CONTRACT MANUFACTURING SERVICE AGREEMENT
This Agreement, dated and effective as of 2012/11/06 (“Effective Date”) is
between Miramar Labs, Inc., a corporation located at 445 Indio Way, Sunnyvale,
CA 94085, USA, the Manufacturer (“MFR”), and Healthcare Technology International
Limited, located at 15/F, Block B, Veristrong Industrial Centre, 36 Au Pui Wan
Street, Fotan, Hong Kong, the Contract Manufacturer (“CM”).
Whereas MFR has expertise in designing and marketing of devices as Manufacturer;
CM has expertise in tool making, plastic part molding and electronic product
assembly. CM is offering contract manufacturing service to MFR to manufacture
the miraDry bioTip (sterile disposable dermatologic treatment accessory)
subassembly (“Product”) under the following terms.
1.
Scope

1.1.
This Agreement applies to all Purchase Orders issued by MFR to CM.

1.2.
This Agreement also applies to all products provided by CM to MFR.

2.
Product Design

2.1.
CM will manufacture the Product in accordance to the specifications provided by
MFR (see Addendum C). MFR will maintain the Design History File and all
associated documents (input, output, design FMEA, verification, and validation).
Copies of relevant Design History File documentation will be provided to CM upon
project commencement. The original Design History File will be maintained by
MFR.

2.2.
MFR shall inspect samples from each pilot lot in accordance with the incoming
inspection criteria specified in Addendum C and provide inspection report to CM
within 5 business days after receipt.

2.3.
The CM is not allowed to make any modification to the Product that would cause
it to be non‑conformant to the specifications or design, including but not
limited to modifications that affect external appearance, functionality,
regulatory approbation or performance, changes in components, materials,
sub‑suppliers, engineering or production process, or manufacturing location
without MFR’s written consent. MFR’s written consent to changes may include
effective date and or implementation timeline.

2.4.
CM will obtain MFR’s written approval on all proposed design changes.

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3.
Quality & Regulatory

3.1.
Quality System Requirements

3.1.1.
CM will maintain an FDA registered facility and ISO 13485 quality system
certified by a Notified Body or CMDCAS Registrar for the manufacture of
Products.

3.1.2.
MFR shall evaluate Supplier’s quality system to initially qualify CM and at
appropriate intervals to ensure continued suitability. Evaluations include
review of CM’ s documented procedures, quality system records and on-site
audits/inspections relevant to this Agreement.

3.1.3.
MFR shall re‑evaluate CM’ s quality system at least once annually through a
written quality survey and conduct on-site audits at least once every 3 years.
MFR reserves the right to evaluate the CM’s quality system and operations,
including on-site audits/inspections relevant to MFR’s Product at any time
during CM’s normal business hours, with 7 calendar days of prior notice.

3.1.4.
CM shall address any deficiencies identified during evaluations in a timeline
approved by the MFR.

3.1.5.
MFR will provide the Quality regulation before tooling and quality
specification, specimen, special purpose test equipment for prototype, and
functional prototypes to CM for building engineering samples, engineering pilot,
production pilot (PP) and mass production. Both parties review PP statistics
after corrective and preventive actions to agree on quality specification and
counter-sign marginal specimens to govern outgoing quality and internal cost of
mass production.

3.2.
Quality Control

3.2.1.
CM will manufacture Products in an ISO Class 8 compliant controlled environment
to minimize Product exposure to airborne particulates. CM shall establish and
maintain procedures including maintenance, adjustment, and inspection procedures
to adequately control conditions to minimize risk of Product exposure to
particulates and bioburden in a manner acceptable to MFR and compliant with
ISO 14644‑1: 1999, Cleanrooms and associated controlled environments – Part 1:

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Classification of air cleanliness; ISO 14644‑2: 2000, Part 2; Specifications for
testing and monitoring to prove continued compliance with ISO 14644‑1;
ISO 14644‑3: 2005, Part 3: Test methods; ISO 14644‑5: 2004, Part 5: Operations,
and 14698‑1:2003 Cleanrooms and associated controlled environments –
Biocontamination control, Part 1 – General principles and methods. Initial
environmental specifications include temperature and humidity, and any
subsequent changes must be approved in writing by MFR.
3.2.2.
CM shall establish and maintain requirements for the health, cleanliness,
personal practices, and clothing of personnel to minimize Product exposure to
particulates and bioburden and adequately control contact between personnel and
Product.

3.2.3.
In accordance with ISO 13485, CM will allow MFR audits and random process and
Product inspections to evaluate CM processes and verify Product conformance. MFR
reserves the right to conduct audits during CM’s normal work hours with
7 calendar days of prior notice. CM shall, either upon request by MFR or in the
normal course of business, carry out similar audits to their suppliers.

3.2.4.

CM shall address any non‑conformances to FDA regulations, ISO requirements or
this agreement identified during MFR audits in a timeline approved in writing by
the MFR.

3.3.
Incoming Inspection

3.3.1.
MFR shall inspect Product in accordance with the incoming inspection criteria
specified in Addendum C.

3.3.2.
MFR shall notify CM and provide defect statistics and samples within 10 business
days after determining that a lot has failed incoming inspection.

3.3.3.
In the event of a disagreement between MFR and CM, a mutually agreed upon third
party investigator shall be utilized. The expense for this service shall be paid
by the party determined to be at fault by the investigator.

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3.4.
Remedies for Defective Product

3.4.1.
The CM shall remedy defective goods as soon as possible, but not to exceed
30 calendar days after confirmation of defect. If requested by CM, MFR shall
return defective Product to CM at CM’s cost.

3.5.
Regulatory Inspection

3.5.1.
MFR shall be solely responsible for all contacts and communications with the FDA
and other Governmental Authorities with respect to all matters relating to the
Product and regulatory approvals. The MFR and CM shall coordinate activities
necessary to ensure ongoing readiness for regulatory inspections pertaining to
Products or the services provided hereunder by CM.

3.5.2.
CM shall notify MFR and provide MFR with copies of any notices or communications
of any inspection, investigation, inquiry, regulatory action, or other material
Governmental notice or communication by or from the FDA or other Governmental
Authorities relating to the Product or the services provided hereunder promptly,
but in no case later than 3 business days after CM becomes aware of such notices
or communications. MFR shall have the right to be present at and to participate
in any such inspection or other regulatory action with respect to the Product.
CM shall provide MFR with copies of any inspection; findings or observations and
any other documentation received by CM from the FDA or any other Governmental
Authority, including, without limitation, any FDA Form 483 or Warning Letters up
to the condition allowed by law. CM shall provide any proposed response thereto
3 business days prior to required response for MFR’s review and approval prior
to submission. No such responses shall include any false or misleading
information with respect to the Product or MFR.

3.5.3.
CM shall provide immediate notice to MFR upon notice of debarment, suspension,
or other regulatory restriction on their ability to provide services
contemplated hereunder.

3.5.4.

To the extent MFR determines it necessary for regulatory

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compliance, CM shall grant MFR full access to CM’s Master File and all other
manufacturing and shipment records associated with MFR.
3.6.
Records for Lot Traceability

3.6.1.
CM will maintain the Device History Record (“DHR”). A copy of the DHR for each
production lot will be provided to MFR for final review and product release. The
DHR will contain the following:

a)
Lot number and Quantity released for Shipment

b)
Certificate of Compliance (C of C) showing product release authorization

c)
Label Records including Label Line Clearance Form

d)
Device History Records including Router Sheets (work order) and Production
Records including Test and Inspection data as requested in writing by MFR and
Component Traceability information as requested in writing by MFR

e)
Final Inspection Record including Completed Inspection Forms

f)
Shipping Documents

g)
All Non-Conforming Material Reports

3.6.2.
CM will maintain all Records for a period of seven (7) years or forward original
records to MFR upon request by MFR. CM will notify MFR at least 30 days prior to
destroying any records and will not destroy such records without approval from
MFR.

3.7.
Change Control

3.7.1.
CM will have the primary role in designing processes to carry out the terms of
this Agreement and shall maintain all associated documents, including, without
limitation, the DHR, MFR related drawings, the Device Specifications, test
specifications and procedures, process FMEA, process verification, process
validation and all other documents required to

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maintain full compliance with the terms of this Agreement (“Records”). All such
records shall be confidential to and the sole property of MFR. MFR will review
and approve process changes proposed by CM prior to implementation.
3.7.2.
CM will maintain a specification and revision control system for all MFR related
drawings. CM will obtain prior written approval by MFR for any changes to Device
Specification. CM will generate and maintain the Device Master Records (“DMRs”)
for the devices and provide copies of such DMRs to MFR within ten (10) calendar
days after request.

3.7.3.

CM will maintain the specifications and procedures for test methods developed by
MFR. CM shall obtain MFR’s written approval for any changes in MFR’s
specifications, procedures or methods. CM shall validate all test methods used
on Devices and provide MFR with written proof of such validation, including
validation data collected, within ten (10) calendar days of MFR’s request for
such proof.

3.8.
Regulatory Reporting Obligations

3.8.1.
MFR shall be solely responsible for (i) receiving all Product complaints and
reports of Product adverse events and malfunctions, and all communications with
complainants and provide appropriate information to CM; and (ii) filing all
required regulatory reports for the Product or the Regulatory Approvals,
including, without limitation, any medical device reports or other adverse event
reports relating to the Product.

3.8.2.
CM shall provide information regarding any complaints, reports of adverse events
or malfunctions relating to the Product due to manufacturing fault to MFR within
5 business days of receipt.

3.8.3.
When requested by MFR, CM will conduct complaint investigations for the Product
manufactured by CM (including investigation of products or services purchased by
CM for use in MFR’s Product) and will follow‑up as soon as possible, but no
later than twenty-one (21) calendar days. CM will respond to requests for
corrective action in writing as soon as possible

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after receipt, but within fourteen (14) calendar days of request. Responses to
Corrective Actions shall address the following:
a)
Root cause of nonconformity

b)
Correction required to address existing nonconformities

c)
Corrective action plan to prevent recurrence of nonconformities

d)
Implementation timeline (correction and corrective action)

e)
Effectiveness check of corrective action

3.9.
Quality Reports

3.9.1.
CM shall provide a report to MFR on a monthly basis containing mutually agreed
upon quality information and metrics. The report shall be provided no later than
the 10th calendar day of each month with information current to the last
calendar day of the preceding month.

3.10.
Approved Supplier List

3.10.1.
CM will maintain an Approved Supplier List. Approved suppliers will be selected
and qualified under the CM’s supplier management process, compliant with FDA QSR
and ISO 13485 requirements. Suppliers providing products or services used in
MFR’s Product must be approved in writing by MFR.

3.10.2.
CM will have purchasing authority for all materials and services associated with
materials used in the production of the Product. CM will maintain appropriate
procedures in accordance with applicable ISO and QSR regulations, including
component identification and traceability. CM will only purchase products and
services used in MFR’s Products from suppliers on the Approved Supplier List.

4.
Tooling and Equipment

4.1.
A list of tooling and equipment (including fixtures) needed to manufacture the
MFR’s Product is listed in Addendum A. The list distinguishes between items
being consigned to CM by MFR free of charge, and items to be developed by CM per
quotation and Purchase Order. All tooling and equipment developed for the
manufacture and testing of MFR’s Products shall be the sole and exclusive

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property of MFR. Addendum A may be modified by mutual consent of CM and MFR to
add or remove items as necessary.
4.2.
Any costs associated with Product design changes requiring modifications to any
of the items listed in Addendum A shall be agreed to in writing and paid by MFR.

4.3.
Tooling and equipment to be developed by CM shall be quoted with the following
minimum payment terms:

a)

Up front deposit of 50% of tooling and development cost plus 100% of equipment
and fixture cost

b)

2nd progress payment of 30% of tooling and development cost

c)

Balance payment of remaining 20% of tooling and development cost

4.4.
Maintenance and Calibration

4.4.5.
CM assures all tooling and equipment used in the manufacture and test of MFR
Product shall be maintained fit for production at all times in good working
order and under calibration control if it is determined necessary by both
parties.

4.4.6.
CM shall ensure all inspection, measuring, and test equipment is suitable for
its intended purposes and is capable of producing valid results. Suitability
includes limits for accuracy and precision. CM shall establish and maintain
schedules for the calibration and preventive maintenance in accordance with the
manufacturer’s recommendations. Calibration standards shall be traceable to
recognized standards.

4.4.7.
MFR shall specify maintenance and calibration schedule to CM for MFR owned
tooling and equipment and shall pay for associated costs. Payment terms to be
agreed to in writing by CM and MFR.

4.4.8.
CM owned tools, furniture, and processing equipment shall be maintained and
calibrated by CM at their own cost.

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4.4.9.
Consumable items used in the manufacture of the Product are the responsibility
of CM.

4.5.
Disposition

4.5.3.
For any MFR owned tooling or equipment which has not been utilized in the
manufacture of Product within the past 12 months, CM shall notify MFR that the
tooling or equipment shall be withdrawn from service. MFR shall have 30 calendar
days from this notice to tell CM what to do with the tooling and equipment. CM
shall provide options for disposition and costs. Tooling or equipment returned
to MFR will be shipped at MFR’s cost.

5.
Forecast and Ordering

5.1.
MFR will use its commercially reasonable efforts to provide CM with a 12 month
rolling non-binding forecast of its intended purchases and requested deliveries.
This non-binding forecast will be updated quarterly with subsequent updates as
needed. Such forecast will be for used for planning purposes only and will in no
way create an obligation on MFR’s part to purchase Product.

5.2.
CM will use provided forecast to plan their capacity and advise MFR of long lead
materials, capital requirements such as tooling and resources needed to support
the plan. MFR may choose to purchase specific long lead materials to support the
extended forecast, but will do so only with an expressly written Purchase Order
(“P.O.”) for said material. MFR will ensure that the amount of finished goods
inventory, work in process, and raw materials (“Inventory”) is limited to that
amount required to support the agreed upon lead times and Purchase Orders,
unless otherwise agreed to by MFR purchase order. The costs associated with any
excess inventory not authorized in writing by MFR will be borne by CM.

5.3.
If and when MFR desires to commit to purchase a product or material, MFR shall
issue a P.O. in written or electronic form describing the Product, identifying
the product by MFR product number, specifying the quantity, price, delivery
date, shipping and any other information required. CM shall make its best
efforts to accept each MFR P.O. unless such P.O. is inconsistent with applicable
terms of this Agreement and will respond to MFR within 3 business days after
receipt of the Purchase Order. When written or electronic acknowledgment of
receipt and

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acceptance of a P.O. is made by CM, the P.O. shall be deemed a commitment to
purchase and sell the specified Products pursuant to the applicable terms of
this Agreement. In the event of any conflict between the terms of this agreement
and the terms of any P.O., the terms of this Agreement shall control.
5.4.
Upon acceptance of P.O., CM shall provide immediate notice to MFR if they are
unable to deliver to the terms, either quantity or delivery date.

5.5.
The MFR shall have the option to defer delivery of all or part of any binding
P.O. up to 2 months subject to written notice 30 calendar days before scheduled
delivery.

5.6.
Cancellation notice

5.6.4.

CM shall periodically update MFR with order lead-time for long lead-time
material and cancellation lead-time for those cancellable materials.

5.7.
Obsolete and Unused Material

5.7.2.

In the event of P.O. cancellation and design changes that result in obsolete
material, the MFR agrees to pay for materials committed to in open Purchase
Orders for raw material, work-in-process and finished goods, except to the
extent that CM has a readily available use for such materials, for example they
can be used for another customer. CM will send an invoice for the cost of the
obsolete material plus 10% material overhead charge to MFR. MFR to pay invoice
within 30 days.

5.7.3.

If material is unused for over 2 months and without open P.O. for product the
material is used for, CM will send an invoice for the cost of the unused
material plus 10% material overhead charge to MFR. MFR to pay invoice within
30 days. The unused material will be kept as MFR’s consigned material for
deposition.

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5.8.
Stop Production Notice

5.8.3.
MFR may, in writing, direct CM to stop the production of Products during any
stage of the manufacturing process (a “Stop Production Notice”). MFR has the
right to direct CM to prepare Products up through a particular level of the
manufacturing process and to hold such partially completed Products pending
resolutions to be implemented as a result of error correction activities. If
such a Stop Production Notice from MFR is not due to CM’ s negligence or failure
to perform its obligations under this Agreement, MFR shall be responsible for
the actual and reasonable costs of downtime and idle capacity charges incurred
by CM resulting from a Stop Production Notice and for the actual and reasonable
costs associated with the holding of partially completed Products and any
required rework of Product.

6.
Logistics & Shipping

6.1.
CM will pack and package Product using agreed upon methods or best practices to
protect the Product from deterioration or damage during processing, storage,
handling, and shipment.

6.2.

Products manufactured under this agreement will be packaged with labeling that
states “Manufactured for MIRAMAR LABS, Inc.” or equivalent.

6.3.
Delivery

6.3.4.
Delivery terms: FOB Hong Kong.

6.3.5.
CM shall quote a delivery date in writing upon acceptance of each Purchase Order
from MFR.

6.3.6.

CM agrees to meet this delivery date within a tolerance of +/-10 business days
for sea freight and +/-3 business days for airfreight.

6.3.7.
MFR shall specify the shipping method at least 2 weeks prior to the shipment
date.

6.3.8.
In the event the CM is unable to ship Product in time for the agreed upon
delivery date due to CM’s fault, then CM shall pay for the additional

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incurred cost for expedited freight to make up delay for minimal urgent quantity
requested by MFR and agreed to by CM. CM’s liability is limited to less than 10%
of the Product price of the portion of the shipment that is 31 or more days late
according to CM’s confirmed schedule.
6.3.9.
CM shall deliver Product in accordance with the Delivery Date set forth in the
relevant Purchase Order. TIME IS OF THE ESSENCE IN MEETING THE REQUIREMENTS OF
ALL PURCHASE ORDERS AND IN DELIVERY OF ALL PRODUCTS.

6.3.10.
If MFR requests to expedite a shipment of Product on CM’s confirmed schedule, CM
is entitled to charge an expedite fee and will provide MFR a quotation for the
fee.

6.4.
CM’s Export Documents (License(s))

6.4.4.
CM is responsible for obtaining and maintaining all export license(s) required
for delivery of the Product to MFR under this Agreement to MFR’s designated
location.

6.4.5.
CM shall issue all documentation that may be required by law or regulation
regarding the export or re‑export of the Product to the MFR’s designated
location.

6.5.
MFR’s Import Documents

6.5.5.
MFR is responsible for obtaining and maintaining any regulatory compliance and
import license(s) required for delivery of the Product to MFR.

6.5.6.
CM shall reasonably cooperate with MFR to the extent required to sell the
Product.

7.
Pricing and Credit Payment

7.1.
Initial pricing for Product is set forth in Addendum B. The price(s) set forth
in Addendum B shall be itemized to include the costs of materials, labor,
overhead and profit. When MFR places a P.O., CM will confirm price changes if
costs exceed 3% of previous quote. Both parties will review cost every 6 months.

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7.2.
The pricing shall be forecast for six (6) months and shall be updated by CM on a
quarterly basis, or more frequently if requested in writing by MFR. As volumes
of Purchase Orders and experience with the Product increase, it is anticipated
that the costs to supply Products will decline and, in connection with that
decline, CM agrees to negotiate in good faith reductions to the initial price
set forth in Addendum B. If there are price increases in transportation,
components or labor costs, MFR agrees to negotiate in good faith increases to
the initial price set forth in Addendum B to reflect such additional costs.

7.3.
Any design change for the Products required by MFR shall be subject to mutual
agreement of the parties on the effect of such design change on pricing of the
Product. If there is no agreement reached regarding pricing, MFR and CM each has
the right to terminate this Agreement pursuant to Clause 8.1.

7.4.
Invoice & Payment

7.4.7.
MFR agrees to pay all invoices within 7 business days of receipt for Engineering
and Tooling charges and Pilot Production shipments; and net 45 calendar days
from date of invoice within bank credit limit. For invoices exceeding credit
limit, MFR agrees to pay 50% deposit upon placing order and the remaining
balance before CM ships Product.

7.5.
Payment Reduction or Deferment

7.5.4.
No Set Off clause. MFR agrees to settle valid payment according to Purchase
Order terms for the delivery of finished goods and any counter claims shall be
paid instead of offsetting by CM after agreement on responsibility.

7.6.
Currency & Taxes

7.6.4.
All money terms shall be in US Dollars.

7.6.5.
Payment to CM shall incur no tax withholding. Provided, however, that payments
shall be made in accordance with applicable law agreed to in Clause 22.

7.7.
Reimbursable Expenses

7.7.1.
MFR will reimburse CM only for expenses which are expressly authorized in this
Agreement or authorized in writing by MFR prior to being incurred

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by CM. EXCEPT AS EXPRESSLY SET FORTH HEREIN, NO OTHER COSTS OR EXPENSES ARE
REIMBURSABLE UNDER THIS AGREEMENT.
7.8.
CM must pay all refunds to MFR in full within 30 business days of receiving
notice of MFR request for refund, provided that such refunds are justified under
the terms of this Agreement. Payment by refund will be either by credit towards
MFR’ s payment, or by Telegraph Transfer, or by Electronic Funds Transfer, at
sole discretion of MFR.

8.
Terms and Termination of Agreement

8.1.
The term of this Agreement shall commence on the Effective Date upon exchange of
signed copies from both parties and remain in effect for at least 3 calendar
years ending December 31st, and will renew automatically unless terminated by
either party by giving following written notices to the other party:

a)
immediately if bankrupt, Insolvent; or

b)
immediately after failure to cure breach due to other than Force Majeure within
30 calendar days after written notice sent; or

c)
immediately after failure to cure breach due to Force Majeure within 60 calendar
days after written notice sent; or

d)
at least six (6) months written notice in all other cases.

8.2.
If CM desires to terminate this agreement, CM agrees to accept and fulfill one
end‑of‑life P.O. from MFR.

8.3.
Effects of Termination

8.3.8.
Obligations. All obligations that accrued prior to the effective date of
termination (including without limitation, payment obligations) shall survive
termination.

8.3.9.
Return of Confidential Information. Each party shall promptly destroy with
certification of destruction or return to the other party all Confidential
Information from the disclosing party.

8.3.10.
Survival. The following provisions shall survive any termination of this
Agreement: Clauses 9, 11, 12, 13, 14, 16, 17 and 23.

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9.
Notices

9.1.
All Notices must be made in writing and delivered personally, by courier, via
registered mail with acknowledgement of receipt, or by electronic means with
printed acknowledgement of receipt, and addressed:

a)
To the CM:

Attn: Division General Manager
Healthcare Technology International Limited
15/F, Block B, Veristrong Industrial Centre
36 Au Pui Wan Street
Fotan, Hong Kong
Fax: (852) 2343-7310

b)
To the MFR:

Attn: Vice President of Manufacturing
Miramar Labs, Inc.
445 Indio Way
Sunnyvale, CA 94085, USA
Fax: 408-940-8795

10.
Insurance

10.1.
MFR shall maintain product liability insurance covering MFR and CM. CM’s
quotation excludes product liability insurance.

11.
Indemnification

11.1.
MFR Indemnification Obligations. MFR shall indemnify, defend and hold CM
harmless from and against any third party claims, losses, liabilities, damages,
cost (including court or arbitration costs) and expense (collectively, “Losses”)
incurred by CM as a result of (i) any defect in MFR’s design of the Product;
(ii) any Intellectual Property (“IP”) infringement or product liability claim
directly resulting from CM’s compliance with MFR’s Product specifications
(Clause 2); (iii) a material breach by MFR of its representations, warranties,
covenants or obligations under this Agreement, or (iv) any gross negligence or
willful

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misconduct of MFR, except Losses to the extent resulting from any action or
inaction of CM for which CM is required to indemnify MFR pursuant to Clause 11.2
hereof.
11.2.
CM Indemnification Obligations. CM shall indemnify, defend and hold MFR harmless
from and against any third party Losses incurred by MFR as a result of (i) any
failure of the Product to meet the Product specifications (Clause 2) or comply
with MFR’s written instructions; (ii) CM’s violation of GMP or any other
applicable Laws; (iii) a material breach by CM of its representations,
warranties, covenants or obligations under this Agreement; or (iv) any gross
negligence or willful misconduct of CM, except Losses to the extent resulting
from any action or inaction of MFR for which MFR is required to indemnify CM
pursuant to Section 11.1 hereof.

12.
Warranty Disclaimer

12.1.
CM warrants Product for 13 months from the date code for repair or replacement.

12.2.
Except as set forth in this Agreement, CM does not provide any warranty of:

c)
Merchantability and fitness for any particular use;

d)
Compatibility with any other product; or

e)
Misuse by user or design fault.

12.3.
Notwithstanding the foregoing disclaimer, CM warrants that the Products shall
be:

a)
manufactured in accordance with U.S. 21 CFR 820 FDA Good Manufacturing Practices
and in accordance with all other regulatory requirements applicable for the
Products for sale in the United States as notified by MFR, and for such other
countries as MFR shall specify from time to time as notified by MFR;

b)
manufactured in accordance with the agreed upon Product specifications
(Clause 2);

c)
shall operate in accordance with the Product design (Clause 2); and

d)
all versions of its Products which are sold and licensed to MFR comply with
Directive 2011/65/EU Restriction of Hazardous Substances (RoHS), and will be
documented for MFR and its

-16-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

customers as meeting the RoHS Compliance definition per the directive.
13.
Limitation of Liability

13.1.
Neither party shall be liable hereunder for any indirect, punitive, incidental
or consequential loss or damages of the counter-party or third party.

14.
Field Failure and Recalls

14.1.
All regulatory assessments including complaint investigations, Medical Device
Reports (“MDRs”) to FDA and all applicable Regulatory Jurisdictions
determination and decisions to recall Product will be the responsibility of MFR.
MFR shall make reasonable efforts to notify CM within two (2) business days of
becoming aware that any regulatory agency has issued a recall of Products. CM is
responsible for acknowledging receipt of MFR’s notification and taking the
actions listed below as soon as reasonably possible. In no event shall MFR’s
failure to notify CM of a recall within two (2) business days relieve CM of any
of its responsibilities hereunder. However, CM shall not be liable for the cost
of any product built that could have been avoided by CM had timely notification
been provided to CM, when such information was available and known.

14.2.
MFR is responsible for field returns due to design defects; while CM will be
responsible for manufacturing defects and restricted to remedy under Clause 3.4.
CM will be liable for any additional out of pocket costs incurred by MFR as a
result of CM’s failure to meet its warranty obligations.

14.3.
For purposes of this Agreement, “Epidemic Failures” shall mean Product failures
within thirteen (13) months after the date of delivery of the Product, equal to
or in excess of 1% of any particular lot, 1% of all shipments within a
particular timeframe, or any defect that may result in a safety related concern,
resulting from substantially similar defects including without limitation
components with inherent or latent defects. Notwithstanding the foresaid, the
Epidemic Failure shall not include any Product failure that is directly caused
by Product designs and specification solely provided by MFR or materials
provided or assigned by MFR, manufacturing process or quality control procedure
instructed by MFR, or sub-supplier designated by MFR.

-17-

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with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

14.4.
In the event that any of the Products are recalled because of Epidemic Failure
where such Epidemic failure results from CM failing to meet its obligations
under this Agreement including without limitation due to CM’s failure to meet
its warranty, negligence or use of non-conforming parts, CM agrees to indemnify
MFR in relation to all losses, actions, proceedings, liabilities, claims,
demands, expenses, and costs (including legal costs, but excluding loss of
profit or loss due to consequential, incidental, or indirect damage) arising or
relating in any way to the recall, and CM will replace the affected lot and pay
a maximum of 20% of the FOB value of the lot for recall cost compensation.

15.
Force Majeure

15.1.
Both parties are not liable for damage of breach owing to acts of God or other
causes beyond its reasonable control. The breaching party has to notify the
other party of the breach within 5 business days the force majeure event begins
or ends. In case the breaching party cannot recover after 60 calendar days, the
other party may terminate the Agreement with written notice to the affected
party.

16.
Intellectual Property

16.1.
MFR Intellectual Property. All intellectual property, tangible and intangible
including without limitation, and any and all data, results, analyses,
techniques, inventions, improvements, discoveries, ideas, processes, know-how,
patents, patent applications, copyrights, trademarks, formulations, trade
secrets and other proprietary information and rights (collectively,
“Intellectual Property”) that is invented solely by MFR before and during the
term of this agreement shall be the sole and exclusive property of MFR.

16.2.
CM Intellectual Property. Except as expressly set forth herein, all intellectual
property, tangible and intangible including without limitation, and any and all
data, results, analyses, techniques, inventions, improvements, discoveries,
ideas, processes, know-how, patents, patent applications, copyrights, trade
secrets and other proprietary information and rights (collectively,
“Intellectual Property”) that is invented solely by CM or its’ associated
companies before and during the term of this agreement shall be the sole and
exclusive property of CM or the assigned and associated entities.

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with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

16.3.
Product Intellectual Property. CM acknowledges the MFR’s exclusive ownership of
all Intellectual Property Rights related to the Product and ownership of the
Product (including any modifications thereto) whether created by MFR or CM
separately or jointly, the unique processes used in the manufacture of the
Product, all unique documentation used in the manufacture of the Product and the
tooling for the Product (“Product Intellectual Property”). CM further
acknowledges that all such Intellectual Property, unique processes, unique
documentation and tooling are confidential to MFR and shall be treated as
Confidential Information under this Agreement. Any Product Improvements shall be
the property of MFR. CM hereby assigns to MFR all right, title and interest in
and to all Product Intellectual Property, Product Improvements and all
intellectual property rights therein. CM shall promptly notify MFR of all
Product Improvements of which CM is aware and shall assist MFR, at MFR’s request
and expense, to seek and maintain intellectual property protection for all
Product Improvements. As used herein, “Product Improvements” means all design
information and all improvements, enhancements or changes to any Product,
processes for manufacturing such Product or tooling for such Product. Product
Improvements excludes any improvements made by CM to its generally applicable
manufacturing methods.

16.4.
CM will deliver all tooling and equipment (including fixtures) paid by MFR to
MFR within thirty (30) calendar days of MFR’s request. CM acknowledges that CM
received no right to, and CM covenants that CM will not, supply Products to any
third party.

16.5.
Infringement

a)
In the event there is proven infringement by one party the Infringed Party is
entitled to injunctive relief and compensation.

b)
Each party shall provide the other with prompt written notice of any claims made
(or threatened) by third parties alleging invalidity or infringement of CM or
MFR Intellectual Property.

16.6.
Confidential Information & Trade Secret

a)
As used herein, Confidential Information means all information or data
(including all oral and visual information and all information

-19-

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with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

or data recorded in writing or electronic writing) which is clearly identified
by a Party as confidential at the time of disclosure;
b)
During the continuance of this Agreement and for a period of four (4) years
after the termination or expiration of this Agreement, each Party agrees: i) not
to disclose or cause to be disclosed either directly or indirectly to any
person, any Confidential Information of the other Party without the prior
written approval of the other Party other than to its affiliates and its and
their employees, officers, directors, contractors and agents who need to know
such information to exercise the receiving party’s rights and perform its
obligations under this Agreement, if such representatives are bound to protect
the other party’s proprietary and confidential information on terms no less
protective of such information than the terms herein and the receiving party
shall be responsible for any breach of this Clause by any such representatives;
ii) to safeguard the Confidential Information of the other Party in the same
manner the receiving party safeguards its own proprietary and confidential
information of like character (but using no less than reasonable care); and
iii) only use such Confidential Information of the other Party except to
exercise its rights and perform its obligations under this Agreement. For the
avoidance of doubt, all specifications and tooling for the Products are the
Confidential Information of the Purchaser.

c)
The obligations imposed on the Parties by Clause a) do not apply to any
information which:

1)
is in, or after the date of this Agreement enters into, the public domain;

2)
was received lawfully by the receiving Party from a third party not being
subject to any obligation or confidence regarding such information;

3)
is required by law to be disclosed; provided that if a court or any other
governmental entity orders the receiving Party to produce any of the disclosing
Party’s Confidential

-20-

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with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Information, the receiving Party shall (i) to the extent permitted by law,
promptly notify the disclosing Party of such order, (ii) produce only the
information specifically required to be disclosed, and (iii) cooperate with the
disclosing Party’s objections regarding the disclosure.
17.
Non-Solicitation/Non-Compete

17.1.
No Party or its directors, employees or agents shall directly or indirectly
solicit, divert or engage any business partners, directors, employees or agents
of the other party for a period of 2 years after the termination of this
Agreement.

17.2.
During the term of this Agreement and for two years after expiration or
termination, CM shall not manufacture competing products for any party other
than those expressly approved in writing by MFR. In no event shall CM, either
during the term of this Agreement thereafter manufacture any products which
incorporate MFR’s Intellectual Property or confidential information or which are
designed to be used with MFR’s products for itself or any third party.

18.
Relationship of Parties

18.1.
The relationship between the MFR and CM established in this Agreement is that of
independent contractors, and nothing contained herein shall be deemed to create
a relationship of employer and employee, principal and agent, partners, or
otherwise. Neither party shall have any authority to obligate the other in any
respect nor hold itself out as having any such authority. All personnel of
either party shall not represent themselves as employees of the counter party.

18.2.
MFG hereby grants to CM a limited license to use MFR’s Intellectual Property and
Confidential Information solely for the purpose of manufacturing Products in
China for MFR under the terms of this Agreement. No other right or license is
granted or may be implied by the terms of this Agreement. All licenses granted
hereunder shall expire upon the termination of this Agreement.

19.
Assignment

19.1.
A Party may not assign any of its rights under this Agreement without the prior
written consent of the other Party; provided however that MFR may assign this
Agreement to an acquirer of all or substantially all of the business or assets
of MFR. CM shall not subcontract or delegate any of its obligations under this

-21-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Agreement to any affiliate or third party without MFR’s prior written consent
and provided that such affiliate or third party agrees in writing to be bound by
provisions no less protective of MFR’s Confidential Information than Clause 16
hereof and provisions which assign to CM all Product Improvements so that such
Product Improvements shall be assigned to MFR hereunder. Any assignment,
transfer, subcontracting or delegation not in accordance with the foregoing
shall be void.
20.
Severability

20.1.
If any provision of this Agreement shall be held to be invalid or unenforceable
for any reason, the remaining provisions shall continue to be valid and
enforceable. If such provision could be limited to become valid and enforceable,
then such provision shall be deemed to be written, construed, and enforced as so
limited.

21.
Waiver

21.1.
The failure of either Party to enforce any provision of this Agreement shall not
be construed as a waiver or limitation of that Party’s right to subsequently
enforce and compel strict compliance with every provision of this Agreement.

22.
Interpretation and Applicable Law

22.1.
The provisions of this Agreement shall be interpreted according to the laws of
England, notwithstanding its conflict of laws provisions.

23.
Dispute Resolution

23.1.
Arbitration. Any controversy or claim arising out of or relating to this
Agreement shall be determined by arbitration in accordance with the
International Arbitration Rules of the International Centre for Dispute
Resolution. The number of arbitrators shall be three (3). The place of
arbitration shall be London, England. The language(s) of the arbitration shall
be English. The official text of the Agreement or any notices given shall be in
English. In the event of any dispute concerning the construction or meaning of
this Agreement, reference shall be made only to this Agreement as written in
English, and not to any other translation into any other language. The award
shall be rendered within two (2) months of the commencement of the arbitration,
unless such time limit is extended by the arbitrator(s). It is the intent of the
Parties that, barring extraordinary circumstances, arbitration proceedings will
be concluded within

-22-

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with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

thirty (30) calendar days from the date the arbitrator(s) are appointed. The
arbitrator(s) may extend this time limit in the interests of justice. Failure to
adhere to this time limit shall not constitute a basis for challenging the
award. Consistent with the expedited nature of arbitration, pre-hearing
information exchange shall be limited to the reasonable production of relevant,
non-privileged documents explicitly referred to by a party for the purpose of
supporting relevant facts presented in its case, carried out expeditiously. This
Agreement, and any and all disputes arising in connection with this Agreement,
will be governed by the laws of England.
23.2.
Mediation. Once the demand for arbitration is initiated, the parties agree to
attempt to settle any controversy or claim arising out of or relating to this
Agreement, or a breach thereof by mediation, administered by the International
Centre for Dispute Resolution under its International Mediation Rules at the
request of either party. The number of mediators shall be one. The place of
mediation shall be London, England. The language of the mediation shall be
English. Mediation may proceed concurrently with arbitration and shall not be a
condition precedent to any stage of the arbitration process.

23.3.
Costs. Each Party must bear its own costs of and incidental to the preparation,
execution, and completion of this Agreement.

23.4.
Injunctive Relief. Notwithstanding anything to the contrary herein, in the event
of any actual or imminent infringement of MFR’s Intellectual Property rights or
disclosure of MFR’s Confidential Information, MFR shall have the right to seek,
obtain and enforce injunctive relief from any court of competent jurisdiction.

24.
Entire Agreement

24.1.
This Agreement, together with any Addendums, comprises the entire agreement
between the Parties with respect to the subject matter of this Agreement, and
supersedes all prior understandings, agreements, representations, and
correspondence with respect to the subject matter hereof.

25.
Amendment

25.1.
No modification, alteration or waiver of this Agreement, together with any
Addendums, shall be binding upon the Parties unless made in writing and signed
and exchanged by the duly authorized representative of the Parties.

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with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

26.
Further Assurance

26.1.
Each Party Agrees to execute such further papers, agreements, documents,
instruments and the like as may be necessary or desirable to effect the purpose
of this Agreement and to carry out its provisions.

-24-

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with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

EXECUTED AS AN AGREEMENT
 
 
 
SIGNED for and on behalf of Healthcare Technology International Limited (CM)
By:
/s/ James Li
 
 
 
 
Name:
James Li
 
 
 
 
Title:
Division General Manager
 

By executing this Agreement, the signatory warrants that the signatory is duly
authorized to execute this agreement on behalf of CM.
SIGNED for and behalf of Miramar Labs, Inc. (MFR)
 
 
 
By:
/s/ Steve Higa
 
 
 
 
Name:
Steve Higa
 
 
 
 
Title:
VP, Manufacturing
 

By executing this Agreement, the signatory warrants that the signatory is duly
authorized to execute this agreement on behalf of MFR.

-25-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Addendum A
Tooling and Equipment List

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

MMR Equipment & Fixture Control List
Item
Control No.
Equipment/Fixture Description
E/F/M
Owned by
Location
Chinese Name
No.
Photo
Remark/ [Chinese]
1
[***]
[***]
Fixture
MMR
[Chinese]
[***]
[***]
[***]
Remake New in AML
2
[***]
[***]
Fixture
MMR
[Chinese]
[***]
[***]
[***]
Remake New in AML
3
[***]
[***]
Fixture
MMR
[Chinese]
[***]
[***]
[***]
Remake New in AML
4
[***]
[***]
Machine
Factory
[Chinese]
[***]
[***]
[***]
Use AML's
5
[***]
[***]
Fixture
MMR
[Chinese]
[***]
[***]
[***]
Reuse current fixture
6
[***]
[***]
Equipment
Factory
[Chinese]
[***]
[***]
[***]
Remake New with conveyor in AML
7
[***]
[***]
Fixture
MMR
[Chinese]
[***]
[***]
[***]
Remake New with conveyor in AML
8
[***]
[***]
Fixture
MMR
[Chinese]
[***]
[***]
[***]
MMR's fixture transfer to AML
9
[***]
[***]
Fixture
MMR
[Chinese]
[***]
[***]
[***]
Transfer to AML (may need to remake new in AML)
10
[***]
[***]
Fixture
MMR
[Chinese]
[***]
[***]
[***]
Transfer to AML (may need to remake new for AMLs USW machine)
11
[***]
[***]
Fixture
MMR
[Chinese]
[***]
[***]
[***]
Transfer to AML
12
[***]
[***]
Fixture
MMR
QC1
[***]
[***]
[***]
Transfer to AML
13
[***]
[***]
Fixture
MMR
QC1
[***]
[***]
[***]
Transfer to AML (maybe need to remake to suit AML's pull force equipment)
14
[***]
[***]
Machine
MMR
[Chinese]
[***]
[***]
[***]
Transfer to AML
15
[***]
[***]
Equipment
Factory
[Chinese]
[***]
[***]
[***]
Transfer to AML
16
[***]
[***]
Equipment
MMR
[Chinese]
[***]
[***]
[***]
Transfer to AML
17
[***]
[***]
Equipment
MMR
[Chinese]
[***]
[***]
[***]
Transfer to AML
18
[***]
[***]
Equipment
MMR
[Chinese]
[***]
[***]
[***]
Transfer to AML
19
[***]
[***]
Equipment
MMR
[Chinese]
[***]
[***]
[***]
Transfer to AML
20
[***]
[***]
Fixture
MMR
[Chinese]
[***]
[***]
[***]
Transfer to AML
21
[***]
[***]
Equipment
Factory
[Chinese]
[***]
[***]
[***]
AML to supply
22
[***]
[***]
Equipment
Factory
[Chinese]
[***]
[***]
[***]
AML to supply
23
[***]
[***]
Machine
Factory
[Chinese]
[***]
[***]
[***]
AML to supply
24
[***]
[***]
Machine
Factory
[Chinese]
[***]
[***]
[***]
AML to supply
25
[***]
[***]
Equipment
Factory
[Chinese]
[***]
[***]
[***]
AML to supply
26
[***]
[***]
Machine
Factory
[Chinese]
[***]
[***]
[***]
AML to supply
27
[***]
[***]
Equipment
Factory
QC1
[***]
[***]
[***]
AML to supply
28
[***]
[***]
Equipment
Factory
QC1
[***]
[***]
[***]
AML to supply
29
[***]
[***]
Machine
Factory
[Chinese]
[***]
[***]
[***]
AML to supply
30
[***]
[***]
Machine
Factory
[Chinese]
[***]
[***]
[***]
AML to supply

-2-

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with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

31
[***]
[***]
Machine
Factory
[Chinese]
[***]
[***]
[***]
AML to supply
32
[***]
[***]
Machine
Factory
[Chinese]
[***]
[***]
[***]
AML to supply
33
[***]
[***]
Equipment
Factory
[Chinese]
[***]
[***]
[***]
AML to supply
34
[***]
[***]
Equipment
Factory
QC1
[***]
[***]
[***]
AML to supply
35
[***]
[***]
Equipment
Factory
QC1
[***]
[***]
[***]
Transfer to AML & AML to supply

-3-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Addendum B
Initial Pricing
Product
Reference Specification
Lead Time from Purchase Order to Delivery
Minimum Order Quantity (MOQ)
Unit Price
G4 bioTip
Assy
PN2091,
Revision E
3 months
[***]
[***]

Remark:
All of the Lead-time from purchasing order to delivery, Minimum order quantity,
unit price will be amended due to the change of the material suppliers.
The minimum order quantity of GLS pre-color resin is [***]. The MOQ of
purchasing order of G4 biotip will be increased after MFR approves to use the
GLS pre-color resin. CM will charge the rest of the resin to MFR if the resin
cannot use up within one year.

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

HEALTHCARE TECHNOLOGY INTERNATIONAL LIMITED
15/F., Blk B, Veristrong Ind, Centre, 34-36 Au Pui Wan Street, Fotan, NT, HK
Tel: 852-23424148
Fax: 852-23437310

Date    :    15th Feb 2012
TO    :    Miramar Labs
FM    :    Felix Yu / Raymond Lau
CC    :    Peter Mok, Michelle Lum, James Li
Subject    :    Quotation for G4 BioTip
Revision
Description
Date
A
Initial Quote
9th April 2011
B
Revised Quote
13th Sept 2011
C
Revised NRE and PCB Tooling
23rd Sept 2011
D
Revised Production setup cost
11th  Nov 2011
E
Revised Unit Price
15th Feb 2012

Dear Sir,
G4 BioTip is an OEM project from Miramar Labs. This quote is based on discussion
with Miramar Labs & ZaoTech on 10th Feb 2012. The unit price was amended due to
the material price changed. Enclosed is the update quotation for G4 BioTip.
Quotation
1.    G4 BioTip Unit Price
Stage
MOQ (Units)
FOB HK Unit Price (USD)
G4 Bio Tip
[***]
[***]

Remarks:
Pls refer the details breakdown in appendix A.
The price for the ES/EP/PP will quote separate after confirmation on the qty
that required.
Confidential & Proprietary Information of Healthcare Technology International
Ltd.
Page 1 of 5

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

HEALTHCARE TECHNOLOGY INTERNATIONAL LIMITED
15/F., Blk B, Veristrong Ind, Centre, 34-36 Au Pui Wan Street, Fotan, NT, HK
Tel: 852-23424148
Fax: 852-23437310

2    Tooling
Item
Description
Amount
Total
1
[***]
[***]
[***]
2
[***]
[***]
3
[***]
[***]
4
[***]
[***]
5
[***]
[***]
[***]
6
[***]
[***]
7
[***]
[***]
8
[***]
[***]
8
[***]
[***]

Remark : [***]
3.    Production Jig & Fixture Setup
Item
Description
Cost (USD)
1
[***]
[***]
2
[***]
3
[***]

Remark: The production setup cost didn't include any specified equipment. If
there is require specified equipment which will quote separately
Assume following equipment is consigned by customer.
•
[***]

•
[***]

•
[***]

•
[***]

•
[***]

•
[***]

If it is not fit to use in HTI's equipment, separate charge on the re-build
fixture will be provided.
Confidential & Proprietary Information of Healthcare Technology International
Ltd.
Page 2 of 5

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

HEALTHCARE TECHNOLOGY INTERNATIONAL LIMITED
15/F., Blk B, Veristrong Ind, Centre, 34-36 Au Pui Wan Street, Fotan, NT, HK
Tel: 852-23424148
Fax: 852-23437310

4.    Testing Fixture
Item
Test station Description
Equipment
Qty
total
A
[***]
[***]
[***]
[***]
B
[***]
[***]
[***]

*Remarks:
a) The quote is not including the [***].
b) Assume following testers are consigned by Miramar Labs.
•
[***]

•
[***]

•
[***]

•
[***]

•
[***]

5.    NRE
Engineering follow up from ES to MP stage    [***]
Confidential & Proprietary Information of Healthcare Technology International
Ltd.
Page 3 of 5

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

HEALTHCARE TECHNOLOGY INTERNATIONAL LIMITED
15/F., Blk B, Veristrong Ind, Centre, 34-36 Au Pui Wan Street, Fotan, NT, HK
Tel: 852-23424148
Fax: 852-23437310

 
TASK
DELIVERABLES
Resp.
Applicable
1
[***]
[***]
AML
Yes
2
[***]
[***]
AML
Yes
3
[***]
[***]
AML
Yes
4
[***]
[***]
AML
Yes
5
[***]
[***]
AML
Yes
6
[***]
[***]
AML
Yes
7
[***]
[***]
AML
Yes
8
[***]
[***]
AML
Yes
9
[***]
[***]
AML
Yes
10
[***]
[***]
AML
Yes
11
[***]
[***]
AML
Yes
12
[***]
[***]
AML
Yes
13
[***]
[***]
AML
Yes
14
[***]
[***]
AML& Cust
 
15
[***]
[***]
AML
Yes
16
[***]
[***]
AML
Yes
17
[***]
[***]
AML
Yes

Remark :
If customer issue order with [***], HTI will absorb [***] on the NRE cost.
6.    Preliminary Schedule — Pls refer to Appendix B
Confidential & Proprietary Information of Healthcare Technology International
Ltd.
Page 4 of 5

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Addendum C

PN2091 bio Tip Assembly, ev. C (Drawing/BOM)
Cosmetic Specification (Zao Tech., Dated 5/22/12)
W10050 G4 Bio Tip Incoming Inspection (Work Instruction)

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Notes:
1.
USE IN CONJUNCTION WITH [***].

2.
COSMETIC REQUIREMENTS FOR INDIVIDUAL PARTS

ALSO APPLY AT THE ASSEMBLY LEVEL.
3.
INSPECTION REQUIREMENTS:

1.
MIRAMAR LABS: INSPECT PER W10050.

4.
ASSEMBLY COSMETIC REQUIREMENTS:

2.
[***]

3.
[***]

4.
[***]

5.
[***]

6.
[***]

5.
PACKAGING:

1.
[***]

2.
[***]

3.
[***]

6.
C OF C REQUIRED INCLUDING PART NUMBER, REV, QTY, LOT NUMBER

7.
COPY OF WORK ORDER/LOT HISTORY RECORD ESTABLISHING MATERIAL/COMPONENT
TRACEABILITY REQUIRED.

[***]

2

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

[***]

3

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

[***]

-4-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

G4 BIOTIP ASSEMBLY
Miramar Labs
PN2091 Rev. C
EO 11-1484

Item
Qty
Description
Miramar Labs P/N
Miramar Labs Sub-Part
MFG
MFG P/N
Vendor
Vendor P/N
Remarks
1
[***]
[***]
PN2045
 
 
 
 
2
[***]
[***]
PN2090
 
 
 
 
 
[***]
[***]
 
PN1782
PALL
PTF045LROP
PROVIDED BY ML
3
[***]
[***]
PN2089
 
 
 
 
 
[***]
[***]
 
PN2118
POLYZEN
N/A
PROVIDED BY ML
4
[***]
[***]
PN2010
 
 
 
 
 
[***]
[***]
 
PN2009
 
 
 
 
[***]
[***]
 
PN2011
 
 
 
5
[***]
[***]
PN2328
 
 
 
 
6
[***]
[***]
PN2097
 
 
 
 
 
[***]
[***]
 
PN2096
 
 
 
 
[***]
[***]
 
PN2098
 
 
 
7
[***]
[***]
PN2329
 
 
 
 
8
[***]
[***]
PN2087
 
 
 
 
9
[***]
[***]
PN2088
 
 
 
 
10
[***]
[***]
PN2109
 
 
 
 
 
[***]
[***]
 
PN2030
 
 
 
11
[***]
[***]
PN2110
 
 
 
 
 
[***]
[***]
 
PN2029
 
 
 
12
[***]
[***]
PN2226
 
 
 
 

-5-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

[miramarapohticontractimage2a.gif]

6

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Surface definition- A Class
[***]

-7-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Zao Tech Confidential

-8-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Surface definition- B Class
[***]

-9-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Zao Tech Confidential

-10-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Surface definition- C Class
[***]

-11-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Zao Tech Confidential

-12-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

[miramarapohticontractimage3a.gif]

-13-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Cosmetic Specification

--------------------------------------------------------------------------------

Miramar G4 BioTip Cosmetic Specification
Defects description
Acceptance Criteria
Classification
A
B
C
D
Major
Minor
Surface cosmetic
[***]
[***]
[***]
X
 
[***]
[***]
[***]
 
X
[***]
[***]
 
X
[***]
[***]
 
X
[***]
[***]
 
X
[***]
[***]
X
 
[***]
[***]
 
X
[***]
[***]
 
X
[***]
[***]
[***]
 
X
[***]
[***]
 
X
[***]
[***]
 
X
[***]
[***]
 
X
[***]
[***]
 
X
[***]
[***]
X
 
[***]
[***]
 
X
[***]
[***]
 
X
[***]
[***]
 
X

-14-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

Cosmetic Specification

--------------------------------------------------------------------------------

Part Level Cosmetic Specification
Defects description
Acceptance Criteria
Classification
A
B
C
D
Major
Minor
[***]
[***]
X
 
[***]
[***]
 
X
[***]
[***]
X
 
[***]
[***]
X
 
[***]
[***]
 
X
[***]
[***]
 
X
[***]
[***]
X
 

Checking criteria:
Class A: [***]
Class B: [***]
Class C: [***]
light source: [***]

-15-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

-16-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

[miramarapohticontractimage4a.gif]

-17-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

[miramarapohticontractimage5a.gif]

-18-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

-19-

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

[miramarapohticontractimage6a.gif]
Document Name
Document Number
Revision
Date Effective
Work Instruction, G4 bioTip Incoming Inspection
WIOO50
B
10/5/11

Page 1 of 2

Revision
EO#
Initiator
Summary of Changes
A
11-1365
P. Bentley
New release
B
11-1580
P Bentley
Change 6.7.4 from 35mmHg. Typo corrections and other clarifications.

1.0PURPOSE:
This document describes the procedure for inspecting and acceptance of incoming
lots of G4 bioTips from contract manufacturers.
2.0    REFERENCES:
PN2091 G4 bioTip Assembly Drawing
OP0007 Material Controls
3.0    RESPONSIBILITIES:
Manufacturing, Quality Assurance and Research and Development are responsible
for performing the functions described in this procedure.
4.0    EQUIPMENT/MATERIALS:
4.1

[***]

4.2

[***]

4.3

[***]

4.4

[***]

4.5

[***]

4.6

[***]

5.0    AQL LEVEL
5.1

[***]

5.2

[***]

Note. Remove qty to be inspected from the lot under the flow hood to prevent
contamination of the balance of the lot.
6.0    PROCEDURE:
6.1

Receive lots of bioTips per OP0007

6.2

Record all inspection data on form FM0011.

Confidential - Do not photocopy without permission from Miramar Labs.

--------------------------------------------------------------------------------

[miramarapohticontractimage6a.gif]
Document Name
Document Number
Revision
Date Effective
Work Instruction, G4 bioTip Incoming Inspection
WIOO50
B
10/5/11

Page 2 of 2

6.3
Inspect assemblies for any cosmetic defects:

6.3.1    Per PN2091 drawing note section 4.
6.3.2    Ensure labels and PCBs are in the proper orientation.
6.3.3    [***]
6.3.4    Any other anomalies
6.4
Per [***]. Note: Non-circled FAI dimensions may be measured using any
appropriate method.

6.5
Using [***]

6.6
[***]

6.7
Place [***] and run test as follows:

6.7.1    [***]
6.7.2    [***]
6.7.3    [***]
6.7.4    [***]
6.7.5    [***]
6.8
Place [***] and run test as follows:

6.8.1    [***]
6.8.2    [***]
6.8.3    [***]
6.8.4    [***]
6.8.5    [***]
6.9
Record pass/fail status and process per OP0007.

6.10
Label inspected units with their lot number and store them as Retain Samples.

6.11
Send an additional [***] testing. Results are for informational purposes only.

Confidential - Do not photocopy without permission from Miramar Labs.