EX-10.33 Letter of Agreement



 












EXHIBIT 10.33




EXECUTION COPY




Letter of Agreement




Mr. Bill Wachter

Chief Executive Officer

The Anspach Effort, Inc.

4500 Riverside Drive

Palm Beach Gardens, FL 33410




     Re:      Agreement on Commercial Arrangement



Dear Bill:



This Letter of Agreement (“LOA”), binding and effective upon execution by both parties, shall
define the scope and terms for a definitive agreement (the “Definitive Agreement”) to be entered
into between MAKO Surgical Corp (“MAKO”) and The Anspach Effort, Inc. (“Anspach”), which shall
include strategic business alliance (the “Alliance”) for integration of the MAKO Haptic Guidance
SystemTM (“HGS”) and the Anspach electric power instrument system, (eMax2/SC-2000) and related
accessories (collectively, the “eMax”).



The parties have previously been operating wider a binding Letter of Intent (“LOI”) effective
November 18, 2005. The LOI is supplanted and replaced in its entirety by this LOA:



MAKO’s experience with the eMax has led to several requested design updates to improve the fit
between the eMax and the HGS (the “Desired Changes”).



The parties recognize that this LOA shall provide the binding terms of the commercial relationship
between them. The parties agree to use best efforts to execute the Definitive Agreement on or
before July 31, 2007, however the parties agree that this LOA shall be binding and in effect unless
and until the consummation of the Definitive Agreement.





	1.	 	Fundamentals of the Alliance:
	 
	 	 	In furtherance of the Alliance, each of the parties hereby agrees to use commercially
reasonable efforts towards:






	 	a.	 	Collaborating on technical efforts towards the Alliance, including, but not
limited to, efforts towards the design, development, manufacturing and testing of
products to support the Alliance and specifically the integration and commercialization
of the integrated subject systems;
	 
	 	b.	 	Establishing a manufacturing relationship for specific devices developed as
part of the Alliance; and
	 
	 	c.	 	Establishing an OEM relationship for sales by MAKO of specific devices
developed as part of the Alliance (the “Alliance Specific Devices”), whereby the
parties will negotiate reasonable transfer and retail pricing for such Alliance
Specific Devices.






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	2.	 	Commitments:
	 
	 	 	In furtherance of the Alliance, each of the parties hereby agrees and covenants (as
applicable) to be bound as follows:






	 	a.	 	MAKO and Anspach will commence engineering collaboration upon the Effective
Date (as defined below), on the selection, development and manufacturing of devices for
the Alliance. Upon selection of desired Products (as defined below), MAKO may
implement Desired Changes to the Anspach design of burrs, attachments and motor
housings to meet the requirements of the MAKO HGS.






Specifically,




	 	I.	 	Off the shelf products:






	 	1.	 	Cutting Burrs: Anspach will provide technical support
to MAKO in the selection of appropriate existing cutting instruments and
definition of cutting instrument interfaces for use in the HGS. Anspach’s
support will be limited to the identification of off-the-shelf products best
suited to meet MAKO needs in current configuration.
	 
	 	II.	 	Anspach products effected by the Desired Changes






	 	1.	 	Alliance Specific Devices: Following communication
by MAKO on the Desired Changes.






	 	1)	 	Anspach will provide MAKO with drawings and
specifications for the affected components and products required for
MAKO to incorporate the Desired Changes.
	 
	 	2)	 	Anspach will provide MAKO with part numbers for
the drawings for the MAKO specific products and associated components.
	 
	 	3)	 	Manufacturing:






	 	a.	 	MAKO may manufacture the MAKO specific
parts with MAKO suppliers and send them to Anspach for final
processing, assembly, marking and packaging, or alternatively,






	 	b.	 	Anspach may manufacture MAKO specific
parts complete through assembly, marking, and packaging






	 	c.	 	MAKO can use its own suppliers to make
MAKO specific cutting burrs and, send them to Anspach for final
machining of proprietary locking flats, marking, packaging and
sterilization.






	 	2.	 	Anspach will be responsible for obtaining and
maintaining the regulatory clearance for each and every Product (as defined
below) and agrees and






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	 	 	 	covenants to be as expeditious as is commercially possible towards that end.
MAKO shall have the right to consult with Anspach as reasonably necessary
to achieve FDA clearance for any Product.
	 
	 	3.	 	Cadaver Labs: Anspach may, in MAKO’s sole
discretion, participate in MAKO cadaver labs in order to learn and
understand the Desired Changes. Cadaver lab may take place at a MAKO
selected facility (at MAKO’s sole expense), or at Anspach as mutually
agreed by the parties.
	 
	 	4.	 	IP & Data Ownership: MAKO shall own all
intellectual property rights in the Alliance Specific Devices resulting
from MAKO design efforts (the “Novel IP”). MAKO will grant Anspach a
non-exclusive fully paid up royalty free license to the Novel IP conceived
for use in any field other than Orthopedics in combination with a Robot
(each as defined below), excepting intellectual property developed
independent of the Alliance and all clinical data generated in furtherance
of the Alliance. "Orthopedics” shall be defined as the medical
specialty concerned with the preservation, restoration, development, repair
and correction of the musculoskeletal system and associated structures,
whereby, for avoidance of doubt, products that may be used in Orthopedics
shall include, but are not limited to, the following: (a) reconstructive
including orthopedic joint replacement, bone cements and accessories,
dental reconstructive products and platelet systems; (b) fixation products
including electrical bone growth, stimulation, internal and external
orthopedic fixation, bone growth substitute materials; (c) spinal products
including spinal stimulation, spinal hardware, pain therapy, and
orthobiologics; and (d) arthroscopy, diagnostics, softgoods, and bracing,
provided however, that notwithstanding the forgoing, the following medical
specialties are, to the extent that they may otherwise come within the
scope of the definition given above, specifically excluded from
Orthopedics: (i) Non-bone oncology; (ii) Blood vessels and vital organs;
(iii) Neurology, which is the medical specialty concerned with the brain,
spinal cord and nervous system, and including neurosurgery; and (iv)
Cranial neurosurgery, ENT and Otolaryngology. "Robot” shall be
defined as a system (a) containing an electromechanical device or
interface; (b) in or by which a user (i) experiences tactile sensations
and/or virtual constraints; (ii) interacts with a computer by receiving
tactile feedback (which feedback may be achieved by applying a degree of
opposing force to the user along the x, y, and z axes, or through any other
means); or (iii) grasps and/or operates any tool or device which is
constrained in its operation by a physical guide which itself is attached
to an electromechanical device.






	3.	 	Commercial sales of products:
	 
	 	 	The parties acknowledge that MAKO intends to sell and install the Alliance Specific Devices
for use with the HGS. Accordingly, in furtherance of the Alliance, each of the parties
hereby agrees to be bound as follows:






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	 	a.	 	Products for Alpha Testing. MAKO shall have the right to purchase the
eMax and other Alliance Specific Devices (collectively, the “Products”) from Anspach
each at an agreed distributor discount and to deliver such products to the MAKO
customers packaged together with other MAKO products as part of a complete kit. MAKO
will provide Anspach with the information on installations of the HGS using the
Alliance Specific Devices on a quarterly basis.
	 
	 	b.	 	Service of the Products. Anspach shall be responsible for the repair
and maintenance of any and all Products installed or operating at MAKO customer site.
Such repair and maintenance shall be in accordance with the Anspach standard Warranty
and Repair Policy as documented in the Warranty and Return Policy of the eMax Operating
Manual, provided however that Anspach shall use its best commercial efforts to provide
either turnaround repair service or loaner replacement in not more than forty-eight
(48) hours.
	 
	 	c.	 	Training: Anspach shall provide appropriate user training on the use
of any and all Products to key MAKO employees as requested by MAKO.
	 
	 	d.	 	Documentation: MAKO will provide its customers with appropriate
documentation to cover the end-user’s operation of the integrated Alliance system.
MAKO will be solely responsible for producing of the HGS documentation instructions and
Complete Reference Guide or the HGS. Anspach will provide MAKO with the appropriate
user manual/IFU for any and all Products that may be incorporated in the HGS manuals.
	 
	 	e.	 	Change to Existing Products: Anspach will provide MAKO with an
advanced reasonable written notification for changes that are planned or expected in
any and all Products, including, without limitation, Alliance Specific Devices, that
affect the overall performance of the eMax or the interface with the HGS. This
notification shall be delivered so as to enable MAKO to plan and prepare in advance for
the changes required in the HGS.
	 
	 	f.	 	Quality, Regulatory & Marketing: MAKO will assume responsibility for
the regulatory clearance for any and all Products and the use of Anspach products as
part of the HGS, excepting disposable and limited use components such as cutting burrs
and attachments, which shall be the responsibility of Anspach. Anspach is responsible
for obtaining and maintenance of FDA clearance of Anspach products for their original
intended use. Anspach will provide support to MAKO upon request to obtain FDA
clearance of any integration specific devices. Alliance Specific Devices manufactured
by Anspach will include the statement “Distributed by MAKO Surgical Corp.; Manufactured
by The Anspach Effort, Inc.” on the product labeling.
	 
	 	g.	 	Non-Solicitation: Anspach shall not, directly or indirectly, solicit,
market or sell any Products to any physician, hospital or other customer whatsoever for
use in the HGS.






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	4.	 	HGS 2.0 Considerations:






	 	a.	 	MAKO is contently finalizing the design requirements for the HGS 2.0 platform.
Prior to finalizing the design requirements, MAKO and Anspach will use commercially
reasonable efforts to assess the potential for MAKO procurement of the eMax console
assembly without housing for integration in the base of the HGS platform by MAKO.






	5.	 	Co-Marketing and Co-Promotion:






	 	a.	 	MAKO and Anspach may support each other in the marketing and promotion of the
integrated system and Alliance products sold.
	 
	 	b.	 	Neither MAKO nor Anspach may use other party’s name for any publicity or
marketing purpose without a written consent by the other party.






	6.	 	Binding Confidentiality Arrangement:
	 
	 	 	The parties agree that the existence of the LOA, the NDA, and the Definitive Agreement, and
the terms and provisions of each, shall be considered “Confidential Information” within the
meaning of that certain mutual Nondisclosure Agreement, between the parties, dated May 24,
2005, the terms of which are expressly incorporated herein. During the period beginning on
the Effective Date and continuing for three (3) years thereafter, neither party shall make a
public statement concerning MAKO’s use, marketing, sale, distribution and/or delivery of the
eMax or any Alliance Specific Devices absent the prior written consent of the other, which
shall not be unreasonably withheld.






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* * * * *





	 	 	If the terms and conditions set forth in this LOA, including the consideration exchanged between
the patties, are acceptable to you, please indicate your agreement and willingness to be bound by
executing and dating this LOI in the space provided below. This LOA shall be effective as of the
date upon which bath parties have executed it (the “Effective Date”). This LOA may be executed in
counterparts (which together shall constitute one instrument) and may be delivered and shall be
binding in facsimile forth.





Sincerely yours,




	 	 	 	 	 
	MAKO SURGICAL	 	 
	 
	 	 	 	 
	/s/ Menashe R. Frank
	 	 
	Menashe R. Frank	 	 
	Vice-President & General Counsel	 	 
	 
	 	 	 	 
	Agreed and accepted this 6th day of July, 2007	 	 
	 
	 	 	 	 
	THE ANSPACH EFFORT, INC.	 	 
	 
	 	 	 	 
	By:

	 	/s/ Bill Wachter	 	 
	Bill Wachter	 	 
	Chief Executive Officer	 	 







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