodynamic "Device"
and "Applicators" respecting said inventions and in the case of the occurrence
of certain events, manufacturing rights to the thermodynamic "Device" and the
"Applicators" additionally.
In consideration for the promises and subject to the conditions set forth in
this Amendment, the parties mutually agree to amend the Agreement as follows:
A. The definitions contained in Section 1 of the Agreement shall be amended
to read as follows:
1. Definitions
-----------
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 and/or CP-2 which consists
of CP-1 connected to ATAK and Applicators that embody 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", and the CP-2;
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 (if any) and
Applicators;
h. "Licensed Patents" shall mean (i) the Patent Application and
any Letters Patent filed in Japan (including any reissues or
extensions thereof that may
2
issue on any of the Patent Applications related to the
System or ATAK, and any other Application that at any time
which 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 related to the System or ATAK 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
j. "ATAK" shall mean the sterile disposable apparatus which
contains appropriate chemicals and allows for the activation
of prothrombin and for the extraction of thrombin from human
plasma.
B-1 Section 2.a shall read in its entirety as follows:
x. Xxxxx of Rights. THERMO grants to ASAHI the right and
license, with rights to grant sublicenses as provided below,
i)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.
ii)to manufacture or have manufactured the Device and the
Applicators in Japan and the unrestricted right, free of
additional charge, to market and distribute the Device,
the Auto-Cryo Kit including Applicators in Japan in case
of the occurrence of certain events set forth in section
15.f of the Amendment.
B-2 Section 2.c and 2.e of the Agreement shall be amended as follows:
c. Technical Support. THERMO shall make available to ASAHI, all
technical and other information in its possession at any
time during the term of this Agreement relating to the
manufacture of the Containers, including specifications and
quality control information. THERMO shall, during the period
from the date of ASAHI's request to the date 12 months
thereafter, make available to ASAHI the services of such
personnel of THERMO as THERMO deems necessary, or as
reasonably requested by ASAHI, for up to 100 hours of
technical support during that period, provided however, that
such time shall not exceed sixty (60) hours of time during
any calendar quarter and provided that ASAHI gives THERMO at
least thirty (30) days advance notice of the need for such
time and provides THERMO with a report of the work
assistance needed. Thereafter, during the term of this
Agreement, in order to reasonably assist ASAHI in its
efforts to manufacture or have manufactured the Auto-Cryo
Kit (with the exception of the Applicators), THERMO shall
provide technical assistance as the parties may agree. When
THERMO personnel are in Japan at the request of ASAHI, the
living and travel expenses from the U.S. to Japan, and back
to the U.S., will be paid by THERMO during the initial 12
month period. After the initial 12 month period, THERMO will
3
make available technical and support assistance, as may be
requested by ASAHI and agreed to by THERMO pursuant to
THERMO's then standard rates and charges, including travel
and accommodation.
e. Clinical Data, Test Material and Advertising Materials.
THERMO shall provide to ASAHI sales, marketing and technical
assistance and Auto-Cryo Kit, Device and Applicators
training and support that THERMO deems appropriate to enable
ASAHI to localize, as defined in the Agreement, the
Auto-Cryo Kit, Device and Applicators, and for ASAHI 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 in English, as prepared by THERMO and
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, but not limited to, all
information exchanged with FDA, within two weeks of receipt
from FDA or submission to FDA) and related information
available to THERMO in order to assist ASAHI in obtaining
governmental approvals for the System.
B-3 The following new section shall be added to the Paragraph 2 of the
Agreement:
h. Manufacturing Information. THERMO shall, within sixty (60)
days following execution of this Amendment, enter into an
arrangement with Tashiro Patent Office in Japan to hold a
certified duplicate copy of all technical and other
information relating to the manufacture of the Device and
Applicators, including specifications, drawings and quality
control information ("Technical Documentation"), which shall
in turn be delivered by the Tashiro Patent Office to ASAHI
upon the occurrence of events stated in Section 15.f of this
Amendment, as certified by the parties. The Technical
Documentation shall be updated by additional certified
copies of current information by THERMO annually on or
before August 30 of each year. ASAHI shall pay for all
storage and holding fees charged by Tashiro Patent Office
for holding the Technical Documentation. In addition to the
foregoing, and following the occurrence of an event stated
in Section 15.f, THERMO shall from time to time, and as
resources are available, make available to ASAHI the
services of such personnel of THERMO as THERMO deems
necessary in order to assist ASAHI in its efforts to
manufacture or have manufactured the Device and Applicators.
THERMO will make available technical and support assistance,
as may be requested by ASAHI and agreed to by THERMO
pursuant to THERMO's then standard rates and charges,
including travel and accommodation.
i. FDA Approval
i) THERMO shall make its best efforts to obtain FDA approval
to market the System containing ATAK and shall submit
periodic reports to show the status and progress of the
development of ATAK to ASAHI at least once
4
every calendar quarter, beginning with the first full
calendar quarter following execution of this Amendment.
ii) THERMO shall submit to FDA an application to market the
System containing ATAK promptly upon completion of
clinical trials and review of trial outcomes and
preparation of submission, but in no event later than
three (3) years after the Effective Date of this
Amendment.
j. Clinical Trial(s) and Governmental Approval in Japan. ASAHI
shall have sole responsibility for diligently conducting
preclinical and clinical trial(s) and shall diligently make
all regulatory submissions necessary for the approval of the
right to market and to receive the reimbursement of the
System in Japan and THERMO shall cooperate with ASAHI for
such trial(s) and regulatory submissions upon reasonable
requests by ASAHI. ASAHI shall purchase the Devices and
Auto-Cryo Kit from THERMO for preclinical and clinical
trial(s) in Japan at pricing as shown in the attached
confidential Exhibit D and THERMO shall provide such
materials upon ASAHI's request for shipment to ASAHI as
scheduled by THERMO. In addition to the foregoing, ASAHI
shall cooperate with THERMO in establishing pre-clinical
protocol for assay of thrombin components extracted with the
ATAK, and shall submit to THERMO the pre-clinical data
collected by ASAHI. THERMO shall pay incremental costs for
such data and formatting of such data as outlined in the
confidential attached Exhibit D.
C-1 Section 3.a. of the Agreement shall be modified to read as follows:
a. License and Distribution Fee. ASAHI previously paid a
non-refundable manufacturing and distribution license fee to
THERMO of net $400,000 US by wire transfer as provided in
Section 3.a of the Agreement. By this Amendment, ASAHI shall
pay THERMO an additional manufacturing and distribution
license fee of a lump sum payment of gross ** [Redacted:
Removed for confidential treatment pursuant to SEC Rule
24b-2 under separate filing] ** for the rights granted to
ASAHI by THERMO set forth in Section B-1 of this Amendment.
The license fee shall be paid by ASAHI and received by
THERMO no later than June 30, 1999, by wire transfer
separate from the wire transfer for the purchase of the
common shares defined below.
C-2 The following paragraph shall be added to Paragraph 3 of the Agreement.
J. Shares. ASAHI shall purchase common shares ("Shares") of
THERMO equivalent to US$700,000, the aggregate number of
shares to be based upon the closing price of THERMO's stock
on June 23, 1999. ASAHI shall purchase the shares of common
stock by wire transfer of the US$700,000 purchase price
which must be sent by separate wire transfer from the
license fee defined above and received by THERMO no later
than June 30, 1999. THERMO represents and warrants to ASAHI
that the shares issued pursuant to this section are or will
be duly authorized, validly and fully paid, and
5
non-assessable shares, free and clear of all liens, claims
and encumbrances of any kind. ASAHI represents that it will
acquire the Shares for investment for its 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, as amended ("1933 Act"). ASAHI
understands that the Shares have not been registered under
the 1933 Act, by reason of a specific exemption therefrom,
which exemption depends upon, among other things, the bona
fide nature of ASAHI's investment intent as expressed
herein. ASAHI further acknowledges and understands that the
Shares are "restricted securities" within the meaning of SEC
Rule 144 and may not be resold unless they are subsequently
registered under the 1933 Act or an exemption from such
registration is available. ASAHI further acknowledges and
understands that THERMO is under no obligation to register
the Shares. ASAHI is aware of the provisions of Rule 144
promulgated under the 1933 Act, which, in substance, permits
limited public resale of "restricted securities" (acquired
directly or indirectly, from the issuer thereof or from an
affiliate of such issuer, in a non-public offering) subject
to the satisfaction of certain conditions, including, among
other things: (i) the availability , in certain cases, of
certain public information about the issuer; (ii) the resale
occurring not less than one (1) year after the party has
purchased and paid for the securities to be sold; and (iii)
in the case of an affiliate, or a non-affiliate who has held
the restricted securities for less than two (2) years, the
sale being made through a broker in an unsolicited "broker's
transaction" or in transactions directly with a market maker
(as such term is defined under the Securities Exchange Act
of 1934) and limited to certain amounts as specified in Rule
144.
D-1 Section 6.a.3 shall be amended to read as follows:
a.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 and prepare the
thrombin solution through activation of prothrombin to
thrombin by appropriate chemicals and apparatus and
extraction of thrombin from donor's plasma 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 purposes for the System, or warrant that
the System is fit or intended for any particular use or
intended purpose.
D-2 The following new paragraph shall be added to the Paragraph 8 of the
Agreement:
6
b. The Grant of Exclusive License on the Licensed Patents
Whenever the Licensed Patents are issued in Japan, ASAHI
shall, in the name of THERMO but at ASAHI's own cost and
expense, have the right to have the grant of the Exclusive
License set forth in the article 77 of Japanese Patent Law
on the Licensed Patents registered with the Japanese Patent
Office and THERMO shall cooperate with ASAHI to register the
grant of the Exclusive License on the Licensed Patents. In
this Amendment, the Exclusive License shall mean "SENYO
JISSIKEN" set forth in the article 77 of the Japanese Patent
Law, of which the grant, transfer (except those by
inheritance or other general succession), modification or
extinguishment (except those resulting form a merger or the
extinguishment of the patent right) of which, or a
restriction on the disposal thereof shall be of no effect
unless they are registered.
E. Section 15.f of the Agreement shall be amended to read as follows:
15.f Suspensive Condition.
(1) 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 as a consequence THERMO becomes
unable to supply the Device and/or the Applicators to
ASAHI, and whether any of the aforesaid events be the
outcome of the voluntary act of THERMO or otherwise, and
such action or appointment remains undismissed for 120
days, THERMO shall grant to ASAHI the right to manufacture
the Device and Applicators for distribution in Japan and
THERMO, shall, as debtor in possession, take all
appropriate actions to transfer the information from
Tashiro Patent Office, located at 2-16, Xxxxxxxxx 0-xxxxx,
Xxxxxx-xx, Xxxxx 000-0000 Xxxxx, to ASAHI for the required
manufacture of the Device and the Applicators. In case of
the occurrence of certain events set forth in this section
15.f (1), ASAHI may manufacture the Device and/or
Applicators, subject to royalty payments for each product
manufactured and in the percentages set forth in Section
3.d of the Agreement. As long as ASAHI manufactures
Devices and/or Applicators, ASAHI may not terminate the
Agreement for the reasons set forth in this Section
15.f(1) and (2). When THERMO re-establishes the ability to
supply the Devices and/or Applicators, ASAHI shall have a
choice either (a) to continue to manufacture the Devices
and/or Applicators; or (b) purchase Devices and/or
Applicators from THERMO under the terms and conditions of
the Agreement; or elect to do both.
(2) Following certification from THERMO of Device and/or
Applicators completion and availability through standard
production, if at any time THERMO shall be unable to
provide ASAHI with the Device and/or Applicators within 90
days of the originally promised shipment date for the
7
Device and/or Applicators THERMO, shall grant to ASAHI the
right to manufacture the Device and Applicators for
distribution in Japan and THERMO, shall take all
appropriate actions to transfer the information from
Tashiro Patent Office, located at 2-16, Xxxxxxxxx 0-xxxxx,
Xxxxxx-xx, Xxxxx 000-0000 Xxxxx, to ASAHI for the required
manufacture of the Device and the Applicators. In case of
the occurrence of such event set forth in this section
15.f(2), ASAHI may manufacture the Device and/or
Applicators, subject to royalty payments for each Device
and Applicator sold, and in the percentages set forth in
Section 3.d of the Agreement. As long as ASAHI
manufactures Devices and/or Applicators, ASAHI may not
terminate the Agreement for the reasons set forth in this
Section 15.f(1) and (2). When THERMO re-establishes the
ability to supply the Devices and/or Applicators, ASAHI
shall have a choice either (a) to continue to manufacture
the Devices and/or Applicators; or (b) purchase Devices
and/or Applicators from THERMO under the terms and
conditions of the Agreement; or elect to do both.
F. Effect of modification. Except as modified by this Amendment, the
Agreement remains in full force and effect. Unless otherwise expressly
defined in Section A of this Amendment, all capitalized terms shall have
the meaning ascribed to them in the Agreement.
G. The following Section 28 shall be added to the Agreement:
Except as may be contemplated hereunder, neither party may issue any
press release or make any public announcement concerning the
transactions contemplated by this Agreement without the prior written
consent of the other party, except for any releases or announcements
which may be required by, or in such party's discretion, reasonably
necessary under applicable law, in which case the party proposing to
make such release or announcement will allow the other party a
reasonable opportunity to review and comment on such release or
announcement in advance of such issuance or making. In addition, THERMO
agrees that it will request under the United States securities laws,
including Rule 24b-2 promulgated under the Securities Exchange Act of
1934, as amended, and use its reasonable best efforts to seek,
confidential treatment of certain information contained in this
Agreement.
8
The parties have caused this Amendment to be duly executed in multiple
counterparts by their respective authorized representatives.
THERMOGENESIS CORP. ASAHI MEDICAL CO., LTD.
/s/XXXXXX X. XXXXXX /s/XXXXXXX XXXXX
---------------- --------------
Xxxxxx X. Xxxxxx, Xxxxxxx Xxxxx,
Chairman & CEO President
Dated: ___________________ Dated: ___________________
