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EXHIBIT 10
DISTRIBUTION AND LICENSE AGREEMENT
This Distribution and Manufacturing License Agreement
("Agreement") is entered
into as of the 28th day of March, 2005 by and between Asahi
Kasei Medical Co.,
Ltd., a Japanese corporation ("ASAHI") with an office and place
of business at
9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo, 101-8482 Japan, and
THERMOGENESIS
CORP., a Delaware corporation, ("THERMO") with an office and
place of business
at 2711 Citrus Road, Rancho Cordova, California, 95742.
WITNESSETH:
WHEREAS, THERMO represents that it owns certain intellectual
property rights
covering certain inventions relating to the design and
manufacture of a
"CryoSeal(R) System" and the Products (defined below) for the
rapid harvesting
of cryoprecipitate and thrombin from human plasma and has the
right to grant the
license herein contained;
WHEREAS, THERMO represents that it has filed patent applications
specified in
Exhibit A (The "Patent Applications") and is preparing
additional patent
applications, all of which either have been and/or will be filed
in the
Territory; and
WHEREAS, ASAHI desires to obtain, and THERMO is willing to grant
certain
manufacturing and distribution rights for the Product (as
defined below);
WHEREAS, the parties executed the "Distribution and
Manufacturing License
Agreement" as of 29th day of May, 1996, as amended by "Amendment
to Distribution
and Manufacturing License Agreement" as of June 21, 1999
("Previous Agreements")
under which THERMO granted to ASAHI the right and license 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 and ASAHI paid to THERMO License and
Distribution Fee
equal to ^Removed pursuant to Rule 24b-2 under the Securities
Exchange Act of
1934^ under Section 3(a) of the Previous Agreements.
WHEREAS, ASAHI purchased common shares of THERMO equivalent to
US$700,000 under
Section 3(j) of the Previous Agreements.
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WHEREAS, Asahi desires to market and obtain distribution and
marketing rights
for the TAD Stand Alone (as defined herein) on a non-exclusive
basis within the
territory;
WHEREAS, THERMO and ASAHI now desire to unify such "Distribution
and
Manufacturing License Agreement" and "Amendment to Distribution
and
Manufacturing License Agreement" into one text and make several
clarifications
and modifications to the terms and conditions thereof.
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.
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As used in this Agreement, the following terms shall have the
meanings
hereinafter set forth:
a. "Applicators" shall mean the hand held devices for mixing and
applying
the cryoprecipitate and thrombin produced by the Processing
Disposable
to the wound site. It is understood each type of applicator
listed in
Exhibit B shall be included in Applicators.
b. "Asian Pacific Rim Countries" means South and North Korea,
Taiwan, the
Philippines, Thailand, Singapore, India and Malaysia.
c. "CryoSeal System" shall mean the system for harvesting
fibrinogen rich
cryoprecipitate and activated thrombin simultaneously from human
plasma
which includes the Device, Processing Disposable, Thrombin
Reagent and
Applicators.
d. "Device" shall mean the thermodynamic device on which the
Processing
Disposable will be placed and which will precisely control and
alter
the temperature of the plasma in order to achieve the separation
and
collection of the cryoprecipitate. It is understood that CS-1
listed in
Exhibit B shall be included in the Device.
e. "Hanging Rack" shall mean the rack to hang Processing
Disposable for
the Device.
f. "Intellectual Property Rights" means the Licensed Patents and
the
Know-How.
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g. "Know-How" shall mean all technical information, secret
processes,
formulae, designs and data relating to the manufacture of the
Product
presently owned by THERMO or acquired by it during the term of
this
Agreement and clinical data and any other technical
information
provided by THERMO to ASAHI hereunder.
h. "Licensed Patents" shall mean; (i) the Patent Applications
and any
corresponding national and regional patent applications with
respect to
the Product in the Territory; (ii) any patent applications with
respect
to the Product in the Territory that are or will be owned or
controlled
by THERMO during the term of this Agreement; (iii) any patent
issued on
the patent applications stated in (i) and (ii); and (iv) any
patent
maturing from (i), (ii) and (iii) including all extensions,
continuations, continuations-in-part or divisions,
reexaminations and
reissues; or equivalent, if any, related to the Product.
i. "Point of Shipment" means THERMO's Rancho Cordova,
California
manufacturing facilities, Kawasumi's manufacturing facility in
Thailand
or the manufacturing facilities designated by THERMO and agreed
by
ASAHI.
j. "Processing Disposable" shall mean the sterile blood
processing
disposable for harvesting fibrinogen rich cryoprecipitate
and/or
activated thrombin from plasma (not including Thrombin Reagent).
It is
understood that CP-3 Disposable, a sterile blood processing
disposable
with TAD, listed in Exhibit B shall be included in the
Processing
Disposable.
k. "Product" shall mean Applicators, Device, Hanging Rack,
Processing
Disposable, TAD, TAD Stand Alone, Thrombin Reagent, and/or
Warming
Tray, including those which are improved or modified. It is
understood
that CryoSeal System shall be included in the Product.
l. "TAD" (Thrombin Activation Device, formerly known as ATAK)
shall mean
the sterile disposable apparatus for the extraction of
activated
thrombin from human plasma except for TAD Stand Alone.
m. "TAD Stand Alone" shall mean the TAD in the form of a product
designed
for stand-alone use or any form other than a part of the
Processing
Disposable. It is understood that TAD Stand Alone includes
Thrombin
Processing Device (TPD) and IC TAD listed in Exhibit B, of
which
specification shall be determined by the parties.
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o. "Territory" shall mean the country of Japan.
p. "Thrombin Reagent" shall mean the reagent for production of
thrombin to
be injected into the TAD or TAD Stand Alone disposables.
q. "Warming Tray" shall mean the device to warm syringes of
cryoprecipitate and/or thrombin in the sterile field.
2. Appointment of Exclusive Distributor.
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THERMO hereby appoints ASAHI as THERMO's exclusive distributor
to market,
distribute and sell the Product except for TAD Stand Alone to be
supplied
by THERMO to all existing and potential customers for any
purpose
including, but not limited to, surgical procedures and
regeneration medical
treatment within the Territory. During the term of this
Agreement, THERMO
may not directly or indirectly market, distribute or sell the
Product
except for TAD Stand Alone within the Territory. ASAHI may
appoint one or
more sub-distributors within any portion of the Territory.
3. Appointment of Non-Exclusive Distributor.
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THERMO hereby appoints ASAHI as THERMO's non-exclusive
distributor to
market, distribute and sell the TAD Stand Alone to be supplied
by THERMO to
all existing and potential customers for any purpose including,
but not
limited to, surgical procedures and regeneration medical
treatment within
the Territory. ASAHI may appoint one or more sub-distributors
within any
portion of the Territory.
4. Clinical Trials and Governmental Approval.
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a. Clinical Trial(s) and Governmental Approval in the Territory.
ASAHI
shall have sole responsibility for conducting preclinical and
clinical
trial(s) and shall make all regulatory submissions for the
approval by
Ministry of Health, Labor and Welfare of Japan ("MHLW") and
supplement
and amendment of such approval necessary for the sale of the
Product
for the application for which ASAHI intends to sell the Product
and
for approval by MHLW to receive the reimbursement of the Product
in
the Territory if available. THERMO shall cooperate with ASAHI
for such
trial(s) and regulatory submissions upon reasonable requests by
ASAHI.
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ASAHI shall purchase the Product from THERMO for preclinical
and
clinical trial(s) in the Territory at market pricing provided
upon
request, if necessary and THERMO shall provide such materials
upon
ASAHI's reasonable request for shipment to ASAHI as scheduled
by
THERMO. All shipping costs and any other special costs arising
from
the express request of ASAHI will be paid by ASAHI.
b. FDA Approval.
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(1) THERMO shall make its best efforts to obtain the United
States
Food and Drug Administration ("FDA") approval to market the
CryoSeal System and shall submit periodic reports to show
the
status to ASAHI at least once every calendar quarter,
beginning
with the first full calendar quarter following execution of
this
Agreement.
(2) THERMO shall submit to FDA an application to market the
CryoSeal
System promptly upon completion of clinical trials and review
of
trial outcomes and preparation of submission.
c. THERMO shall 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 CryoSeal
System.
5. Supply of the Product for Distribution.
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a. After obtaining regulatory approval by MHLW set forth in
Section 4(a),
ASAHI shall purchase from THERMO and THERMO shall supply to
ASAHI the
Product which is listed in Exhibit B for distribution in the
Territory
at pricing to be separately agreed by the parties and to be
shown in
Exhibit B, provided that the parties acknowledge that such
prices set
forth in Exhibit B are based on the estimate of the
reimbursement
prices to be approved by MHLW and agree to review and adjust the
price
set forth in Exhibit B after obtaining the reimbursement
approval by
MHLW. THERMO may have Kawasumi Laboratories, Inc. with its
principle
office of business at 3-28-15, Minami-Oi, Shinagawa-ku,
Tokyo
140-8555, Japan manufacture the Product to be supplied to
ASAHI,
provided that, it is understood that this provision shall not
release
THERMO from its obligations hereunder.
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b. (1) Upon agreement of pricing described in Section 5(a),
ASAHI agrees
to project, and then purchase the minimum quantity of
Processing
Disposable, Applicators and Thrombin Reagent from THERMO as
set
forth on Exhibit C for each YEAR. For the purpose of this
Section, "YEAR" shall mean one (1) year period commencing on
April 1st that comes after the date of reimbursement approval
on
Processing Disposable, Applicators and Thrombin Reagent by
MHLW
and each one (1) year period thereafter. In addition, for
the
purpose of this Section, Processing Disposable, Applicators
and
Thrombin Reagent shall be considered purchased upon the
delivery
under Section 5(d).
(2) The parties acknowledge that the minimum purchase quantity
for
each YEAR set forth in Exhibit C are based on the prices
listed
Exhibit B and agree to review and adjust the minimum
purchase
quantity set forth in Exhibit C if the prices are adjusted.
(3) If ASAHI manufactures by itself Processing Disposable,
Applicators
and/or Thrombin Reagent pursuant to Sections 7(a) and/or 7(f),
the
minimum purchase quantity for a YEAR set forth in Exhibit C
shall
be deducted by the number of units of Processing Disposable,
Applicators and/or Thrombin Reagent manufactured and sold by
ASAHI
in such a YEAR. For the purpose of this Section, Processing
Disposable, Applicators and/or Thrombin Reagent shall be
considered manufactured and sold upon the shipment thereof.
(4) The parties understand that any failure to meet the
minimum
purchase quantity in each Year set forth in Exhibit C due to
any
cause not attributable to ASAHI including, but not limited
to,
THERMO's rejection of ASAHI's order or failure to deliver all
or
part of the Product in accordance with an accepted order shall
not
be deemed ASAHI's breach of this Section and in such case
THERMO
shall have no right to terminate this Agreement pursuant to
Section 20(e).
c. Order and Acceptance. All orders for the Product to be
supplied by
THRMO to ASAHI shall be by means of a signed written purchase
order, in
a form to be furnished by THERMO, which shall be submitted to
THERMO at
THERMO's address for notice purposes set forth in Section 27,
and shall
request a delivery date. Orders may be placed by fax. THERMO
shall make
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its best effort to accept ASAHI's purchase order. THERMO shall
notify
ASAHI in writing of its acceptance or rejection of an order
within
seventy-two (72) hours of receipt. THERMO shall have no
liability to
ASAHI with respect to purchase orders that are rejected by
THERMO
despite its best effort in accordance with the foregoing,
provided
that, THERMO shall accept a purchase order placed ninety (90)
days
before the delivery date.
d. Delivery Term. The delivery term for the Product to be
delivered by
THERMO to ASAHI shall be F.O.B. THERMO Point of Shipment. THERMO
shall
render ASAHI documents and cooperation necessary for the
exportation
and importation of the Product.
e. Invoicing; Payment. THERMO shall submit an invoice to ASAHI
with each
shipment of the Product ordered by ASAHI. Each invoice shall be
due and
payable net thirty (30) days from the date of ASAHI's receipt of
the
Product at ASAHI's facility. All invoices shall be sent to
ASAHI's
address for notice purposes set forth in Section 27, without
regard to
the actual shipping address for the Product. Each such invoice
shall
state ASAHI's aggregate and unit purchase price for the Product
in the
relevant shipment. ASAHI shall make all payments to a bank
account
designated by THERMO.
f. All Product delivered by THERMO to ASAHI pursuant to this
Agreement
shall be suitably packed for surface or air shipment, in ASAHI's
sole
discretion, in THERMO's standard shipping cartons, marked for
shipment
to such location or locations as ASAHI may designate. The
Product
listed in Exhibit B except for Device, Hanging Rack and Warming
Tray
delivered by THERMO to ASAHI pursuant to this Agreement shall
be
sterilized in accordance with applicable laws and regulations
within
ninety (90) days before the delivery. For such sterilization to
occur
on a timely basis, ASAHI acknowledges that the purchase order
should be
placed to THERMO not later than ninety (90) days before the
delivery.
g. The specification of any Product to be supplied to ASAHI by
THERMO
shall be agreed on by the parties and provided to ASAHI by
THERMO. The
specification of such Product or any part of it and the
manufacturing
process for such Product including sterilization process shall
not be
changed unless otherwise agreed by the parties.
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h. Payment Currency. All payments for the price of the Product
due or
payable under this Agreement shall be made in United States
Dollars
("USD"). The parties will meet to negotiate a new price for
items
listed in Exhibit B annually or upon either party's request.
6. Warranty and Liability.
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The warranty for the Product supplied by THERMO to ASAHI under
this
Agreement shall be as provided below:
a. Specific Warranties. THERMO warrants that:
(1) Title. The title to the Product supplied to ASAHI from
THERMO,
when conveyed to ASAHI, shall be good and transferred
rightfully
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 Product 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. The Product supplied to ASAHI 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; and
(4) Unless otherwise provided herein, THERMO does not warrant
the
result of various possible uses or purposes for the Product
or
warrant that the Product 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 Section 6(a)(l), above THERMO
shall
promptly secure removal of any encumbrance on the title. Except
as set
forth in Section 19 below, ASAHI's remedy for a breach of
the
warranties set forth in Sections 6(a)(2) and 6(a)(3) above,
and
THERMO's obligation and liability therefor, are expressly
limited to
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the repair, rework or replacement of any non-conforming Product,
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 Product 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.
c. In case of the Device, THERMO's obligation under Section 6(b)
with
respect to the breach of Section 6(a)(2) and (3) is limited to
defects
becoming apparent within the shorter of (i) two years from the
date of
delivery of the Device from THERMO to ASAHI or (ii)one (1) year
from
the date of installation of the Device at the customer's
premises.
d. THERMO's obligation under Section 6(b) with respect to the
breach of
Sections 6(a)(2) and 6(a)(3) is limited to defects becoming
apparent
within the usable period of the Product approved by MHLW in case
of
the Product which is required to be sterilized pursuant to
the
applicable law in the Territory.
e. THERMO's obligation under Section 6(b) with respect to the
breach of
Sections 6(a)(2) and 6(a)(3) is limited to defects becoming
apparent
within twelve (12) months from the date of delivery of the
Product in
case of any Product other than Device and the Product mentioned
in
Section 6(d).
f. ASAHI shall notify of written notification stating such
particulars as
may reasonably be necessary to notify THERMO of the nature of
the
asserted non-conformance promptly after such defect becomes
apparent,
but in no event later than fifteen (15) days following
expiration of
each period stated in Sections 6(c), (d) and (e). The Product or
parts
or components thereof repaired, reworked, or furnished in
replacement
pursuant to this Section 6(b) shall, upon installation or
delivery to
ASAHI, also be subject to the provisions of this clause to the
same
extent as Product initially delivered or installed.
g. Agreement on Warranties. THERMO and ASAHI agree that Section
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 Product and the other mutual agreements of
the
parties set forth in any contractual documents which incorporate
this
clause; provided, however, that this Section 6 shall not apply
in case
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of product liability claims and the provision for
indemnification
found in Section 19.
7. Grant of Exclusive License and Manufacturing.
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a. Grant of Exclusive License. THERMO hereby grants ASAHI the
exclusive
right and license under the Intellectual Property Right, with
the right
to sublicenses, (i) to use, market, distribute and sell the
Product
(except for TAD Stand Alone, which are provided for in Section 8
below
on a non-exclusive basis) within the Territory, (ii) to
manufacture and
have manufactured the Processing Disposable and Thrombin Reagent
and
any improvement and modification thereof within the Territory,
for any
purpose including, but not limited to, surgical procedures.
During the
term of this Agreement, THERMO may not grant to any third party
a right
or license that conflicts with the right and license granted to
ASAHI
under this Section 7(a) within the Territory.
b. ASAHI agrees that it shall conform to the good manufacturing
practice
and performance standards and other requirements of the MHLW
that are
applicable to the manufacture and distribution of the Product in
the
Territory. ASAHI will deliver to THERMO the following
information and
corroborative data on their manufacturing and testing of
Processing
Disposable and Thrombin Reagent manufactured by ASAHI:
o Materials used in Processing Disposable and Thrombin
Reagent
o Biocompatibility testing that complies with Tripartite
Guidance
o Labeling
o Intended Use
o Characterization of the Cryoprecipitate
and/or thrombin
o Sterilization Data
c. Sell Back of Products. ASAHI agrees, upon terms and other
standard
conditions to be agreed upon by the parties, to sell
Processing
Disposable, Thrombin Reagent and Applicators manufactured by
ASAHI to
THERMO at a price which is equivalent to ASAHI's manufacturing
cost and
transportation and insurance charges plus ^Removed pursuant to
Rule
24b-2 under the Securities Exchange Act of 1934^.
d. 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 Processing
Disposable
and Thrombin Reagent, including specifications and quality
control
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information. THERMO shall, during the period from the date of
ASAHI's
request to the date twelve (12) months thereafter, make
available to
ASAHI the services of such personnel of THERMO as THERMO
deems
necessary, or as reasonably requested by ASAHI, 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 Processing Disposable and
Thrombin
Reagent, THERMO shall provide technical assistance as the
parties may
agree. All technical support to be provided pursuant to this
Section
shall be at ASAHI's expense at THERMO's then standard rates
and
charges, including living and travel expenses from the U.S. to
Japan,
and back to the U.S., if requested by ASAHI.
e. Manufacturing Information. Under Joint Escrow Agreement dated
8th day
of June 2000, executed by THERMO, ASAHI and Tashiro Patent
Office,
located at 2-16, Toranomon 1-chome, Minato-ku, Tokyo 105-0001
Japan
("Tashiro Patent Office")(such agreement shall be referred to
as
"Escrow Agreement"), THERMO shall deposit in Tashiro Patent
Office in
Japan 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
7(f),
as certified by the parties. The Technical Documentation shall
be
updated by additional certified copies of current information by
THERMO
immediately after the execution hereof, annually on or before
August 30
of each year. ASAHI shall pay for all storage and holding fees
charged
by Tashiro Patent
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