Document:

exv10w10

 

Exhibit 10.10

SALES REPRESENTATIVE AGREEMENT

     THIS
SALES REPRESENTATIVE AGREEMENT (the “Agreement”), dated as
of ___________, 200__ is made
and entered into by and between St. Francis Medical Technologies, Inc., a Delaware corporation (the
“Company”), and _______________
(the “Distributor”) and ______________ (the
“Responsible Party”).

WITNESSETH:

     WHEREAS, the Company desires to sell the products identified on Schedule A to this Agreement
(the “Products”) in the territory identified on Schedule B to this Agreement (the “Territory”).

     WHEREAS, the Company desires to engage Distributor to promote, market and solicit orders for
such products on the terms and conditions set forth in this Agreement.

     NOW, THEREFORE, in consideration of the foregoing premises and mutual covenants contained
herein, the parties hereby agree as follows:

     Section 1. Representation.

          1.1 Appointment of Distributor. The Company hereby appoints Distributor as its
exclusive representative to promote, market and solicit orders for the Products within the
Territory in accordance with the terms and conditions contained in this Agreement during the term
this Agreement. Nothing contained herein shall in any manner be deemed to restrict or limit the
ability of the Company to appoint another representative for the Products in areas other than in
the Territory.

          1.2 Acceptance of Appointment. Distributor hereby accepts the appointment in
accordance with the terms and conditions set forth herein, and agrees that neither Distributor, nor
anyone in its employ, shall sell, offer for sale, promote, receive or solicit orders for, or engage
in any other competitive activities with respect to products which, in the reasonable business
judgment of the Company, are competitive with the Products during the term of this Agreement and
for six (6) months following the expiration or termination of this Agreement.

     Distributor shall not be constituted the agent, employee or legal representative of the
Company for any purpose whatsoever. Distributor shall conduct its business in its own name as an
independent contractor and shall be solely responsible for its acts, conduct and expenses and the
acts, conduct and expenses of its employees and agents, including payment of Social Security
withholding tax and all other federal, state and local taxes. Distributor is not granted any
express or implied right or authority to accept orders on behalf of the Company, to assume or
create any obligation or responsibility on behalf of or in the name of the Company or to bind the
Company in any manner. Distributor shall make no quotations of prices or terms or representations,
warranties or commitments about or with respect to Products, except as may be approved by the
Company.

 

 

     Any place or places of business maintained by Distributor in connection with the performance
of this Agreement shall be maintained at Distributor’s own cost and expense and in Distributor’s
own name.

          1.3 Duties of Distributor. In the performance of its obligations under this
Agreement, Distributor shall, at its sole expense:

               (a) use its best efforts to promote, market and solicit orders for the Products in the
Territory and meet minimum sales quotas for the Products which may from time to time be established
by the Company and set forth on Schedule B;

               (b) maintain a fully staffed force of trained, qualified sales personnel and have such
personnel call on all actual customers and potential purchasers (collectively, “Customers”) as
frequently as is required by good business practice;

               (c) attend, and cause all Distributor’s sales personnel to attend, training sessions as
designated by the Company;

               (d) promptly submit to the Company in writing all orders it obtains or receives for the
purchase of Products and all inquiries it receives with respect to the purchase of Products. All
such orders shall be on such forms as the Company shall provide and shall contain and be
accompanied by such information as the Company shall specify;

               (e) monitor and advise the Company of the financial condition of Customers and furnish the
Company with such financial and credit information in respect of Customers as the Company may
request from time to time;

               (f) at the Company’s request, use its best efforts to assist the Company in collecting sums
due for Products purchased by Customers;

               (g) at the Company’s request, use its best efforts to assist the Company in resolving any
complaints or disputes that may arise in connection with sales of Products to Customers; provided,
however, that no allowance, adjustment or return may be granted without the prior written approval
of the Company;

               (h) provide the Company with such written or verbal reports relating to Distributor’s
activities pursuant to this Agreement as the Company may reasonably request and promptly send the
Company copies of all correspondence and other written communications between Distributor and
Customers;

               (i) perform all such activities strictly in accordance with such instructions as the Company
may issue from time to time;

               (j) monitor and advise the Company of changes and trends in sales and economic conditions;

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               (k) act as technical advisor to and provide liaison between Customers and the Company;

               (l) comply with all applicable laws, rules and regulations, procure and maintain all licenses
and permits necessary to the performance of its business and its obligations hereunder, and conduct
its business in a manner that will reflect favorably on the Company, the Products and the good name
and goodwill and reputation thereof;

               (m) within five (5) business days following the execution of this Agreement, provide to the
Company in writing a list of all companies represented by Distributor and promptly notify the
Company in writing of any additions or deletions to such list;

               (n) use only those catalogs, advertising materials, descriptive literature and other marketing
materials which may be provided from time to time by the Company to Distributor in connection with
the solicitation of orders for Products, or which are otherwise approved in advance in writing by
the Company:

               (o) refrain from altering, removing or in any way obscuring any of the designations or marking
on the Products before or after the sale of the Products by Distributor, and

               (p) not make any representation or warranty regarding the Company or the Products, except for
those warranties regarding the Products made by the Company in a writing accompanying the Products
or as expressly authorized by the Company in writing.

          1.4 Duties of the Company. The Company shall provide Distributor with reasonable
quantities of marketing materials and promotional literature regarding the Products, together with
such additional promotional and marketing supplies as the Company reasonably determines at no
charge to Distributor. All such materials shall be and remain the property of the Company and
shall promptly be returned to the Company upon expiration or termination of this Agreement.

          1.5 Rights of the Company. The Company shall have the right, in its sole discretion,
to:

               (a) establish, change, alter or amend, from time to time, prices and other terms and
conditions governing the sale and delivery of the Products;

               (b) accept or reject any order for the purchase of Products. No contract for sale of Products
shall result except by the Company’s written acceptance of an order;

               (c) suspend or cancel deliveries of Products for any reason which the Company deems
sufficient; and

               (d) amend Schedule A to this Agreement by adding or deleting Products at any time and from
time to time upon thirty (30) days’ written notice to Distributor.

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          1.6 Responsible Party. The Responsible Party shall have full authority and
responsibility for Distributor’s performance pursuant to this Agreement.

     Section 2. Solicitation and Acceptance of Orders.

          2.1 Solicitation of Orders. Unless otherwise authorized by the Company in writing.
Distributor shall:

               (a) quote only those prices (“List Prices”) for Products which have been established by the
Company from time to time and such other terms and conditions with respect to the sale of Products
as may be established by the Company from time to time (all of which may be established and/or
changed in the sole discretion of the Company by written notice to Distributor);

               (b) make only such representations as to the quality, capacity and other technical and
operational features of Products as may from time to time be authorized in writing by the Company:

               (c) make each quotation subject to the express condition that it and any order of the Customer
based on it shall be subject to the written approval and acceptance of the Company, and

               (d) send copies of all quotations promptly to the Company upon receipt thereof.

          2.2 Acceptance of Orders. The Company reserves the right to accept or reject in whole
or in part any order solicited by Distributor and no order shall be effective unless and until
accepted in writing by the Company. The Company shall notify Distributor in writing no later than
five (5) business days after the Company’s receipt of an order if it intends to reject such order
or any part thereof.

          2.3 Billing of Customers. All Products for which orders are accepted by the Company
will be shipped and billed by the Company directly to the Customer. All payments made by any
Customer shall be made directly to the Company, and Distributor shall have no authority to directly
bill Customers or make collections from Customers except when requested by the Company in writing
to do so.

     Section 3. Commissions.

          3.1 Payment of Commissions. The Company shall pay to Distributor a commission equal
to a percentage of the Net Sales Price (as such term is defined below) determined by reference to
Schedule B to this Agreement. The Company may, at any time and from time to time, upon thirty (30)
days written notice to Distributor, make changes to the commission percentages set forth in
Schedule B to this Agreement; provided, however, no such changes shall affect the commissions
payable pursuant to any order accepted by the Company prior to the effective date of the change.
Subject to the terms of this Section 3, such commissions shall be paid to Distributor no later than
the last day of the calendar month following the calendar month in which the Company accepts in
writing any order solicited by and submitted to the Company by the

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Distributor. Commission paid pursuant this Section 3.1 shall constitute the full compensation
and consideration due to Distributor for the performance of services and the agreements of
Distributor contained herein.

     The Company may cancel, alter or permit cancellation or alteration by its Customers of any
order before or after acceptance, may accept return of any or all Products sold and may grant such
allowances as the Company may, in its sole discretion, determine, without incurring any liability
to Distributor in respect thereof for the payment of any commission, and the Company shall provide
written notice to Distributor of any adjustment in the commission payable to Distributor as a
result (“Adjustment Notice”). In the event of (i) cancellation or alteration of any order, (ii)
return of Products or allowances granted to any Customer for any order, or (iii) any order for
which actual payment from the Customer is not received by the Company within ninety (90) days from
the date on which the Company ships the Products to the Customer, the amount of commissions payable
with respect to such order shall be reduced, or if commission with respect to such order has been
paid to Distributor, a credit shall be applied against future commissions earned by Distributor so
that, in any such case, the total commissions received by Distributor reflect the amount
Distributor should have received based on the final Net Sales Price for such order. If
insufficient future commissions have been earned by Distributor under this Agreement within ninety
(90) days after Distributor’s receipt of the Adjustment Notice to credit such amount, then
Distributor shall immediately refund to the Company any commissions paid so that the total
commissions received by Distributor reflect the amount Distributor should have received based on
the final Net Sales Price for such order. The Company shall not be liable to Distributor for any
failure, delay or errors in delivery or shipment of any Products to any Customers, whether or not
caused by conditions within the reasonable control of the Company.

          3.2 Net Sales Price. For the purposes of this Agreement, “Net Sales Price” shall
mean, with respect to orders for Products solicited by Distributor in the Territory, the price
invoiced to the Customer, by the Company, for such Product, less any freight, storage, handling and
insurance charges, custom duties, clearance charges, discounts, credits, return allowances, taxes
and similar items, whether or not separately invoiced.

          3.3 Commissions Payable After Termination. Following the expiration or termination of
this Agreement, the Company shall pay Distributor commissions as provided for in Section 3.1 only
on those sales of Products made pursuant to an order accepted by the Company prior to the
expiration or termination of this Agreement. The commissions, if any, shall be paid only after the
Company has received full and final payment from Customers in accordance with the terms and
conditions of such sales. The obligation of the Company to pay commissions pursuant to this
Section 3.3 is expressly conditioned upon Distributor’s full and timely performance of all
continuing obligations of Distributor pursuant to this Agreement and to Distributor’s cooperation
with all reasonable requests for the Company with respect to continuing orders. Distributor shall
not be entitled to further compensation of any kind upon expiration or termination of this
Agreement. Following the expiration or termination of this Agreement, Distributor shall promptly
refund the amount of any outstanding adjustments or credits to commissions paid to the Distributor.

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          3.4 Expenses. All expenses incurred by Distributor in connection with this Agreement
shall be for Distributor’s own account and shall not be subject to reimbursement by the Company.

     Section 4. Confidential Information and Inventions.

          4.1 Confidentiality. All Confidential Information (as defined below) shall be the
sole property of the Company, and the Company shall be the sole owner of all patents and other
intellectual property rights in connection therewith. Distributor hereby assigns to the Company
any rights it may have or acquire in all Confidential Information and any intellectual property
rights it may acquire in connection with its performance of its obligations under this Agreement.
At all times during the term of this Agreement and thereafter, Distributor shall keep in confidence
and trust all Confidential Information, and Distributor shall not use for any other purpose than
soliciting orders for Products, or disclose to any third party, any Confidential Information
without the written consent of the Company.

     The confidentiality obligations contained in this Section 4.1 shall not apply to the extent
that Distributor can demonstrate that the Confidential Information (i) was in the public domain at
the time it was disclosed or has entered the public domain through no fault of Distributor, (ii)
was known to Distributor, without restriction, at the time of disclosure, as demonstrated by files
in existence at the time of disclosure, (iii) is disclosed with the prior written approval of the
Company, (iv) was independently developed by Distributor without any use of the Confidential
Information, as demonstrated by files created at the time of such independent development, (v)
becomes known to Distributor, without restriction, from a source other than the Company without
breach of this Agreement by Distributor and otherwise not in violation of the Company’s rights,
(vi) is disclosed pursuant to the order or requirement of a court, administrative agency, or other
governmental body, provided, however, that Distributor shall provide prompt notice thereof to the
Company to enable the Company to seek a protective order or otherwise prevent or restrict such
disclosure.

          4.2 Confidential Information. For purposes of this Agreement, “Confidential
Information” shall mean, collectively, all technical, financial and business information of any
kind whatsoever including, where appropriate and without limitation, all data, compilations,
specifications, strategies, projections, prototypes, reports, customer lists, customer ordering
patterns, pricing structures and discount information, all tangible and intangible embodiments
thereof of any kind whatsoever and any other information relating to the Company, the Products, the
Company’s business or the business of any third party, in each case disclosed by the Company to
Distributor or obtained by Distributor through observation or use of the foregoing in circumstances
in which Distributor is told or should reasonably believe that the information has been provided on
a confidential basis.

          4.3 Confidential Information After Termination. Distributor further agrees that
immediately upon expiration or termination of this Agreement with the Company or at any other time
requested by the Company, and as a condition precedent to the Company’s obligations to pay any
commissions then due to Distributor under this Agreement, Distributor shall promptly deliver to the
Company any and all property belonging to the Company, including without limitation, all

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Confidential Information (including all physical repositories or photocopies thereof) then in
Distributor’s custody, control or possession.

          4.4 Inventions and Discoveries.

               (a) Distributor shall promptly disclose to the Company all inventions, discoveries and
improvements, whether patentable or not, made or conceived during the term of this Agreement which
are within or related to the existing or contemplated scope (now or at any later time during such
period) of the business of the Company. Any invention, discovery or improvement shall be deemed to
have been made during the term of this Agreement if it is made or conceived prior to a date which
is one hundred twenty (120) days after expiration or termination of this Agreement.

               (b) Distributor shall, upon request, assign to the Company or to any other party designated by
the Company any or all of said inventions, discoveries or improvements, any patent applications
filed thereon, together with all extensions, reissues and renewals thereof in this and in all
foreign countries; and Distributor shall promptly execute all proper papers for these purposes and
for use in applying for, obtaining and maintaining all such patents as the Company may request, but
at the expense of the Company. Distributor’s obligation to execute the papers and make assignments
as specified in this Section 4.4(b) shall continue beyond the term of this Agreement and shall bind
the Distributor’s successors and assigns.

     Section 5. Indemnification and Insurance.

          5.1 Indemnification by Company. Company and the Distributor shall each defend,
indemnify and hold harmless the other, its officers, directors, agents, subagents, consultants,
employees, shareholders, parent, subsidiaries and affiliates from and against any and all claims,
liability, and expenses, including reasonable attorneys’ fees and costs, which arise as a direct
result of: (a) a breach of any warranty made by the indemnifying party hereunder; or (b) the gross
negligence or willful misconduct in the performance of this Agreement attributed to the
indemnifying party, its officers, directors, agents, sub-agents, consultants, employees,
shareholders, parent, subsidiaries and affiliates.

          5.2 Insurance. Distributor shall maintain, at its own cost and expense, the following
kinds of insurance, in such amounts as it customarily maintains for similar activities, covering
Distributor as the insured: (i) workmen’s compensation as required by applicable law, (ii) public
liability insurance for bodily injury and property damage, (iii) automobile liability and (iv)
product liability insurance against claims regarding the manufacture, sale, distribution or use of
the Products under the Agreement.

     Section 6. Property Rights.

          6.1 Records. All records of the accounts of customers and any other records and books
relating in any manner whatsoever to Customers, Products or the Company, whether prepared by
Distributor or otherwise coming into its possession, shall be the exclusive property of the

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Company. Upon expiration or termination of this Agreement, Distributor shall deliver all such
books and records in its possession to the Company in accordance with the Company instructions.

          6.2 Trademarks. The Company authorizes Distributor to use, in connection with the
sale, promotion and advertising of Products, such trademarks and trade names as may be used by the
Company in the advertising, promotion and sale of Products. Distributor shall have no right or
interest in or claim to any such marks or names and shall not use them in any manner which might
tend to defeat or diminish them. Distributor shall not use the Company’s name or any such marks or
names in its trade name and shall immediately discontinue all use upon demand of the Company, and,
in any event, upon expiration or termination of this Agreement.

          6.3 Copyrights. Distributor hereby acknowledges that the Company has claimed, or may
claim, sole and exclusive copyright protection with respect to certain parts of the marketing
materials and promotional literature regarding the Products. Distributor shall take no action or
make no omission which is in any way inconsistent with the Company’s claim of copyright protection
with respect to such items. Nothing contained in this Section 6 shall prohibit Distributor from
copying, and distributing to its sales representatives, such marketing materials and promotional
literature prepared by or on behalf of the Company and provided to Distributor for the purpose of
fulfilling Distributor’s obligations under this Agreement. All such copyrighted materials of the
Company used by Distributor in conducting its activities contemplated by this Agreement shall bear
appropriate copyright markings.

     Section 7. Representations and Warranties.

     Distributor represents and warrants to the Company as follows:

          7.1 Corporate Existence and Power. Distributor is a corporation duly organized,
validly existing and in good standing under the laws of the jurisdiction in which it is
incorporated.

          7.2 Authorization and Enforcement of Obligations. Distributor (a) has the corporate
power and authority and the legal right to enter into this Agreement and to perform Distributor’s
obligations hereunder and (b) has taken all necessary corporate action on Distributor’s part to
authorize the execution and delivery of this Agreement and the performance of Distributor’s
obligations hereunder. This Agreement has been duly executed and delivered on behalf of
Distributor, and constitutes a legal, valid, binding obligation, enforceable against Distributor in
accordance with its terms.

          7.3 Consents. All necessary consents, approvals and authorizations of all
governmental authorities and other persons or entities required to be obtained by Distributor in
connection with this Agreement have been obtained.

          7.4 No Conflict. The execution and delivery of this Agreement and the performance of
Distributor’s obligations hereunder (a) do not conflict with or violate any requirement of
applicable laws or regulations, and (b) do not conflict with, or constitute a default under, any
contractual obligation of Distributor. Distributor further warrants that it does not currently
promote, market or solicit order for products that are competitive with the Products.

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     Section 8. Term and Termination.

          8.1 Term. The effective date of this Agreement shall be the later of the date of this
Agreement first above written and approval of the Company’s X-Stop implant product by the United
States Food & Drug Administration for sale in the United States (the “Effective Date”); provided,
however, that Sections 1.1, 1.2, 1.3(c), 1.3(j), 1.3(l), 1.3(m), 1.3(p), 4, 5, 6, 7, 8 and 9 shall
be effective and binding upon the execution of this Agreement by the parties. The initial term of
this Agreement shall be one (1) year from the Effective Date, subject to earlier termination
pursuant to Section 8.2 below. After the initial one year term of this Agreement, this Agreement
shall be automatically renewed for successive one (1) year periods unless either party shall have
delivered written notice to the other, not later than thirty (30) days prior to the expiration of
the initial term or any subsequent renewal term, that such notifying party does not intend to renew
this Agreement after the expiration of such term or except as provided in Section 8.2 below.

          8.2 Termination. The Company shall have the right to terminate this Agreement at any
time with or without cause on thirty (30) days written notice to Distributor, and this Agreement
shall terminate immediately upon the [death or disability of the Responsible Party or] voluntary or
involuntary bankruptcy, insolvency or similar proceeding with respect to Distributor. In the event
of a breach by a party to this Agreement of any of its covenants or agreements hereunder, the other
party may terminate this Agreement by giving the breaching party ten (10) business days written
notice effective on the expiration of the 10-business day period specified herein.

          8.3 Effect of Termination. Expiration or termination of this Agreement shall not
relieve the Company or Distributor of any obligation accruing prior to such expiration or
termination. The provisions of Section 3.3, Section 3.4, Section 4 and Section 5.1 shall survive
the expiration or termination of this Agreement.

     Section 9. Miscellaneous.

          9.1 Waiver. The failure of either party to enforce at any time, or for any period,
any provision of this Agreement shall not be construed as a waiver of the provision or of the right
of such party thereafter to enforce such provision. No claim or right arising out of the breach of
this Agreement may be discharged in whole or in part by a waiver or renunciation of the claim or
right unless the waiver of renunciation is in writing and signed by the aggrieved party.

          9.2 Assignment. This Agreement shall inure to the benefit of and shall be binding
upon Distributor and its successors, and the Company and its successors and assigns; provided
however, that Distributor may not assign or delegate any of its rights or obligations hereunder
without the prior written consent of the Company.

          9.3 Construction. No course of prior dealing between the parties and no usage of the
trade shall [be relevant to supplement, explain or] vary the terms used in this Agreement. Any
ambiguity shall not be construed against either party because it drafted or participated in the
preparation of this Agreement.

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          9.4 Severability. In the event any provision hereof is held by a court of competent
jurisdiction to be invalid or unenforceable or to violate any applicable law, it shall be deemed
null and void to the extent thereof, without invalidating, amending or deleting any other term or
provisions of this Agreement.

          9.5 Governing Law. This Agreement shall be governed by and construed in accordance
with the laws of the State of California, without regard to the conflicts of law principles
thereof. All disputes arising under this Agreement shall be decided by a court of competent
jurisdiction located in the State of California, to the jurisdiction of which all parties hereto do
hereby submit.

          9.6 Notices. Unless agreed to in writing by the parties hereto, all communications
provided for hereunder shall be in writing and shall be deemed to be given (i) when given if
delivered in person, (ii) on the next business day if delivered by facsimile or overnight courier
(iii) five (5) business days after being sent by first-class mail, registered or certified, return
receipt requested, with proper postage prepaid at:

	 	 	 	 	 	 
	 

	 	If to the Company:
	 	St. Francis Medical Technologies, Inc.	 
	 

	 	 	 	960 Atlantic Avenue, Suite 102	 
	 

	 	 	 	Alameda, CA 94501	 
	 
	 	 	 	 	 
	 

	 	If to Distributor:
	 	 
	 
	 

	 	 	 	 
	 
	 

	 	 	 	 
	 

          9.7 Entire Agreement. This Agreement is intended by the parties hereto to be the
final expression of their agreement with respect to the subject matter hereof and is the complete
and exclusive statement of the terms hereof, notwithstanding any representations, statements or
agreements to the contrary heretofore made. Only a written instrument signed by each of the
parties may modify any provision of this Agreement.

          9.8 Headings. The section and paragraph headings contained in the Agreement are for
reference purposes only and shall not affect in any way the meaning or interpretations of this
Agreement.

          9.9 Counterparts. This Agreement may be executed in one or more counterparts, each of
which shall be deemed to be an original but all of which together shall constitute one and the same
agreement.

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     IN WITNESS WHEREOF, the parties hereto have executed the Agreement as of the date first
written above.

	 	 	 	 	 
	 	 	St. Francis Medical Technologies, Inc.
	 
	 	 	 	 
	 

	 	By:	 	 
	 

	 	 	 	 
	 
	 	 	 	 
	 

	 	Its:	 	 
	 

	 	 	 	 
	 
	 	 	 	 
	 	 	[Distributor]
	 
	 	 	 	 
	 

	 	By:	 	 
	 

	 	 	 	 
	 
	 	 	 	 
	 

	 	Its:	 	 
	 

	 	 	 	 
	 
	 	 	 	 
	 	 	[Responsible Party]
	 
	 	 	 	 
	 	 	 
	 
	 	 	 	 
	 

	 	Name:	 	 
	 

	 	 	 	 

 

 

Schedule A

Products for Sale

X Stop Instruments and Implants

 

 

Schedule B

Commission Structure

     % Commission on Net Sales

Territory Assignment:exv10w11

 

Exhibit 10.11

     This AGREEMENT (“Agreement”) is made and entered the                      200    
 “Effective Date”) by and
between (herein after called “Supplier”) a                      corporation with its principal
place of business at                      and                      (herein after called
“Distributor”)                      company with its principal place of business at                                                                                 .

WITNESSETH

     WHEREAS, the Supplier is engaged in the business of the sale of orthopaedic implants and
instruments manufactured by its parent company St. Francis Medical Technologies, Inc. residing at
960 Atlantic Avenue, Suite 102, Alameda, California, USA, (hereinafter called: Manufacturer) as
described in Exhibit B, hereinafter collectively referred to as the “Products” and individually as
a “Product”.

     WHEREAS, the Distributor has knowledge and experience in distributing and servicing such
products and desires to purchase the Products from Supplier for resale to and servicing customers
for the Products.

     WHEREAS, Supplier and Distributor desire to execute this Agreement to evidence the terms and
conditions of their business relationship for a three (3) year period, with the possibility of
extending such relationship subject to the terms and conditions set forth herein;

     NOW, THEREFORE, in consideration of the premises and of the mutual covenants and other terms
and conditions contained herein, the parties hereto agree as follows:

     1. Appointment; Territory.

          1.1 Supplier hereby appoints Distributor, and Distributor hereby accepts such appointment, as
the exclusive, stocking independent distributor of the Products for sale in the “Territory” (as
defined below).

          1.2 Subject to the terms and conditions set forth in this Agreement, the Distributor shall
have the exclusive right to distribute the Products allocated to such Distributor hereunder in all
of the areas set forth on Exhibit A attached hereto (the “Territory”). Supplier reserves all areas
other than the Territory for itself to exclusively distribute the Products or to grant third
parties such distribution rights. Distributor shall not actively approach customers outside the
Territory. Nothing contained herein shall in any manner be deemed to restrict or limit the ability
of Manufacturer and/or Supplier to appoint another distributor for the Products in areas other than
the Territory.

          1.3 Conflict of Interest. Distributor warrants to Supplier that Distributor does not
currently represent or promote any lines or products that compete with the Products. During the
term of this Agreement, with a maximum of five years (inclusive of extensions of this Agreement),
Distributor shall not, without Supplier’s prior written consent, represent, promote or otherwise
try to sell within the Territory any lines or products that, in Supplier’s judgment compete with the
Products covered by this Agreement.

 

 

          1.4 Sub-distribution: The Distributor shall not appoint any sub-distributor in the Territory,
without the prior written consent of Supplier.

     2. Term.

     This Agreement shall become effective on the date of its signature by both parties (“Starting
Date”) and shall remain in force for a period of three (3) years unless terminated early due to
failure to comply with the terms of this agreement. Six (6) months before the end of the initial
term, renewal of this Agreement for additional periods of one (1) year will be discussed and
negotiated. The parties are however not obliged to renew this Agreement.

     3. Products price and delivery:

          3.1 The Products and their prices per Product unit to be paid by the Distributor to the
Supplier shall be as set forth in Exhibit B.

     Exhibit B could be amended from time to time at the sole option of the Supplier by delivery of
a copy thereof to the Distributor to provide for additional Product(s) or to delete discontinued
Product(s). The Supplier shall give the Distributor at least 90 days prior written notice
preceding the date the change becomes effective of each price change. The Supplier will honor the
Distributor’s existing purchase orders at the prices in effect immediately prior to the effective
date of any such notice.

          3.2 Terms of payment shall be

	 	•	 	60 days from the date of the invoice. Every order is to be supported
by a Letter of Credit from an accredited official commercial bank in the
“Territory”.
	 
	 	•	 	Further orders will only be implemented with payment under
“Cash-on-Delivery” conditions. Supplier will compensate Distributor for
such payments with     % of the net value of the order.

     Any invoiced amount not paid when due shall be subject to a service charge at a rate of one
percent (1.5%) per month over the bank charge at the moment as permitted by law. If Distributor
fails to make any payment to Supplier when due, Supplier may, without affecting its rights under
this Agreement or law, cancel or delay any future shipments of the Products to Distributor. The
Product is delivered Ex Works as defined in Incoterms 2000. Shipping and handling costs will be
paid by the Supplier and invoiced by the Supplier to the Distributor. Transfer of risk of the
Products occurs when Supplier places them at the disposal of the carrier. Title to the Products
shall continue to be
held by Supplier until all amounts payable by Distributor in connection to any deliveries by
Supplier, including interests and collection costs, have been paid in full by Distributor to
Seller.

-2-

 

          3.3 Supplier shall deliver the Products within 10 working days after the order has been placed
by the Distributor and provided that the ordered amounts per month do not exceed the amounts
forecasted under 6.3 (b) of this agreement. In the event of excess ordering, Supplier will inform
Distributor of the applicable delivery terms. The mere fact of a delivery term being exceeded
shall not constitute default on Supplier’s part nor does it constitute a right to defer payment.

          3.4 Re-label of products: The Supplier agrees to supply the Distributor with the Products
labelled according to CE Mark specifications. In the event local law or practice necessitates
substitute or additional labelling, the Distributor agrees to draft and produce the substitute or
additional labelling and submit it to the Supplier for written approval before applying it to the
Product or distributing it in any manner.

     4. Record Keeping.

     The Distributor agrees to maintain appropriate records of the distribution of all Product(s)
consistent with the information requirements described in the United States Food and Drug
Administration’s Medical Device Reporting Regulations and applicable sections of the United States
Food and Drug Administration’s Quality Systems Regulations (21 Code of Federal Regulations 820,
sections 820.140, 820.150, 820.160), or any applicable future (replacement) regulations. On
request, the Supplier will provide the Distributor with a copy of these information requirements,
in addition, for distribution of the Product(s) within the European Community, the Distributor
agrees to comply with the Final Draft of Guidelines on a Medical Devices Vigilance System,
published by the Joint Commission of the European Communities (MEDDEV 2.12-1 rev 4, April 2001)
[Attachment #1], or any applicable future (replacement) regulations or guidelines.

     The distribution records will contain at a minimum, the following information for each
shipment of Product:

	 	–	 	name and address of the customer or consignee
	 
	 	–	 	Product numbers and quantity of each Product number sold
	 
	 	–	 	date the Product was sold
	 
	 	–	 	lot number and/or serial number as applicable

     The Supplier may review these records at its discretion and in case of product recall or when
regulatory or quality regulations requires.

     If the Agreement with the Distributor ends or is terminated or if the Distributor ceases
operations, then the Distributor will provide the Supplier copies of all of its distribution
records for Product(s) within 30 days of the end or termination of the Agreement or the
Distributor’s cessation of operations.

5. Product Warranty; Technical Support

          5.1 Supplier warrants to Distributor that Products purchased by Distributor hereunder will be
free from defects in materials and workmanship under normal use and conditions at the time of
shipment of such Products to Distributor and that said Products are manufactured in full compliance
with the Company Quality System of Manufacturer, in particular in compliance with

-3-

 

the International
Standards CE Mark, ISO 13485:1996, EN 46001:1996, and any applicable future (replacement)
standards. This warranty is intended solely for the benefit of Distributor. All claims hereunder
shall be made by Distributor and may not be made by Distributor’s customers. This warranty does
not extend to Products that have been subject to misuse, accident, tampering or improper
installation. This warranty is in lieu of all other warranties, express or implied, all of which
are hereby disclaimed and excluded by Supplier, including, without limitation, any warranty of
merchantability or fitness for a particular purpose or use and all obligations or liabilities on
the part of Supplier for damages arising out of or in connection with the use, repair or
performance of the Products.

          5.2 Upon receipt of the Products, Distributor will inspect them in accordance with Exhibit D
sub 3. If any Product is defective at the time of shipment to Distributor, Supplier will, at its
option, either replace or repair such Product or refund the purchase price thereof; provided that
in each case such Product is returned at Supplier’s expense to Supplier within thirty days after
the date of original shipment. Prior to returning any Product alleged to be defective, the
Distributor agrees to notify Supplier in writing in accordance with Exhibit D sub 3, with a
description of the claimed defect, and shall include the model and lot number of such Product. No
Product shall be returned without a Returned Goods Authorisation (RGA) obtained in advance from
Supplier, said RGA not to be unreasonably withheld. Returned Products travel at the risk of
Distributor. The obligations of Supplier under this subparagraph 5.2 are the exclusive remedies
for any breach of Product warranty. The sole purpose of these remedies shall be to provide
Distributor with the replacement or repair of non-conforming Products, or, alternatively, a refund
of the purchase price thereof, in the manner provided in this subparagraph 5.2. These exclusive
remedies shall not be deemed to have failed their essential purpose so long as Supplier is willing
and able to repair or replace the non-conforming Products or refund the purchase price thereof in
the manner provided in this subparagraph 5.2. Supplier neither assumes, nor authorizes any other
person to assume for it, any other additional liability or responsibility in connection with the
Products.

          5.3 Any liability of Supplier to Distributor for failure attributed to Supplier in the
performance of the obligations under the Agreement, on the basis of a wrongful act of Supplier or
Manufacturer or any other basis shall be limited to compensation for the direct damage to a maximum
of                     , except for damage caused by wilful intent or gross negligence by Supplier, meaning
wilful intent or gross negligence by Supplier’s senior executives.

          5.4 Supplier and Manufacturer shall not be liable for consequential or indirect damage
suffered by the Distributor. Consequential/indirect damage is understood to mean all damage which
is not direct damage, including but not limited to, loss of profit, loss due to discontinuation of
the company, loss of information/ data files, non-material damage and missed savings.

          5.5 Supplier and Manufacturer shall nave no liability to Distributor in the event that the
Distributor has not taken measures immediately after the damage causing event took place in order
to limit the damage or prevent more or other damage respectively, as well as not giving Supplier
all the relevant information regarding this matter as soon as reasonably possible and not giving
Supplier the opportunity to take measures to minimise the loss. Every right to damages shall

-4-

 

further lapse in the event Distributor did not institute legal proceedings regarding its alleged
claim within one year after the damage causing event took place.

     6. Product Sales Promotion and Co-operation

          6.1 The Distributor shall use its best efforts to promote and sell the Products in the
Territory. Without limiting the generality of the foregoing, Distributor shall maintain Product
inventory and personnel adequate to meet customer demand for Product sales and services in the
Territory, The Distributor shall also designate appropriate personnel to attend an initial Product
training session which may be held at Supplier’s facilities in                     , or at such other
location as Supplier may reasonably designate. Supplier shall provide such initial Product
training without charge. The Distributor shall bear travel costs of its personnel and Supplier
shall bear meals and lodging expenses, according to Supplier’s practices for its own employees,
directly associated with Distributor’s personnel’s attendance at such training session.

     The Distributor shall be solely responsible for all sales, advertising, promotional and
training expenses incurred in connection with promoting and selling the Products allocated to it
hereunder in the Territory. The Distributor shall offer for sale and sell its Products only on the
basis of the Product information, representations and “Limited Warranty Policy”, as defined in
sections 5.1, 5.2 and 5.4 above, which Supplier provides to Distributor or which are approved by
Supplier in advance for their use.

          6.2 The Supplier shall supply the Distributor with English language sales aids and Product
promotional materials, including brochures, technique guides, article reprints and videotapes
(collectively: “Promotional Materials’), so that the Distributor may employ them in its promotional
efforts. The Distributor is authorised to, at his expense, modify the Promotional Materials before
use. Modifications include, but are not limited to, translations into local language or
overlabelling. The Distributor must submit any modification in Promotional Material to the
Supplier for written approval, which approval may be withheld at Supplier’s sole discretion. For
approval, the Distributor will supply the Supplier three copies of the modified Promotional
Materials for the Supplier’s regulatory records. Distributor shall only use modified Promotional
Materials after receipt of Supplier’s written approval. Distributor will equip all its spinal
product specialists with a product demonstration kit (see Exhibit B) at its expense, as these also
can be deployed for individual surgical loaner cases.

          6.3 Quotas; Forecasts

     Quota. The Distributor will be required to sell a minimum number of Products annually in the
Territory (the “Quota”). The Quota for the initial one-year term of this Agreement is set forth on
Exhibit E hereto. The Quota is broken down into quarterly Product unit sales. The Distributor and
the Supplier have mutually agreed upon the targets for Product unit sales of the Product(s) in the
Territory (the “Minimum Performance Requirement”) for the four (4) quarters commencing at the
Starting Date. This Minimum Performance Requirement is documented and attached to the Agreement as
Exhibit E. At least 90 days prior to each of the Starting Date’s anniversaries, the Distributor
and the Supplier will agree upon a Minimum Performance Requirement for the four (4)

-5-

 

quarters
commencing at the respective anniversary. These agreed-upon Minimum Performance Requirements will
be documented and attached to the Agreement as Exhibit E.

               (a) The minimum sales of Products per quarter will be 20 percent (20%) of the annual Quota for
the respective year. Distributor is to hold an inventory to satisfy at least 1 month of sales, but
no more than 3 months of actual sales in units.

               (b) Forecasts. Upon execution of this Agreement, the Distributor will provide Supplier with a
written twelve (12) month forecast of the Sales of Products it expects to generate in the
Territory. Thereafter, the Distributor will furnish to Supplier within 20 business days before the
beginning of each quarter a written rolling twelve (12) month forecast of the sales of Products it
expects to generate in the Territory in order to secure appropriate product availability from
Supplier. Each forecast will constitute a non-binding good faith estimate of expected sales of the
Products.

               (c) Special Right to Terminate Agreement. The Distributor understands and agrees that the
establishment and achievement of the Quota pursuant to Section 6.3a is the essence of this
Agreement and that any failure by the Distributor to satisfy its obligation under Section 6.3a will
entitle Supplier to terminate this Agreement pursuant to Section 11. In addition, the Distributor
understands and agrees that the failure to agree with Supplier on an annual Quota for any year will
entitle Supplier to terminate this Agreement upon thirty (30) days written notice pursuant to
Section 11.

7. Product Names, Trademarks.

          7.1 Supplier hereby grants to the Distributor a non- exclusive and non-transferable license
permitting it, its agents and its subdistributors to use Supplier’s name, all marks and designs on
the packaging of the Products and trademarks as described in Exhibit F, (the “Trademarks”) solely
to promote and sell the Products allocated to such Distributor pursuant to this Agreement. The
Distributor shall not:

	 	–	 	use or permit any agent or subdistributor of the Distributor to
use any trademark or product names confusingly similar to those used by
Supplier; or
	 
	 	–	 	use or permit any agent or subdistributor of the Distributor to
use the Trademarks on any objects not containing the Products.

     Distributor agrees that Supplier and/or Manufacturer own all right, title and interest in the
Trademarks. Except as specifically provided herein, nothing in this Agreement shall be deemed to
confer or transfer upon the Distributor, any of its agents or any of its subdistributors any right,
title or interest in any of the Trademarks.

     Any other intellectual property rights, including but not limited to patents, patent
applications, design rights, copyrights, database rights, or trade secrets with respect to the
Products (collectively referred to as “Product IP”) shall remain with Supplier and/or Manufacturer.
Unless expressly stipulated otherwise in this Agreement, none of the Product IP or license thereof
shall be transferred or granted to Distributor, any of its agents or any of its subdistributors.

-6-

 

     Unless expressly agreed otherwise herein or permitted under mandatory statutory provisions and
upon 60 days written notice to Supplier, Distributor shall not further develop, alter or modify the
Product nor make any copy of the Products.

          7.2 The Distributor agrees to notify Supplier in writing of any claim or action or
infringement threatened or brought against the Distributor, conflicting uses of, application or
registrations for, or acts of infringement or unfair competition involving the Products or Product
IP, promptly after the Distributor learns of any such matter. The Distributor shall furnish all
records, documents, specimens and testimony relating to such claim or action as Supplier may
request and shall otherwise cooperate with Supplier in any such claim or action.

          7.3 Except as otherwise required by applicable law or other governmental regulation, Supplier
shall manage any registrations for the Products, Product IP or its reimbursement or the Trademarks
required by local government authorities, and the Distributor agrees to provide such assistance in
such registrations as Supplier may from time to time request. Supplier and/or Manufacturer at all
times owns such registrations. Distributor shall not make any registration relating to the
Products unless expressly agreed upon by the parties in writing.

     8. Confidential information.

          8.1 The Distributor acknowledges that, during the continuance of this Agreement, it may have
access to Product IP, (other) proprietary business information and to trade secrets of Supplier
and/or Manufacturer regarding the Products, including but not limited to, information regarding
surgical procedures relating to the installation of the Products (collectively, the “Confidential
Information”). To the extent Supplier considers any such information to be Confidential
Information, it will so indicate to such Distributor, in the case of information in documentary or
other tangible form, by summarising or identifying the same in writing and sending such summary to
Distributor as confirmation that such information is Confidential Information. The Distributor
agrees that it shall use the Confidential Information solely to further sales of the Products as
contemplated by this Agreement and shall not disclose or use any such Confidential Information,
directly or indirectly, for any other purpose. The Distributor further agrees to take all steps
necessary or advisable to preserve and protect such Confidential Information. Without limiting the
generality of the foregoing, except as required or ordered by any governmental agency, court or
tribunal of competent jurisdiction, Distributor shall not, without obtaining prior approval of
Supplier, divulge such Confidential Information to any person who does not require access to it for
the purpose of exercising such Distributor’s rights or obligations under this Agreement.
Distributor further agrees that immediately upon expiration or termination of this Agreement and as
a condition precedent to the Suppliers obligations to pay any amount then due to Distributor under
this Agreement, Distributor shall promptly deliver to Supplier any and all property belonging to
the Supplier, including without limitation, all Confidential Information (including all physical
repositories or photocopies thereof) then in Distributor’s custody, control or possession.

          8.2 Distributor shall promptly disclose to Supplier all inventions, discoveries and
improvements, whether patentable or not, made or conceived during the term of this Agreement which
are within or related to the existing or contemplated scope (now or at any later time during such
period) of the business of Supplier and/or Manufacturer. Any invention, discovery or

-7-

 

improvement shall be deemed to have been made during the term of this Agreement if it is made or conceived
prior to a date which is one hundred twenty (120) days after expiration or termination of this
Agreement.

     Distributor shall, upon request, assign to Supplier or to any other party designated by
Supplier any or all of said inventions, discoveries or improvements, any patent applications filed
thereon, together with all extensions, reissues and renewals thereof in The Territory and in all
foreign countries; and Distributor shall promptly execute all proper papers for these purposes and
for use in applying for, obtaining and maintaining all such patents as Supplier may request, but at
the expense of Supplier. Distributor’s obligation to execute the papers and make assignments as
specified in this Section shall continue beyond the term of this Agreement.

     9. Government Regulations.

     At all times during the continuance of this Agreement, the Distributor shall have in affect
all licenses, permits and authorisations which are legally necessary or commercially advisable to
its performance hereunder. The Distributor shall comply with all local and                      laws, rules
and regulations necessary to the performance of this Agreement.

     10. Indemnification

          10.1 Distributor’s indemnity. Distributor shall indemnify and hold harmless Supplier, its
subsidiaries, affiliates, customers, and their directors, employees, successors and assignees
(“Supplier Indemnities”) from and against any losses, damages, claims, demands, suits, liabilities
and expenses (including court costs and reasonable attorneys fees) that arise out of or result from
(i) any acts or omissions of Distributor, his agents or employees or from any failure of the
Distributor, his agents or employees to perform its obligations under this Agreement (ii) any
performance or non-performance by Distributor or his agents or employees under this Agreement
resulting, in whole or in part, in any damage to property, injury to, or death of persons,
including those resulting from the use of any motor vehicle or other equipment or property, (iii)
the failure of Distributor to comply with any applicable laws, rules and regulation or (iv) the
failure to procure and maintain all licenses and permits necessary to the performance of its
business and its obligations hereunder, or in any way related to the breach by Distributor of its
representations, warranties or covenants hereunder. Distributor will give Supplier prompt written
notice of any such claim of loss, liability, damage or fine of which it becomes aware. Distributor
shall assume the investigation, defense or settlement of any action, at its own expense, with
counsel reasonably satisfactory to Supplier. Distributor shall not settle any such claim without
Supplier’s written consent unless such settlement contains a complete release of Supplier from any
liability.

          10.2 Insurance. Distributor shall maintain, at its own cost and expense, the following kinds
of insurance, in such amounts as it customarily maintains for similar activities, covering
Distributor as the insured: (i) workmen’s compensation as required by applicable law, (ii) public
liability insurance for bodily injury and property damage, (iii) professional liability insurance
(iv) automobile liability and (v) product liability insurance against claims regarding the
manufacture, sale, distribution or use of the Products under the Agreement.

-8-

 

          10.3 Supplier’s indemnity; product liability. Supplier shall indemnify and hold Distributor
harmless from and against any claim, toss, liability or damage (including courts costs and
reasonable legal fees) instituted by a third party against the Distributor (1) arising from the
application or use of any Product in the Territory or (2) which arise in territories other than
Distributor’s Territory, provided that such claim, loss liability or damage (including court costs
and reasonable legal fees) does not arise out of the act or omission of Distributor. Supplier
shall assume the investigation, defence and settlement of any such claim, at its own expense, with
counsel reasonably satisfactory to Distributor. Supplier shall not be liable for any settlement or
consent judgement or other voluntary final disposition of any claim of action effected without its
consent. The Distributor shall furnish all records, documents, specimens and testimony relating to
such claim or action as Supplier may request and shall otherwise cooperate with Supplier in any
such claim or action.

     11. Termination

          11.1 The following events constitute grounds for the Supplier to terminate the Agreement upon
the notice specified therein;

               (a) failure to agree upon a Minimum Performance Requirement, 30 days written notice;

               (b) the Distributor’s decision to sell a product in the Territory which is directly
competitive with the Product(s), as determined solely by the Supplier, with the Product(s), 10 days
written notice;

               (c) failure by the Distributor to comply with the provisions of Section 4, Record Keeping, 30
days written notice: and

               (d) failure by the Distributor to comply with the provisions of Schedule B, Sections 3-4,
Product Storage and Shipment, 30 days written notice;

     In the event the parties have not agreed respectively the Distributor did not remedy a breach
of its obligations within the applicable notice period, the Supplier has the right to terminate
this agreement with immediate effect by registered mail without owing any remuneration to the
Distributor.

          11.2 In addition to the grounds for termination upon notice set forth in Section 11.1 above,
this Agreement may be terminated with immediate effect by registered mail by either of the parties
hereto, without owing any remuneration to the other party, if the other party fails under any of
the following occasions:

               (a) The other party fails or defaults in the performance of any of its obligations under this
Agreement (other than mentioned under article 11.1 above) unless such failure or default is cured
within ten (10) days from the written notice of the terminating party or, in case or failure of
payment, within ten (10) days from the written notice, except for the case of force majeure as
defined hereafter, or

-9-

 

               (b) The other party suspends payment of its debts, enters or becomes subject to corporate
rehabilitation procedures, liquidation, dissolution or bankruptcy proceedings, makes composition
with its creditors, seeks relief under similar laws for debtors’ relief.

               (c) The other party sells or terminates all or substantially all of its business;

               (d) Failure by the Distributor to achieve the quarterly Minimum Performance Requirement for
two (2) consecutive quarters.

          11.3 If one of the events mentioned in article 11.1 and 11.2 occurs, Supplier has the right to
suspend its obligations under this Agreement immediately, without any written notice being
required.

     12. Assignment of Rights and Change of Control

          12.1 Distributor may not assign or license its rights and obligations under this Agreement in
whole or in part to any third party (including subsidiary/group companies) without prior written
consent of Supplier. Supplier has the right to transfer its rights and obligations under this
agreement at all times without requiring Distributor’s consent.

          12.2 In the event of a change of control over Distributor, included but not limited to a
change in Distributor’s executive management or a transfer of ownership or transfer of the voting
power in Distributor, Supplier has the right to terminate this Agreement with immediate effect by
registered mail.

          12.3 In the event of a change of control over Supplier and/or Manufacturer, included but not
limited to any reorganization, bankruptcy of, or any sale of substantially all the assets of, or
any transfer of control of more than 50% of the voting power of Supplier and/or Manufacturer,
Supplier has the right to terminate this Agreement with immediate effect by registered mail.

     13. Effects of Termination

     Upon the termination or expiration of this Agreement, the following provisions shall apply:

          13.1 Pending orders. Supplier shall honour all orders transmitted by Distributor to Supplier
prior to the date of termination upon all of the terms and conditions contained herein.

-10-

 

          13.2 Payments by Distributor. Distributor shall pay Supplier all unpaid amounts for Products
purchased by Distributor from Supplier on their due date.

          13.3 Reversion of rights to Supplier. Distributor shall have no further right to use in any
way the Trademarks, Product IP or Confidential Information as authorised by section 7.1 and 8. All
rights granted by this Agreement to Distributor shall expire, and shall revert to Supplier.
Distributor shall convey to Supplier any rights it has to the Trademarks or any derivation thereof
and shall promptly return to Supplier any and all written and electronic documents and copies
thereof containing Trademarks, Product IP or Confidential Information, unless otherwise agreed to
between the parties. Distributor will upon Supplier’s first request transfer any and all Product
registrations or reimbursements listings to (the name of) Supplier, or render all required
co-operation for such transfer.

          13.4 Provision that are intended to survive termination or expiration of this agreement,
including but not limited to Sections 4, 8, 9 and 10, shall survive any termination or expiration.

          13.5 In case of contract termination as referred to in § 13.1 Supplier offers a buy back
provision as applicable to all the products that are commercially usable. Implants, with a
remaining shelf life of at least 1 year and in undamaged original packaging, are bought at            of
the price originally invoiced, capped to the inventory as specified in § 6.3a. Instruments at a
depreciation over                 starting at           % of the price originally invoiced.

     14. Relationship of the Parties.

     The relationship between the Supplier and the Distributor hereunder is that of a buyer and
seller, not principal and agent, with the Distributor purchasing Products for resale for its own
account. As an independent contractor, the Distributor shall have complete charge of any persons
engaged by such Distributor for the resale and servicing of the Products. The Distributor has not
authority to act on behalf of the Supplier or to bind Supplier or Manufacturer by any promise or
representation unless specifically authorised in writing to do so by the Supplier.

     15. Force Majeure

     None of the parties hereunder shall be liable for failure or delay of performance of
obligations under this Agreement (other than payment of moneys) due to causes arising from or
attributable to acts, events, omissions or accidents beyond reasonable control of such party,
including, but not limited to, acts of God, strike, lockout, labor disputes, shortage of
transportation, embargo, prohibition of import or export of the Products, governmental orders or
restrictions, shortage of materials or labour, utility or communication failure, war, fire,
explosion, sabotage, storm, flood, earthquake, or epidemics. The party affected by the force
majeure shall promptly
notify the other party hereof. If any of these causes prevents or delays performance for more
than 90 consecutive days or for more than 180 days in any calendar year, any party hereunder may
terminate this Agreement, effective immediately on written notice to the other parties.

-11-

 

     16. Exhibit D

     Exhibit D to this Agreement contains further obligations of the parties hereto. Exhibit D, as
all other Exhibits, forms an integral part of this Agreement.

     17. Notices.

     Any notice or approval required or permitted under this Agreement shall be in writing and
shall be sent by facsimile, e-mail or by registered or certified airmail, postage prepaid, to the
address specified below or to any other address designated by prior notice. Any notice or approval
sent by facsimile shall be deemed to have been received one business day after its transmission if
there is a confirmation of a successful transmission. Any notice or approval sent by airmail shall
be deemed to have been received five business days after its date of posting.

	 	 	 	 	 
	 

	 	If to Supplier
	 	                    
	 

	 	 	 	                    
	 

	 	 	 	                    
	 
	 	 	 	 
	 

	 	If to Distributor
	 	                    
	 

	 	 	 	                    
	 

	 	 	 	                    
	 

	 	 	 	                    
	 

	 	 	 	Tel:                      Fax:                     

     18. Agreement Scope, Effective Date & Applicable Law.

     This Agreement and its Exhibits constitute the full and complete agreement between both
parties and supersedes any prior understanding or agreement between the parties. Both parties
understand that this Agreement does not constitute either of the parties as an agent, legal
representative, employee or servant of the other party hereto for any purpose whatsoever.
Furthermore, it is understood between the parties that each party is independent and neither
Supplier or Distributor is in any way authorized to make any contract, warranty or representation
or to create any obligation, expressed or implied on behalf of any other party hereto. Except for
Section 3, Prices and Payment Terms, this Agreement may not be altered, amended, modified or a
provision hereof waived except in writing signed by both parties. All disputes arising out of or
in connection with this Agreement including the Annexes, which the parties have not been able to
settle amicably, will exclusively be brought before the competent court of Suppliers residence,
unless the Supplier decides to bring such dispute before the competent court of Distributors
residence.

     This Agreement shall not become effective until duly executed by both the Distributor and the
Supplier.

     This Agreement shall be governed by                 law.

-12-

 

     19. Severability

     If any provision of this Agreement is illegal or invalid, such provision shall be deemed
severed, with the remaining provisions of this Agreement being deemed to remain in full force and
effect. The parties are obliged to replace the illegal or invalid provisions with other clauses
that are binding, in such a way that the new provisions differ as little as possible from the
illegal or invalid provisions, taking into account the object and purpose of this Agreement.

     20. Distributor’s Representations and Warranties

     Distributor represents and warrants to the Company as follows:

          20.1 Corporate Existence and Power. Distributor is a corporation duly organized, validly
existing and in good standing under the laws of the jurisdiction in which it is incorporated.

          20.2 Authorization and Enforcement of Obligations. Distributor (a) has the corporate power
and authority and the legal right to enter into this Agreement and to perform Distributor’s
obligations hereunder and (b) has taken all necessary corporate action on Distributor’s part to
authorize the execution and delivery of this Agreement and the performance of Distributor’s
obligations hereunder. This Agreement has been duly executed and delivered on behalf of
Distributor, and constitutes a legal, valid, binding obligation, enforceable against Distributor in
accordance with its terms.

          20.3 Consents. All necessary consents, approvals and authorizations of all governmental
authorities and other persons or entities required to be obtained by Distributor in connection with
this Agreement have been obtained.

          20.4 No Conflict. The execution and delivery of this Agreement and the performance of
Distributor’s obligations hereunder (a) do not conflict with or violate any requirement of
applicable laws or regulations, and (b) do not conflict with, or constitute a default under, any
contractual obligation of Distributor. Distributor further warrants that it does not currently
promote, market or solicit order for products that are competitive with the Products.

-13-

 

     IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their authorised
representatives on the day and year first above written.

	 	 	 	 	 
	SUPPLIER:	 	 
	 
	 	 	 	 
	By:

	 	 	 	 
	 
	 	 	 	 
	Title:

	 	 
	 	 
	 

	 	 
	 	 
	 
	 	 	 	 
	Signature:	 	Signature:
	 
	 	 	 	 
	 	 	 
	 	 	 
	 
	 	 	 	 
	DISTRIBUTOR:	 	 
	 
	 	 	 	 
	By:

	 	 	 	 
	 
	 	 	 	 
	Title:

	 	 	 	 
	 

	 	 	 	 
	 
	 	 	 	 
	Signature:	 	 
	 
	 	 	 	 
	 	 	 

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EXHIBIT A

Territory

 

 

 

 

EXHIBIT B

Section 1 & 2

Products and Price List

Per reference: hospital sales price (as implemented in                     )

          ,– per implant (               )

Sales Price to Distributor:

	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	ROE€ Price	 	Transfer price
	Description	 	Catalog #	 	(ex. VAT)	 	(ex. VAT)
	6mm X STOPpk
	 	1-3006	 	 	 	 	 	 	 	 
	8mm X STOPpk
	 	1-3008	 	 	 	 	 	 	 	 
	10mm X STOPpk
	 	1-3010	 	 	 	 	 	 	 	 
	12mmX STOPpk
	 	1-3012	 	 	 	 	 	 	 	 
	14mm X STOPpk
	 	1-3014	 	 	 	 	 	 	 	 
	16mm X STOPpk
	 	1-3016	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Small Curved Dilator
	 	2-2004	 	 	 	 	 	 	 	 
	Large Curved Dilator
	 	2-2005	 	 	 	 	 	 	 	 
	Sizing Distractor
	 	2-2016	 	 	 	 	 	 	 	 
	Spacer Insertion
	 	2-2301	 	 	 	 	 	 	 	 
	Instrument
	 	 	 	 	 	 	 	 	 	 
	Wing Insertion
	 	2-2002	 	 	 	 	 	 	 	 
	Instrument
	 	 	 	 	 	 	 	 	 	 
	Hex Head Screwdriver
	 	2-2003	 	 	 	 	 	 	 	 
	Sterilization Container
	 	3-3001	 	 	 	 	 	 	 	 
	(Total Instruments)
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Complete Instrument Set
	 	4-2000	 			 	 			 
	W/Container
	 	 	 	 	 	 	 	 	 	 
	Demonstration case
	 	 	 			 	 			 

Section 3

     Product Storage: According to GMP

Section 4

     Shipments: According to GMP

 

 

EXHIBIT C

(not applicable)

 

 

Exhibit D

Additional Agreements Between the Supplier and the Distributor

     1. Regulatory. The Distributor agrees to notify Supplier in writing before the close
of business on the next business day after becoming aware of any customer complaints or Product
malfunctions. The Distributor also agrees to cooperate fully with the Supplier’s personnel in the
investigation of complaints, including the collection of appropriate information from customers,
patients or user facilities, and to sharing that information in a timely manner with the Supplier.
Any complaint involving a Product which:

          a. may have caused or contributed to a death or serious injury (Incident) or;

          b. has malfunctioned under conditions which would be likely to cause or contribute to a death
or serious injury if the malfunction were to recur (Near Incident)

is a Reportable Event, which must be reported to the United States Food and Drug Administration and
the appropriate Competent Authority. A copy of the Medical Devices Vigilance System, European
Commission Guidelines, which outlines the responsibilities of the Supplier and the Competent
Authority, is attached (Attachment #2).

     In the case of a Reportable Event, the Distributor and the Supplier agree to take any action
specified by local law to address the potential adverse incident including reporting the Reportable
Event to the Competent Authority or recall of the Product(s). Such a report to the Competent
Authority or a recall will be authorized by the Supplier. In the event of a recall of the Product,
the Distributor will carry out the recall of the Product(s) at the Supplier’s expense subject to
the Distributor’s documentation of its compliance with the Supplier’s instructions for storage and
handling of the Product(s). The Supplier will replace recalled Product(s) at its expense.

     2. Supplier Order Receipt & Fulfillment. The Distributor agrees to submit in writing
all orders for Product(s) to the Supplier’s Customer Service Department in Driebergen, The
Netherlands. The Supplier has no obligation to reclaim from the Distributor any Product
reaching its expiration date unless reclamation is agreed to at the time of shipment.

The Supplier will include a Packing Slip with all orders it ships. The Packing Slip will
specify the Distributor’s purchase order number for the shipment, the date of order receipt at the
Supplier, the date of shipment for the order and the contents of the shipment. The Packing
Slip will also specify whether or not the Product(s) shipped require refrigeration or other special
instructions.

     3. Distributor Order Acceptance & Product Storage. The Distributor will receive
Product(s) shipments at its warehouse and, within 24 hours from receipt, inspect them against the
Supplier’s packing slips and the Distributor’s order forms and will inspect the Product’s
packaging for any signs of damage to the Product(s). The Distributor will notify the
Supplier in writing of any additional acceptance tests it will perform on Product(s)
shipments. Distributor shall notify Supplier in writing within ten (10) days from the date
of delivery about any defects of the Product(s). This notification must specify the complaint in
detail.

 

 

The Product(s) are considered to be accepted irrevocably and unconditionally after expiry of this
ten day term.

     4. Distributor Order Fulfillment. The Distributor will observe “First In, First Out”
(FIFO) Inventory management practices.

On request, the Distributor must allow the Supplier to inspect its product storage and
shipping areas and records related to the storage and shipment of the Supplier’s
Product(s).

 

 

EXHIBIT E

QUOTA

          

 

 

EXHIBIT F

Trademarks:

X STOP

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