EXHIBIT 10.1
ASSIGNMENT AND ASSUMPTION AGREEMENT
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This AGREEMENT is made and entered into as of April 12, 2002 (the
"Agreement"), by and between Bionix, L.L.C., a Delaware limited liability
company ("Assignor") and Orthometrix, Inc., a Delaware corporation ("Assignee").
WITNESSETH
WHEREAS, Assignor and M.I.P. GmbH, a Swiss corporation ("MIP") have entered
into a certain Product Approval and Licensing Agreement, dated February 12, 2002
(the "MIP Agreement"); and
WHEREAS, Assignor has agreed to assign to Assignee all right, title, and
interest of Assignor in, to and under the MIP Agreement.
NOW, THEREFORE, in consideration of good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, the parties hereto
agree as follows:
1. Assignor hereby assigns and transfers, as of the date first above
written (the "Closing Date"), all of Assignor's right, title and interest,
arising from and after the Closing Date, under and pursuant to the XxXxx
Agreement.
2. Assignee hereby assumes, from and after the Closing Date, and agrees to
pay, discharge and perform, as and when the same shall become due, all of the
obligations of Assignor, arising from and after the Closing Date, pursuant to
the XxXxx Agreement.
3. Assignee shall have whatever rights Assignor has relating to the XxXxx
Agreement, including the rights to contest in good faith the legality, validity
or enforceability of the XxXxx Agreement.
4. This Agreement shall be governed by and construed in accordance with the
internal laws of the State of New York.
5. Nothing in this document shall in any way limit, expand or otherwise
modify in any way Assignor's and Assignee's respective rights and obligations
under the Purchase Agreement. Further, and without limiting the generality of
the foregoing, to the extent of any inconsistency between the terms of this
document and the Purchase Agreement, the terms of the latter shall control.
6. This Agreement may be executed in counterparts, each of which shall be
deemed an original, but all of which shall together constitute one and the same
instrument.
7. This Agreement and all the provisions hereof shall be binding, upon and
inure to the benefit of the parties hereto and their respective successors,
legal beneficiaries and permitted assigns. This Agreement may not be assigned by
any party except with the prior written consent of the other party hereto, which
shall not be unreasonably withheld.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of
the day and year first above written.
BIONIX, L.L.C.
By: /s/ Xxxxxxx X. Xxxxxxx
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Name: Xxxxxxx X. Xxxxxxx
Title: President
ORTHOMETRIX, INC.
By: /s/ Xxxxx Xxxxx
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Name: Xxxxx Xxxxx
Title: Corporate Secretary and
Director
PRODUCT APPROVAL AND LICENSING AGREEMENT
PRODUCT APPROVAL AND LICENSING AGREEMENT made this day of February 12, 2002
by and between M.I.P. GmbH, a Swiss corporation ("MIP"); and BIONIX L.L.C., a
Delaware limited liability company ("Bionix").
WHEREAS, MIP has developed and manufactures the Orbasone(TM), a system
designed to treat soft tissue pain using orthopedic shock wave treatment (the
"Product");
WHEREAS, Bionix is engaged in the business of, among other things,
designing, manufacturing, selling and servicing health care systems;
WHEREAS, MIP is willing to grant to Bionix and Bionix is willing to acquire
from MIP on the terms and conditions of this Agreement, a License assemble,
manufacture, develop, market, sell and service the Product in the Territory.
NOW, THEREFORE, for good and valuable consideration, receipt of which is
hereby acknowledged, MIP and Bionix hereby agree as follows:
ARTICLE I
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DEFINITIONS
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As used in this Agreement, the following terms shall have the following
meanings (such meanings to be equally applicable to both the singular and plural
forms of the terms defined):
"Act" shall mean the Federal Food, Drug and Cosmetic Act, as amended.
"Clinical Studies" shall mean such tests of the Product as shall be
required by the FDA to support a PMA for the Product.
"FDA" shall mean the United States Food and Drug Administration.
"Gross Margin" shall mean, with respect to the Product Kits, the difference
between the Product Kit Price and the Product Kit Cost, and with respect to a
Spare Part or a Consumable Part, the difference between the Part Price and the
Part Cost for such Spare Part or Consumable Part.
"License" shall have the meaning set forth in Section 2.1 hereof.
"Manufacturer's Standard Cost" shall have the meaning set forth in Exhibit
A hereof.
"Minimum Purchase Amount" shall have the meaning set forth in Section
2.2(b) hereof.
"Minimum Purchase Period" shall mean the period from the Pre-Market
Approval to such time as Bionix or any of its Sublicensees have purchased from
MIP the Minimum Purchase Amount.
"Part Cost" shall have the meaning set forth in Exhibit B hereof.
"PMA Application" shall mean Pre Market Approval application to be filed
with the FDA with respect to the Product.
"Pre-Market Approval" shall mean the FDA approval of the PMA Application.
"Product" shall mean the Orbasone(TM), a system designed to treat soft
tissue pain using orthopedic shock wave treatment.
"Product Kit" shall mean a fully tested and operational Product,
disassembled in a minimum of four subassembly kits prior to shipment to Bionix
for re-assembly, testing and certification.
"Product Kit Cost" shall have the meaning set forth in Exhibit A hereof.
"Product Kit Price" shall mean the price paid to MIP by Bionix for each
Product Kit purchased by Bionix from MIP during the Minimum Purchase Period.
"Spare Parts" and "Consumable Parts" shall mean the parts used in the
manufacturing, operation and service of the Product.
"Sublicensee" shall mean any person or entity sublicensed by Bionix to
manufacture the Product for marketing and sale only in the Territory.
"Technology" shall mean all trade secrets, know-how, technical knowledge,
procedures, processes, recipes, formulae, blueprints, schematics, specifications
and other information and rights which MIP now or at any time hereafter,
possesses and which are related to the Product or to the approval, development,
manufacture, marketing, sale or service thereof.
"Territory" shall mean the United States of America and its territories and
possessions, the Commonwealth of Puerto Rico, all US military bases worldwide
and Canada. In addition, subject to MIP's prior written consent, such consent
not to be unreasonably withheld, Bionix may from time to time extend the
Territory to include countries in which MIP does not have distribution for the
Product.
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ARTICLE II
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LICENSE: PAYMENTS
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2.1 Grant of License
(a) MIP hereby grants to Bionix the exclusive (even as to MIP, but subject
to Section 6. 1(a) hereof) and perpetual authority, right and license in the
Territory (i) to use the Technology in connection with the Product, (ii) to seek
PMA Approval for the Product, (iii) to assemble the Product, (iv) to develop the
Product, (v) to manufacture the Product and (vi) to market, promote, sell,
distribute and service the Product (collectively, the "License"). The License
shall include the right to sublicense to Sublicensees any of the Technology
covered by the License and to engage other persons to develop, manufacture,
market, advertise, promote; sell, distribute and or service the Product on
behalf of Bionix, provided, however, that during the Minimum Purchase Period,
such sublicense shall be subject to MIP's prior written consent, such consent
not to be unreasonably withheld. Such persons may use the Technology for such
purposes. Notwithstanding the foregoing, MIP hereby accepts Norland Medical
Systems, Inc. as a Sublicensee.
(b) MIP covenants and agrees that MIP shall not, subject to its, rights
under Section 6.1 hereof:
(i) develop, seek FDA approval of, manufacture, market, promote,
sell, distribute and service the Product in the Territory;
(ii) engage anyone else to do any of the activities referred to in
clause (i) in the Territory; or
(iii) grant any license, distribution right or other right to any
person (other than the License) to do any of the activities
referred to in clause (i) in the Territory.
(c) MIP also covenants and agrees that it will ensure that any person with
whom it deals with respect to the Technology or the Product outside the
Territory will refrain from doing any of the activities referred to in paragraph
(b)(i) above in the Territory.
2.2 Payments
(a) in consideration of the License granted to Bionix by this Agreement,
Bionix agrees to make an advance payment to MIP of $* against amounts payable
under Section 2.2(b) hereof, upon such time as Bionix receives notification from
the FDA that the PMA Application coveting the Product has been accepted by the
FDA, such acceptance being evidenced by the assignment of an identification
number. Such Royalty Advance shall be nonrefundable, except upon termination
pursuant to Section 7.2.
* Confidential treatment requested.
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If this Agreement is terminated for any reason prior to the date any payment is
required to be made to MIP pursuant to this Section 2.2(a), Bionix shall have no
obligation to make such payment.
(b) In further consideration of the License granted to Bionix. by this
Agreement, Bionix agrees to purchase from MIP, and MIP agrees to sell to Bionix,
from time to time Product Kits at the Product Kit Price, Spare Parts and
Consumable Parts at the Part Costs until such time as Bionix has purchased from
MIP an aggregate of ninety (90) Product Kits (the "Minimum Payment Amount")
provided, however, that the $* advance payment referred to in Section 12(a)
hereof shall be offset against, and shall reduce, the Gross Margin payable to
MIP for the purchase of the first Product Kits pursuant to this Section 2.
During the Minimum Purchase Period, (subject to Section 6.2 hereof) Bionix will
solely purchase Product Kits from MIP and will not independently manufacture the
Product. The License shall continue in effect after Bionix has purchased the
Minimum Purchase Amount from MIP.
(c) Prices are FOB Tokyo. Shipment of Product Kits shall be arranged by MIP
(with shippers reasonably acceptable to Bionix), and such shipment shall be made
to Bionix or its Sublicensee, as directed by Bionix. MIP will arrange for
shipper to xxxx Bionix for shipping costs. MIP will deliver good and marketable
title to each Product Kit, free of all liens and encumbrances. Payment terms for
each Product Kit purchased by Bionix from MIP shall be net 30 days from the date
at which the Product Kits have been delivered to the facility of Bionix or its
Sublicensee or net 60 days from the shipment date. All payments pursuant to this
Agreement shall be in U.S. dollars.
2.3 Further Assurances
In furtherance of this Agreement, MIP agrees to transfer to Bionix
ownership of the Orbasone unit s/n 01202014 presently stored at Bionix facility
in White Plains, NY. MIP also agrees that, to the best of its ability it will
provide Bionix with (i) written copies of all Technology which is in written
form, duly translated in English, (ii) other information regarding the
Technology needed by Bionix and/or any Sublicensees to manufacture, test,
market, advertise, sell or distribute the Product, (iii) technical assistance
reasonably requested by Bionix or any Sublicensees to enable Bionix and/or any
Sublicensees to manufacture, test, market, advertise, sell or distribute the
Product, and (iv) additional information and assistance regarding any ,
improvements or developments in, or problems with, the Product. Bionix agrees
that it will proceed in good faith in an effort to develop and obtain PMA market
clearance for the Product and that if PMA market clearance is obtained, it will
use its reasonable best efforts to market the Product. Upon termination of this
Agreement pursuant to Section 6.1, Bionix shall transfer ownership of Orbasone
Unit s/n 01202014 to MIP.
* Confidential treatment requested.
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ARTICLE III
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PRODUCT APPROVAL / DEVELOPMENT
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3.1 Pre-Market Approval
In connection with seeking Pre-Market Approval for the Product, Bionix
shall be responsible for and perform in a reasonable and timely manner the
following:
(a) If necessary, conducting Clinical Studies, or having Clinical Studies
conducted in the Territory with respect to the Product;
(b) Following the successful completion of the Clinical Studies1, preparing
and filing a PMA application with the FDA covering the Product; and
(c) Responding to any questions raised by the FDA with respect to the PMA
application, the Clinical Studies, and otherwise dealing with the FDA review
process.
3.2 Cooperation
MIP covenants and agrees that it will cooperate fully and to the best of
its ability with Bionix in the efforts to obtain Pre-Market Approval for the
Product, and in connection therewith, MIP will provide Bionix with all Clinical
Studies conducted outside of the Territory with respect of the Product. MIP also
covenants and agrees that it will provide Bionix with such information and
assistance as Bionix may request in order to conduct Clinical Studies in the
Territory, to prepare and file the PMA application and to respond to issues
which may arise in the FDA review process. Expenses incurred by MIP in
connection therewith shall be borne by MIP, provided, however, that MIP shall
approve in advance any international travel expenses.
3.3 Product Improvement and PMA Process
MIP and Bionix agree that they will work together to seek to exploit any
improvements to the Technology which may be developed by MIP or Bionix. The
party developing any such improvement shall have proprietary rights to such
improvement and Bionix shall grant MIP a royalty free perpetual worldwide (other
than in the Territory) license to use such improvement and MIP shall grant
Bionix a royalty free license to use such improvement in the Territory, subject
to the terms and conditions of this Agreement.
Bionix shall be responsible for filing any PMA Application supplements or
amendments which may be necessary or appropriate in connection therewith.
However, Bionix shall not be obligated to make any such filing unless Bionix
determines that there is a reasonable probability that such application,
supplement or amendment will be approved. If Bionix determines
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not to file, MIP shall be entitled to make such filing at its own cost and
expense and Bionix shall automatically have the right to manufacture, sell and
use such improvement in the Territory under the terms of the Agreement. Bionix
shall not be obligated to have any Clinical Studies performed in connection with
any such filing unless Bionix determines that there is a reasonable probability
that such study will be successful and that funding for such study is available
on acceptable terms, in which case development of the improved Product will
proceed as described in Sections 3.1 and 3.2 hereof. If Bionix does not proceed
with such Clinical Studies, MIP shall be entitled to do so at its own cost and
expense and, thereafter, to file a PMA supplement or amendment, and Bionix shall
automatically have the right to manufacture, sell and use such improvement in
the Territory under the terms of the Agreement
3.4 Manufacture
During the Minimum Purchase Period, MIP shall be responsible for the lawful
manufacture of high quality Products that at least meet Bionix or Norland
standards. Products manufactured by MIP shall be of high quality workmanship and
materials with strict adherence to the designs, drawings and materials
specifications filed with the FDA as part of the PMA Application, unless
approved in writing by Bionix.
3.5 Termination
Upon any termination of this Agreement pursuant to Article 6 hereof, any
obligation of MIP and Bionix to take action or spend money under this Article 3
shall terminate immediately upon such termination.
ARTICLE IV
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REPRESENTATIONS AND WARRANTIES
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4.1 Representations and Warranties of MIP
MIP hereby represents and warrants to Bionix as follows:
(a) MIP is a corporation duly organized, validly existing and in good
standing under the laws of Switzerland and has the corporate power and authority
to enter into this Agreement and the transactions contemplated hereby and
thereby;
(b) the execution, delivery and performance by MIP of this Agreement and
the transactions contemplated hereby and thereby have been authorized by all
necessary corporate action and do not violate or conflict with any provision of
the Articles of Incorporation: `or by-laws of or any contract, agreement or
other instrument or obligation to which MIP is a party or by which MIP or any of
its property or assets are or may be bound or affected;
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(c) MIP is the sole owner of the entire right, title and interest in and to
the Technology and has full authority to license the Technology to Bionix as
provided in this Agreement;
(d) to the best of its knowledge, the Technology does not infringe upon any
patents in the Territory;
(e) MIP has granted no other right or license permitting the use in the
Territory of the Technology (and, without limiting this clause, has not taken
any of the actions referred to in Section 2.1(b) above);
(f) to the best of its knowledge, the use of the Technology by Bionix and
any Sublicensees does not conflict with, infringe upon or violate any right of
any other person or entity; and
(g) there are no outstanding claims, disputes, disagreements, actions or
proceedings (whether by or against MIP) pending or threatened with respect to
any of the Technology (whether or not involving infringement claims), nor to the
best of its knowledge is there any basis therefore.
4.2 Representations and Warranties of Bionix
Bionix hereby represents and warrants to MIP as follows:
(a) Bionix is a limited liability company duly organized, validly, existing
and in good standing under the laws of the State of Delaware and has the
corporate power and authority to enter into `this Agreement and the transactions
contemplated hereby and thereby.
(b) The execution, delivery and performance by of this Agreement and the
transactions contemplated hereby and thereby have been authorized by all
necessary corporate action and do not conflict with any provisions of the
Certificate of Incorporation or by-laws of or any contract, agreement or other
instrument or obligation to which Bionix is a party or by which Bionix or any of
its property or assets are or may be bound or affected.
(c) There are no outstanding claims, disputes, disagreements, actions or
proceedings (whether by or against Bionix) pending or threatened against Bionix
nor to the best of its knowledge is there any basis therefore.
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ARTICLE V
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CERTAIN AGREEMENTS REGARDING THE TECHNOLOGY
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5.1 Confidentiality
Bionix will, and will cause any Sublicensees to agree to, hold and keep
confidential (and not use, other than in connection with this Agreement) any and
all information regarding the Technology except:
(i) information which is publicly available or which is or becomes publicly
available (through no act of or any Sublicensee in violation of this Agreement);
(ii) information which is disclosed to Bionix or a Sublicensee by a third
party which did not, to the knowledge of Bionix or such Sublicensee, disclose it
in violation of a duty of confidentiality;
(iv) information which was known to Bionix or a Sublicensee before such
information was provided to them or their representatives by or on behalf of
MIP; or
(v) disclosures which are required to he made by or a Sublicensee under
legal process by subpoena or other court order or other applicable laws or
regulations.
5.2 Sharing of Information
Bionix agrees to grant timely and reasonable access to information and data
as they are generated with respect to the Clinical Studies and any adverse
reaction reports for the Product. MIP may provide such information and data to
other persons and entities to whom it may license all or part of the Technology
in connection with the manufacture and sale of the Product outside the
Territory; provided, however, that MIP and such persons and entities agree that
they will use such information and data only for purposes of evaluating,
developing and/or obtaining governmental approvals of the Product outside the
Territory and that they will hold all information and data received from Bionix
confidential to the same extent as Bionix is required to hold information
regarding the Technology confidential pursuant to Section 6.1 hereof. MIP agrees
that it will, and that it will use its best efforts to cause such other
licensees to, grant Bionix access to information and data developed by MIP and
such other licensees with respect to the Product, including information with
respect to clinical studies and adverse reaction reports.
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ARTICLE VI
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TERMINATION
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6.1 Termination by MIP
(a) During the Minimum Purchase Period and upon the occurrence, and during
the continuance, of the following events, MIP may give written notice to Bionix
declaring that the Agreement is terminated:
(i) Bionix shall, in a bankruptcy proceeding before a court of
competent jurisdiction, file a voluntary petition in bankruptcy
or be adjudicated a bankrupt or insolvent or file any petition or
answer seeking reorganization or liquidation; or
(ii) any bankruptcy proceeding before a court of competent
jurisdiction against Bionix seeking! reorganization or
liquidation shall have been instituted and shall not have been
dismissed within one hundred twenty (120) days.
(b) If Bionix shall default in making any payment required to be made by it
to MIP pursuant to Section 2.2 hereof, and such default shall continue for a
period of thirty days following written notice of such default from MIP to
Bionix, MIP may, at any time thereafter during the continuance of such default,
terminate this Agreement by giving written notice to Bionix.
(c) If there has been a material breach by Bionix of any representation,
warranty, covenant or agreement set forth in this Agreement which Bionix fails
to cure within thirty days following written notice from MIP
6.2 Termination by Bionix
(a) During the Minimum Purchase Period and upon the occurrence, and during
the continuance, of the following events, Bionix may give written notice to MIP
declaring that the Agreement is terminated:
(i) MIP shall, in a bankruptcy proceeding before a court of competent
jurisdiction, file a voluntary petition in bankruptcy or be
adjudicated a bankrupt or insolvent or file any petition or
answer seeking reorganization or liquidation; or
(ii) any bankruptcy proceeding before a court of competent
jurisdiction against MIP seeking reorganization or liquidation
shall have been instituted and shall not have been dismissed
within one hundred twenty (120) days.
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(b) If MIP shall default in its obligations under this Agreement to provide
Bionix with the Product Kits necessary to meet market demand, and such default
shall continue for a period of thirty days following written notice of such
default from Bionix to MIP, Bionix may, at any time thereafter during the
continuance of such default, terminate this Agreement by giving written notice
to MIP;
(c) If there has been a material breach by MIP of any representation,
warranty, covenant or agreement set forth in this Agreement which MIP fails to
cure within thirty days following written notice from Bionix.
6.3 Effects of Termination
Upon termination of this Agreement for any reason:
(i) all payments due to MIP as of the effective date of termination,
if any, shall become immediately due and payable;
(ii) all payments due to Bionix as of the effective date of
termination, if any, shall become immediately due and payable;
(a) Upon termination of this Agreement by MIP pursuant to Section 6.1
hereof:
(i) Bionix shall promptly return to MIP all information relating to
the Product and the Technology, including, without limitation,
written or electronic data and documents, including originals,
copies, translations, and reproductions thereof, relating to the
Product and the Technology, except that Bionix may retain one
necessary copy of such data and documents for purposes of: (A)
proving compliance with laws, rules and regulations in its
manufacture, sale and use of the Product, (B) defending against
an infringement action brought by a third party, or (C) providing
information to an auditor, and
(ii) Bionix shall immediately cease any activities relating to the
Product and the Technology, including sale, advertising,
servicing and use of the Product and Technology.
6.4 Terms Surviving Termination
Notwithstanding the termination of this Agreement, no party shall he
released from any obligation that accrued prior to the date of such termination,
and each party shall remain bound by the provisions of this Agreement which by
their terms impose obligations upon such party that extend beyond the date of
such termination, including the provisions of Articles IV, V and VII.
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ARTICLE VII
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INDEMNIFICATION
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7.1 MIP Indemnification
MIP shall defend, hold harmless, and indemnify Bionix, and the officers,
directors, employees, representations, and agents of Bionix, from all damages,
liabilities, times, penalties, costs, and expenses (including reasonable
attorneys' fees) with respect to any claims, litigation or proceeding resulting
from, arising out of, relating to, or connected with a breach of MIP's
representations or warranties set forth in Article IV, and all other agreements
or obligations contained herein.
7.2 Bionix Indemnification
Bionix shall defend, hold harmless, and indemnify MIP, and the officers,
directors, employees, representations, and agents of MIP, from all damages,
liabilities, fines, penalties, costs, and expenses (including reasonable
attorneys' fees) with respect to any claims, litigation or proceeding resulting
from, arising out of, relating to, or connected with a breach of Bionix's
representations or warranties set forth in Article IV, and all other agreements
or obligations contained herein.
7.3 Litigation
MIP shall, in its sole and absolute discretion, have the right to determine
whether it alone or in conjunction with Bionix enforce MIP's rights in the
Technology and the Product, and The improvements owned or controlled by MIP. If
MIP determines to enforce the rights itself, it shall have, without limitation,
the right to control any litigation and licensing resulting from such
enforcement. Absent agreement by MIP and Bionix to the contrary, all costs of
any such proceedings shall be borne by MIP and all proceeds received as a result
thereof, whether by settlement, judgment or otherwise, shall be for the benefit
of MIP. If MIP determines that Bionix and MIP shall jointly enforce MIP's
rights, all costs of any such proceedings shall be borne equally by MIP and
Bionix and all proceeds received as a result thereof, whether by settlement,
judgment or otherwise, shall be divided equally for the benefit of MIP and
Bionix. Bionix shall cooperate in any enforcement proceedings. If required by
law or requested by MIP, Bionix, will join as a party in any such proceedings.
If MIP determines not to enforce its rights in the Technology and the
Product, then Bionix shall be entitled to do so at its own cost and expense. All
costs of any such proceedings shall be borne by Bionix and all proceeds received
as a result thereof, whether by settlement, judgment or otherwise, shall be for
the benefit of Bionix.
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7.4 Infringement
Bionix shall promptly notify MIP if Bionix becomes aware of any third
party's infringement of the Product or Technology or unauthorized use of the
Product or Technology.
ARTICLE VIII
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OTHER AGREEMENTS
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8.1 Service
(a) Subject to the provisions of this Article VIII, Bionix or its
Sublicensee shall provide all installation and maintenance service, including
warranty service, with respect to the Product sold by Bionix or its Sublicensee
pursuant to this Agreement. All service shall be performed in a workmanlike
manner, consistent with industry standards, and in accordance with MIP's service
manual. If any service call performed by Bionix is covered by MIP's warranty,
then MIP shall promptly (i) provide Bionix with all necessary parts at no cost
to Bionix, and (ii) either dispatch its service personnel to perform such
service call at no expense to Bionix, or pay Bionix an amount equal to (A) 120%
of the aggregate direct labor costs and (B) the out-of-pocket expenses incurred
by Bionix in performing such service call. For service calls not covered by
MIP's warranty, Bionix shall establish its own charges for parts and labor, and
Bionix shall procure its own parts or purchase them from MIP.
(b) MIP shall provide Bionix at no cost with such technical advice and
information as may be necessary for a full understanding and maintenance of the
Product, and during the Minimum Purchase Period, MIP shall from time to time, at
times agreed with Bionix, send: its employees to a facility designated by Bionix
for instruction and training free of charge at least two thirds per year. Bionix
may request that MIP send its employees for instruction and training free of
charge more often than two times per year, provided, however, that travel
expenses incurred by such MIP's employees in connection therewith shall be borne
by Bionix, and provided further that Bionix shall approve such travel expenses
in advance.
8.2 Product Liability Insurance
MIP hereby agrees that, during the Minimum Manufacturing Period it shall
assume all costs and expenses for manufacturers' product liability claims
whenever they shall arise in connection with the Products manufactured by MIP,
and warrants that following Pre-Market Approval it has and shall maintain, at
its expense, product liability insurance with a financially sound insurer
covering liability claims arising out of its manufacture of the Products,
providing minimum coverage of Five Million Dollars ($5,000,000) to the extent
available on commercially acceptable terms and shall name Bionix as an
additional insured under its policy and shall provide Bionix with an insurance
certificate.
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Bionix hereby agrees that, during the Minimum Manufacturing Period it shall
assume all costs and expenses for product liability claims whenever they shall
arise in connection with the assembly, sale and service of the Products by
Bionix, and warrants that following Pre-Market Approval it has and shall
maintain, at its expense, product liability insurance with a financially sound
insurer covering liability claims arising out of its assembly, sale and service
of the Products, providing minimum coverage of Five Million Dollars ($5,000,000)
to the extent available on commercially acceptable terms and shall name MIP as
an additional insured under its policy and shall provide MIP with an insurance
certificate.
ARTICLE IX
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MISCELLANEOUS
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9.1 Amendments: Waivers, Etc.
This Agreement may be amended, modified or supplemented by written
agreement executed and delivered by MIP and Bionix.
9.2 Notices
Any and all notices or other communications required or permitted under
this Agreement shall be in writing and shall be deemed sufficient when sent by
confirmed facsimile transmission or mailed by internationally recognized
overnight courier with a signed delivery slip, or delivered in person against
receipt to the party to whom it is to be given at the address of such party set
forth below:
If to MIP:
X.X.X. XxxX
Xxxxxxxxxxxxxxxxx 0
Xxxxxxxxxxx
Attention: Xxxx Xxxxxxxxx
Fax No.: 00-000 0000 000
If to Bionix:
Bionix, L.L.C.
000 Xxxxxxxxx Xxxx Xxxxx, Xxxxx 000
Xxxxx Xxxxxx, Xxx Xxxx 00000
Attention: Xxxxxxx X. Xxxxxxx
Fax No: 0-000 000 0000
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or to such other address as the party shall have furnished in writing in
accordance with the provisions of this Section 8.2.
9.3 Brokers
Each of MIP and Bionix represents and warrants to the other that no broker
or finder is entitled to any brokerage or finder's fee or other commission based
on agreements, arrangements or undertakings made by such party in connection
with the transactions contemplated hereby.
9.4 Counterparts
This Agreement may be executed in two or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and
the same instrument.
9.5 Headings
The headings herein are for convenience of reference only, do not
constitute a part of this Agreement and shall not be deemed to limit or affect
any of the provisions hereof.
9.6 Successors and Assigns.
During the Minimum Purchase Period, neither party hereto may assign,
delegate or otherwise transfer this Agreement, or any of its rights and
obligations hereunder, or any portion thereof, without the prior written consent
of the other party, which consent shall not be unreasonably withheld; provided,
however, that either party may assign this Agreement without the consent of the
other in connection with a merger, consolidation or other change in control of
such party or a sale of all! or substantially all of such party's assets
(provided that as a result of such transaction the resulting entity does not
have rights with respect to a product that competes with the Product). MIP
hereby consent to the assignment of this Agreement and any of its rights and
obligations hereunder to Norland Medical Systems, Inc. Subject to the foregoing,
the provisions of this Agreement shall be binding upon and inure to the benefit
of the parties hereto and their respective successors and assigns.
9.7 Governing Law
This Agreement shall be governed by and construed in accordance with the
laws of the State of New York without regard to the conflicts of law principles
thereof.
9.8 Entire Agreement
This Agreement constitutes the entire understanding of the parties and
supersedes any prior agreements or understandings, written or oral, between the
parties with respect to the subject matter hereof, including the distribution
agreement in force between MIP and Bionix.
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9.9 Further Assurances
Each party shall cooperate and take such action as may be reasonably
requested by another party in order to carry out the provisions and purposes of
this Agreement and the transactions contemplated hereby.
9.10 No Partnership, Employment Agency or Joint Venture
Nothing in this Agreement shall create or be deemed to create any
relationship of partnership, agency or joint venture between MIP and Bionix.
IN WITNESS WHEREOF, the parties hereto have executed and delivered this
Agreement as of the date first above written.
M.I.P. GMBH
By: /s/ Xxxx Xxxxxxxxx
-----------------------------
Name: Xxxx Xxxxxxxxx
Title: President
BIONIX, L.L.C.
By: /s/ Xxxxxxx Xxxxxxx
-----------------------------
Name: Xxxxxxx Xxxxxxx
Title: President
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EXHIBIT A
"Product Kit Price" shall mean, with respect to each Product Kit, an amount
equal to the sum of (i) the Product Kit Cost and (ii) the Gross Margin payable
to MIP for such Product Kit.
"Product Kit Cost" shall mean, with respect to each Product Kit, an amount equal
to the sum of (i) the Manufacturer's Standard Costs of all components and other
parts used in such Product Kit, as in effect at the time of shipment of such
Product Kit by MIP, and (ii) the Labor Costs related to such Product Kit.
The term "Manufacturer's Standard Cost" shall mean, at any time that the
Manufacturer's Standard Cost of any component or part is to be established by
the MIP, the average cost to the manufacturer (or to MIP if MIP is the
manufacturer) of such Product Kit of all units of such component or part
purchased by the manufacturer of such Product Kit during the preceding six
months. If there have been no purchases of such component or part during such
six-month period, the then established Manufacturer's Standard Cost shall not be
changed. All Manufacturer's Standard Costs shall be expressed in U.S. dollars.
MIP hereby agrees to grant to Bionix (and its employees and other authorized
representatives) access, at reasonable times and upon reasonable notice to its
books and records for purposes of verifying any information provided by MIP in
connection with the Product Kit Costs and Manufacturer's Standard Costs.
MIP shall maintain a list setting forth the Manufacturer's Standard Cost of each
component and part used in the Product Kit. Such list shall be updated by MIP at
least twice each year. If, at the time the list of Manufacturer's Standard Costs
is to be revised, the aggregate Manufacturer's Standard Costs of all components
and parts used in the Product Kit would not increase or decrease by more than 5%
from the aggregate Manufacturer's Standard Costs of such components and parts
then in effect, the Manufacturer's Standard Costs of such components and parts
shall not be changed.
The term "Labor Cost" shall mean, with respect to the Product Kit, an amount
equal to the lesser of (i) the actual labor cost incurred by the manufacturer in
producing such Product Kit (using standard cost accounting methods) and (ii) 15%
of the Manufacturer's Standard Costs of all components and other parts used in
the Product Kit.
The initial list of Manufacturer's Standard Costs is attached hereto and made a
part !hereof.
The initial Product Kit Cost shall be $*, which is comprised of:
o aggregate Manufacturer's Standard Costs: $*, plus
o Labor Cost: $*.
The initial Product Kit Price shall be $*, which is comprised of:
o Product Kit Cost: $*, plus
o Gross Margin: $*.
* Confidential treatment requested.
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EXHIBIT B
"Part Cost" shall mean, with respect to each Spare Part or Consumable Part, an
amount equal to the Manufacturer's Standard Costs of components and other parts
used in such Spare Part or Consumable Part, as in effect at the time of shipment
of such Spare Part or Consumable Part by MIP.
The term "Manufacturer's Standard Cost" shall mean, at any time that the
Manufacturer's Standard Cost of any component or part is to be established by
the MIP, the average cost to the manufacturer (or to MIP if MIP is the
manufacturer) of all units of such component or part purchased by the
manufacturer during the preceding six months. If there have been no purchases of
such component or part during such six-month period, the then established
Manufacturer's Standard Cost shall not be changed. All Manufacturer's Standard
Costs shall be expressed in U.S. dollars. MIP hereby agrees to grant to Bionix
(and its employees and other authorized representatives) access, at reasonable
times and upon reasonable notice to its books and records for purposes of
verifying any information provided by MIP in connection with the Part Costs and
Manufacturer's Standard Costs.
MIP shall maintain a list setting forth the Manufacturer's Standard Cost of each
component and part used in the Spare Parts and Consumable Parts. Such list shall
be updated by MIP at least twice each year. If, at the time the list of
Manufacturer's Standard Costs is to be revised, the Manufacturer's Standard Cost
of a component or part used in the Spare Part or Consumable Part would not
increase or decrease by more than 5% from the Manufacturer's Standard Costs of
such component and part then in effect, the Manufacturer's Standard Cost of such
component or part shall not be changed.
The list initial Part Cost for each Spare Part and Consumable Part, and for each
component and part used in the Product Kit is attached hereto and made a part
hereof.
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