EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
MINNETRONIX
PRODUCTION SERVICES AGREEMENT
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PH: 651.917.4060
FAX: ▇▇▇.▇▇▇.▇▇▇▇
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EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
PRODUCTION SERVICES AGREEMENT
THIS AGREEMENT ("Agreement") is made and entered into as of the 17th day of
August, 2006, ("Effective Date") by and between HeartWare, Inc., a Delaware
corporation with its principal place of business at ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇ ▇▇▇▇▇ ("Buyer"), and Minnetronix, Inc., a Minnesota corporation with its
principal place of business at ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇, ▇▇. ▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
("Seller").
WHEREAS, Seller is in the business of contract design and manufacturing of
electronic, software, and mechanical assemblies and has the capability to
manufacture Buyer's products described in Exhibit A ("Exhibit A") attached
hereto and made a part hereof (each a "Product" and collectively, "Products") as
well as to provide design, engineering, sustaining, manufacturing, test, and
support services related to such Products ("Services"); and
WHEREAS, Buyer is in the business of manufacturing, distributing and selling
medical devices and wishes to enter into a relationship during which Seller will
provide Products and Services to Buyer; and
WHEREAS, Buyer and Seller desire to establish the terms of sale for all Products
and Services now or hereafter purchased by Buyer from Seller during the term of
this Agreement;
NOW, THEREFORE, Buyer and Seller hereby agree as follows:
1.0 AGREEMENT SCOPE.
1.1 Application of Agreement. Buyer and Seller agree that all sales of Products
and Services from Seller to Buyer made during the term of this Agreement shall
be subject to the terms of this Agreement.
1.2 Products and Services. Each Product and additional required terms specific
to such Product is defined in Exhibit A, which sets forth a description thereof,
additional terms of sale and purchase, and unit pricing that shall apply thereto
("Price"). The parties may, from time to time, add new products by executing
addenda and/or amendments to Exhibit A. Services included in a Price, if any,
are described in the section entitled "Pricing" on Exhibit A.
1.3 Specifications. Complete specifications required to inspect, manufacture,
test, and ship the Products and the Components (as referenced in Section 4) in a
manner acceptable to Buyer, including part numbers, revisions, bills of material
and any other specifications applicable to Products ordered pursuant to this
Agreement ("Specifications") will be supplied by Buyer or Buyer's agent and
agreed upon in writing by Seller, or will be otherwise established and accepted
by Buyer and Seller via Seller's Engineering Change Order ("ECO") process and
documented in the Device Master Record ("DMR") and by part number. Seller and
Buyer have
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
agreed upon the current Specifications for the Products, which are too complex
to attach as an exhibit hereto. Neither Seller nor the Product shall be expected
or required to perform outside of the Specifications, unless it is discovered
that such Specifications do not comply with the requirements of a regulatory
agency or board (including without limitation the U.S. Food and Drug
Administration), in which event Seller shall cooperate with Buyer at Buyer's
expense to change the Specifications in order to so comply.
1.4 Engineering Change Orders. Prior to Seller's making any "major revision"
(i.e., a change that may affect the form, fit or function of a Product) to a
Product assembly or sub-assembly (including, to the extent practicable, changes
incorporated by Seller's vendors, manufacturers and subcontractors
("Suppliers")), Seller will request Buyer's consent to such major revision by
issuing an ECO to Buyer. At a minimum, Buyer's approval of an ECO issued by
Seller with respect to the top level assembly of a Product will be required
prior to release of the Product to production. Notwithstanding any failure by
Buyer to specifically approve ECOs previously presented to Buyer by Seller,
Buyer's execution of an ECO shall be deemed to constitute Buyer's approval of
the revision subject to such ECO, together with all Components and
Specifications that are incorporated into the assembly or sub-assembly that is
the subject of such ECO. In no event will Seller ship any Products to Buyer that
incorporate Specifications that have not been approved by Buyer in accordance
with this Section 1.4, or that have been rendered obsolete by an ECO approved by
the parties in accordance with this Section 1.4. Seller will provide all
documentation reasonably requested by Buyer in connection with its review of any
ECO presented by Seller.
1.5 Inconsistencies in Documents. In the event of any inconsistency or conflict
between any of the documents described above and/or Purchase Orders (as defined
below in Section 3.1) issued pursuant to this Agreement, the following order of
priority, listed here from the highest priority (a) to the lowest priority (e),
in interpretation shall apply:
(a) Amendments or other modifications made to this Agreement.
(b) Exhibits of this Agreement.
(c) Product Specifications agreed to via Seller's ECO process.
(d) Purchase Order (exclusive of any terms and conditions attempting to
amend this Agreement).
(e) This Agreement.
2.0 TERM AND TERMINATION.
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
2.1 Term. This Agreement shall commence upon its execution and shall continue
for an initial period of one year, and shall automatically renew for additional
periods of one year unless either party gives at least ninety (90) days of prior
written notice of its intention not to renew this Agreement or unless it is
terminated as provided herein.
2.2 Termination for Cause. In the event of a breach of a material term of this
Agreement by either party, the other party may, upon not less than sixty (60)
days' prior written notice to the party in breach, terminate this Agreement
unless the breach is cured prior to the end of the notice period, to the extent
susceptible of cure. Notwithstanding the foregoing, in the event that a party
has more than two (2) material breaches within a one hundred eighty (180) day
period, the other party may terminate this Agreement upon written notice to the
party in breach, with no right to a cure period for the party in breach. A
breach of a material term shall include, without limitation, the following:
a) Components and/or Products delivered to Buyer by Seller do not conform
to the applicable Specification at the time of such delivery, and
Seller does not operate in good faith to reasonably cure such
non-conformance in a timely manner;
b) Buyer fails to make payment to Seller for Products on a timely basis;
c) Buyer fails to receive Products according to the agreed upon delivery
schedule; or
d) Seller fails to make deliveries of Products on a timely basis in
accordance with Section 3.4 other than as a result of a Force Majeure
Event, as defined in Section 11.9 hereof.
Notwithstanding the foregoing, if Seller or Buyer ceases to conduct its
operations in the normal course of business (including an inability to meet its
obligations as they mature), or if any proceeding under the bankruptcy or
insolvency laws are brought by or against Seller or Buyer (and not dismissed
within 60 days) or if a receiver is appointed to or applied for by Seller or
Buyer, the other party may terminate this Agreement and/or any Purchase Orders
upon such event without liability, except for deliveries previously made or for
Products ordered and covered by this Agreement that are completed or in process
at the time of termination and subsequently delivered in accordance with the
terms of this Agreement.
2.3 Buyer's Termination for Convenience. During any renewal term of this
Agreement, Buyer may, upon at least one hundred eighty (180) days' prior written
notice to Seller, terminate this Agreement for Buyer's convenience; provided
that such termination shall not affect any outstanding Purchase Orders.
2.4 Seller's Termination for Convenience. Seller may discontinue supply of any
Product under this Agreement by giving Buyer prior written notice one hundred
eighty (180) days in
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
advance of said discontinuation, provided that Buyer shall have the option to
purchase up to a "Lifetime" supply of the Product at the then-current Product
revision level for delivery within such one hundred eighty (180) day period.
2.5 Effects of Termination. Upon termination of this Agreement, Sections 2, 5.3,
5.6, 5.7, 5.8, 8 (as it relates to payments due but not yet paid as of the date
of termination), 9, 10, and 11 shall survive in accordance with their provision.
A party's right to terminate this Agreement shall be without prejudice to any
other remedies available to such party at law or in equity. In the event of
notification of termination of the Agreement, Buyer's and Seller's obligations
under this Agreement shall continue without interruption through the date of
termination.
3.0 ORDERS, DELIVERY, AND ACCEPTANCE.
3.1 Purchase Orders. Buyer's purchase orders issued to Seller will be properly
authorized, written, emailed, or facsimile documents specifying, and/or
attaching items including: Products, Components, description, applicable part
numbers, quantity, revision, delivery schedule, destination, shipping method,
Specifications, special acceptance criteria (if any), unit price, and total
authorized cost of the order ("Purchase Order"). The parties shall agree in
writing on each Purchase Order, and the Specifications referenced thereon (using
Seller's part numbers), prior to the commencement of any work related to such
Purchase Order, after which Seller shall manufacture for Buyer the Products
identified in such Purchase Order.
Commencement of work related to this Agreement or related to Purchase Orders is
done so under the terms of this Agreement. Any additional or different terms
from Buyer sent together with Purchase Orders or otherwise sent to Seller or
from Seller to Buyer shall be excluded unless signed by both parties as an
Amendment or an Exhibit to this Agreement.
3.2 Packaging. Seller shall prepare and pack Products in accordance with the
Specifications. Costs for preparation and Product packaging are included in the
Price unless not specified as part of the Product part number ordered by Buyer.
Costs for crating, palletizing, and/or bulk packaging are not included in the
Price.
3.3 Shipping. Shipping terms are FOB Seller's facility. Seller shall select
freight carrier of its choosing unless otherwise specified by Buyer in a
Purchase Order.
3.4 Delivery. The Purchase Order shall specify requested delivery dates. Seller
shall ship products with appropriate lead-time such that Products arrive at
Buyer's dock on or reasonably around the requested arrival dates (absent a Force
Majeure Event); provided, that Seller shall notify Buyer if it has reason to
believe that any particular shipment of Products may not arrive at Buyer's dock
within ten (10) days after the requested arrival dates, it being agreed and
understood by the parties that the failure by Seller, on more than three (3)
occasions with respect to any five (5) consecutive required delivery dates as
set forth in Purchase Orders previously
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
delivered by Buyer and agreed upon by Seller, to deliver all units required to
be delivered pursuant to such Purchase Orders upon any particular delivery date
to Buyer's dock within the ten-day period following the respective delivery date
(provided the cause of such delivery failure is not attributable to a request by
Buyer that Seller make modifications to one or more Products prior to delivery
that would not otherwise have had to been made by Seller in order to deliver
Products in accordance with a then-effective Purchase Order) may result in Buyer
terminating this Agreement under Section 2.2.
3.5 Acceptance. The acceptance criteria for each Product shall be "conformance
to the Specifications at the time of delivery." In the event that there are
additional acceptance criteria by Buyer, they must be specified on the Purchase
Order at the time of the initial order in accordance with Section 3.1.
3.5.1 Within ten (10) business days of Buyer's receipt of Product, Buyer
shall notify Seller in writing of any rejected Product and listing therein
any and all Specifications which remained unmet at the time of delivery.
Buyer bears the risk of loss and expense due to unnecessary return of
Product that was in fact conforming to the Specifications at the time of
delivery as verified by Seller through the testing and inspection
procedures defined in the Device Master Record for such Product or
otherwise established and agreed to by Buyer via Seller's ECO system. See
additionally Section 6.0 below. In the event Product is returned to Seller
that was conforming at the time of delivery, additional expense of Buyer
includes the reasonable expense incurred by Seller in investigating the
purported defect or damage.
3.5.2 Upon return of non-conforming Product, Seller will as soon as
reasonably practical (at its own option) either repair, replace or credit
Buyer for non-conforming Product. The cost associated with any such repair,
replacement or credit will be the responsibility of Seller. In the case of
replacement or credit, title to the non-conforming Products shall pass to
Seller on return delivery to Seller's dock and Seller's receipt of returned
Product.
3.5.3 In the absence of earlier notification of rejection, Buyer will be
deemed to have accepted Products ten (10) business days after Buyer's
receipt of the Product. Buyer payments for Product after approval or
acceptance of any Products shall not (a) relieve Seller from responsibility
to deliver Products in conformance with the Specifications, or (b) waive
any warranty rights of Buyer hereunder.
4.0 COMPONENTS AND CONFIGURATION MANAGEMENT.
4.1 Configuration Control. Seller will maintain source control on all parts,
materials, subassemblies, and components used in connection with the manufacture
of Products in accordance with the provisions of Section 5.1 hereof
("Components"), unless otherwise
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
specified. Buyer will have access to ▇▇▇▇ of material ("BOM") data, including
without limitation the cost associated with the subcomponents and subassemblies,
inventory status, and production status as reasonably requested.
4.2 Product Revisions. Seller uses a product revision format that indicates
different levels of product release. All revisions have a format of [major
revision]-[minor revision]. Major revisions (i.e., changes that may affect the
form, fit or function of any Product) are less than "1" (e.g., .01, .02, .5,
etc.) prior to production release and are "001" or greater (e.g., 001, 002,
etc.) after production release. Minor revisions start with alpha characters
beginning at "a" after each major revision change and are incremented for each
minor revision change (e.g., a, b, c, etc.). All Products provided at a revision
less than 001-a (e.g., .01-a, .01-b, .5-a, etc.) shall be considered prototypes
or pre-production units ("Engineering Units"). All Products provided at a
revision level of 001-a or higher (e.g., 001-a, 001-b, 002-a, etc.) shall be
considered production units ("Production Units").
4.3 Component Scheduling. Seller shall maintain scheduling control over
Components ordering and their delivery scheduling according to Seller's
production scheduling processes. Seller will issue purchase orders, or otherwise
place orders, for all Components to support Buyer's Purchase Orders throughout
the term of the Agreement. Any scheduling outside of Seller's standard processes
shall require Buyer's prior written approval. Seller will commit to longer-term
buys on an exception basis as reasonably requested by Buyer provided that all
such requests are issued in writing to Seller by Buyer.
4.4 Components and other Parts Purchases. Seller agrees to sell sub-assemblies,
Components, and other parts, from its inventory to Buyer on a "cost plus" basis,
upon Buyer's reasonable request. Seller will quote a price, including any
minimum quantity, to Buyer for such Components upon request by Buyer. All such
sales are subject to the terms of this Agreement. For purposes of this section
only (Section 4.4), the term "cost plus" shall mean Seller's actual cost in
manufacturing or purchasing such sub-assemblies, Components and other parts,
plus 25% of such actual cost. See Section 8.7 below which defines Seller's
"actual cost."
4.5 Product Orders. Forecasts and Schedule Changes. Buyer will provide Purchase
Order(s) representing a firm commitment for Products to be delivered as
specified on the Purchase Order. In addition, Buyer shall provide non-binding
forecasts to Seller ("Forecasts"), which Forecasts reflect Buyer's expected
Product(s) volume requirements over a 12 month period. Seller will make
reasonable efforts to accommodate schedule change requests, subject to Component
availability and capacity, at Seller's sole reasonable discretion. Aggressive
schedule increases will be accommodated to the best of Seller's ability
according to the terms of this Agreement. Seller may use the Forecasts to
purchase long lead-time items and to achieve price breaks due to order size.
Forecasts and Purchase Orders may be combined to make best effort purchasing
decisions. Excess or scrap Components that occur as a result of Seller's best
effort purchasing
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
decisions, pursuant to Purchase Orders only, are Buyer's responsibility in the
event of an order cancellation, Product change, or production delay.
4.6 Disaster Recovery Plan. Seller represents and warrants to Buyer that it has
in place a disaster recovery plan consistent with industry standards that
describes the resources, actions, tasks and data required to manage Seller's
business recovery process in the event of a business interruption (the "Plan"),
including without limitation a significant or catastrophic event adversely
affecting in any material respect Seller's ability to supply Products. At all
times during the term of this Agreement, Seller shall maintain such Plan, or a
similar plan that has at least the protections contained in the Plan, in full
force and effect.
5.0 QUALITY SYSTEMS, REGULATORY, AND AGENCIES.
5.1 Quality Systems Requirements. Seller will establish and maintain formal
quality systems and processes that are compliant with the FDA's Quality System
Regulation ("QSR") and ISO 13485, and shall use its commercially reasonable
efforts to ensure that all of Seller's Suppliers are compliant therewith to the
extent that compliance by such Suppliers is required thereunder. Such systems
and processes will be provided and maintained at all times during the term of
this Agreement by Seller and, to the extent reasonably practicable, all
Suppliers to the extent required under the QSR and/or ISO 13485. Any and all
special quality system requirements for the Products shall be provided by or
agreed to by Buyer via the Specifications for the Product or as subsequently
changed via Seller's ECO processes, in writing, at the time of Purchase Order.
Seller will inform Buyer and obtain prior approval in accordance with Seller's
ECO process, as described under Section 1.4, for any changes to be made,
including changes with respect to Seller's Suppliers, that can affect the form,
fit or function of the Products.
5.2 Buyer Audit Rights. Seller agrees that Buyer or any of its duly authorized
representatives shall have access to and the right to reasonably perform routine
audits on any pertinent design, manufacturing, or quality systems, and
associated documentation, provided that Buyer shall provide Seller with five (5)
business days' prior written notification and require two (2) business days or
less to complete. Such audits shall occur at most once every six (6) month
period, provided that, in the event Buyer discovers a major non-conformance,
there shall not be any continuing limitation on the number of audits that Buyer
may undertake, provided that such additional audits are requested by Buyer in
good faith and Buyer clearly identifies in writing to Seller its reasons for
conducting such additional audit and the proposed scope of such audit. In the
event Buyer discovers a major non-conformance that is attributable to one of
Seller's Suppliers, Seller shall use its commercially reasonable efforts to
obtain such Supplier's consent to affording Buyer access to such Supplier's
facility so that Buyer may review such major non-conformance. Buyer and Seller
shall each incur all of its own costs in connection with routine audits.
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
If, as a result of any of the aforesaid audits, Buyer becomes aware that
the production, packaging and/or quality systems and processes of Seller would
result in a major non-conformance, Buyer shall promptly notify Seller about such
non-conformance and Seller herewith undertakes to rectify all major
non-conformances in production, packaging or quality systems and processes.
Without limiting the generality of the foregoing, in the event that the major
non-conformance relates to the quality systems or processes of Seller, Buyer
shall be entitled to conduct a source inspection in order to determine the
specific issues relating to the major non-conformance.
5.3 Quality System Records. Seller shall keep records, including Device Master
Records (as such term is used in the QSR), on the Products in accordance with
the QSR and ISO 13485 standards for the period specified in the relevant product
addendum. All such records shall be subject to the confidentiality provisions of
Section 9.1 hereof. Seller shall provide Buyer access onsite to any such
records. If for any reason Buyer shall require hard copies of such records,
Buyer shall bear Seller's costs of compliance with Buyer's request. Electronic
courtesy access to such records may be provided Buyer.
5.4 Traceability. Seller will provide lot or serial traceability to selected
Components for Product as agreed to by Buyer and Seller in accordance with
Section 5.1.
5.5 Corrective and Preventive Action. A corrective and preventive action system
will be managed and maintained by Seller as necessary to meet the requirements
of the QSR and ISO 13485 or otherwise as a Seller of Products to Buyer in
accordance with Section 5.1.
5.6 Regulatory Responsibility. Buyer shall be responsible for all FDA and other
applicable international (e.g., MDD, CMDCAS, etc.) regulatory reporting and
registration, regulatory submissions, Product performance monitoring, complaint
handling, and field service. Buyer shall notify Seller of customer complaints
related to the work performed by Seller, and any Medical Device Reports or
vigilance reports that are submitted to the FDA or other international
regulatory agencies regarding the Products within 10 business days of their
notification or submission. Seller agrees to cooperate, support and investigate
such matters as requested by Buyer. Seller shall be responsible for maintaining
FDA registration for the facility that manufactures the Products.
5.7 Agencies. If Buyer seeks regulatory or safety agency approval for its own
product into which Products of Seller under this Agreement are incorporated,
Seller shall cooperate and fully support Buyer as requested. Seller will
cooperate with agency inspections (e.g., UL, CSA, etc.) relating specifically to
the Products.
5.8 Inquiries. If any governmental agency contacts Buyer or Seller to inquire
about or investigate Buyer's system, therapy, treatment, device, or instrument
into which the Products of Seller under this Agreement have been incorporated or
Product (or component supplied Buyer)
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
which is the subject matter of this Agreement, the contacted Party shall use its
best efforts to give notice thereof to the other party within 24 hours of
receipt of such contact.
6.0 RETURNED PRODUCT AND REPAIRS.
6.1 Returned Product. All Products that Buyer deems to be non-conforming to
Specifications in the relevant purchase order shall be returned to Seller after
acquiring and including a Seller's Return Material Authorization (RMA) number
and paperwork indicating the details of the unit being returned with a serial or
lot number and a description of the problem. An RMA number is available on
request from Seller's Quality Department.
6.1.1 Shipping. Buyer shall pay for freight for Product return to Seller,
and Seller shall pay for domestic Product shipment back to Buyer. Seller
shall use a shipping method of the same or better expediency to that which
Buyer returned Product to Seller.
6.1.2 Decontamination. Buyer shall supply Seller with a Certificate of
Decontamination along with all returned Product certifying that it is free
of all toxic and biohazard materials. If no such certificate is provided,
Seller may perform decontamination services as needed.
6.2 Repairs. In-warranty repairs shall be performed in accordance with Section
10.4. Seller agrees to perform out-of warranty depot repair, upgrade, and
troubleshooting services as requested by Buyer. All repairs, troubleshooting,
field upgrades, and field service work performed by Buyer will be at Buyer's
sole expense.
7.0 BUYER AND SELLER RESPONSIBILITIES AS TO DESIGN, PROCUREMENT, ASSEMBLY, AND
TEST RESPONSIBILITY.
7.1 Design Responsibility. Buyer shall be solely responsible for the design of
the Products and for their safety and efficacy for the indications and intended
uses. Buyer shall bear any financial or other responsibility for Product
deficiencies discovered by Buyer or Seller, provided that Seller shall conduct
an initial investigational analysis in its sole discretion regarding any such
deficiency at its sole expense. It is Buyer's sole responsibility to review,
validate, and approve the Product design, any Engineering Units Seller provides,
and to ensure that any resulting product is tested, manufactured, packaged,
labeled (including adequate warnings), sold and/or used in a safe, careful, and
effective manner. Buyer is responsible for obtaining and maintaining FDA, UL,
CE, CSA, FCC or any other necessary approvals.
7.2 Seller's Disclaimers of Responsibility. Any and all Seller supplied
engineering services and results of services (i.e., designs, pre-production
units, or prototypes) are provided "as is." Every design necessarily involves
individualized professional judgments, the results of which cannot be
guaranteed. Any Engineering Units provided by Seller may or may not meet
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
regulatory standards for medical equipment or software. Only those Engineering
Units that (a) have been manufactured by Seller for Buyer pursuant to a Purchase
Order delivered hereunder for Products, (b) represent an "interim release"
Product as described in Section A.1 of Exhibit A (i.e., is at a revision level
at or above .50-a but below 001-a) and (c) are accompanied by a certificate of
conformance pursuant to Section A.13 of Exhibit A are suitable for human use.
7.3 Procurement, Assembly and Test Responsibility. Seller's procurement,
assembly and test responsibility is limited to providing a Product that is
"built to print" according to written Specifications provided to Seller by Buyer
(and agreed upon by Seller) or as otherwise agreed to by Buyer via Seller's ECO
process. Seller agrees to perform additional Services as may be needed from time
to time as requested by Buyer.
7.4 Product Changes, Support and Sustaining Engineering. As requested by Buyer,
Seller agrees to provide technical support and sustaining engineering services
required to develop, design, engineer, test, support, and implement Product or
process changes.
8.0 PAYMENT AND OTHER CONSIDERATION.
8.1 Invoices and Payment Terms. Seller shall issue invoices to Buyer as Products
are shipped from Seller's plant for the price of shipped units and shipping
costs, with a credit of any applicable prepayment, downpayment, deposit or
allowance for Buyer-supplied products as established in the relevant product
addendum to this Agreement. For Services performed, Seller shall issue invoices
to Buyer once per month. Buyer shall deliver payment in full to Seller within
thirty (30) calendar days after an invoice date. A late fee will be assessed to
any overdue invoices. Such late fee shall be the lesser of a) 1.5%/month, or
portion thereof, or b) the maximum amount permitted by law. In the event that
payment is not made within sixty (60) days after invoice date, Seller may cease
all efforts on the Products and refer the account to a collection agency at its
sole discretion. Buyer shall be responsible for any and all collections and
attorneys' fees incurred relating to Seller's collection of funds owed by Buyer
to Seller. Notwithstanding the foregoing, Buyer may withhold payments under this
Agreement or any Purchase Order while Seller is in material breach and
subsequent cure period under Section 2.2 herein so long as the sum total of
payment withheld is not inclusive of any amounts due and payable for prior
performance of Seller for which Product Seller was not in material breach of
this Agreement or the relevant Product Addendum at the time of delivery.
8.2 Out of Pocket Expenses. Buyer shall pay Seller for all reasonable
out-of-pocket expenses, that Seller incurs in relation to the Services provided
hereunder, provided that expenses individually or in the aggregate in excess of
$7,500 shall require Buyer's prior written approval, and provided further that
expenses that are incurred by Seller in the ordinary course of its business,
including periodic visits to Suppliers, shall not be reimbursable by Buyer.
Reasonable out-of-pocket expenses, shall include, but not be limited to,
out-of-town air and
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
ground travel, food, and lodging where applicable, and video conference,
internet meetings, hosted conference calls, supplier non-recurring charges, fees
or surcharges, or other miscellaneous third party costs resulting from Seller's
performance under this Agreement. Mileage reimbursement for personal vehicle use
shall be at the current IRS rate per mile where Seller travels out-of-town by
personal or company vehicle in relation to the Services provided hereunder.
8.3 Expedite Costs. Seller shall be responsible for Seller's or Suppliers'
reasonable expedite costs incurred in order to meet the standard delivery
schedule unless such expedite costs become necessary due to, or are specially
requested by, Buyer and are in excess of the Forecast or the delivery schedule
specified on the Purchase Order. Any reasonable expedite costs incurred by
Seller due to, or requested by, Buyer shall be recharged to Buyer.
8.4 Overtime Costs. Seller shall be responsible for Seller's overtime costs
incurred in order to meet the standard delivery schedule unless such overtime
costs become necessary due to, or are specially requested by, Buyer. Any
reasonable overtime costs incurred by Seller due to, or requested by, Buyer
shall be recharged to Buyer.
8.5 Production Delays. In the event of production delays requested or caused by
Buyer in excess of 30 days, Buyer shall, at Seller's sole discretion, pay to
Seller during the delay period either (a) an inventory deposit and fee as
specified in the relevant product addendum, (b) an inventory deposit and a
1.25%/month Storage Fee (as defined in Section 8.6.1), or (c) a 2.5%/month
Maintenance Fee (as defined in Section 8.6.2).
Unless otherwise specified in the product addendum for given Product(s), the
standard inventory deposit shall be an amount equal to the fair market value of
the Component inventory, Component purchase orders, or other written commitments
from Seller to Seller's Suppliers purchased by or otherwise committed to by
Seller as a result of Purchase Orders or Product Forecasts ("Committed
Inventory") including Components received, or on non-cancelable, non-returnable
or limited change purchase orders from Seller to Seller's Suppliers for
Components that will be received by Seller during the delay period. The fee
calculation shall be made using the applicable percentage from either 8.5(b) or
8.5(c) above multiplied by the average monthly value of the Committed Inventory
held by Seller during the period as to which the fee applies. This fee will be
charged each month, or portion thereof, during the delay.
In the event that Seller is holding Buyer-supplied or Buyer-owned inventory
during the delay period, Buyer shall pay a 1.25%/month Storage Fee for those
materials. In the event of production delays requested or caused by Buyer in
excess of 90 days, Buyer shall purchase from Seller all Committed Inventory held
at Seller during the period and pay a 1.25%/month Storage Fee until delivery of
all Products or Committed Inventory from Seller to Buyer is made.
8.6 Fee Definitions.
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
8.6.1 "Storage Fee" In the event of a production delay per Section 8.5,
this fee covers Seller's costs for the storage, maintenance, warranty,
material handling, shrinkage, cycle counting, storage space, floor space
and other overhead associated with the inventory as well as supplier
management, discrepant material handling, purchasing efforts, reporting,
tracking, and rescheduling associated with storing and managing inventory
during a delay in production. The storage fee as referenced in Section 8.5
shall be 1.25% per month of actual costs associated with the Committed
Inventory ("Storage Fee").
8.6.2 "Maintenance Fee" In the event of a production delay per Section 8.5,
this fee covers Seller's costs for the storage, maintenance, warranty
extension, material handling, cost of capital, shrinkage, cycle counting,
floor space, storage space and other overhead associated with the inventory
as well as the supplier management, discrepant material handling,
purchasing efforts, reporting, tracking and rescheduling associated with
storing, owning, and managing inventory during a delay in production. The
maintenance fee as referenced in Section 8.5 shall be 2.5%/month of actual
costs associated with the Committed Inventory ("Maintenance Fee").
8.6.3 G&A Fee. This fee covers Seller's costs for general and
administrative efforts associated with various business issues including,
but not limited to, purchasing, inspecting, providing warranty,
inventorying, invoicing, storing, receiving, space, capitalizing, managing,
and other overhead issues associated with the business relating to the
items or issues to which the fee is applicable. This fee shall only be
applied to costs incurred by Seller that are not included in the Price, but
are otherwise covered by this Agreement and are being recharged to Buyer
including, but not limited to, costs associated with Sections 8.2, 8.3,
8.4, 8.5, and 8.8. The standard G&A fee shall be 25% of the amount to which
to fee is applied.
8.7 Cancellation of Purchase Orders in Whole or in Part. In the event that Buyer
cancels a Purchase Order or terminates this Agreement pursuant to Section 2.0,
the following terms shall apply to Committed Inventory purchased or committed to
as a result of Purchase Order.
(a) Seller will make all commercially reasonable efforts to return
unneeded Components to Suppliers; and
(b) Buyer will be responsible for the following costs arising from Buyer's
Purchase Order and subsequent cancellation:
i. Seller's actual costs associated with non-returnable or
non-cancelable Committed Inventory including Committed Inventory
that has been rendered non-returnable due to work performed in
accordance with this Agreement and associated Purchase Orders;
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
ii. Seller's actual costs associated with returnable or cancelable
Committed Inventory; and
iii. Seller's cancellation fee of twenty (20) percent of the remaining
Purchase Order value at the time of the cancellation at Seller's
sole discretion; provided, however, that this cancellation fee
will not be required to be paid by Buyer if Buyer terminates the
Agreement pursuant to Section 2.2.
Upon payment by Buyer of the amounts set forth in Section 8.7(b) above, Buyer
shall own all Committed Inventory and Components, and Seller shall deliver such
Committed Inventory and Components to Buyer in accordance with Section 3.3
above.
A Purchase Order shall be deemed to be cancelled if Buyer delays production
thereunder for one or more successive periods in excess of nine (9) months in
the aggregate (which period may be extended by up to three (3) additional months
on account of a delay in Buyer's receipt of regulatory approval of Buyer's
Product, for a total of twelve (12) months in the aggregate), unless such delays
are primarily a result of (i) Seller's actions or inactions under this
Agreement, or (ii) a Force Majeure Event.
Seller's "actual costs" include labor, overhead and other out-of-pocket expenses
incurred in the purchasing, receiving, inspecting, testing, assembling, storing,
counting, shipping, handling, canceling, returning, or otherwise managing or
processing the Components and associated expenses of retaining and dealing with
Suppliers.
8.8 Other Costs. Other costs may be incurred for Products or additional Services
provided by Seller in support of Buyer's Products as requested by Buyer. Such
costs may include, but are not limited to, Services requested by Buyer as per
Subsection 3.5.1 and Sections 4.5, 5.6, 6.1.2, 6.2, 7.2, 7.3, 7.4, and 9.3.
Costs shall be charged to Buyer based on materials costs, third party costs, or
at the then-current rates of Seller's personnel.
8.9 Cost Reduction. Buyer and Seller agree that the parties will share the
benefits of any and all cost reduction efforts on a 70/30 split. The split will
be allocated 70% to the originator of the cost reduction effort and 30% to the
other party, via unit cost reduction, after Seller's implementation costs are
recovered.
8.10 Pricing Review. Buyer and Seller agree to evaluate and/or adjust the Unit
pricing stated in Exhibits no more often than once every six months at the
request of Buyer or Seller.
8.11 Security Interest. Until the price for Products shipped by Seller pursuant
to a Purchase Order has been paid in full, Seller shall retain and Buyer hereby
grants Seller a purchase money security interest in those Products. The purchase
money security interest shall automatically terminate as to any Products Buyer
sells in the ordinary course of business. Buyer hereby
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
authorizes Seller to take any and all actions necessary to perfect such purchase
money security interest, including the filing of Forms UCC-1. Upon payment in
full for Products with respect to which Seller has filed a Form UCC-1, Seller
shall promptly at its expense take all steps necessary to terminate such UCC-1
filing.
8.12 Buyer's Further Assurances. Nothing in this Agreement generally or in
Section 9.3 specifically shall prejudice or shorten the rights of Seller to
payment in full for (a) all Seller invoiced engineering time and material and
related Q&A fees ordered and agreed to in writing by Buyer during the term of
this Agreement, and (b) all Production Units and Engineering Units delivered to
Buyer under the terms and conditions of this Agreement.
9.0 INTELLECTUAL PROPERTY RIGHTS.
9.1 Confidential Information.
(a) Confidential Information ("Confidential Information") includes all
information furnished to the receiving party ("Receiving Party")
relating to the business conducted or to be conducted by the
disclosing party ("Disclosing Party"), including, but not limited to,
information on markets, customers, products, software, source code,
inventions, procedures, designs, financial status, plans, organization
and general business strategy. Confidential Information includes
information furnished in written or electronic format as well as any
information that may be derived from review of Product samples,
software or other assets. Confidential Information includes
information disclosed before, on or after the date of this Agreement.
A Receiving Party has the right to exception of information being
deemed "Confidential Information" but subject to written notice to the
Disclosing Party that information is or has been published to third
parties in a manner specified below at Section 9.2 below.
(b) All Confidential Information shall remain the property of the
Disclosing Party. Each party shall keep Confidential Information
received from the other party in confidence and trust and shall not
use it for any purpose other than for the purposes of this Agreement.
(c) The contents of this Agreement and all Confidential Information
exchanged between Buyer and Seller pursuant to this Agreement, or that
has previously been exchanged between Buyer and Seller relating to the
subject matter hereof, shall be kept confidential by each party during
the term of this Agreement and for a period of five (5) years from the
day of expiration of this Agreement, with the same degree of care
normally accorded by such party to its own confidential information
except for purposes authorized by this Agreement. Neither party shall
disclose such Confidential Information to any person or firm, for as
long as
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
said information is not in the public domain, unless previously
authorized in writing by the other party to do so; provided, however,
that each party may disclose said Confidential Information to
responsible officers and employees of that party who require said
information for the purposes contemplated by this Agreement, provided
that said officers and employees shall have assumed like obligations
of confidentiality.
(d) Upon termination of this Agreement, either party may request the other
party to return the Confidential Information that the other party has
in its possession or control provided, however, that neither party
will be obligated to deliver or destroy any Confidential Information
that is in electronic format; rather, the parties will be permitted to
retain such Confidential Information subject to the ongoing
confidentiality terms and conditions of this Agreement.
9.2 Exclusions to Confidential Information. Notwithstanding any other provision
of this Agreement, a Party's Information shall not be deemed Confidential
Information hereunder if it (a) is or becomes publicly known through no act or
omission of Receiving Party; (b) is information that the Receiving Party can
demonstrate was in the Receiving Party's possession before disclosure by the
Disclosing Party and was not acquired, directly or indirectly, from the
Disclosing Party; (c) is obtained from a third party without obligation to the
Disclosing Party and with a legal and contractual right to transmit the
information; or (d) is required to be disclosed pursuant to law; provided, that
the Party shall give prompt and prior written notice thereof to the Disclosing
Party, and, that the Receiving Party shall give reasonable cooperation to the
Disclosing Party to limit any public release of such information to the extent
provided by law.
9.3 Technical Data and Intellectual Property Ownership.
(a) Seller shall perform in strict compliance with this Agreement so that
no third party rights in any invention arising hereunder are created,
except rights in favor of Buyer. To the maximum extent permitted by
law, all Products, materials, notes, records, drawings, designs,
ideas, inventions, improvements, developments, discoveries,
algorithms, know-how, techniques, processes, concepts and derivative
works or other intellectual property, whether or not patentable, that
are conceived, made or discovered by Seller solely or in collaboration
with others, from the work performed pursuant to this Agreement
(collectively, "Developed Materials"), shall be the sole and exclusive
property of Buyer. Developed Materials that are (i) copyrightable,
(ii) considered by Buyer, in its reasonable determination, to be a
trade secret of Buyer, or (iii) considered by Buyer, in its reasonable
determination, to be patentable by Buyer, shall be referred to herein
as "Buyer Materials." Seller shall use its commercially reasonable
efforts to notify Buyer promptly in writing of the identification of
any new Developed Materials
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
that may be copyrightable, patentable or trade secret material. Buyer
hereby grants to Seller a non-exclusive, perpetual, fully-paid up,
royalty free, worldwide, irrevocable right and license, with the right
to grant sublicenses, to all Developed Materials that are not Buyer
Materials, to make, have made, use, reproduce, modify, make derivative
works, make improvements, publicly display, distribute, sell (either
directly or indirectly), and offer to sell (either directly or
indirectly), lease, import, practice and otherwise transfer or dispose
of such item as part of or in connection with such Developed Materials
that are not Buyer Materials. Each party shall use commercially
reasonable efforts to notify the other party in writing within 90 days
of receipt or notice thereof of any Developed Materials that it
considers to be patentable or for which a copyright registration
should be sought or that it considers to be a trade secret and, if
applicable or appropriate in Buyer's reasonable commercial judgment,
to cooperate in the preparation of a patent review plan at Buyer's
expense. Notwithstanding the foregoing, any failure to deliver such a
notice within such 90-day period shall not affect in any way Buyer's
ownership of and property rights in any Developed Materials; provided
that, in the event that Seller or a third party makes use of any such
Developed Materials after the 90-day period, but prior to receipt of a
notice from Buyer provided for above, any such Developed Materials
that would have been Buyer Materials if proper notice had been given
shall be deemed to be Developed Materials (and not Buyer Materials)
and shall be subject to the rights granted to Seller pursuant to the
terms of this Section 9.3. Whenever requested to do so by Buyer,
Seller shall execute any and all applications, assignments, oaths or
other instruments and give testimony which Buyer shall deem necessary
to apply for and obtain letters of patent of the United States or of
any foreign country or to protect otherwise Buyer's interest therein.
Seller further agrees that Seller's obligation to execute or cause to
be executed, when it is in Seller's power to do so, any such
instrument or papers shall continue after the termination of this
Agreement.
(b) Seller agrees that if Buyer is unable because of Seller's
unavailability or unwillingness after 10 business days prior written
notice, or dissolution, to secure Seller's signature, which will not
be unreasonably withheld, to apply for or to pursue any application
for any United States or foreign patents or mask work or copyright
registrations covering the Developed Materials assigned to Buyer
above, then Seller hereby irrevocably designates and appoints Buyer
and its duly authorized officers and agents as Seller's agent and
attorney in fact, to act for and in Seller's behalf and stead to
execute and file any such applications and to do all other lawfully
permitted acts to further the prosecution and issuance of patents,
copyright and mask work registrations thereon with the same legal
force and
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
effect as if executed by Seller, this power and agency being coupled
with an interest and being irrevocable.
(c) Buyer and Seller understand and acknowledge that certain materials:
(i) created by or for Seller prior to its beginning work for Buyer
pursuant to this Agreement (except with respect to Materials
developed by Seller for Buyer under the System Development
Proposal effective January 20, 2004 by and between Buyer and
Seller, as amended to date ("Development Agreement"), the
ownership of which shall be governed by such Development
Agreement) ("Preexisting Materials"),
(ii) created by or for Seller in separate efforts at its own expense
not in connection with its obligations under this Agreement, even
to the extent that such materials may be used by Seller in its
performance of this Agreement ("Ancillary Materials"),
(iii) generally known or available to those skilled in the art, or
(iv) owned by third parties and licensed to Seller,
collectively, shall be excluded from Developed Materials.
(d) Seller hereby grants, and has the right to so grant, to Buyer, a
non-exclusive, perpetual, worldwide, royalty-free license to all
Preexisting Materials and Ancillary Materials that may be included in
the Products, in order for Buyer to use, import, sell and have sold
the Products. In addition, Seller covenants and agrees, with respect
to any and all Components that Seller purchases from Suppliers
("Supplier Materials"), from and after the date of this Agreement,
that Seller shall obtain the right, and shall grant to Buyer, or shall
obtain on Buyer's behalf, a non-exclusive, perpetual, worldwide,
royalty-free license to all such Supplier Materials that may be
included in the Products, in order for Buyer to use, import, sell and
have sold the Products. Subject to the foregoing, Buyer shall own all
rights (including all intellectual property rights) in and to the
Products, and all related design information and documentation.
9.4 Seller's Inability to Deliver. In the event that Seller can no longer
provide the Products to Buyer due to Seller's bankruptcy, insolvency, or Seller
otherwise ceasing to conduct its operations, Seller shall provide Buyer with
exclusive, perpetual, irrevocable, worldwide, royalty-free license rights in the
Field to any intellectual property owned by Seller necessary for the production
of the Products. Seller shall provide to Buyer all information, designs, and
documentation required to produce the Products, including, but not limited to,
design, assembly,
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
test, and manufacturing documentation, test equipment, electronic files,
software source code and executables, programming equipment, and any other
Components required to produce the Products. These Components shall be provided
by Seller to Buyer in a timely manner and at a reasonable cost.
10.0 INDEMNITIES, LIMITATION OF DAMAGES, AND WARRANTIES.
10.1 Buyer's Indemnification. Buyer shall indemnify, defend, and hold harmless
Seller and its officers, directors, employees, agents, successors and assigns
from and against any and all losses, claims, actions, costs, liabilities,
expenses, fines, damages, and other relief or penalties it or they may suffer
(including, but not limited to, reasonable attorneys' fees and expenses) arising
out of, relating to, or resulting from:
(a) any material breach or default in the performance by Buyer of any
covenant or agreement of Buyer contained in this Agreement or any Exhibit
hereto;
(b) any act or omission of Buyer or its employees or agents that
constitutes gross negligence, willful misconduct, or actual fraud;
(c) illness, injury or death to any person relating to or arising out of
Buyer's performance of this Agreement;
(d) damage to any real or tangible personal property relating to or
arising out of Buyer's performance of this Agreement;
(e) the provision, sale, use or other exploitation of the Products or any
part thereof, or any products that incorporate the Products, which
infringes or violates any patent, copyright, trademark, tradename, trade
secret or any other proprietary right of any third party;
(f) the testing, possession, provision, sale, use, operation or other
exploitation of a Product or the testing, possession, provision, sale, use,
operation or other exploitation of any of Buyer's products using or
containing a Product or any other claims whatsoever by whomsoever relating
to or arising out of the Product or Buyer's products that incorporate any
aspect of the Services provided or Products sold hereunder; and
(g) any and all actions, suits, proceedings, claims, demands, judgments,
costs and expenses (including reasonable legal and accounting fees)
incident to any of the foregoing,
provided that, Buyer's obligation to indemnify Seller hereunder shall apply only
if:
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(a) Seller gives Buyer prompt notice after learning of any such claims or
actions,
(b) Buyer shall have exclusive control over the defense and settlement of
any such claim or actions,
(c) Seller shall not settle or compromise any such claims or actions
without Buyer's prior written approval, and
(d) Seller shall cooperate with Buyer in a defense and settlement of any
claim, at Buyer's expense, provided that Buyer shall not be liable
hereunder for any settlement or compromise negotiated by Seller unless
Buyer agrees in writing to be so bound. If Seller provides notice of a
claim in accordance with (a) above and is not notified within ten (10) days
thereafter that Buyer intends to defend the claim, Seller shall be entitled
to defend such claim, and settle or compromise such claim, subject to the
indemnification provided for herein.
The foregoing indemnity shall not apply to the extent that such claims or
actions for damages or other relief arise from or are related to the gross
negligence, willful misconduct, breach of any terms or provisions of this
Agreement by, or other unlawful conduct of, Seller or any of Seller's employees
or agents.
10.2 Seller's Indemnification. Seller shall indemnify, defend, and hold harmless
Buyer and its officers, directors, employees, agents, successors and assigns
from and against any and all losses, claims, actions, costs, liabilities,
expenses, fines, damages, and other relief or penalties it or they may suffer
(including, but not limited to, reasonable attorneys' fees and expenses) arising
out of, relating to, or resulting from:
(a) any material breach or default in the performance by Seller of any
covenant or agreement of Seller contained in this Agreement;
(b) any act or omission of Seller or its employees or agents that
constitutes gross negligence, willful misconduct or actual fraud;
(c) illness, injury or death to any person relating to or arising out of
Seller's performance of this Agreement arising from Products manufactured
by Seller, except as to any such damage arising out of or relating to
Buyer's testing, possession, provision, sale, use, operation or other
exploitation of the Products (unless arising from an act or omission
covered by Section 10.2(b), which shall not be carved out of Seller's
indemnification obligations);
(d) material damage to any real or tangible personal property relating to
or arising out of Seller's performance of this Agreement except as to any
such damage arising out of or
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
relating to Buyer's testing, possession, provision, sale, use, operation or
other exploitation of the Products; and
(e) any and all actions, suits, proceedings, claims, demands, judgments,
costs and expenses (including reasonable legal and accounting fees)
incident to any of the foregoing,
provided that, Seller's obligation to indemnify Buyer hereunder shall apply only
if:
(a) Buyer gives Seller prompt notice after learning of any such claims or
actions,
(b) Seller shall have exclusive control over the defense and settlement of
any such claim or actions,
(c) Buyer shall not settle or compromise any such claims or actions
without Seller's prior written approval, and
(d) Buyer shall cooperate with Seller in a defense and settlement of any
claim, at Seller's expense, provided that Seller shall not be liable
hereunder for any settlement or compromise negotiated by Buyer unless
Seller agrees in writing to be so bound. If Buyer provides notice of a
claim in accordance with (a) above and is not notified within ten (10) days
thereafter that Seller intends to defend the claim, Buyer shall be entitled
to defend such claim, and settle or compromise such claim, subject to the
indemnification provided for herein.
The foregoing indemnity shall not apply to the extent that such claims or
actions for damages or other relief arise from or are related to the gross
negligence, willful misconduct, breach of any terms or provisions of this
Agreement by, or other unlawful conduct of, Buyer or any of Buyer's employees or
agents.
10.3 Limitation of Damages. Neither party shall be liable to the other party for
lost revenues, lost profits or other incidental, indirect, special,
consequential, or exemplary damages in connection with this Agreement or
performance hereunder, whether or not a party has been advised by the other
party of the probability of such damage or loss, whether such damage or loss
arises in contract, tort, including negligence, strict liability or otherwise.
Buyer is obligated to train and instruct its employees and any potential users
of the Products with regard to their safe and proper use. Buyer assumes all
risks, both known and unknown, associated with the use, misuse, or loss of use
of the Products. Seller shall have no liability for any injury to the operator
or subject of the Products' application regardless of the reason for the injury
(including, but not limited to, inappropriate therapy, use, or Product
malfunction). Buyer's sole remedy under this Agreement for any Products that
fail to conform to the applicable Specifications or otherwise for
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Seller's breach of this Agreement shall be the repair or replacement of the
Products or a refund of the amount actually paid to Seller by Buyer for the
Product(s).
10.4 Warranties. Seller warrants to Buyer that, with respect to those Products
that constitute finished goods primarily manufactured, assembled, tested,
inspected and packaged by Seller, all Production Units and/or Engineering Units
manufactured by Seller for Buyer pursuant to Purchase Orders delivered hereunder
for Products, for the period specified in Exhibit A, shall: (a) conform in all
respects to all of the Product Specifications and (b) be free from all defects
in materials and workmanship, in each case to the extent verified by Seller
through the testing and inspection procedures defined in the Device Master
Record for such Product or otherwise established and agreed to by Buyer via
Seller's ECO system as of the date of shipment of such units and so certified by
Seller to Buyer at the time of shipment. The foregoing warranties shall not
apply to any Products that have been manufactured, assembled, tested, inspected
and packaged primarily by third parties. Seller shall assign to Buyer any
warranties received from Seller's Suppliers with respect to any Components to
the extent that Seller is permitted to make such assignments. If Seller is not
permitted to make such assignments, Seller shall enforce such warranties on
behalf of Buyer.
During this period and only during this period, Seller's responsibility shall
include and be limited to the labor costs for work performed by Seller at
Seller's facility, component replacement, and domestic ground shipment of
Products from Seller's facility. In all cases, costs not related to warranty
repair or replacement shall be borne by Buyer.
EXCEPT AS SET FORTH ABOVE, SELLER MAKES NO WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE PRODUCTS.
11.0 MISCELLANEOUS.
11.1 Amendment. No amendment or modification of this Agreement shall be binding
upon Buyer or Seller unless set forth in a written instrument signed by Buyer
and Seller.
11.2 Changes. Any change in the (a) Product technical requirements and
descriptions, Specifications, statement of work, drawings or designs; (b)
shipment or packing methods; (c) place of delivery; (d) amount of Buyer-fumished
Components or property; or (e) Product production methods and processes which
may affect form, fit, function, interchangeability, reliability, or safety of
the Products, shall require the prior mutual, written consent of Buyer and
Seller, which consent shall not be unreasonably withheld. If any such changes
cause an increase or decrease in the cost of or the time required for
performance of this Agreement, an equitable adjustment in the Prices and
schedules of this Agreement shall be made to reflect such increase or decrease
and this Agreement shall be modified in writing accordingly.
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
11.3 Insurance.
(a) Seller agrees to obtain and maintain the following minimum insurance
coverages and limits:
1. Worker's Compensation: Statutory limits in each state in which
Seller is required to provide Worker's Compensation coverage.
2. Employer's Liability: Not less than $100,000.
3. Comprehensive General Liability: $2,000,000 per occurrence
excluding completed products and completed operations.
Seller is responsible for any theft, loss, or damage to Buyer-owned
property for which Seller is legally liable.
(b) Buyer agrees to obtain and maintain the following minimum insurance
coverages and limits:
1. Worker's Compensation: Statutory limits in each state in which
Buyer is required to provide Worker's Compensation coverage.
2. Employer's Liability: $100,000.
3. Comprehensive General Liability: $2,000,000 per occurrence
including completed products and completed operations.
4. Product Liability Insurance: Appropriate and adequate for
Products naming Seller as Additional Insured on a primary basis.
Buyer shall provide Seller with a copy of Buyer's certificate of insurance
indicating that Seller is named as an Additional Insured on a primary
basis. Buyer assumes responsibility, except as specified above, for any
theft, loss, or damage, including ordinary wear and tear, to Buyer-owned
property regardless of location, upon its delivery to Seller or its
manufacture or acquisition by Seller on Buyer's behalf. This includes, but
is not limited to, equipment, materials, parts, assemblies, work in
process, finished goods, returned goods, data, documentation, tooling, and
any other property of Buyer.
11.4 Subcontract Management. Seller is responsible for the management of its
subcontractors, suppliers, and/or vendors at its sole discretion, provided that
Seller shall use its commercially reasonable efforts to ensure that all
Suppliers are compliant with the QSR and ISO 13485, to the
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
extent that compliance by such Suppliers is required thereunder, as contemplated
under Section 5.1.
11.5 Personnel Assignment. Seller reserves the right to assign, or reassign
personnel at its sole discretion.
11.6 Location of Work. All work will principally be performed at Seller's
facility.
11.7 Public Announcements. Neither party shall disclose, advertise, or publish
the terms or conditions of this Agreement or the existence of this Agreement
itself without the prior written consent of the other party, except for internal
purposes and as is required by court order and the force of law and/or
regulation. Except as required by law, Buyer may not disclose in its public
announcements the involvement of Seller without Seller's prior written consent,
which consent may not be unreasonably withheld, although it may confirm the
involvement once Seller makes public announcement of its involvement with Buyer
in the manufacture of Production Units for Buyer's Product.
11.8 Assignment. A party's rights under this Agreement may not be assigned or
transferred in whole or in part by operation of law or otherwise without the
other party's prior express written consent, which shall not be unreasonably
withheld, conditioned, or delayed, provided that Buyer may assign its rights
under this Agreement to any party that purchases substantially all of its stock
or assets with the consent of Seller. Any attempted assignment of any rights,
duties or obligations hereunder without such consent shall be void. This
Agreement shall be enforceable by, inure to the benefit of, and shall be binding
upon the successors and permitted assigns of the parties hereto.
11.9 Force Majeure. If performance of this Agreement, or of any obligation
hereunder, is prevented, restricted or interfered with by any act or condition
beyond the reasonable control of the party affected thereby (each, a "Force
Majeure Event"), including without limitation fire or other casualty or
accident; strikes or labor disputes; war, terrorist attacks or other violence;
any law, order, proclamation, regulation, ordinance, demand or requirement of
any governmental or intergovernmental agency or body, the party so affected
shall be excused from such performance to the extent of such prevention,
restriction or interference. Notwithstanding the foregoing, the affected party
shall continue to use its commercially reasonable efforts to recommence
performance whenever and to whatever extent possible without unreasonable delay,
including through the use of alternate sources, workaround plans or other means.
If such Force Majeure Event prevents or delays the performance of a party
hereunder, Buyer and Seller shall extend the Agreement for a period of time
equal to the period of time during which such Force Majeure Event continues, and
during such period, each party shall be temporarily released from its
obligations under this Agreement and Exhibit A hereto (other than the
obligations set forth in this Section 11.9), with each of Buyer and Seller
responsible for bearing its own costs incurred
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
during such period, it being agreed and understood that, during such period,
Buyer shall be permitted to manufacture the Products or engage a third party
mutually acceptable to Buyer and Seller to do the same to prevent an
interruption in supply of Products to Buyer, in which event Seller shall
cooperate with Buyer as reasonably requested to facilitate such activities,
which may include providing copies of the Device Master Records and Device
History Records for the Products to Buyer or a third party engaged to
manufacture the Products during the period of the Force Majeure Event.
11.10 Taxes. Pricing stated in Exhibits shall be exclusive of any federal,
state, or local excise, sales, use or other applicable taxes. Any such costs and
taxes shall be the responsibility of Buyer.
11.11 Severability. Should any provision of this Agreement be finally determined
to contravene any applicable law or governmental regulation, such provision
shall be automatically terminated and performance thereof by both parties shall
be waived to the extent of such contravention. Should such provision be
considered by either party to be an essential element of this Agreement, the
parties hereto agree to negotiate a new, applicable provision in good faith.
11.12 Waiver and Discharge. The failure of any party hereto to enforce at any
time any of the provisions of this Agreement shall in no way be construed to be
a waiver of any such provision, nor in any way to affect the validity of this
Agreement or any part thereof or the right of the party thereafter to enforce
each and every such provision. No waiver of any breach of this Agreement shall
be held to be a waiver of any other or subsequent breach.
11.13 Notices. Any notice given under this Agreement shall be in writing and
shall be: (1) given by confirmed facsimile transmission, (2) sent certified
mail, postage prepaid, return receipt requested, or (3) sent by any nationally
recognized overnight delivery service that delivers to the noticed destination
and provides proof of delivery to sender. All notices shall be effective when
first received at the following addresses:
If to Buyer: Heartware, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Attention: Chief Operating Officer
Facsimile: ▇▇▇-▇▇▇-▇▇▇▇
With a copy to: Convergent GC, LLC
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇▇ ▇. ▇▇▇▇
Facsimile: ▇▇▇-▇▇▇-▇▇▇▇
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
If to Seller: Minnetronix, Inc.
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇
▇▇. ▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
Facsimile: ▇▇▇-▇▇▇-▇▇▇▇
11.14 Governing Law. This Agreement shall be governed by the internal laws of
the State of Delaware without regard to any choice of law provisions thereof.
11.15 Benefit. Nothing in this Agreement, expressed or implied, is intended to
confer on any person other than the parties to this Agreement or their
respective successors or assigns, any rights, remedies, obligations or
liabilities under or by reason of this Agreement.
11.16 Injunctive Relief; Attorneys' Fees. Each party shall be entitled to seek
injunctive relief in any court of competent jurisdiction in addition to any
other remedy at law or in equity in the event of a breach of this Agreement
without the necessity of proving actual damages or posting any bond. In the
event of any legal action or proceeding arising out of or resulting from this
Agreement, the prevailing party shall also be entitled to recover its reasonable
attorneys' fees and costs thereby incurred.
11.17 Complete Agreement. This Agreement, together with all Exhibits,
Amendments, Purchase Orders and related documents contains the complete
agreement between Buyer and Seller with respect to its subject matter, provided
that the parties agree that the Development Agreement shall not be deemed to be
a part of this Agreement. This Agreement supersedes any and all previous
discussions, prior understandings, agreements or representations, written or
oral, by or between the parties related to the subject matter hereof, other than
the Development Agreement.
11.18 Relationship of the Parties. Seller and Buyer intend that an independent
contractor relationship shall be created by this Agreement, and nothing herein
shall be construed as creating an employer/employee relationship, partnership,
joint venture, or concerted action. Personnel assigned by either party to
provide deliverables under this Agreement will be employees or agents of such
party and will not for any purpose be considered employees or agents of the
other party. Each party assumes full responsibility for the actions of such
personnel while performing all its obligations hereunder, either at Seller's or
Buyer's facility, and shall be solely responsible for their supervision, daily
direction and control, payment of salary (including withholding of income taxes
and social security), workmen's compensation and occupational disease insurance
as required by law, comprehensive public liability insurance, compensation,
disability benefits and the like.
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
11.19 Dispute Resolution.
(a) Senior Executives. Controversies between Buyer and Seller shall be
resolved, to the extent possible, by informal meetings and discussions in
good faith between the parties. If a controversy cannot be resolved by
informal meetings and discussions within five days after commencement
thereof, the dispute shall be referred to senior executives of the parties
("Senior Executives"), who shall work together in good faith to resolve the
dispute. The initial Senior Executives shall be ▇▇▇▇▇▇ ▇▇▇▇ on behalf of
Buyer and ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ on behalf of Seller.
(b) Arbitration. If the parties are unable to resolve a controversy
pursuant to Section 11.19(a) within fifteen (15) days after commencement
thereof, the dispute shall be settled binding arbitration in accordance
with the Commercial Arbitration Rules of the American Arbitration
Association ("AAA"), and the procedures set forth below. In the event of
any inconsistency between the Rules of AAA and the procedures set forth
below, the procedures set forth below shall control. Judgment upon the
award rendered by the arbitrators may be enforced in any court having
jurisdiction thereof.
(d) Location. The location of the arbitration shall be in Chicago,
Illinois.
(e) Selection of Arbitrators. The arbitration shall be conducted by a
panel of three neutral arbitrators who are independent and disinterested
with respect to the parties, this Agreement, and the outcome of the
arbitration. Each party shall appoint one neutral arbitrator, and these two
arbitrators so selected by the parties shall then select the third
arbitrator. If one party has given written notice to the other party as to
the identity of the arbitrator appointed by the party, and the party
thereafter makes a written demand on the other party to appoint its
designated arbitrator within the next ten days, and the other party fails
to appoint its designated arbitrator within ten days after receiving said
written demand, then the arbitrator who has already been designated shall
appoint the other two arbitrators.
(e) Discovery. Unless the parties mutually agree in writing to some
additional and specific pre-hearing discovery, the only pre-hearing
discovery shall be (a) reasonably limited production of relevant documents,
and (b) the identification of witnesses to be called at the hearing, which
identification shall give the witness's name, general qualifications and
position, and a brief statement as to the general scope of the testimony to
be given by the witness. The arbitrators shall decide any disputes and
shall control the process concerning these pre-hearing discovery matters.
Pursuant to the Rules of AAA, the parties may subpoena witnesses and
documents for presentation at the hearing. Notwithstanding anything to the
contrary contained in the foregoing, in no event shall discovery extend
past thirty (30) days.
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(f) Case Management. Prompt resolution of any dispute is important to
both parties; and the parties agree that the arbitration of any dispute
shall be conducted expeditiously. The arbitrators are instructed and
directed to assume case management initiative and control over the
arbitration process (including scheduling of events, pre-hearing discovery
and activities, and the conduct of the hearing), in order to complete the
arbitration as expeditiously as is reasonably practical for obtaining a
just resolution of the dispute, provided that in no event may the entire
arbitration process extend past sixty (60) days.
(g) Remedies. The arbitrators may grant any legal or equitable remedy
or relief that the arbitrators deem just and equitable, to the same extent
that remedies or relief could be granted by a state or federal court,
provided however, that no punitive damages may be awarded. No action may be
maintained seeking punitive damages. The decision of any two of the three
arbitrators appointed shall be binding upon the parties.
(h) Expenses. The expenses of the arbitration, including the
arbitrators' fees, expert witness fees, and attorney's fees, may be awarded
to the prevailing party, in the discretion of the arbitrators, or may be
apportioned between the parties in any manner deemed appropriate by the
arbitrators. Unless and until the arbitrators decide that one party is to
pay for all (or a share) of such expenses, both parties shall share equally
in the payment of the arbitrators' fees as and when billed by the
arbitrators.
11.20 Binding Agreement. Execution of this document shall create a binding
Agreement and constitutes a commitment on the part of Buyer to pay for all
Products delivered hereunder according to the purchase price or rate structure
stated in the Agreement, Product or Service Addenda (Exhibits), or Amendments.
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
IN WITNESS WHEREOF, the authorized representatives of the parties have executed
this Agreement as of the Effective Date.
MINNETRONIX, INC. HEARTWARE, INC.
Signature: /S/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ Signature: /S/ ▇▇▇▇▇▇ ▇. ▇▇▇▇
-------------------------- -----------------------------
---------------------------------- -------------------------------------
By [print name of signer]: By [print name of signer]:
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇. ▇▇▇▇
Title: President/CEO Title: COO
Date Signed: 8/17/06 Date Signed: 8/31/06
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
MINNETRONIX
PRODUCTION SERVICES AGREEMENT
EXHIBIT A
HEARTWARE LVAD COMPONENTS
PRODUCT ADDENDUM
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇
▇▇. ▇▇▇▇, ▇▇ ▇▇▇▇▇
PH: 651.917.4060
FAX: ▇▇▇.▇▇▇.▇▇▇▇
▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
EXHIBIT A
HEARTWARE LVAD COMPONENTS
PRODUCT ADDENDUM
This Product Addendum on Exhibit A shall be effective as of August 17, 2006
("Effective Date") and shall be attached to and considered a part of the
Minnetronix Production Services Agreement ("Agreement") dated as of August 17,
2006 by and between HeartWare, Inc. ("Buyer") and Minnetronix, Inc. ("Seller").
Capitalized terms used but not otherwise defined in this Exhibit A shall have
the meanings ascribed to such terms in the Agreement.
A.1. Product Description. Buyer intends to purchase from Seller various
components to be used in clinical testing of its Left Ventricular Assist
Device (LVAD) System (each such component being referred to herein as a
"Product" and collectively, "Products"). All Products initially will be in
"interim release," as defined in Seller's Engineering Changes SOP, document
# DQ-0000-13-0, revision 007-a, and described in the Pioneer System
Development Plan, Seller's document # DP-0001-46-9, revision .02-a. A list
of Products is included under A.2 below.
A.2. Pricing. The applicable price for each Product in effect from time to
time ("Price") shall be determined in accordance with the terms and
conditions set forth in the Agreement and this Exhibit A. The initial
Product Price schedule shall be as shown in the table below. The initial
Product Price schedule is based on the minimum number of units of each
Product expected to be ordered by Buyer and delivered by Seller between
the Effective Date and June 30, 2007 ("Initial Pricing Period"), which
minimum order volumes are set forth in the table below. Any Products
ordered by Buyer on or before September 1, 2006 for delivery by Seller
during the Initial Pricing Period, provided the minimum order volume
requirements set forth below are met, will be sold at the initial Prices
set forth below; provided, however, that, notwithstanding the foregoing,
the initial Price for each Product is subject to change during the Initial
Pricing Period if the Agreement, Specifications, Components, Products,
Services, Exhibit, order quantity or delivery period with respect to such
Product is changed in a manner that impacts the initial Product Price,
either as to increase or decrease; provided, however, that any such change
arising from the actions or inactions of Seller in material breach of its
obligations under the Agreement shall not trigger any price increase
hereunder. Each Purchase Order for any Product must specify Seller's part
and revision numbers for such Product.
MINIMUM ORDER
DESCRIPTION SELLER'S PART # VOLUME REV. PRICE/UNIT
Pioneer Extender Cable CC-0000-01-4 50 .50-a [***]
-----
▇▇▇▇ Pioneer Controller AE-0000-67-8 100 .53-a [***]
-----
▇▇▇▇ Pioneer Monitor AE-0000-70-4 10 .51-a [***]
▇▇▇▇ Pioneer Monitor A/C Power Supply with -----
Customer Label AM-0000-86-8 25 .50-a [***]
-----
Pioneer Monitor Data Cable CC-0000-01-5 25 .50-a [***]
-----
▇▇▇▇ Pioneer AC Adapter kit AM-0000-84-1 100 .51-a [***]
-----
▇▇▇▇ Pioneer DC Adapter AE-0000-70-7 50 .51-a [***]
-----
Pioneer Controller Serial Port Dongle CC-0000-02-0 100 .50-a [***]
▇▇▇▇ Pioneer Battery Pack with Customer -----
Label* AM-0000-86-5 100+ .50-a [***]
-----
▇▇▇▇ Pioneer Battery Charger with Customer
Label AM-0000-86-6 50 .50-a [***]
-----
* Note: The Price for this Product does not reflect any amounts for
hazardous material shipping requirements, as this Product currently does
not have a regulatory exemption. Therefore, an additional amount will be
charged by Seller to cover its actual costs incurred in compliance with
all applicable hazardous material shipping requirements to the extent an
exemption from such requirements is not obtained; provided that Seller
notifies Buyer in advance of any such charge. Seller shall cooperate with
Buyer, at Buyer's expense, to obtain any necessary regulatory exemption to
the extent requested by Buyer.
Buyer and Seller have worked in good faith to support device needs prior to
execution of the Agreement and this Exhibit A. This has resulted in some units
to be built in quantities different than the quantities shown in the table
above. The Products and quantities set forth in the attachment to the email
dated July 19, 2006 from ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ to ▇▇▇▇▇▇ ▇▇▇▇ summarizing Product
status as of July 18, 2006 (as set forth in Column G in such e-mail attachment),
shall be converted into a Purchase Order (the "Initial Purchase Order") to be
placed by Buyer, at the Prices set forth in the above table, separate from, and
prior to placing, a Purchase Order under the Agreement and this Exhibit A for
the minimum order quantities shown above. All terms and conditions set forth in
the Agreement and this Exhibit A shall apply to the Initial Purchase Order,
except that the minimum order volumes set forth in the above table will not
apply, and the Initial Purchase Order will also include an additional charge
payable to Seller in the amount of $20,250.
For Products to be ordered by Buyer for delivery following expiration of the
Initial Pricing Period, the Price shall be determined via a Seller's Price
quotation and corresponding placement of a Purchase Order by Buyer accepting
such Price. The Price shall be quoted and agreed to from time to time based on a
quantity and delivery schedule as requested by Buyer and stated on Purchase
Order(s) placed by Buyer. Subsequent to placement of such Purchase Order(s), it
is subject to change if the Agreement, Specifications, Components, Products,
Services, Exhibit, order quantity or delivery period are changed in a manner
that impacts such Price, either as to increase or decrease; provided, however,
that any such change arising from the actions or inactions of Seller in material
breach of its obligations under the Agreement shall not trigger any Price
increase hereunder. In addition, Prices may change as a result of increases or
decreases in the prices charged by Seller's suppliers or as manufacturing
efficiencies are developed (see Section 8.8 of the Agreement regarding cost
reduction efforts). The Price for any Product provided by Seller shall be valid
for ninety (90) days after the date the quote is made.
A.3. Downpayment. A downpayment equal to 20% of the value (i.e., Price
times number of units) of each order of Products shall be paid by Buyer at
the time of placement of a Purchase Order. The downpayment is intended to
share the materials and schedule risk that is taken on by both parties once
a Purchase Order is placed for Products. As invoices are issued by Seller
to Buyer with respect to shipped Products, a pro rata credit per shipped
unit will be reflected on such invoices to account for the downpayment.
A.4. Delivery Schedule. The delivery schedule for Product orders will be as
stated on Purchase Orders placed by Buyer, based on quantity and delivery
terms included in Seller's Price quote, and agreed upon by Seller.
A.5. Testing. The Product functional and quality control testing to be
performed to verify the Products' conformance to the Specifications at the
time of delivery will be as per the testing and inspection procedures
defined in the Device Master Record ("DMR") or otherwise established and
agreed to by Buyer via Seller's Engineering Change Order ("ECO") process.
A.6. Packaging. The Product packaging will be as currently specified in the
DMR or otherwise established and agreed to by Buyer via Seller's ECO
process.
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
A.7. Warranty. The warranty period for each Production Unit and/or
Engineering Unit of those Products covered by the warranty provisions set
forth in Section 10.4 of the Agreement shall be 180 days parts and labor.
Any damage due to sources other than the Production Unit or Engineering
Unit itself, abuse, or misuse of such Production Unit or Engineering Unit
after shipment voids Seller's limited warranty of such Production Unit or
Engineering Unit.
A.8. Documentation. Consistent with FDA Class III/MDD Class III
requirements.
A.9. Records. Consistent with FDA Class III/MDD Class III requirements for
clinical trial devices. The DMR and Device History Records shall be kept by
Seller for the lesser of (a) ten (10) years from the date of manufacture
for each device or (b) two (2) years after Seller's last production date of
the Product. The Design History File shall be kept by Seller for two (2)
years after Seller's last production date of the Product. In any event, the
records shall be made available to Buyer upon request and offered for
transfer prior to their deletion or destruction by Seller.
A.10. Seller Responsibilities. Seller shall be responsible for the
assembly, testing, and inspection of each Product as defined in the DMR.
A.11. Buyer Responsibilities. Buyer shall be responsible for ensuring that
the use of the Products in clinical trials meets all applicable regulatory
requirements.
A.12. Labeling, Serialization, and Traceability Requirements. Labeling,
serialization and traceability of the Products shall be performed by Seller
in a manner consistent with FDA Class III/MDD Class III requirements, as
currently specified in the DMR or otherwise established and agreed to by
Buyer via Seller's ECO process.
A.13. Certificate of Conformance. Each shipment of Products at "interim
release" or above will be accompanied by a certificate of conformance
signed by a duly authorized representative of Seller certifying that, for
those Products covered by the warranty provisions set forth in Section 10.4
of the Agreement, the shipped Production Units and/or Engineering Units
meet the warranty requirements set forth in Section 10.4 of the Agreement.
In addition, the certificate of conformance shall expressly identify by
serial number those Engineering Units and/or Production Units, if any, that
are not intended for human use and Seller shall affix a "not for human use"
label to such units prior to shipment.
A.14. Units Suitable for Human Use. Each Engineering Unit that (a) has been
manufactured by Seller for Buyer pursuant to a Purchase Order delivered
hereunder for Products, (b) represents an "interim release" Product as
described in A.1 above (i.e., is at
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
a revision level at or above .50-a but below 001-a) and (c) is accompanied
by a certificate of conformance pursuant to A.13 is suitable for human use.
A.15. Process FMEA/Validation. Seller remains responsible for performing,
at Buyer's expense, a Process FMEA per Seller's quality system and
validation on any special processes or qualifications required under the
QSR to build the device. In the event it is determined that any additional
process validation activities are required, Seller will inform Buyer of the
fees associated with such activities prior to performing the work.
A.16. NRE Fees. Any non-recurring engineering ("NRE") fees incurred by
Seller with respect to the Products, including without limitation any
required supplier NRE fees, will be recharged to Buyer in accordance with
the sustaining services and clinical support agreement contemplated by A.25
below.
A.17. Long Lead-Time Purchases. Seller's current long lead times for
purchasing Components for the Products (i.e., the lead times required to
order and receive Components at Seller's dock, but not including Seller's
receiving, inspection and Product assembly time, which typically requires
an additional two to four weeks) are set forth in the following table:
Seller's Product Long Lead ▇▇▇▇ ▇▇▇▇▇▇'▇ Component Required Lead
Product Part # Component(s) Part # Time(s)
---------------------- ---------------- ---------------------- ------------------ -------------
Pioneer Extender Cable CC-0000-01-4 Pioneer Extender Cable CC-0000-01-4 7 weeks
▇▇▇▇ Pioneer AE-0000-67-8 ▇▇▇▇ PCB Pioneer AP-0000-76-8 16 weeks
Controller System Controller
Board
▇▇▇▇ PCB Pioneer AP-0000-77-2 16 weeks
Controller Power Board
▇▇▇▇ Pioneer Monitor AE-0000-70-4 PC Getac CA27 Rugged EP-0000-03-2 9 weeks
Tablet PC with 256MB
RAM, 40GB Hard Drive.
Accessories:
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Xbay-l, Global AC
adapter.
Pioneer Monitor A/C AM-0000-86-8 Pioneer Monitor AC CE-0000-09-2 10 weeks
Power Supply with Adapter
Customer Label
Pioneer Monitor Data CC-0000-01-5 Pioneer Monitor Data CC-0000-01-5 7 weeks
Cable Cable
▇▇▇▇ Pioneer AC AM-0000-84-1 Pioneer AC Adapter CE-0000-07-5 10 weeks
Adapter kit
▇▇▇▇ Pioneer DC AE-0000-70-7 ▇▇▇▇ PCB Pioneer DC AP-0000-80-4 16 weeks
Adapter Adapter Board
Pioneer Controller CC-0000-02-0 Pioneer Controller CC-0000-02-0 7 weeks
Serial Port Dongle Serial Port Dongle
▇▇▇▇ Pioneer Battery AM-0000-86-5 Pioneer Battery Pack CE-0000-08-9 15 weeks
Pack with Customer
Label
▇▇▇▇ Pioneer Battery AM-0000-86-6 Pioneer Battery CE-0000-09-0 15 weeks
Charger with Customer Charger
Label
Upon becoming aware of a material change in any lead-time requirements,
Seller shall forthwith communicate such change to Buyer. All Purchase
Orders for Products, including the requested delivery schedule set forth
therein, shall be submitted by Buyer and accepted by Seller in recognition
of Seller's lead time requirements for Components and receiving, inspection
and assembly activities as communicated pursuant to this Section A.17.
A.18. Service/Spare Parts Needs. Buyer is responsible for identifying and
placing Purchase Orders for Buyer's spare parts requirements at the time of
order. A separate arrangement will be made for the handling of spare units
and the associated costs.
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24B-2
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
THE OMITTED MATERIALS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
A.19. Excess/Scrap Components. The costs of scrap and/or non-conforming
material incurred during normal production activities shall be borne by
Seller. The cost of scrapped and/or excess Components up to 10% over the
order quantity or other pre-approved purchase quantities shall be borne by
Buyer in the event of part obsolescence, or the end of Product life at
Seller. This is intended to cover Components that are no longer needed for
the Product due to ECOs, or end of the Product manufacturing at Seller.
Additionally, Buyer is responsible for excess Components that are purchased
due to minimum buy quantities from the Product Component suppliers. Excess
parts may be transferred to Buyer upon completion of the production orders
in accordance with Section 4.5 of the Agreement.
A.20. Design Changes. Seller will manage suppliers, parts specifications,
and other associated documentation for the Products in Seller's internal
systems, consistent with its obligations under the Agreement. However, the
Price does not include the cost of future design changes to the Products.
In the event of required or requested design changes, Seller will inform
and obtain written approval from Buyer for the fees associated with such
design changes prior to performing the work.
A.21. Troubleshooting. Buyer is responsible for making improvements if any
to resolve design issues. Seller will make reasonable efforts to increase
Product yields and repair Products. Extensive troubleshooting and repair of
design-related issues encountered during production and testing will be at
Buyer's expense in accordance with Section 8.7 of the Agreement and/or
pursuant to the separate sustaining services agreement contemplated by
A.25.
A.22. Service. See separate Servicing Agreement between Seller and Buyer
for service terms.
A.23. Equipment Maintenance. Seller will maintain equipment used in the
assembly and testing of the Products as required by FDA regulations and ISO
13485 standards. This includes inspection, calibration and/or other
maintenance as necessary. Buyer-owned equipment, if any, shall be
calibrated and maintained as required at Buyer's expense in accordance with
Section 8.2 of the Agreement.
A.24. Test Fixtures and Equipment. Seller will provide standard assembly
and test equipment. Any non-standard test equipment or fixtures will be
provided by or purchased by Buyer. In addition, Buyer will provide
Product-specific test equipment, fixtures and training on such devices free
of charge.
A.25. Sustaining Services; Clinical Support. A separate sustaining services
and clinical support agreement with respect to the Products will be entered
into by Seller and Buyer.
[***] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request.
IN WITNESS WHEREOF, each of the parties has caused this Exhibit A to be
executed by its duly authorized representative effective as of the Effective
Date.
SELLER: BUYER:
MINNETRONIX, INC. HEARTWARE, INC.
For Seller Authorized For Buyer Authorized
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇
--------------------------------- ------------------------------------
Printed Name: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ Printed Name: ▇▇▇▇▇▇ ▇. ▇▇▇▇
Title: President/CEO Title: COO
Date of Signature: 8/17/06 Date of Signature: 8/31/06
INVOICE
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇
▇▇. ▇▇▇▇, ▇▇ ▇▇▇▇▇
tel: ▇▇▇.▇▇▇.▇▇▇▇
[MINNETRONIX INCORPORATED LOGO] fax: ▇▇▇.▇▇▇.▇▇▇▇
▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇
Invoice #: 00014197
Date: 9/6/2006
Ship Via
▇▇▇▇ To: Page: 1
▇▇▇▇▇ ▇▇▇▇ Ship To:
HeartWare HeartWare
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Description Amount
Heartware
The Pioneer PSA (section A.2) calls for an additional $20,250.00
charge of $20,250 to be paid at the time of the initial Purchase Order.
The initial Purchase Order has been place. This invoice covers the
additional charges as described in the PSA.
Subtotal: $20,250.00
YOUR ORDER #: AGREEMENT Freight: $ 0.00
SHIPPING DATE:
TERMS: NET 10 Total Amount: $20,250.00
PLEASE REMIT TO: MINNETRONIX, INC. Amount Applied: $ 0.00
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇
▇▇. ▇▇▇▇, ▇▇ ▇▇▇▇▇ BALANCE DUE: $20,250.00
We appreciate your business