Document:

Manufacture and Supply Agreement dated March 7, 2005

 Exhibit 10.9 
  
 MANUFACTURE AND SUPPLY AGREEMENT 
  
 This MANUFACTURE AND SUPPLY AGREEMENT (this “Agreement”) is made and entered into as March 7, 2005
(“Effective Date”), by and between HemoSense, Inc., having an office at 651 River Oaks Parkway, San Jose, CA 95134 (“HemoSense”), and Haematologic Technologies, Inc., having an office at 57 River Road, Unit 1021,
Essex Junction, VT 05452 (“HTI”). (Each of HemoSense and HTI are a “Party”; collectively the “Parties.”) 
  
 BACKGROUND 
  
 A. HemoSense is in the business of making and selling various medical diagnostic products, including products used to monitor prothrombin time (“PT”) for
patients on anticoagulation therapies. 
  
 B. HTI is engaged in the business of
manufacturing and selling coagulation proteins, including anti-coagulant control cocktails. 
  
 C. HemoSense desires to purchase, and HTI to sell, Coagulation Cocktail 2 (as defined below) in accordance with the provisions of this agreement. 
  
 In consideration of the promises and the mutual covenants contained herein, the Parties therefore agree as follows: 
  
 AGREEMENT 
  
 ARTICLE 1 
 DEFINITIONS 
  
 All defined terms that are used
but not defined in the body of this Agreement have the meanings set forth in Schedule A. 
  
 ARTICLE 2 
 SALE AND PURCHASE 
  
 2.1 Supply of Product. HTI shall manufacture and provide Coagulation Cocktail 2 to HemoSense and Affiliates as set
forth in this Agreement. 
  
 2.2 HemoSense Purchase
Requirements. HemoSense shall purchase from HTI during the initial two (2) years of the term of this Agreement (“Requirements Period”), one hundred percent (100%) of the Coagulation Cocktail 2 that HemoSense requires for
purposes of commercial sale, subject to the terms and conditions of this Agreement (including Section 13.5) and the further limitations that: 
  
 2.2.1 During the Requirements Period, HemoSense may purchase such quantities of Coagulation Cocktail 2 from alternative or additional
manufacturers solely as is necessary to qualify and validate the manufacturing processes of such alternative and additional manufacturers. 
  

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 2.2.2 HemoSense’s obligations to purchase Coagulation Cocktail 2 from HTI under this
Section 2.2 shall not apply to the extent: 
  
 (a) HTI is unable to supply HemoSense with its Coagulation Cocktail 2 requirements due to capacity constraints, force majeure events or otherwise. 
  
 (b) HemoSense requires Coagulation Cocktail 2 for purposes of commercial sale into a territory for which HTI has not obtained such
regulatory approvals and registrations as are necessary for HTI to perform as HemoSense’s commercial supplier of Coagulation Cocktail 2 under this Agreement. 
  
 2.3 No Further Restrictions. Except as expressly set forth in Section 2.2, nothing in this Agreement shall be
construed as preventing or otherwise inhibiting HemoSense from (a) manufacturing some or all of its Coagulation Cocktail 2 requirements, or (b) obtaining some or all of its Coagulation Cocktail 2 requirements from third party(ies). 
  
 2.4 HTI Exclusivity. During the term of this Agreement and for three
(3) years after its expiration or termination, neither HTI nor any of its Affiliates shall, either alone or in collaboration with a third party, (i) engage in activities solely related to the development, manufacture, supply or commercialization of
Coagulation 2 Cocktail for any Point-of-care, PT reagent/test manufacturer or (ii) develop, manufacture, supply or commercialize Coagulation 2 Cocktail for any Point-of-care, PT reagent/test manufacturer. 
  
 ARTICLE 3 
 MANUFACTURING AND PROCESSING ACTIVITIES 
  
 3.1 Manufacturing at Facility. HTI shall manufacture Coagulation Cocktail 2 for HemoSense under this Agreement exclusively at the Facility. HTI
shall be responsible for all scheduling related to the Facility and for the operation of the Facility. 
  
 3.2 Changes. HTI shall not make any changes to raw materials (or suppliers thereof), formulations, processes, equipment, facilities,
Specifications, tests or any other item in any manner that would impact the manufacturing or processing activities to be performed by HTI hereunder, or affect any regulatory filing, without the prior written consent of HemoSense. 
  
 3.3 Required Changes. Subject to HemoSense’s written approval,
HTI shall promptly make and implement such changes to the Specifications or HTI’s manufacturing or processing activities as are required (a) by any regulatory requirements that are (i) applicable to the manufacture of Coagulation Cocktail 2,
(ii) the result of a specific guideline, law or regulation and (iii) not discretionary; or (b) by any concerns of HemoSense or regulatory authorities as to the toxicity, safety and/or efficacy of any Coagulation Cocktail 2 to be manufactured by HTI
as provided herein (“Required Changes”). 
  
 3.4
Discretionary Changes. Each Party may propose certain changes to the Specifications or the Coagulation Cocktail 2 manufacturing process which it reasonably believes will improve the manufacturing process. Upon HemoSense’s request, HTI
shall review and analyze such proposed changes and provide such details as HemoSense may reasonably request 
  

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regarding the proposed change. Changes to be further developed or implemented, if any, will be as agreed upon by the Parties. (“Proposed
Discretionary Changes”). 
  
 3.5 Payment. All
Changes to the Specifications, Required Changes, and Discretionary Changes initiated by HemoSense that result in an implementation cost or an increase in manufacturing costs shall be at the expense of HemoSense. HTI shall be responsible for any
costs associated with the development and implementation of any Required Changes and Discretionary Changes initiated by HTI and approved by HemoSense hereunder. 
  

ARTICLE 4 
 ORDERS AND SHIPMENT

  
 4.1 Forecasts. By the first day of the first full
calendar quarter following the execution of this Agreement, and by the first day of each calendar quarter thereafter, HemoSense shall provide HTI with a good-faith written forecast of the quantities of Coagulation Cocktail 2 that HemoSense shall
require from HTI for following twelve (12) calendar-month period (each, a “Forecast”). Each such Forecast shall be divided into four calendar-quarter forecasts (“Ql,” “Q2,” “Q3” and “Q4,” as
updated on a rolling basis), and shall include HemoSense’s anticipated requirements from HTI for each such calendar quarter. Thus, for example, a Forecast provided by October 1, 2004 would cover the calendar months commencing with October 1,
2004 and ending with September 30, 2005, and in that case HemoSense would also provide a breakout of the Forecast for October 1, 2004 through December 31, 2004 (as Q1), January 1, 2005 through March 31, 2005 (as Q2), April 1, 2005 through June 30,
2005 (as Q3) and July 1, 2005 through September 30, 2005 (as Q4). Each Forecast shall be non-binding, except that (i) HemoSense’s Purchase Orders under Section 4.2.1 shall at least cover the quantity of Coagulation Cocktail 2 specified for Q1
of HemoSense’s then-current Forecast, and (ii) the quantity of Coagulation Cocktail 2 specified for Q1 of each Forecast shall be within plus or minus twenty-five percent (25%) of the quantity that HemoSense previously forecast for that quarter
when that quarter first appeared as Q2 of a Forecast. Notwithstanding the provisions of this Section 4.1, the Forecasts that HemoSense is to provide under this Agreement need not extend beyond this Agreement’s Term. 
  
 4.2 Purchase Orders. 
  
 4.2.1 Provision of Purchase Order. With each
Forecast, HemoSense shall provide to HTI a purchase order (each, a “Purchase Order”) for such quantities of Coagulation Cocktail 2 that HemoSense wishes to order from HTI. Each Purchase Order shall specify the delivery date(s),
delivery location(s) and amounts of Coagulation Cocktail 2 to be delivered over the calendar month represented by the Purchase Order. 
  
 4.2.2 Acceptance. HTI shall acknowledge and provide HemoSense with a written acceptance of each Purchase Order within five (5)
business days following HTI’s receipt thereof, and if no such acceptance is provided to HemoSense within such period, such Purchase Order shall be deemed accepted by HTI. HTI may reject only that portion of any Purchase Order that HTI is unable
to fill due to unexpected demand where HemoSense’s aggregate Purchase Orders for a particular calendar quarter exceed the quantity of Coagulation Cocktail 2 that HemoSense forecast as its anticipated requirement for the quarter in its
then-current Forecast (the 
  

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“Excess Portion”). In addition, to the extent a HemoSense Purchase Order requests a delivery date that is less than thirty (30) days from
the Purchase Order date (a “Inside Lead-Time Request”), HTI may consider the required shipment date to be thirty (30) days from the Purchase Order date. Notwithstanding the foregoing, HTI shall use commercially reasonable efforts to
satisfy the Excess Portion and Inside Lead-Time Requests of each Purchase Order. 
  
 4.2.3 Conflict. If the terms of HemoSense’s Purchase Order, HTI’s acknowledgement or acceptance, or any other document
that the parties exchange in connection with the purchase and sale of Coagulation Cocktail 2 are inconsistent with the terms of this Agreement, the terms of this Agreement shall control. 
  
 4.3 Delivery. Delivery of the Coagulation Cocktail 2 shall be DDU (Incoterms 2000); HemoSense’s designated
location in the United States (which may be a third-party location). Shipping charges shall be prepaid by HTI and added to the invoice. 
  
 4.4 Documentation. Each lot shall be accompanied by, a certificate of analysis showing the results of release testing, as well as a certificate of
conformance confirming that the Coagulation Cocktail 2 is Conforming Product (pursuant to Section 6.1). At HemoSense’s request, HTI shall provide HemoSense with reasonable access to any applicable supporting data relating to the documentation
provided under this Section 4.4 (including without limitation master batch records, executed batch production records, laboratory notebooks and any applicable testing results). 
  
 4.5 Notice of Inability to Supply. HTI shall promptly notify HemoSense of any occurrence expected to inhibit
HTI’s ability to provide on-time delivery of Coagulation Cocktail 2 meeting the terms and conditions of this Agreement. In addition, HTI shall immediately inform HemoSense of any notice, written or oral, received from any of its subcontractors
regarding a possible shortage or inability to obtain or supply raw materials or any components or materials used in the manufacture of Coagulation Cocktail 2. 
  

4.6 Consequences of Delay. In the case of any material failure or anticipated material failure of HTI to supply Coagulation Cocktail 2 meeting
the requirements of this Agreement in the quantities and within the time periods specified in any of HemoSense’s Purchase Orders (each, a “Delay”), HTI shall remedy the Delay and resume supplying Coagulation Cocktail 2 meeting
the requirements of this Agreement to HemoSense as soon as possible. Moreover, upon a Delay, HemoSense shall be relieved from its obligations to purchase any quantities of Coagulation Cocktail 2 identified in any Purchase Orders that are delayed
more than five (5) days. 
  
 ARTICLE 5 
 PAYMENT 
  
 5.1 Supply Price. The per-milliliter Supply Price of Coagulation Cocktail 2 shall be as set forth on Schedule C. Except as otherwise permitted
herein, HemoSense shall pay HTI the applicable Supply Price for each milliliter of Coagulation Cocktail 2 received in accordance with the terms of this Agreement, within thirty (30) days after the date of HTI’s invoice for such shipment;
provided that HTI’s invoice for each shipment shall be dated no earlier than the date of 
  

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shipment of the particular lot of Coagulation Cocktail 2 to the delivery location designated under Section 4.3. 
  
 5.2 No Other Costs. Except as otherwise expressly set forth in this
Agreement, HemoSense shall not be obligated to pay any amounts other than the Supply Price, shipping cost, and handling charges for all Coagulation Cocktail 2 supplied by HTI hereunder. HTI shall be solely responsible for costs and other expenses
required to fulfill its obligations under this Agreement. 
  
 5.3
Payment Terms. Terms of payment shall be Net 30. Payment of all amounts shall be in U.S. dollars. 
  
 5.4 Taxes. The Supply Price shall exclude any applicable sales, use, consumption, value-added or excise taxes, duties, tariffs and other similar
assessments which may be imposed by any governmental authority as a result of the sale of Coagulation Cocktail 2 to HemoSense (other than with respect to any corporate or other taxation based on HTI’s net income) (“Transfer
Taxes”); provided, however, that the parties shall cooperate and take any reasonable steps necessary to reduce or eliminate any Transfer Taxes. 
  
 ARTICLE 6 
 QUALITY OF COAGULATION
COCKTAIL 2 
  
 6.1 Conforming Product. HTI represents
and warrants that all Coagulation Cocktail 2 provided to HemoSense’s designated location under Section 4.3 shall at the time of delivery (1) conforms with the Specifications, (2) has been manufactured in accordance with the approved master
batch records and executed batch production records, (3) is not adulterated within the meaning of the Federal Food, Drug and Cosmetic Act, as amended (the “FFDCA”), or any foreign counterpart thereof, and (4) has been manufactured,
labeled, packaged, stored, tested, documented, released and shipped in accordance with regulatory requirements, ISO 9001:2000, and all applicable laws. Such Coagulation Cocktail 2 shall be deemed “Conforming Product.” 
  
 6.2 Lot. Each lot of Coagulation Cocktail 2 manufactured by HTI
hereunder shall be within the process parameters as validated and set forth in the master batch record. Upon any deviation, HTI shall prepare a deviation report for HemoSense and shall resolve such situation in accordance with ISO 9001:2000.

  
 6.3 Non-Conforming Product. For any delivered
Coagulation Cocktail 2 that is not Conforming Product, HTI shall, at HemoSense’s sole discretion, either reimburse HemoSense the purchase price (if already paid) of such Coagulation Cocktail 2 within ten (10) business days after receiving
notice from HemoSense of the non-Conforming Product or, as soon as practicable and in any event within three (3) months, replace such Coagulation Cocktail 2 at no additional cost to HemoSense. HemoSense shall notify HTI of the existence of
Coagulation Cocktail 2 that is not Conforming Product within thirty (30) days after receipt of such Coagulation Cocktail 2 from HTI, or if later, within thirty (30) days after HemoSense actually learns that the Coagulation Cocktail 2 is not
Conforming Product. 
  

	***	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
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 ARTICLE 7 
 INSPECTIONS; RECORDS 
  
 7.1 Inspections by HemoSense. 
  
 7.1.1 Inspection. HemoSense (or its representative) shall have the right, upon reasonable advance notice and during regular business hours, to inspect and audit (a) the Facility, and (b) any of HTI’s manufacturing and quality
control records and all other documentation relating to the manufacturing and processing activities (including, without limitation, any internal quality control audits or reviews conducted by HTI). Such right to inspect and audit shall extend to HTI
and the Affiliates and subcontractors of HTI. 
  
 7.1.2 Notice of Non-Compliance. To the extent HemoSense reasonably determines during any inspection and audit of the Facility, or the records being maintained by HTI in connection with such manufacture (including master batch records
and executed batch production records), that HTI is not in compliance with regulatory requirements, ISO 9001:2000 or this Agreement, HemoSense shall provide HTI with written notice detailing such material non-compliance. 
  
 (a) Upon receipt of such notice from HemoSense, HTI shall,
as soon as practicable, remedy or cause to be remedied such non-compliance in accordance with a mutually agreed schedule. HemoSense shall, if requested by HTI, assist HTI by providing reasonably detailed information about the non-compliance. HTI
shall provide HemoSense with progress reports of its corrective actions and reasonable documentary and other evidence that all compliance items have been corrected. 
  
 (b) Thereupon, HemoSense shall have the right to re-inspect and re-audit the Facility, or the records being
maintained by HTI in connection with such manufacture, upon reasonable notice and during regular business hours to determine whether HTI has remedied or caused to be remedied such non-compliance. 
  
 7.2 Records. HTI shall generate and maintain complete and accurate
records (including, without limitation, files, certificates and authorizations) necessary to evidence compliance with all applicable laws, regulatory requirements and other requirements of applicable governmental authorities relating to the
manufacture of Coagulation Cocktail 2, including, without limitation, all validation data, master batch records, executed batch production records, quality control and laboratory testing, and any other data required under ISO 9001:2000 and other
regulatory requirements. HTI shall not dispose of records or samples generated in conjunction with this Agreement within seven years of creation without first offering to transfer such records or samples to HemoSense or its designee at
HemoSense’s expense. 
  
 ARTICLE 8 
 REGULATORY MATTERS 
  
 8.1 Compliance with ISO 9001:2000; Monitoring of Records. Throughout the term of this Agreement, and for so long thereafter as is reasonably
necessary, HTI shall monitor and 
  

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maintain appropriate records respecting its compliance with ISO 9001:2000, including through the establishment and implementation of such operating
procedures and the training of personnel as are required to assure such compliance. 
  
 8.2 Regulatory Communications and Correspondence. Each Party shall promptly notify the other Party of all such Party’s communications from and to the FDA or other regulatory authorities that may affect,
impact or change the manufacturing or processing activities performed by HTI, or affect the ability of HTI to comply with its obligations under this Agreement. 
  

8.3 Document Preparation and Maintenance. HTI shall prepare and maintain all files, certificates, authorizations, data and other records
pertaining to the manufacture of Coagulation Cocktail 2 for HemoSense that are reasonably necessary to support and maintain any regulatory filings. 
  
 8.4 Notification of Changes to the Manufacturing Process. HTI shall notify HemoSense in writing prior to submitting any documentation to any
regulatory authority regarding any manufacturing process changes approved by HemoSense pursuant to 3.2. HemoSense shall be permitted to review all documentation proposed to be filed with any regulatory authority regarding such changes. Within [***]
business days after receiving such documentation, through consultation between the Parties, HemoSense shall provide HTI with comments, which shall be incorporated in the documentation prior to filing it with any regulatory authority. HTI shall
obtain HemoSense’s written approval prior to submitting any such documentation. 
  
 8.5 Cooperation in Obtaining Government Approvals. HTI shall reasonably assist HemoSense, at HemoSense’s request, to secure and maintain governmental approvals for the HemoSense Product and shall
participate as is reasonably necessary and as may be requested in resolving the concerns of any regulatory authority arising with respect to the manufacture of Coagulation Cocktail 2 for HemoSense. 
  
 8.6 Ownership of Regulatory Filings. HemoSense shall be the sole owner
of all regulatory filings and all governmental approvals obtained by HemoSense from any regulatory authority with respect to the HemoSense Product. 
  
 8.7 HemoSense Access to Manufacturing Data and Documentation. HemoSense shall have full access to and the right to use and reference any regulatory
filings, correspondence, validation documentation, master batch records, executed batch production records, reports, analyses and any other data and documentation generated in connection with the manufacturing and/or processing activities conducted
by HTI hereunder. 
  
 8.8 Safety and Efficacy Claims. Each
Party shall promptly notify the other of any information or notice it is or becomes aware of concerning the safety or efficacy claims of any HemoSense Product, including, without limitation, any threatened or pending action by any regulatory
authority. HemoSense shall be responsible for handling all complaints and communications from regulatory authorities with respect to the HemoSense Product. HTI shall cooperate in resolving such complaints and responding to such communications to the
extent 
  

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they pertain to Coagulation Cocktail 2 and are reasonably requested by HemoSense in connection therewith. 
  
 ARTICLE 9 
 RECALLS 
  
 9.1 Notification. Each Party shall keep the other Party fully informed of any notification, or other information of which it has actual knowledge, which might result in the Recall, Seizure or other enforcement action relating to the
HemoSense Product or Coagulation Cocktail 2. 
  
 9.2 HTI’s
Recall or Withdrawal Suggestion. If HTI independently believes that a HemoSense Product Recall or HemoSense Product withdrawal or field corrective action may be necessary or appropriate, HTI shall so notify HemoSense of HTI’s conclusion
within [***] ([***]) [***] and the Parties shall cooperate with each other to ascertain the necessity and nature of such action. 
  
 9.3 Recall Determination by HemoSense. Promptly after HemoSense notifies a regulatory authority of a HemoSense Product withdrawal or HemoSense
Product Recall, HemoSense shall so notify HTI. HTI shall assist HemoSense, at HemoSense’s reasonable request, in its investigation to determine the cause and extent of the problem. 
  
 9.4 HemoSense Discretion. Notwithstanding anything to the contrary in the foregoing, HemoSense shall make the final
decision whether HemoSense Product is withdrawn or Recalled. 
  
 9.5 Responsibility for Expenses of Recall. If any governmental authority withdraws its approval to sell the HemoSense Product (“Approval Withdrawal”) or issues a directive or request that all or specified quantities of the
HemoSense Product be Recalled (“Recall Directive”) for product safety reasons or HemoSense reasonably determines that all or specified quantities of the HemoSense Product should be Recalled, HemoSense shall pay all costs, including
HTI’s reasonable out-of-pocket expenses, associated with the Recall. However, to the extent such Recall is the result of an Approval Withdrawal or Recall Directive, and the Approval Withdrawal or Recall Directive is wholly attributable to (i)
the Coagulation Cocktail 2 not conforming to the Specifications as set forth in Schedule B; or, (ii) manufacturing or processing that was not done in accordance HTI’s standard operating procedures as approved by the parties, or as modified and
reapproved by the parties, (i) HTI shall be responsible for all such costs, (ii) HemoSense shall have the right to cancel any Purchase Orders already submitted, and (iii) HemoSense shall have no obligations or liabilities with respect to Coagulation
Cocktail 2 not yet shipped to HemoSense. 
  
 9.6 Definition of
Recall and Seizure. For purposes of this Article 9, “Recall” shall mean any action by HemoSense, or any Affiliate of HemoSense, to recover title to or possession of HemoSense Product sold or shipped to third parties. The term
“Recall” also includes the failure by HemoSense to sell or ship HemoSense Product to third parties who would have been subject to recall if it had been sold or shipped. For purposes of this Article 9, “Seizure” shall mean
any action by any governmental authority to detain or destroy HemoSense Product. For 
  

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purposes of this Article 9, neither “Recall” nor “Seizure” shall include any actions taken by HemoSense that are solely related to
nonpayment or contract issues and are not related to any toxicity, safety, efficacy or Regulatory-related issues. 
  
 ARTICLE 10 
 INTELLECTUAL PROPERTY 
  
 10.1 Ownership. 
  
 10.1.1 Product Technology. As between the Parties,
HemoSense owns and shall continue to own all right, title and interest (including all patent and other intellectual-property rights) in and to (i) Coagulation Cocktail 2 and (ii) any inventions made by a Party or the Parties in connection with the
performance of this Agreement or in connection with the development or manufacture of Coagulation Cocktail 2 prior to the date of this Agreement that primarily relate to Coagulation Cocktail 2 or constitute improvements to Coagulation Cocktail 2
(collectively, the “Product Technology”). Product Technology includes, but is not limited to, the compositions, formulations, recipes and specifications for Coagulation Cocktail 2. 
  
 10.1.2 Manufacturing Process Technology. As between
the Parties, HTI owns and shall continue to own all right, title and interest (including all patent and other intellectual-property rights) in and to all inventions constituting manufacturing methods or processes made by a Party or the Parties in
connection with the performance of this Agreement or the development or manufacture of Coagulation Cocktail 2 prior to the date of this Agreement (“Manufacturing Process Technology”). 
  
 10.1.3 Other Developed Technology. Subject to
HemoSense’s ownership of Product Technology under Section 10.1.1 and HTI’s ownership of Manufacturing Process Technology under Section 10.1.2, as between the Parties, each Party shall own all right, title and interest in and to any
inventions made by such Party in connection with performance under this Agreement or the development or manufacture of Coagulation Cocktail 2 prior to the date of this Agreement, to the extent that such Party’s personnel (including
representatives working on behalf of such Party) would be an inventor thereof under applicable patent law. Patent rights to inventions that are made jointly by employees of HTI and HemoSense shall be owned jointly. For purposes of this Section
10.1.3, whether an invention is made “jointly” shall be determined under principles of inventorship in accordance with applicable patent law, and “owned jointly” means that, subject to the terms of the licenses granted hereunder
and the other provisions of this Agreement, each Party is free to exploit or enforce such rights and authorize others to do so, with no obligation to account to the other Party for profits or otherwise, and each Party hereby waives any right it may
have under the laws of any country to require such consent or accounting. 
  
 10.2 Assignment. 
  
 10.2.1 By HTI. HTI hereby assigns and shall continue to assign to HemoSense all of its right, title and interest in all Product Technology. If HemoSense requests and at HemoSense’s expense, HTI shall
execute any and all applications, assignments or other instruments and provide testimony as necessary to apply for and obtain patent and other intellectual-property rights with respect to all Product Technology. 
  

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 10.2.2 By HemoSense. HemoSense hereby assigns and shall continue to assign to HTI
all of its right, title and interest in all Manufacturing Process Technology. If HTI requests and at HTI’s expense, HemoSense shall execute any and all applications, assignments or other instruments and provide testimony as necessary to apply
for and obtain patent and other intellectual-property rights with respect to all Manufacturing Process Technology. 
  
 10.3 Manufacturing License. HTI shall document any and all Manufacturing Process Technology owned by it and all other manufacturing processes,
know-how and technology necessary or useful to performing the manufacturing under this Agreement, including that which is publicly known and that which is proprietary to HTI or a third party and authorized for HTI’s use. HTI hereby grants
HemoSense a nonexclusive right to use all such technology not owned by HemoSense under Section 10.1 or otherwise (the “Licensed Technology”) to make and have made Coagulation Cocktail 2 (and thereafter to use, sell, offer for sale
and import such Coagulation Cocktail 2 and any HemoSense Products); provided that this Agreement obligates HTI to deliver a physical copy of such Licensed Technology to HemoSense only: (i) if HTI should become Insolvent, or (ii) whether or not HTI
becomes Insolvent, to the extent the use of the Licensed Technology in connection with the manufacture Coagulation Cocktail 2 would require HemoSense to make additional regulatory filings, amend its then-existing regulatory filings (without
limitation, by filing a change-of-process petition with the FDA) and/or manufacture additional lots of Coagulation Cocktail 2 for use in stability trials. For purposes of this Section 10.3, “Insolvent” means HTI is unable to pay its
debts as they become due, or if HTI’s income and cash are less than would be adequate for two months of operations, if HTI is subject to receivership or bankruptcy proceedings or any other proceedings for the settlement of its debts under
applicable law, or makes an assignment for the benefit of creditors. 
  
 ARTICLE 11 
 CONFIDENTIALITY 
  

11.1 Confidentiality. 
  
 11.1.1 Confidential Information. “Confidential Information” means all data, specifications, training and any other
know-how related to the design, development, manufacture (including, without limitation, equipment and processes), marketing, distribution or performance of HemoSense Products or Coagulation Cocktail 2, as well as all other information and
data provided by either Party to the other Party pursuant to this Agreement, to the extent the disclosing party treats such other information and data confidentially. Notwithstanding the foregoing, the term “Confidential Information” does
not include any information that: (i) is or becomes generally available to the public other than as a result of a breach of this Agreement by the receiving Party, (ii) is known to the receiving Party prior to receipt from the disclosing Party
directly or indirectly from a source other than one having an obligation of confidentiality to the disclosing Party; (iii) becomes known to the receiving Party (independently of disclosure by the disclosing Party) directly or indirectly from a
source other than one having an obligation of confidentiality to the disclosing Party; or (iv) is independently developed by the receiving Party. 
  
 11.1.2 Non-Disclosure and Non-Use. It is contemplated that a Party may from time to time disclose its Confidential Information to
the other Party. Each Party shall not disclose to third parties any Confidential Information of the disclosing Party and shall not use 
  

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any Confidential Information of the disclosing Party, except for the limited purposes of performing the receiving Party’s obligations or exercising the
receiving Party’s rights as set forth in this Agreement. The receiving Party shall take all reasonable steps to prevent any unauthorized use or disclosure of the Confidential Information of the disclosing Party. The receiving Party may disclose
Confidential Information to those of its representatives who have a need to have access to such Confidential Information in connection with such Party’s performance of its obligations and exercise of its rights under this Agreement. If the
receiving Party so discloses any Confidential Information pursuant to this Section 11.1, such Party shall (1) inform the persons to whom such Confidential Information is disclosed of the confidential nature of such Confidential Information, and (2)
direct those persons to keep such Confidential Information confidential. The provisions of this Section 11.1 shall survive termination or expiration of this Agreement and shall continue for five (5) years after the date thereof. 
  
 11.1.3 Disclosures Required By Law. The terms of this
Section 11.1 shall not be construed to limit either Party’s right to disclose the other Party’s Confidential Information to the extent required in response to a valid order of a court or other governmental body of competent jurisdiction,
provided that the receiving Party shall first have given notice to the disclosing Party and give the disclosing Party a reasonable opportunity to quash such order and to obtain a protective order requiring that the Confidential Information that is
the subject of such order be held in confidence by such court or body and shall reasonably cooperate with the disclosing Party in seeking to obtain such an order. 
  
 11.1.4 Confidentiality of Agreement. Each Party agrees that the terms and conditions, but not the
existence, of this Agreement shall be treated as the other’s Confidential Information and that no reference to the terms and conditions of this Agreement or to activities pertaining thereto can be made in any manner without the prior written
consent of the other Party; provided, however, that each Party may disclose the terms and conditions of this Agreement: (i) as required by any court or other governmental body; (ii) as otherwise required by law; (iii) to legal counsel of the
Parties; (iv) in connection with the requirements of a public offering or securities filing; (v) in confidence, to accountants, banks, and financing sources and their advisors; (vi) in confidence, in connection with the enforcement of this Agreement
or rights under this Agreement; or (vii) in confidence, in connection with a merger or acquisition or proposed merger or acquisition, or the like. 
  
 ARTICLE 12 
 INDEMNIFICATION

  
 12.1 Indemnification. 
  
 12.1.1 HTI shall indemnify HemoSense, its Affiliates and
representatives, and the heirs, executors, successors and assigns of any of the foregoing, against the following: 
  
 (a) Indemnifiable Losses arising out of a material breach by HTI of any of its obligations under this Agreement (including any Schedules
hereto); 
  
 (b) Indemnifiable Losses arising
only from HTI’s manufacturing and processing techniques, (excluding Product and Coagulation Cocktail 2 formulation defined in 
  

	***	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 11 

 
Schedule A), including without limitation infringement or violation of Third-Party intellectual property rights arising out of such manufacturing and
processing techniques (excluding HemoSense Product and Coagulation Cocktail 2 formulation defined in Schedule A); and 
  
 (c) Indemnifiable Losses arising out of gross negligence or willful misconduct on the part of HTI or any of its agents or employees;
provided, however, that HTI shall have no liability to HemoSense for any such Indemnifiable Losses to the extent that such Indemnifiable Losses were caused by: (x) the gross negligence or willful misconduct of HemoSense or any persons or entities
for whose actions or omissions HemoSense is legally liable; or (y) a material breach by HemoSense of its obligations under this Agreement. 
  
 12.1.2 HemoSense shall indemnify HTI, its Affiliates and representatives, and the heirs, executors, successors and assigns of any of the
foregoing, against the following: 
  
 (a)
Indemnifiable Losses arising out of a material breach by HemoSense of any of its obligations under this Agreement (including any Schedules hereto); 
  
 (b) Indemnifiable Losses arising out of the sale or distribution of the HemoSense Product, including without limitation infringement or
violation of Third-Party intellectual property rights arising out of such sale or use of the HemoSense Product; and 
  
 (c) Indemnifiable Losses arising out of gross negligence or willful misconduct on the part of HemoSense or any of its agents or employees;

  
 provided, however, that HemoSense shall have no liability for
any such Indemnifiable Losses to the extent that such Indemnifiable Losses were caused by: (x) the gross negligence or willful misconduct of HTI or any persons or entities for whose actions or omissions HTI is legally liable, or (y) a material
breach by HTI of its obligations under this Agreement. 
  
 12.2
Procedures Relating to Indemnification. In order to be entitled to indemnification under this Article 12, the person or entity seeking indemnification under this Agreement (the “Indemnified Party”) must (i) promptly notify
the Party obligated to indemnify it (the “Indemnifying Party”) in writing of the third party Claim for which indemnification is sought (provided that any failure to give any such notification shall only relieve the Indemnifying
Party of its obligations to the extent the failure prejudices the Indemnifying Party’s ability to defend or settle the third party Claim), (ii) give the Indemnifying sole control over the defense and settlement of the Claim, and (iii) provide
such assistance as the Indemnifying Party reasonably requests (at the Indemnifying Party’s expense) in connection with the defense and settlement of the Claim. 
  
 12.3 Indemnifiable Losses. As used in this Article 12, “Indemnifiable Losses” means all losses,
liabilities, taxes, damages, deficiencies, obligations, fines, expenses, penalties, costs, fees, settlement amounts and expenses (including without limitation court costs, interest and reasonable fees for attorneys, accountants and other experts)
awarded or otherwise required to be paid to third parties with respect to any Third Party Claim by reason of any judgment, order, decree, stipulation or injunction, or any settlement entered into in accordance with the provisions of this Agreement,
together with all documented out-of-pocket costs and expenses paid to third 
  

	***	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 12 

 
parties and incurred in connection with defending against or settling such Third Party Claim (including without limitation reasonable fees of attorneys,
accountants and other experts and expenses incurred in asserting, preserving or enforcing any of the Indemnified Party’s rights to indemnification hereunder). 
  
 ARTICLE 13 
 TERM AND TERMINATION 
  
 13.1 Term. This
Agreement shall commence on the Effective Date and shall continue in effect for a period of two (2) years from the Effective Date or until earlier terminated in accordance with the terms and conditions of Section 13.2 (the “Initial
Term”). The Agreement shall renew itself for a one-year renewal term (the “Renewal Term”) at the end of the Initial Term and on each one year anniversary following the end of the Initial Term, unless the Agreement is
terminated by either Party in accordance with the terms and conditions of Section 13.2. (The Initial Term and each Renewal Term are collectively the “Term”). 
  
 13.2 Termination. 
  
 13.2.1 Termination for Convenience. Commencing six (6) months after this Agreement’s Effective Date, either Party may
terminate this Agreement for any reason, or no reason at all, by providing the other Party with a written notice of termination at least eighteen (18) months prior to the effective date of such termination. For clarity, no termination under this
Section 13.2.1 may take effect before the end of the two (2) year anniversary of this Agreement’s Effective Date. 
  
 13.2.2 Breach by HTI. HemoSense may terminate this Agreement immediately upon written notice if HTI has breached any of its
material obligations under this Agreement and has not cured that breach prior to expiration of a sixty (60) day period from the date of notice of breach. 
  
 13.2.3 Breach by HemoSense. HTI may terminate this Agreement immediately upon written notice if HemoSense has breached any of its
material obligations under this Agreement and has not cured that breach prior to expiration of a sixty (60) day period from the date of notice of breach. 
  
 13.2.4 Discontinuance of HemoSense Product. HemoSense may terminate this Agreement immediately upon written notice to HTI if: (a)
HemoSense, in its sole discretion, determines that the HemoSense Product shall not be marketed or shall be withdrawn from the market; or (b) the FDA withdraws approval of or fails to approve the manufacturing or marketing of the HemoSense Product or
HemoSense reasonably believes that the FDA will take (or, as context requires, fail to take) any such action. 
  
 13.2.5 Force Majeure. Either Party may terminate this Agreement in accordance with the terms of Section 13. 
  

	***	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 13 

 13.3 Effects of Termination. 
  
 13.3.1 Payment of Outstanding Amounts. Upon the termination of this Agreement for any reason
whatsoever, HemoSense shall pay to HTI (or, as may be applicable, HTI shall return to HemoSense) all undisputed amounts due and payable up to the effective date of termination but not yet paid. 
  
 13.3.2 Payment for Outstanding Purchase Orders. If
HemoSense or HTI terminate this Agreement for any reason (excluding only HTI’s termination for HemoSense’s breach under Section 13.2.3), HemoSense shall have no obligation to purchase any Coagulation Cocktail 2 ordered in any Purchase
Orders. Otherwise, HTI shall use commercially reasonable efforts to mitigate costs related to HemoSense’s then-outstanding Purchase Orders, and HemoSense shall only be required to pay the raw material and direct labor costs actually incurred in
connection with such Purchase Orders, to the extent HTI is unable to avoid or offset such costs; provided that such amount shall be capped at the applicable Supply Prices for the Coagulation Cocktail 2. 
  
 13.4 Survival. Termination or expiration of this Agreement shall not
affect the rights and obligations of either Party that may have accrued prior to the date of termination or expiration, or any obligation contained in Article 6 though Article 12, Article 14 through Article 16, Sections 2.3, 2.4 and 5.2 and this
Section 13.3. 
  
 13.5 Termination of Purchase
Requirements. Without limiting the foregoing, HemoSense’s obligations under this Section 2.2 shall immediately terminate in their entirety if: 
  
 13.5.1 HTI delivers any quantity of any Coagulation Cocktail 2 more than sixty (60) days after the date such Coagulation Cocktail 2 was
due for delivery, (ii) if in any given calendar quarter HTI fails to deliver at least seventy-five percent (75%) of the quantity of Product due for delivery in such calendar quarter, or (iii) if in any two calendar quarters of the same calendar
year, HTI fails to deliver at least ninety percent (90%) of the quantity of Product due for delivery in each such calendar quarter. 
  
 13.5.2 Any two (2) consecutive shipments contain Coagulation Cocktail 2 that fails to conform to the Specifications, ISO 9001:2000 or
regulatory requirements, or is otherwise defective, and HTI (1) fails to replace the non-conforming Coagulation Cocktail 2 with conforming Coagulation Cocktail 2 in a timely manner. 
  
 13.5.3 Any of the events described in Section 13.2.3 occur that would give HemoSense a right to terminate
this Agreement (whether or not HemoSense elects to exercise its rights to so terminate this Agreement). 
  
 13.5.4 HTI dissolves or otherwise ceases to do business, or such dissolution or cessation of business is reasonably likely. 
  

	***	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 14 

 ARTICLE 14 
 LIMITATION OF LIABILITY 
  
 EXCEPT FOR GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, AND A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER THIS AGREEMENT, NEITHER PARTY SHALL HAVE ANY LIABILITY TO THE OTHER PARTY OR ITS AFFILIATES FOR ANY LOSS OF PROFITS, SPECIAL,
INDIRECT, CONSEQUENTIAL, EXEMPLARY, PUNITIVE OR INCIDENTAL DAMAGES ARISING OUT OF OR RELATED TO THIS AGREEMENT HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY (INCLUDING NEGLIGENCE), WHETHER OR NOT A PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES. NOTWITHSTANDING, THIS Article 14 SHALL NOT BE CONSIDERED TO LIMIT THE PARTIES’ OBLIGATIONS UNDER Article 9 (RECALLS) OR Article 12 (INDEMNIFICATION). 
  
 ARTICLE 15 
 NOTICES 
  
 Every notice or other communication
required or contemplated by this Agreement must be in writing and sent by one of the following methods: (a) by personal delivery, in which case delivery shall be deemed to occur the day of delivery; or (b) by a recognized overnight delivery service
such as Federal Express or DHL Worldwide Express, in which case delivery shall be deemed to occur the day of delivery. In each case, a notice or other communication sent to a Party must be directed to the address for that Party set forth in this
Agreement’s introductory paragraph (Attention: President), or to another address designated by that Party by written notice. 
  
 ARTICLE 16 
 MISCELLANEOUS

  
 This Agreement (together with the addendums, exhibits and
agreements incorporated herein) is the entire agreement between the parties regarding the subject matter set forth in this Agreement. No amendment or modification of this Agreement will be valid or binding upon the Parties unless made in writing and
signed by the duly authorized representatives of both Parties. The relationship of the Parties under this Agreement is that of independent contractors, and this Agreement will not be construed to imply that either party is the agent, employee, or
joint venture of the other. If any provision of this Agreement is held to be unenforceable, that provision shall be enforced to the maximum extent permissible consistent with the Parties’ original intent and the remainder of this Agreement
shall continue in full force and effect. The laws of the State of California shall govern this Agreement, without regard to its conflict-of-laws principles. Any claim or controversy arising out of or relating to this Agreement or breach of this
Agreement shall be settled by arbitration in San Francisco, California, in accordance with the commercial rules of the American Arbitration Association. HTI shall not assign this Agreement, or any obligation or right under this Agreement, in whole
or in part, without HemoSense’s prior written consent, and any prohibited assignment will be void. HemoSense may assign this Agreement in whole or in part to any affiliate or in connection with the merger, consolidation or transfer of all or
substantially all of the assets to which this Agreement relates. Subject to the foregoing, this Agreement will be binding upon and will inure to the benefit of the Parties permitted successors and assignees. The rights and remedies of the Parties
under this Agreement are cumulative and in addition to all similar and other rights and remedies of the Parties under 
  

	***	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 15 

 
other agreements, at law or in equity. Either Party’s failure to enforce any provision of this Agreement shall not be considered a waiver of future
enforcement of that or any other provision. This Agreement may be executed in one or more counterparts, each of which will be considered an original, but all of which will constitute but one and the same instrument 
  
 IN WITNESS WHEREOF, the Parties have caused this Manufacture and Supply
Agreement to be executed by their duly authorized officers as of the day first above written. 
  

					
	HEMOSENSE, INC.
		
	By:	 	 /s/ Maria C. Navarro

	 	 	 Name: Maria C. Navarro

	 	 	 Title:
	 	 Exec VP Operations

  

					
	HAEMATOLOGIC TECHNOLOGIES, INC.
		
	By:	 	 /s/ Richard J. Jenny

	 	 	 Name:
	 	 Richard J. Jenny

	 	 	 Title:
	 	 President & General Manager

  

	***	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 16 

  
 SCHEDULE A 

 
 DEFINED TERMS 
  
 “Affiliate” means, with reference to a Party, another person or entity that,
directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with such Party. For purposes of this paragraph, “control” shall be presumed to exist if one of the following conditions is
met: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (b) in the case of non-corporate entities, direct or indirect
ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities. 
  
 “Coagulation Cocktail 2” means the anti-coagulant control cocktail described in the Specifications. 
  
 “Facility” means the HTI facility located at 57 River Road, Essex Junction,
VT 05452. 
  
 “HemoSense Product” means HemoSense products that
incorporate Coagulation Cocktail 2 for purposes of generating quality-control results in connection with PT tests. 
  
 “Specifications” means those specifications for Coagulation Cocktail 2 that are attached and incorporated into this Agreement as Schedule B, as such
specifications may be amended from time to time by HemoSense in accordance with Section 3.2 of this Agreement. 
  

	***	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 17 

  
 SCHEDULE B 

 
 SPECIFICATIONS 
  
 Material Specification 
  

	1.0	Description 

  
 Coagulation Cocktail 2 (CC2) 
  

	2.0	Material/Product Information 

  

			
	 Appearance:
	  	Frozen Solid (slightly cloudy to clear when thawed)
		
	 Storage:
	  	Freezer [***]C

  

	3.0	Documentation (Certificate of Conformance or Compliance or Analysis) 

  

	 	•	 	Product Information Sheet with following information: 

  

	 	•	 	Item 

  

	 	•	 	Catalog Number 

  

	 	•	 	Lot Number 

  

	 	•	 	Storage Conditions 

  

	 	•	 	Quantity Shipped 

  

	 	•	 	Date of Manufacture (DOM) 

  

	 	•	 	Incoming material must be received at HemoSense within two weeks from the DOM 

  

	 	•	 	CAUTION statement for Cocktail – 2 

  

	 	•	 	Test Results 

  

			
	 Test

	  	Acceptance Range

	 [***]
	  	[***]
	 [***]
	  	[***]
	 [***]
	  	[***]

  

	 	•	 	The following parameters will be provided for informational purposes only 

  

			
	 Parameter

	  	Target

	 [***]
	  	[***]
	 [***]
	  	[***]
	 [***]
	  	[***]
	 [***]
	  	[***]
	 [***]
	  	[***]
	 [***]
	  	[***]
	 [***]
	  	[***]

  

	***	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 18 

	4.0	Safety Considerations 

  
 Refer to MSDS 
  

	5.0	Suggested Sources 

  

			
	 Supplier

	  	Supplier #

	 Haematologic Technologies, Inc.
	  	Hemosense-CC2

  

	6.0	Packaging Requirements 

  
 A label with product description, lot number, date of manufacture (DOM) and amount per vial must be on the primary container. 
  
 The Coagulation Cocktail 2 must come in 1 ml vials and have a label attached
to each vial with product description, lot number, date of manufacture (DOM) and amount. The vials are to be segregated from each other by a separator inside primary container. 
  
 The CC2 must to be shipped in a shipping container with polyfoam packer and dry ice. 
  

	7.0	References 

  

	 	7.1	Incoming Inspection for Coagulation Cocktail 2 (II# 0301012) 

  

	***	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 19 

  
 SCHEDULE C 

 
 SUPPLY PRICE 
  
 HemoSense Cocktail 2: $[***]/ml 
  
 Annual price adjustments not to exceed [***]% 
  

	***	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 20Professional Service Agreement dated October 29, 2003

 Exhibit 10.10 
  
 

 
  
 Professional Service Agreement

 (for Use with Manufacturing Services Only) 
  
 This Agreement is hereby entered into on this 29th day of October 2003 by and between Hemosense Inc., of 600 Valley Way, Milpitas, CA 95035 (hereinafter “Customer”), and Plexus Services Corp., of 55 Jewelers Park Drive, Neenah, WI 54956,
(including its subsidiaries and affiliates, hereinafter collectively referred to as “Plexus”). 
  
 WHEREAS, Plexus is in the business of providing manufacturing services that include the custom manufacture of printed electronic circuit boards, systems and related services; 
  
 WHEREAS, the parties desire to establish the terms and conditions that will apply to
Customer’s purchase from Plexus of certain printed electronic circuit boards and/or systems and related services; and 
  
 NOW, THEREFORE, in consideration of the mutual promises hereinafter set forth, the receipt and adequacy of which are hereby acknowledged, the parties, intending to
be legally bound, hereby agree as follows: 
  

	 	1.	DEFINITIONS 

  

	 	a.	Assembly 

  
 Shall mean those products that Plexus will manufacture for Customer according to Customer-supplied specifications and deliver to Customer as a completed
product. 
  

	 	b.	Business Days 

  
 Shall mean any day that Plexus is open for normal business as detailed in the Plexus annual calendar or any subsequent updates. 
  

	 	c.	Component Value 

  
 Shall mean the direct, out-of-pocket cost paid by Plexus to Suppliers for Components plus standard mark-up as defined in Attachment A, is made a part
hereof and incorporated herein to this Agreement. To the extent any terms in Attachment A (or any attachment to this Agreement) conflict with the terms of the body of this Agreement, the terms in the body of this Agreement shall control. 

 

	 	d.	Components 

  
 Shall mean any and all material used in the manufacture of the Customer’s Assembly. 
  

	 	e.	Custom Components 

  
 Shall mean those Components that are manufactured specifically for Customer, which have special procurement conditions such as limited change parameters
or other special liability conditions required by Plexus’ Suppliers for which Customer will be liable. 
  

	 	f.	Customer-Supplied Components 

  
 Shall mean Components that are provided by the Customer to Plexus for use in the manufacture of the Customer’s Assemblies. 
  

	 	g.	Delivery Date 

  
 Shall mean the date the Customer’s Assemblies are scheduled to be released to the carrier as set forth in Customer’s Purchase Order.

  

	 	h.	Demand 

  
 Shall mean quantities of Assemblies required by Customer and communicated to Plexus via Forecast and/or Customer’s Purchase Orders. 
  

	 	i.	Engineering Change (“EC”) 

  
 Shall mean mechanical, software, electrical, design and/or specification changes which, if made to the Assemblies, would affect the form, fit, function,
delivery schedule, performance, reliability. 

 *** Confidential treatment requested pursuant to
a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.*** 
  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	1	  	 

	 	j.	Excess Components 

  
 Shall mean those Components in inventory or on-order that are projected to be consumed by Customer Demand, but not within the next [***] ([***]) calendar
days. 
  

	 	k.	Forecast 

  
 Shall mean a twelve (12) month rolling estimate of Demand provided by Customer for each Assembly including the quantities to be manufactured, and the
requested Delivery Date. 
  

	 	l.	Inactive Components 

  
 Shall mean those Components in inventory or on-order that are on the bill of material for an Assembly that has current Forecast Demand, but which the
Forecast Demand will not consume such Components. 
  

	 	m.	Long Lead-Time Components 

  
 Any Component with a lead-time greater than [***] ([***]) calendar days. 
  

	 	n.	Manufacturing Lead Time 

  
 Unless otherwise mutually agreed by the parties in writing, shall mean [***] ([***]) calendar days. 
  

	 	o.	NCNR Components 

  
 Shall mean Components in inventory or on-order deemed non-cancelable or non-returnable by Plexus’ Suppliers. For the avoidance of doubt, all open
packages or broken reels of Components shall also be considered NCNR Components. 
  

	 	p.	Obsolete Components 

  
 Shall mean those Components in inventory or on-order that do not appear on a Customer bill of materials, or which appear on a Customer bill of materials
of an Assembly that has no Demand. 
  

	 	q.	OIX Components 

  
 Shall mean Obsolete Components, Inactive Components, and Excess Components. 
  

	 	r.	Purchase Order 

  
 Shall mean a commitment by the Customer, communicated via EDI, email, facsimile or other means, to purchase a specific Assembly, at a stated quantity,
unit price, and Delivery Date. 
  

	 	s.	Quarterly Business Review (“QBR”) 

  
 Shall mean a strategic business meeting between the Customer and Plexus to discuss current business issues and opportunities as further defined in
Section 6. 
  

	 	t.	Supplier 

  
 Shall mean any vendor that is not affiliated with Plexus, including Customer, that provides Components or services to Plexus. 
  

	 	2.	DELIVERY SCHEDULES, FORECASTS AND PURCHASE ORDERS  

  

	 	a.	Forecasts 

  
 Customer agrees to provide Plexus an updated Forecast each month for each Assembly manufactured by Plexus. Plexus will use the Forecast to identify any
Long Lead-Time Components, Custom Components, NCNR Components, and to negotiate Component pricing. The first 90 days of Customer’s then-current Forecast shall be considered binding Purchase Orders under Section 2.b. below. Otherwise, all
Forecasts that Customer provides to Plexus under this Agreement are non-binding, except to the extent of Long Lead Time Components that are NCNR Components ordered by Plexus to support Customer Forecasts. 
  
 It is acknowledged that Plexus may procure Long Lead-Time Components in
advance of receipt of a Customer Purchase Order, and Customer agrees to assume ultimate financial responsibility for 
  

 *** Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission.
Omitted portions have been filed separately with the Commission. 
  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	2	  	 

 these Long Lead-Time Components that are NCNR Components provided they were ordered by Plexus to support
Customer Forecasts (plus any minimum or economic order quantities required by the Supplier or Customer) and in a manner reasonably consistent with the applicable Component’s lead times at the time of order and provided further that the purchase
of the applicable Long-Lead Time, NCNR Component has been pre-approved in writing by Customer. 
  

	 	b.	Purchase Orders 

  
 Customer may procure Assemblies by issuing Purchase Orders to Plexus. Plexus will attempt to acknowledge receipt of each Customer Purchase Order within
two (2) Business Days of receipt of the order. All Customer Purchase Orders are subject to Plexus’ written acceptance or rejection; provided however that Plexus will make reasonable efforts to accept, all Purchase Orders submitted by Customer.
All Customer Purchase Orders that Plexus does not reject in writing within five (5) Business Days shall be considered accepted by Plexus. 
  

	 	3.	DELIVERY SCHEDULE CHANGES AND CANCELLATION 

  

	 	a.	Schedule Increases or Pull-ins 

  

	 	i.	Outside Manufacturing Lead Time 

  
 If Customer requests that delivery of particular Assemblies be expedited from the Delivery Date originally specified in Customer’s Purchase Order,
(a “Schedule Increase”), and such request is made within 90 days of the requested re-scheduled Delivery Date (but outside the Manufacturing Lead Time), Plexus will attempt to provide written acknowledgement of acceptance or rejection of
such Schedule Increase to Customer within a reasonable period of time, normally five (5) Business Days of receipt of the Schedule Increase. Such acknowledgement may state the Components, if any, that Plexus has identified as impeding its ability to
meet the requested Delivery Date. 
  

	 	ii.	Within Manufacturing Lead Time 

  
 If Customer requests a Schedule Increase within the Manufacturing Lead Time, Plexus will attempt to provide written acknowledgement of acceptance or
rejection to Customer no later than three (3) Business Days after receipt of Schedule Increase request. Such acknowledgement will state the Components, if any, that it has identified as impeding its ability to meet the requested Delivery Date.

  
 If Plexus identifies Components that will impede the
requested Delivery Date, upon written authorization from Customer, Plexus shall proceed with purchasing Components to meet the Customer Delivery Date despite the identification of Components that may delay delivery. Customer agrees to pay all
related freight costs to meet the required Delivery Date. 
  
 In
the event that Plexus is unable to obtain all Components required to manufacture the Assembly by the requested Delivery Date, then Plexus will notify Customer in writing of the total Component Value of the Components on-hand or on-order that Plexus
has procured or ordered to support Customer’s requested schedule increase. Customer agrees to remit a deposit to Plexus in the amount of such Component Value within ten (10) Business Days of receipt of such notification as a security to Plexus
of Customer’s liability for the same. 
  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	3	  	 

	 	b.	Schedule Delays 

  
 Unless otherwise agreed by both parties, schedule changes to the Purchase Orders placed by Customer to Plexus will be managed to the following matrix:

  

						
	 Delivery Dates
Occurring within

	  	Percent
Demand
Deferrable

	 	 	 Deferral Limits

			
	 0-30 calendar days
	  	[***]	%	 	None
			
	 31-60 calendar days
	  	[***]	%	 	Defer delivery one (1) time for a maximum of 30 calendar days from the originally scheduled Delivery Date
			
	 61-90 calendar days
	  	[***]	%	 	Defer delivery one (1) time for a maximum of 60 calendar days from the originally scheduled Delivery Date

  
 Customer may defer
Purchase Order deliveries at any time based upon the above flexibility schedule. Subject to the terms of Section 4.a., Customer will be liable to Plexus for Component liability related to Inactive and Excess Components in inventory arising out of
such delivery deferments in accordance with the terms of Section 4.c. herein. 
  
 This Section 3.b. (including Section 4.c. as referenced herein) states Plexus’ sole remedy, and Customer’s sole liability, for Customer’s deferment of any Purchase Order deliveries. 
  

	 	c.	Schedule Cancellations 

  
 Customer may cancel any Purchase Order or Demand specified in Forecast that has Delivery Dates beyond ninety (90) calendar days at any time. Plexus will
make commercially reasonable efforts to notify Customer in writing within twenty (20) Business Days of a Demand cancellation of the total value of Components, if any, for which Customer is financially responsible under Section 2.a. of this Agreement
as a result of the cancellation. 
  
 Customer may also cancel
any Purchaser Order that has Delivery Dates within ninety (90) calendar days, provided that Customer shall be liable for (i) any and all Component Value related to Components on-hand, on-order, or in process for the cancelled Assemblies; (ii) labor
costs to assemble the cancelled Assemblies to the then-current state of Assembly; and (iii) any labor costs required to remove the cancelled Assemblies and Components from the manufacturing facility, provided that: (a) Customer’s liability for
Components applies only to OIX liability (or, in the case of a termination of this Agreement, all Components on-hand or on-order at Plexus that Plexus ordered to support Customer’s Purchaser Orders or, subject to Section 2.a., that Plexus
ordered to support Customer’s Demand Forecasts) that Plexus is unable to mitigate as set forth in Section 4.a; and (b) at Customer’s request and upon payment, Customer shall be entitled to delivery of the then-current state of the
cancelled Assembly and/or any Components paid for by Customer. 
  
 This Section 3.c. (including Section 4 as referenced herein) states Plexus’ sole remedy, and Customer’s sole liability, for Customer’s cancellation of any Purchase Order or of Demand specified in any Forecast. 
  

	 	4.	COMPONENT INVENTORY REPORTING, LIABILITY AND COVERAGE 

  
 All Customer liability for Components under this Agreement shall be subject to the terms of this Section 4, which in turn shall be further subject to the
terms of Section 2.a. (above). 
  

	 	a.	Component Liability Mitigation 

  
 In all circumstances related to Component procurement and management, Plexus will use its reasonable efforts to minimize Component liability to the
Customer. These efforts include, but are not limited to, using Components on non-Customer projects, returning Components to Suppliers, restocking Components with Suppliers, or canceling orders with Suppliers. Customer liabilities 

  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	4	  	 

 
for Components will be net of Plexus’ reasonable efforts to mitigate total Component liability in the supply chain, including any non-recurring costs
from Plexus’ Suppliers related to these efforts. 
  
 Notwithstanding the above, Plexus may have OIX inventory on-hand or on-order from time to time as a consequence of Customer’s Demand cancellation, reduction, or reschedule, Plexus’ support of upside flexibility requested by
Customer, the failure of Purchase Orders to consume previously Forecasted requirements, Customer’s failure to provide adequate or conforming supplies of Components to be consigned, supplied or managed by Customer, Customer allocations, end of
life purchases that Customer approves in advance in writing, minimum order quantities that Customer approves in advance in writing, Customer-approved Engineering Change orders, or Customer-approved material change orders. Customer will be liable for
such OIX on-hand or on-order in accordance with the provisions set forth below. Where Customer is liable for such OIX inventory and issues a Purchase Order in accordance with this Agreement and payment for such OIX, Customer shall, upon request, be
entitled to delivery of such OIX inventory without further charge beyond the Component Value of Customer’s Component liability for such OIX inventory. 
  

	 	b.	Obsolete Components 

  
 Plexus will use commercially reasonable efforts to notify Customer in writing within ten (10) Business Days of receipt of a schedule change or
Engineering Change, of the total Component Value of Customer liabilities related to Obsolete Components created as a result of the change. Customer agrees to review the Customer liabilities, and if Customer elects to proceed with the Engineering
Change, Customer shall issue a separate Purchase Order and payment and written disposition for all items within ten (10) Business Days of receipt of notification by Plexus. 
  

	 	c.	Inactive and Excess Components 

  
 Plexus will notify Customer in writing as often as necessary of Customer liabilities related to Inactive and Excess Components in inventory. Customer
agrees to review the Customer liabilities as communicated in writing by Plexus and remit a deposit to Plexus for the total Component Value of all Inactive and Excess Components within ten (10) Business Days of receipt of the written request from
Plexus. 
  
 The remittance of a deposit by Customer under this
Agreement will represent a security to Plexus for Customer’s Component liability under this Agreement. Plexus and Customer will review any amounts on deposit with Plexus from time to time at either party’s discretion and make adjustments
to the same to reflect the then-current Component Value of Inactive Components and Excess Components on-hand and on-order at Plexus. Plexus may hold any such deposits made by Customer under this Agreement in any manner at its discretion. Title and
risk of loss for Components against which a deposit has been made shall remain with Plexus. Plexus will also retain responsibility to insure and warehouse such Components according to Plexus’ then-current practices. Notwithstanding, in the
event Components for which Plexus has received a deposit are not consumed within six (6) months of receipt by Plexus, said deposit, at Plexus’ option, will be converted into a payment by Customer for such Components. In addition, in the event
this Agreement or the manufacturing relationship between Customer and Plexus has terminated, any deposits from Customer then held by Plexus will convert, at Plexus’ option, into a payment by Customer for any Components on-hand or on-order at
Plexus and relating to an Assembly. Upon the conversion of any deposit into a payment by Customer for Components, Plexus will ship such Components as soon as practicable FOB Plexus’ facility. 
  

	 	d.	Component Cost Purchase Price Variance 

  
 Plexus agrees to notify Customer of Component purchases related to any particular Component that will create adverse purchase price variance in excess of
$[***] with respect to the aggregate quantity of such particular Component required to support any Customer Purchase Order. Customer agrees to issue a separate Purchase Order for the value of the purchase price variance plus markup as identified on
Attachment A, or to change its Assembly Purchase Order(s) to reflect the revised unit purchase price including the adverse purchase price variance plus 

  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	5	  	 

 
markup as supplied in Attachment A. All Component purchase price variances under $[***] each shall be aggregated and paid for by Customer at the end of the
quarter. 
  

	 	5.	COMPONENTS SUPPLIED BY CUSTOMER 

  
 Customer may provide Plexus with Customer-Supplied Components for the manufacture of Customer’s Assemblies. Customer will be responsible as a
Supplier to Plexus for the quality and on-time delivery of Components supplied to Plexus. Plexus shall be responsible for handling, warehousing and industry standard care for the Components. For Customer-Supplied Components that have not been
purchased by Plexus, title shall be maintained by Customer, but risk of loss and insurance shall be Plexus’ responsibility. Plexus will not be liable for warranty or attrition in the manufacturing or related processes relating to
Customer-supplied Components. 
  
 Customer’s inability to
provide Components in a timely manner may affect Plexus’ ability to meet its delivery schedule. Any additional expenses that Plexus must incur due to delayed shipment as a direct result of a quality or delivery issue from Customer will be borne
by the Customer. In addition, Plexus reserves the right to define a new schedule for delivery based upon the availability and condition of Components supplied by Customer. Any OIX on-hand or on-order as a result of Customer’s failure to timely
deliver conforming Components shall be managed in accordance with Section 4 herein. 
  
 Process for managing customer owned inventory: 
  
 For all usable inventory previously purchased from Plexus and on-hand at Customer as of June 1, 2003, the following process will be used to consume inventory and provide credit: 
  
 1) Move all parts on-hand at Customer into a Customer Supplied (CS)
location. This will make the components available to manufacturing. 
  
 2) At the end of each month Plexus will provide a status report of what has been taken out of CS for manufacturing. 
  
 3) Plexus will continue to ship and bill the full unit price for all Customer units. 
  
 Plexus will then issue a credit to Customer for the parts that were used in the month. The CS credit will be the Component
cost set forth on Attachment A, plus [***]% ([***]% markup less [***]% handling, storage, and materials management fees) 
  
 4) Components that are Customer supplied beyond the balance of current on-hand inventory purchased from Plexus by Customer will be subject to full mark
up. 
  
 5) All component procurement after consumption of the
on-hand inventory will be full turnkey, subject to full mark-up. Customer will provide quarterly updates to any component pricing that has been negotiated by Customer for inclusion in the Plexus costed BOM for pricing purposes. 
  

	 	6.	QUARTERLY BUSINESS REVIEWS (“QBR”) 

  
 Plexus and Customer agree to meet quarterly, or as otherwise agreed by both parties, to discuss the state of business and to review business performance
issues and improvement initiatives. The items to be reviewed include, but are not limited to, the following: 
  

	 	a.	Customer and Plexus Business Trends 

  
 Customer and Plexus agree to review their business initiatives and any significant changes that may affect the relationship of Customer and Plexus. In
addition, Customer will present business trends and performance to Forecast so that Plexus can better serve the current Customer requirements. 
  

	 	b.	Cost Savings Initiatives (Components and Labor) 

  
 Plexus and Customer agree to review initiatives to reduce cost from the bill of materials and manufacturing process for the Assemblies. 
  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	6	  	 

	 	c.	Delivery Performance 

  
 Plexus and Customer agree to measure, review and discuss delivery performance for all Assemblies. Both parties agree to measure actual Delivery Dates as
compared to Customer requested Delivery Dates and to Plexus’ expected Delivery Dates. 
  

	 	d.	Quality Performance 

  
 Plexus and Customer agree to discuss the agreed upon quarterly quality metrics for the program. 
  

	 	e.	Payment Performance 

  
 Plexus and Customer agree to review any issues that are preventing payment within the agreed upon payment terms. 
  

	 	f.	Assembly Pricing 

  
 Plexus and Customer agree to review Assembly pricing. Any Assembly price adjustments required shall be based upon total Assembly order quantities,
prevailing Component market prices, supply chain programs, Engineering Change requests or other relevant data. 
  

	 	g.	Long Lead-Time, Custom, and NCNR Parts Review 

  
 Plexus and Customer agree to review Long Lead-Time Components, Custom Components, and NCNR Components. 
  

	 	7.	PRICING AND PAYMENT  

  
 Plexus Pricing and Quotations 
  

	 	a.	The initial prices for the Assemblies are set forth on Attachment A, which shall be subject to adjustment as set forth in this Agreement. Unless otherwise agreed by Plexus in
writing, prices quoted are F.O.B. Plexus’ manufacturing facility. Any manufacturer’s tax, retailer’s occupation tax, use tax, sales tax, excise tax, or tax of any nature whatsoever imposed on or measured by the transaction between
Plexus and Customer (other than taxes based on Plexus’ net income) shall be paid by Customer in addition to the prices set forth in Attachment A. In the event Plexus is required to pay such tax, Customer shall reimburse Plexus for the same,
within ten (10) days of written demand by Plexus to Customer for such reimbursement. If the transaction between Plexus and Customer is exempt from all such taxes, Customer shall provide Plexus with a tax exemption certificate or other document
acceptable to all taxing authorities at the time the order or contract is submitted. The prices quoted do not include, unless specifically stated otherwise, the cost for testing and/or submittals for Assembly approvals or any annual file maintenance
fee, such as for UL, VDE, CSA or FCC. Plexus will assist Customer in obtaining such approvals and charge for such services at Plexus’ current hourly billing rate. 

  

	 	b.	Pricing will be reviewed at QBRs conducted by the parties. Plexus will use its diligent efforts to lower costs while maintaining quality by seeking productivity improvements,
minimizing waste, improving yields, purchasing quality Components at reduced costs, and improving manufacturing processes. Where cost savings are achieved, such savings will be passed on [***] percent ([***]%) to Customer in the form of lower
Assembly pricing, subject to the terms of Section 7.c. below. In the event new pricing is agreed to at a QBR (or at any other time by mutual agreement), such new pricing will be implemented on shipments by Plexus beginning on the day following the
QBR or, as applicable, the date of such other agreement between the parties. On the day new pricing is implemented, Plexus will also write-down or write-up, as applicable, existing raw materials, work-in-process and finished goods inventory held by
it to reflect the new agreed to pricing and invoice or credit Customer for the same, as applicable. Customer will pay such invoices as provided below. 

  

	 	c.	 In the event that the cost of Assemblies declines and the cost saving is initiated by Plexus Purchasing or Plexus Manufacturing, through an approved Engineering
Change, Plexus will be entitled to retain the benefit of such cost reduction for [***] ([***]) months from the time such cost saving is generated. At the first pricing review conducted by the parties after such [***] ([***]) month 

  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	7	  	 

	 	 
period and thereafter, [***]% of such cost savings will be passed on to Customer in the form of a price reduction to be implemented as set forth above. In
the event a cost reduction is not initiated by Plexus Purchasing or Plexus Manufacturing, through an approved Engineering Change, (such as general decreases in Component costs due to market conditions and other cost reductions initiated and obtained
by Customer, such cost reduction will be passed on to Customer entirely at the next pricing review conducted by the parties in the form of a price reduction to be implemented as set forth above. Cost reductions initiated by Customer will include any
cost out initiatives obtained by contracting Plexus Technology Group for specific tasks associated with cost reduction projects related to design or test development and improvements. All cost savings that result from these activities will also be
passed on entirely to the Customer at the next QBR. 

  

	 	d.	Unless otherwise stated herein, all payments hereunder by Customer to Plexus shall be paid in US dollars, net 30 days from the date of invoice without set-off of any kind (other
than set-off for credit memos issued by Plexus). Without limiting Customer’s rights and remedies under Section 13, Customer shall report any believed discrepancies in Plexus’ packing slips no later than ten (10) days after the date of
receipt. Payment shall be deemed made when Customer’s check is received by Plexus or electronic fund transfer is completed. 

  

	 	e.	Customer acknowledges that the above payment terms, and any other credit terms, limits, or vehicles granted by Plexus to Customer during the course of the performance of this
Agreement, will be subject to periodic review, and may be modified by Plexus as reasonably necessary if Customer’s financial condition materially deteriorates. In addition, Customer acknowledges that Plexus may request, and Customer shall
provide to Plexus promptly upon any such request, the following financial information to the extent reasonably necessary to verify the financial condition of Customer, monthly cash balances and available equipment credit line information directly
from Customer, current quarterly balance sheets, quarterly cash flow statements and quarterly statements of income. Plexus will maintain any such information provided by Customer to Plexus confidential in accordance with the terms of the
non-disclosure agreement in place between the parties at the time of disclosure. Disclosure of monthly and quarterly financial information as requested will cease once Customer demonstrates [***] ([***]) [***] months of positive cash
flow/profitability. Plexus shall be entitled to obtain annual audited financial information from the Customer after Customer has achieved [***] of positive cash flow/profitability if reasonably necessary. ‘ 

  

	 	8.	ENGINEERING CHANGES 

  

	 	a.	Notice of change 

  
 Customer agrees to submit all Engineering Changes (“EC”) to Plexus in writing. Plexus will attempt to evaluate the feasibility of the EC
requested by the Customer within five (5) Business Days of receipt and respond to Customer in writing with the potential impact of the EC on current on-hand or on-order inventory, work-in-progress and the delivery schedule. 
  

	 	b.	Notice of EC cost impact (Assembly pricing, Component liability, NRE expenses) 

  
 In addition to the written response provided above, Plexus will attempt to respond to the Customer within ten (10) Business
Days with a written evaluation of the EC including: a) the administrative cost to implement the EC; b) the cost to modify tooling or related non-recurring expenses; c) the obsolete quantity of Components Plexus has on-hand and/or on-order with its
Suppliers related to the EC; d) the cost to rework work-in-process and any ongoing unit price adjustment resulting from the EC; e) the expected effect on the delivery schedule to include the effect on all in-process work (e.g., re-workable,
repairable, etc.); and f) the manner in which the EC will be implemented. 
  

	 	c.	Plexus ECs. Plexus may not implement an EC without the express written consent of Customer. 

  

	 	9.	QUALITY STANDARDS 

  

	 	a.	General 

  
 Plexus agrees to maintain a quality assurance program compliant with the requirements of ISO 9002: 1994 (or later as applicable). 
  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	8	  	 

	 	b.	Components 

  
 Upon receipt, Plexus shall inspect all Components to be used in the manufacture of Assemblies under this Agreement for compliance with Customer’s
quality specifications. Plexus shall promptly inform its Suppliers of Components that do not comply with Customer’s specifications, and shall return to such Suppliers (and not use in connection with any Assemblies) any such Components.

  

	 	c.	Workmanship Requirements 

  
 Assemblies manufactured by Plexus shall be assembled, inspected and tested by Plexus in accordance with Customer product specifications. Unless otherwise
agreed upon in writing, Plexus shall maintain an Assembly assurance “workmanship” requirement which mandates internal compliance to IPC-A-610 Class 2. Target process and product first pass yields (or PPM’s) in manufacturing shall be
jointly agreed to between Plexus Quality Engineering and the Customer. These Customer goals will form the basis for Continuous Quality Improvement (“CI”) Activities at Plexus and process and yield requirements which requirements will be
established within one calendar quarter after the Effective Date. The Quality Control (“QC”) Vision and Functional Test Issues document as set forth in Attachment B, is made a part hereof and incorporated herein to this Agreement.

  

	 	d.	Continuous Improvement 

  
 Plexus and Customer agree to hold a CI meeting or conference call as often as necessary to be established with the Customer’s Quality Team and
Plexus CI Team. This CI event will result in documented action items at Plexus that drive improvement efforts that can be reported to management at both organizations. 
  

	 	e.	Chronic Tests Failures (“Production”) 

  
 Customer Assemblies will be manufactured and tested to the Customer-supplied documentation and test specifications associated with the current Assembly
revision. Assemblies that fail the approved tests three (3) times for the same issue and that cannot be repaired by Plexus due to a design related issue will be deemed non-repairable Assemblies. The non-repairable Assemblies will be clearly marked
as “failed Assemblies.” Both companies agree to review the status of all “failed Assemblies” within ten (10) Business Days of identification and to dispose of them by scrapping the Assemblies at Plexus and invoicing the Customer
or shipping the Assemblies and invoicing the Customer. Assembly invoices will be issued at the quoted Assembly price with payment terms as described in Section 7 of this Agreement. Assemblies that fail the approved tests for manufacturing-related
issues covered by Section 13 shall be subject to Section 13. 
  

	 	10.	TEST EQUIPMENT 

  
 Plexus shall at the request of Customer maintain Customer test equipment. The equipment will be repaired on a time and materials basis. Labor will be
charged at the current billing rate. Replacement parts for test equipment will be charged at cost plus material overhead and profit. Travel expenses will be added to any repairs including travel between Plexus and/or one of its affiliates.
Notwithstanding the foregoing, Customer need not pay any amounts associated with test-equipment maintenance/repair unless Customer requests such work pursuant to a written Purchase Order. 
  

	 	11.	TOOLING AND RELATED NON-RECURRING EXPENSES (“NRE”) 

  
 All tooling produced or obtained for the Assemblies delivered hereunder and paid for by Customer will be at a price equal to Plexus’ direct
out-of-pocket costs for such tooling plus a [***] percent ([***]%) markup for items under $[***] each and [***] percent ([***]%) markup for items greater than $[***] each. Tooling shall become and remain the property of Customer at the time payment
in full is received by Plexus. Such tooling shall be used by Plexus only for the benefit of Customer, and shall be delivered to Customer upon request. If Customer requests the return of any tooling from Plexus and Plexus reasonably determines that
the return of such tooling would prevent Plexus from providing the complete Assemblies to Customer, then Plexus shall inform Customer in writing, and Customer and Plexus shall negotiate a mutually acceptable resolution. 
  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	9	  	 

 Customer, at its sole discretion, may consign items to Plexus including, but not limited to, materials
and/or equipment relating to the production and/or testing of the Assemblies at Plexus’ manufacturing location. Plexus shall utilize the material and/or equipment only for the production and/or testing of the Assemblies. Customer shall assist
Plexus in installing the materials and/or equipment and shall provide training and calibration/ maintenance instructions, if requested by Plexus or required by Customer. Customer shall be financially responsible for insuring, calibrating, repairing,
upgrading, replacing and/or maintaining the materials and/or equipment consigned to Plexus. However, Plexus shall provide routine maintenance. Customer agrees to reimburse the cost of equipment calibration should Plexus assume the responsibility for
the calibration of Customer-supplied equipment based on Customer direction. 
  

	 	12.	DOCUMENTATION 

  
 Customer is responsible for supplying Plexus with complete documentation and updates to the same. This includes complete and current sets of documentation
including, at a minimum, all prints, software, artwork, and bill of materials with manufacturer and part number, and any specifications, including test specializations or procedures called for on any Customer prints. It is the Customer’s
responsibility to assure that Plexus receives timely notification of any changes to the documentation, and updated prints reflecting such changes. 
  

	 	13.	LIMITED WARRANTY 

  
 Except as set forth below, Plexus warrants that the Assemblies will be free from defects in workmanship, and will conform to the Customer’s
manufacturing specifications, for a period of [***] ([***]) year from date of shipment. If the Components furnished contain a Supplier’s Component warranty, then Plexus hereby extends, to the extent possible, such Supplier’s Component
warranty to Customer. If the Assemblies do not conform to the foregoing warranty, Plexus shall within [***] ([***]) days repair or replace, at Plexus’ option and free of charge, defective Assemblies which are returned to Plexus securely
packaged, and insured, which bear a Return Material Authorization (“RMA”) number issued by Plexus to Customer pursuant to a Customer request made within the warranty period, and which are returned to Plexus by Customer within [***] ([***])
calendar days after Customer’s receipt of Plexus’ RMA number. Plexus’ warranty for replacement or repaired Assemblies shall be the same as the warranty stated herein provided that the duration of such warranty shall be limited to the
duration of the warranty which remained on the original defective Assemblies returned to Plexus as of the date of Plexus’ receipt of the same, or [***] ([***]) calendar days, whichever is longer. Plexus will make all reasonable efforts to
respond to Customer promptly after receiving an RMA number request. Plexus will return any Assemblies repaired or replaced pursuant to this paragraph to Customer with freight prepaid. 
  
 This warranty does not apply to: 
  

	 	a)	Design deficiencies 

 Plexus expressly disclaims any
warranty relating to design deficiency. 
  

	 	b)	Malfunctions, defects, or failures resulting from misuse; abuse; accident; neglect; improper installation, operation or maintenance; theft; vandalism; acts of God; power failures or
surges; casualty; alteration, modification, or repairs by any party other than Plexus; or any other cause beyond Plexus’ reasonable control occurring after shipment of the Assemblies. 

  

	 	c)	Components incorporated into the Assemblies, except as provided in the second sentence of this Section 13. 

  

	 	d)	Assemblies shipped by Plexus and not tested according to agreed-upon test procedures at the direction of Customer. 

  
 THE FOREGOING AND SECTION 15 CONSTITUTE CUSTOMER’S SOLE REMEDIES
AGAINST PLEXUS FOR BREACH OF WARRANTY CLAIMS. EXCEPT AS PROVIDED IN THIS SECTION AND SECTION 15, PLEXUS MAKES NO WARRANTIES WITH RESPECT TO THE ASSEMBLIES OR ITS SERVICES HEREUNDER, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES RESPECTING
NONINFRINGEMENT, OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY IMPLIED WARRANTIES ARISING FROM A COURSE OF PERFORMANCE, A 

  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	10	  	 

 
COURSE OF DEALING, OR TRADE USAGE. PLEXUS MAKES NO WARRANTY WITH RESPECT TO SOFTWARE. ALL SOFTWARE IS PROVIDED “AS IS.” 
  
 Any repair services requested of Plexus by Customer not explicitly covered
by the above warranty, including, but not limited to, upgrade services, will be out-of-warranty services and performed by Plexus at its option and on a time and materials basis. In addition, Assemblies for which Plexus cannot duplicate the failure
reported by Customer shall be returned to Customer at Customer’s expense. 
  

	 	14.	PROPRIETARY RIGHTS AND CONFIDENTIALITY 

  

	 	a.	Proprietary Rights 

  
 As between the parties, all intellectual property rights in subject matter produced or developed by Customer during the term of this Agreement in
connection with the design of the Assemblies shall be owned exclusively by Customer. As between the parties, all intellectual property rights in subject matter produced or developed by Plexus during the term of this Agreement in connection with the
manufacture of the Assemblies for Customer shall be owned exclusively by Plexus. As between the parties, all intellectual property rights in subject matter produced or developed jointly by Plexus and Customer during the term of this Agreement in
connection with the manufacture of the Assemblies for Customer shall be jointly owned by Plexus and Customer. Notwithstanding the foregoing provisions of this Section 14, changes to the design of the Assemblies (including all intellectual property
rights therein) produced or developed by Plexus, if any, either alone or jointly with Customer (for example, to improve manufacturability or facilitate testing), shall be owned exclusively by Customer. Subject to the terms and conditions of this
Agreement, Customer grants to Plexus a non-exclusive, non-transferable, royalty-free, worldwide, limited right and license under Customer’s intellectual property rights in the Assemblies solely for Plexus to manufacture Assemblies for, and sell
Assemblies to, Customer as set forth in this Agreement. Otherwise no license, express or implied, or by estoppel or otherwise, with regard to any trade secret, patent, copyright, mask-work right, trademark or other intellectual property right of
either party is granted to the other party under this Agreement. Each party expressly reserves all rights under trade secrets, patents, copyrights, mask-work rights, trademarks or other intellectual-property rights owned by such party. 

 

	 	b.	Confidentiality. 

  
 Each party shall keep confidential all information identified by the other party as confidential or proprietary (“Confidential Information”).
Without limiting the foregoing, Customer hereby identifies all of the Forecasts, Purchase Orders, Assembly specifications and designs provided by Customer under this Agreement as Customer Confidential Information. Each party shall keep and instruct
its employees and agents to keep Confidential Information confidential by using at least the same care and discretion as used with that party’s own confidential information, but in no case less than a prudent and reasonable standard of care.
Information shall not, with respect to a party, be subject to such confidentiality obligations if it is: (a) in the public domain through no fault of the receiving party; (b) known to such party prior to the time of disclosure by another party; (c)
lawfully and rightfully disclosed to such party by a third party on a non-confidential basis; (d) developed by such party without reference to Confidential Information; or (e) required to be disclosed by law, provided that the receiving party
promptly provide notice to the disclosing party of such request or requirement so the disclosing party may seek appropriate protective orders. Notwithstanding the dispute-resolution provisions set forth in Section 23, if any party, its employees or
agents breaches or threatens to breach the confidentiality obligations or obligations relating to use of the Confidential Information, the affected party may obtain injunctive relief from a court of competent jurisdiction, in addition to its other
remedies. 
  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	11	  	 

	 	15.	INDEMNIFICATION 

  

	 	a.	Intellectual Property 

  
 By Customer. Customer represents and warrants that the manufacture, use, delivery and sale of any Assemblies manufactured by Plexus for Customer
hereunder will not infringe any patent, trademark or other intellectual property rights of any third party as a result of the Assembly designs or specifications provided by Customer, Customer-Supplied Components, and/or Customer-approved Engineering
Changes. As Plexus’ sole remedy for Customer’s breach of the foregoing warranty, Customer agrees to defend at its expense any third-party claims or actions arising out of Customer’s breach of the foregoing warranty, and to hold
harmless and indemnify Plexus, including its officers, directors, and employees, from and against any judgments, liabilities, expenses, or costs (including reasonable attorneys’ fees) resulting from any such third-party claims or actions.

  
 By Plexus. Plexus represents and warrants that the
manufacture, use, delivery and sale of any Assemblies manufactured by Plexus for Customer hereunder will not infringe any patent, trademark or other intellectual property rights of any third party as a result of the manufacturing process used by
Plexus to manufacture Assemblies (unless specifically required by Customer). As Customer’s sole remedy for Plexus’ breach of the foregoing warranty, Plexus agrees to defend at its expense any third-party claims or actions arising out of
Plexus’ breach of the foregoing warranty, and to hold harmless and indemnify Customer, including its officers, directors, and employees, from and against any judgments, liabilities, expenses, or costs (including reasonable attorneys’ fees)
resulting from any such third-party claims or actions. 
  

	 	b.	General 

  
 By Customer. Customer agrees to defend at its expense any third-party claims or actions on account of personal injury, tangible property damage or death
arising out of the Assembly designs or specifications provided by Customer, Customer-Supplied Components, and/or Customer-approved Engineering Changes, and to hold harmless and indemnify Plexus, including its officers, directors, and employees, from
and against any judgments, liabilities, expenses, or costs (including reasonable attorneys’ fees) resulting from any such third-party claims or actions. 
  

By Plexus. Plexus agrees to defend at its expense any third-party claims or actions on account of personal injury, tangible property damage or death
arising out of the breach by Plexus of its warranties under Section 13 hereof, and to hold harmless and indemnify Customer, including its officers, directors, and employees, from and against any judgments, liabilities, expenses, or costs (including
reasonable attorneys’ fees) resulting from any such third-party claims or actions. 
  

	 	c.	Notification and Assistance 

  
 Neither party (the “Indemnifying Party”) shall have any obligation under this Section 15.b. unless the other party (the “Indemnified
Party”) (i) notifies the Indemnifying Party promptly upon receiving or learning of any claim or action pursuant to which indemnity will be sought; (ii) provides reasonable assistance to the Indemnifying Party, at the Indemnifying Party’s
expense, in the defense of any such action; and (iii) gives the Indemnifying Party sole control over the defense and/or settlement of the claim or action. 
  

	 	d.	This Section 15 constitutes the sole indemnification of either party to the other arising out of the performance of this Agreement. 

  

	 	16.	TERMS AND TERMINATION  

  

	 	a)	Term 

  
 This Agreement shall remain in effect for a period of one (1) year from the date first above written. Thereafter, this Agreement shall automatically
renew for successive one (1) year periods. 
  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	12	  	 

	 	b)	Termination 

  
 Either party may terminate this Agreement at any time and for any reason upon one hundred and eighty (180) days prior written notice to the other party.
In addition, either party may terminate this Agreement in the event that the other party (i) fails to cure a material default under this Agreement within thirty (30) days after receiving written notice thereof; or (ii) becomes insolvent, files or
has filed against it a petition in bankruptcy, makes an assignment for the benefit of creditors, or generally becomes unable to pay its debts as they become due. 
  

	 	c)	Effect of Termination 

  
 Upon termination of this Agreement, all outstanding Customer Purchase Orders shall be deemed canceled unless otherwise agreed by the parties in writing.
Customer agrees, subject to Sections 2.a., 3.c, and 4, to pay Plexus the Component Value of any Components on-hand or on-order as of the date of Termination. 
  

	 	17.	SURVIVAL 

  
 Sections 1, 3, 4, 5, 7, 11, 13, 14, 15, 16, 17, 18, 22, 23, 24, 25, 26, 27, 28, 29, 31, 32 and 33, of this Agreement shall survive the termination of this
Agreement in accordance with their terms. 
  

	 	18.	LIMITATION OF LIABILITY 

  
 EXCEPT FOR AMOUNTS PAYABLE TO THIRD PARTIES UNDER SECTION 15 (INDEMNIFICATIONS), IN NO EVENT, WHETHER AS A RESULT OF BREACH OF CONTRACT, WARRANTY, TORT
(INCLUDING NEGLIGENCE), STRICT LIABILITY, PRODUCT LIABILITY, OR OTHERWISE, SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY LOSS OF PROFITS, LOSS OF USE, OR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES OF ANY KIND, WHETHER OR NOT
SUCH PARTY IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND NOTWITHSTANDING THE FAILURE, OR ESSENTIAL PURPOSE, OF ANY REMEDY. EACH PARTIES’ LIABILITY UNDER SECTION 15 SHALL BE LIMITED TO $3 MILLION IN THE AGGREGATE. 
  

	 	20.	MUTUAL COOPERATION 

  
 Plexus and Customer agree that they will make all reasonable efforts to cooperate with each other in pursuing the objectives of this Agreement. Plexus and
Customer will each appoint and maintain a manager of their respective organization who will, for the duration of this Agreement, coordinate all activities between the parties. In the event that the manager of one (1) party is not performing
satisfactory in the opinion of the other party, such other party will bring such performance issues to the attention of senior management in the manager’s organization. 
  

	 	21.	FORCE MAJEURE 

  
 Plexus shall not be liable for any delay in or failure of performance under this Agreement due to any unforeseeable contingency beyond Plexus’
reasonable control, including, but not limited to, an act of God, war, acts of terrorism, insurrection, fire, riot, strikes or labor unrest, sabotage, an act of public enemy, flood, storm, accident, Component shortages, equipment failure, laws or
regulations. 
  

	 	22.	ASSIGNMENT 

  
 Neither Plexus nor Customer shall assign any of its rights or delegate or subcontract any of its responsibilities under this Agreement, and any purported
attempt to do so will be null and void, unless agreed to by both parties in writing; provided, however, either party may, without consent and without forfeiting any of its rights hereunder, assign this Agreement, in whole or in part, to any direct
or indirect subsidiary, parent, or affiliate, or to any successor organization to such party resulting from a merger, spin-off, or other reorganization, or any sale of all or substantially all of such party’s assets. 
  

	 	23.	ALTERNATE DISPUTE RESOLUTION (“ADR”) 

  
 If attempts to resolve a dispute by each parties’ executive management fail, then the dispute will be mediated by a mutually acceptable mediator to
be chosen by Customer and Plexus within forty-five (45) days after written notice by either party demanding mediation. Neither party may unreasonably withhold consent to the selection of a mediator or to the venue for the mediation, and Customer and
Plexus will share the costs of the mediator 

  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	13	  	 

 
equally. Each party shall pay its own attorneys’ fees. By mutual agreement, however, Customer and Plexus may postpone mediation until each has completed
some specified but limited discovery regarding the dispute. The parties may also agree to replace mediation with some other form of alternate dispute resolution, such as neutral fact finding or a mini-trial. 
  
 Any dispute which cannot be resolved between the parties through
negotiation, mediation or other form of ADR within three (3) months of the date of the initial demand for ADR by one of the parties may then be submitted to a court of competent jurisdiction. The use of any ADR procedures will not be construed under
the doctrines of laches, waiver or estoppel to affect adversely the rights of either party. Nothing in this Section will prevent either party from resorting to judicial proceedings if (i) good faith efforts to resolve the dispute under these
procedures have been unsuccessful; or (ii) interim relief from a court is necessary to prevent serious and irreparable injury to that party or to others. 
  

	 	24.	APPLICABLE LAW 

  
 The parties hereby agree that this Agreement shall be governed by and will be construed in accordance with the laws of the State of New York, irrespective
of the conflicts of law provisions thereof. 
  

	 	25.	LANGUAGE 

  
 The parties agree that (i) the English language shall be the exclusive and official language of this Agreement, (ii) this Agreement shall be interpreted
exclusively in the English language; and (iii) the English language will govern all future relations of the parties, including, but not limited to, any proceeding, mediation, arbitration, dispute, or claim hereunder. 
  

	 	26.	RELATIONSHIP OF THE PARTIES 

  
 Neither party is designated or appointed an agent or representative to the other party and no party will have any authority, either expressed or implied,
to create or assume any agency or obligation on behalf of or in the name of the other party. The relationship of Plexus to Customer is that of independent contractor, and neither party will have any responsibility for or obligations to the employees
of the other. 
  

	 	27.	NO RECRUITING 

  
 Plexus and Customer agree that during the term of this Agreement and for twelve (12) months thereafter, that each shall not solicit or recruit, directly
or indirectly, the employees of the other. This shall not preclude an employee of either Plexus or Customer from independently pursuing and securing employment opportunities with the other on such employee’s own initiative. In addition, neither
party shall be prohibited from making general solicitations or recruitments in newspapers, magazines, trade journals and the like. 
  

	 	28.	SUCCESSORS 

  
 This Agreement shall be binding upon and inure to the benefit of the parties hereto and their successors and permitted assigns. 
  

	 	29.	SEVERABILITY 

  
 If any provision of this Agreement is adjudged to be unenforceable in whole or in part, such adjudication shall not affect the validity of the remainder
of this Agreement. Each provision of this Agreement is severable from every other provision and constitutes a separate, distinct and binding covenant. 
  

	 	30.	COOPERATION 

  
 The parties cooperated in the preparation and negotiation of this Agreement and this Agreement will not be construed against or in favor of any party by
virtue of the identity, interest, or affiliation of its preparer. 
  

	 	31.	NON-WAIVER 

  
 Failure by either party to exercise any right granted in this Agreement shall not be deemed a waiver of such right. A waiver of any right under this
Agreement must be in writing and signed by an authorized representative of the party making such waiver. 
  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	14	  	 

	 	32.	MEDICAL DEVICE PROVISIONS 

  
 Medical device provisions as set forth in the attached Medical Rider known as Attachment C, is made a part hereof and incorporated herein to this
Agreement. 
  

	 	33.	ENTIRE AGREEMENT; MODIFICATION 

  
 This Agreement contains the entire understanding of the parties pertaining to the subject matter hereof, and no other agreements, oral or otherwise, shall
be deemed to exist or to bind the parties pertaining to the subject matter hereof. This agreement may not be modified or terminated orally, and no claimed modification, termination, or waiver shall be binding unless in writing and signed by
authorized representatives of both parties. The parties expressly agree that any preprinted terms and conditions on any Plexus or Customer forms or documents shall be void and of no effect in interpreting the obligations of either party during the
term of this Agreement. 
  
 In witness whereof, the parties have
executed this Agreement as of the date first above-written. 
  

									
	 HEMOSENSE INC.
	 	 	 	 PLEXUS SERVICES CORP.

					
	By:	 	 /s/ J. D. Merselis
	 	 	 	 By:
	 	 /s/ Robert Kronser

	 Title:
	 	 Pres. & CEO
	 	 	 	 Title:
	 	 Vice President

	 Date:
	 	 11-14-03
	 	 	 	 Date:
	 	 12-05-03

  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 29, 2003
 LF PSA-Mfg. Only-Med.
Prov.
	  	15	  	 

 Plexus Corp. Proposal 
  
 Attachment A 
  

			
	

	  	Proposal and Quotation

  
 HEMOSENSE

  

			
	 Assembly
	  	3868.143
		
	 Description
	  	INRATIO ASSEMBLY
		
	 Proposal Number
	  	QA3-43700
		
	 Submitted By
	  	Scott Bahn
		
	 Date
	  	02/13/2003

  
 The information
contained in this proposal is to be considered confidential and is subject to the terms of the Non-Disclosure Agreement currently in force with Plexus Corp. 
  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 Plexus Corp. Proposal 
  
 Attachment A 
  

					
	

	 	 Plexus Corp.
 55 Jewelers Park
Drive
	 	Quote # QA3-43700
	 	 Neenah, WI 54957-0529
 (920) 722-2826 Fax (920)
720-6700
	 	 Quote Issue Date: 2/13/03        
 Materials Quote Issued: 2/13/03        

  

							
	Company:	 	HEMOSENSE	 	 	 	 
	 	 	 	 	Assembly # :	 	3868.143
	 Attention:
 cc:
	 	 Joe Widunas
 Mike Thiede
	 	 Assembly Rev:
 Assembly Name:
 Prepared By:
 Phone:
	 	 019686
 INRATIO ASSEMBLY
 Scott Bahn
 [***]

  
 UNIT COST ESTIMATE 

 

															
	Estimated P.O./Forecast Quantity*	  	 	[***]	  	 	[***]	  	 	[***]	  	 	[***]
	Minimum Release Size**	  	 	[***]	  	 	[***]	  	 	[***]	  	 	[***]
						
	I.	 	RAW MATERIALS	  	$	[***]	  	$	[***]	  	$	[***]	  	$	[***]
	II.	 	MATERIALS MARK-UP	  	$	[***]	  	$	[***]	  	$	[***]	  	$	[***]
	III.	 	LABOR	  	$	[***]	  	$	[***]	  	$	[***]	  	$	[***]
	IV.	 	ICT TEST	  	$	[***]	  	$	[***]	  	$	[***]	  	$	[***]
	V.	 	FUNCTIONAL TEST	  	$	[***]	  	$	[***]	  	$	[***]	  	$	[***]
	VI.	 	PACKAGING	  	$	[***]	  	$	[***]	  	$	[***]	  	$	[***]
	 	 	 	  	
	
	  	
	
	  	
	
	  	
	

	 	 	SUB-TOTAL	  	$	[***]	  	$	[***]	  	$	[***]	  	$	[***]
	VII.	 	PROFIT	  	$	[***]	  	$	[***]	  	$	[***]	  	$	[***]
	 	 	 	  	
	
	  	
	
	  	
	
	  	
	

	VIII.	 	TOTAL	  	$	[***]	  	$	[***]	  	$	[***]	  	$	[***]
	 	 	 	  	
	
	  	
	
	  	
	
	  	
	

  

	*	Estimated P.O./Forecast Quantity refers to the total quantity of raw material to be purchased for a given period. 

  

	**	Minimum Release Size refers to the minimum quantity to be built at one time. 

  

			
	NON-RECURRING CHARGES	  	

  

								
	A.	 	RAW PCB TOOLING	  	[	***]	 	 
	B.	 	RAW PCB ELECTRICAL TEST FIXTURE	  	[	***]	 	 
	C.	 	IN CIRCUIT TEST FIXTURE(S)	  	[	***]	 	 
	D.	 	FUNCTIONAL TEST FIXTURE(S)	  	[	***]	 	 
	E.	 	CUSTOM (SELECTIVE) WAVE PALLETS	  	[	***]	 	 
	F.	 	XRAY INSPECTION PROGRAMMING	  	[	***]	 	 
	G.	 	SMT PROGRAMMING	  	[	***]	 	 
	H.	 	SMT STENCIL (S)	  	[	***]	 	 
	1.	 	AUTO-INSERT PROGRAMMING	  	[	***]	 	 
	J.	 	MFG SETUP (GOLD CARDS/CERTIFIED MFG SAMPLES)	  	[	***]	 	 
	K.	 	TAKAYA PROGRAMMING (PRE-PROD)	  	[	***]	 	 
	L.	 	AUTO-OPTICAL INSPECTION PROGRAMMING	  	[	***]	 	 
	M.	 	OTHER	  	[	***]	 	 

  
 SPECIFIC ASSEMBLY NOTES AND
ASSUMPTIONS 
  

			
	A.	 	 [***]

	B.	 	 
	C.	 	 
	D.	 	 
	E.	 	 
	F.	 	 
	G.	 	 
	H.	 	 
	I.	 	 
	J.	 	 

  
 This estimate is
valid for thirty (30) days from date materials quote was issued. Beyond this 
 date materials pricing is subject to change.

  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 Plexus Corp. Proposal 
  
 Attachment A 
  

							
	 

  
	  	 Company:
 Assembly #:
 Assembly Rev:
	  	 HEMOSENSE
 3868.143
 019686
	  	 Quote # QA3-43700 
  
 Date: 02/13/2003

  
 PROPOSAL NOTES AND ASSUMPTIONS

  

	A	Plexus Corp. Professional Service Agreement (PSA) or similar, comprehensive manufacturing agreement to be complete and in place prior to acceptance of purchase order.

  

	B	The default standard quoted to is: ANSI/IPC-A-610 (Class 2) 

  

	C	Plexus Corp uses No Clean Solder Paste, Wave Solder, Hand Solder and Flux Plexus Corp. does not attempt to clean the flux residues from assemblies unless otherwise specified.

  

	D	Plexus Corp.’s Documentation Control Dept will require the following at the time a purchase order is placed: 

  
 1. One complete, current set of documentation. 
  
 2. The specifications called for on any customer documents. 
  
 3. Properly identified (part number and rev) software or magnetic media, if
customer supplied. 
  
 4. Plexus Corp. must be placed on internal
routings to ensure that we will always have the latest revision of any of the above. 
  

	E	Price will be reviewed upon receipt of complete and current documentation at time of order. Engineering Change Orders will result in a one time non-recurring charge as well as a
potential increase to material cost, associated mark-up and labor charge. 

  

	F	Estimated Lead time for production to begin on your assemblies is 4 weeks after receipt of purchase order, proper documentation and longest lead time, component (See attachment A
for long-lead times.) However, exact lead-time depends on quantity of purchase order and manufacture inventory at time of purchase order. 

  

	G	Labor Only Purchase Orders: Plexus Corp. will charge, per bill of material line item, for the handling of material. 

  

	H	Prototypes or quick-turn orders: A special department has been established specifically to respond to our strategic customer’s prototype and quick-turn needs. Plexus Corp. will
accept proto-type orders on a time and materials basis. Costs will be determined after each build and / or the completion of your order, and conveyed to you for P.O. update prior to shipment 

  

	I	Plexus Corp’s Engineering. Safety and Environmental Departments must review all chemicals specified for the manufacture of the products herein for health and safety issues,
compliance with regulations and manufacturabilily Labor and cost are not reflected in the quote until MSDS sheet are reviewed and approved by Plexus’ Corporate Engineering, Safety and Environmental Departments 

  

	J	The estimated annual usage (EAU) of all assemblies contained in this proposal has been combined to reflect maximum buying power. To achieve this pricing, this quotation assumes that
Plexus Corp. will receive visibility to the entire 12 month demand for all assemblies at time of initial purchase order placement. Price will be reviewed and adjusted if demand differs from EAU’s quoted 

  

	K	The following applicable exceptions are itemized for your convenience on Attachment A: 

  
 l. Minimums: At the appropriate quantities listed in Item I, excess inventory would have to be purchased due to minimum buy
requirements. Plexus Corp. will maintain this excess inventory for a period of six (6) months, except in those instances where the magnitude of the minimums for a specific program exceeds a reasonable amount. Reels cannot be split to accommodate
purchase quantities. 
  
 2. Long Lead-Time Components.

  
 3. Customer Supplied Components or Pricing (Labor cost has
been included). 
  
 4. Specials - Non-Cancelable and
Non-Returnable (Labor cost has been included) 
  
 5. Components
omitted from Bill of Material cost. (Labor cost has been included). 
  
 6. Device Programming (if required): Unit Cost estimates have been included herein, however exact unit and tooling costs are TBD. 
  

	L	All custom fabricated parts are subject to cancellation charges. Should there be a change in design, quantity, or order cancellation, charges would be based on work in process and
finished goods at Plexus Corp. 

  

	M	Terms of payment are net-thirty (30) days and subject to final credit approval by Plexus Corp. 

  

	N	All shipments are FOB point of shipment, manufacturing site. 

  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 Attachment B 
  
 QC Visual and Functional Test Issues: 
  
 Certificate of Compliance contains the following information 
  

	 	•	 	Date of Shipment 

  

	 	•	 	Plexus EAC Job # 

  

	 	•	 	Plexus ASM # 

  

	 	•	 	Plexus ASM Rev # 

  

	 	•	 	Customer PO # 

  

	 	•	 	Plexus Lot # 

  

	 	•	 	Quantity Shipped 

  

	 	•	 	List of Serial Numbers in sequential order 

  

	 	•	 	A manifest of Serial Numbers in each box on the top in sequential order 

  

	 	•	 	Quality Assurance signature and date 

  
 Shipping container label contains the following information: 
  

	 	•	 	Plexus Job# 

  

	 	•	 	Customer PO # 

  

	 	•	 	Part Number (PN) 

  

	 	•	 	Revision (Rev) 

  

	 	•	 	Quantity (Qty) 

  
 Primary Container 
  
 Verify each
meter packaged [***]. Verify the manifest of serial numbers is in sequential order and is in each box on the top. 
  
 If any meter does not pass the following record results on form II# 0402004 F-1. 
  
 Inspection of Outer Casing 
  
 Each meter casing is free of cosmetic defects 
  

	 	•	 	[***] 

  

	 	•	 	[***] 

  

	 	•	 	[***] 

  

	 	•	 	[***] 

  

	 	•	 	[***] 

  

	 	•	 	[***] 

  

	 	•	 	[***] 

  
 Inspection of cleaning door and heater assembly 
  

	 	•	 	[***] 

  

	 	•	 	[***] 

  

	 	•	 	[***] 

  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 Inspection of Battery Compartment 
  

	 	•	 	[***] 

  

	 	•	 	[***] 

  

	 	•	 	[***] 

  
 Label legibility and presence 
  
 All print/read items are legible and free from smudges or other cosmetic defects 
  

	 	•	 	HemoSense Label with serial number. Human readable portion is legible and the bars of the barcode are consistent. The label does not cross the battery door and is located in the
correct area. 

  

	 	•	 	UL/CE label does not cross the battery door and is located in the correct area. 

  

	 	•	 	The letters on the buttons are legible and consistent 

  

	 	•	 	Product name and menu silk screen 

  
 All failures of the above criteria are noted on form 0402004-F1. 
  
 Perform [***] test [***] using procedure TP # 1023 record information for pass or fail of [***] on form TP1023-Fl. 
  
 [***] are released that have passed all of the above criteria. One failure is a failure of
the [***] 
  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

 Attachment C 
  
 

 
  
 Medical Rider 
 (for Use with Manufacturing Services Only for Professional Services Agreement) 
  
 These Medical Device Provisions are attached hereto and incorporated herein.  
  
 MEDICAL DEVICE PROVISIONS 
  

	I.	Manufacturing Phase: 

  

	A.	Customer is responsible for ensuring that the devices covered by this Agreement comply with all applicable laws and regulations, including the Food, Drug and Cosmetic Act and
implementing regulations. Customer responsibilities under these provisions, include but are not limited to the following: 

  

	 	i)	Establishing the finished device specifications. 

  

	 	ii)	Ensuring that governmentally-required marketing authorizations, including any necessary Food and Drug Administration (FDA) approvals or clearances, have been obtained.

  

	 	iii)	Determining the content of any label or labeling. 

  

	 	iv)	Making any required reports to governmental entities, including but not limited to Medical Device Reports. 

  

	 	v)	Determining whether any recall or other corrective action is required or appropriate, and developing, implementing and financing any voluntary or mandatory recall or corrective
action. 

  

	 	vi)	Reviewing and approving the quality system prior to production of the devices. 

  

	B.	Plexus will provide Customer ongoing access to its facilities and procedures for quality assurance related to the devices covered by this Agreement. Plexus authorizes Customer to
conduct periodic quality systems audits of the manufacturing processes and quality systems related to this Agreement. Plexus will manufacture the devices covered by this Agreement in accordance with its procedures for manufacturing components of
medical devices or finished medical devices, as applicable. 

  

	C.	Customer will provide Plexus with sufficient information to verify, calibrate, operate, test and maintain any Customer supplied equipment. 

  

	D.	Customer shall be responsible for the software validation of any embedded product software and the validation of all Customer-supplied: (1) test equipment or test software; (2)
production equipment or software; and (3) firmware. Plexus is responsible for the validation of any Plexus software used in production in, or as part of the Quality System. The responsibilities described in this section also apply to any revisions
of any software. 

  

	E.	Customer will provide Plexus with copies of the specifications and written certification that the validation reports for the items listed in Section D above have been performed
prior to the production of the devices. 

  

	F.	Customer is responsible for defining and validating the finished device packaging. Customer will provide Plexus with written certification that the packaging validation has been
performed prior to the production of the devices. 

  

	G.	 Plexus is responsible for conducting and documenting corrective and preventive actions based upon the analysis of the quality data available to Plexus. Quality data
or information known to Customer, but not 

  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 24, 2003
 Medical Rider-Mfg. Only for
PSA
	  	 	  	 

	 	 
provided to Plexus, shall not be included in the analysis of quality data, and Customer shall be responsible for the analysis of data not provided to Plexus.

  

	H.	Any Customer-initiated request for change to a specification, method, process or procedure or Customer-supplied equipment will be evaluated by Plexus, and Plexus reserves the right
to decline to make such change. Customer is responsible for verification and/or validation of such changes. Customer shall reimburse Plexus for any costs Plexus incurs in making and/or implementing such changes, as mutually agreed by the parties
prior to the implementation of the change. 

  

	I.	Plexus may not make changes in specifications, methods, processes or procedures (other than immaterial changes in methods, processes, or procedures) that could affect the devices
covered by this Agreement without Customer’s prior written approval, and, as to any such change, Customer and Plexus shall decide jointly whether, how and when to implement such change, and who shall be responsible for verification and/or
validation of such changes. Customer and Plexus shall also decide jointly who will be responsible for the costs associated with such changes. 

  

	J.	Customer must define any “critical” components requiring component level traceability. Customer must also select the appropriate component level or device level
traceability grade, in order to meet any applicable Food and Drug Administration (FDA) requirements or regulations. Plexus is responsible for implementing the defined manufacturing-level traceability requirements and for ensuring that the
appropriate manufacturing-level traceability records and associated records are retained for the duration of this Agreement. 

  

	K.	Unless otherwise specified in this Agreement, Plexus is not responsible for ensuring traceability of the devices covered by this Agreement after distribution to the end user(s).

  

	L.	Plexus is responsible for retaining the appropriate manufacturing records as required by Customer (including any such records necessary to support any filings that the FDA and other
regulatory agencies require in respect of such activities). Plexus shall provide all reasonable assistance to Customer, at no additional charge, to assist Customer in complying with all FDA and other applicable regulatory regulations with respect to
the Assemblies. When this Agreement between Plexus and Customer terminates, Plexus shall forward all applicable documentation and records to Customer, upon request. 

  

	M.	Customer may authorize in writing the release of nonconforming components or devices covered by this Agreement. Customer must assess whether the use of the nonconforming product
will affect any regulatory submittals or requirements, and accept responsibility therefore. 

  

	N.	Customer is responsible for all complaint handling, including but not limited to maintenance of complaint files, investigation of complaints, resolution of complaints, trending or
otherwise analyzing complaints, and maintaining complaint-related records. Customer will promptly provide to Plexus copies of all complaints received by Customer that refer or relate to an assembly manufactured by Plexus and all adverse event
reports to a governmental entity that refer or relate to an assembly manufactured by Plexus. Plexus will provide to Customer information regarding any complaints Plexus receives about the product in which the devices covered by this Agreement are
incorporated. 

  

							
				
	 /s/ Illegible
	 	 Plexus Initial and Date
	 	 /s/ Illegible
	 	 Customer Initial and Date

	 12-05-03
	 	 	 	 11/14/03
	 	 

  

	***	 	Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with
the Commission. 

  

					
	 Plexus and Hemosense, Inc.
 FINAL EXECUTION
DOCUMENT
 October 24, 2003
 Medical Rider-Mfg. Only for
LOI

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