EX-10.32 Manufacturing Supply Agreement



 





EXHIBIT 10.32




EXECUTION COPY




MANUFACTURING SUPPLY AGREEMENT




     This MANUFACTURING SUPPLY AGREEMENT (this “Agreement”), effective as of July 26, 2007
(the “Effective Date”), is made by and between MAKO SURGICAL, INC., having a place of
business at 2555 Davie Road Ft. Lauderdale, FL 33317 (“MAKO Surgical”), and SYMMETRY
MEDICAL, having a place of business at 220 West Market Street, Warsaw IN 46580-2827 (“Service
Provider”).



BACKGROUND




     A. MAKO Surgical is engaged in the business of development and commercialization of medical
device products including interactive, surgeon-based guidance systems focused on minimally
invasive, orthopedic procedures that will assist in early stage degenerative joint diseases.



     B. Service Provider is engaged in, among other things, the manufacture, development and supply
of products for the medical device industry; and



     C. MAKO Surgical desires to engage, and Service Provider desires to perform, services for MAKO
Surgical relating to: (i) the implementation, validation, and manufacture of certain MAKO Surgical
products; and (ii) the supply of such products pursuant to any Purchase Orders from MAKO Surgical
in accordance with the terms and conditions hereof and the Exhibits attached hereto.



     NOW, THEREFORE, for and in consideration of the covenants, conditions, and undertakings
hereinafter set forth, it is agreed by and between the Parties as follows:



ARTICLE 1

DEFINITIONS




     As used in this Agreement, the following terms shall have the meanings indicated below:



     1.1 “Applicable Laws” means all laws, ordinances, rules, and regulations of any
governmental or regulatory authority that apply to the Services or this Agreement, including
without limitation (a) all applicable federal, state, and local laws and regulations; (b) the U.S.
Federal Food, Drug and Cosmetic Act (“FDCA”), (c) regulations and guidelines of the FDA and
other Regulatory Agencies, and (d) GMP.



     1.2 “FDA” means the United States Food and Drug Administration, or any successor
agency thereto.



     1.3 “GMP” means current good manufacturing practice and standards as provided for (and
as amended from time to time) in the “Current Good Manufacturing Practice Regulations” of the U.S.
Code of Federal Regulations Title 21 (21 CFR §§ 820) and in European Community Council Directive
93/42/EEC concerning medical devices, any U.S., European, or other applicable laws, regulations or
respective guidance documents now or subsequently established by a governmental or regulatory
authority, and any arrangements, additions, or clarifications




 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




 









 







agreed from time to time between the Parties.



     1.4 “Products” means the medical device products manufactured by Service Provider for
MAKO Surgical pursuant hereto.



     1.5 “Purchase Order” means any of MAKO Surgical’s written orders to purchase Products
from Service Provider, as MAKO Surgical may deliver to Service Provider from time to time.



     1.6 “Regulatory Agency” means any governmental regulatory authority involved in
regulating any aspect of the conduct, development, manufacture, market approval, sale,
distribution, packaging, or use of the Services or the products resulting therefrom, including the
FDA and similar regulatory agencies.



     1.7 “Services” means the manufacturing services to be provided by Service Provider
pursuant hereto.



     1.8 “Specifications” means any specifications provided by MAKO Surgical that set forth
design and functional specifications and other requirements for Services Provider’s performance of
the Services and manufacture and pricing of the Products, which may be modified from time to time
by MAKO Surgical. Whether or not expressly set forth therein, the Specifications shall be deemed to
include compliance with all Applicable laws. The Specifications, as amended from time to time,
shall be attached hereto as Exhibit A incorporated herein by reference. The Specifications shall be
deemed to include the “Quality Assurance & Regulatory Affairs Guidelines” attached hereto as
Exhibit B incorporated herein by reference.



ARTICLE 2

DEVELOPMENT SERVICES




     2.1 Standards of Performance. Service Provider shall perform Services and deliver upon
request by MAKO Surgical all results, data, records, and reports created or generated in connection
with such performance. Service Provider shall perform the Services in compliance with GMP and all
other Applicable Laws, and in accordance with applicable Specifications



     2.2 Performance of Services MAKO Surgical may, at any time and from time to time,
submit to Service Provider a request for changes to the Specifications or any component of the
Services or Products, whether applicable to Service’s Provider’s past, present, or future
performance hereunder (each, a “Change Order”). If, upon review of a Change Order, Service
Provider determines that the requests set forth in the Change Order can be implemented without
resulting in material increases in Service Provider’s time or cost, and without materially
affecting Service Provider’s ability to provide Services or Products, Service Provider shall inform
MAKO Surgical thereof, the Change Order shall thereupon become part of the Specifications
hereunder, and Service Provider shall implement such Change Order at no additional cost to MAKO
Surgical. Otherwise, Service Provider shall inform MAKO Surgical of the commercially reasonable fee
and scheduling changes that would be required for Service Provider to implement the Change Order.
If MAKO Surgical agrees to such fee and scheduling changes in a signed writing within a reasonable
time thereafter, the Change Order shall thereupon become part of the Specifications hereunder, and
Service Provider shall implement such Change Order in




 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




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accordance with the terms and conditions so agreed to by MAKO Surgical. Service Provider shall
at all times use its commercially reasonable efforts to comply with all Change Orders requested by
MAKO Surgical, and to minimize the time, delays, and additional charges required as a result of
such changes.



     2.3 Records. Service Provider shall maintain all technical, scientific, accounting,
and other records in good scientific manner, as applicable, and in sufficient detail (to reflect
all material work done, results achieved, and intellectual property developed in the course of
performing the Services, including all data in the form required by Applicable Law.



     2.4 Inspections. Upon reasonable prior written notice given by MAKO Surgical to
Service Provider, Service Provider shall permit MAKO Surgical or its representatives to inspect and
audit Service Provider and/or, in collaboration with Service Provider, any third-party provider to
Service Provider, during normal business hours, including performance of the Services hereunder,
the facilities used, and the relevant books and records in order to monitor compliance with
Applicable Laws and this Agreement. Notwithstanding the foregoing, such compliance shall at all
times remain Service Provider’s sole and absolute responsibility, and MAKO Surgical’s failure to
inform Service Provider of any noncompliance shall not be construed to imply MAKO Surgical’s
approval thereof or to relieve Service Provider from any obligation to remediate any noncompliance.



ARTICLE 3

SUPPLY OF PRODUCTS




     3.1 Supply. Service Provider’s shall complete all Services in accordance with
applicable Specifications and shall supply the resulting Products in accordance with applicable
Specifications and any supplemental provisions set forth on MAKO Surgical’s Purchase Orders agreed
to or ratified by Service Provider either in a signed writing or by full or partial fulfillment
thereof. Any provisions amended to or excised from any Purchase Order by Service Provider will be
null and void and of no force or effect unless and to the extent that the same are agreed to in a
writing signed by MAKO Surgical.



     3.2 Delivery. At such times and locations, and in such manner and means, as may be
set forth in the Specifications of applicable Purchase Order for such purpose, Service Provider
shall deliver Products to MAKO Surgical, F.O.B. MAKO Surgical’s receiving facilities. Risk of loss
shall pass to MAKO Surgical’s only upon MAKO Surgical’s knowing receipt thereof. Service Provider
shall suitably pack Products for shipment in accordance with Service Provider’s validated internal
packaging and shipping procedures.



     3.3 Acceptance. Within 30 days after Service Provider’s delivery of each Product, or
at such other time(s) as may be set forth in the Purchase Order (the “Acceptance Period”),
MAKO Surgical shall verify that such Product reasonably conforms to applicable Specifications and
applicable provisions of the Purchase Order. MAKO Surgical shall notify Service Provider in writing
of any nonconformities exhibited by such Product (a “Rejection Notice”), and Service
Provider shall thereupon immediately remedy such nonconformities, and re-deliver any Products, as
appropriate with documentation as to how such non-conformity was addressed, whereupon the
provisions of this Section 3.3 shall iterate with respect thereto. Should MAKO Surgical inform
Service Provider of its acceptance or fail to deliver a Rejection Notice during an Acceptance




 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




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Period, then applicable delivered Products shall be deemed accepted.



     3.4 Quality Control. Notwithstanding the provisions of Section 3.3, MAKO Surgical may
engage in customary quality control inspection techniques to ascertain the likelihood that
particular shipments of Products contain an overabundance of nonconforming units, and MAKO Surgical
may reject any shipment of Licensed Products reasonably so shown to be nonconforming.



ARTICLE 4

PAYMENTS AND PRICING




     4.1 Services. In consideration for the Services performed by Service Provider, within
30 days after MAKO Surgical’s acceptance of Product hereunder, MAKO Surgical shall pay Service
Provider for the purchase of all accepted Products in accordance with the respective pricing
provisions of the Specifications and the Purchase Order (the most recent of which, to the extent
that the differ, will supersede the older), by check or other negotiable instrument drawn on U.S.
funds, or by wire transfer to such account as Service Provider may specify for such purpose.



     4.2 Pricing Service Provider shall maintain and honor the per part pricing as set
forth in Exhibit “A” for a period of two years from execution of this agreement. However,
notwithstanding the foregoing, Service Provider shall maintain the right to submit new pricing to
MAKO in the following circumstances:




	 	a.	 	Where raw material prices rise greater than [***]% and negatively effect the
ability of Service Provider to provide products at agreed upon costs set forth in
Exhibit A
	 
	 	b.	 	Where, as set forth in Section 2.2, MAKO shall request engineering or
specification changes to the manufacturing process.





     4.3 Notice for a Requested Pricing Increase Should Service Provider request a price
increase in accordance with section 4.2, such request shall be submitted to MAKO in writing and
provide 60 days notice prior to the effective date of such increase.



     4.4. Currency. All amounts payable by MAKO Surgical hereunder will be made in United
States Dollars.



     4.5 Accounting Records. Service Provider shall maintain complete and accurate
accounting records related to this agreement in accordance with generally accepted accounting
principles in the United States. Service Provider shall make such records available for inspection,
review, and audit at reasonable times by MAKO Surgical or its duly authorized representative, at
MAKO Surgical’s expense, for three (3) years following the end of the calendar year to which such
records pertain.



ARTICLE 5

QUALITY AND REGULATORY MATTERS




     5.1 Regulatory Actions. Service Provider shall permit the FDA and other Regulatory
Agencies to conduct inspections of Service Provider’s facilities as they may request, including
pre-approval inspections, and shall cooperate with Regulatory Agencies with respect to




 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




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the inspections and any related matters. Service Provider shall give MAKO Surgical prior
notice, to the extent practicable, of any such inspections related to the Services, the Products,
or otherwise effecting MAKO Surgical hereunder, and shall keep MAKO Surgical informed about the
results and conclusions of each regulatory inspection, including actions taken by Service Provider
to remedy conditions cited in the inspections. Service Provider shall permit MAKO Surgical or its
representative to be present at such inspections. Service Provider shall provide MAKO Surgical
with copies of any written inspection reports issued by a Regulatory Agency and all correspondence
between Service Provider and the Regulatory Agency, including, but not limited to, FDA Form 483,
Notice of Observation, and all related correspondence, in each case relating to the Services,
Products, or general manufacturing concerns (i.e., facility compliance or the like). Service
Provider shall promptly notify and provide MAKO Surgical copies of any request, directive, or other
communication of the FDA or other Regulatory Agency relating to the Services or Products and shall
cooperate with MAKO Surgical in responding to such requests, directives, and communications.



     5.2 Information. Service Provider shall provide upon request from MAKO Surgical, at a
reasonable cost, all available information in Service Provider’s control necessary or useful for
MAI O Surgical to apply for, obtain, and maintain regulatory approvals for Products in any country,
including without limitation information relating to the facilities, process, methodology, raw
materials, and intermediates used in the manufacture, processing, and packaging of Products.



     5.3 Manufacturing Changes. Service Provider shall proceed in accordance with all
specifications and manufacturing procedures as provided by MAKO and validated by Service Provider’s
internal quality system. Service provider shall make no changes in such procedures or processes
without prior approval by MAKO. Any and all such changes shall be properly documented in
accordance with industry quality standards, GMP’s, and any Applicable Laws.



ARTICLE 6

INTELLECTUAL PROPERTY




     6.1 Intellectual Property. All inventions, works of authorship, improvements,
discoveries, modifications, methods, processes, technology, materials, trade secrets, know-how,
data, and information of every kind or description conceived, developed, generated, made, fixed in
a tangible medium of expression, or reduced to practice by Service Provider, either alone or
jointly with others, in connection with the Services, the Products, or the performance of this
Agreement, including all worldwide patent, copyright, trademark, trade secret, and all other
intellectual property rights therein and thereto shall be the sole and exclusive property of MAKO
Surgical, including without limitation the right to apply for and renew the same in MAKO Surgical’s
name alone, all of the foregoing being hereby deemed under Applicable Law to be specially
commissioned works made for hire, as applicable. Notwithstanding the foregoing, should Service
Provider discover, adapt or improve a technology or method of manufacture used under this contract
nothing herein shall prevent Service Provider from using such method, process or invention on other
Symmetry products provided activities in no way compete with MAKO’s business interests.



     6.2 Exception; License. The provisions of Section 6.1 shall not apply to Service
Providers proprietary inventions, works, and technology conceived or developed by Service Provider
prior to the Effective Date, title to which shall remain with Service provider. However,




 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




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Service Provider hereby grants to MAKO Surgical the nonexclusive, perpetual, irrevocable,
fully paid-up right and license to make, use, sell, reproduce, make derivative works of, and
otherwise commercially practice in every way, and sublicense the same to third parties, any and all
of Service Provider’s pre-existing works that are included in or required for the operation of any
Products.



ARTICLE 7

REPRESENTATIONS AND WARRANTIES




     7.1 General. Each party hereby represents and warrants to the other that: (a) it is a
corporation in good standing under the laws of its state of incorporation; (b) it has full
corporate power to enter into this Agreement and to grant to the other party the rights so granted
hereunder; and (c) it has obtained all necessary corporate approvals to enter into, execute, and
perform its obligations under this Agreement.



     7.2 Services. Service Provider represents and warrants that: (a) it shall perform all
Services in a timely, professional, and workmanlike manner, with due care and in accordance with
prevailing industry standards, including without limitation GMP; (b) it shall perform and document
each Service in accordance herewith, with MAKO’s requests, and with all Applicable Laws; (c) that
the Services and Products, as delivered, shall conform to all applicable and agreed-upon
Specifications and Purchase Orders; and (d) that the Services and the Products will not infringe
the intellectual property rights of any third party.



     7.3 Personnel. Service Provider represents and warrants to MAKO Surgical that neither
Service Provider nor any of its employees have been “debarred” by the FDA, or subject to a similar
sanction from another Regulatory Agency, nor have debarment proceedings against Service Provider or
any of its employees been commenced or reasonably threatened.



     7.4 Disclaimer. EXCEPT AS PROVIDED IN THIS Article 7, NEITHER PARTY MAKES ANY
WARRANTIES OR CONDITIONS (EXPRESS, IMPLIED, STATUTORY OR OTHERWISE) WITH RESPECT TO THE SUBJECT
MATTER HEREOF AND EACH PARTY EXPRESSLY DISCLAIMS ANY SUCH ADDITIONAL WARRANTIES.



ARTICLE 8

TERM AND TERMINATION




     8.1 Term. The term of this Agreement shall commence on the Effective Date and
continue in full force until terminated in accordance with this Article 8.



     8.2 Termination for Breach. In the event of a party’s material breach hereof, the
other party may terminate this Agreement by sending written notice thereof to the breaching party,
and, if such breach is not cured within thirty (30) days after the breaching party’s receipt of
such written notice, this Agreement shall thereupon terminate. Notwithstanding the foregoing, if
during such thirty (30) day period, the breaching party disputes that it has materially breached
this Agreement, then this Agreement shall not terminate until it has been finally determined in
accordance with Section 11.2 below that the allegedly breaching party has materially breached this
Agreement, and such party then fails to cure such breach within thirty (30) days thereafter.



 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




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     8.3 Permissive Termination.



     8.3.1 Agreement. MAKO Surgical may terminate this Agreement for any reason or for no
reason, at its convenience, upon one hundred and eighty (180) days prior written notice to Service
Provider. Symmetry Medical may terminate this Agreement for any reason or for no reason, at its
convenience, upon one year prior written notice to MAKO Surgical.



     8.4 Effect of Expiration or Termination.



     8.4.1 Rights and Obligations. Termination or expiration of this Agreement shall not
relieve a Party from any liability that, at the time of such termination or expiration, has already
accrued. Upon expiration or termination of this Agreement, Service Provider shall, as promptly as
practicable: (a) cease all work on the Services; and (b) turn over to MAKO Surgical all applicable
reports, data, and MAKO Surgical Confidential Information then in Service Provider’s possession or
control.



ARTICLE 9

CONFIDENTIALITY




     9.1 Confidential Information. The Parties may from time to time disclose to each
other Confidential Information. “Confidential Information” means any information disclosed
by one Party to the other Party that, if disclosed in tangible form, is marked “confidential” or
with other similar designation to indicate its confidential or proprietary nature or, if disclosed
orally, is indicated orally to be confidential or proprietary by the Party disclosing the
information at the time of the disclosure and is confirmed in writing as confidential or
proprietary by the disclosing Party within forty-five (45) days after such disclosure.
Notwithstanding the foregoing or anything herein to the contrary, Confidential Information shall
not include any information that, in each case as demonstrated by written documentation: (a) was
already known to the receiving Party, other than under an obligation of confidentiality, at the
time of disclosure; (b) was generally available to the public or otherwise part of the public
domain at the time of its disclosure to the receiving Party; (c) became generally available to the
public or otherwise part of the public domain after its disclosure and other than through any act
or omission of the receiving Party in breach of this Agreement; or (d) was subsequently lawfully
disclosed to the receiving Party by a person other than the disclosing Party.



     9.2 Confidentiality. Each Party shall hold and maintain in strict confidence all
Confidential Information of the other Party. Without limiting the foregoing, neither Party shall
use or disclose the Confidential Information of the other Party, except as otherwise permitted by
this Agreement or as may be necessary or useful to exercise its rights or perform its obligations
under this Agreement. Nothing contained in this Article 9 of this Agreement shall prevent either
Party from disclosing any Confidential Information of the other Party to the extent reasonable
necessary in prosecuting or defending litigation, complying with applicable governmental laws,
regulations, such as SEC regulations, or court order or otherwise submitting information to tax or
other governmental authorities, in submissions to Regulatory Agencies, or as a part of patent
applications filed on inventions made under this Agreement; provided that if a Party is required by
law to make any such disclosure, other than pursuant to a confidentiality agreement, it will give
reasonable advance notice to the other Party of such disclosure and, save to the extent unavailable
in the case of patent applications or the like, will use its reasonable efforts to secure




 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




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confidential treatment of such information.



     9.3 Confidential Terms. Each Party shall treat the terms of this Agreement as the
Confidential Information of the other Party. Notwithstanding anything to the contrary, however,
each Party may disclose the terms of this Agreement (a) to advisors, actual or potential investors,
acquisition partners, sublicensees, and others on a need to know basis under circumstances that
reasonably ensure the confidentiality thereof, or (b) as required by securities or other applicable
laws or regulations, such as SEC regulations.



ARTICLE 10

INDEMNIFICATION




     10.1 MAKO Surgical. MAKO Surgical shall indemnify, defend, and hold harmless Service
Provider, its directors, officers, employees, agents, successors and assigns from and against any
liabilities, expenses, or costs (including reasonable attorneys’ fees and court costs) arising out
of any claim, complaint, suit, proceeding, or cause of action brought against any of them by a
third party resulting from: (a) the negligent or intentionally wrongful acts or omissions of MAKO
Surgical; and (b) breach by MAKO Surgical of any of its representations and warranties under this
Agreement, in each case subject to the requirements set forth in Section 10.3 below.
Notwithstanding the foregoing, MAKO Surgical shall have no obligations under this Section 10.1 for
any liabilities, expenses, or costs arising out of or relating to claims covered under Section 10.2
below.



     10.2 Service Provider. Service Provider shall indemnify, defend, and hold harmless
MAKO Surgical, its directors, officers, employees, agents, successors, and assigns from and against
all liabilities, expenses, and costs (including reasonable attorneys’ fees and court costs) arising
out of any claim, complaint, suit, proceeding, or cause of action brought against any of them by a
third party resulting from: (a) the negligent or intentionally wrongful acts or omissions of
Service Provider; and (b) breach by Service Provider of any of its representations and warranties
under this Agreement, in each case subject to the requirements set forth in Section 10.3.



     10.3 Indemnification Procedure. A Party that intends to claim a right of
indemnification hereunder (“Indemnitee”) shall promptly notify the indemnifying Party
(“Indemnitor”) in writing of any third party claim, suit, or proceeding included within the
indemnification described in this Article 10 (each a “Claim”) with respect to which the
Indemnitee intends to claim such indemnification, and the Indemnitor shall have sole control of the
defense and settlement of the Claim. The Indemnitee shall have the right to participate at its own
expense and with counsel of its own choosing in the defense or settlement of the Claim. The
indemnification obligations under this Article 10 shall not apply to amounts paid in settlement of
any Claim if such settlement is effected without the consent of the Indemnitor. The Indemnitee and
its employees, at the Indemnitor’s request and expense, shall provide full information and
reasonable assistance to Indemnitor and its legal representatives with respect to Claims.



 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




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ARTICLE 11

GENERAL




     11.1 Governing Law. This Agreement shall be governed by, and construed and
interpreted in accordance with, the laws of the United States and the State of Florida.



     11.2 Disputes. In the event of any dispute or claim arising out of or in connection
with this Agreement, any Purchase Order, or the performance, breach or termination thereof, either
Service Provider or MAKO Surgical may, by written notice to the other Party, have such dispute
referred to the Chief Executive Officers (or equivalent) of Service Provider and MAKO Surgical, for
attempted resolution by good faith negotiations within thirty (30) days after such notice is
received by such other Party. If the Parties are unable to resolve such dispute within such thirty
(30) day period, such dispute shall be finally settled by binding arbitration by Judicial
Arbitration and Mediation Services, Inc. (JAMS) under its rules of arbitration, by one (1)
arbitrator appointed in accordance with said rules. The decision and/or award rendered by the
arbitrator shall be written, final and non-appealable, and judgment on such decision and/or award
may be entered in any court of competent jurisdiction. The arbitral proceedings and all pleadings
and evidence shall be in the English language. The place of arbitration shall be in the state of
Florida, U.S.A. The costs of any arbitration, including administrative fees and fees of the
arbitrator, shall be shared equally by the Parties to the dispute, unless otherwise determined by
the arbitrator. Each Party shall bear the cost of its own attorneys’ and expert fees. The Parties
agree that, any provision of applicable law notwithstanding, they will not request, and the
arbitrator shall have no authority to award, punitive or exemplary damages against any Party.



     11.3 Assignment. The parties acknowledge and agree that MAKO Surgical is engaging
Service Provider for its unique abilities. The rights and obligations of Service Provider under
this Agreement may not be assigned or otherwise transferred to a third party without the prior
written consent of MAKO Surgical. Any assignment in violation of this Section 11.3 shall be null
and void ab initio and of no force or effect. MAKO Surgical may assign his Agreement for its
convenience.



     11.4 Notices. Any notice or report required or permitted to be given or made under
this Agreement by either Party shall be in writing and delivered to the other Party at its address
indicated in this Agreement (or to such other address as a Party may specify by notice under this
Agreement) by courier or by registered or certified airmail, postage prepaid, courier service, or
by facsimile, which facsimile is promptly confirmed, in writing, by registered or certified
airmail, postage prepaid. All notices shall be effective as of the date received by the addressee.




	 	 	If to Service Provider: Symmetry Medical Inc. 220 West Market Street, Warsaw IN,
46580-2827





     If to MAKO Surgical: MAKO Surgical Inc. 2555 Davie Road Ft. Lauderdale, FL 33317



     11.5 Limitation of Liability. EXCEPT TO THE EXTENT SUCH PARTY MAY BE REQUIRED TO
INDEMNIFY THE OTHER PARTY HEREUNDER OR IN THE CASE OF SERVICE PROVIDER’S WILLFUL BREACH OF THIS
AGREEMENT, NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY FOR ANY SPECIAL,
CONSEQUENTIAL, EXEMPLARY, OR INCIDENTAL DAMAGES (INCLUDING LOST OR




 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




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ANTICIPATED REVENUES OR PROFITS RELATING TO THE SAME), ARISING FROM ANY CLAIM RELATING TO THIS
AGREEMENT, WHETHER SUCH CLAIM IS BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EVEN
IF AN AUTHORIZED REPRESENTATIVE OF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF
SAME.



     11.6 Subcontractors. Service Provider shall not subcontract any Services or any of
its obligations hereunder to another entity without MAKO Surgical’s prior written approval, unless
said subcontractor is a solely-owned division of Symmetry Medical or an approved supplier per the
Symmetry Medical Quality System.



     11.7 Non-Waiver. Neither party shall be deemed, by any act or omission, to have
waived any provision hereof or any of its rights or remedies hereunder unless such waiver is in
writing and signed by the waiving Party, and then only to the extent specifically set forth in such
writing. A waiver with reference to one event shall not be construed as continuing or as a bar to
or waiver of any right or remedy as to a subsequent event.



     11.8 Severability. Should any provision hereof be held invalid or unenforceable for
any reason in any jurisdiction or under any particular facts and circumstances by any court of
competent authority or by a legally enforceable directive of any governmental body, such section or
portion thereof will be validly reformed so as to approximate the intent of the Parties as nearly
as possible and, if unreformable, will be deemed divisible and severed herefrom with respect to
such jurisdiction or such facts and circumstances, but the Agreement will not otherwise be
affected, and such section or portion will be unaffected with respect to other jurisdictions,
facts, and circumstances.



     11.9 Independent Contractors. The relationship of MAKO Surgical and Service Provider
established by this Agreement is that of independent contractors. Nothing in this Agreement shall
be construed to create any other relationship between MAKO Surgical and Service Provider. Neither
Party shall have any right, power, or authority to assume, create, or incur any expense, liability,
or obligation, express or implied, on behalf of the other.



     11.10 Entire Agreement. This Agreement, together with the Exhibits hereto,
constitutes and contains the entire understanding and agreement of the parties respecting the
subject matter hereof and cancels and supersedes any and all prior and contemporaneous
negotiations, correspondence, understandings, and agreements between the Parties, whether oral or
written, regarding such subject matter. Notwithstanding the foregoing, the Exhibits hereto are
intended by the parties to supplement, not to countermand, the provision of the body of this
Agreement. To the extent the terms and conditions of the body of this Agreement conflict with the
terms and conditions of any Exhibit hereto, the terms and conditions of the body of this Agreement
shall govern, unless expressly set forth to the contrary in a writing that expressly refers to the
provisions of this Agreement (including, without limitation, the Specifications) to be amended or
superseded and that is signed by duly authorized officers or representatives of the parties, and
the provisions of the Agreement not specifically superseded or amended thereby shall remain in full
force and effect.



     11.11 Counterparts. This Agreement may be executed in counterparts and by fax, each
of which shall be deemed an original, but which together shall constitute one and the same




 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




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instrument.



     IN WITNESS WHEREOF, the Parties by their duly authorized representatives hereby execute this
Agreement.



	 	 	 	 	 	 	 	 	 	 	 
	MAKO SURGICAL	 	 	 	SYMMETRY MEDICAL	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Maurice Ferré
	 	 	 	By:
	 	/s/ Fred Hote	 	 
	Name:

	 	Maurice Ferré
	 	 	 	Name:
	 	Fred Hote	 	 
	Title:

	 	CEO
	 	 	 	Title:
	 	CFO	 	 
	 

	 	 

	 	 	 	 	 	 

	 	 








 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




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EXHIBIT A




TO




MANUFACTURING SUPPLY AGREEMENT




Specifications




[PART I — DMR as attached hereto in electronic form — CD format]




[PART II — Product Pricing — appears on the following page]




[PART III — Packaging, Labeling & Process Validation Services — follows PART II]




 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




- 12 -









 





	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Item	 	Part Number(s)	 	Description	 	Quote #	 	5 Pc Price	 	10 Pc Price	 	20 Pc Price	 	Tooling Charges	 	 
	1	 	180101/180105	 	EPIK KNEE FEMUR SZ4
	 	 	 	$[***]	 	$[***]	 	$[***]	 	$[***]	 	 
	2	 	180102/180106	 	EPIK KNEE FEMUR SZ6
	 	 	 	$[***]	 	$[***]	 	$[***]	 	$[***]	 	 
	3	 	180103/180107	 	EPIK KNEE FEMUR SZ8
	 	 	 	$[***]	 	$[***]	 	$[***]	 	$[***]	 	 
	4	 	180104/180108	 	EPIK KNEE FEMUR SZ10
	 	 	 	$[***]	 	$[***]	 	$[***]	 	$[***]	 	 
	5	 	180111/180116	 	EPIK BASEPLATE, SZ35
	 	 	 	$[***]	 	$[***]	 	$[***]	 	$[***]	 	 
	6	 	18011/2180117	 	ERIE BASEPLATE, SZ37
	 	 	 	$[***]	 	$[***]	 	$[***]	 	$[***]	 	 
	7	 	180113/180118	 	EPIK BASEPLATE, SZ40
	 	 	 	$[***]	 	$[***]	 	$[***]	 	$[***]	 	 
	8	 	180114/180119	 	EPIK BASEPLATE, SZ42
	 	 	 	$[***]	 	$[***]	 	$[***]	 	$[***]	 	 
	9	 	180115/180120	 	EPIK BASEPLATE, SZ45
	 	 	 	$[***]	 	$[***]	 	$[***]	 	$[***]	 	 
	10	 	180121/180123	 	EPIK ALL-POLY INIAY, 29 MM
	 	 	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	11	 	180124/180126	 	ERIE ALL-POLY INLAY, 32 MM
	 	 	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	12	 	180127/180129	 	EPIK ALL-POLY INLAY, 35 MM
	 	 	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	13	 	180141//80143	 	EPIK TIBIAL INSERT, 5Z 35
	 	 	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	14	 	180144/180146	 	EPIK TIBIAL INSERT, SZ 37
	 	 	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	15	 	180147/180149	 	EPIK TIBIAL INSERT, SZ 40
	 	 	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	16	 	180150/180152	 	EPIK TIBIAL INSERT, SZ 42
	 	 	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	17	 	180153/180155	 	EP/K TIBIAL INSERT, SZ 45
	 	 	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	18	 	120063	 	Epik Knee Posterior Drill Guide H
	 	55834	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	19	 	120064	 	Femoral Inserter
	 	55835	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	20	 	120065	 	Epik Femoral Trial Inserter/Extra
	 	55808	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	21	 	120066	 	Epik Femoral Impactor
	 	55788	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	22	 	120071	 	Epik Intertroch Retractor
	 	55793	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	23	 	120072	 	Epik MCL Retractor
	 	55794	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	24	 	120073	 	Headed Pin Pusher
	 	55795	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	25	 	120074/120075	 	Epik Femoral Sizer Sm/Lg
	 	55800	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	26	 	120050/120057	 	Epik DFPS Size 410 LM/RL — RM/LL
	 	55801	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	27	 	120058/120059	 	Epik DFPS Drill Bit (2, 3, & 4mm)
	 	55802	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	28	 	120101	 	EPIK Femoral Tibia System Case
	 	19894	 	$[***]	 	$[***]	 	$[***]	 	$[***]	 	Prototype & Silkscreening Charges
	29	 	120102	 	EPIK Inlay Tibia System Case
	 	19893	 	$[***]	 	$[***]	 	$[***]	 	$[***]	 	Prototype & Silkscreening Charges
	30	 	120103	 	EPIK Onlay Tibia System Case
	 	19892	 	$[***]	 	$[***]	 	$[***]	 	$[***]	 	Prototype & Silkscreening Charges
	31	 	120104	 	EPIK DFPS Case
	 	19891	 	$[***]	 	$[***]	 	$[***]	 	$[***]	 	Prototype & Silkscreening Charges
	32	 	120060	 	Epik Knee Scoville Haverfield Ret
	 	55809	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	33	 	120061	 	Epik Knee Distractor Pins
	 	55803	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	34	 	120048	 	Epik Inlay Tibial Template 29/32m
	 	55804	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	35	 	120049	 	Epik Inlay Tibial Template 35/37m
	 	55805	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	36	 	120012/120023	 	Epik Inlay Tibial Trial, Size 29/
	 	55806	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	37	 	120076	 	Epik Inlay Tibial Impactor
	 	55807	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	38	 	120078	 	EM Varus-Valgus Ankle Guide
	 	55811	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	39	 	120000/120003	 	Epik Knee Femoral Drill/Keel Guid
	 	55832	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	40	 	120079	 	Extension EM Guide
	 	55812	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	41	 	120080/120077	 	Epik Saw Block LM/RL & RM/LL
	 	55813	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	42	 	120081	 	Epik Onlay Tibial Stylus
	 	55814	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	43	 	120082	 	Epik Femur Post Drill
	 	55833	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	44	 	120083/120084	 	Epik Onlay Gap Gauge 9, 10, 11mm
	 	55815	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	45	 	120085	 	Epik Onlay Handle
	 	55816	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	46	 	120024/120027	 	Epik Onlay
Baseplate Template37/45
	 	55818	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	47	 	120028/120035	 	Epik Onlay Drill Guide/Trial Base
	 	55819	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	48	 	120093	 	Baseplate Post Drill Guide
	 	55820	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	49	 	20094	 	Epik Onlay Baseplate Post Punch
	 	5582	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	50	 	120036/120047	 	Epik Onlay Trial Insert, Sizes 37
	 	55822	 	$[***]	 	$[***]	 	$[***]	 	 	 	 
	51	 	120086	 	Epik Baseplate Impactor
	 	55823	 	$[***]	 	$[***]	 	$[***]	 	 	 	 









 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




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Packaging and Labeling Services




     The following is a list of the related cost estimations which correspond with the mentioned
list in the proposal:




	 	•	 	Tooling and setup fees for sterile packaging supplies






	 	à 	 	 Nonrecurring costs (estimates):
	 
	 	à 	 	Fixtures, and sealing requirements for trays and lids — $[***]
	 
	 	à 	 	 Engineering set-up, internal IQ, OQ, PQ (burst, peel tests) — $[***]






	 	 	– 	Packaging verification and validation testing (and bioburden tests)






	 	à 	 	 Bioburden — $[***]- $[***]






	 	•	 	Setup fees for printed packaging and labeling supplies






	 	 	–  	Each implant or set of implants packaged within one blister tray $[***] — $[***],
cost dependent on size of blister which may be relative to the size of the implant or
the number of implants in one blister tray, including the double barrier packaging
within a class 10,000 room.
	 
	 	 	–  	Box, which will hold the blister tray:






	 	à 	 	 $[***] = $[***] per box depending on box size
	 
	 	à 	 	 Die charge for each box design — $[***]
	 
	 	à 	 	Artwork/Graphics per box design — $[***]
	 
	 	à 	 	Final packaging, blister placed in box with applicable IFU’s, labeled & shrink
wrapped — $[***] — $[***] each package.






	 	•	 	Sterilization verification and validation testing






	 	 	 	- Gamma Sterilization, initial batch sterilization validation (Nonrecurring cost) -
$[***]






	 	 	 	à Subsequent batch validations/quarterly sterilization audits — $[***]






	 	•	 	Label and IFU product translation — 5 languages (which excludes English), French,
Italian, Spanish, German & Japanese, layout and printing set-up fees






	 	 	 	- Label translation — 150 to 180 labels cost $[***]
	 
	 	 	 	- IFU translation -$[***]





     Project
expenses that would be included at no additional expense:




	 	•	 	Cleaning verification and validation -






	 	 	 	-Cytotoxicity — $[***]
	 
	 	 	 	-Pyrogen — $[***]
	 
	 	 	 	-Mfg. Chemical residuals — $[***]






	 	•	 	Polymer cell environment controls verification and validation — $[***]
	 
	 	•	 	Pre-sterile packaging clean room verification and validation — $[***] — $[***] (based on
room size)







 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




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EXHIBIT B




TO




MANUFACTURING SUPPLY AGREEMENT




"Quality Assurance & Regulatory Affairs Guidelines”




     The following describes the quality assurance and regulatory affairs guidelines relating to
the Agreement to which it is attached for the EPIK unicompartmental knee implant system (“EPIK”).
Undefined, capitalized terms appearing in this Exhibit shall have the meanings ascribed to them in
the Agreement.



1. Quality System





	 	1.1.	 	Service Provider will maintain a current quality system that is adequate to ensure
compliance with the applicable standards and regulations.
	 
	 	1.2.	 	Service Provider will immediately notify MAKO Surgical of any notification of
non-compliance regarding the quality system received from a the FDA or other Regulatory
Agency.
	 
	 	1.3.	 	Service Provider will follow its own Standard Operating Procedures (SOP’s) to ensure
compliance with its quality system and all relevant standards.
	 
	 	1.4.	 	Service Provider will supply a confidential list of pertinent to EPIK SOP’s and copies of
SOP’s as requested by MAKO Surgical. Any proprietary information contained in the SOP’s will
be available for on-site inspection at the relevant Service Provider facility but shall be
removed from any documents to be supplied to MAKO Surgical.
	 
	 	1.5.	 	Service Provider will be responsible for selecting outside contracted suppliers but will
consider for use MAKO Surgical-requested suppliers, subject to Service Provider approved
supplier procedures.





2. Production





	 	2.1.	 	Service Provider will perform validations of manufacturing processes as applicable, subject
to Service Provider internal procedures for process validation. MAKO Surgical will review and
approve validation documentation, as it deems applicable. Service Provider will maintain
documentation that these validations have occurred and are current. Validation protocols will
be approved by MAKO prior to execution for any unique MAKO process or processes. Test reports
performed by Service Provider will also be approved by MAKO Surgical. Completed protocols and
reports will be forwarded to MAKO Surgical.
	 
	 	2.2.	 	Service Provider is responsible for all manufacturing training per Service Provider
internal training procedures.
	 
	 	2.3.	 	Service Provider will inspect all incoming material to the specifications and maintain
appropriate inspection records per Service Provider internal inspection procedures.





 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




- 4 -









 












	 	2.4.	 	Service Provider will inspect final EPIK Products to finished goods drawings or
specifications and maintain appropriate inspection records. MAKO Surgical will approve the
final inspection protocol prior to implementation.
	 
	 	2.5.	 	Service Provider will provide MAKO Surgical with a Certificate of Compliance (“C of
C”) for EPIK Products shipped. The C of C will provide objective evidence that the
shipped products are manufactured to established specifications and procedures and are in
compliance with the quality system requirements. A copy of the C of C will be saved by
Service Provider for a period not less than 20 years.
	 
	 	2.6.	 	Service Provider will maintain complete traceability of the EPIK through shipment to MAKO
Surgical. Service Provider will provide MAKO Surgical notice of shipment.





3. Corrective and Preventive Actions





	 	3.1.	 	Service Provider will maintain a system for handling Corrective and Preventative Action
(“CAPA”) requests from MAKO Surgical. Service Provider will provide summary reports
(within 45 days of initiation) for investigations into complaints, CAPA’s, and
product/product-related non-conformances.





4 Documentation





	 	4.1.	 	Product Specification: MAKO Surgical will create and provide to Service Provider the
Specifications. Along with the prints and assembly drawings, the Specifications will define
all requirements for the Product including user requirements, critical inspection points,
performance characteristics, compatibility with accessories, physical characteristics,
labeling, etc. Service Provider will ensure manufactured Products conform to the
Specifications.
	 
	 	4.2.	 	Quality Records: Service Provider will maintain manufacturing quality records for EPIK
products. Service Provider will make those documents available within a reasonable time
period at the request of MAKO Surgical or within 48 hours in the event of any mandatory audit
of MAKO Surgical by the FDA or other similar regulatory agency.
	 
	 	4.3.	 	Manufacturing Documents: Service Provider will maintain all manufacturing documents in
accordance with Document Control SOPs such that any documents relating to EPIK IMPLANT
systems will be available for MAKO Surgical’s approval and requests for modification. Service
Provider will maintain, under their Document Control System, an approved copy of MAKO
Surgical’s current manufacturing Device Master Record (“DMR”) including all
documentation related to the manufacture of the EPIK. Copies of the master documents used to
manufacture the EPIK per the approved DMR will be forwarded to MAKO Surgical upon release. At
a minimum, Service Provider will maintain:






	 	•	 	Bills of Materials
	 
	 	•	 	Component and Finished Goods Drawings and specifications
	 
	 	•	 	EPIK product Travelers or Routers
	 
	 	•	 	Manufacturing Instructions
	 
	 	•	 	Process Specifications





 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




- 5 -









 






	 	•	 	Process and tooling validations
	 
	 	•	 	Incoming, in-process, and final acceptance tests
	 
	 	•	 	Certificates of Compliance
	 
	 	•	 	Device History Records
	 
	 	•	 	Approved supplier lists
	 
	 	•	 	Inspection tool calibration records
	 
	 	•	 	Manufacturing plan / flowchart






	 	4.4.	 	Design History File: MAKO Surgical will maintain the EPIK Design History File
(“DHF”) including the Product Specification.
	 
	 	4.5.	 	Device History Records: Service Provider will maintain documentation related to EPIK
IMPLANT production history in Device History Records (“DHR”) per Service Provider
internal DHR procedures. Shipping and use documents will be maintained by MAKO Surgical per
product serial/lot number.
	 
	 	4.6.	 	Changes / Additions of Specifications:






     4.6.1. Service Provider will require MAKO Surgical’s approval for all changes / additions
to EPIK Prints, Source Control Documents (“SCD’s”), Assembly Drawings, Component and
Finished Goods Drawings, specifications, 3-D model database, and final inspection / testing
procedures. Changes related to internal manufacturing processes do not require MAKO Surgical’s
approval prior to implementation however notification and a certified copy of all documents
affected by the changes and which also support the changes i.e., evidence of
verification/validation, should be provided to MAKO Surgical prior to the implementation of any
change. All changes to internal manufacturing processes must be identified, documented,
validated or where appropriate verified, reviewed and approved by Service Provider in accordance
with relevant process change procedures prior to their implementation.




     4.6.2. Changes by MAKO Surgical. MAKO Surgical will notify Service Provider of any changes
it desires to make to the Specifications, Prints, SCD’s, Assembly Drawings, Component and
Finished Goods Drawings, specifications, and final inspection / testing procedures or
Procedures, all of which shall be governed by Section 2.2 of the Agreement.




     4.6.3. Changes by Service Provider. Service Provider will make document changes per its
document change SOP. MAKO Surgical approval is required for changes.




     4.6.4. Change Approval Medium. Each company will include a field on their ECN/ECO form for
the other company to approve a proposed change. Signatures on these forms will serve as approval
for the change. MAKO Surgical may approve a Service Provider ECO either by signing the Service
Provider ECO or by submitting a signed MAKO Surgical ECN with a description of the change to
Service Provider.




	 	4.7.	 	Service Provider documentation to be maintained at MAKO Surgical: All DMR and DMR related
documents, controlled copies of prints, assembly drawings, SCDs, 3-D model database and any
other documents that MAKO Surgical requires will be maintained by MAKO Surgical. Service
Provider will copy MAKO Surgical on any changes to these





 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




- 6 -









 






	 	 	 	documents. At any given time, the documentation maintained at MAKO Surgical will reflect the
actual product manufactured by Service Provider.
	 
	 	4.8.	 	Record Retention: Service Provider will maintain its records with respect to the
manufacture of the EPIK for a minimum of twenty years after the date of manufacture of the
last product under this Agreement, after which such records may be destroyed by Service
Provider. However, prior to the destruction of such records, MAKO Surgical will be notified
and given first right of refusal to take possession of such records. In the event of
bankruptcy, insolvency, or acquisition, Service Provider will transfer all EPIK related
records to MAKO Surgical.
	 
	 	4.9.	 	Document Approval: Service Provider Engineering Change Orders (“ECO’s”) will include a
space for MAKO Surgical approval of documents. MAKO Surgical approval will be via signature.
	 
	 	4.10.	 	Proprietary Information: Any documentation containing Service Provider proprietary
information will be made available for on-site inspection at the relevant Service Provider
facility. Any documentation to be supplied to MAKO Surgical shall have the proprietary
information removed.





5. Obsolete Inventory.





	 	5.1.	 	Service Provider will notify MAKO Surgical in advance of obsolescing any EPIK related
inventory.





6. Order Fulfillment





	 	6.1.	 	Service Provider will provide, when requested by MAKO Surgical, limited finished goods
warehouse space and drop-ship service to MAKO Surgical’s distributors and end-users. Service
Provider will receive orders from MAKO Surgical, ship to the designated customer, and provide
MAKO Surgical with order confirmation details. Manufacturing records and order confirmation
details must be adequate to support per-lot systematic recalls and/or EPIK withdrawals. These
records will be part of the DHR and maintained in accordance with the Service Provider’s
internal DHR procedures.





7. EPIK product Complaints.





	 	7.1.	 	MAKO Surgical will be solely responsible for EPIK advisory notices, recalls, EC vigilance,
end-user customer complaints, post-production monitoring, and post-market surveillance.





8. Regulatory Matters





	 	8.1.	 	Adverse Experience Reports. Each party (the “Receiving Party”) agrees to provide to the
other, within twenty-four (24) hours of the initial receipt by the Receiving Party, any
report of any serious adverse experience with respect to any EPIK product. Serious adverse
experiences mean any experience that suggests a significant hazard, contraindication, side
effect or precaution, or any experience that is fatal or life threatening, is permanently





 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




- 7 -









 






	 	 	 	disabling, or requires or prolongs inpatient hospitalization. Notwithstanding, MAKO Surgical
will be obligated to provide to Service Provider a report of an Adverse Experience that impacts
Service Provider’s businesses or if MAKO Surgical has determined the cause is likely due to
activities at or responsibilities of Service Provider or if required by law. MAKO Surgical will
have sole right and responsibility for filing Medical Device Reports (“MDR’s”) or other
equivalent reports required in other countries with Regulatory Authorities.






     8.1.1. Adverse Experience Reports from MAKO Surgical will be forwarded to the Service
Provider QA Manager or his designee at Service Provider. Adverse Experience Reports from Service
Provider will be forwarded to the Director of Quality Assurance / Regulatory Affairs or his
designee at MAKO Surgical.




	 	8.2.	 	Notices from Regulatory Authorities. The Receiving Party will promptly provide to the other
party copies of any communications it receives from any Regulatory Authority related to the
EPIK. The Receiving Party will promptly notify the other party of the receipt of any FDA Form
483 Report on Inspectional Observations or equivalent notice from any Regulatory Authority
which affects the EPIK. Notwithstanding, MAKO Surgical will only be obligated to provide to
Service Provider copies of communications if MAKO Surgical has determined them relevant to
activities at or responsibilities of Service Provider or if Service Provider’s business is
impacted or if required by law.





9. Facility Inspections





	 	9.1.	 	Facility Reviews. MAKO Surgical will have the right, upon reasonable advance notice and
during regular business hours, to inspect the facilities being used by Service Provider for
production of the EPIK to confirm that such facilities are adequate to meet the requirements
of this Agreement, the prevailing Regulatory Authority, and EN ISO 13485, and any applicable
successors to those EN requirements. If any such inspection reveals that the manufacturing
facilities do not satisfy such requirements, then MAKO Surgical will provide written notice
of such fact, which notice will contain in reasonable detail the deficiencies found in the
manufacturing facilities and, if practicable, those steps Service Provider should undertake
in order to remedy such deficiencies.
	 
	 	9.2.	 	Remedying Deficiencies. Service Provider will be responsible for remedying any deficiencies
identified by MAKO Surgical under Section 9.1 within 30 days following notice from MAKO
Surgical. With respect to any such inspections for which any deficiencies are not capable of
being remedied by Service Provider within thirty (30) days of the notification thereof, then
Service Provider and MAKO Surgical will discuss in good faith a corrective action plan which
will enable the EPIK to be supplied in accordance with this Agreement until such deficiencies
are remedied.





 



			
	[***]	 	Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has
been filed separately with the Securities and Exchange Commission.




- 8 -