LICENSE AGREEMENT
EXHIBIT 10.23
EXECUTION VERSION
THIS LICENSE AGREEMENT (this “Agreement”) is made and entered into this 1st
day of September, 2005 (the “Effective Date”), by and among Integrated Surgical Systems,
Inc., a Delaware corporation (“ISS”), and MAKO Surgical Corp., a Delaware corporation
(“MAKO”). ISS and MAKO are each referred to as a “Party” and collectively as
“Parties.”
WHEREAS, ISS and MAKO have entered that certain Confidentiality and Non-Disclosure Agreement,
dated July 22, 2005 (the “NDA”), a copy of which is annexed hereto as Exhibit A,
and the terms of which are expressly incorporated herein by reference.
WHEREAS, ISS and MAKO have entered that certain Binding Letter of Intent, effective as of
August 16, 2005 (as amended August 24, 2005, the “LOI”), by which the Parties have agreed
to enter into a definitive agreement, which this Agreement is intended to be.
AGREEMENT
NOW, THEREFORE, for and in consideration of the premises, the mutual representations,
warranties and covenants herein contained and other good and valuable consideration, the receipt
and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
DEFINITIONS
1.1 An “Affiliate” of a party means an entity directly or indirectly controlling,
controlled by or under common control with that party, where control means the ownership or
control, directly or indirectly, of more than fifty percent of all of the voting power of the
shares (or other securities or rights) entitled to vote for the election of directors or other
governing authority, as of the date of this Agreement or hereafter during the term of this
Agreement. However, the entity will be considered an Affiliate only for the time during which such
control exists.
1.2 “IP Rights” mean patents and patent applications, including provisional patents, design
patents and registrations, utility patents, utility models, xxxxx patents; any continuation,
continuation-in-part, divisional, extension, provisional application, substitute, reissue,
reexamination, renewal, or extension (including any supplementary protection certificate) of any
such patent or patent application; any confirmation patent or registration patent or patent of
addition based on any such patent; all foreign counterparts of any of the foregoing, and any patent
claiming priority to any such patent or patent application (collectively “Patents”); U.S.
and foreign copyrights and copyright registrations, database protection rights, mask works and mask
work registrations, and all renewals, continuations, and extensions thereof (collectively
“Copyrights”); ownership and all rights to control possession, use and/or disclosure of
Technical Information, trade secrets and other confidential information; all causes of action
relating to any of the forgoing, including the
[***] 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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right to collect and receive past damages; all applicable rights under all international and
transnational treaties and conventions relating to protection of intellectual or industrial
property arising from any of the forgoing, and all other legal rights (whether they arise under
contract, statute or common law) for the protection of intellectual or industrial property
throughout the world, including, without limitation, all advancements, developments, improvements,
and/or modifications thereto made and/or acquired by ISS during the term of this Agreement.
1.3 “License” has the meaning given to it in Article 2.1.
1.4 “Licensed IP Rights” mean all the IP Rights in, of and/or related to (a) the Licensed
Patents; and (b) [***].
1.5 “Licensed Patents” means those Patents identified on Schedule 1.5, and all
Patents claiming the benefit of, priority to, or any subject matter found in, the identified
Patents.
1.6 “MAKO Field” shall be defined as [***], which more specifically means any use of a
system [***].
1.7 “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, craniomaxillofacial devices and 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.
1.8 “Provider” means each and every current and/or former employee, consultant, customer,
supplier and vendor of ISS.
1.9 “Technical Information” means, collectively, all past, present and future knowledge and
work product of ISS relating to any and all of the items set forth in Schedule 1.9 hereto.
1.10 “Technical Information Delivery Deadline” has the meaning given to it in Article 2.5.
1.11 “ISS Field” means all fields other than the MAKO Field.
[***] 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 2
GRANTS OF LICENSE, LICENSE FEE & DELIVERABLES
GRANTS OF LICENSE, LICENSE FEE & DELIVERABLES
2.1 Grants of License to MAKO. Subject to all of the terms and conditions of this
Agreement, ISS grants to MAKO a worldwide, fully transferable, perpetual, royalty-free and fully
paid-up (a) exclusive license under the Licensed IP Rights, even as to ISS, within the MAKO Field,
and (b) non-exclusive license under the Licensed IP Rights, but subject to the provisions of
Article 2.4, within the field of Orthopedics (collectively, the “License”). The License granted
hereunder (i) shall include the right to sublicense, (ii) is irrevocable and cannot be terminated
for any reason (including material breach of this Agreement), and (iii) is transferable to the
extent that such transfer is in compliance with Article 11.2.
2.2 Scope of Grant. The License includes, unless it is otherwise expressly stated in this
Agreement, the following rights:
(i) with respect to Patents, to make, have made, use, lease, sell, offer to sell, and import
machines and articles of manufacture; and to make, have made, use and import machines, tools,
materials and other instrumentalities, insofar as such machines, tools, materials and other
instrumentalities are involved in or incidental to the development, manufacture, testing or repair
of products, which are made or imported under the authority of the licensee;
(ii) with respect to Technical Information, to make, use, sell, lease, distribute, publicly
display, and make available products incorporating or embodying the Technical Information;
(iii) with respect to copyrights, to copy, publicly distribute, publicly perform, publicly display,
prepare derivatives, and digitally transmit the work in which the copyright exists; and
(iv) to convey to any purchaser, lessee, or user of any product, which is made under authority of
MAKO or its sublicensee, rights to use and resell the product.
2.3 License Fee. In full consideration for the License granted by ISS to MAKO and the
transfer of Technical information, MAKO will pay to ISS by wire transfer a one time license fee of
One Hundred Ninety Thousand Dollars ($190,000) upon execution of this Agreement.
2.4 Right of First Refusal. Without limiting the grants contained in the License, for as
long as MAKO has rights to the Licensed IP Rights, ISS hereby grants MAKO a [***] business days
right of first refusal to enter into any arrangement or transaction (whether for the license,
transfer or otherwise) concerning the Licensed IP Rights for fields other than the MAKO Field, for
which ISS receives a bona fide offer from a third party.
2.5 Delivery of Technical Information. All Technical Information set forth in Schedule 1.9
is being delivered by ISS to MAKO contemporaneous with the execution and consummation of this
Agreement on the Effective Date, except as to that Technical Information specifically designated on
Schedule 1.9 to be delivered to MAKO by ISS within a reasonable time following the Effective Date
(the “Post-Closing Technical Information”) which shall in no event exceed two (2) weeks
following the Effective Date (the “Technical Information Delivery Deadline”). ISS hereby
covenants to use its best efforts to deliver all Post-Closing Technical Information on or before
the Technical Information Delivery Deadline.
[***] 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.
-3-
2.6 Delivery of Parts. As set forth in Schedule 2.6 hereto, MAKO is hereby
ordering certain parts and components, which shall be considered Technical Information for all
purposes under this Agreement, which ISS shall deliver on or before the Technical Information
Delivery Deadline, for which MAKO shall pay ISS the amount set forth on Schedule 2.6 within
ten (10) business days of receipt.
2.7 Delivery of Letter from IP Counsel. Consistent with Section 7.3, ISS shall deliver to
MAKO on or before the Effective Date a confirmation in writing from counsel (or counsels, as the
case may be) responsible for filing, prosecution and maintenance of the Licensed Patents, agreeing
to provide MAKO, if requested (in its sole discretion) with complete copies of the prosecution
files for the Licensed Patents on or before the Technical Information Delivery Deadline (as defined
below), at a fixed cost to MAKO of $[***].
ARTICLE 3
PUBLICITY AND CONFIDENTIALITY
PUBLICITY AND CONFIDENTIALITY
3.1 Confidentiality and Public Statements. The existence of the LOI, the NDA, and/or the
Definitive Agreement, and the terms and provisions of each, shall be considered “Proprietary
Information” within the meaning of the NDA for the term of the NDA. During the period beginning as
of the Effective Date and ending on the fifth (5th) anniversary of the Effective Date, neither ISS
nor MAKO shall make any public statement or disclosure concerning the LOI, the NDA, and/or the
Definitive Agreement, and/or the terms and provisions of each except (a) with the written consent
of the other Party, (b) to a Party bound by a covenant of confidentiality, or (c) as required by
law.
3.2 Publicity and Trademarks. Nothing in this Agreement will be construed as conferring
upon either Party or its Affiliates any right to include in advertising, packaging or other
commercial activities related to a product, any reference to the other Party (or any of it
Affiliates), its trade names, trademarks or service marks in a manner which would be likely to
cause confusion or to indicate that such product is in any way certified by the other Party hereto
or its Affiliates.
ARTICLE 4
PATENTING; MAINTENANCE OF PATENTS; PAYMENTS
PATENTING; MAINTENANCE OF PATENTS; PAYMENTS
4.1 Patent Prosecution and Maintenance.
(a) MAKO will have the sole right to prosecute, control prosecution of, and maintain the Licensed
Patents. However, it may, at is sole option, give control to ISS to prosecute any one or more the
Licensed Patents.
(b) The Party having control over prosecution of a patent application or patent included in the
Licensed Patents will consult and reasonably cooperate with the other Party in determining the best
course of action for prosecuting each patent application that is included in the Licensed Patents.
The Party in control will keep the other Party informed on each application’s or patent’s status
and will promptly provide to the other Party copies of all papers and correspondence filed or sent
in connection with the application. The Party not having control must have reasonable opportunity
to consult with the other Party prior to the
[***] 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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Party in control undertaking any action that may materially affect the scope, validity, or
existence of the application.
(c) Should a Party decide to give up control and responsibility for prosecution of a patent
application, or decide to abandon such application with the intent not to continue examination of
the claimed invention in another application, it must give the other Party reasonable notice of its
intentions and take all reasonable steps to cooperate with the other Party and to transfer to it
control of the application without loss of rights.
(d) Should MAKO be given or take control of prosecution or maintenance of a patent application, ISS
will execute, and will take reasonable actions to obtain the cooperation of their respective
employees in executing, all papers reasonably required to enable the other Party to file, prosecute
and maintain such patent applications.
(e) Nothing in this Article 4.1 shall be deemed to require MAKO to prosecute or maintain any
Licensed Patents that MAKO (i) deems in its sole discretion no longer necessary to conduct MAKO’s
business and (ii) renounces pursuant to Article 4.6.
4.2 Maintenance Fees and Prosecution Costs.
(a) For patents and patent applications included in the Licensed IP Rights, MAKO will pay its
Ratable Share (defined in Article 4.2(c)) of all reasonable costs associated with prosecution and
issuance of each patent or patent application (“Prosecution Costs”) included within the
Licensed Patents. Examples of Prosecution Costs include reasonable legal fees and foreign
associate charges, filing fees, duplication costs, courier fees and the like. Maintenance, renewal
fees (or “annuities”) and other periodic fees and taxes that must be paid to maintain a
patent or patent application are not, for purposes of this section, Prosecution Costs. Should MAKO
take responsibility for prosecution of any of the Licensed Patents, ISS will be responsible for
reimbursing MAKO for amounts in excess of its Ratable Share of the Prosecution Costs for each such
patent or patent application.
(b) MAKO will pay its Ratable Share of costs (other than Prosecution Costs) associated with
maintaining each patent and patent application included in the Licensed Patents, including without
limitation any periodic government fees (“Maintenance Fees”) — e.g. maintenance fees,
renewal fees, “annuities” and the like — and reasonable third-party charges and costs associated
with tracking and paying the fees (collectively, “Maintenance Costs”). Should MAKO take
responsibility for payment of the Maintenance Costs of any of the Licensed Patents, ISS will,
within 15 days after receipt of written notice from MAKO, reimburse MAKO for amounts in excess of
MAKO’s Ratable Share of the Maintenance Costs.
(c) For the purposes of this Article 4.2, “Ratable Share,” with respect to any particular
patent or patent application, shall be equal to [***] where [***] is
[***] under the particular patent or patent application.
4.3 Renunciation of License. MAKO may give up its license with respect to any one or more
Licensed Patents by giving written notice to ISS of its intention to do so, which will be effective
immediately. MAKO will remain liable for any Prosecution Costs and
[***] 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-
Maintenance Costs incurred prior to giving up its license, but will have no further rights or
obligations under this Article 4 with respect to the particular patent or patent application.
ARTICLE 5
OTHER OBLIGATIONS AND RIGHTS OF MAKO
OTHER OBLIGATIONS AND RIGHTS OF MAKO
5.1 Marking. MAKO will place a patent notice in accordance with 35 U.S.C. §287 on any
products made by or on behalf of MAKO, which are covered by, or made with a process covered by, a
US patent included within the Licensed IP Rights. MAKO will also require that each such product
made under its authority (other than a product made by, on behalf of, or under authority of the
other Party) will also be marked with a notice in accordance with 35 U.S.C. §287. Otherwise, MAKO
shall not have any obligation to xxxx any product.
5.2 Rights as to Employees, Customers and Others.
ISS hereby:
(a) completely and forever releases each and every Provider from any and all restrictive
covenants, obligations, limitation and duties owed by each such Provider to ISS, if any, including,
without limitation, a covenant of non-competition or covenant of non-disclosure, at all times
(whether before or after the Effective Date) for all purposes including, without limitation, (i)
assisting MAKO in conducting its due diligence with respect to ISS, (ii) providing consulting
services to MAKO, and (iii) entering into discussions with MAKO concerning possible employment or
commercial opportunities with MAKO (collectively, the “Purposes”).
(b) completely and forever waives any rights that ISS had (prior to the Effective Date), has
(as of the Effective Date), and will have (subsequent to the Effective Date), relating to
restrictive covenants, obligations, limitation and duties, if any, owed to ISS by each and every
Provider for all Purposes.
(c) grants MAKO an unlimited right (but not an obligation) to communicate with, solicit, hire,
or otherwise engage any and all Providers for all Purposes.
(d) unconditionally represents and warrants to MAKO that no restrictive covenants of any kind
apply to any and all Providers as to any Purposes, and that ISS holds no rights relating thereto.
(e) represents, warrants and agrees, that the releases, waivers, grants, covenants,
representations and warranties contained in this Article 5.2 shall in no way affect the covenants
of non-disclosure made between MAKO and ISS as set forth in the NDA.
ARTICLE 6
ENFORCEMENT
ENFORCEMENT
6.1 No Obligation to Enforce; Cooperation. Neither Party has an obligation to enforce
through a legal proceeding any Licensed IP Rights. MAKO will not enforce any of the Licensed IP
Rights outside the MAKO Field without the prior consent of ISS. ISS will not
[***] 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-
enforce the Licensed IP Rights inside the MAKO Field without the prior consent of MAKO. In the
event one Party desires to bring a legal action to enforce any of the Licensed IP Rights, the
Parties will act promptly and in good faith, subject to the rights of the relevant Licensor of each
of the Licensed IP Rights to be enforced, to negotiate terms and conditions under which one or both
of the Parties may bring the action.
ARTICLE 7
WARRANTIES; REPRESENTATIONS AND COVENANTS
WARRANTIES; REPRESENTATIONS AND COVENANTS
7.1 ISS represents and warrants that it is the owner of the Licensed Patents and has the right to
grant the licenses granted to MAKO in this Agreement. ISS further represents and warrants that it
possesses the authority and necessary rights to make the grants of the License to MAKO in Article
2.
7.2 ISS further represents, warrants and covenants that ISS has not granted nor will ISS grant
during the term of this Agreement, to any other party any licenses under the Licensed Patents for
the MAKO Field.
7.3 ISS further represents and warrants that, (a) to the knowledge of ISS, the practice of the
Licensed IP Rights, within the scope of the License granted in this Agreement (including all of its
limitations), does not infringe any third party IP Rights, (b) the Licensed IP Rights are all of
the IP Rights held, owned or otherwise possessed by ISS in the area of bone motion tracking and
registration with mechanical arms; (c) except for the Post-Closing Technical Information, ISS has
delivered or is delivering contemporaneous with the consummation of this Agreement all Technical
Information set forth on Schedule 1.9; (d) all Technical Information has, is or, in the
case of Post-Closing Technical Information, shall be provided by ISS to MAKO in both hard-copy and
electronic format to the extent available to ISS; (e) ISS has requested in writing that ISS’s
appropriate legal counsel deliver, and such counsel has agreed in writing to deliver, if requested
in MAKO’s sole discretion, complete copies of the prosecution files for the Licensed Patents on or
before the Technical Information Delivery Deadline, at a fixed cost to MAKO of $[***]; (f) the
price paid by MAKO for each and every item set forth in Schedule 2.6 represents [***] .
7.4 The undersigned signatory, executing on behalf of ISS, represents and warrants that (a) the
execution and delivery of, and compliance with, this Agreement has been duly authorized by the
Board of Directors of ISS, (b) such signatory has actual necessary legal authority to bind ISS to
the terms of this Agreement and the transactions contemplated herein, and (c) this Agreement shall,
by its terms, bind ISS to the provisions and covenants set forth herein.
7.5 ISS agrees to take all further actions and execute and deliver any additional instruments on or
after the Effective Date as MAKO deems reasonably necessary to effectuate the transactions
contemplated by this Agreement, including, without limitation, delivery of all Technical
Information discovered or created by ISS or reasonably requested by MAKO after the Effective Date.
[***] 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-
ARTICLE 8
BANKRUPTCY
BANKRUPTCY
ISS and MAKO each acknowledges and agrees that this Agreement (i) constitutes a license of
Intellectual Property (as such term is defined in the United States Bankruptcy Code, as amended
(the “Code”)), and (ii) is an executory contract, with significant obligations to be
performed by ISS and MAKO. The parties hereto agree that each may fully exercise all of its rights
and elections under the Code following any event of bankruptcy affecting the other, including,
without limitations, those set forth in Section 365(n) of the Code. If requested by MAKO, MAKO
shall be entitled to (a) enjoy all of the rights, benefits and use granted hereunder for the
remaining duration of the terms plus any renewal periods and (b) ISS shall immediately make
available to MAKO all product, source code, formulas, information, documents and raw materials as
may be necessary for MAKO to continue to utilize the License and sublicenses granted hereunder
following a rejection of the License and/or the sublicenses set forth in this Agreement in a ISS
bankruptcy.
ARTICLE 9
INDEMNIFICATION
INDEMNIFICATION
9.1 Indemnification.
(a) Subject to the provisions of this Article 9, including, without limitation, Article 9.2, ISS
will indemnify in respect of, and hold MAKO and its officers, directors, employees and agents
harmless against, any and all damages, claims, deficiencies, losses, including taxes, and all
expenses (including interest, penalties, and reasonable attorneys’ and accountants’ fees and
disbursements but reduced by any tax savings, benefits or offsets to which any party shall be
entitled directly or indirectly by reason thereof) (collectively “Damages”), resulting from
a third party claim of any misrepresentation, breach of warranty or failure to perform any covenant
or agreement on the part of ISS under this Agreement. ISS further agrees to indemnify in respect
of, and hold MAKO, its officers, directors, employees and agents harmless against, all Damages,
injuries and deaths claimed by a third party resulting directly or indirectly from production,
manufacture, sale, marketing, lease, use of a product or service by ISS or its Affiliates, except
to the extent such Damages, injury or death results from the negligence, gross negligence or
intentional misconduct of MAKO, its employees, officers and directors.
(b) Subject to the provisions of this Article 9, including, without limitation, Article 9.2, MAKO
agrees to indemnify in respect of, and hold ISS and its officers, directors, employees and agents
harmless against, any and all Damages resulting from a third party claim of: (i) any
misrepresentation, breach of warranty, or (ii) failure to perform any covenant or agreement on the
part of MAKO under this Agreement, except to the extent such Damages result from the negligence,
gross negligence or intentional misconduct of ISS or its respective employees, officers and
directors. MAKO further agrees to indemnify in respect of, and hold ISS and its officers,
directors, employees and agents harmless against, all Damages, injuries and deaths claimed by a
third party resulting directly or indirectly from production, manufacture, sale, marketing, lease,
use of a product or service by MAKO or its
[***] 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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Affiliates, except to the extent such Damages, injury or death results from the negligence, gross
negligence or intentional misconduct of ISS or its employees, officers and directors.
9.2 Method of Asserting Claims, etc. The party or parties claiming indemnification under
this Article (whether one or more) are hereinafter collectively referred to as the “Indemnified
Party” and the party against whom such claims are asserted hereunder is hereinafter referred to
as to the “Indemnifying Party.” All claims for indemnification by any Indemnified Party
under this Article 9 will be asserted and resolved follows:
(a) MAKO shall have the right to enforce all claims in connection with the use of the Licensed
Patents in the MAKO Field and ISS shall have the right to enforce all claims in connection with the
use of the Licensed Patents in the ISS Field.
(b) In the event that any claim or demand for which an Indemnifying Party would be liable to an
Indemnified Party hereunder is asserted against or sought to be collected from such Indemnified
Party by a third party (a “Third Party Claim”), such Indemnified Party will with reasonable
promptness notify the Indemnifying Party of such claim or demand, specifying the nature of and
specific basis for such claim or demand and the amount or the estimated amount thereof to the
extent then feasible (which estimate will not be conclusive of the final amount of such claim and
demand (the “Claim Notice”)). The Indemnifying Party will not be obligated to indemnify
such Indemnified Party with respect to any such claim or demand to the extent the failure of such
Indemnified Party to promptly notify the Indemnifying Party of such a claim or demand materially
prejudices the Indemnifying Party’s ability to defend against the claim or demand. The
Indemnifying Party will have 30 days from the personal delivery or mailing of the Claim Notice (the
“Notice Period”) to notify such Indemnified Party (i) whether or not it disputes the
liability of the Indemnifying Party to such Indemnified Party hereunder with respect to such claim
or demand and (ii) whether or not it desires at the sole cost and expense of the Indemnifying
Party, to defend such Indemnified Party against such claim or demand; provided, however, that such
Indemnified Party is hereby authorized prior to and during the Notice Period to file any motion,
answer or other pleading which it deems necessary or appropriate to protect its interests or those
of the Indemnifying Party and not materially prejudicial to the Indemnifying Party. In the event
that the Indemnifying Party notifies such Indemnified Party within the Notice Period that it
desires to defend such Indemnified Party against such claim or demand, except as hereinafter
provided, the Indemnifying Party will have the right to defend by all appropriate proceedings. If
such Indemnified Party desires to participate in, but not control, any such defense or settlement
it may do so at its sole cost and expense. If requested by the Indemnifying Party, such
Indemnified Party agrees to cooperate with the Indemnifying Party and its counsel in contesting any
claim or demand which the Indemnifying Party elects to contest, and, if appropriate and related to
the claim in question, in making any counterclaim against the person asserting the third party
claim or demand, or any cross-complaint against any person. No claim may be settled by the
Indemnifying Party without the consent of such Indemnified Party, which consent will not be
unreasonably withheld. Notwithstanding the foregoing, in connection with a Third Party Claim
asserted against both such Indemnified Party and the Indemnifying Party, if (x) such Indemnified
Party has available to it defenses which are in addition to those available to the Indemnifying
Party, (y) such Indemnified Party has available to it defenses which are inconsistent with the
[***] 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.
-9-
defenses available to the Indemnifying Party or (z) a conflict exists or may reasonably be expected
to exist in connection with the representation of both such Indemnified Party and the Indemnifying
Party by the legal counsel chosen by the Indemnifying Party, such Indemnified Party will have the
right to select its own legal counsel. If such Indemnified Party selects its own legal counsel
pursuant to the immediately preceding sentence and the underlying Third Party Claim is otherwise
subject to the scope of the indemnification obligations of the Indemnifying Party pursuant to this
Article 9, the reasonable fees and expenses of such legal counsel will be included within the
indemnification obligations of the Indemnifying Party; provided that under no circumstances will
the Indemnifying Party be obligated to indemnify such Indemnified Party against the fees and
expenses of more than one legal counsel selected by such Indemnified Party in connection with a
single claim (notwithstanding the number persons against whom the Third Party Claim may be
asserted).
(c) In the event any Indemnified Party should have a claim against any Indemnifying Party hereunder
which does not involve a claim or demand being asserted against or sought to be collected from it
by a third party, such Indemnified Party will send a Claim Notice with respect to such claim to
such Indemnifying Party. If such Indemnifying Party does not notify such Indemnified Party within
the Notice Period that such Indemnifying Party disputes such claim, the amount of such claim will
be conclusively deemed a liability of such Indemnifying Party hereunder.
ARTICLE 10
TERM AND TERMINATION
TERM AND TERMINATION
10.1 Term. This Agreement will become effective as of the Effective Date and will continue
until terminated according to its terms or until all of the License Agreements terminate and all
Licensed IP Rights have expired.
10.2 Voluntary Termination By MAKO. MAKO may voluntarily terminate this Agreement upon 60
days written notice to ISS.
10.3 Survival. Articles 1, 3 and 9 will survive and continue after termination..
ARTICLE 11
MISCELLANEOUS PROVISIONS
MISCELLANEOUS PROVISIONS
11.1 Registration and Recordation of License Agreement. Notwithstanding the obligations of
confidentiality of the NDA and Article 3, each Party consents to registration of this Agreement if
required by law, for the grants of licenses to be effective, or to make it effective against
subsequent assignees or licensees. Specifically, and without limiting the foregoing, each Party
consents to recordation of this Agreement in connection with any patents or copyright registrations
included in the Licensed IP Rights. However, Exhibits to this Agreement must be removed or
redacted to show only the patents and copyright registrations and no additional information.
11.2 Assignment. MAKO may assign this Agreement upon (a) a written notice to ISS
specifying the assignee and (b) the assignee agrees to be bound by all of the terms and conditions
of this Agreement as applicable to such assignee. This Agreement will be
[***] 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.
-10-
binding on successors in interest and permitted assigns. ISS may assign this Agreement with the
prior written consent of MAKO, which shall not be unreasonably withheld only if the assignee agrees
to be bound by all of the terms and conditions of the Agreement.
11.3 Notices. All notices and other communications which are required or which may be
given under the provisions of this Agreement will be in writing and may be delivered (a)
personally, (b) by facsimile transmission, (c) expedited delivery service with proof of delivery or
(d) sent by United States Mail, postage prepaid, registered or certified, return receipt requested,
addressed as follows:
If to ISS:
Integrated Surgical Systems, Inc.
0000 Xxxxxxxx Xxxx Xxxxx
Xxxxx 000
Xxxxx, XX 00000
Telephone: (000) 000-0000
Fax: (000) 000-0000
Attention: Xx. Xxxxxxx X. Xxxxxxx, President & CEO
0000 Xxxxxxxx Xxxx Xxxxx
Xxxxx 000
Xxxxx, XX 00000
Telephone: (000) 000-0000
Fax: (000) 000-0000
Attention: Xx. Xxxxxxx X. Xxxxxxx, President & CEO
If to MAKO:
MAKO Surgical Corp.
0000 Xxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Phone: (000) 000-0000
Facsimile: (000) 000-0000
Attention: General Counsel
0000 Xxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Phone: (000) 000-0000
Facsimile: (000) 000-0000
Attention: General Counsel
or to such other address designated by the parties as provided above. Any such notice will be
deemed to have been given either at the time of personal delivery or, in the case of delivery
service or mail, as of the date of first attempted delivery at the address and in the manner
provided herein.
11.4 Choice of Law. THIS AGREEMENT WILL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH
THE LAWS OF THE STATE OF DELAWARE (EXCLUSIVE OF CONFLICTS OF LAW PRINCIPLES).
11.5 Captions. The captions, headings, and arrangements used in this Agreement are for
convenience only and do not in any way affect, limit, amplify, or modify its terms and provisions.
11.6 No Strict Construction. This Agreement is the result of substantial negotiations
among the Parties and their counsel and has been prepared by their joint efforts. Accordingly, the
fact that counsel to one Party or another may have drafted this Agreement or any portion of this
Agreement is immaterial and this Agreement will not be strictly construed against any Party.
[***] 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.
-11-
11.7 Severability and reformation. Wherever possible, each provision of this Agreement
will be interpreted in such manner as to be effective. If any provision of this Agreement is held
to be illegal, invalid, or unenforceable under present or future laws effective during the term of
this Agreement, such provision will be fully severable and this Agreement will be construed and
enforced as if such illegal, invalid, or unenforceable provision had never comprised a part of this
Agreement, and the remaining provisions of this Agreement will remain in full force and effect.
Furthermore, in lieu of each such illegal, invalid, or unenforceable provision, there will be added
automatically as a part of this Agreement a provision as similar in terms to such illegal, invalid,
or unenforceable provision as may be possible and be legal, valid, and enforceable; provided,
however, that, if any such change will materially diminish the practical realization of the
benefits intended to be conferred to any party to this Agreement, such party may terminate this
Agreement upon written notice to each other party within 30 days after learning such change has
been effected.
11.8 Consents; Waivers. Any consent or approval required as a condition to an action under
this Agreement will be effective only (a) if in writing and signed by the Party whose consent is
sought, (b) with respect to the specific matter made the subject to such consent or approval (and
no other matter), and (c) for the specific instance(s) expressly set forth in such consent or
approval (and no earlier or subsequent instances). Any Party may waive any condition, covenant,
term, or provision of this Agreement, but any such waiver will be effective only (a) if in writing
and signed by the Party sought to be bound by such waiver, (b) with respect to the specific
condition, covenant, term, or provision expressly made the subject to such waiver (and no other
condition, covenant, term, or provision), and (c) for the specific instance(s) expressly set forth
in such waiver (and no earlier or subsequent instances). Without limiting the foregoing sentence,
none of the following will constitute a waiver of the rights of a Party to this Agreement to demand
exact compliance with the conditions, covenants, terms, and provisions of this Agreement: (a) a
failure of such Party to exercise any power reserved to it in this Agreement; (b) a failure of such
Party to insist upon compliance by any other Party to this Agreement with any condition, covenant,
term, or provision in this Agreement; (c) a delay, forbearance, or omission of such Party to
exercise any power; or (d) any custom or practice of the Parties at variance with the terms of this
Agreement. The consent or approval of any Party to this Agreement with respect to the act of any
other Party to this Agreement will not be deemed to waive or render unnecessary consent to or
approval of any subsequent similar act. Subsequent acceptance by a Party to this Agreement of any
performance due to it under this Agreement will not be deemed to be a waiver by such Party of any
preceding breach by any other Party of any terms, provisions, covenants, or conditions of this
Agreement.
11.9 Force Majeure. Neither party will be in default or otherwise liable for any delay in
or failure of its performance under this Agreement if such delay or failure arises by any reason
beyond its reasonable control, including any act of God, any acts of the common enemy, the
elements, earthquakes, floods, fires, epidemics, riots, failures or delay in transportation or
communications, or any act or failure to act by the other party or such other party’s employees,
agents, or independent contractors or representatives; provided, however, that lack of funds will
not be deemed to be a reason beyond a party’s reasonable control. The
[***] 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-
parties will promptly inform and consult with each other as to any of the above causes that in
their judgment may or could be the cause of a delay in the performance of this Agreement.
11.10 Legal Costs. If any action is brought to enforce or interpret the terms of this
Agreement (including through arbitration), the prevailing Party will be entitled to reasonable
legal fees, costs, and disbursements in addition to any other relief to which such Party may be
entitled.
11.11 Equitable Remedies. Each Party to this Agreement recognizes that the obligations
imposed on it in Articles 2 and 3 are special, unique, and of extraordinary character.
Accordingly, each Party to this Agreement agrees and declares that it is impossible to measure in
money the damages that will accrue by reason of its failure to perform any of its obligations under
Articles 2 and 3 and that, in the event of breach by it of any such obligation, the remedy at law
for such breach will be inadequate. Therefore, each Party to this Agreement, by execution of this
Agreement, waives the claim or defense that there is an adequate remedy at law and agrees it will
not urge in any action or proceeding to which it is a party that relates to Articles 2 and 3 the
claim or defense that such remedy at law exists. Furthermore, the parties, by execution of this
Agreement, agree that each other Party is entitled (without proving damages or posting bond) to
equitable remedies, including specific performance and injunctive relief (in addition to damages)
as a remedy for the enforcement of Articles 2 and 3.
11.12 Integration. This Agreement sets forth the entire agreement and understanding
between the Parties as to the subject matter hereof and merges all prior discussions between them.
Neither of the Parties shall be bound by any warranties, understandings or representations with
respect to such subject matter other than as expressly provided herein or in a writing signed with
or subsequent to execution hereof by an authorized representative of the Party to be bound thereby.
11.13 No Partnership. Neither this Agreement, nor any terms and conditions contained
herein, will be deemed or construed to create a partnership, joint venture, other form of business
enterprise or association or cooperative arrangement, agency relationship, or franchise
relationship between the Parties or otherwise to create any liability for either Party whatsoever
with respect to the indebtedness, liabilities, and obligations of the other Party.
11.14 Counterparts. This Agreement may be executed in any number of counterparts and will
be effective when each Party to this Agreement has executed at least one counterpart, with the same
effect as if all signing parties had signed the same document. All counterparts will be construed
together and evidence only one agreement, which, notwithstanding the actual date of execution of
any counterpart, will be deemed to be dated the day and year first written above. In making proof
of this Agreement, it will not be necessary to account for a counterpart executed by any Party
other than the Party against whom enforcement is sought or to account for more than one counterpart
executed by the Party against whom enforcement is sought.
[***] 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.
-13-
11.15 Facsimile Signatures.. The manual signature of any Party to this Agreement that is
transmitted to any other Party or counsel to any other Party by facsimile will be deemed for all
purposes to be an original signature.
[NEXT PAGE IS SIGNATURE PAGE]
[***] 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.
-14-
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed in duplicate
originals by its duly authorized representatives on the respective
dates entered below.
INTEGRATED SURGICAL SYSTEMS, INC. |
||||
By: | /s/ X.X. Xxxxxxx | |||
Name: | X.X. Xxxxxxx | |||
Title: | President & CEO | |||
Date: | September 1, 2005 | |||
MAKO SURGICAL CORP. |
||||
By: | /s/ Xxxxxxx X. Xxxxx | |||
Name: | Xxxxxxx X. Xxxxx | |||
Title: | President & CEO | |||
Date: | September 1, 2005 |
[***] 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.
-15-
EXHIBIT A
CONFIDENTIALITY AND NON DISCLOSURE AGREEMENT
[to be attached]
[***] 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.
-16-
CONFIDENTIALITY AND NON-DISCLOSURE AGREEMENT
THIS CONFIDENTIALITY AND NON-DISCLOSURE AGREEMENT (“Agreement”) is made and entered into this
22nd day of July, 2005, by and between (i) Integrated Surgical Systems, Inc., a Delaware
corporation which has a place of business at 0000 Xxxxxxxx Xxxx Xxxxx, Xxxxx, Xxxxxxxxxx, XXX 00000
(“ISS”), and (ii) MAKO Surgical Corp., a Delaware corporation which has a place of business at 0000
Xxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxx, XXX 00000 (“MAKO”) who, intending to be legally bound, hereby
agree as follows:
RECITALS
WHEREAS, representatives of MAKO and ISS wish to communicate for the purpose of evaluating the
prospect for future cooperation, subject to the parties’ agreement to hold the existence and
substance of such communications in confidence in accordance with this Agreement; and
WHEREAS, each party agrees to hold the substance and existence of communications between their
representatives in confidence;
NOW, THEREFORE, in consideration of the mutual promises contained herein, the parties agree as
follows:
1. This Agreement shall apply to all information: (i) which the disclosing party designates as
confidential, (ii) the receiving party should reasonably have known would be confidential from its
nature or from the circumstances surrounding its disclosure, and (iii) disclosed by the parties to
each other, including without limitation information related to product designs, capabilities,
specifications, program code, data bases (business forms and documents), and information regarding
regulatory and financial affairs, personnel, sales, commercial files, future technical business and
marketing plans and product strategies, the identity of actual and potential partners, customers
and suppliers, and other intellectual property (hereinafter referred to as “Proprietary
Information”). Proprietary Information may be owned by MAKO or any affiliate thereof, ISS or any
affiliate thereof, or by any third party which has disclosed such information to any of the
foregoing subject to a nondisclosure obligation. Proprietary Information shall not include
information which (a) was already known to the receiving party prior to disclosure by the other
party, (b) is in or has entered the public domain through no breach of this Agreement or other
wrongful act by the receiving party, (c) has been rightly received in good faith from a third party
who is not under any obligation of confidentiality with respect to such information, (d) has been
approved for release by written authorization of the disclosing party, or (e) the receiving party
independently developed without use of the other party’s Proprietary Information. MAKO and ISS
hereby agree that any information which falls within the definition of Proprietary Information and
which was disclosed prior to the signing of this Agreement shall be deemed to be included in and
covered by the terms and conditions of this Agreement.
[***] 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.
-17-
2. Each of MAKO and ISS acknowledges that the disclosure of the Proprietary Information,
including but not limited to the existence of communications between the parties, or use of the
Proprietary Information for any purpose other than the purposes identified herein could result in
irreparable injury to the business and goodwill of the other party whether such disclosure occurs
during the course of such communications or after their completion or abandonment. Accordingly,
each party agrees that it will keep the Proprietary Information in strictest confidence and will
not disclose the Proprietary Information to any third party. In addition, each party shall take
all steps necessary to protect the Proprietary Information from unauthorized or inadvertent
disclosure, including without limitation all steps such party takes to protect the confidentiality
of its own proprietary information, but in no event less than ordinary degree of care.
Notwithstanding the foregoing, the receiving party may disclose and grant access to the Proprietary
Information only to those of its employees, agents and consultants, or the employees, agents and
consultants of its affiliates or subsidiaries, who have a legitimate need to know the Proprietary
Information for the purposes of this Agreement and who shall have agreed to abide by the terms and
provisions of this Agreement.
3. Except with the written consent of the disclosing party, neither party shall:
(a) modify the disclosing party’s Proprietary Information;
(b) disclose any part of the disclosing party’s Proprietary Information;
(c) make any notes, sketches, drawings or photocopies, or other written or photographic
records of the disclosing party’s Proprietary Information, except for such copies as may be
reasonably required for the purpose of this Agreement; or
(d) use or allow the use of the disclosing party’s Proprietary Information for any purpose
other than those of this Agreement, including but not limited to developing, directly or
indirectly, any product competing with or similar in functionality to any product marketed or
developed by the disclosing party.
4. In the event the receiving party is required by law, regulation, or court order to disclose
any of the disclosing party’s Proprietary Information, the receiving party will promptly notify the
disclosing party in writing prior to making any such disclosure in order to facilitate the
disclosing party seeking a protective order or other appropriate remedy.
5. Upon the completion or abandonment of the communications contemplated hereby, and in any
event upon the written request of the disclosing party at any time, whether during the course of
communications or after their completion or abandonment, each party shall immediately return to the
other party all items of Proprietary Information and all copies thereof and shall destroy any notes
or personal memoranda which include or make reference to the Proprietary Information.
6. Each party shall be deemed the owner of all Proprietary Information disclosed by it to the
other party hereunder, including without limitation all patent, copyright,
[***] 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.
-18-
trademark, trade secret and other proprietary rights and interests therein, and each party
recognizes and agrees that nothing in this Agreement shall be construed as granting any rights, by
license or otherwise, in or to any Proprietary Information. The disclosing party provides
Proprietary Information without warranty of any kind, other than a warranty that it has the right
to disclose the Proprietary Information and that the Proprietary Information is disclosed in good
faith. Neither party makes, and each party hereby expressly disclaims, any warranty regarding the
accuracy or completeness of the Proprietary Information.
(7) Each party hereby acknowledges that unauthorized disclosure, use or disposition of any
Proprietary Information would cause irreparable harm and significant injury to the other party
which would be difficult to ascertain. Accordingly, each party agrees that the other party shall
have the right to seek an immediate injunction against any breach, threatened breach or attempted
breach of this Agreement, in addition to any other remedies that may be available at law or in
equity. Each party agrees to promptly notify the other party in writing of any unauthorized use or
disclosure of the other party’s Proprietary Information of which such party becomes aware and will
provide reasonable assistance to the other party to bring about the cessation of such unauthorized
use or disclosure.
8. Each party further acknowledges and agrees that:
(a) The termination of its communications with the other party shall not in any way affect the
obligations set forth herein;
(b) This Agreement and the obligations set forth herein shall expire two (2) years after the
date of last disclosure of Proprietary Information, provided however, that to the extent the
Proprietary Information are trade secrets, these obligations will survive until such information is
no longer treated as a trade secret by the disclosing party.
(c) This Agreement constitutes the entire agreement between the parties in connection with the
subject matter hereof and supersedes all prior and contemporaneous agreements, understandings,
negotiations and discussions between the parties, whether oral or written.
(d) The validity, construction and performance of this Agreement shall be governed by and
construed in accordance with the substantive law of the State of Delaware, without regard to
conflicts of law provisions and any action or claims by or between any of the parties hereto
concerning the Proprietary Information, whether asserted on the basis of contract, tort (including
negligence and strict liability) or otherwise, shall be resolved exclusively under the law of such
jurisdiction. If any provision of this Agreement or the application of any such provision shall be
held by a tribunal of competent jurisdiction to be contrary to law, the remaining provisions of
this Agreement shall remain in full force and effect to the maximum extent permissible.
(e) This Agreement is not assignable or transferable in whole or in part without written
consent of the other party. Any attempted assignment without such written consent shall be void
and shall constitute a breach of this Agreement.
[***] 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.
-19-
(f) This Agreement may be signed in original or by fax in counterparts, each of which will be
deemed to be an original, and the counterparts will together constitute one complete document.
(g) Each of the undersigned signatories, executing on behalf of the respective party, hereby
represents and warrants that (i) the execution and delivery of, and compliance with, this Agreement
has been duly authorized by such party, (ii) such signatory has actual necessary legal authority to
bind such party to the terms of this Agreement, and (iii) this Agreement shall, by its terms, bind
such party to the covenants set forth herein.
IN WITNESS WHEREOF, the parties hereto have executed this Confidentiality Agreement to be
effective as of the date first written above.
MAKO SURGICAL CORP. |
||||
By: | /s/ Xxxxxxx Xxxxx | |||
Name: | Xxxxxxx Xxxxx | |||
Title: | CEO/Pres. | |||
Date: | 7/25/05 | |||
INTEGRATED SURGICAL SYSTEMS, INC. |
||||
By: | /s/ X.X. Xxxxxxx | |||
Name: | X. X. Xxxxxxx | |||
Title: | President & CEO | |||
Date: | 7/25/05 | |||
[***] 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.
-20-
Schedule 1.5
Licensed Patents
The following U.S. patents (and rights to additional and future IP rights associated
therewith):
[***]
[***]
[***]
and all Patents claiming the benefit of, priority to, or any subject matter found
in, the identified Patents.
[***] 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.
-21-
Schedule 1.9
Technical Information
All formulation, fabrication, design, manufacturing processes and techniques, formulas, ideas,
inventions, innovations, discoveries, concepts, know-how, engineering and research data,
preclinical and clinical data material specification, drawings, diagrams, descriptions, reports and
records, related to the following:
If requested by MAKO in its sole discretion, copies of the complete patent prosecution files for
each of the Licensed Patents, which shall be provided by IP counsel for ISS to MAKO on or before
the Technical Information Delivery Deadline.
Copy of the [***] .
Validation Protocol — [***]
Test Report — [***]
Test Report — [***]
Paper Copies of all CAD files (Released Prints) referencing the manufacturing of the
[***].
a)
[***] [***]
1.
[***] [***]
2.
[***] [***]
3.
[***] [***]
4.
[***] [***]
5.
[***] [***]
6. [***]
[***]
b)
[***] [***]
c)
[***] [***]
d)
[***] [***]
e)
[***] [***]
f)
[***] [***]
1. [***]
[***]
2. [***]
[***]
3. [***]
[***]
4. [***]
[***]
5. [***]
[***]
6. [***]
[***]
7. [***]
[***]
8. [***]
[***]
9. [***]
[***]
g)
[***] [***]
h)
[***] [***]
i)
[***] [***]
j)
[***] [***]
k)
[***] &
nbsp; [***]
[***] 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.
-22-
1) [***]
[***]
m)
[***] [***]
n) [***]
[***]
o)
[***] [***]
p) [***]
[***]
CD containing Electronic versions of the CAD files (Prints)
a)
[***] [***]
b)
[***] [***]
c)
[***] [***]
d)
[***] [***]
e)
[***] [***]
f)
[***] [***]
g)
[***] [***]
h)
[***] [***]
(Which includes copies of all [***])
1. [***]
[***]
2. [***]
[***]
3. [***]
[***]
4. [***]
[***]
5. [***]
[***]
6. [***]
[***]
i)
[***] [***]
1. [***]
[***]
2. [***]
[***]
3. [***]
[***]
4. [***]
[***]
5. [***]
[***]
6. [***]
[***]
7. [***]
[***]
8. [***]
[***]
9. [***]
[***]
j)
[***] [***]
k)
[***] [***]
1)
[***] [***]
m)
[***] [***]
n)
[***] [***]
A sample copy of receiving inspection and vendor qualification (if available):
[***] 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.
-23-
a)
[***] [***]
b)
[***] [***]
c)
[***] [***]
d)
[***] [***]
e)
[***] [***]
f)
[***] [***]
g)
[***] [***]
h)
[***] [***]
i)
[***] [***]
j)
[***] [***]
k)
[***] [***]
1)
[***] [***]
Vendor List & Qualifications
[***] &n
bsp; — [***]
[***] &n
bsp; — [***]
[***] &n
bsp; — [***]
[***] &n
bsp; — [***]
All available Documentation and CD’s containing a copy of the software code (which includes
appropriate comments and specific documentation pertaining to the [***] :
1 — [***]
2 — [***]
3 — [***]
4 — [***]
Copies of the following design control and development documents
a)
[***] [***]
b)
[***] [***]
c)
[***] [***]
d)
[***] [***]
e)
[***] [***]
f)
[***] [***]
g)
[***] [***]
h)
[***] [***]
i)
[***] [***]
j)
[***] [***]
k)
[***] [***]
l)
[***] [***]
m)
[***] [***]
n)
[***] [***]
o)
[***] [***]
p)
[***] [***]
q)
[***] [***]
[***] 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.
-24-
r)
[***] [***]
s)
[***] [***]
t)
[***] [***]
u)
[***] [***]
v)
[***] [***]
Regulatory memorandum authored by [***] describing in summary form the Complaint,
NPR, CAPA file, reportable incidents and/or advisories for component or subassembly related to the
Technical Information
[***] 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.
-25-
Schedule 2.6
At-Cost Parts/Components Order
One each of the following:
Part | Part Number | Dollar Cost | ||||||
1. | [***]
|
[***] | $[***] | |||||
2. | [***]
|
[***] | $[***] | |||||
3. | [***]
|
[***] | $[***] | |||||
4. | [***]
|
[***] | $[***] | |||||
5. | [***]
|
[***] | $[***] | |||||
6. | [***]
|
[***] | $[***] | |||||
7. | [***]
|
[***] | $[***] | |||||
8. | [***]
|
[***] | $[***] | |||||
9. | [***]
|
[***] | $[***] | |||||
10. | [***]
|
[***] | $[***] | |||||
11. | [***]
|
[***] | $[***] | |||||
12. | [***]
|
[***] | $[***] | |||||
13. | [***]
|
[***] | $[***] | |||||
14. | [***]
|
[***] | $[***] | |||||
SUBTOTAL: | $[***] | |||||||
10% Handling & Shipping |
$[***] | |||||||
GRAND TOTAL | $[***] |
[***] 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.
-26-