Document:

exv10w22

 

Exhibit 10.22

Execution Copy

CONFIDENTIAL

CO-MARKETING AGREEMENT

     This Co-Marketing Agreement (this Agreement), effective as of April 30, 2007 (the
“Effective Date”), is made by and between St. Jude Medical, Inc., a Minnesota corporation with
offices at One Lillehei Plaza, Saint Paul, MN 55117 (“St. Jude”), and Hansen Medical, Inc.,
a Delaware corporation having its principal place of business at 380 North Bernardo Avenue,
Mountain View, CA 94043 (“Hansen”).

Intending to be legally bound, Hansen and St. Jude agree as follows:

	1.	 	Definitions. For purposes of this Agreement, the following terms, whether singular or plural,
shall have the following meanings:

(a) “Act” means the United States Food, Drug and Cosmetic Act and the
regulations promulgated thereunder, as amended from time to time.

(b) “Affiliate” of a Party or third party means any person or entity
directly or indirectly controlling or controlled by, or under direct or indirect
common control with such Party or third party, during the term of this Agreement
and only so long as such control exists. For purposes of this definition,
“control” means the power to direct the management and policies of such person or
entity directly or indirectly, through majority ownership or control of voting
securities , and shall include persons or entities which become Affiliates after
the Effective Date, but a person or entity will remain an Affiliate only for so
long as such control continues to exist.

(c) “Business Day” means any day other than a Saturday, Sunday, or other
day on which most or all commercial banks are closed in New York, New York.

(d) “Commercialization Date” for a given Region other than the United
States of America means the date of the first sale of (the date of the invoice
for) a Fully Integrated Sensei System in such Region, and for the United States of
America means the date of the first sale of (the date of the invoice for) a Fully
Integrated Sensei System in the United States of America, or ******, whichever
occurs first.

(e) “EnSite System” means St. Jude’s EnSiteTM System for mapping and
navigating electrophysiology catheters in real time, as such may be improved,
redesigned or modified.

(f) “Excluded Countries” means ******.

 

 

(g) “FDA” means the Food and Drug Administration of the United States
Department of Health and Human Services.

(h) “FDA Approval” means clearance for marketing by the FDA under Section
510(k) of the Act, 21 U.S.C. §360(k), and 21 C.F.R. Part 807, Subpart E, or FDA
premarket approval granted in accordance with 21 U.S.C. § 360e and 21 C.F.R. Part
814.

(i) “Field of Use” means the development, manufacture, sale, distribution
and servicing of medical devices, systems and accessories designed for the
diagnosis and/or treatment of ******.

(j) “Fully Integrated EnSite System” means the EnSite System, made
compatible with the Fully Integrated Sensei System in accordance with the terms of
the Joint Development Agreement.

(k) “Fully Integrated Sensei System” means the Sensei System, made
compatible with the Fully Integrated EnSite System in accordance with the terms of
the Joint Development Agreement, excluding a Sensei System for which the
integration capability has been disabled.

(l) “Fully Integrated System” means a computerized interventional
electrophysiological localization and mapping instrument control system comprising
one Fully Integrated EnSite System and one Fully Integrated Sensei System.

(m) “Hansen Intellectual Property” means the Intellectual Property rights
of Hansen used by Hansen in the research, design, development, manufacture or
distribution of the Sensei System, the Fully Integrated Sensei System and the
Sensei Disposables, but not any Intellectual Property jointly owned by Hansen and
St. Jude under the terms of the Joint Development Agreement, to the extent that
such jointly owned Intellectual Property is derived from Intellectual Property
otherwise developed or acquired by St. Jude outside of the Joint Development
Agreement.

(n) “Hansen Products” means the Fully Integrated Sensei System, the
Non-Integrated Sensei System, the Sensei Disposables and any other products
mutually agreed to by the Parties in writing.

(o) “Intellectual Property” means any U.S. or foreign patents and patent
applications (including any substitutions, extensions, reissues, renewals,
divisionals, or continuations); trademarks, service marks and registrations
thereof and applications therefore; copyrights and copyright

 

 

registrations and applications; mask works and registrations thereof; all
discoveries, innovations, ideas, inventions, technology, techniques, methods,
know-how, trade secrets, processes, formulas, specifications, drawings and
designs, computer programs or software, including all amendments, modifications,
and improvements to any of the foregoing, and any other proprietary information.

(P) “Joint Development Agreement” means that certain Joint Development
Agreement dated as of the Effective Date between Hansen and St. Jude for the
development of the Fully Integrated System.

(q) “Leveraged Sale” means any sale of a Fully Integrated Sensei System
******.

(r) “NDA” means that certain Mutual Non-Disclosure Agreement between the
parties dated as of May 8, 2006.

(s) “Non-Integrated Sensei System” means any Sensei System that is not a
Fully Integrated Sensei System, ******.

(t) “Non-Leveraged Sale” means any sale of the Sensei System that is not a
Leveraged Sale.

(u) “Other Products” means products or services, including but not limited
to disposable and implantable medical devices, other than Hansen Products, that
are of a type commonly used by purchasers or potential purchasers of the Sensei
System.

(v) “Region” means one of the following geographic areas: (1) the United
States of America; (2) ******; (3) ******; (4) ******; and (5) ******.
Notwithstanding the foregoing, none of the Regions shall be deemed to include the
Excluded Countries.

(w) “Restricted Period” means the period commencing on the Effective Date
and ending on the later to occur of: (i) the expiration or termination of this
Agreement, or (ii) ****** after the Commercialization Date in the United States of
America; provided, however, that if this Agreement is terminated earlier by St.
Jude under the terms of Section 12(b)(iii), then the Restricted Period will end on
the date of such termination.

(x) “Sensei Disposables” shall mean Hansen’s ArtisanTM catheters and other
single-use sheaths, catheters, drapes, transseptal kits or other

 

 

products specifically designed, adapted or modified for use by Hansen with the
Sensei System and/or labeled for use with the Sensei System.

(y) “Sensei System” means Hansen’s robotic catheter control system
marketed under the name “Sensei,” including the Fully Integrated Sensei System and
the LC Sensei System, as such may be improved, redesigned or modified. “Sensei
System” does not include the Sensei Disposables.

(z) “St. Jude Intellectual Property” means the Intellectual Property
rights used by St. Jude in the research, design, development, manufacture or
distribution of the EnSite System and the Fully Integrated EnSite System, but not
any Intellectual Property jointly owned by Hansen and St. Jude under the terms of
the Joint Development Agreement, to the extent that such jointly owned
Intellectual Property is derived from Intellectual Property developed or otherwise
acquired by Hansen outside of the Joint Development Agreement.

(aa) “Territory” means the world.

	2.	 	Appointment and Authority of St. Jude; Co-Exclusivity.

(a) Appointment. Subject to the terms and conditions of this Agreement, Hansen
hereby appoints St. Jude, and St. Jude hereby accepts such appointment, as the
co-exclusive distributor with Hansen of the Hansen Products in the Territory (but
not in the Excluded Countries) in the Field of Use, subject to the following
restrictions:

(i) ******

(ii) ******

(b) Subdistributors. St. Jude shall have the right to engage its Affiliates, and
any independent distributors or sales agents of St. Jude as of the Effective Date,
to market and sell Hansen Products in Leveraged Sales hereunder. St. Jude may also
engage new distributors and sales agents to sell Hansen Products hereunder,
provided that if any such distributor or sales agent is to be engaged by St. Jude
solely to sell Hansen

 

 

Products, then St. Jude shall not enter into such an agreement without the prior
written consent of Hansen, which consent will not be unreasonably withheld.

(c) Distribution Rights. During the Term, if any agreement for the
distribution of Hansen Products in the Excluded Countries expires or otherwise
terminates (each, an “Excluded Country Agreement”) or Hansen determines to pursue
a new distributorship in a particular market not within the Excluded Countries, in
place of a previously-existing Hansen direct sales force effort, St. Jude shall
have a right to negotiate with Hansen during the Distribution Rights Negotiation
Period (as defined below) to become a distributor for the Hansen Products in the
geography covered by the Excluded Country Agreement or the new distributorship
(the “St. Jude Distribution Negotiation Right”). The St. Jude Distribution
Negotiation Right will commence on the date that Hansen provides St. Jude written
notice of the pending or actual expiration or termination of an Excluded Country
Agreement or of Hansen’s determination to pursue a new distributorship, and will
continue until the expiration of the Distribution Rights Negotiation Period.
Hansen shall provide St. Jude with prompt written notice of the pending or actual
expiration or termination of each Excluded Country Agreement, and of each
determination to pursue a new distributorship, which notice shall set forth in
reasonable detail the products and geography covered by each such Excluded Country
Agreement or new distributorship. St. Jude shall have the right (but not the
obligation) to exercise the St. Jude Distribution Negotiation Right with respect
to each such Excluded Country Agreement or new distributorship by written notice
to Hansen given within ****** day of its receipt of Hansen’s original notice. If
St. Jude elects to exercise the St. Jude Distribution Negotiation Right, the
parties shall, during a ****** day period commencing as of Hansen’s receipt of St.
Jude’s notice (the “Distribution Rights Negotiation Period”), use
reasonable efforts to negotiate in good faith the commercially reasonable terms
and conditions of a distribution agreement covering the products and geography
covered by the underlying Excluded Country Agreement or new distributorship.

	 	(d)	 	Technical Assistance Rights. During the Term, if Hansen determines to
seek technical assistance in regulatory, sales and/or marketing matters in any
geography, St. Jude shall have a right to negotiate with Hansen during the
Technical Assistance Negotiation Period (as defined below) to provide such
assistance in the geography for which such assistance is sought (the “St. Jude
Assistance Negotiation Right”). The St. Jude Assistance Negotiation Right will
commence on the date that Hansen provides St. Jude written notice of its
determination to obtain such assistance, and will continue until the expiration of
the Technical Assistance Negotiation Period. Hansen shall provide St. Jude with
prompt written notice of its determination to obtain such assistance, which notice
shall set forth in reasonable detail the products and geography covered by such
determination. St. Jude shall have the right (but not the obligation) to exercise
the St. Jude Assistance Negotiation Right with respect to each

 

 

	 	 	 	such determination by written notice to Hansen given within ****** day of its
receipt of Hansen’s original notice. If St. Jude elects to exercise the St. Jude
Assistance Negotiation Right, the parties shall, during a ****** day period
commencing as of Hansen’s receipt of St. Jude’s notice (the “Technical
Assistance Negotiation Period”), use reasonable efforts to negotiate in good
faith the commercially reasonable terms and conditions of a technical assistance
agreement covering the products and geography covered by the determination to seek
technical assistance.

(e) Manner of Sale. Subject to the terms of this Agreement, St. Jude and Hansen
shall be entitled to sell the Hansen Products in any manner each of them deems
appropriate.

(f) Hansen Collaboration Obligations. During the Restricted Period:

	 	(i)	 	Hansen agrees that it will not enter into
any agreement with any third party that contemplates the
distribution, sale or marketing of Hansen Products or of Other
Products made by ******.
	 
	 	(ii)	 	Notwithstanding Section 2(f)(i), but
subject to Section 2(c), during the Restricted Period Hansen shall
have the right to enter into agreements with third parties that
contemplate the distribution, sale or marketing of Hansen Products or
of any Other Products in the Field of Use in the Excluded Countries,
******.
	 
	 	(iii)	 	Notwithstanding Section 2(e)(i), during
the Restricted Period if a customer requests ******

 

 

	 	(iv)	 	******

(g) Independent Contractors. St. Jude and Hansen are independent contractors and
are engaged in the operation of their own businesses. Neither party is to be
considered the agent of the other party for any purpose whatsoever, and neither
party has any authority to enter into any contracts or assume any obligations for
the other party or make any warranties or representations on behalf of the other
party unless agreed to in writing by the other party.

3. Obligations of St. Jude.

(a) St. Jude Products. Subject to the terms and conditions of this Agreement, St.
Jude shall be solely responsible for Leveraged Sales in the Field of Use in the
Territory (but not in the Excluded Countries, which shall be the responsibility of
Hansen pursuant to Section 4(a)). St. Jude will use such efforts as it deems
appropriate, in light of market conditions and other factors, to complete
Leveraged Sales to sales leads provided by Hansen in the Field of Use in the
Territory (but not in the Excluded Countries).

(b) Invoicing. St. Jude shall be responsible for invoicing customers for (i)
Leveraged Sales and (ii) sales of Sensei Disposables made by St. Jude, including,
without limitation, those made in connection with Leveraged Sales.

(c) Sales of EnSite System. Sales by St. Jude of the Fully Integrated EnSite
System and the latest version of the EnSite software compatible

 

 

with for the Fully Integrated Sensei System to customers referred to St. Jude by
Hansen will be made on St. Jude’s standard or other commercially reasonable terms
and conditions.

(d) Regulatory Services. St. Jude shall provide mutually agreed upon regulatory
services in connection with Hansen obtaining Regulatory Approvals, as reasonably
requested by Hansen, subject to Hansen reimbursing St. Jude for Hansen-preapproved
direct and indirect costs incurred by St. Jude in connection with the provision of
such regulatory services related to Hansen Products. Hansen will pay all such
costs to St. Jude within 30 days of receipt of an invoice therefor.

(e) EnSite System. During the Term, St. Jude shall provide to Hansen, one EnSite
System, on loan and free of charge, and related disposables, at a transfer price
to be determined as part of the Sales and Marketing Plan, for sales demonstration
and training purposes under this Agreement. Unless otherwise agreed in writing by
the parties, Hansen shall promptly return such EnSite System to St. Jude, at
Hansen’s expense, in good working order, reasonable wear and tear excepted, upon
the expiration of the Term or any termination of this Agreement.

(f) Software ******. Any software incorporated into or provided for use in a
Hansen Product is not sold, but rather is licensed solely for use in that Product
in accordance with the documentation therefor. Such license is non-exclusive,
non-sublicensable and does not include the right to (and neither St. Jude nor its
Affiliates will) ******, but St. Jude will not have any liability to Hansen for
any tortious or wrongful acts of third parties with respect to Hansen Products.

	4.	 	Obligations of Hansen.

(a) Hansen Sales. Subject to the terms and conditions of this Agreement, Hansen
shall be solely responsible for Non-Leveraged Sales in the Field of Use in the
Territory, and, subject to the terms hereof, shall have the opportunity to pursue
any kind of sales of Hansen Products without limitation in the Excluded Countries
or outside of the Field of Use.

(b) Non-Leveraged Sales. For all Non-Leveraged Sales and sales of Sensei
Disposables by Hansen, Hansen shall be responsible for order fulfillment,
invoicing and all account services, including, without limitation, Sensei
Disposable sales.

(c) Leveraged Sales. For all Leveraged Sales by St. Jude and sales by St. Jude of
Sensei Disposables, Hansen shall: (i) fill such orders, including by drop shipping
Sensei Disposables included in Leveraged Sales, (ii) sell and provide maintenance
and upgrades in support of such Leveraged Sales for at least as long as the term
of St. Jude’s Leveraged Sale programs continue and in any event for not less than
****** after the Term; and (iii)

 

 

provide warranty, repair, technical service, and maintenance/upgrades under
Hansen’s standard warranty service and follow-on software/equipment service
paradigm, which, outside of the standard warranty service, shall involve
commercially reasonable fees payable by the customer to Hansen.

(d) Marketing Materials. Hansen shall be solely responsible for the preparation of
sales and marketing materials for the marketing and sale of Hansen Products, and
shall translate the instructions for use for each of the Hansen Products into the
required foreign language for each geography in the Territory (other than the
Excluded Countries). In addition, Hansen shall provide to St. Jude such quantities
of such marketing materials as St. Jude shall reasonably request from time to time
during the Term. St. Jude shall reimburse Hansen for pertinent out of pocket costs
other than costs incurred in translating instructions for use or marketing
materials.

(e) Training. In each of the United States of America and Europe, Hansen shall
provide “awareness training” regarding the Hansen Products for up to ****** key
St. Jude sales and marketing personnel, no later than ****** days after the
Commercialization Date in the United States of America or Europe, as applicable,
in order to facilitate the handling of demo/site presentations. Each party shall
bear its own expenses to attend such training (St. Jude shall cover travel and
lodging for its attendees). In addition, St. Jude will be allowed to attend
Hansen’s regularly-scheduled sales, marketing, and other training meetings,
subject to availability of the pertinent resource, subject to St. Jude covering
its own costs associated with attending (travel, lodging). Availability and timing
of such Hansen regularly-scheduled meetings is at the sole discretion of Hansen,
and Hansen is under no obligation to have such meetings. Further, subject to the
pertinent terms of the Sales and Marketing Plan, including terms detailing costs
to St. Jude and key points of contact for St. Jude regarding pertinent Hansen
resources, St. Jude shall have access to Hansen centers of excellence.

(f) Call Center, Field Support and Case Coverage. Hansen will provide and maintain
a call center to provide commercially reasonable customer service for each Region
for as long as Hansen or St. Jude commercializes Hansen Products in the Region.
Subject to the pertinent terms of the Sales and Marketing Plan, which terms shall
be reviewed and updated subject to mutual agreement by the parties every six (6)
months after finalization of the first version of the Sales and Marketing Plan,

Hansen will provide and maintain field support personnel to provide commercially
reasonable customer service in furtherance of marketing and sales activity in the
Territory (but not in the Excluded Countries), in accordance with industry norms,
for at least as long as the term of St. Jude’s Leveraged Sales program hereunder,
and for not less than 12 months thereafter. Such services shall be provided under
Hansen’s standard warranty service and follow-on software/equipment service

 

 

paradigm, which, outside of standard warranty service, shall involve commercially
reasonable fees payable to Hansen. In furtherance of the foregoing, Hansen shall
provide at least one direct or contracted field service and/or technical resource
in each Region.

(g) Promotion of St. Jude Products. Hansen shall promote the EnSite Fully
Integrated System to customers in combination with St. Jude products, except that,
subject to Section 2(t), Hansen may promote a non-St. Jude product for use with
the Sensei System if and to the extent that St. Jude does not offer a product that
performs substantially the same function or functions as such non-St. Jude
product.

(h) Leveraged Sale Referrals. Hansen shall refer to St. Jude all inquiries
regarding Leveraged Sales in the Territory (but not the Excluded Countries) in the
Field of Use received by Hansen.

(i) EnSite Referrals. Hansen shall refer to St. Jude all inquiries regarding the
EnSite System and/or the EnSite integration software module/upgrade.

(j) Fully Integrated Sensei System. During the Term, Hansen shall provide to St.
Jude (i) one Fully Integrated Sensei System, on loan and free of charge, (ii) up
to two Fully Integrated Sensei Systems at ******, not for resale, and for the sole
purpose of demonstration in geographies where either Hansen does not have a center
of excellence (e.g., Korea and Japan) or St. Jude reasonably determines that the
use of a demonstration unit outside of a center of excellence is necessary and
(iii) such quantities of related Sensei Disposables as St. Jude shall reasonably
request from time to time during the Term, at a transfer price to be determined as
part of the Sales and Marketing Plan, for sales demonstration and training
purposes under this Agreement. Unless otherwise agreed in writing by the parties,
St. Jude shall promptly return to Hansen the Fully Integrated Sensei System
provided under clause (i) above, at St. Jude’s expense, in good working order,
reasonable wear and tear excepted, upon the expiration of the Term or any
termination of this Agreement.

(k) No Third Party Distributors. During the Term, Hansen agrees that it shall not,
directly or indirectly, engage any third party to market, distribute or sell
Hansen Products in the Field of Use in the Territory, except, subject to Section
2(c), in the Excluded Countries.

(l) Regulatory Approvals and Clearances. Hansen shall be responsible for obtaining
and bearing the costs of all regulatory approvals required for the sale of Hansen
Products in the Territory.

5. Mutual Responsibilities of Hansen and St. Jude

(a) Market Development. Hansen and St. Jude shall jointly develop and share costs
of mutually agreed upon market development activities (e.g., post-marketing
clinical studies and exhibition space).

 

 

(b) Sales and Marketing. Hansen and St. Jude shall jointly develop and attach
hereto as Appendix A within ****** after the Effective Date a mutually agreed upon
detailed coordinated marketing and sales plan outlining the cooperative
involvement of Hansen and St. Jude resources in the marketing, sale and
distribution of the Hansen Products in the Territory (the “Sales and Marketing
Plan”).

(c) Joint Selling Opportunities. St. Jude’s field sales organization shall
promptly notify Hansen’s field organization of any opportunities identified by St.
Jude that would allow for Leveraged Sales in the Territory (excluding the Excluded
Countries) in the Field of Use. St. Jude’s representatives will then partner with
Hansen’s field representatives to conduct all related sales presentations and
messaging representing the Fully Integrated Sensei System, Sensei Disposables, and
St. Jude products. All joint sales calls will be coordinated between St. Jude’s
and Hansen’s field sales organizations. Hansen clinical specialists will be solely
responsible for in-servicing the end users once the Fully Integrated Sensei System
has been delivered to the account.

(d) Notice of Leveraged Sale Opportunity. Within ****** business days of a
customer requesting a sales quote for a Leveraged Sale in the Field of Use in the
Territory (but not the Excluded Countries) from either party, the party receiving
the request will notify the other party in writing. For a period of ****** days
after the date of such notice, St. Jude shall have the exclusive right to obtain a
purchase order with respect to a Leveraged Sale to such customer, provided that if
prior to the expiration of such ****** period it becomes reasonably clear to
either St. Jude that the customer is not going to enter into such a Leveraged Sale
with St. Jude, St. Jude shall so notify Hansen in writing (“No Interest Notice”).
If St. Jude does not obtain a purchase order with respect to a Leveraged Sale
within such ****** period or St. Jude provides Hansen with a No Interest Notice,
Hansen shall thereafter have the right to approach the same customer and solicit a
Non-Leveraged Sale.

 

 

	6.	 	Trademark License. Hansen grants to St. Jude the right and license to use Hansen’s
trademarks and any trademark registrations which Hansen obtains and designates for the
Sensei System (including the Fully Integrated Sensei System) and the Sensei Disposables,
including, without limitation, the trademarks and trademark registrations set forth on
Schedule 6 hereto (the “Trademarks”) solely to market and distribute
hereunder the Hansen Products to which such Trademarks relate in accordance with Hansen’s
then current trademark usage guidelines and subject to prior written approval by Hansen of
all uses, except for uses consistent with uses previously approved by Hansen in writing.
This trademark license shall continue in effect only while St. Jude retains its distribution
rights under this Agreement. St. Jude agrees not to remove or obscure any product label
affixed by Hansen, unless necessary to comply with local language labeling requirements. All
trademarks of or used by, and trademark registrations obtained by, Hansen and/or its
Affiliates shall be and remain owned by Hansen and its Affiliates and will not be challenged
or registered by St. Jude or its Affiliates.
	 
	7.	 	Terms and Conditions of Sale.

(a) Terms of Orders. All purchases of Hansen Products by St. Jude from Hansen
during the Term will be subject to the terms and conditions of this Agreement. St.
Jude shall submit purchase orders to Hansen for Hansen Products. Each purchase
order shall include: (i) identification of the Hansen Products ordered; (ii)
quantity; (iii) requested delivery date; (iv) pricing terms; and (v) shipping
instructions and shipping address. Absent mutual written agreement to the
contrary, any terms or conditions associated with purchase orders, other than
those described in this section 7(a), shall have no force or effect.

(b) Packaging. All quantities of Hansen Products purchased from Hansen by St. Jude
shall be delivered, packaged ready for resale in the applicable geography, with
all artwork and labeling prepared by Hansen, to the carrier for shipment to the
location set forth in the purchase order.

(c) Prices; Other Fees; Invoicing. The prices, other fees and invoicing
mechanics, related to the sale of the Hansen Products are set forth in
Appendix B hereto.

(d) Expenses. Except as otherwise set forth herein, each party shall bear its own
expenses with respect to promotion, sales and distribution, as well as
administrative and overhead expenses.

(e) Credit. Each party assumes all credit and other risks involved in its sales
under this Agreement. All collection expenses on sales invoiced by St. Jude will
be at St. Jude’s expense and all collection expenses on sales invoiced by Hansen
(except to St. Jude) will be at Hansen’s expense.

 

 

(f) Payment Terms. Payment terms are net thirty (30) days after receipt of
evidence of the following (i) successful installation of the Fully Integrated
Sensei System sold to the customer, (ii) completion of customer training, and
(iii) successful use of the Fully Integrated Sensei System in ******.

(g) Shipping Terms: Ex Works (Incoterms 2000) Hansen’s facility, Mountain View,
CA, provided that Hansen shall be responsible for obtaining and bearing the cost
of all import and export licenses.

	8.	 	Regulatory Matters.

(a) Medical Device Establishment Registrations. Hansen will maintain a Medical
Device Establishment Registration (as defined under the Act) as manufacturer and
specifications developer for the Products, as is required by law or regulation.
St. Jude will maintain a Medical Device Establishment Registration (as defined
under the Act) as manufacturer and specifications developer for the Fully
Integrated EnSite System (hereinafter the “Fully Integrated EnSite System”), as is
required by law or regulation.

(b) Complaints and Medical Device Reporting. Each party will comply with
applicable provisions of the Medical Device Reporting systems, including the
requirements of21 CFR Part 803, and each party will cooperate with the other for
the efficient compliance therewith. Each of the parties agrees to notify the other
within three (3) Business Days of receipt of any significant complaint or
information relating to the safety or effectiveness of any Hansen Products or
Fully Integrated EnSite System or otherwise relating to an event that could
trigger a need to file a Medical Device Report (“MDR”). Each party will provide
the results of a preliminary investigation into any event covered by such
notification to the other party, along with the pertinent device hardware itself,
as soon as is practicable, in any event within sufficient time for the other party
to comply with all applicable reporting laws and regulations. With respect to each
Hansen Product or each Fully Integrated EnSite System covered by such
notification, the party in control of the subject product shall provide to the
other party a minimum of the following information within five days following
receipt of the notification: (i) Device History Record evaluation, (ii) Batch/Lot
size and (iii) Assurance Record (visual, dimensional, functional inspections or
process controls). The party in control of the subject product shall provide
written follow-up within ten Business Days of any additional “request for
analysis” or “corrective/preventive action request” received from the other party
associated with the notification. The party in control of the subject product
shall provide the other party with a monthly report outlining key non-conformance
activity associated with the products covered by such notification indicating key
component, in-process, or finished device non-conformance (scrap, non-conforming
material) trends. Content of report

 

 

shall include six-month running trends and include frequency, root cause,
corrective/preventive actions, and assigned due dates associated with mitigating
identified trends.

(c) Remedial Actions. Hansen will monitor regulatory matters with respect to
Hansen Products and will take all commercially reasonable actions necessary to
maintain Hansen Product availability in conformity with applicable legal
requirements. Similarly, St. Jude will monitor regulatory matters with respect to
the Fully Integrated EnSite System and will take all commercially reasonable
actions necessary to maintain availability of the Fully Integrated EnSite System
in conformity with applicable legal requirements. The parties will notify each
other within two Business Days of learning of any material regulatory development
with respect to Hansen Products or the Fully Integrated EnSite System. Each party
will notify the other immediately, and promptly confirm such notice in writing, if
it obtains information indicating that any of the Hansen Products or the Fully
Integrated EnSite System may be subject to any Remedial Action. “Remedial Action”
shall mean any recall, field corrective action, safety alert, notification or
other regulatory action with respect to one or more of the Hansen Products or the
Fully Integrated EnSite System taken either by virtue of applicable federal,
state, foreign or other law or regulation or good business judgment. The parties
will assist each other in gathering and evaluating such information as is
reasonably necessary to allow the party controlling the pertinent product to
determine the necessity of conducting any Remedial Action. Each party will
maintain adequate records to permit the other party to trace the manufacture of
the Hansen Products and the Fully Integrated EnSite System and the distribution
and use of the Hansen Products and the Fully Integrated EnSite System. In the
event that the party in control of a product (i.e., Hansen controls the Hansen
Products and St. Jude controls the Fully Integrated EnSite System) determines that
any Remedial Action with respect to a product must be commenced or Remedial Action
is required by any governmental authority having jurisdiction over the matter, the
party in control of such product will control and coordinate all efforts necessary
to conduct such Remedial Action. Without limiting the foregoing, such
responsibility shall apply to any recall, whether required or recommended by any
government or other authority or organization, or otherwise deemed appropriate by
the party in control of such product. Hansen shall monitor on-going manufacturing
quality trends and promptly notify St. Jude in writing of any known safety-related
defects which are known to directly impact present St. Jude inventory or
previously distributed Products. Similarly, St. Jude shall monitor on-going
manufacturing quality trends and promptly notify Hansen in writing of any known
safety-related defects which are known to directly impact present Hansen inventory
or previously distributed Fully Integrated EnSite System. Notification shall
include description of issue, product/batch scope, and scope mitigation
recommendation. The notifying party shall follow-up within three days of
notification with a Risk Analysis/Health

 

 

Hazard Evaluation associated with the issue outlining investigative elements
associated with issues severity, occurrence, and detection.

(d) Audits by St. Jude. Hansen will give St. Jude reasonable access to its
facilities and records to allow an independent consulting firm selected by St.
Jude, such firm being reasonably acceptable to Hansen, to conduct full compliance
audits relating to the manufacture of Hansen Products, at St. Jude’s expense, as
reasonably deemed necessary by St. Jude, but no more than once per year. The audit
may include, without limitation, records relating to manufacturing compliance with
the applicable Specifications (as defined in Section 1O(a)), compliance with
quality control and inspection reports procedures, compliance with Good
Manufacturing Practices/Quality Systems Regulations promulgated under the Act,
regulatory compliance, CE mark certification records and procedures, and
compliance with ISO 13485 requirements, as applicable. All audits will be
conducted during Hansen’s normal business hours, after two weeks’ prior written
notice to Hansen by St. Jude, and at times mutually agreeable to the parties.
Hansen will make its regulatory compliance and quality assurance personnel
reasonably available to St. Jude’s independent consulting firm in connection with
such audits. If the auditor recommends any corrective actions to Hansen in
connection with such audits, Hansen will take any corrective action recommended by
the auditor with which Hansen agrees within 30 days of receipt of any corrective
action recommendations, if possible, or will inform St. Jude in writing of the
reasons why Hansen believes such corrective action is not required or cannot be
completed within such 30 day period. St. Jude’s independent consulting firm will
be given access to audit any corrective action. If such audit discloses, in St.
Jude’s good faith opinion, that the progress made by Hansen as of the date of the
audit with respect to the Hansen Products is such that Hansen will be unable to
make shipments to St. Jude materially in accordance with the purchase orders
submitted by St. Jude to Hansen or that all or any part of the Hansen Products are
not materially in accordance with the applicable Specifications, St. Jude shall
have the right to cancel any unshipped Hansen Products by written notice to
Hansen, without any liability for breach of this Agreement.

(e) Audits by Hansen. St. Jude will give Hansen reasonable access to its
facilities and records to allow an independent consulting firm selected by Hansen,
the firm being reasonably acceptable to St. Jude, to conduct full compliance
audits relating to the manufacture of the Fully Integrated EnSite System, at
Hansen’s expense, as reasonably deemed necessary by Hansen, but no more than once
per year. The audit may include, without limitation, records relating to
manufacturing compliance with the applicable specifications, compliance with
quality control and inspection reports procedures, compliance with Good
Manufacturing Practices/Quality Systems Regulations promulgated under the Act,
regulatory compliance, CE mark certification records and procedures, and
compliance with ISO 13485 requirements, as applicable. All audits will

 

 

be conducted during St. Jude’s normal business hours, after two weeks’ prior
written notice to St. Jude by Hansen, and at times mutually agreeable to the
parties. St. Jude will make its regulatory compliance and quality assurance
personnel reasonably available to Hansen’s independent consulting firm in
connection with such audits. If the auditor recommends any corrective actions to
St. Jude in connection with such audits, St. Jude will take any corrective action
recommended by auditor with which St. Jude agrees within 30 days of receipt of any
corrective action recommendations, if possible, or will inform Hansen in writing
of the reasons why St. Jude believes such corrective action is not required or
cannot be completed within such 30 day period.

(f) Regulatory Inspections. The party in control of a product (i.e., Hansen
controls the Hansen Products and St. Jude controls the Fully Integrated EnSite
System) will promptly notify the other party of any inspection of its facilities
manufacturing the Hansen Products or the Fully Integrated EnSite System, or any
component part of one or more of the Hansen Products or the Fully Integrated
EnSite System, by the Food and Drug Administration of the U.S. Department of
Health and Human Services, ISO, CE mark certification organization or other
federal, state, or local regulatory agency which relates to the manufacture,
assembly, or packaging of the Hansen Products or the Fully Integrated EnSite
System and provide the other party with information about the progress and outcome
of such inspection, including, without limitation, copies of any notice of
observations or warnings, requests for remedial action, corrective actions or
other adverse findings.

(g) Assistance Between Parties. Each party shall provide reasonable assistance to
the other, at no charge, if necessary to respond to regulatory audits,
inspections, inquiries or requests concerning the Hansen Products or the Fully
Integrated EnSite System. If either party is required to submit any information
concerning the Hansen Products or the Fully Integrated EnSite System as part of a
regulatory inspection or audit in connection with the manufacture and sale of the
Hansen Products or the Fully Integrated EnSite System, either party will provide
to the other party such documentation, data and other information as may be
required for submission to the regulatory agency. Each party shall, if required,
also provide to the regulatory agency or to the other party, as applicable,
information concerning its quality control procedures and marketing of the Hansen
Products or the Fully Integrated EnSite System and any other information
reasonably requested by the regulatory agency. The parties shall each provide
their reasonable cooperation and consultation to the other in addressing any issue
raised by the regulatory agency concerning the marketing, sale or manufacture of
the Hansen Products or the Fully Integrated EnSite System.

 

 

	9.	 	Representations and Warranties.

(a) Hansen Representations and Warranties. Hansen represents and warrants to St.
Jude, as of the date of this Agreement and throughout the Term, that, except as
set forth in that certain disclosure letter delivered by Hansen to St. Jude on the
date hereof, and in any updates thereto delivered by Hansen to St. Jude from time
to time:

	 	(i)	 	it is a corporation duly organized, validly
existing and in good standing under the laws of the state of
Delaware;
	 
	 	(ii)	 	it has full power and authority to execute
and deliver this Agreement, and to perform its obligations hereunder;
this Agreement constitutes the valid and legally binding obligation
of Hansen, enforceable in accordance with its terms and conditions;
	 
	 	(iii)	 	neither the entering into of this
Agreement nor the performance of any of its obligations hereunder
will conflict with or constitute a breach under any obligation of
Hansen or under any agreement, contract or instrument to which Hansen
is a party or any other obligation, law or regulation by which Hansen
is bound;
	 
	 	(iv)	 	the Sensei System (including the Fully
Integrated Sensei System) and the Sensei Disposables purchased under
this Agreement are not (and will not be) manufactured in violation of
any federal, state or local law, executive order or administrative
ruling;
	 
	 	(v)	 	Hansen will convey good title to the Sensei
System (including the Fully Integrated Sensei System) and the Sensei
Disposables to St. Jude free from all security interests, liens or
encumbrances; with the exception that Hansen licenses –and does not
sell or convey title to – software;
	 
	 	(vi)	 	Hansen owns (or will own) or possesses (or
will possess) licenses or other rights to use all Hansen Intellectual
Property;
	 
	 	(vii)	 	no claim is pending or, to the best of
Hansen’s knowledge, threatened, to the effect that the Hansen
Products or Hansen’s use of the Hansen Intellectual Property
infringes upon or conflicts with the valid rights of any other person
under any Intellectual Property;

 

 

	 	(viii)	 	no claim is pending or, to the best of Hansen’s knowledge,
threatened, to the effect that any Hansen Intellectual Property is
invalid or unenforceable by Hansen;
	 
	 	(ix)	 	Hansen has delivered to St. Jude true and
correct copies of all correspondence between Hansen and the FDA with
respect to the Hansen Products;
	 
	 	(x)	 	the FDA has not requested additional data,
beyond any data requirements previously disclosed to St. Jude, in
order for the Hansen Products to receive FDA clearance; and
	 
	 	(xi)	 	its manufacturing facility is in compliance
with all applicable FDA 21 CFR Part 820 Good Manufacturing Practices/
Quality System Regulations promulgated under the Act, and has
obtained applicable ISO 13485 certification.

(b) St. Jude Representations and Warranties. St. Jude represents and warrants to
Hansen as of the date of this Agreement and throughout the Term, that, except as
set forth in that certain disclosure letter delivered by St. Jude to Hansen on the
date hereof, and in any updates thereto delivered by St. Jude to Hansen from time
to time:

	 	(i)	 	it is a corporation duly organized and
validly existing and in good standing under the laws of the State of
Minnesota;
	 
	 	(ii)	 	it has full power and authority to execute
and deliver this Agreement and to perform its obligations hereunder;
	 
	 	(iii)	 	this Agreement constitutes the valid and
legally binding obligation of St. Jude, enforceable in accordance
with its terms and conditions;
	 
	 	(iv)	 	neither the entering into of this Agreement
nor the performance of any of its obligations hereunder will conflict
with or constitute a breach under any obligation of St. Jude or under
any agreement, contract or instrument to which St. Jude is a party or
any other obligation, law or regulation by which St. Jude is bound;
	 
	 	(v)	 	St. Jude owns (or will own) or possesses
(or will possess) licenses or other rights to use all St. Jude
Intellectual Property used in the research, design, development,
manufacture or distribution of the EnSite System (including the Fully
Integrated EnSite System);
	 
	 	(vi)	 	no claim is pending or, to the best of St.
Jude’s knowledge, threatened to the effect that the EnSite System
(including the

 

 

	 	 	 	Fully Integrated EnSite System) or St. Jude’s use of the St. Jude
Intellectual Property infringes upon or conflicts with the valid
rights of any other person under any Intellectual Property, other
than pending infringement claims made by BioSense which Hansen
acknowledges it is aware of; and
	 
	 	(vii)	 	no claim is pending or, to the best of St.
Jude’s knowledge, threatened to the effect that any St. Jude
Intellectual Property is invalid or unenforceable by St. Jude, other
than pending infringement claims made by BioSense which Hansen
acknowledges it is aware of.

	10.	 	Product Warranty/Disclaimer/Liability Limitation. Hansen warrants to St. Jude that all
Hansen Products: (i) will materially conform with all specifications set forth in the
initial development plan contained in the Joint Development Agreement, as updated from time
to time by mutual agreement of the parties (referred to herein as the “Specifications”), and
written descriptions thereof provided by Hansen to St. Jude prior to any sale of the Hansen
Products by St. Jude, (ii) will be free of material defects in material, workmanship and
design, and (iii) will be of merchantable quality, suitable for the purposes for which they
are intended to be used, and (iv) will be manufactured in accordance with all applicable
laws and regulations. Hansen will exchange or accept the return by St. Jude of existing
inventory and issue credit at St. Jude’s Fully Landed Cost if the Hansen Products do not
meet requirements (i) through (iii). All warranties shall survive any inspection, delivery,
acceptance or payment. Hansen will provide, when requested by St. Jude, certification that,
to the best of its knowledge, it is in compliance with United States laws, statutes, rules,
regulations and relevant orders relating to the manufacture, use, distribution and sale of
each Hansen Product. St. Jude will use commercially reasonable efforts to afford Hansen the
reasonable opportunity to inspect any allegedly defective Hansen Product at the location of
its use or storage. St. Jude will, or will cause, upon request and in accordance with
Hansen’s instruction, repair, replacement, or refund with respect to any defective Hansen
Product failing to meet the above warranty that is returned to Hansen within twelve (12)
months of original shipment by Hansen; the foregoing is the sole remedy for breach of
warranty or defects. EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE 10 OR ARTICLE IX, EACH
PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY
KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF TITLE,
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THE INTELLECTUAL
PROPERTY RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE
OR TRADE PRACTICES. Without limiting the generality of the
foregoing, neither Party makes any warranty of any kind related to: (i) the success of the
research conducted by the Parties under the Agreement; or (ii) the safety or usefulness for
any purpose of the technology or other materials or information it
provides hereunder. EXCEPT FOR BREACHES OF A PARTY’S
OBLIGATIONS UNDER ARTICLE 15, NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR ANY
SPECIAL,

 

 

CONSEQUENTIAL, INCIDENTAL, INDIRECT OR PUNITIVE DAMAGES
ARISING OUT OF OR RELATED TO ANY ASPECT OR SUBJECT MATTER
OF THIS AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF
LIABILITY, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.

	11.	 	Pass-through of Hansen Terms and Conditions. To the extent permitted by applicable law, St.
Jude shall pass-through to its customers Hansen’s standard terms and conditions of sale for
Hansen Products.
	 
	12.	 	Term and Termination.

(a) Initial Term. This Agreement shall commence on the Effective Date and continue
in force until the date two (2) years from the Commercialization Date in the
United States of America (the “Initial Term” and, as may be extended by written
agreement of the parties, the “Term”). The parties agree to discuss modification
of the foregoing, and of the Restricted Period, based on anticipated and/or actual
regulatory and reimbursement approval timelines and commercialization dates, as
part of the Sales and Marketing Plan.

(b) Termination. This Agreement may be terminated:

	 	(i)	 	by either party after (A) such party has
given written notice to the other party that such other party has
committed a material breach of its obligations hereunder and (B) such
other party has failed to correct such material breach within 90 days
of such written notice;
	 
	 	(ii)	 	by either party if the other party becomes
insolvent, makes or seeks to make an arrangement with or an
assignment for the benefit of creditors, or if proceedings in
voluntary or involuntary bankruptcy are instituted by, on behalf of
or against, such other party, or if a receiver or trustee of the
other party’s property is appointed; or
	 
	 	(iii)	 	by St. Jude upon ****** prior written
notice to Hansen.

(c) Effect of Expiration or Termination. In the event of expiration or termination
of this Agreement for any reason, the parties shall have the following rights and
obligations:

	 	(i)	 	termination of this Agreement shall not
release either party from the obligation to make payment of all
amounts then or thereafter due and payable (which are not the subject
of a good faith dispute).

 

 

	 	(ii)	 	St. Jude may, in its sole discretion, elect
to continue to market and sell, and Hansen shall continue to supply
St. Jude’s requirements, within the Field of Use and Territory
(except the Excluded Countries) the Hansen Products for Leveraged
Sales for a period of ****** following any early termination of this
Agreement prior to the expiration of the Term, on the terms and
conditions of this Agreement which survive termination;
	 
	 	(iii)	 	With respect to a termination not covered
by Section 12(c)(ii) above, Hansen shall continue to supply St.
Jude’s requirements for Hansen Products to the extent necessary for
St. Jude to perform its obligations under any orders existing on the
date of termination for a period of ****** months after such date of
termination;
	 
	 	(iv)	 	St. Jude shall deliver to Hansen or
destroy, upon request, all Hansen Product materials supplied by
Hansen and all Hansen Product marketing materials of any kind, except
for such materials as are required by St. Jude in connection with any
sales of inventory, sales under Section 12(c)(ii), and sales to
fulfill outstanding orders under Section 12(c)(iii);
	 
	 	(v)	 	the license to use Trademarks shall
terminate (except to the extent needed to sell inventory and fulfill
Hansen Product orders existing on the date of termination under this
Section 12(c)) and as may be required for sales pursuant to Section
12(c)(ii) and (iii); and
	 
	 	(vi)	 	the obligations of Hansen and St. Jude
pursuant to Sections 4(c), (d), (f) and (1) (Obligations of Hansen),
7(c) (Price; Fees; Invoicing), 9 (Representations and Warranties), 10
(Product Warranty and Insurance), 11 (Pass-through of Hansen Terms
and Conditions), 12 (Term and Termination), 14 (Indemnification), 15
(Confidential Information and Publicity), and 16 (General Provisions)
of this Agreement will survive any expiration or termination of this
Agreement.

	 	 	Nothing herein will limit any remedies which a party may have for the other party’s
default, except as expressly provided herein. Neither party shall be liable to the other
for any damage in connection with that party’s termination of this Agreement by written
notice in accordance with Section 12(c).
	 
	13.	 	Intentionally Omitted.
	 
	14.	 	Indemnification.

          (a) Hansen Indemnification.

 

 

(i) Hansen agrees to indemnify, defend, and hold St. Jude and its
directors, officers, employees, agents and representatives harmless from
and against, and to assume all direct and indirect costs and expenses
(including reasonable attorney’s fees) for:

	 	1.	 	claims or suits for bodily
injury, including, but not limited to, death, or property
damage to the extent that such claims or suits allege that such
injury or damage was caused by: (A) the defective design or
manufacture of a Hansen Product; (B) the unreasonably dangerous
condition of a Hansen Product; (C) negligent failure to warn
concerning a Hansen Product; or (D) a breach by Hansen of any
representations, warranties or covenants of Hansen hereunder;
	 
	 	2.	 	any recalls or replacements of
Hansen Products, whether required or recommended by any
government or other authority or organization or otherwise
deemed appropriate by Hansen and St. Jude; and
	 
	 	3.	 	any product liability claims
arising from the Product Warranty provided by Hansen in Section
10;

except to the extent that such injury, damage, cost, or expense is
caused by the negligence or other fault of St. Jude (including but not
limited to claims, representations and/or warranties about the Hansen
Product that are made by St. Jude without the authorization of Hansen);
and

(ii) Hansen agrees to further indemnify, defend, and hold St. Jude and its
directors, officers, employees, agents and representatives harmless from
and against, and shall assume all direct and indirect costs and expenses
(including attorney’s fees) for any claim that the Hansen Intellectual
Property, the Sensei System (including the Fully Integrated Sensei System)
or the Sensei Disposables infringe or violate any patent, copyright,
trademark, trade name, trade secret, or other intellectual property right.

     (b) St. Jude Indemnification.

(i) St. Jude agrees to indemnify, defend, and hold Hansen and its
directors, officers, employees, agents and representatives harmless from
and against, and to assume all direct and indirect costs and expenses
(including attorney’s fees) for:

	 	1.	 	claims or suits for bodily
injury, including, but not limited to, death, or property to
the extent that such claims or suits

 

 

	 	 	 	allege that such injury or damage was caused by: (A) the defective
design or manufacture of any EnSite System; (B) the unreasonably
dangerous condition of an EnSite System; (C) negligent failure to
warn concerning an EnSite System; or (D) a breach by St. Jude of
any representations, warranties or covenants of St. Jude
hereunder; and
	 
	 	2.	 	any recalls or replacements of
the EnSite System (including the Fully Integrated EnSite
System), whether required or recommended by any government or
other authority or organization or otherwise deemed appropriate
by Hansen and St. Jude.

except, in each case, if such injury, damage, cost, or expense is
caused by the negligence or other fault of Hansen (including but not
limited to claims, representations and/or warranties about any EnSite
System that are made by Hansen without the authorization of St. Jude); and

(ii) St. Jude agrees to further indemnify, defend, and hold Hansen and its
directors, officers, employees, agents and representatives, harmless from
and against, and shall assume all direct and indirect costs and expenses
(including attorney’s fees) for any claim that the St. Jude Intellectual
Property or the EnSite System (including the Fully Integrated EnSite
System) infringe or violate any patent, copyright, trademark, trade name,
trade secret, or other intellectual property right.

(c) Any duty of one party under this section 14 shall be contingent upon such
party receiving from the other party prompt notice of any claims or threats, full
cooperation, and full control over defense and settlement, except to the extent
that any delay is not prejudicial to the indemnifying party.

15. Confidential Information and Publicity.

(a) The parties hereto will keep confidential any non-public information (whether written
or oral and whether or not identified as “Confidential”) exchanged by the parties (whether
prior to, on or after the date hereof) in connection with the matters contemplated by this
Agreement, as well as the existence and terms of this Agreement and the existence of the
parties’ discussions and collaboration hereunder, strictly in accordance with the terms of
the NDA, and will use such information solely in the performance of their obligations, and
the exercise of their rights, provided hereunder. The NDA shall expressly survive any
termination of this Agreement in accordance with its terms.

(b) Neither party nor any of its Affiliates or representatives may initiate or make any
public announcement (by press release, press interview or otherwise) or

 

 

other disclosure concerning the existence, terms and conditions, or subject matter of this
Agreement to any third party without the prior written consent of the other party, except
as may be required by law or regulation. In those circumstances where a party believes that
any such disclosure is required by law or regulation, then it shall (i) seek to notify the
other party on a timely basis in advance of such disclosure, and (ii) use its best efforts
to seek confidential treatment of the material provisions of this Agreement to the
greatest extent permitted by law or regulation.

16. General Provisions.

(a) Governing Law. This Agreement shall be governed by and interpreted in accordance with
the laws of the State of New York, excluding the United Nations Convention on Contracts for
the International Sale of Goods, including all matters of construction, validity,
performance and enforcement, without giving effect to principles of conflict of laws
thereof.

(b) Entire Agreement. This Agreement (including any exhibits attached or to be attached
hereto, which are incorporated by this reference), together with the Joint Development
Agreement and the NDA, represent the entire agreement and understanding of Hansen and St.
Jude with respect to the subject matter hereof and supersede all previous agreements,
representations and understandings, whether written or oral, between the parties concerning
the subject matter hereof. No inference shall be drawn from any variance between this
Agreement and any prior negotiations, term sheets, letters of intent relating to, or drafts
of, this Agreement. Each party acknowledges and agrees that no representations,
inducements, promises, commitments or agreements, orally or otherwise, have been made by
any party, or anyone acting on behalf of any party, which are not expressed herein.

(c) Amendments. This Agreement may only be amended or modified in writing signed by
authorized representatives of St. Jude and Hansen.

(d) Severability. In the event that any provision of this Agreement is held to be invalid
or unenforceable, this Agreement will continue in full force and effect without said
provision and will be interpreted to reflect the original intent of the parties. In such
event, the parties shall in good faith attempt to negotiate a substitute clause for any
provision declared invalid or unenforceable, which substitute clause shall most nearly
approximate the intent of the parties in agreeing to such invalid or unenforceable
provision, without itself being invalid or unenforceable.

(e) Construction Against Waiver. Waiver by either party of a breach of any provision of
this Agreement or the failure by either party to exercise any right hereunder will not
operate or be construed as a waiver of any subsequent breach of that provision or as a
waiver of any other right.

 

 

(f) Counterparts. This Agreement may be executed in two or more counterparts, each of which
shall be deemed an original and all of which together shall constitute one instrument. A
facsimile signature of this Agreement shall be valid and have the same force and effect as
a manually signed original.

(g) Assignment. Neither Hansen nor St. Jude may assign any of its rights or obligations
pursuant to this Agreement without the prior written consent of the other party, except to
a successor to substantially all of the business or assets of either party by merger, sale
of assets, or other form of reorganization; provided, however, that St.
Jude may assign its rights, interests or obligations hereunder to any of its Affiliates
without the prior consent of Hansen;.

(h) Notices. All notices under this Agreement must be in writing and will be deemed given
if sent by facsimile (except for legal process), certified or registered mail or commercial
courier (return receipt or confirmation of delivery requested), or by personal delivery to
the party to receive the notice or other communications called for by this Agreement at the
following addresses (or at another address for a party as specified by a party by like
notice):

	 	(1)	If to Hansen:

Hansen Medical, Inc.

380 North Bernardo Avenue

Mountain View, CA

Facsimile: 650-404-5900

Attn: President and Chief Operating Officer

and

Hansen Medical, Inc.

380 North Bernardo Avenue

Mountain View, CA

Facsimile: 650-404-5900

Attn: Vice President of Legal Affairs

	 	 	 	with a copy to (which shall not constitute notice):

Hansen Medical, Inc.

380 North Bernardo Avenue

Mountain View, CA

Facsimile: 650-404-5900

Attn: Chief Financial Officer

	 	(2)	If to St. Jude:

St. Jude Medical, Inc.

 

 

One Lillehei Plaza

Saint Paul, MN 55117

Attention: Chief Financial Officer

and

St. Jude Medical, Atrial Fibrillation Division, Inc.

6500 Wedgwood Road

Maple Grove, MN 55311

Attention: President

and

St. Jude Medical, Atrial Fibrillation Division, Inc.

14901 DeVeau Place

Minnetonka, MN 55345

Attention: General Counsel

and

St. Jude Medical, U.S. Division

807 Las Cimas Parkway

Suite 400

Austin, TX 78746

Attention: General Counsel

and

St. Jude Medical, International Division

One Lillehei Plaza

Saint Paul, MN 55117

Attention: President

with a copy to (which shall not constitute notice):

(i) Force Majeure. Each of the parties hereto will be excused from its performance of its
obligations hereunder if the performance is prevented by force majeure, and that excuse
will continue so long as the condition constituting that force majeure continues plus 30
days after the termination of the condition. Either party, if excused from such
compliance as aforesaid under this Section 16(i), agrees to give prompt notice to the other
party of the relevant circumstances, to use its best efforts to overcome the obstacles of
such performance, and to resume performance as soon as practicable. For the purposes of
this Agreement, “force majeure” is defined to include causes beyond the

 

 

control of St. Jude or Hansen, including without limitation acts of God, acts, regulations
or laws of any government, war, warlike activity, acts of terrorism, insurrection, civil
commotion, transportation delay, governmental action (whether or not with proper authority)
destruction of production facilities or materials by fire, flood, earthquake or storm, or
medical epidemics.

(j) No Strict Construction. This agreement has been prepared with the participation of each
party and will not be strictly construed against either party. Each party acknowledges that
it has consulted with, or has had the opportunity to consult with, counsel of its choice,
and that in executing this Agreement it has not relied upon any statements, representations
or agreements of any other person other than those contained herein.

(k) Headings; Interpretation. The captions to the several sections hereof are not a part of
this Agreement, but are included for convenience of reference only and shall not affect its
meaning or interpretation. Each reference to “include” or “including” or “includes” shall
be deemed to be followed by the words “without limitation.”

(l) Non-Hire. Without the prior written consent of the other party, neither party shall,
during the Term and for 12 months thereafter, solicit (other than a solicitation by general
advertisement), hire or otherwise engage, or cause any other person or entity (including
its subsidiaries, parents or other Affiliates) to solicit (other than a solicitation by
general advertisement), hire or otherwise engage, any current or former employee of the
other party or any affiliate of the other party for a period of 6 months after the
termination of such individual’s employment relationship with the other party or affiliate
of the other party.

(m) Third Party Beneficiaries. St. Jude’s Affiliates, including, without limitation, (i)
St. Jude Medical, Atrial Fibrillation Division, Inc., (ii) St. Jude Medical S.C., Inc., and
(iii) SJM International, Inc., are third party beneficiaries of this Agreement.

 

 

     To witness their agreement, the parties have caused this Agreement to be signed below by their
respective officers.

	 	 	 	 	 	 	 
	HANSEN MEDICAL, INC.	 	ST. JUDE MEDICAL, INC.
	 
	 	 	 	 	 	 
	By:

	 	/s/ Gary Restani
	 	By:
	 	/s/ Pamela S. Krop
	 

	 
	 
	 	 
	 
	 
	 	 	 	 	 	 
	Gary Restani	 	Pamela S. Krop
	(Print Name)	 	(Print Name)
	 
	 	 	 	 	 	 
	Title:
President and Chief Operating Officer 
	 	Title: Vice President, General Counsel and Secretary

[Signature Page to Co-Marketing Agreement]

 

 

Appendix A

Sales and Marketing Plan

 

 

Appendix B

Prices, Other Fees and Invoicing

          
          ******exv10w21

 

Exhibt
10.21

AMENDMENT TO

THE HALLWOOD GROUP INCORPORATED

2005 LONG-TERM INCENTIVE PLAN

FOR

BROOKWOOD COMPANIES INCORPORATED

     This Amendment (this “Amendment”) to The Hallwood Group Incorporated 2005 Long-Term Incentive
Plan for Brookwood Companies Incorporated (the “Plan”) is made by The Hallwood Group Incorporated,
pursuant to the provisions of Section 9(a) of the Plan. Terms not otherwise defined in this
Amendment shall have the meanings given them in the Plan.

W I T N E S S E T H:

     WHEREAS, the Plan was adopted effective December 16, 2005;

     WHEREAS, the Board deems it to be in the best interest of the Company and Brookwood to amend
the Plan to allow for the participation by consultants and advisers to Brookwood or its
Subsidiaries, to clarify that changing from one eligible category of participant to another is not
a termination of employment or service; and to clarify further that references to the Plan, unless
otherwise expressly provided, are references to the Plan as amended at the time of reference; and

     WHEREAS, the Board has determined that the proposed amendments do not adversely affect any
Award currently outstanding under the Plan;

     NOW, THEREFORE, in consideration of the foregoing, the Plan is amended as follows:

	1.	 	Amendments to the Plan

	 	A.	 	Section 2 is hereby amended by deleting the section in its entirety and
substituting the following:

2. Purpose of the Plan. The purpose of the Plan is to advance the best interests of
the Company, Brookwood, their Subsidiaries and the stockholders of the Company in order to
attract, retain and motivate directors, officers, key employees, consultants and advisers by
providing them with additional incentives through the grant of Units.

	 	B.	 	Section 3(i) is hereby amended by deleting the section in its entirety and
substituting the following:

(i) “Eligible Participant” means those persons who are directors, officers or key
employees of, or consultants or advisers to, Brookwood or its Subsidiaries.

	 	C.	 	Section 5 is hereby amended by deleting the section in its entirety and
substituting the following:

5. Eligible Participants. Directors of Brookwood, key employees, including officers
of Brookwood and its Subsidiaries, and consultants and advisers to Brookwood and its

1

 

Subsidiaries shall be eligible to be awarded Units under the Plan. Unless expressly
provided to the contrary in an Award, there will be no interruption in service to or
employment by Brookwood where a Participant ceases to perform services in one eligible
capacity (e.g. ceases to be a Director), and immediately (or within such additional time as
shall be granted by the Committee in writing) begins to render services to Brookwood in a
different eligible capacity (e.g. consultant).

	 	D.	 	Section 9(a) is hereby amended by deleting the section in its entirety and substituting
the following:

     “(a) The Board may at any time and from time to time and in any respect amend, modify
or terminate the Plan; provided, further, and without limiting the generality of the
provisions of this Plan, unless expressly provided to the contrary in an Award, all
references to the Plan shall be deemed to refer to the Plan as amended at the time of
reference; provided, however, that no amendment may substantially impair any
Award previously granted to any Participant without the consent of such Participant. No
such termination shall adversely affect any Award then outstanding under the Plan, except as
provided in paragraphs (b) and (c). The power of the Committee to construe and administer
any Awards granted prior to the termination of the Plan shall nevertheless continue after
such termination.”

	 	E.	 	Section 12 is hereby amended by deleting the section in its entirety and substituting
the following:

12. No Employment Agreement or Other Rights. Neither the adoption of this Plan, the
receipt of any Unit or any other action in association with this Plan shall be construed in
any manner as entitling any Eligible Participant to any employment rights or other rights
not specifically provided for in this Plan or the Award Agreement. The Plan shall not in
any way obligate the Company to continue the employment or other relationship of any
Eligible Participant nor does it limit the right of the Company to terminate, at any time,
an Eligible Participant’s employment or other relationship. The holder of Units shall, as
such, have none of the rights of a stockholder. The award of Units pursuant to the Plan
shall not affect in any way the right or power of the Company or Brookwood to pay or refrain
from paying dividends on any class of equity securities, to engage in any transaction, to
change its capital or business structure or to merge, consolidate, dissolve, liquidate, or
sell or transfer all or any part of its business or assets.

IN WITNESS WHEREOF, this Amendment has been duly executed on behalf of the Company on June 19,
2007.

	 	 	 	 	 	 	 
	 	 	THE HALLWOOD GROUP INCORPORATED	 	 
	 
	 	 	 	 	 	 
	 

	 	By:
	 	/s/ Melvin J. Melle	 	 
	 

	 	 	 	 	 	 
	 	 	Name: Melvin J. Melle	 	 
	 	 	Title: Vice President	 	 

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