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): February 16, 1998.
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.)
3146 GOLD CAMP DRIVE, RANCHO CORDOVA, CA 95670
(Address of Principal Executive Officer)(Zip Code)
Registrant's telephone number, including area code: (916) 858-5100
Item 5. Other
On February 16, 1998, the Company entered into an exclusive Distribution
Agreement (the "Agreement") with Dideco S.p.A., located in Mirandola,
Italy. Pursuant to the Agreement, Dideco S.p.A. will act as the Company's
exclusive distributor in Europe of the Company's CryoSeal System, which
consists of a small, floor-standing thermodynamic machine, a disposable
blood processing plastic container used to harvest cryoprecipitate ("Cryo")
from plasma, and a disposable two-tipped applicator used to apply the Cryo
on wound sites during surgical procedures. The system is designed to
simplify and streamline the harvesting of clotting and adhesive proteins
from a surgical patient's plasma for application during surgical procedures
in Europe.
Under the Agreement, the Company will manufacture and sale the CryoSeal
System to Dideco for distribution in (i) all of Europe west of the Ural
Mountains, including all countries, territories, provinces and other
jurisdictions within the European Union and the other portions of Europe,
including, without limitation, the United Kingdom, France, the Benelux
countries, Germany, Switzerland, Spain, Portugal, Italy, Austria, Greece,
Yugoslavia, Turkey, Hungary, the Czech Republic, Slovakia and the other
countries of Eastern Europe, and Russia and the other countries and
territories that formerly constituted the Union of Soviet Socialist
Republics, and (ii) Israel, but specifically excluding Denmark, Finland,
Norway and Sweden.
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The Agreement is for an initial term of three years, commencing on the date
the Company obtains CE certification for the CryoSeal System and its
components, with provision for annual renewals thereafter. In addition to
distribution, Dideco will also establish service and warranty repair
centers or operations to for the CryoSeal System in the territory.
The Agreement contains certain milestone dates and performance obligations
directed at bringing the product to market as early as possible and
Dideco's maintenance of exclusivity. The Agreement also grants Dideco a
future right to obtain a manufacturing license for the plastic disposable
container used with the system for Europe upon meeting certain sales
threshold and satisfaction of other conditions, including payment of
license fees.
Dideco S.p.A., a part of the SORIN Biomedical Group active in various
medical device areas, such as cardiovascular, hemodialysis and blood
banking, is a leader in the manufacture and distribution of advanced
medical devices, and has a large base of presently installed
autotransfusion devices in the European Operating theater.
Item 7(c). Exhibits.
10. Distribution Agreement by and between THERMOGENESIS CORP. and Dideco
S.p.A entered into and effective February 16, 1998. Portions of the
Distribution Agreement have been omitted pursuant to a request for
confidential treatment.
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: February 26, 1998 By:
Philip Coelho, Chief Executive Officer
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EXCLUSIVE INTERNATIONAL DISTRIBUTION AGREEMENT
THIS EXCLUSIVE INTERNATIONAL DISTRIBUTION AGREEMENT is made and entered
into as of the 16th day of February, 1998 (this "Agreement"), between
THERMOGENESIS CORP., a Delaware corporation ("THERMO"), and DIDECO S.P.A., a
company organized under the laws of Italy ("Distributor").
R E C I T A L S
A. THERMO designs, manufactures (directly or indirectly through manufacturing
subcontractors) and sells medical devices and other products which utilize
its proprietary thermodynamic and/or "fibrin glue" technology for the
processing of biological substances, including the cryopreservation,
thawing and harvesting of blood components.
B. THERMO has designed and developed the Cryoseal System<trademark> (as such
System may be improved, enhanced, upgraded or otherwise modified from time
to time, the "Cryoseal System"), which currently consists of a small,
floor-standing thermodynamic machine, a disposable blood processing
plastic container which harvests cryoprecipitate ("Cryo") from plasma and
a disposable two-tipped applicator used to apply the Cryo on wound sites
during surgical procedures. The Cryo harvested by the Cryoseal System is
referred to as "Cryosealant," and THERMO believes that Cryo might become
an alternative to the commercial tissue sealant known as "fibrin glue."
C. Distributor is engaged, either directly or indirectly through its
Affiliates and other Persons, in the business of designing, developing,
manufacturing, distributing and selling medical devices and other products
worldwide.
D. THERMO is currently in the process of applying to TUV Rheinland, one of
the European Union regulatory authorities responsible for implementing the
Medical Device Directive, to obtain the right to place CE Marks on the
Products initially listed in EXHIBIT A and to be distributed and sold by
Distributor within the European Union.
E. THERMO desires to appoint Distributor as its exclusive distributor of the
Cryoseal System, including the Products that are the components thereof,
and, when developed, the Autologous Thrombin System, within the Territory,
and Distributor is willing to accept such appointment, all on the terms
and subject to the conditions set forth in this Agreement.
F. In addition, THERMO desires to grant to Distributor, and Distributor is
willing to accept, an option to acquire the exclusive right and license to
make, have made, market, use, sell and otherwise dispose of the CP-1
within the Territory, on the terms and conditions set forth in the
Manufacturing License Agreement.
A G R E E M E N T
NOW, THEREFORE, in consideration of the foregoing, and for other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, on the terms and subject to the conditions set forth herein, the
parties hereby agree as follows:
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1. DEFINITIONS.
When used herein, the following capitalized terms shall have the following
meanings:
"Additional Products" has the meaning set forth in Section 2.8.
"Affiliate" means, in respect of any specified Person, any other Person which,
but only for so long as such other Person, directly or indirectly, controls, is
controlled by, or is under common control with, such specified Person. The
term "control" means the possession, directly or indirectly, of the power to
direct or cause the direction of the management or policies of a Person,
through the ownership of voting securities or other equity interests, and the
terms "controlled" and "common control" have correlative meanings.
"Affiliated Parties" means, in respect of any specified Person, the Affiliates,
directors, officers, employees, agents and representatives of such Person.
"Agreement" has the meaning set forth in the preamble.
"Applicable THERMO Technology" means the Patent Rights and all Know-how
relating to the Cryoseal System or the Autologous Thrombin System.
"Autologous Thrombin System" means a system currently being developed by THERMO
relating to the preparation of autologous or allogenic thrombin from a
patient's own plasma, as such system is developed, improved, enhanced, upgraded
or otherwise modified from time to time.
"CE Mark" means the "CE Mark" referenced in the Medical Device Directive and
required to be placed on medical devices (including, without limitation, the
Products) to be sold in the European Union after June 14, 1998.
"Confidential Information" has the meaning set forth in Section 9.1.
"CP-1" has the meaning set forth in EXHIBIT A.
"Cryo" has the meaning set forth in the recitals.
"Cryoseal System" has the meaning set forth in the recitals.
"CS-1" has the meaning set forth in EXHIBIT A.
"Customers" has the meaning set forth in Section 2.1.
"Distributor" has the meaning set forth in the preamble.
"Entitlement Date" means the first date upon which THERMO (or its designated
original equipment manufacturer (OEM)) is entitled to place its (or its OEM's)
CE Mark on all of the Products initially listed on EXHIBIT A.
"FDA" means the United States Food and Drug Administration, or any successor
agency.
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"Know-how" means any and all current and future know-how, technical
information, technical knowledge, unpatentable inventions, manufacturing
procedures, methods, trade secrets, processes, formulas, documentation and
other tangible or intangible property or rights relating to the Cryoseal System
or the Autologous Thrombin System, whether or not capable of precise separate
description but which alone, or when accumulated, gives to the Person acquiring
it an ability to study, test, formulate, manufacture, produce or market
something which it otherwise would not have known to study, test, formulate,
manufacture, produce or market in the same or similar way.
"Manufacturing License Agreement" means a manufacturing license agreement
between THERMO and Distributor, substantially in the form of EXHIBIT D.
"Manufacturing Option" has the meaning set forth in Section 11.1.
"Medical Device Directive" means European Union Council Directive 93/42/EEC of
June 14, 1993, concerning medical devices, as the same may be amended,
supplemented, modified or replaced from time to time.
"Notice Date" has the meaning set forth in Section 11.3(b).
"Patent Rights" means any and all patents and patent applications existing now
or in the future relating to the Cryoseal System or the Autologous Thrombin
System, as the same may be amended, supplemented or otherwise modified from
time to time, and any renewals, continuations, continuations-in-part,
divisions, reissues, examinations or extensions of any of the foregoing, and
any corresponding foreign patents and patent applications, and any patents
(whether foreign or domestic) issuing from any of the foregoing applications.
**[REDACTED: REMOVED FOR CONFIDENTIAL TREATMENT PURSUANT TO SEC RULE 24B-2]**
"Person" means any natural person or any corporation, partnership, limited
liability company, business association, joint venture or other entity.
"Products" means the devices, products and related components and accessories,
whether patented or unpatented, manufactured or distributed by or on behalf of
THERMO and relating to the Cryoseal System or the Autologous Thrombin System,
including, without limitation, the devices, products and related components and
accessories listed on EXHIBIT A, together with all improvements, modifications,
enhancements and upgrades to any of the foregoing. The parties hereby
acknowledge and agree that from time to time Products may be discontinued by
THERMO and therefore may be removed from EXHIBIT A, and that, pursuant to
Section 2, Additional Products may be added to EXHIBIT A and become subject to
the terms and conditions of this Agreement. THERMO agrees that any Products
that may be removed from EXHIBIT A will not be sold by THERMO or any other
Person within the Territory during the term of this Agreement. In addition,
THERMO agrees to make available to Distributor for distribution within the
Territory hereunder any improved, modified, enhanced or upgraded device,
product, component or accessory that replaces any discontinued Product, and
such device, product, component or accessory will be treated as a Product
hereunder.
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"Subdistributor" has the meaning set forth in Section 2.2(a).
"Territory" means (i) all of Europe west of the Ural Mountains, including all
countries, territories, provinces and other jurisdictions within the European
Union and the other portions of Europe, including, without limitation, the
United Kingdom, France, the Benelux countries, Germany, Switzerland, Spain,
Portugal, Italy, Austria, Greece, Yugoslavia, Turkey, Hungary, the Czech
Republic, Slovakia and the other countries of Eastern Europe, and Russia and
the other countries and territories that formerly constituted the Union of
Soviet Socialist Republics, but specifically excluding Denmark, Finland, Norway
and Sweden, and (ii) Israel.
"THERMO" has the meaning set forth in the preamble.
"THERMO COMMON STOCK" means the common stock, par value US$.001 per share, of
THERMO (as such class of securities may be increased, decreased or exchanged
for or converted into a different number or kind of securities as a result of
any reorganization, merger, consolidation, recapitalization, reclassification,
dividend or other distribution, stock split, reverse stock split or the like).
"THERMO Marks" means any and all trademarks, trade names, service marks,
service names, logos and similar proprietary rights owned, controlled or
licensed by THERMO and currently used or to be used in connection with the
Cryoseal System or the Autologous Thrombin System.
"THERMO Shares" has the meaning set forth in Section 11.3(a).
"THERMO's Point of Shipment" means THERMO's Rancho Cordova, California
manufacturing facilities or the manufacturing facilities of the OEM designated
by THERMO in writing.
2. DISTRIBUTION RIGHTS.
2.1 APPOINTMENT AS EXCLUSIVE DISTRIBUTOR. THERMO hereby appoints Distributor
as THERMO's exclusive distributor to market, distribute and sell the Cryoseal
System, including the Products that are the components thereof, and, when
developed, the Autologous Thrombin System, to all existing and potential
customers ("Customers") within the Territory. During the term of this
Agreement, neither THERMO nor any other Person (other than Subdistributors
appointed by Distributor) may, directly or indirectly, exercise, license or use
any of the exclusive rights granted to Distributor herein (PROVIDED, HOWEVER,
that THERMO may conduct clinical studies or trials within the Territory with
respect to the Products upon prior written notice to, and consultation with,
Distributor).
2.2 APPOINTMENT OF SUBDISTRIBUTORS.
(a) Distributor may appoint one or more Persons to act as a subdistributor
(each a "Subdistributor" and, collectively, the "Subdistributors") within any
portion of the Territory and assign to such Subdistributor any and all of
Distributor's rights hereunder, and delegate to such Subdistributor any and all
of Distributor's obligations hereunder, with respect to any Subdistributor's
portion of the Territory. Distributor may appoint only one Subdistributor
within any portion of the Territory. Notwithstanding any such appointment,
Distributor shall remain responsible for the performance by any Subdistributor
of Distributor's obligations within such Subdistributor's portion of the
Territory.
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(b) Pursuant to its rights under Section 2.2(a), Distributor hereby appoints
the Persons listed on EXHIBIT B as Subdistributors under this Agreement. The
appointment of any additional Person as a Subdistributor under this Agreement
shall be subject to the prior written approval of THERMO.
2.3 TRADEMARK LICENSE. In addition, THERMO hereby grants to Distributor and
its Subdistributors the non-exclusive, royalty-free right and license to use
all THERMO Marks in connection with the marketing, distribution, sale and post-
sale field service, technical assistance and support of the Products.
Distributor agrees not to alter, obliterate, deface or remove any THERMO Marks
displayed on any Product or its packaging, or add any name, brand or trademark
thereto without the prior written consent of THERMO. Notwithstanding the
foregoing, "Dideco S.p.A." and/or Dideco's trademarks may be displayed on
Product packaging, and the parties shall reasonably cooperate with one another
to ensure that all Product packaging and labelling prepared by THERMO or its
designated OEM complies with applicable law. Except as provided in this
Agreement, nothing herein shall grant to Distributor or any of its
Subdistributors any right, title or interest in the THERMO Marks, which right,
title and interest shall be vested in THERMO. Distributor shall notify THERMO
if, during the term of this Agreement, Distributor becomes aware of any other
Person who is using any trademark, trade name, service mark, service name or
logo that is substantially or confusingly similar to those owned or used by
Distributor pursuant to the authority granted by THERMO hereunder.
2.4 RESERVATION OF TITLE. THERMO reserves to itself and retains all right,
title and interest in and to the Applicable THERMO Technology and to any
modifications, enhancements, improvements and upgrades thereto. Except as
otherwise provided in the Manufacturing License Agreement, Distributor may not
duplicate, translate, decompile, reverse engineer or adapt the Products without
THERMO's prior written consent.
2.5 OTHER DISTRIBUTORS. THERMO shall forward to Distributor all inquiries or
requests for information regarding, or purchase orders for, Products from
Persons within the Territory. THERMO shall not sell Products to any Person
outside of the Territory that THERMO knows or should have known intends to ship
the same to Persons within the Territory. Notwithstanding the foregoing,
nothing in this Agreement shall prevent any authorized distributor of THERMO
located in a member state of the European Union that is not part of the
Territory from making passive sales into the Territory, nor shall anything in
this Agreement prohibit Distributor from accepting passive sales orders for
Products from Persons located in member states of the European Union that are
outside of the Tively seeking customers for Products outside of the Territory
or has not established a branch office or does not maintain a warehouse
primarily for the purpose of seeking customers for Products outside the
Territory.
2.6 NO OTHER RIGHTS. Except as expressly provided in this Agreement, no
right, title, or interest is granted by THERMO to Distributor hereunder.
Subject to Section 2.8, THERMO may distribute products other than Products and
Additional Products within the Territory, either directly or indirectly through
distributors, and no right, title or interest is granted by THERMO to
Distributor relating to such products.
2.7 CE MARKS. THERMO shall satisfy, or shall cause its designated OEM to
satisfy, all requirements necessary under the Medical Device Directive to place
its CE Mark, or the CE Mark of its designated OEM, on each of the Products
initially listed on EXHIBIT A, and, with respect to each such Product, THERMO
or its designated OEM must be entitled under the Medical Device Directive to
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place its CE Mark on such Product no later than June 14, 1998. Without
limiting the generality of the foregoing, THERMO shall prepare, maintain and
provide to Distributor a copy of the "Technical Documentation File" for each
Product on or before April 15, 1998, to facilitate Distributor's compliance
obligations for market vigilance under the Medical Device Directive with
respect to Products sold within the European Union. In addition, THERMO shall
keep Distributor informed periodically and at Distributor's request of the
status of its and its designated OEM's efforts to become qualified to place
CE Marks on the Products.
2.8 ADDITIONAL PRODUCTS.
(a) Subject to the terms and conditions of this Section 2.8, THERMO hereby
grants to Distributor, and Distributor hereby accepts, the right of first
refusal to distribute, market and sell exclusively to Customers within the
Territory any additional devices, products and related components and
accessories manufactured by or on behalf of THERMO prior to or after the date
hereof and available, or expected to be made available, for commercial use
(hereinafter referred to as an "Additional Product"); PROVIDED, HOWEVER, that
Distributor may not exercise the right of first refusal granted to it under
this Section 2.8(a) until the date upon which Distributor is deemed to have
exercised the Manufacturing Option under Section 11.
(b) THERMO shall give Distributor prompt written notice at least six (6)
months prior to THERMO's projected launch date of any Additional Product.
Distributor shall furnish written notice to THERMO within sixty (60) days from
the date of its receipt of such written notice from THERMO of Distributor's
acceptance or non-acceptance of the addition of such Additional Product as a
Product hereunder. If Distributor delivers timely a written notice to THERMO
accepting the addition of such Additional Product, Distributor shall become the
exclusive distributor of such Additional Product within the Territory and such
Additional Product shall constitute a Product hereunder (and be added (or
deemed to be added) to EXHIBIT A). The initial price of any Additional Product
to be purchased hereunder will be subject to negotiation between the parties;
PROVIDED, HOWEVER, that if the parties are unable to agree upon a price for
such Additional Product, the initial price will be equal to the lesser of
(a) seventy-five percent (75%) of THERMO's U.S. retail list price, if any,
established by THERMO for such Additional Product and (b) the lowest price
being paid or to be paid by any other THERMO distributor at any time for such
Additional Product. Distributor shall promote each accepted Additional Product
within the Territory in accordance with the terms of this Agreement, PROVIDED,
HOWEVER, that the parties will use their commercial best efforts to agree upon
minimum purchase requirements for such Additional Product as soon as
practicable after the date that Distributor delivers a written notice of
acceptance of such Additional Product, but no later than the date upon which
THERMO (or its designated OEM) obtains the right to place its CE Mark on such
Additional Product (which THERMO shall bear the responsibility of obtaining).
(c) In the event Distributor does not deliver a written notice of acceptance
of such Additional Product within the sixty (60) day period set forth in
Section 2.8(b), THERMO shall be free to seek other means of distributing such
Additional Product within the Territory.
3. TERMS OF PURCHASE OF PRODUCTS.
3.1 TERMS AND CONDITIONS. All purchases of Products hereunder shall be
subject to the provisions of this Agreement. Unless otherwise agreed in
writing, nothing contained in any purchase order submitted pursuant to this
Agreement shall in any way modify or add any provision to this Agreement. In
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the event of a conflict between the terms of any purchase order and the
provisions of this Agreement, the provisions of this Agreement shall govern.
3.2 PRICES. All prices for Products purchased by Distributor hereunder shall
be F.O.B., THERMO's Point of Shipment. The initial price to Distributor for
each Product is set forth opposite such Product in EXHIBIT A, and such initial
price will remain fixed for the period commencing on the Entitlement Date and
ending on the second anniversary of the Entitlement Date. Thereafter, the
purchase price to Distributor for such Product may be increased or decreased by
THERMO upon not less than ninety (90) days' prior written notice to
Distributor, PROVIDED, HOWEVER, that in no event shall the purchase price of
any Product at any time exceed the lesser of (a) seventy-five percent (75%) of
THERMO's U.S. retail list price, if any, established by THERMO for such Product
and (b) the lowest price being paid at such time or to be paid by any THERMO
distributor for such Product.
3.3 CERTAIN TAXES. The parties acknowledge that the purchase prices of
Products set forth in EXHIBIT A do not include any sales, excise, use, value
added or other government taxes or duties that may be applicable to the export,
import or purchase of the Products, and Distributor agrees that it will bear
all such taxes and duties. When THERMO has the legal obligation to collect
and/or pay such taxes or duties, the appropriate amount shall be added to
Distributor's invoice and paid by Distributor to THERMO, unless Distributor
provides THERMO with a valid tax exemption certificate authorized by the
appropriate governmental taxing authority. Notwithstanding anything to the
contrary, THERMO shall be solely liable for all income and income-based taxes
imposed on THERMO under applicable law, which taxes shall be the sole
responsibility of THERMO, and Distributor may withhold or deduct such taxes
from payments made to THERMO if required under applicable law.
3.4 ORDER AND ACCEPTANCE. All orders for Products 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 12.4, and shall request a delivery date. Orders may be placed by
telephone, facsimile transmission or, upon the parties' agreement, on THERMO's
Web-Site; PROVIDED, HOWEVER, that a signed confirming purchase order is
received by THERMO ten (10) business days after a telephonic or facsimile
order. No order shall be binding upon THERMO until accepted by THERMO in
writing, and THERMO shall accept or reject an order within 72 hours of its
receipt. THERMO shall have no liability to Distributor with respect to
purchase orders that are not accepted. Notwithstanding anything to the
contrary, all orders for Products placed by Distributor shall be accorded by
THERMO at least equal priority and treatment with orders placed by other
Persons (including, without limitation, THERMO's other distributors).
3.5 INVOICING; PAYMENT. THERMO shall submit an invoice to Distributor with
each shipment of Products ordered by Distributor. Each invoice shall be due
and payable net sixty (60) days from the date of invoice. All invoices shall
be sent to Distributor's address for notice purposes set forth in Section 12.4,
without regard to the actual shipping address for the Products. Each such
invoice shall state Distributor's aggregate and unit purchase price for
Products in the relevant shipment, plus any freight, taxes or other costs
incident to the purchase or shipment initially paid by THERMO and to be borne
by Distributor hereunder. Distributor shall make all payments to THERMO under
this Agreement in United States dollars in immediately available funds to a
bank account designated by THERMO in such invoice.
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3.6 SHIPPING; RISK OF LOSS.
(a) All Products delivered by THERMO pursuant to this Agreement shall be
suitably packed for surface or air shipment, in Distributor's sole discretion,
in THERMO's standard shipping cartons, marked for shipment to such location or
locations as Distributor may designate, and delivered to Distributor or its
carrier, F.O.B., THERMO's Point of Shipment. Risk of loss of Products shall
pass to Distributor upon delivery to the carrier at the F.O.B. point of
shipment. All Products shipped by THERMO hereunder shall have affixed to it
and bear its (or its OEM's) CE Mark in accordance with the Medical Device
Directive which shall be in a visible, legible and indelible form on the
Products or its sterile pack, and on the instructions for use. Where
applicable, the CE Mark shall appear on the sales packaging for the Products.
(b) THERMO shall ship all Products in accordance with Distributor's delivery
instructions specified in Distributor's purchase orders; PROVIDED, HOWEVER,
that if Distributor does not provide delivery instructions with respect to the
carrier to be used, THERMO may use its customary carrier. All freight,
insurance and other shipping expenses, as well as any special packing expenses,
shall be paid by Distributor. Distributor shall also bear all applicable taxes
and duties that may be assessed against the Products after delivery to the
carrier F.O.B., THERMO's Point of Shipment.
(c) THERMO shall use its commercial best efforts to deliver all Products
ordered by Distributor in accordance with the requested delivery dates
indicated in Distributor's purchase orders; PROVIDED, HOWEVER, that such
purchase orders are submitted at least ninety (90) days prior to the requested
delivery date. All orders for Products placed by Distributor shall be accorded
at least equal priority and treatment with orders placed by other Persons
(including, without limitation, THERMO's other distributors). All shipments of
Pss THERMO receives from Distributor, no later than sixty (60) days after the
receiving date of a given shipment, written notice specifying the shipment, the
purchase order number and the exact nature of the discrepancy between the
shipment and the order. All freight charges shall be deemed correct unless
THERMO receives from Distributor, no later than sixty (60) days after the
receiving date of a given shipment, written notice specifying the shipment, the
purchase order number and the exact nature of the discrepancy in the freight
cost. THERMO shall issue an explanation of the charges or a credit to
Distributor's account within thirty (30) days of receipt of any such written
notice from Distributor.
4. WARRANTIES; REMEDIES FOR NON-CONFORMING PRODUCTS.
4.1 THERMO warrants to Distributor and the Subdistributors that (a) with
respect to the CS-1, such Product conforms to the written specifications
contained in the Operator's Manual and/or Service Manual for such Product and
is free from defects in material and workmanship under normal and proper use in
accordance with applicable instructions for a period equal to the lesser of
(i) two (2) years from the date of shipment or (ii) one (1) year from the date
such device is placed in service, and (b) with respect to all other Products,
such Product is free from defects in material and workmanship during the shelf
life of such Product, PROVIDED, HOWEVER, that, in the case of clauses (a) and
(b), the warranty periods shall be no less than that prescribed by applicable
law.
4.2 In the event that any Product purchased hereunder is defective or fails to
conform to the warranties set forth in Section 4.1, THERMO will (a) with
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respect to the CS-1, repair or replace, at THERMO's election, such defective or
non-conforming Product, PROVIDED that Distributor is unable to repair such
defective or non-conforming Product at one of Distributor's warranty service
centers located within the Territory, and (b) with respect to any other
Products, replace the defective or non-conforming Product. Any Product returns
must be assigned a Return Authorization number. To obtain a Return
Authorization number for any Products to be returned, Distributor shall notify
THERMO of the description of such Product, the quantity to be returned, the
reason for the return and the date of its original purchase. The Return
Authorization number shall be displayed on the outside of the shipping box and
the Product shall be suitably packed to prevent damage. All Product returns
shall be sent directly to THERMO, insured by Distributor, the Subdistributor or
its Customer. All cost and expenses reasonably incurred in connection with the
return of any defective or non-conforming Product shall be reimbursed by
THERMO.
4.3 DISCLAIMER OF OTHER WARRANTIES. EXCEPT AS PROVIDED IN THIS AGREEMENT,
THERMO MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, AS TO THE PERFORMANCE OF
PRODUCTS OR AS TO SERVICE TO DISTRIBUTOR OR TO ANY OTHER PERSON. THERMO
SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS
FOR A PARTICULAR PURPOSE.
4.4 CUSTOMER WARRANTIES. Distributor and its Subdistributors shall pass on to
their Customers the Product warranties set forth in Section 4.1, a copy of
which Product warranties will be included in THERMO's packaging of the
Products.
5. ADDITIONAL OBLIGATIONS OF DISTRIBUTOR.
5.1 COMPLIANCE WITH LAWS. Distributor shall comply in all material respects
with the laws and regulations (including, without limitation, health and safety
regulations) applicable to the marketing, distribution and sale of Products
within the Territory. Distributor shall monitor the appropriate information
sources in the Territory for material changes in such laws and regulations
relating to the distribution of Products within the Territory and notify THERMO
in writing of all such material changes.
5.2 CLINICAL TRIALS. Distributor may, at its expense, organize and conduct
clinical trials that Distributor believes is reasonably necessary to market,
distribute and sell the Products within the Territory, it being understood that
Distributor may determine that it is not economically feasible to conduct
clinical trials in all countries within the Territory. Distributor shall
promptly notify THERMO of any clinical trials conducted by Distributor within
the Territory, and THERMO will cooperate with any clinical design measures or
other requirements reasonably requested by Distributor. All data collected
from, and written reports prepared with respect to, such clinical trials shall
be furnished to THERMO for its review and use as it deems reasonably
appropriate.
5.3 REGISTRATIONS, LICENSES AND PERMITS (OTHER THAN CE MARKS). Except as
provided in Section 2.7 with respect to the CE Marks, if and as required from
time to time under the laws of any country within the Territory, Distributor
shall, at its expense, apply for and use its commercially reasonable efforts to
obtain all registrations, licenses and permits that Distributor deems necessary
to market, distribute and sell the Products within such country. THERMO shall
reasonably cooperate with Distributor in connection with Distributor's efforts
to obtain such registrations, licenses and permits. Distributor shall furnish
to THERMO copies of all applications, and all registrations, licenses and
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permits obtained therefrom, for the Products. Upon the expiration or earlier
termination of this Agreement and except as otherwise required by Distributor
to perform its obligations under the Manufacturing License Agreement, such
registrations, licenses and permits shall be transferred to THERMO or to a
Person reasonably designated by THERMO, to the extent permitted by the terms of
such registrations, licenses or permits and by applicable law, and THERMO shall
reimburse Distributor for the expenses reasonably incurred to transfer the
same.
5.4 PROMOTION OF PRODUCTS; ADVERTISING.
(a) The parties acknowledge and agree that Distributor is and will be under no
obligation to market, distribute or sell any Products until the Entitlement
Date. Thereafter, Distributor shall use its good faith commercially reasonable
efforts to promote the sale of the Products within the Territory. Distributor
shall advertise and otherwise promote the Products in a commercially reasonable
manner and furnish appropriate Product information and promotional materials to
its Customers. Distributor shall sell the Products under the THERMO Marks
and/or other trademarks or trade names by which they are labeled (which
labelling shall be mutually agreed upon by the parties). Distributor may not
add any trade names or trademarks to the Products (other than Distributor's
name and trademarks) without the prior written consent of THERMO.
(b) Distributor may refer to and advertise itself as an"Authorized Distributor"
of the Products within all or any portion of the Territory, and may
indicate on its stationery, business cards or other printed materials that it
is an "Authorized Distributor" of Products and, subject to THERMO's prior
approval, may have THERMO Marks imprinted thereon.
5.5 MINIMUM PURCHASES. Distributor agrees to purchase from THERMO the minimum
number of units of each Product as set forth on EXHIBIT C during each of the
four calendar quarters commencing in the calendar quarter during which the
Entitlement Date occurs. Thereafter, the parties shall use their respective
good faith commercially reasonable efforts to agree on new minimum purchase
requirements hereunder for each of the next four calendar quarter periods (or
such lesser period), which negotiations shall commence no later than
ninety (90) days prior to end of the then-current four-calendar quarter period.
If the parties are unable to reach an agreement on new minimum purchase
requirements, such requirements shall be based on the purchase forecasts
furnished by Distributor to THERMO under Section 5.6. Notwithstanding the
foregoing, Distributor shall be under no obligation to purchase any CP-1's
hereunder from and after the date upon which Distributor has obtained the right
to place its CE Mark on the CP-1 for sale within the European Union, as
contemplated by the Manufacturing License Agreement.
5.6 PURCHASE FORECASTS. Distributor acknowledges that THERMO must enter into
long-term commitments for materials to complete the manufacture of Products to
be purchased by Distributor hereunder. Accordingly, within twenty (20)
business days following the Entitlement Date and, thereafter, within ten (10)
business days following the last day of each calendar quarter during the term
of this Agreement, Distributor shall furnish to THERMO a tentative, non-binding
forecast for Distributor's purchase requirements of Products during the
immediately succeeding four (4) calendar quarters.
5.7 QUARTERLY SALES REPORTS. Distributor shall furnish to THERMO, no later
than the tenth business day following the end of each calendar quarter during
the term of this Agreement, sales data as may be reasonably requested by THERMO
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for each of the Products distributed within the Territory during such calendar
quarter.
5.8 FACILITIES AND INVENTORY; REPAIR AND REPLACEMENT PARTS STOCK. Distributor
shall maintain sufficient Product inventory, essential spare parts, warehousing
and distribution facilities and warranty service centers within the Territory
to fulfill adequately the reasonable needs of its Customers for Products and to
service the CS-1. Distributor shall purchase THERMO's standard "Repair and
Service Parts Package" which currently consists of components that may require
replacement in the normal course of installation and service of the CS-1. In
addition, Distributor shall purchase replacement parts for all Products used on
a monthly basis to ensure that Distributor may timely respond to requests from
Customers for replacement parts.
5.9 TRANSLATION OF MATERIALS. Distributor shall bear the cost of preparing
sales literature and other promotional materials for the Products in the local
country languages of the Territory, and shall arrange and pay for the
translation of all service and operator manuals for the Products as may be
necessary, in Distributor's judgment, for the sale of Products in the
Territory. Distributor shall reimburse THERMO for any expenses reasonably
incurred by it prior to the date hereof for such translation.
5.10 MARKET RESEARCH. Distributor shall assist THERMO in assessing customer
requirements for the Products, including modifications and improvements
thereto, in terms of quality, design, functional capability and other features.
Distributor shall advise THERMO on market conditions as reasonably requested by
THERMO.
5.11 OTHER INFORMATION REPORTING.
(a) Distributor shall provide to THERMO, at Distributor's expense, (i) within
three (3) calendar days (or such other time period as required under applicable
FDA regulations) after Distributor becomes aware of any death, serious injury
or suspected serious injury relating to the Products, detailed information
relating to Customer complaints concerning death, serious injury or suspected
serious injury, and (ii) within five (5) days (or such other time period under
applicable FDA regulations) after Distributor becomes aware of any other
Customer complaint relating to the Products, detailed information relating to
such other Product complaints from Customers. Such information shall be
provided in English and shall include, without limitation, any and all follow-
up information as such follow-up information becomes available to Distributor.
(b) Distributor shall provide to THERMO, at Distributor's expense and in
English, each and every quality and/or service complaint within thirty (30)
business days after receipt of such complaint by Distributor.
5.12 CONSEQUENCES OF FAILURE TO REPORT. If Distributor fails to submit in a
timely manner any report described in Section 5.11 and fails to cure within
thirty (30) days of written notice by THERMO, THERMO may withhold Product
shipments hereunder until the report is received by THERMO.
5.13 POST-SALE FIELD SERVICE, TECHNICAL ASSISTANCE AND SUPPORT; WARRANTY
SERVICE. Subject to this Section 5.13, Distributor shall provide to its
Customers post-sale field service, technical assistance and support for
Products sold by Distributor in the Territory. At the request of Customers,
Distributor shall (a) install and service the CS-1, (b) perform all required
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inspections of installation and required service of the CS-1, as applicable,
and (c) timely respond to Customer calls and claims with respect to the
Products. If Distributor performs any post-sale warranty service for its
Customers during the warranty period for any Product, THERMO shall reimburse
Distributor for the costs and expenses reasonably incurred by Distributor in
performing such service (PROVIDED that if such warranty service is performed in
the European Union, such expenses shall be based on customary "tariff"
charges). The cost of any field service or other support for any Product
performed by Distributor after the expiration of the applicable warranty period
for such Product shall be agreed upon between Distributor and its Customers.
Distributor shall furnish to THERMO copies of any written reports prepared by
Distributor with respect to warranty repairs made by Distributor to the CS-1.
5.14 MARKET VIGILANCE. Following the Entitlement Date, Distributor shall, in
accordance with the Medical Device Directive, prepare and maintain during the
term of this Agreement the "Device Master Record" for market vigilance with
respect to the Products sold in the Territory.
5.15 U.S. EXPORT CONTROLS. Distributor understands and acknowledges that
THERMO is subject to regulation by agencies of the United States Government,
including, without limitation, the United States Department of Commerce and the
FDA, which prohibit export or diversion of certain products and technology to
certain countries. Any and all obligations of THERMO to provide the Products,
documentation, or any media in which any of the foregoing is contained, as well
as any other technical assistance shall be subject in all respects to such
United States laws and regulations as shall from time to time govern the
license and delivery of technology and products abroad by Persons subject to
the jurisdiction of the United States, including the Export Administration Act
of 1979, as amended, any successor legislation, and the Export Administration
Regulations issued by the Department of Commerce, Bureau of Export
Administration. Distributor agrees to cooperate with THERMO, including,
without limitation, providing required documentation, in order to obtain export
licenses or exemptions therefrom.
6. ADDITIONAL OBLIGATIONS OF THERMO.
6.1 COMPLIANCE WITH LAWS. THERMO shall comply, and shall cause its designated
OEM to comply, in all material respects with all laws and regulations within
the Territory and the United States applicable to the manufacture, labelling,
packaging and sale of the Products. Without limiting the generality of the
foregoing, THERMO shall manufacture, and shall cause its designated OEM's to
manufacture, all Products in accordance with "Quality Systems Regulations"
(QSR's) and other applicable laws, rules and regulations.
6.2 PRO PURPOSES, (A) 100 CP-1'S, (B) 100 CRYOSEAL SYSTEM AP-1 DISPOSABLE
APPLICATORS, (C) 50 CRYOSEAL SYSTEM DT-1 DISPOSABLE DOT TIP APPLICATORS, (D) 50
CRYOSEAL SYSTEM DISPOSABLE ST-1 DISPOSABLE SPRAY TIP APPLICATORS AND
(E) TWO (2) CS-1'S (ONE OF WHICH, AS OF THE DATE HEREOF, HAS BEEN DELIVERED TO
DISTRIBUTOR).
6.3 PROMOTIONAL MATERIALS. THERMO, at THERMO's expense, shall provide to
Distributor reasonable quantities of Product sales literature, advertising and
promotional materials and point-of-purchase materials (I.E., product displays)
in English that have been prepared by or on behalf of THERMO. In addition,
THERMO shall cooperate with Distributor in preparing promotional materials for
use in the Territory.
6.4 TRADE SHOWS. THERMO shall send a representative of THERMO, at THERMO's
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expense, to the major international meeting trade shows for products that are
similar to the Products, including the International Society of Blood and
Transfusion (ISBT), the European Society for Hemapheresis (ESPH) and the
European Association of Cardiothoracic Surgeons (EACTS).
6.5 SUPPORT. THERMO, at THERMO's expense, shall provide consultation to
Distributor concerning technical aspects and use of the Products from time to
time as reasonably requested by Distributor.
6.6 SCIENTIFIC AND TECHNICAL INFORMATION. THERMO shall provide to Distributor
scientific and technical information available to THERMO and required for
distribution to obtain any registrations, licenses and permits required for the
sale and distribution of the Products within the Territory, or to respond to
inquiries from Customers, or governmental or regulatory authorities.
6.7 TRAINING. THERMO shall provide Product training for Distributor's product
managers and field service personnel on an as-needed basis to enable
Distributor to promote the sale of Products and to perform post-sale field
service, technical assistance and support for its Customers. Without limiting
the generality of the foregoing, within sixty (60) days following the date
hereof, at least one of Distributor's product managers or sales representatives
shall be trained by THERMO in the marketing, installation and servicing of the
Products. Such training shall be conducted, at THERMO's election, at THERMO's
Rancho Cordova, California facilities or at Distributor's Mirandola, Italy
facilities, and will be provided without charge to Distributor; PROVIDED,
HOWEVER, that all out-of-pocket expenses incurred by Distributor's personnel
while attending such training in California, including travel and housing
expenses, shall be borne by Distributor, or such out-of-pocket expenses
reasonably incurred by THERMO to send a training representative to
Distributor's facilities in Italy shall be reimbursed by Distributor. In
addition, THERMO will provide Product updates and service bulletins as they
become available.
6.8 INFORMATION REPORTING. THERMO shall provide to Distributor, at THERMO's
expense, (a) information regarding any discovered defects in the Products, or
any malfunction or deterioration in the performance of the Products, (b) any
inadequacy in the labeling or the instructions for use which might lead to or
might have led to the death of a patient or user or to a serious deterioration
in his state of health, (c) within three (3) calendar days (or such other time
period as required under applicable FDA regulations) after THERMO becomes aware
of any death, serious injury or suspected serious injury relating to the
Products, detailed information relating to Customer complaints concerning
death, serious injury or suspected serious injury and (d) within five (5) days
(or such other time period under applicable FDA regulations) after THERMO
becomes aware of any other Customer complaint relating to the Products,
detailed information relating to such other Product complaints from customers.
6.9 MAINTENANCE OF PATENTS AND TRADEMARKS. THERMO shall, at its own cost and
expense, apply for, prosecute, register, maintain and renew all Patent Rights
and THERMO Marks within the European Union (and, if necessary, all countries
within the European Union) and Israel, and Distributor shall cooperate with
THERMO with respect to the same at THERMO's reasonable request. In addition,
THERMO shall, at its own cost and expense, apply for, prosecute, register,
maintain and renew all Patent Rights and THERMO Marks in such other portions of
the Territory as THERMO may determine in its reasonable judgment, and
Distributor shall cooperate with THERMO with respect to the same at THERMO's
reasonable request. In the event that THERMO elects to abandon or otherwise
not maintain any Patent Rights or THERMO Marks, it shall furnish to Distributor
at least ninety (90) days' prior written notice before the expected date of
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abandonment or non-maintenance, and furnish to Distributor all information
reasonably necessary and appropriate relating to such Patent Rights or THERMO
Marks. Distributor may pursue the maintenance and renewal of such Patent
Rights or THERMO Marks in THERMO's name, in which event THERMO shall reimburse
Distributor for such costs and expenses (or Distributor may deduct such costs
and expenses from any payments due to THERMO hereunder or under the
Manufacturing License Agreement). Notwithstanding anything to the contrary,
THERMO will not at any time do or permit to be done any act or thing that would
in any way impair the rights of Distributor in and to the Patent Rights or the
THERMO Marks, or which would adversely affect the validity of the Patent Rights
or THERMO Marks.
6.10 RESPONSIBLE PERSON. THERMO shall notify the TUV Rheinland and the
competent authorities of the member states of the European Union within the
Territory that it has designated Distributor as the person responsible for the
marketing and distribution of the Products within the Territory, and
Distributor's address for notice purposes in Section 12.4 shall be the
registered place of business for such purposes.
7. REPRESENTATIONS AND WARRANTIES OF THE PARTIES.
7.1 THERMO. THERMO hereby represents and warrants to Distributor that:
(a) THERMO is a corporation duly incorporated, validly existing and good
standing under the laws of the State of Delaware, and has all corporate power
and authority to own, lease and operate its properties and to carry on its
businesses as it is currently being conducted. THERMO has all necessary
corporate power and authority to enter into this Agreement and to perform its
obligations hereunder. This Agreement has been duly authorized, executed and
delivered by THERMO.
(b) The execution, delivery and performance by THERMO of this Agreement and
the consummation of the transactions contemplated hereby do not violate or
conflict with the Certificate of Incorporation or Bylaws of THERMO, any
material contract, agreement or instrument to which THERMO is a party or by
which it or its properties are bound, or any judgment, decree, order or award
of any court, governmental body or arbitrator by which THERMO is bound, or any
law, rule or regulation applicable to THERMO.
(c) THERMO is the sole, exclusive and lawful owner of all right, title and
interest in and to the Applicable THERMO Technology incorporated in the
Cryoseal System and the Autologous Thrombin System and to the THERMO Marks,
free and clear of all liens, claims, security interests or other restrictions
or encumbrances. THERMO has not granted to any other Person any license,
franchise or other rights to acquire, use or exploit the Applicable THERMO
Technology within the Territory (or any portion thereof). THERMO has the right
to grant the distribution and other rights to Distributor hereunder, without
the consent of any other Person.
(d) (i) To the best knowledge of THERMO, all patents, patent applications and
provisional patent applications constituting the Applicable THERMO Technology
are currently in compliance with all formal legal requirements and are valid
and enforceable, (ii) none of the Applicable THERMO Technology has been or is
currently involved in any interference, reissue, re-examination or opposition
proceeding, (iii) to the best knowledge of THERMO, there is no potentially
interfering patent, patent application or provisional patent application of any
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Person with respect to the Applicable THERMO Technology, (iv) to the best
knowledge of THERMO, no patent, trade secret or know-how that constitutes
Applicable THERMO Technology is being infringed or has been challenged or
threatened in any way, and (v) to the best knowledge of THERMO, the marketing,
distribution and sale of the Products does not and will not infringe upon the
rights of any third party. There is no pending or, to its knowledge,
threatened claim, suit, action or other proceeding involving a claim that the
manufacture or sale of the Cryoseal System infringes or violates the
intellectual property rights of any other Person.
7.2 DISTRIBUTOR. Distributor hereby represents and warrants to THERMO that:
(a) Distributor is a company duly organized and existing under the laws of
Italy, and has all power and authority to own, lease and operate its properties
and to carry on its businesses as currently conducted. Distributor has all
necessary power and authority to enter into this Agreement and to perform its
obligations hereunder. This Agreement has been duly authorized, executed and
delivered by Distributor.
(b) The execution, delivery and performance by Distributor of this Agreement
and the consummation of the transactions contemplated hereby do not violate or
conflict with the Certificate of Incorporation or Bylaws of Distributor, any
material contract, agreement or instrument to which Distributor is a party or
by which it or its properties are bound, or any judgment, decree, order or
award of any court, governmental body or arbitrator by which Distributor is
bound, or any law, rule or regulation applicable to Distributor.
(c) Distributor and its Affiliates have the distribution facilities and
personnel reasonably necessary to perform its functions and otherwise carry out
its obligations under the terms of this Agreement.
8. TERM AND TERMINATION.
8.1 TERM. The term of this Agreement shall commence on the date hereof and
shall continue until the third anniversary of the Entitlement Date, unless
earlier terminated pursuant to Section 8.2. This Agreement shall be renewed
automatically for successive one (1) year periods unless either party gives the
other written notice of its election to terminate this Agreement at least
ninety (90) days prior to the expiration of the then-current term of this
Agreement.
8.2 TERMINATION OF AGREEMENT. This Agreement may be terminated as follows:
(a) The parties may terminate this Agreement upon their mutual written
agreement.
(b) THERMO may terminate this Agreement if Distributor breaches any of its
material representations, warranties, covenants or obligations under this
Agreement and such breach continues for a period of sixty (60) days following
Distributor's receipt of written notice from THERMO setting forth the nature of
such breach; PROVIDED, HOWEVER, that in the event such breach is not cured
within such sixty (60) day period, THERMO may not terminate this Agreement if
Distributor promptly commences to cure such breach within such sixty (60) day
period and thereafter diligently pursues such cure to completion; PROVIDED
FURTHER, HOWEVER, that the cure period for any such breach shall not exceed
ninety (90) days from the date of Distributor's receipt of written notice from
THERMO.
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(c) Distributor may terminate this Agreement if THERMO breaches any of its
material representations, warranties, covenants or obligations under this
Agreement and such breach continues for a period of sixty (60) days following
THERMO's receipt of written notice from Distributor setting forth the nature of
such breach; PROVIDED, HOWEVER, that in the event such breach is not cured
within such sixty (60) day period, Distributor may not terminate this Agreement
if THERMO promptly commences to cure such breach within such sixty (60) day
period and thereafter diligently pursues such cure to completion; PROVIDED
FURTHER, HOWEVER, that the cure period for any such breach shall not exceed
ninety (90) days from the date of THERMO's receipt of written notice from
Distributor.
(d) Either party may terminate immediately this Agreement by written notice
upon the occurrence of any of the following events: (i) the other party is or
becomes insolvent or unable to pay its debts as they become due within the
meaning of the United States Bankruptcy Code (or any successor statute) or any
analogous foreign statute; or (ii) the other party appoints or has appointed a
receiver for all or substantially all of its assets, or makes an assignment for
the benefit of its creditors; or (iii) the other party files a voluntary
petition under the United States Bankruptcy Code (or any successor statute) or
any analogous foreign statute; or (iv) the other party has filed against it an
involuntary petition under the United States Bankruptcy Code (or any successor
statute) or any analogous foreign statute, and such petition is not dismissed
within ninety (90) days.
8.3 EFFECT OF TERMINATION.
(a) The expiration or earlier termination of this Agreement shall not
relieve any party of any of its rights or liabilities arising prior to or
upon such expiration or earlier termination.
(b) Within ten (10) business days following the effective date of the
expiration or earlier termination of this Agreement, Distributor shall
provide to THERMO a complete inventory of Products in Distributor's
possession, in transit between Distributor's authorized locations or in
transit to Distributor from THERMO or otherwise in Distributor's control.
THERMO may inspect Distributor's Product inventory and audit Distributor's
records in the manner provided hereinabove.
(c) Notwithstanding the expiration or earlier termination of this
Agreement, Distributor may continue to market, distribute and sell
Products within the Territory after the expiration or earlier termination
of this Agreement until the earlier of (i) the date that Distributor has
sold all of its Product inventory existing as of the effective date of
expiration or earlier termination and (ii) the six (6) month anniversary
of the effective date of expiration or earlier termination.
8.4 RETURN OF MARKETING MATERIALS. Distributor shall return to THERMO all
promotional materials for Products previously furnished by THERMO and in
Distributor's possession at the time that Distributor is no longer entitled to
distribute and sell any Products hereunder or under the Manufacturing License
Agreement.
8.5 FORCE MAJEURE. Neither party shall be liable to the other party for non-
performance of or delay in performing its obligations hereunder to the extent
that performance is rendered impossible by strike, riot, war, acts of God,
earthquake, fire, flood, governmental acts or orders or restrictions, failure
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of suppliers, or any other reason to the extent that the failure to perform is
beyond the reasonable control of the non-performing party.
9. CONFIDENTIALITY.
9.1 CONFIDENTIALITY. Each party acknowledges that, in the course of
performing its duties and obligations under this Agreement, certain information
that is confidential or proprietary to such party ("Confidential Information")
will be furnished by the other party or such other party's representatives.
Each party agrees that any Confidential Information furnished by the other
party or such other party's representatives will not be used by it or its
representatives except in connection with, and for the purposes of, the
promotion, marketing, distribution and sale or Products under this Agreement
and, except as provided herein, will not be disclosed by it or its
representatives without the prior written consent of the other party.
Notwithstanding the foregoing, the parties agree that all Confidential
Information shall be clearly marked "CONFIDENTIAL" or, if in furnished in oral
form, shall be stated to be confidential by the party disclosing such
information at the time of such disclosure and reduced to a writing by the
party disclosing such information which is furnished to the other party or such
other party's representatives within forty-five (45) days after such
disclosure.
9.2 EXCEPTIONS. The confidentiality obligations of each party under
Section 9.1 do not extend to any Confidential Information furnished by the
other party or such other party's representatives that (i) is or becomes
generally available to the public other than as a result of a disclosure by
such party or its representatives, (ii) was available to such party or its
representatives on a nonconfidential basis prior to its disclosure thereto by
the other party or such other party's representatives, (iii) was independently
developed without the use of the other party's Confidential Information by
representatives of such party who did not have access to the other party's
Confidential Information, as established by contemporaneous written records, or
(iv) becomes available to such party or its representatives on an
nonconfidential basis from a source other than the other party or such other
party's representatives; PROVIDED, HOWEVER, that such source is not bound by a
confidentiality agreement with the other party or such other party's
representatives.
9.3 COMPELLED DISCLOSURE. In the event that either party or its
representatives are requested or become legally compelled (by oral questions,
interrogatories, requests for information or document subpoena, civil
investigative demand or similar process) to disclose any Confidential
Information furnished by the other party or such other party's representatives
or the fact that such Confidential Information has been made available to it,
such party agrees that it or its representatives, as the case may be, will
provide the other party with prompt written notice of such request(s) so that
the other party may seek a protective order or other appropriate remedy and/or
waive compliance with the provisions of this Agreement. In the event that such
protective order or other remedy is not obtained, or that the other party
waives compliance with the provisions of this Agreement, such party agrees that
it will furnish only that portion of such Confidential Information that is
legally required and will exercise its best efforts to obtain reliable
assurance that confidential treatment will be accorded to that portion of such
Confidential Information and other information being disclosed.
9.4 OWNERSHIP OF CONFIDENTIAL INFORMATION. The party disclosing or otherwise
furnishing Confidential Information to the other party will retain the
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exclusive ownership of all right, title and interest in and to such
Confidential Information.
9.5 SURVIVAL. The obligations of the parties under this Section 9 shall
survive the expiration or earlier termination of this Agreement for a period of
three (3) years.
9.6 DISTRIBUTOR AFFILIATES. THERMO acknowledges that certain Confidential
Information furnished to THERMO or THERMO's representatives by Distributor or
Distributor's representatives hereunder may be information concerning
Affiliates of Distributor. THERMO agrees that (i) such information shall be
deemed to be Confidential Information for purposes of this Agreement and
(ii) such information shall be treated by it and its representatives in the
same manner as it and its representatives shall treat Confidential Information
of Distributor pursuant to its obligations hereunder.
10. INDEMNIFICATION; INSURANCE.
10.1 THERMO'S INDEMNITY. THERMO agrees to indemnify, defend and hold harmless
Distributor and its Affiliated Parties from and against any claims, losses,
damages, liabilities, causes of action, suits, costs and expenses, including
all reasonable attorneys' fees and disbursements of counsel and expenses of
investigation, incurred by Distributor or such Affiliated Parties arising out
of or relating to:
(a) any breach by THERMO of its material representations, warranties,
covenants and agreements under this Agreement;
(b) any third party claims, actions, suits or proceedings alleging personal
injury or death, or any damage to any property, caused or allegedly caused by
any defect in any Product, or the failure to warn any Person of any defect in
any Product;
(c) any compliance by Distributor or any Subdistributor with Article VIII (the
safeguard clause) of the Medical Device Directive or the laws of any member
state of the European Union implementing such Article; and
(d) subject to Section 10.6, any claim, action, suit or proceeding brought, or
threatened to be brought, against Distributor, any Subdistributor or any of
their Affiliates alleging that the marketing, distribution, use or sale of any
Products infringes or violates any patent, trademark, distribution or other
proprietary rights of any third party.
10.2 DISTRIBUTOR'S INDEMNITY. Distributor agrees to indemnify, defend and hold
harmless THERMO and its Affiliated Parties from and against any claims, losses,
damages, liabilities, causes of action, suits, costs and expenses, including
all reasonable attorneys' fees and disbursements of counsel and expenses of
investigation, incurred by Distributor or such Affiliated Parties arising out
of or relating to:
(a) any breach by Distributor of its material representations, warranties,
covenants and agreements under this Agreement; and
(b) the performance by Distributor or its Subdistributors of its obligations
under this Agreement.
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10.3 CLAIMS FOR INDEMNIFICATION. Whenever any indemnification claim arises
under this Agreement, the party seeking indemnification (the "Indemnified
Party") shall promptly notify the other party (the "Indemnifying Party") of the
claim and, when known, the facts constituting the basis of such claim;
PROVIDED, HOWEVER, that failure to give such notice shall not relieve the
Indemnifying Party of its obligation hereunder unless and to the extent that
such failure substantially prejudices the Indemnifying Party.
10.4 THIRD PARTY CLAIMS (OTHER THAN INTELLECTUAL PROPERTY CLAIMS). In the
event of a third party claim (other than as provided in Sections 10.5 and 10.6)
giving rise to indemnification hereunder, the Indemnifying Party may, upon
prior written notice to the Indemnified Party, assume the defense of such claim
with counsel reasonably satisfactory to the Indemnified Party, and shall
thereafter be liable for all expenses incurred in connection with such defense,
including attorneys' fees and expenses; PROVIDED, HOWEVER, that if the
Indemnifying Party assumes the defense of any such claim, the Indemnified Party
may participate in such defense at its own expense and with counsel of its
choice; PROVIDED FURTHER, HOWEVER, that if there are one or more legal defenses
available to the Indemnified Party that conflict with those available to the
Indemnifying Party or there exists any other conflict of interest, the
Indemnifying Party shall not have the right to assume the defense of such claim
but the Indemnified Party shall have the right to employ separate counsel at
the expense of the Indemnifying Party and to participate in the defense
thereof. If the Indemnifying Party elects to control the defense of such
claim, it shall do so diligently and shall have the right to settle any claim
for monetary damages, PROVIDED such settlement includes a complete and absolute
release of the Indemnified Party. Notwithstanding anything to the contrary,
the Indemnifying Party may not settle any claims for fines, penalties or the
like without the prior written consent of the Indemnified Party.
10.5 THIRD PARTY INFRINGEMENT. Notwithstanding Section 10.4, in the case of
any infringement or violation by any third party of any Applicable THERMO
Technology or the distribution or other rights granted to Distributor
hereunder, Distributor shall have the right, but not the obligation, to take
such actions as it, in its sole judgment, deems appropriate to cause such third
party to cease such infringement and to otherwise enforce the Applicable THERMO
Technology or its distribution or other rights hereunder. THERMO will
cooperate with Distributor as reasonably requested by Distributor in taking any
such actions against such infringer. Any costs and expenses (including,
without limitation, attorneys' fees and related expenses) incurred by
Distributor in connection with such actions shall be borne equally by the
parties, and any amounts recovered as a result or consequence of such actions
(whether by settlement or otherwise) shall be divided equally between the
parties.
10.6 ALLEGED INFRINGEMENT. Notwithstanding Sections 10.1(d) and 10.4, if any
claim, action, suit or proceeding is brought, or is threatened to be brought,
against Distributor, any Subdistributor or any of their Affiliates alleging
that the marketing, distribution, use or sale of any Products infringes or
violates any patent, trademark or other proprietary rights of any third party,
Distributor may assume the defense of such claim, action, suit or proceeding
or, after consulting with THERMO, procure for itself the right to exercise all
distribution and other rights granted to it under this Agreement without any
additional payment therefor by Distributor. THERMO will cooperate with
Distributor as reasonably requested by Distributor in connection with the
assumption of such defense, and any claims, losses, damages, liabilities,
causes of action, suits, costs and expenses, including all reasonable
attorneys' fees and disbursements of counsel and expenses of investigation,
incurred by Distributor in connection with such defense shall be borne equally
by the parties.
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10.7 GENERAL AND PRODUCT LIABILITY INSURANCE. During the term of this
Agreement, THERMO shall maintain comprehensive general liability insurance
policies, including, without limitation, product liability insurance coverage
in the minimum amount of US$5,000,000, and shall furnish to Distributor, at
Distributor's request, certificates of insurance evidencing the foregoing
coverage. The liability insurance maintained by THERMO shall be written by its
current liability insurance carrier or an insurance carrier with at least the
same insurance rating, name Distributor as an additional insured, and contain
an endorsement to provide Distributor with at least sixty (60) days prior
written notice of any cancellation, non-renewal or reduction in coverage. In
the event that THERMO fails to provide Distributor with evidence of the
liability insurance required to be maintained pursuant to this Section 10.7
within thirty (30) days following THERMO's receipt of a notice advising THERMO
of its failure to provide such evidence, then at any time thereafter during the
pendency of such failure, Distributor may, in its sole discretion, terminate
this Agreement in accordance with Section 8.2(c) or purchase such insurance at
THERMO's sole cost and expense.
10.8 LIMITATION ON LIABILITY. IN NO EVENT SHALL ANY PARTY BE LIABLE TO THE
OTHER PARTY OR ANY OTHER PERSON FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR
INCIDENTAL DAMAGES, HOWEVER CAUSED AND BASED ON ANY THEORY OF LIABILITY,
ARISING OUT OF THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY, AND
WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
THIS LIMITATION SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF
ANY LIMITED REMEDY PROVIDED FOR HEREIN. NOTWITHSTANDING THE FOREGOING, NOTHING
CONTAINED IN THIS SECTION 10.8 SHALL RESTRICT EITHER PARTY'S RIGHT TO
INDEMNIFICATION OR CONTRIBUTION FROM THE OTHER PARTY WITH RESPECT TO LIABILITY
FOR PERSONAL INJURY, INCLUDING DEATH.
10.9 The indemnification provided for under this Section 10 is not the
exclusive remedy for breach of any provision of this Agreement.
11. MANUFACTURING LICENSE; BOARD REPRESENTATION.
11.1 OPTION TO ACQUIRE MANUFACTURING LICENSE. In addition to the other rights
granted by THERMO to Distributor hereunder, THERMO hereby grants to Distributor
an irrevocable option (the "Manufacturing Option") to acquire the right and
license to make, have made, market, use, sell and otherwise dispose of the CP-1
for sale within the Territory, on the terms and subject to the conditions set
forth in the Manufacturing License Agreement.
11.2 EXERCISE OF MANUFACTURING OPTION. The Manufacturing Option may be
exercised by Distributor at any time after the date upon which Distributor
**[REDACTED: REMOVED FOR CONFIDENTIAL TREATMENT PURSUANT TO SEC RULE 24B-2]**
by satisfying the following conditions:
(a) Distributor shall have delivered to THERMO a written notice of its
exercise of the Manufacturing Option;
(b) Distributor shall have paid to THERMO a manufacturing license fee
**[REDACTED: REMOVED FOR CONFIDENTIAL TREATMENT PURSUANT TO SEC RULE 24B-
2]** by wire transfer in immediately available funds to an account
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designated by THERMO; and
(c) **[REDACTED: REMOVED FOR CONFIDENTIAL TREATMENT PURSUANT TO SEC RULE
24B-2]**
Immediately following the satisfaction by Distributor of the conditions set
forth in clauses (a) through (c) above, Distributor shall be deemed to have
acquired the manufacturing rights described in Section 11.1, and the parties
shall execute the Manufacturing License Agreement and, thereafter, perform
their respective obligations thereunder.
11.3 **[REDACTED: REMOVED FOR CONFIDENTIAL TREATMENT PURSUANT TO SEC RULE 24B-
2]**
11.4 BOARD REPRESENTATION. At the written request of Distributor at any time
following the date that Distributor shall have exercised the Manufacturing
Option under Section 11.1, the board of directors of THERMO shall cause a
Person designated by Distributor to become a full member of such board.
12. GENERAL PROVISIONS.
12.1 INDEPENDENT CONTRACTORS. The relationship of THERMO and Distributor
established by this Agreement is that of independent contractors, and nothing
shall be deemed to create or imply any employer/employee, principal/agent,
partner/partner or co-venturer relationship, or that the parties are
participants in a common undertaking. Neither party may direct or control the
activities of the other party or incur or assume any obligation on behalf of
the other party or bind such other party to any obligation for any purpose
whatsoever.
12.2 GOVERNING LAW. This Agreement and all acts and transactions pursuant
hereto and the rights and obligations of the parties hereto shall be governed,
construed and interpreted in accordance with the laws of the State of
California, without reference to rules of conflicts or choice of laws.
12.3 ENTIRE AGREEMENT. This Agreement, including the Exhibits, sets forth the
entire agreement and understanding of the parties relating to the subject
matter hereof and supersedes all prior oral and written, and all contemporary
oral, negotiations, agreements and understandings with respect to the same.
12.4 NOTICES. All notices, requests, claims, demands and other communications
hereunder shall be in writing and shall be given (and shall be deemed to have
been duly given upon receipt) by delivery in person, by cable, telegram,
facsimile or telex, or by registered or certified mail (postage prepaid, return
receipt requested), to the other party at the following address (or at such
other address for which such party gives notice hereunder):
If to Distributor, to: Dideco S.p.A.
Via Statale 12 Nord, 86
41037 Mirandola (MO) ITALY
Attention: Dr. Alberto Chierici
Telephone: 011-39-535-29994
Telecopier: 011-39-535-29990
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WITH A COPY TO:
Stradling Yocca Carlson & Rauth
660 Newport Center Drive, Suite 1600
Newport Beach, CA 92660
Attention: Mitchell S. Cohen, Esq.
Telephone: (714) 725-4184
Telecopier: (714) 725-4100
If to THERMO, to: Thermogenesis Corp.
3146 Gold Camp Drive
Rancho Cordova, CA 95670
Attention: Philip Coelho
Telephone: (916) 858-5100
Telecopier: (916) 858-5199
12.5 ASSIGNMENT AND BINDING EFFECT. Except as otherwise provided in this
Agreement, neither party may, directly or indirectly, assign its rights or
delegate its duties under this Agreement without the prior written consent of
the other party. No permitted assignment of rights or delegation of duties
under this Agreement shall relieve the assigning or delegating party of its
liabilities hereunder. For purposes of this Agreement, either party shall be
deemed to have assigned this Agreement if any Person other than an Affiliate of
such party purchases or otherwise acquires more than 33% of the outstanding
voting securities of such party or more than 33% of the total assets of such
party. This Agreement is binding upon, and inures to the benefit of, the
parties and their respective successors and permitted assigns.
12.6 PARTIAL INVALIDITY. If any provision of this Agreement is held to be
invalid by a court of competent jurisdiction, then the remaining provisions
shall remain, nevertheless, in full force and effect. The parties agree to
renegotiate in good faith any term held invalid and to be bound by the mutually
agreed substitute provision in order to give the most approximate effect
intended by the parties.
12.7 NO WAIVER; AMENDMENT. No waiver of any term or condition of this
Agreement shall be valid or binding on any party unless agreed to in writing by
the party to be charged. The failure of either party to enforce at any time
any of the provisions of the Agreement, or the failure to require at any time
performance by the other party of any of the provisions of this Agreement,
shall in no way be construed to be a present or future waiver of such
provisions, nor in any way affect the validity of either party to enforce each
and every such provision thereafter. This Agreement may not be amended or
modified except by the written agreement of the parties.
12.8 COUNTERPARTS. This Agreement may be executed in two or more counterpaen
together, shall constitute one instrument.
12.9 CONSENT NOT UNREASONABLY WITHHELD. No party given the right to approve or
consent to any matter shall unreasonably withhold, condition or delay its
approval or consent. The failure to respond in writing within any specified
time period shall be deemed unconditioned approval of or consent to the
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relevant matter, PROVIDED that the party requesting such approval or consent
gives written notice requesting a response at least two (2) business days prior
to the expiration of the specified time period, if any.
12.10 CONSTRUCTION; INTERPRETATION. The headings contained in this Agreement
are for reference purposes only and shall not affect in any way the meaning or
interpretation of this Agreement. Any section, recital, exhibit, schedule and
party references are to this Agreement unless otherwise stated. No party, nor
its counsel, shall be deemed the drafter of this Agreement for purposes of
construing the provisions of this Agreement, and all provisions of this
Agreement shall be construed in accordance with their fair meaning, and not
strictly for or against any party.
12.11 FURTHER ASSURANCES. Each party agrees to cooperate fully with the other
and execute such instruments, documents and agreements and take such further
actions to carry out the intents and purposes of this Agreement.
12.12 PRESS RELEASES AND ANNOUNCEMENTS. 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 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,
including the pricing information set forth on EXHIBIT A, the minimum purchase
requirements set forth on EXHIBIT B and such other information as may be
mutually agreed upon by the parties.
12.13 ALTERNATIVE DISPUTE RESOLUTION.
(a) Any controversy, dispute or claim arising out of or relating to this
Agreement (or the breach hereof) that cannot be resolved by good faith
negotiation between or among the parties shall be finally submitted to the
American Arbitration Association ("AAA") for final and binding arbitration
pursuant to the Commercial Arbitration Rules of the AAA. Such arbitration
shall be held in Los Angeles, California, before a single arbitrator who shall
be a retired federal or California state judge. The arbitrator may enter a
default decision against any party who fails to participate in the arbitration
proceedings. The decision of the arbitrator shall be final, unappealable and
binding, and judgment on the award rendered by the arbitrator may be entered in
any court having jurisdiction thereof. The arbitrator shall be authorized to
award any relief, whether legal or equitable, to the party so entitled to such
relief.
(b) In respect of any suit, action or other proceeding relating to the
enforcement of any award rendered by the arbitrator, each party irrevocably
submits to the non-exclusive jurisdiction of any state or federal court located
in the City of Los Angeles, State of California.
(c) The arbitrator shall be authorized to apportion its fees and expenses
and the reasonable attorney's fees and expenses of the parties as the
arbitrator deems appropriate. In the absence of any such apportionment, the
prevailing party in any arbitration or other proceeding shall be entitled, in
addition to any other rights and remedies it may have, to reimbursement for its
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expenses, including court costs and reasonable fees of attorneys and other
professionals.
(d) The parties agree that this Section 12.13 has been included to resolve
rapidly and inexpensively any claims or disputes between them with respect to
this Agreement, and that this Section 12.13 shall be grounds for dismissal of
any action commenced by any party in any court with respect to any controversy,
dispute or claim arising out of or relating to this Agreement (or the breach
hereof).
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
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IN WITNESS WHEREOF, each of the undersigned has caused this Agreement to be
duly executed as of the date first written above.
THERMO THERMOGENESIS CORP., a Delaware Corporation
By: James H. Godsey
Its: President and Chief Operating Officer
By: David C. Adams
Its: Secretary
DISTRIBUTOR DIDECO S.p.A., a company organized under the laws of
Italy
By: Albrto Chierici
Its: Chief Executive Officer
