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EXHIBIT 10 DISTRIBUTION AND LICENSE AGREEMENT

Distribution Agreement

EXHIBIT 10 DISTRIBUTION AND LICENSE AGREEMENT | Document Parties: Asahi Kasei Medical Co, Ltd THERMOGENESIS CORP You are currently viewing:
This Distribution Agreement involves

Asahi Kasei Medical Co, Ltd THERMOGENESIS CORP

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Title: EXHIBIT 10 DISTRIBUTION AND LICENSE AGREEMENT
Governing Law: California     Date: 3/31/2005
Industry: Scientific and Technical Instr.     Sector: Technology

EXHIBIT 10 DISTRIBUTION AND LICENSE AGREEMENT, Parties: asahi kasei medical co  ltd thermogenesis corp
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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.

----------------

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.

-----------------------------------------

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.

--------------------------------------------

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.

----------------------------------------------

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.

-------------

(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.

-------------------------------------------

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.

---------------------------

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.

-------------------------------------------------

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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