DISTRIBUTION AGREEMENT
between
WORLD HEART CORPORATION
and
XXXXXXX LIFESCIENCES LLC
dated
June 30, 2000
This Agreement is made effective as of the 30th day of June, 2000
("Effective Date"), by and between World Heart Corporation, a corporation
organized and existing under the laws of the Province of Ontario and located at
0 Xxxxx Xxxxxx, Xxxxxx, Xxxxxxx X0X 0X0 ("World Heart") and Xxxxxxx Lifesciences
LLC, a limited liability company organized under the laws of the State of
Delaware, located at Xxx Xxxxxxx Xxx, Xxxxxx, XX 00000 ("Distributor" or
"Xxxxxxx").
WHEREAS, World Heart and its subsidiaries are engaged in the business
of developing, manufacturing, and marketing medical devices and desires that the
sale and use of its products be actively promoted worldwide; and
WHEREAS, World Heart and its subsidiaries have developed or acquired
heart assist and replacement products (the "Heart Assist and Replacement
Products" or the "Products"), as further described in Exhibit A hereto; and
WHEREAS, Xxxxxxx is a well-known company in the medical devices field,
with experience and expertise in the commercialization and distribution of
medical devices; and
WHEREAS, Xxxxxxx is an organization capable of commercializing medical
devices, such as the Products; and
WHEREAS, World Heart desires to engage Xxxxxxx and its subsidiaries to
purchase, resell, distribute and support the Products worldwide, subject to
specified restrictions; and
WHEREAS, Xxxxxxx desires to obtain rights to purchase, resell,
distribute and support the Products in exchange for World Heart's assumption of
specified obligations;
NOW, THEREFORE, in consideration of the mutual undertakings
obligations and covenants contained herein, and for other good and valuable
consideration, the receipt and sufficiency of which are acknowledged, the
parties agree as follows:
I. Appointment
A. Subject to the terms and conditions contained in this Agreement,
World Heart hereby appoints Xxxxxxx as World Heart's and its subsidiaries'
exclusive independent distributor of Products worldwide. World Heart shall not
appoint any other agents, representatives, or distributors for the purpose of
selling the Products, nor shall it sell or distribute the Products directly, by
itself or through any subsidiary or affiliate, except in the United States as
provided herein.
X. Xxxxxxx' exclusive distribution rights, as defined in this
Agreement, shall extend to improvements and/or derivative replacements to the
Products and to related products developed or acquired by World Heart or its
subsidiaries from inception of this Agreement.
X. Xxxxxxx shall not sell any devices which directly compete with the
Products during the term of this Agreement. Notwithstanding the foregoing,
however, Xxxxxxx may sell medical devices, including without limitation, heart
assist devices so long as they do not directly compete with the Products, and
all other medical devices (other than as set forth in Exhibit A) which it is
selling as of the Effective Date.
X. Xxxxxxx shall have the right to contract with third parties to sell
the Products on behalf of Xxxxxxx in territories outside of the United States
where Xxxxxxx' own products are sold by such third party distributors.
E. Subject to the terms and conditions contained in this Agreement,
Xxxxxxx shall be entitled to identify itself as the distributor on the Products'
labeling and other manufacturing materials.
F. In addition to the distribution rights granted herein, in the event
of any transfer of the World Heart business or any of the Products to a third
party, Edward's rights to distribute the Products under this Agreement shall
survive such transfer, subject only to approval of Xxxxxxx, in its sole
discretion.
II. Obligations of Distributor
X. Xxxxxxx shall use commercially reasonable efforts to perform its
specified distribution obligations as described in this Agreement, and shall,
among other requirements:
1. Promote the sale and use of Products in all markets and
territories other than the United States in which (a) such Products have been
approved by all appropriate legal and regulatory authorities for commercial
sale, and (b) Xxxxxxx sells its own products. Xxxxxxx shall have absolute
discretion with respect to what, if any, efforts it shall make to promote the
sale and use of the Products in each market or territory not covered in
paragraph (a) and (b) above. If Xxxxxxx is unwilling or unable to promote the
sale and use of the Products in any market or territory, World Heart shall have
absolute discretion with respect to the sale and use of the Product in each
market or territory and such efforts by World Heart shall not be subject to the
terms and conditions of this Agreement;
2. Purchase and maintain appropriate inventories of Products;
3. Provide its customers with support with respect to the
Products, including without limitation, troubleshooting of technical problems
and assistance for patients with respect to proper setup of equipment;
4. Provide customer service, including responding to customer
inquiries, requests for quotes on Product pricing and complaints on a timely
basis and providing such assistance and information as is reasonably requested;
5. Provide invoices to customers and manage accounts receivable
and collection responsibilities for sales by Xxxxxxx of the Products during the
term of Agreement;
6. Process and return any defective Products to World Heart for
credit or replacement, as Xxxxxxx shall determine;
7. Process and return to World Heart, at World Heart's expense,
explants reasonably available to Xxxxxxx for clinical study or for other
purposes reasonably requested by World Heart. World Heart shall reimburse
Xxxxxxx for all costs incurred in obtaining, preparing, decontaminating,
shipping and other processing of any such explanted devices;
8. Meet with World Heart at least twice annually, or at World
Heart's request, more frequently, in order to discuss sales opportunities,
current market trends and to keep World Heart informed of pertinent events and
competing products having an impact upon the Product's marketability, including
but not limited to, forecasts as to future sales;
9. Cooperate with World Heart in World Heart's marketing and in
the conversion of market positioning into customer relationships and orders.
10. Maintain, at its own expense, such office space and
facilities, and hire and train such personnel, as may be required to carry out
its obligations under this Agreement; and
11. Comply with all applicable requirements in the countries in
which Products are sold relating to the reporting of adverse reactions suffered
by end users of Products, and will promptly report all such instances to World
Heart, specifying the date, time, and nature of the occurrence, the customer's
name and address, the Products (including batch number if available) and any
other relevant information reasonably available to Xxxxxxx which World Heart may
reasonably request.
B. At Xxxxxxx' option, Xxxxxxx may use World Heart's sales materials,
or develop promotional literature, including product brochures and other sales
aids for Products, which shall be subject to prior written approval of World
Heart.
III. Obligations of World Heart
A. In supplying Xxxxxxx with Products, World Heart shall, among other
requirements:
1. Provide all sales support and customer interface in the United
States until such time as Xxxxxxx and World Heart agree that United States sales
warrant the establishment by Xxxxxxx of a direct sales force;
2. Fulfill Xxxxxxx' purchase requests, provided, however, that
World Heart shall not be liable in any way for failure to ship or for any delay
in shipment caused by events or circumstances beyond World Heart's control;
3. Pay for all costs and expenses associated with regulatory and
clinical approval of the Products and the maintenance of such status in all
markets and territories incurred by World Heart or by Xxxxxxx at the request of
World Heart;
4. Pay for all direct marketing costs including the training of
clinicians and implanting centers and World Heart's sales and support personnel
and all costs incurred in establishing and maintaining reference centers to be
used by World Heart for customer training;
5. Provide Xxxxxxx with product information, clinical papers,
sales and promotional literature, and product use training reasonably necessary
to enable Xxxxxxx to perform its obligations under this Agreement;
6. Provide finished products which are compliant with all
applicable laws and regulations in whatever jurisdiction the Product will be
used; the product labeling shall include the statement, "Manufactured by World
Heart for Xxxxxxx" and all other statements required by such applicable laws and
regulations;
7. Issue a credit or refund to Xxxxxxx for, or replace at no
charge to Xxxxxxx, all defective or otherwise unmerchantable Products returned
by Xxxxxxx, or returned by customers to Xxxxxxx and subsequently returned to
World Heart by Xxxxxxx, within 30 days of return to World Heart, and provide
Xxxxxxx with written reports of evaluation of such Products, and pay all costs
associated with such Products including any freight charge reasonably necessary
under the particular circumstances;
8. Obtain and keep in force during the term of this Agreement a
Comprehensive General Liability insurance policy in an amount not less than the
greater of (a) $5,000,000 or (b) one times the amount of World Heart Gross Sales
for the previous twelve (12) month period to a maximum of $100 million, for each
occurrence for bodily injury and property damage for: (i) premises-operations;
(ii) products/completed operations; (iii) blanket contractual liability; and
(iv) personal injury. During the term of this Agreement and for a period of four
(4) years following the expiration or termination of this Agreement for any
reason, such insurance policy shall evidence Xxxxxxx as an additional insured
and shall provide for written notification to Xxxxxxx by the insurer not less
than 30 days prior to cancellation, expiration or modification. World Heart
shall provide a certificate of insurance evidencing compliance with this Section
to Xxxxxxx within 30 days after the Effective Date;
9. Comply with all applicable requirements in the countries in
which Products are sold relating to the reporting of adverse reactions suffered
by end users of Products, and will promptly report all such instances to
Xxxxxxx, specifying the date, time, and nature of the occurrence, the customer's
name and address, the Products (including batch number if available) and any
other relevant information which Xxxxxxx may reasonably request;
10. Inspect all Products for compliance with specifications in
accordance with World Heart quality control standards and systems; and
11. Replace Products which have become obsolete due to
improvements to the Products which impact the clinical effectiveness of the
Products.
IV. Registration of Products; Import and Export Restrictions
X. Xxxxxxx shall pay for all import and export licenses and permits,
pay customs charges and duty fees, and take all other actions required to
accomplish the export and import of the Products it purchases.
B. All sales of the Products made by Xxxxxxx pursuant to this
Agreement shall be in strict compliance with applicable United States laws
dealing with foreign trade and commerce including but not limited to, the U.S.
Foreign Corrupt Practices Act. Xxxxxxx shall comply with all applicable laws and
regulations in each jurisdiction in which it sells the Products.
C. World Heart shall retain all rights and obligations associated with
governmental and other regulatory approvals and shall use commercially
reasonable efforts to obtain required approvals in any country in which World
Heart and Xxxxxxx determine a reasonable commercial opportunity exists.
V. Purchase Requirements
A. All orders for Products submitted by Xxxxxxx shall be initiated by
written purchase orders sent to World Heart and requesting a delivery date
during the term of this Agreement; provided, however, that an order may
initially be placed orally or by facsimile if a confirmational written purchase
order is received by World Heart within five (5) days after said oral or
facsimile order. World Heart shall use commercially reasonable efforts to notify
Xxxxxxx of the acceptance or rejection of an order and of the assigned delivery
date for accepted orders within five (5) days but in no event later than
fourteen (14) days after receipt of the purchase order. World Heart shall have
no liability with respect to purchase orders that are not accepted. World Heart
shall use commercially reasonable efforts to deliver products at the times
specified either in its quotation or in its written acceptance of purchase
orders.
X. Xxxxxxx shall provide World Heart with a rolling twelve (12) month
forecast of its purchase requirements for the Products, updated on a monthly
basis. In conjunction with each monthly update of the forecast, Xxxxxxx will
provide World Heart with a binding purchase order equal to the first three (3)
months of the forecast.
VI. Pricing, Payment, Shipping
A. The price to Xxxxxxx for the Products is structured in tiers based
on the following annual purchase levels and will be determined on a regional
basis. As used herein, the term "Base Price" shall mean Xxxxxxx' average sales
price in the applicable region for such Product to customers during the 90 day
period immediately prior to the Effective Date. If the relevant Product or
territory is a product which or territory where Xxxxxxx is not selling on the
Effective Date, Xxxxxxx shall forecast Base Prices ("Forecasted Base Prices")
prior to beginning its sales of such Product or in such region, and after the
first 90 days of sales, each Forecasted Base Price shall be adjusted based on
actual average sales prices over the initial 90 days of sales.
B. For the first $10 million United States Dollars ("U.S. Dollars") of
worldwide purchases of the Products by Xxxxxxx during any year of this
Agreement, the purchase price for any Product shall be the Base Price less 35%
of such Base Price. During any such one year period in which worldwide annual
purchases of the Products by Xxxxxxx do not exceed $10 million U.S. Dollars,
World Heart hereby guarantees that Xxxxxxx' gross profit for its distribution
activities pursuant to this Agreement shall be at least $2 million U.S. Dollars.
C. For worldwide purchases of the Products by Xxxxxxx during any year
of this Agreement which are made after Xxxxxxx has purchased Products totaling
$10 million U.S. Dollars during such year but before Xxxxxxx has purchased
Products totaling $100 million U.S. Dollars in value during such year, the
purchase price shall be the Base Price less 30% of such price.
D. For worldwide purchases of the Products by Xxxxxxx during any year
of this Agreement which are made after Xxxxxxx has purchased Products totaling
$100 million U.S. Dollars during such year, the purchase price shall be the Base
Price less 25% of such price.
E. At the end of each calendar year during the term of this Agreement
and the end of the calendar year during which this Agreement expires or is
otherwise terminated, World Heart and Xxxxxxx shall make purchase price
adjustments necessary to insure that Xxxxxxx' guaranteed gross profit from the
distribution activity contemplated by this Agreement is at least $2 million on a
pro-rated annual basis.
F. In the event the economics of either party with respect to the
transactions contemplated by this Agreement change substantially, both parties
agree to review in good faith the pricing terms of this Agreement. Specific
exceptions to the pricing set forth herein may be mutually agreed to by the
parties.
G. All prices are F.O.B. World Heart's manufacturing facility and do
not include any foreign, federal, state or local sales, use, excise or value
added tax that may be applicable. When World Heart has the legal obligation to
collect such taxes, the appropriate amount shall be added to Xxxxxxx' invoice
and paid by Xxxxxxx unless Xxxxxxx provides World Heart with a valid tax
exemption certificate authorized by the appropriate taxing authority. In all
cases, title, risk of loss and all responsibility for transportation, insurance
and storage shall pass from World Heart to Xxxxxxx upon shipment from World
Heart's plant.
H. For purposes of this Agreement, "Shipment Date" shall mean the time
when any Product is first shipped F.O.B. World Heart's plant. Xxxxxxx shall
specify a method of transportation and a carrier in writing at the time Xxxxxxx
submits the purchase order to World Heart. If Xxxxxxx does not so specify, World
Heart will determine the method of transportation and the carrier in its
reasonable discretion.
I. Full payment (including any freight, taxes or other applicable
costs initially paid by World Heart but to be borne by Xxxxxxx pursuant to the
terms hereof) for Products shall be made by Xxxxxxx to World Heart within sixty
(60) days of the date of shipment. Payment shall be made in United States
Dollars.
VII. Product Recalls
A. In the event that Xxxxxxx or World Heart recalls any Products for
any reason, the party instituting the recall shall immediately notify the other
party in writing. Xxxxxxx shall, immediately upon receipt of such notice, give
notice of the recall to each customer to which it has sold, along with
instructions, if any, delivered by World Heart relating to the recall.
X. Xxxxxxx shall make commercially reasonable efforts to assist World
Heart in giving effect to the recall. World Heart shall bear all costs and
expenses of any recall including, without limitation, obligations to third
parties, costs of notifying customers and costs associated with the shipment of
recalled Products from customers to Xxxxxxx or World Heart, and replacement of
such products.
C. In the event that Xxxxxxx desires to recall any Products for a
reason caused by acts or omissions of Xxxxxxx, Xxxxxxx shall notify World Heart
prior to said recall and shall bear all costs associated with such recall.
VIII. Discontinuance of Product Manufacture or Clinical Support
Xxxxxxx shall receive at least one year prior written notice of any
intent by World Heart to discontinue the manufacture, or clinical support of,
the Products. World Heart shall not give such notice to Xxxxxxx prior to
December 31, 2001, unless World Heart agrees to provide hardware support
consistent with previous practices to any patient implanted with a Product until
such time as such support is no longer clinically required.
IX. Term and Termination
A. Term. This Agreement shall commence on the Effective Date and be
valid for an initial term of five (5) years ("Initial Term"). Upon expiration of
the Initial Term, and at each anniversary of such expiration, this Agreement
shall automatically renew for additional terms ("Additional Term") of one (1)
year unless terminated pursuant to the terms of this Article IX.
B. Immediate Termination. This Agreement may be terminated by either
party immediately in the event that (i) any material breach by the other party
remains uncured 30 days after written notice containing details of the breach
has been delivered to the other party; (ii) the other party shall file for
protection from its creditors under any applicable bankruptcy or insolvency
laws, shall make an assignment for the benefit of creditors, or shall have a
receiver appointed for its property; or (iii) operation of local law invalidates
this Agreement, but in the case of (iii), only with respect to such market,
products and/or territory where this Agreement is invalidated.
C. Change of Control. In the event that a third party acquires control
of a party to this Agreement ("Change of Control"), the party that has undergone
a Change of Control shall notify the other party of such change in writing no
less than 30 days after the Change of Control and the other party shall have 60
days following receipt of such notice to terminate this Agreement.
D. 18 Months Notice. Either party may terminate this Agreement upon 18
months prior written notice to the other at any time following two years after
the Effective Date of this Agreement. In the event that World Heart terminates
this Agreement pursuant to this subsection, World Heart shall pay Xxxxxxx:
1. 150% of all expenses paid by Xxxxxxx as a result of World
Heart's termination, including without limitation, severance costs and costs
related to closing of office and warehouse space used in the performance of this
Agreement; plus
2. for all Products distributed by Xxxxxxx prior to termination,
three percent (3%) of World Heart's gross sales of such Products for the most
recent 12 months, for three (3) years following termination. Xxxxxxx shall have
the right to audit World Heart's financial records upon reasonable notice and
during regular business hours in order to ascertain compliance with this
provision.
E. Continuation of Patient Support. In the event of any termination or
expiration of this Agreement for any reason, World Heart shall continue all
customer and patient support at levels consistent with Xxxxxxx' previous
practices and the maintenance of patient life and safety until such time as such
support is no longer clinically required.
F. Trademarks upon Termination. Upon any termination of this
Agreement, Xxxxxxx shall immediately cease using the name, trademark, service
xxxx, logo or any other reference of or to World Heart and shall, at its
expense, surrender and deliver to World Heart within thirty (30) days, all
documents, papers and records which contain confidential information of World
Heart and all undistributed samples, instruments, equipment, pamphlets,
catalogs, booklets, technical information, advertising, demonstration equipment,
consigned inventory, selling data and other papers relating to the business of
World Heart (collectively, the "Sales Materials").
G. Inventory Return. Upon any termination of this Agreement, World
Heart shall accept the return of Xxxxxxx' inventory of Products and refund the
price Xxxxxxx paid, provided that the Products are returned unused and packaged
in their original, unopened, unmarked and unbroken sterile containers.
X. Warranties and Indemnification
A. World Heart warrants that it possesses good and marketable title to
any Products sold to Xxxxxxx under this Agreement and that each Product is free
from defects and fit for the purposes and indications described in its labeling.
B. World Heart hereby indemnifies and agrees to defend and to hold
harmless Xxxxxxx, its officers, directors, shareholders, employees, parents,
successors, affiliates, assigns, customers and users of Products from and
against any and all claims, demands, actions, causes of action, liabilities,
losses, damages and expenses, including reasonable attorney fees, arising out of
or in connection with: (i) the manufacture or use of any Products; (ii) the
design of any Products or component not developed exclusively by Xxxxxxx or
(iii) any claim of infringement of patents, trademarks, tradenames, or
copyrights, any claim of misappropriation or misuse of trade secrets or
information or any similar claim, by reason of the sale or use of Products.
Xxxxxxx shall promptly notify World Heart of any such claim and may either
tender its defense of such claim to World Heart or may retain its own counsel
without waiving any of its right to indemnification hereunder.
X. Xxxxxxx hereby indemnifies and agrees to defend and to hold World
Heart, its successors, affiliates, assigns, customers and users of the Products
harmless from and against all claims, liabilities, losses or expenses, including
reasonable attorney fees, to the extent of harm resulting from: (i) physical
mishandling of the Products by Xxxxxxx; or (ii) any misrepresentation by Xxxxxxx
concerning any of the characteristics of the Products or the proper manner of
usage or the performance of the Products or (iii) Xxxxxxx' actions in support of
Products for clinics pursuant to paragraph II(A)(3) of this Agreement.
D. The party seeking indemnification (the "Indemnified Party") shall
notify the indemnifying party (the "Indemnifying Party") of all claims that may
be subject to indemnification under this Article within a reasonable time after
their receipt. The Indemnified Party will cooperate fully with Indemnifying
Party in defending or otherwise resolving each such claim. The Indemnifying
Party will have full control of the defense of all such claims. The Indemnified
Party, at its expense, shall be entitled to be represented by its own counsel in
any such claim. The Indemnifying Party agrees to bear all costs and expenses of
defense, including its own attorney's fees in connection with such claim, and
the Indemnifying Party will reimburse the Indemnified Party for each
disbursement made by the Indemnified Party in satisfaction of a final judgment
issued in such claim.
XI. Intellectual Property Rights and Confidentiality
A. Limited Use of Intellectual Property. Xxxxxxx agrees that Xxxxxxx
has no intellectual property interest in the Products or in World Heart's
patents, trademarks, service marks, trade names, inventions, copyrights,
know-how, and trade secrets relating to the design, manufacture, operation or
service of Products. The use by Xxxxxxx of any of these property rights is
authorized only for the purposes herein set forth, and upon termination of this
Agreement for any reason such authorization shall cease.
B. Trademarks. World Heart agrees that:
1. World Heart has no right, title or interest in the trademarks
and trade names connoting Xxxxxxx. Should any such use vest in World Heart any
rights in a trademark, trade name or logo used by Xxxxxxx, World Heart shall
transfer such rights to Xxxxxxx or its designee upon request of Xxxxxxx; and
2. During the term of this Agreement, Xxxxxxx will have the right
to indicate to the public that it is an authorized distributor of the Products
and to advertise under the trademarks, service marks and trade names that World
Heart may adopt from time to time (the "World Heart Trademarks").
C. Confidential Information. In order to avoid disclosure of
confidential and proprietary information ("Information") to any other person,
firm or corporation, the parties agree that during the term of this Agreement
and for a period of 3 years from the expiration or termination of this Agreement
each will treat any such information which is received from one another in
writing and clearly xxxx such information "Confidential" or if disclosed orally,
which is confirmed in writing as "Confidential" within thirty (30) days of
initial disclosure, with the same degree of care that each employs with respect
to its own information which it does not desire to have published or
disseminated. It is understood that each party shall be liable for any
unauthorized disclosure should it fail to safeguard the disclosed information
with such care. This obligation shall survive the termination of this Agreement.
The parties shall not have any obligation with respect to such information which
is:
1. independently developed by the receiving party without the
benefit of the disclosure or is already known to the receiving party at the time
of the disclosure, as evidenced by written documentation;
2. publicly known or becomes publicly known without the wrongful
act or breach of this Agreement by the receiving party; or
3. rightfully received by the receiving party from a third-party
who is not under any obligation of confidentiality or trade secret obligation to
the originating party.
XII. Miscellaneous
A. Relationship. The relationship of Xxxxxxx and World Heart
established by this Agreement is of independent contractors and not agents, and
nothing in this Agreement shall be construed:
1. To give either party the power to direct or control the daily
activities of the other party beyond the obligations imposed on Xxxxxxx and
World Heart, respectively, by this Agreement;
2. To constitute the parties as partners, joint ventures,
co-owners or otherwise as participants in joint undertaking; or
3. To allow either party to create or assume any obligation on
behalf of the other party for any purpose whatsoever. The purchase, promotion,
and resale of, or any other legal transactions concerning the Products hereunder
shall be carried out in the name of and for the account of Xxxxxxx as principal,
and Xxxxxxx shall not enter into any agreement with third persons binding in any
way on World Heart.
B. No Conflict. Each party represents and warrants to the other party
that it is not subject to any contractual obligation or restraint which will
materially interfere with its right and ability to perform pursuant to the terms
of this Agreement.
C. Compliance With Laws. Each party represents and agrees that it is
and will remain in compliance with all applicable federal, state and local laws,
regulations and orders, including laws of the countries in which Xxxxxxx sells
products.
D. Dispute resolution. Any controversy or claim relating to or arising
from this Agreement that is not fully resolved pursuant to negotiation and/or
mediation within thirty (30) days after a party first notifies the other party
of such claim or controversy shall be solely and finally settled by arbitration
in accordance with the CPR Rules for Non-Administered Arbitration of Business
Disputes ("CPR Rules"). The arbitration shall be conducted by a sole arbitrator,
who shall be a former judge, appointed by jointly by the parties ("Arbitrator").
If the parties cannot agree on the appointment of an Arbitrator, they shall each
propose one individual from CPR's Regional Panel of Distinguished Neutrals for
the State of California. The two proposed individuals shall mutually appoint a
third individual, who is a former judge from the same panel, to be the
Arbitrator. The arbitration shall be governed by the provisions of the CPR
Rules, and judgment upon the award rendered by the Arbitrator may be entered by
any court having jurisdiction thereof. The arbitration proceedings shall be held
in the State of California. To the extent permissible under applicable law, the
parties agree that the award of the Arbitrator shall be final and shall be
subject only to the judicial review permitted by the CPR Rules. It is the intent
of the parties that the arbitration provisions hereof be enforced to the fullest
extent permitted by applicable law. The Arbitrator may not award multiplied,
consequential or punitive damages, and the parties hereby irrevocably waive any
right to multiplied, punitive or consequential damages.
E. Governing Law. This agreement shall be governed by, interpreted
under, and construed in accordance with the internal laws of the State of
California without respect to its choice of law provisions.
F. Notices. All notices, demands, requests, consents, approvals or
other communications required or permitted to be given hereunder or which are
given with respect to this Agreement shall be in writing and shall be delivered
(charges prepaid, receipt confirmed or return receipt requested (if available))
by hand, by nationally recognized air courier service, by certified mail or
facsimile, addressed as set forth below or to such other address as such party
shall have specified most recently by written notice. Notice shall be deemed
given and effective:
1. if delivered by hand or by nationally recognized courier
service, when delivered at the address specified in this agreement (or in
accordance with the latest unrevoked written direction from such party);
2. if by certified mail, upon mailing; or
3. if given by facsimile when such facsimile is transmitted to
the fax number specified in this agreement (or in accordance with the latest
unrevoked written direction from such party), provided the appropriate
confirmation is received.
To World Heart:
World Heart Corporation
0 Xxxxx Xxxxxx
Xxxxxx, Xxxxxxx
X0X 0X0
Attn: Chief Financial Officer
Fax: (000) 000-0000
with a copy (which shall not constitute notice) to:
XxXxxxxx Xxxxxxxx
The Xxxxxxxx
0000-00 Xxxxx Xxxxxx
Xxxxxx, Xxxxxxx X0X 0X0
Attn: Xxxxxx X. Xxxxxxx
Fax: (000) 000-0000
To Xxxxxxx:
Xxxxxxx Lifesciences LLC
Xxx Xxxxxxx Xxx
Xxxxxx, XX 00000
Attn: Associate General Counsel
Fax: 000-000-0000
with a copy (which shall not constitute notice) to:
Skadden, Arps, Slate, Xxxxxxx & Xxxx LLP
000 Xxxxx Xxxxx Xxxxxx, Xxxxx 0000
Xxx Xxxxxxx, Xxxxxxxxxx 00000-0000
Attn: Xxxxxx X. Xxxxxx, Esq.
Fax: (000) 000-0000
G. Expenses. Except as otherwise provided in this Agreement, each
party to this Agreement shall bear its respective expenses incurred in
connection with the preparation, execution, and performance of this Agreement
and the transactions contemplated hereby, including all fees and expenses of
agents, representations, counsel and accountants.
H. Entire Agreement. This Agreement, including all exhibits hereto and
thereto, by and between Xxxxxxx and World Heart, constitute the entire agreement
of the parties with respect to the subject matter hereof and supersedes all
prior agreements with respect to the subject matter hereof.
I. No Third Party Beneficiaries. This Agreement and the provisions
hereof shall be binding upon and shall inure to the benefit of each of the
parties and their respective successors and permitted assigns and is not
intended to confer any rights, remedies or benefits on any Persons other than as
expressly set forth in this Section.
J. Severability. In the event that any one or more of the provisions
contained herein, or the application thereof in any circumstances, is held
invalid, illegal or unenforceable in any respect for any reason, the parties
shall negotiate in good faith with a view to the substitution therefore of a
suitable and equitable solution in order to carry out, so far as may be valid
and enforceable, the intent and purpose of such invalid provision; provided,
however, that the validity, legality and enforceability of any such provision in
every other respect and of the remaining provisions contained herein shall not
be in any way impaired thereby, it being intended that all of the rights and
privileges of the parties hereto shall be enforceable to the fullest extent
permitted by law.
K. Amendments; Modifications. No amendment, modification or
termination of this Agreement shall be binding upon any other party unless
executed in writing by the parties hereto intending to be bound thereby.
L. Assignment. Neither this Agreement nor any rights, duties or
obligations hereunder may be assigned or delegated by any of the parties hereto
without the prior written consent of the other party. Notwithstanding the
foregoing, Xxxxxxx shall be entitled to assign this Agreement to any person or
entity controlling, controlled by or under common control with Xxxxxxx without
consent. Any attempted assignment or delegation of rights, duties or obligations
hereunder in contravention hereof shall be void and of no effect.
IN WITNESS WHEREOF, the parties hereto execute this Agreement as of
the date first written above.
Xxxxxxx Lifesciences LLC World Heart Corporation
By: /s/ Xxxxxxx X. Xxxxxxxxx By: /s/ Xxxxxxxx X. Xxxxxx
------------------------------- ---------------------------
Name: Xxxxxxx X. Xxxxxxxxx Name: Xxxxxxxx X. Xxxxxx
Title: President and Title: President and
Chief Executive Officer Chief Executive Officer
EXHIBIT "A" TO DISTRIBUTION AGREEMENT
Description of Products
The Products, for purposes of the Distribution Agreement between World Heart and
Xxxxxxx of which this Exhibit "A" is a part, shall mean all mechanical or
electronic devices which assist the pumping function of the human heart or
replace the biological heart in patients, including without limitation:
Novacor Left Ventricle Assist Device
Heart Saver
