CONFIDENTIAL JOINT DEVELOPMENT AGREEMENT
Exhibit 10.21
CONFIDENTIAL
THIS JOINT DEVELOPMENT AGREEMENT (this “Agreement”), effective as of April 27, 2007
(the “Effective Date”), is made by and between St. Jude Medical, Atrial Fibrillation Division,
Inc., a Minnesota corporation with offices at 0000 Xxxxxxxx Xxxx, Xxxxx Xxxxx, XX 00000
(“SJM”), and Xxxxxx Medical, Inc., a corporation organized under the laws of Delaware,
having its principal place of business at 000 Xxxxx Xxxxxxxx Xxxxxx, Xxxxxxxx Xxxx, XX 00000
(“Xxxxxx”). Each of SJM and Xxxxxx may be referred to in this Agreement as
“Party,” and collectively as, the “Parties”.
RECITALS
WHEREAS, SJM and its Affiliates are engaged in the design, development, manufacture, assembly,
importation, exportation, offering for sale, sale and distribution of medical devices and
accessories for such devices, including the EnSite™ System for mapping and navigating
electrophysiology catheters in real time (as it may be improved or otherwise modified from time to
time, the “EnSite System”);
WHEREAS, Xxxxxx is engaged in the design, development, manufacture, assembly, importation,
exportation, offering for sale, sale and distribution of a robotic catheter control system known as
the Sensei™ System (together with the capital equipment and accessories necessary for use of the
Sensei System, but excluding transeptal kits, sheaths or catheters, as it may be improved or
otherwise modified from time to time, the “Sensei System”); and
WHEREAS, SJM and Xxxxxx desire to enter into an agreement by which they will work together to
make the EnSite System and the Sensei System fully compatible and to jointly develop such other
products as the Parties may mutually agree to develop from time to time (collectively, the
“Program Products”);
NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good
and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties agree to the following terms, conditions, and obligations:
ARTICLE I
DEFINITIONS
DEFINITIONS
For purposes of this Agreement, the following terms, whether singular or plural, shall have
the following meanings:
1.1 Affiliate. The term “Affiliate” means any person or entity at the time
directly or indirectly controlling or controlled by, or under direct or indirect common control
with a 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, whether through ownership of voting or other equity securities, by
contract or otherwise, and shall include entities which become Affiliates after the Effective Date
of this Agreement.
1.2 Business Day. The term “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.
1.3 Field of Use. The term “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 ******.
1.4 Co-Marketing Agreement. The term “Co-Marketing Agreement” means the
Co-Marketing Agreement between Xxxxxx and SJM dated as of the Effective Date.
1.5 Development Plan. The term “Development Plan” shall have the meaning
ascribed to such term in Section 2.1 below.
1.6 Effective Date. The term “Effective Date” shall have the meaning ascribed
to such term in the Preamble above.
1.7 EnSite System. The term “EnSite System” shall have the meaning ascribed to
such term in the Recitals above.
1.8 FDA. The term “FDA” means the Food and Drug Administration of the United
States Department of Health and Human Services.
1.9 FDA Approval. The term “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.
1.10 Fully Integrated EnSite System. The term “Fully Integrated EnSite System”
means the EnSite System, made compatible with the Fully Integrated Sensei System in accordance with
the terms of this Agreement.
1.11 Fully Integrated Sensei System. The term “Fully Integrated Sensei System”
means the Sensei System, made compatible with the Fully Integrated EnSite System in accordance with
the terms of this Agreement.
1.12 Fully Integrated System. The term “Fully Integrated System” means a
computerized interventional electrophysiological system comprising one Fully Integrated EnSite
System and one Fully Integrated Sensei System.
1.13 Xxxxxx Independent IP. The term “Xxxxxx Independent IP” shall have the
meaning ascribed to such term in Section 3.1.2 below.
1.14 “Initial Development Plan.” The term “Initial Development Plan” shall
have the meaning ascribed to such term in Section 2.1.2 below.
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1.15 Intellectual Property. The term “Intellectual Property” means any and all
intellectual property rights arising from or associated with the following, whether protected,
created or arising under the laws of the United States or any other jurisdiction: any patents,
patent applications, copyrights, trade secrets, technical information, designs, drawings,
processes, algorithms, procedures, formulae, test data, know-how, improvements, plans (engineering
or otherwise), or any other compilation of information whatsoever, whether or not in written form
and whether or not marked confidential, secret, or the like, which is not generally available to
the public.
1.16 LC Sensei System. The term “LC Sensei System” shall have the meaning
ascribed to that term in Section 4.2.4 below.
1.17 NDA. The term “NDA” means that certain Mutual Non-Disclosure Agreement
between the Parties dated as of May 8, 2006.
1.18 Pre-Existing IP. The term “Pre-Existing IP” means all of the Intellectual
Property of a Party (whether owned by or licensed to such Party) in existence as of the Effective
Date, as evidenced by tangible records of such Party in possession of such Party prior to the
Effective Date.
1.19 Program Development. The term “Program Development” means any
improvement, development or other Intellectual Property that is invented, conceived of and/or
reduced to practice by either Party in direct connection with carrying out its responsibilities
under any Development Plan.
1.20 Program Products. The term “Program Products” shall have the meaning
ascribed to such term in the Recitals above.
1.21 Sensei System. The term “Sensei System” shall have the meaning ascribed
to such term in the Recitals above.
1.22 SJM Independent IP. The term “SJM Independent IP” shall have the meaning
ascribed to such term in Section 3.1.3 below.
1.23 Term. The term “Term” has the meaning ascribed thereto in Section 9.1
below.
ARTICLE II
JOINT DEVELOPMENT PROJECTS
JOINT DEVELOPMENT PROJECTS
2.1 Development Plans; Development of Initial Program Product.
2.1.1 The joint development work to be performed by the Parties hereunder for each Program
Product shall be carried out pursuant to the terms of a written development plan that will be
jointly prepared and mutually agreed to by the Parties (each, a “Development Plan”). Each
Development Plan will include, among other things, responsibilities, major development milestones
and expected completion dates. For each Program Product that the Parties mutually agree to develop
hereunder, Xxxxxx shall propose the initial draft of the Development Plan for
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consideration by the Parties. Each Party agrees to use commercially reasonable efforts to carry out
the responsibilities assigned to it in each Development Plan.
2.1.2 SJM and Xxxxxx agree to work together to develop the Fully Integrated System as the
initial Program Product hereunder, as described in the Initial Development Plan. The Parties agree
to use commercially reasonable efforts to prepare and complete the Development Plan for the initial
Program Product (the “Initial Development Plan”) in mutually agreed to form within ******** days
after the Effective Date. The Initial Development Plan, once prepared and agreed to by the
Parties, shall be attached as Exhibit A to this Agreement and made a part hereof.
2.2 Xxxxxx’x Responsibilities. Xxxxxx shall be responsible for completing the
following activities in accordance with the Initial Development Plan (or, as applicable, any other
Development Plan) at Xxxxxx’x sole cost and expense:
2.2.1 Xxxxxx shall make the Sensei System fully compatible with the EnSite System such that
the EnSite System is qualified and supported for use with the Sensei System, in accordance with the
specifications of the Initial Development Plan; Xxxxxx shall perform verification and validation
testing relating to making such Sensei System fully compatible with the EnSite System.
2.2.2 Except as otherwise mutually agreed by the Parties, Xxxxxx shall be responsible for, and
shall pay for all its costs (including, without limitation, Xxxxxx-preapproved direct and indirect
costs incurred by SJM related to approval of Xxxxxx disposable products) associated with gaining
regulatory approvals for the Program Products and the technologies incorporated therein
(“Regulatory Approvals”), including, without limitation, the Fully Integrated System.
Unless otherwise agreed by the Parties in writing, Xxxxxx shall own all such Regulatory Approvals.
2.2.3 Xxxxxx shall have the right to keep its guide catheter platform open to delivery of
catheters from any manufacturer. In addition, nothing herein shall require Xxxxxx to modify its
guide catheter platform so that such platform no longer is capable of being used with catheters
provided by any catheter manufacturer. However, Xxxxxx shall include SJM products in its standard
verification and validation processes (such SJM products provided to Xxxxxx for such processes at
no cost to Xxxxxx), subject to Xxxxxx’x reasonable discretion.
2.2.4 Xxxxxx shall maintain compatibility between the current Sensei System and any upgraded
or new version thereof that is commercially released during the Term and the current EnSite System
and any upgraded or new versions thereof that are commercially released during the Term for a
period of at least ****** from the Effective Date, unless this Agreement is terminated earlier
subject to the terms of Sections 9.2.2,9.2.6, or 9.2.7.
2.2.6 Xxxxxx shall perform such other activities as the Parties may mutually agree in
connection with the development activities contemplated by this Agreement.
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2.3 SJM Responsibilities. SJM shall be responsible for completing the following
activities in accordance with the Initial Development Plan (or, as applicable, any other
Development Plan) at SJM’s sole cost and expense (except as otherwise specified below):
2.3.1 SJM shall develop and market an EnSite software module/upgrade that enables the EnSite
System to provide an interface to the Sensei System, in accordance with the specifications of the
Initial Development Plan.
2.3.2 SJM shall provide Xxxxxx with technical specifications of the EnSite System to enable
Xxxxxx to develop the Sensei System so it can plug into the EnSite System to receive localization
and orientation information of catheters with electrodes when used with the EnSite System, in
accordance with the specifications of the Initial Development Plan.
2.3.3 SJM shall provide mutually agreed upon engineering consulting services related to
Program Products, including support for verification and validation testing related to making the
Sensei System compatible with the EnSite System.
2.3.4
SJM shall provide mutually agreed upon regulatory services in connection with Xxxxxx obtaining Regulatory Approvals, as reasonably
requested by Xxxxxx, subject to Xxxxxx reimbursing SJM for Xxxxxx-preapproved direct and indirect
costs incurred by SJM in connection with the provision of such regulatory services.
2.3.6 SJM shall maintain compatibility between the current EnSite System and any upgraded or
new version thereof that is commercially released during the Term and the current Sensei System and
any upgraded or new version thereof that is commercially released during the Term for a period
******, unless this Agreement is terminated earlier subject to the terms of Sections 9.2.2, 9.2.6,
or 9.2.7.
2.3.7 SJM shall provide, on loan, an EnSite System to Xxxxxx for use in connection with the
performance of Xxxxxx’x obligations under the Initial Development Plan. Unless otherwise agreed in
writing by the Parties, Xxxxxx will promptly return the EnSite System to SJM, at Xxxxxx’x expense,
in good working order, reasonable wear and tear excepted, upon the earlier to occur of the
completion of the Initial Development Plan or any termination of this Agreement.
2.3.8 SJM shall perform such other activities as the Parties may mutually agree in connection
with the development activities contemplated by this Agreement.
2.4 Joint Responsibilities. The Parties shall work toward including in the Initial
Development Plan mutually agreeable technical specifications on the information that will be
transferred as well as any communications interfaces and protocols.
2.5 Project Coordinators. Within ten (10) business days after the Effective Date, each
Party will designate in a writing delivered to the other Party an individual who will serve as the
Project Coordinator (the “Project Coordinator”) for such Party and who will be the
principal point of contact for the Development Plans to be carried out hereunder. Either Party
may designate a different Project Coordinator for each Development Plan, and may change a Project
Coordinator from time to time by written notice to the other Party
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2.6 Coordination Meetings. During the joint development activities contemplated
hereby, a coordination meeting will be held periodically (e.g., monthly or at such other interval
as the Parties may agree). The date and time for each such meeting shall be agreed to in advance by
the Project Coordinators.
2.7 Reports. Xxxxxx shall provide SJM with quarterly written reports describing its
progress under each Development Plan in such reasonable detail as SJM may request from time to
time.
2.8 Non-Solicitation. Without the prior written consent of the other Party, neither
Party shall, during the Term and for twelve (12) months thereafter, either directly or indirectly,
hire or otherwise engage, or cause, aid or assist any other person or entity, including, without
limitation, its Affiliates, to hire or otherwise engage, any current or former employee of the
other Party or its Affiliates for a period of twelve (12) months after the termination of such
individual’s employment relationship with the other Party or its Affiliates. Notwithstanding the
foregoing, this Section 2.6 shall not prohibit a Party from soliciting, hiring or otherwise
engaging any employees or former employees of the other Party or its Affiliates who respond to
solicitations of employment contained in publications of general circulation.
ARTICLE III
INTELLECTUAL PROPERTY
INTELLECTUAL PROPERTY
3.1 Ownership.
3.1.1 Pre-Existing IP. Each Party shall retain all right, title and interest it holds
in such Party’s Pre-Existing IP.
3.1.2 Xxxxxx Independent IP. Xxxxxx shall own all right, title and interest in any
Intellectual Property that Xxxxxx hereafter develops or has developed independently of the
performance of its obligations hereunder (together with Xxxxxx’x Pre-Existing IP, the “Xxxxxx
Independent IP”).
3.1.3 SJM Independent IP. SJM shall own all right, title and interest in any
Intellectual Property that SJM hereafter develops or has developed independently of the performance
of its obligations hereunder (together with SJM’s Pre-Existing IP, the “SJM Independent
IP”).
3.1.4 Program Developments. The intellectual property rights in any Program
Development shall be allocated as provided below in this Section 3.1.4:
3.1.4.1 SJM shall own all Intellectual Property rights arising from any Program
Development wherein SJM employees or contractors are the sole inventors (each, a
“SJM-Related Program Development”). Xxxxxx shall own all Intellectual Property
rights arising from any Program Development wherein Xxxxxx employees or contractors are the
sole inventors (each, a “Xxxxxx-Related Program Development”). The Parties will
jointly-own the Intellectual Property rights arising from any Program Development that is
jointly invented by employees or contractors of both Parties (each, a “Jointly-Owned
Program Development”), with each Party having the unrestricted right to
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utilize or exploit or license any Intellectual Property rights arising from any Jointly-
Owned Program Development without any consent of or accounting to the other Party. For the
purposes of this paragraph 3.1.4.1, neither Party will be deemed a contractor of the other.
Inventorship of patentable inventions conceived or reduced to practice during the course of
the performance of activities pursuant to this Agreement shall be determined in accordance
with U.S. patent laws.
3.1.4.2
Patent Prosecution. Each Party shall have the sole right to
control the process of preparing, filing, and prosecuting one or more patent applications,
and of maintaining one or more issued patents relating to any Program Development, the
intellectual property rights in which are solely owned by such Party; in the case of
Intellectual Property rights arising from Jointly-Owned Program Development, the Parties
shall use reasonable efforts to cooperate regarding patent application preparation, filing,
prosecution, abandonment, and enforcement of patents or other Intellectual Property rights.
Following execution of this Agreement, appropriate personnel from the Parties will meet to
establish appropriate guidelines for prosecution and enforcement of Intellectual Property
rights arising from Jointly-Owned Program Development.
3.1.4.3 Cooperation. If a Party that owns the Intellectual Property in any
Program Development desires to seek patent protection with respect thereto (including,
without limitation, in connection with seeking to file a continuation in part patent
application with respect thereto), such other Party shall reasonably cooperate in
connection therewith, including, without limitation, by executing and delivering such
conveyance, assignment, assurance, power of attorney and other instruments or documents as
may be reasonably required by such Party and using commercially reasonable efforts to
procure any executed assignment or other instrument or document from any employee or
contractor of such other Party who is a co-inventor of such Program Development. The Party
requesting such assistance shall reimburse the other Party for all reasonable out-of-pocket
costs and expenses incurred by such other Party in providing such assistance.
3.2 Cross-Licenses.
3.2.1. Xxxxxx IP. Xxxxxx hereby grants to SJM during the Term a non-exclusive,
worldwide, fully-paid, royalty free right and license, with rights to sub-license, to use the
Xxxxxx Independent IP and the Xxxxxx-Related Program IP solely for the limited purpose of
fulfilling SJM’s development responsibilities under Article II, to the extent that such Xxxxxx
Independent IP may be so licensed absent contravention of encumbrances of Xxxxxx Independent IP
preexisting the Effective Date. Xxxxxx warrants that it is not aware, as of the Effective Date, of
any encumbrances that would materially limit Xxxxxx’x ability to provide the right and license
described in the Section 3.2.1, and Xxxxxx agrees that it will provide SJM with prompt written
notice if Xxxxxx becomes aware at any time during the Term of any such limiting encumbrance, and in
such case will use commercially reasonable efforts to obtain for SJM the right and license
described in this Section 3.2.1.
3.2.2 SJM IP. SJM hereby grants to Xxxxxx during the Term a non-exclusive, worldwide,
fully-paid, royalty free right and license to use the SJM Independent IP and the SJM-
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Related Program IP solely for the limited purpose of fulfilling Xxxxxx’x development
responsibilities under Article II, including the right to sublicense for such limited purpose.
Xxxxxx shall provide SJM with written notice of any such sublicense, which sublicense shall be
consistent with the terms and conditions of this Agreement, including, without limitation, this
Article III.
3.4 Assignment of Rights. Each Party hereby assigns and agrees to assign to the other
Party all of such Party’s right, title and interest in and to any Intellectual Property in any
Program Development that is to be owned by the other Party in accordance with the allocation of
ownership of SJM-Related Program Developments and Xxxxxx-Related Program Developments that is set
forth in Section 3.1.4.1. Each Party shall execute and deliver any and all assignments or other
documents necessary to effectuate such assignment of such Intellectual Property. Each Party hereby
assigns and agrees to assign to the other Party an undivided one-half interest in all of such
Party’s right, title and interest in and to any Jointly-Owned Program Development. Each Party shall
execute and deliver any and all assignments or other documents necessary to effectuate such
assignment of Program Developments to the other Party.
3.5 Reservation of Rights. All rights of each Party that are not expressly granted in
this Agreement are reserved and retained by such Party. Except as expressly provided in this
Agreement, no rights are granted whatsoever, whether expressly or by implication or estoppel or
otherwise, by either Party to the other Party.
3.6 Disclosure of Jointly-Owned Program Developments. Each Party shall disclose to the
other Party any and all Jointly-Owned Program Developments not already disclosed to the other
Party, which disclosure will occur at the next coordination meeting conducted pursuant to Section
2.6 and, in any event, within thirty (30) days after being conceived or reduced to practice.
ARTICLE IV
COLLABORATION OBLIGATIONS
COLLABORATION OBLIGATIONS
4.1 Except as set forth below in Section 4.2, Xxxxxx shall not ******, unless terminated by
SJM under Sections 9.2.1, 9.2.5, 9.2.6, or 9.2.7 hereof, or unless terminated by Xxxxxx under
Sections 9.2.2, 9.2.5, 9.2.6, or 9.2.7 hereof.
4.2 Xxxxxx may develop and offer for sale to its customers in the Field of Use a communication
capability strictly limited to ******
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ARTICLE V
REPRESENTATIONS AND WARRANTIES; DISCLAIMER OF WARRANTIES;
LIMITATION OF LIABILITY
REPRESENTATIONS AND WARRANTIES; DISCLAIMER OF WARRANTIES;
LIMITATION OF LIABILITY
5.1 General. Each Party represents, warrants and covenants that it (i) has full power
and authority to enter into this Agreement and carry out the transactions contemplated hereby,
(ii) that all necessary corporate action has been duly taken by such party to authorize the
execution, delivery and performance by such Party of this Agreement and (iii) has not, and will
not, enter into any agreement with a third party that conflicts with such Party’s obligations
hereunder or the rights granted by such Party hereunder to the other Party.
5.2 No Debarred Person. Each Party represents and warrants that it shall not knowingly
employ, contract with, or retain any person directly or indirectly in connection with the
development work contemplated hereby if such person is under investigation by the FDA for debarment
or is presently debarred by the FDA pursuant to the Generic Drug Enforcement Act of 1992, as
amended (21 U.S.C. § 301, et seq.). In addition, each Party represents and warrants that it will
not engage in any conduct or activity which could lead to any such debarment actions. If, during
the term of this Agreement, a Party becomes aware that it or any person employed or retained by it
to perform development work hereunder (i) has come under investigation by the FDA for a debarment
action, (ii) has been debarred, or (iii) has engaged in any conduct or activity that could lead to
debarment, such Party shall immediately notify the other Party.
5.3 No Implied Obligation. Nothing contained in this Agreement shall be construed as:
5.3.1 a warranty or representation by either Party as to the validity, enforceability
or scope of any class or type of Intellectual Property licensed hereunder;
5.3.2 a warranty or representation that any manufacture, sale, lease, use or other
disposition of Products will be free from infringement, misappropriation or other violation
of any intellectual property rights other than the Intellectual Property licensed
hereunder, subject to the indemnity by Xxxxxx in Section 6.2 and the indemnity by SJM in
Section 6.3;
5.3.3 an agreement to bring or prosecute proceedings against third parties for
infringement or conferring any right to bring or prosecute proceedings against third
parties for infringement;
5.3.4 conferring any right to use in advertising, publicity, or otherwise, any
trademark, trade name or names, or any contraction, abbreviation or simulation thereof, of
either Party; or
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5.3.5 requiring any Party to defend any proceeding brought by a third party
challenging or concerning the validity of any Intellectual Property licensed under this
Agreement.
5.4 Disclaimer of Warranties. EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE V, 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: (a) the success of the research conducted
by the Parties under the Agreement; or (b) the safety or usefulness for any purpose of the
technology or other materials or information it provides hereunder.
5.5 Limitation of Liability. EXCEPT FOR BREACHES OF A PARTY’S OBLIGATIONS UNDER
ARTICLE VII, NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, CONSEQUENTIAL,
INCIDENTAL, INDIRECT OR PUNITIVE DAMAGES OR COST OF PROCUREMENT OF SUBSTITUTE GOODS, SERVICES,
TECHNOLOGY, OR INTELLECTUAL PROPERTY ARISING OUT OF OR RELATED TO THIS AGREEMENT, HOWEVER CAUSED,
UNDER ANY THEORY OF LIABILITY, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES.
ARTICLE VI
INDEMNIFICATION
INDEMNIFICATION
6.1 Survival of Representation and Warranties. The representations and warranties of
each of the Parties contained in this Agreement shall survive the Effective Date.
6.2 Indemnification by Xxxxxx. Subject to Section 6.4, Xxxxxx shall indemnify and hold
harmless SJM and its Affiliates and their respective directors, officers employees and agents
(“SJM Indemnitees”) from and against any and all losses, liabilities, claims, damages or
expenses (including, without limitation, reasonable legal fees and expenses) to the extent
resulting or arising from or in connection with any claim, action or proceeding by a third party
brought against any SJM Indemnitee and based solely on any one or more of the following:
6.2.1 An allegation that any SJM Indemnitee infringes or misappropriates any Intellectual
Property right of a third party, to the extent such allegation is based on the use or practice of
the Xxxxxx Independent IP and/or the Xxxxxx-Related Program IP within the scope of the license
granted in Section 3.2.1 and in performance of its obligations under this agreement;
6.2.2 The negligence or willful misconduct of Xxxxxx or its Affiliates or their respective
consultants or contractors in connection with their activities under this Agreement;
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6.2.3 The breach of any of the covenants, agreements, warranties or representations made by
Xxxxxx under this Agreement by Xxxxxx or its Affiliates or their respective consultants or
contractors; or
6.2.4 The violation of any applicable laws or regulations by Xxxxxx or its Affiliates or their
respective consultants or contractors in connection with their activities under this Agreement.
Notwithstanding the foregoing, Xxxxxx shall only be obligated to so indemnify and hold the SJM
Indemnitees harmless to the extent that such claim, action or proceeding does not arise from the
negligence or willful misconduct of SJM or its Affiliates or their respective contractors or
employees.
6.3 Indemnification by SJM. SJM shall indemnify and hold harmless Xxxxxx and its
Affiliates and their respective directors, officers employees and agents (“Xxxxxx Indemnitees”)
from and against any and all losses, liabilities, claims, damages or expenses (including, without
limitation, reasonable legal fees and expenses) suffered or incurred by any such Xxxxxx Indemnitee
to the extent resulting or arising from or in connection with any claim, action or proceeding by a
third party brought against any Xxxxxx Indemnitee based on any of the following:
6.3.1 An allegation that any Xxxxxx Indemnitee infringes or misappropriates any Intellectual
Property right of a third party, to the extent such allegation is based on the use or practice of
the SJM Independent IP and/or the SJM-Related Program IP within the scope of the license granted in
Section 3.2.2 and in performance of its obligations under this Agreement;
6.3.2 The negligence or willful misconduct of SJM or its Affiliates or their respective
consultants or contractors in connection with their activities under this Agreement;
6.3.3 The breach of any of the covenants, agreements, warranties or representations made by
Xxxxxx under this Agreement by SJM or its Affiliates or their respective consultants or
contractors; or
6.3.4 The violation of any applicable laws or regulations by SJM or its Affiliates or their
respective consultants or contractors in connection with their activities under this Agreement.
Notwithstanding the foregoing, SJM shall only be obligated to so indemnify and hold the Xxxxxx
Indemnitees harmless to the extent that such claim, action or proceeding does not arise from the
negligence or willful misconduct of Xxxxxx or its Affiliates or their respective contractors or
employees.
6.4 Procedures.
6.4.1 In order for an indemnified party to be entitled to any indemnification provided for
under this Article VI in respect of, arising out of or involving a claim, action or proceeding made
by any person who is not a Party to this Agreement or an Affiliate thereof (a “Third-Party
Claim”), such indemnified party must notify the indemnifying party in writing, and
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in reasonable detail, of the Third-Party Claim as promptly as reasonably possible after receipt by
such indemnified party of written notice of the Third-Party Claim; provided,
however, that failure to give such notification shall not affect the indemnification
provided hereunder except to the extent the indemnifying party is actually prejudiced as a result
of such untimely notice. The indemnified party shall deliver to the indemnifying party, within five
(5) business days after the indemnified party’s receipt thereof, copies of all notices and
documents (including court papers) received by the indemnified party relating to the Third-Party
Claim.
6.4.2 If a Third-Party Claim is made against an indemnified party, the indemnifying party
shall be entitled to participate in the defense thereof and, if it so chooses, it may assume the
defense thereof with counsel selected by the indemnifying party and reasonably satisfactory to the
indemnified party. Should the indemnifying party so elect to assume the defense of a Third-Party
Claim, the indemnifying party shall not be liable to the indemnified party for legal costs and
expenses subsequently incurred by the indemnified party in connection with the defense thereof. If
the indemnified party assumes such defense, the indemnified party shall have the right to
participate in the defense thereof and to employ counsel, at its own expense, separate from counsel
employed by the indemnifying party, it being understood that the indemnifying party shall control
such defense and settlement.. The Parties shall cooperate in the defense or prosecution of any
Third-Party Claim. Such cooperation shall include the retention and the provision of records and
information that are reasonably relevant to such Third-Party Claim.
ARTICLE VII
CONFIDENTIALITY AND PUBLICITY
CONFIDENTIALITY AND PUBLICITY
7.1 Confidentiality. 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.
7.2 Publicity. Neither Party, nor any of its Affiliates or representatives, may
initiate nor 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 (b) use its best efforts to seek confidential treatment of the
material provisions of this Agreement to the greatest extent permitted by law or regulation.
ARTICLE VIII
INTENTIONALLY OMITTED
INTENTIONALLY OMITTED
Page 12 of 17
ARTICLE IX
TERM AND TERMINATION
TERM AND TERMINATION
9.1 Term. This Agreement shall become effective on the Effective Date and, subject to
Section 9.2, shall continue in effect until the completion of all of the development work
contemplated by the Initial Development Plan and any other Development Plan on which the Parties
agree prior to termination of this Agreement, subject to early termination of this Agreement (the
“Term”).
9.2 Termination.
9.2.1 Either Party may terminate this Agreement ****** by giving not less than ****** prior
written notice to the other Party.
9.2.2 Either Party may terminate this Agreement immediately upon written notice to the other
Party, if the other Party materially breaches any of its obligations set forth in this Agreement
and fails to cure such breach within ********** after receiving written notice from the
non-breaching Party describing such breach.
9.2.5 Either Party may terminate this Agreement immediately upon written notice to the other
Party if the Co-Marketing Agreement terminates.
9.2.6 Either Party may terminate this Agreement upon written notice to the other Party should
either Party be enjoined by a court of competent jurisdiction from making, using, or selling the
Sensei System, the EnSite System, the Fully Integrated Sensei System, the Fully Integrated EnSite
System, the Fully Integrated System, or material portions thereof.
9.2.7 Either Party may terminate this Agreement upon written notice to the other Party should
******
9.3 Survival. This Section 9.3, Section 2.2.4, Section 2.3.6, and Articles III (other
than Section 3.2), V, VI, VII, VIII, and X shall survive any termination or the expiration of the
Term of this Agreement.
ARTICLE X
GENERAL
GENERAL
10.1 Notices. All notices, requests, demands required or desired, or instructions to
be given hereunder shall be in writing and considered effective when delivered personally, upon
Page 13 of 17
receipt if sent by certified mail or by delivery via Federal Express or similarly recognized
overnight courier with all postage or freight charges prepaid, and addressed as follows:
| (1) | If to Xxxxxx: |
Xxxxxx Medical, Inc.
000 Xxxxx Xxxxxxxx Xxxxxx
Xxxxxxxx Xxxx, XX
Attn: Chief Executive Officer
000 Xxxxx Xxxxxxxx Xxxxxx
Xxxxxxxx Xxxx, XX
Attn: Chief Executive Officer
| (2) | If to SJM: |
St. Jude Medical, Atrial Fibrillation Division, Inc.
00000 XxXxxx Xxxxx
Xxxxxxxxxx, XX 00000
Facsimile: 000-000-0000
Attention: General Counsel
00000 XxXxxx Xxxxx
Xxxxxxxxxx, XX 00000
Facsimile: 000-000-0000
Attention: General Counsel
and
St. Jude Medical, Atrial Fibrillation Division, Inc.
0000 Xxxxxxxx Xxxx
Xxxxx Xxxxx, XX 00000
Facsimile: 000-000-0000
Attention: President
0000 Xxxxxxxx Xxxx
Xxxxx Xxxxx, XX 00000
Facsimile: 000-000-0000
Attention: President
with a copy to (which shall not constitute notice):
St. Jude Medical, Inc.
Xxx Xxxxxxxx Xxxxx
Xx. Xxxx, XX 00000
Facsimile: 000-000-0000
Attn: Chief Financial Officer
Xxx Xxxxxxxx Xxxxx
Xx. Xxxx, XX 00000
Facsimile: 000-000-0000
Attn: Chief Financial Officer
10.2 Entire Agreement. This Agreement (including any exhibits and schedules attached
or to be attached hereto which are incorporated herein by this reference), together with the NDA,
represent the entire understanding of the Parties with respect to the subject matter hereof. This
Agreement supersedes all prior agreements, representations and understandings, whether written or
oral, between the Parties concerning the subject matter hereof, and may not be changed or modified
in any manner except by an instrument in writing that is signed by the Parties. 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.
Page 14 of 17
10.3 Modification. No alteration, amendment, waiver, cancellation or any other change
in any term of condition of this Agreement shall be valid or binding on any Party unless such
alteration, amendment, waiver, cancellation or any other change shall have been mutually agreed to
in writing by the Parties to this Agreement.
10.4 Severability. The Parties agree that if any provision of this Agreement shall be
found or held to be invalid or unenforceable, then the provisions of this Agreement shall be deemed
amended to modify or delete, as necessary, the offending provision, and this Agreement as so
amended or modified shall not be rendered unenforceable or impaired but shall remain in full force
and effect, to the fullest extent possible in keeping with the intention of the Parties.
10.5 No Waiver. Failure of any Party at any time to require performance of any
provision of this Agreement shall not affect the right of any party to require full performance
thereafter; a waiver by any Party of a breach of any provision of this Agreement shall not be taken
or held to be a waiver of any further or similar breach or as nullifying the effectiveness of such
provision.
10.6 Costs. Except as otherwise herein provided, each of the Parties hereto shall bear
its own expenses in connection with this Agreement and the transactions contemplated herein.
10.7 Assignment. This Agreement shall be binding upon, and shall inure to the benefit
of, the Parties to this Agreement and their respective successors and assigns. No Party may assign
any of its rights or privileges or (except to subcontractors or consultants under commercially
reasonable written agreements) delegate any of its duties or obligations (by operation of law or
otherwise) hereunder without prior written consent of the other Party; provided,
however, that either Party may make such an assignment or delegation when done so in
conjunction with (a) the acquisition of the Party or of all or substantially all of the Party’s
assets relating to this Agreement or (b) a corporate restructuring or reorganization in which such
Party assigns its right, title and interest under this Agreement to an Affiliate. Any attempted or
purported assignment or transfer without such consent, when required under this provision, shall be
void and of no effect and shall constitute a material breach of this Agreement.
10.8 Governing Law. This Agreement shall be governed by and construed in accordance
with the laws of the State of New York, without regard to the conflict of laws provisions thereof.
10.9 Relationship of the Parties. The Parties hereto are independent contractors under
this Agreement. Nothing contained herein is intended nor is to be construed so as to constitute
the Parties hereto as partners or participants in a joint venture with respect to this Agreement,
or the subject matter hereof. Employees and agents of one Party remain employees or agents of
that Party and shall not be considered at any time to be agents of, or obligated to render a
fiduciary duty to, the other Party. There is no principal-agent relationship between the Parties.
Neither Party shall have the authority to contract, bind, or act on behalf of the other Party.
Page 15 of 17
10.10 Drafting of this Agreement. Each Party has equally participated in the drafting
of this Agreement, and the Parties agree that neither Party shall be found to be the sole or
primary drafter of any portion of this Agreement.
10.11 Counterparts. This Agreement may be executed in counterparts, each of which
shall be deemed an original, but all of which taken together shall constitute one and the same
instrument.
IN WITNESS WHEREOF, authorized representatives of the parties have executed this Agreement as
of the dates written below.
| XXXXXX MEDICAL INC. | ST. JUDE MEDICAL, ATRIAL
FIBRILLATION DIVISION, INC. |
|||||
By:
|
/s/ Xxxx Xxxxxxx | By: | /s/ Xxxx X. Song | |||
Name:
|
Xxxx Xxxxxxx | Name: | Xxxx X. Song | |||
Title:
|
President and Chief Operating Officer | Title: | President, St. Jude Medical, Atrial | |||
| Fibrillation Division, Inc. | ||||||
Page 16 of 17
EXHIBIT A
Initial Development Plan
Initial Development Plan
********************************************************
Page 17 of 17
