Exhibit 10.1
[***] A CONFIDENTIAL PORTION OF
THIS EXHIBIT HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
DEVELOPMENT, SUPPLY AND
DISTRIBUTION AGREEMENT
THIS DEVELOPMENT, SUPPLY AND
DISTRIBUTION AGREEMENT (this “Agreement” ) is
made effective as of June 22, 2009 (the “Effective
Date” ) between Cambridge Heart, Inc. (
“CHI” ), a Delaware corporation having its
principal place of business at 100 Ames Pond Road, Tewksbury, MA
01876, and [***] (the “Distributor” ), a
Delaware corporation having its principal place of business at
[***]. CHI and Distributor are each referred to individually as a
“Party” and together as the
“Parties . ”
WHEREAS, Distributor is engaged in
the design, development, manufacture and sale of a cardiac stress
test system known as the Stress System (the “Stress
System” );
WHEREAS, CHI is engaged in the
design, development, manufacture and sale of medical devices,
equipment, related hardware, software and accessories used to
perform CHI’s Analytic Spectral Method, a proprietary
Microvolt T-Wave Alternans ( “MTWA” ) test for
the purpose of identifying patients at risk for Sudden Cardiac
Arrest (the “MTWA Test” );
WHEREAS, Distributor desires to sell
CHI’s MTWA Test initially as a stand-alone module for use in
connection with Distributor’s Stress System and, upon
completion of the Integrated ASM Development Plan (as defined
below) and receipt of any and all applicable regulatory approvals
and clearances, as an integrated component of Distributor’s
Stress MTWA System, and Distributor desires to obtain from CHI a
supply of the software, related hardware and Sensor Test Kits
necessary to conduct a MTWA Test with the Stress MTWA System;
and
WHEREAS, CHI desires to supply to
Distributor such software, related hardware and Sensor Test Kits
pursuant to the terms and conditions set forth herein;
NOW, THEREFORE, CHI and Distributor,
intending to be legally bound, hereby agree as follows:
|
1.
|
DEFINITIONS. As used in this Agreement, the following
capitalized terms 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) “Analytic Spectral
Method Software” means CHI’s MTWA measurement
software application using CHI’s proprietary Analytical
Spectral Method for the purpose of identifying patients at risk for
Sudden Cardiac Arrest, CHI’s proprietary data formats, and
CHI’s methods for unpacking data from CHI’s proprietary
data formats.
(c) “Annual Forecast
Report” shall have the meaning ascribed thereto in
Section 3(a).
(d) “ASM
Software” means the Analytic Spectral Method Software as
customized pursuant to the terms of this Agreement for installation
on and use with the Stress MTWA System. ASM Software also includes
all modifications, derivative works, changes and improvements made
to the ASM Software by CHI, including all error corrections, bug
fixes, new versions, releases, updates, and upgrades
thereto.
(e) “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.
(f) “CHI Intellectual
Property” means the Intellectual Property rights of CHI
used by CHI in the development, manufacture, distribution or sale
of the Products.
(g) “Cost of Goods
Sold” means the cost of goods sold recognized by
Distributor from the sale of Products to Stress MTWA System
Purchasers in accordance with the terms of this Agreement,
calculated in accordance with GAAP, except, however, that cost of
goods for the purposes of Section 3(j) will include any third
party distribution costs Distributor may incur in the sale of
Products.
(h) “Development
Work” means the development work carried out pursuant to
the Non-Integrated Product Development Plan or the Integrated ASM
Development Plan, as the case may be.
(i) “Event of
Bankruptcy” shall have the meaning ascribed thereto in
Section 14(c).
(j) “FDA” means
the Food and Drug Administration of the United States Department of
Health and Human Services, or any successor thereto having
administrative authority to regulate the marketing of medical
devices in the United States of America.
(k) “ 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.
(l) “Field” means
cardiac stress testing, including without limitation, exercise,
pharmacology, nuclear and pacing.
(m) “Gross
Profit” means Net Sales minus Cost of Good
Sold.
(n) “Installation Training
Service” shall have the meaning ascribed thereto in
Section 8(c).
(o) “Integrated ASM
Development Plan” shall have the meaning ascribed to such
term in Section 2(e).
(p) “Intellectual
Property” means any U.S. or foreign patents and patent
applications (including any substitutions, extensions, reissues,
renewals, divisionals, or
2
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.
(q) “MTWA Test
Module” means all components necessary to use CHI’s
MTWA Test with Distributor’s Stress System as a stand-alone
or integrated component, as the case may be, including the Patient
Cable, the PDAM and the ASM Software but excluding the
Sensors.
(r) “ NDA” means
that certain non-disclosure agreement between CHI and Distributor
dated as of September 5, 2008.
(s) “Net Sales”
means the invoiced sales price charged for the Products sold by
Distributor to end-users of MTWA Test Modules sold by Distributor
in accordance with the terms of this Agreement, minus allowances,
returns, refunds, rebates, credits, discounts, taxes, tariffs and
duties, and non-reimbursable shipping and handling charges. For the
avoidance of doubt, “Net Sales” shall accrue no earlier
than the date that the customer’s payment of the invoiced
amount clears to Distributor’s bank account. In cases where
Products are bundled or integrated with other products or services,
“Net Sales” shall be the proportionate contribution of
the Products to the total invoiced sales price for the bundled or
integrated offering.
(t) “Non-Integrated Product
Development Plan” means the document attached hereto as
Appendix B .
(u) “Patient
Cable” means the Sensor connector cabling used to acquire
the electrocardiogram (“ ECG ”) and other
signals from the Sensors and to transmit the signals to the
PDAM.
(v) “ PDAM” means
the active patient data acquisition module used to record the ECG
and other signals of patients for measurement of MTWA and to send
the signal to the host cardiac stress test system via an integrated
data cable.
(w) “Products”
means the MTWA Test Module, Sensor Test Kits and any other product
that can be ordered by Distributor as listed in Appendix A
(CHI Products and Purchase Prices).
(x) “Product Launch
Date” means the date on which Distributor introduces the
MTWA Test Module on the Stress MTWA System for purchase generally
by end-user customers.
(y) “Purchase
Order” means a purchase order released by Distributor for
Products, including the MTWA Test Module and Sensor Test
Kits.
(z) “Purchase
Prices” shall have the meaning ascribed thereto in
Section 4(a).
3
(aa) “Quarterly Forecast
Amount” shall have the meaning ascribed thereto in
Section 3(a).
(bb) “Sensor”
means a single-use disposable Micro-V Alternans sensor for the
surface recording of a patient’s ECG and other signals and
used with the MTWA Test Module.
(cc) “Sensor Test
Kit” means a package of Sensors and related accessories
developed and manufactured by or for CHI for use in a single MTWA
Test.
(dd) “Shipping
Point” means (i) the common carrier designated by
Distributor in the Purchase Order or (ii) if CHI does not use
Distributor’s designated carrier, Distributor’s
facility at the address set forth in the Purchase Order.
(ee)
“Specifications” means the product uses,
characteristics, design requirements, processing, labeling and
packaging requirements, protocols and standards pertaining to the
manufacture, supply or use of the MTWA Test Module contained in the
Non-Integrated Product Development Plan or the Integrated ASM
Development Plan, as the case may be, in each case as may be
modified and supplemented from time to time by the mutual written
agreement of the Parties.
(ff) “Starter Test
Kit” means a package of ten (10) Sensor Test
Kits.
(gg) “Steering
Committee” shall have the meaning ascribed thereto in
Section 2(c).
(hh) “Stress MTWA
System” means the version of Distributor’s Stress
System or alternative, derivative or successor stress system that
includes the MTWA Test Module.
(ii) “Stress MTWA System
Purchasers” means end-user customers who purchase a
Stress MTWA System and/or a MTWA Test Module from Distributor, its
distributors or sub-distributors in accordance with the terms of
this Agreement.
(jj) “Territory”
means worldwide.
(a) CHI Responsibilities
. CHI shall use its commercially reasonable efforts
(i) to design, develop, and test the MTWA Test Module
according to the Specifications and on the development schedule set
forth in the Non-Integrated Product Development Plan, (ii) to
carry out the other activities assigned to CHI in the
Non-Integrated Product Development Plan and (iii) upon the
Parties’ mutual execution of the Integrated ASM Development
Plan, to meet CHI’s obligations under the Integrated ASM
Development Plan on the development schedule set forth in the
Integrated ASM Development Plan.
(b) Distributor
Responsibilities . Distributor shall use its commercially
reasonable efforts (i) to assist CHI in performing its
activities under the Non-Integrated Product Development Plan, and
(ii) to furnish to CHI in accordance with the schedule set
forth in the Non-Integrated Product Development Plan, the design
requirements and other data as may be necessary to allow CHI to
develop the MTWA Test Module and to interface the MTWA
Test
4
Module with the Stress System, (iii) to
carry out the other activities assigned to Distributor in the
Non-Integrated Product Development Plan, and (iv) upon the
Parties’ mutual execution of the Integrated ASM Development
Plan, to meet Distributor’s obligations under the Integrated
ASM Development Plan on the development schedule set forth in the
Integrated ASM Development Plan.
(c) Steering Committee. The
Parties shall establish a Steering Committee consisting of two
(2) members, one representative designated by each Party. The
proposed initial representatives are Ali Haghighi-Mood (CHI) and
[***] (Distributor). The Steering Committee shall, unless agreed
otherwise in writing by the Parties, be responsible for:
(i) updating or modifying by mutual written agreement, as may
be required from time to time, the Non-Integrated Product
Development Plan, including the Specifications contained therein,
and the Integrated ASM Non-Integrated Product Development Plan,
including the Specifications contained therein;
(ii) monitoring the conduct of the Development Work and the
progress and results according to the Non-Integrated Product
Development Plan and the Integrated ASM Development Plan;
(iii) mutually agreeing in writing to corrections or
modifications to the Specifications; (iv) deciding other
issues of importance on behalf of each of the Parties relating to
the Development Work under the Non-Integrated Product Development
Plan or the Integrated ASM Development Plan. The Steering Committee
shall meet regularly based on the project needs and status of the
Development Work to discuss and resolve any issues or problems.
These meetings may be held in person or by teleconference. Each
Party shall bear its own communication and travel costs in
connection with the Development Work.
(d) Product Launch .
It is estimated that the Development Work under the Non-Integrated
Product Development Plan will be completed and the Product Launch
Date will take place on or before September 30,
2010.
(e) Integrated ASM Development
Plan. Following the Product Launch Date and subject to
Distributor’s determination of the market need and customer
demand, the Parties will work together in good faith to prepare a
mutually agreeable plan for the development of an alternative
version of the ASM Software that will be fully integrated with the
Stress MTWA System software platform (the “Integrated ASM
Development Plan” ). Distributor will have primary
responsibility, with reasonable assistance from CHI, for the
development of a software interface between the ASM Software and
the Stress MTWA System allowing for the integration of the ASM
Software with the Stress MTWA System. The Integrated ASM
Development Plan in the form approved and signed by the Parties
will be attached to this Agreement as Appendix C . Until
such time, this appendix shall remain empty other than the Appendix
title page. In the event that the Parties are unable to reach an
agreement regarding the terms of the Integrated ASM Development
Plan, the remaining terms of this Agreement shall continue in full
force and effect without change. The Parties contemplate that the
Integrated ASM Development Plan will, among other
things:
(i) define the responsibilities of
each of the Parties in developing the integrated ASM Software and
the schedule for performing such activities, including timing,
milestone schedules, scope of work, specifications, allocation of
development costs, general quality and regulatory requirements and
other relevant terms and information, including the Parties
respective ownership rights in the work product contemplated by the
Integrated ASM Development Plan;
5
(ii) specify the obligations of CHI
to provide Distributor with access to the ASM Software source code
necessary to create the user interfaces to the Stress MTWA System
(excluding the formulaic algorithm code contained in the ASM
Software);
(iii) specify the obligations of CHI
to provide technical support during the development of the
integrated ASM Software, including at least two trips to
Distributor’s development center and two man-weeks of onsite
engineering support if reasonably requested by Distributor;
and
(iv) specify the obligations of CHI
to provide a reasonable number of MTWA Test Modules necessary to
facilitate Distributor’s development efforts under the
Integrated ASM Development Plan.
(f) Escrow. The Parties shall
enter into a technology escrow agreement (the “ Escrow
Agreement ”) within ninety (90) days of the
Effective Date with a mutually acceptable independent escrow agent
in the United States. The Escrow Agreement shall require CHI to
deposit and maintain a complete and current copy of the following
deposit materials (the “Deposit Materials” ):
(i) the formulaic algorithm code (in object and source code
form) contained in the ASM Software and (ii) the
specifications and Intellectual Property related to the Sensors (in
each case suitable to enable Distributor to manufacture or have
manufactured the Products) in the escrow semiannually. The
following events shall be triggering events with respect to the
release of the Deposit Materials under the Escrow Agreement (a
“Triggering Event” ):
(i) CHI ceases to do business and no
successor has agreed to assume CHI’s obligations to
Distributor,
(ii) CHI is in material breach of
any of the Product manufacturing, supply, or warranty provisions of
Sections 3(b) or 7 of this Agreement and fails to cure that breach
within sixty (60) days after written notice
thereof,
(iii) CHI files for liquidation
under the U.S. Bankruptcy Code or other similar legislation in
another jurisdiction, or
(iv) CHI files for reorganization
under the U.S. Bankruptcy Code or other similar legislation in
another jurisdiction and does not remain debtor in possession or
trustee of the estate.
If a Triggering Event occurs and
there is a release of Deposit Materials to Distributor in
accordance with the terms and conditions of the Escrow Agreement,
Distributor shall have the right to use the Deposit Materials
solely in accordance with the terms and conditions of
Section 3(i) of this Agreement and Distributor agrees not to
exercise its rights under Section 3(i) of this Agreement
unless and until the occurrence of a Triggering Event.
6
(g) Development Expenses .
Except as otherwise set forth in this Agreement, including the
Development Plan and the Integrated ASM Development Plan, each
Party shall bear its own expenses with respect to the Development
Work.
|
3.
|
PURCHASE AND
SALE OBLIGATIONS.
|
(a) Forecasts . At least 60
days before the Product Launch Date and thereafter at least 60 days
before each calendar quarter, Distributor shall provide to CHI a
rolling forecast of its anticipated Product needs for the next year
(the “Annual Forecast Report” ), including
Distributor’s forecast for the next calendar quarter and each
of the subsequent three (3) calendar quarters. The Annual
Forecast Report shall not create any binding obligation on the part
of Distributor to purchase the amount of Product forecast in such
report. In any calendar quarter, CHI shall not be required to
supply hereunder more than the lower of (i) the quantity of
Products for the calendar quarter forecast in the most recent
Annual Forecast Report delivered at least 60 days before such
calendar quarter and (ii) 125% of the quantity of such
Products purchased by Distributor in the preceding quarter (the
“Quarterly Forecast Amount” ).
(b) Manufacture and Supply.
Upon completion of the Development Work under the Non-Integrated
Product Development Plan, subject to the terms and conditions of
this Agreement, CHI agrees to manufacture (or have manufactured on
its behalf) and supply to Distributor the Products. Lead times for
the Products are set forth in Appendix A .
(c) Third Party
Manufacturers. CHI may use a third party manufacturer to
manufacture any Product, with or without the approval of
Distributor. If CHI uses a third party manufacturer to manufacture
any Product, CHI shall enter into a binding written agreement with
such manufacturer (a “ Third Party Agreement ”)
prior to the provision of any Distributor Confidential Information
to such third party. Such Third Party Agreement shall
(i) provide for the protection of any Distributor Confidential
Information provided to such third party manufacturer on
substantially equivalent terms to those contained in this Agreement
and (ii) provide limitations on the disclosure and use of such
Distributor Confidential Information that are substantially
equivalent to those contained in this Agreement. CHI shall be
responsible for any acts or omissions of such third parties in
breach of CHI’s representations, warranties and obligations
under this Agreement to the same extent as if CHI had committed the
breach itself. CHI shall use commercially reasonable efforts to
monitor and enforce its Third Party Agreements as required to
ensure the adequate protection of Distributor’s rights and
Distributor’s Confidential Information and shall promptly
notify Distributor of any actual or suspected breach
thereof.
(d) Resale of Products.
Distributor may resell the Products in accordance with the terms of
this Agreement through both its direct sales force and through its
distributors and sub-distributors in its distribution network.
Distributor shall only sell CHI approved parts (i.e., cables,
sensors, etc.) for use in connection with any MTWA Test
Module.
(e) Commitment to Purchase.
Distributor’s commitment to purchase Products from CHI shall
be limited to Purchase Orders released by Distributor and accepted
by CHI pursuant to Section 5. Unless agreed otherwise in
writing by the Parties, Distributor shall not be responsible or in
any way liable to CHI or any third party with respect to any
material commitments or production arrangements in excess of the
amounts or in advance of the times necessary to meet
Distributor’s delivery schedules set forth in its accepted
Purchase Orders.
7
(f) Field and Territory. The
MTWA Test Module and the components thereof purchased by
Distributor from CHI under this Agreement shall only be used or
sold by Distributor as components in, incorporated into, or
integrated with Distributor’s Stress Systems for use in the
Field by end-user customers in the Territory. Distributor shall use
commercially reasonable efforts to ensure that the MTWA Test Module
and the components thereof shall only be resold, leased, rented,
licensed or otherwise transferred by Distributor, its distributors
or its sub-distributors to end-user customers located in the
Territory for use as part of a Stress System. The MTWA Test Module
may be sold by Distributor, its distributors or its
sub-distributors separately in the form of an upgrade to Stress
Systems that have previously been installed with end-user customers
or as a component of a new Stress MTWA System. Distributor shall
use commercially reasonable efforts to ensure that the Sensor Test
Kits shall only be sold or otherwise transferred to Stress MTWA
System Purchasers. For the avoidance of doubt, nothing in this
Agreement or this Section shall be construed as a limitation on the
market segment or customer type to whom Distributor is permitted to
sell Products. Distributor is expressly authorized hereby to sell
Products to any customer located in the Territory that has or is
purchasing a Stress System.
(g) CHI Distribution Rights.
Distributor acknowledges and agrees that its right to resell
CHI’s MTWA Test Modules pursuant to the terms and conditions
of this Agreement is non-exclusive and that CHI may, whether
through its direct sales force, distributors and/or
sub-distributors or otherwise, sell, distribute and license to
other third parties both generic and customized versions of
CHI’s MTWA Test Modules (including CHI’s Analytic
Spectral Method Software, PDAM, Patient Cables and Sensors) to meet
the needs of other OEM customers and end-users. Nothing in this
Agreement shall prohibit CHI from continuing to sell, distribute or
license these products or components thereof to distributors or
customers other than Distributor. CHI shall not sell Sensors or
Sensor Test Kits for use with a Stress System.
(h) Sensors. Sensor Test Kits
sold by CHI to Distributor for use with MTWA Test Modules and
Stress MTWA Systems shall bear the name of both CHI and Distributor
on the packaging and shall be marked with a unique part number for
sales tracking purposes. The Sensor Test Kits sold by CHI to
Distributor hereunder shall be customized such that the Sensors in
any Sensor Test Kit only function when used for or conjunction with
the components of a Distributor Stress System. Other sensors
produced or sold for or by CHI that are not intended for use with
Stress MTWA System must be engineered and sold in a form or
configuration that will not function when used for or in
conjunction with the MTWA Test Modules sold to Distributor under
this Agreement for use with a Stress MTWA System.
(i) Alternative Manufacture and
Supply . In the event that a Triggering Event occurs and there
is a release of Deposit Materials to Distributor in accordance with
the terms and conditions of the Escrow Agreement, then
(A) Distributor may elect to purchase Products directly from
any third party manufacturer of the Products in lieu of purchasing
them from CHI hereunder, (B) at Distributor’s request,
CHI shall provide Distributor with the Specifications relating to
the Products and any Intellectual Property in CHI’s
possession or control necessary to manufacture the Products, and
(C) CHI automatically grants to Distributor a
non-exclusive,
8
non-transferable license to use any CHI
Intellectual Property necessary to manufacture or have manufactured
the Products s