Development and Supply Agreement for Implantable Lithium Primary Battery between Quallion LLC and DexCom Inc.
Quallion LLC and DexCom Inc. have entered into an agreement for Quallion to design, develop, and manufacture a lithium primary battery (model QC0025B) for DexCom’s implantable continuous glucose sensor system. The agreement outlines the scope of work, pricing, production schedules, and payment terms. DexCom must approve the proposal and provide a purchase order for work to begin. Quallion retains all intellectual property rights developed during the project. The agreement is subject to Quallion’s standard terms and conditions of sale, and any changes to product specifications require written amendments signed by both parties.
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Exhibit 10.11
CONFIDENTIAL TREATMENT REQUESTED
[QUALLION LOGO]
PROPOSAL COVER SHEET
CUSTOMER INFORMATION
Company: | DexCom Inc. | |
Contact Person: | Mr. Jim Brauker, Vice President of R&D | |
Phone Number: | [*****] | |
Fax Number: | [*****] | |
Address: | 6725 Mesa Ridge Road, Suite 100, San Diego, CA 92121 | |
PROPOSAL SUMMARY | ||
Proposal No.: | 356 Rev. C | |
Title: | Development of Implantable Lithium Primary Battery for Continuous Glucose Sensor Devices | |
Submission Date: | May 21st, 2003 | |
Expiration Date: | 30 days | |
Contact Person: | Naoki Ota, Sr. Manager of Technologies and Applications Development | |
Contact Numbers: | [*****] | |
[*****] | ||
Content: | X I. Scope of Work | |
X II. Schedule & Pricing | ||
X III. Contingencies | ||
X IV. Specifications & Qualification Plan | ||
IV. Drawings | ||
X VI. Terms & Conditions | ||
Other: |
PROPOSAL ACCEPTANCE
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Quallion LLC | DexCom Inc. | |
/s/ WERNER HAFELFINGER Werner Hafelfinger President | /s/ JIM BRAUKER Jim Brauker Vice President of R&D | |
/s/ STEVE KEMPER Steve Kemper Chief Financial Officer | ||
CONFIDENTIAL | Proposal No. 356 Rev. C | |
Page 1 of 6 |
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
[QUALLION LOGO]
I. SCOPE OF WORK
This proposal is for the design, development and manufacture of a lithium primary cell ("Cell") with the following model number:
QC0025B
The product is designed for use in the following Customer's Device(s):
Implantable Continuous Glucose Sensor System
For the following application:
Glucose Monitoring
Quallion's proposal is based on the specification and qualification protocol provided by the Customer as defined in section IV, Specifications & Qualification Plan.
CONFIDENTIAL | Proposal No. 356 Rev. C | |
Page 2 of 6 |
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
[QUALLION LOGO]
II. SCHEDULE & PRICING
DEVELOPMENT:
Item Description | Qty | Timeline | Unit Price | Total | |||||
---|---|---|---|---|---|---|---|---|---|
Phase I: R&D Engineering Cells | [*****] | [*****] | [*****] | [*****] | |||||
Phase II: Prototype Cells | [*****] | [*****] | [*****] | [*****] | |||||
TOTAL | [*****] |
PRODUCTION:
Item Description | Qty | Timeline | Unit Price | Total | |||||
---|---|---|---|---|---|---|---|---|---|
First Articles (Limited Qualifications)(1) | [*****] | [*****] | [*****] | [*****] | |||||
TOTAL | [*****] |
NRE:
Item Description | Qty | Timeline | Unit Price | Total | |||||
---|---|---|---|---|---|---|---|---|---|
NRE & Small Tooling | [*****] | [*****] | [*****] | [*****] | |||||
TOTAL | [*****] |
Production capacity scale-up plan:
- 1)
- Small-production:
- a.
- Maximum capacity of [*****] units/month, established [*****] after execution
- b.
- of development work stated in this proposal.
- c.
- Order lead-time: [*****]
- d.
- Minimum order: [*****]
i. | [****] | [*] / cell | ||
ii. | [****] | [*] / cell | ||
iii. | [****] | [*] / cell |
- 2)
- Scale-up production:
- a.
- advanced notification from Customer required.
- b.
- Additional fee may apply for production tooling to support scale-up effort.
- c.
- Pricing configuration
i. | [****] | [*] / cell | ||
ii. | [****] | [*] / cell | ||
iii. | [****] | [*] / cell |
Price to be reviewed by September 2003
- (1)
- First Articles are provided with limited qualification testing.
CONFIDENTIAL | Proposal No. 356 Rev. C |
Page 3 of 6
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
[QUALLION LOGO]
III. CONTINGENCIES
This proposal is effective upon:
- 1)
- Customer's approval and signed acceptance of proposal prior to proposal expiration date.
- 2)
- Quallion's receipt of Customer Purchase Order per the Terms & Conditions listed in section VI.
The successful execution of deliverables is contingent upon:
- 1)
- Customer's approval and signed acceptance of Product Specification and Qualification Plan within 30 days after execution of Proposal.
CONFIDENTIAL | Proposal No. 356 Rev. C |
Page 4 of 6
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
[QUALLION LOGO]
IV. SPECIFICATIONS & QUALIFICATION PLAN
Please see attached documents:
- 1)
- Product Specification for QC0025B (#PS0013 Rev.2)
- 2)
- Customer Requirement of QC0025B for DexCom (#300456 Rev.2)
- 3)
- Qualification Plan for QC0025B
V. DRAWINGS
NONE APPLICABLE
CONFIDENTIAL | Proposal No. 356 Rev. C |
Page 5 of 6
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
[QUALLION LOGO]
VI. TERMS & CONDITIONS
Delivery:
Work will start on the first day after receipt of a written purchase order and follow the timeline shown in Section II, Schedule & Pricing.
Payment terms:
Tooling & NRE | [*****] | Down payment with written purchase order | ||
[*****] | 30 days after delivery of First Articles | |||
Qualified Cell Purchases: | [*****] | Down payment with purchase order | ||
[*****] | Net 30 days after delivery of cells |
Others:
- 1)
- If Customer desires to make any modifications to the Cell specification, such modifications may be proposed to Quallion in writing and Quallion shall give such proposal its prompt attention. Quallion will respond to Customer's proposed modifications by estimating the effect, if any, of proposed modifications on Cell performance, manufacturability, terms of delivery and warranty. All modifications to Cell specifications shall be documented through an appropriate amendment signed by both parties.
- 2)
- [*****]
- 3)
- Quallion will retain all rights to intellectual property it develops in connection with this project.
- 4)
- Please see attached Quallion's general Terms & Conditions of Sale.
CONFIDENTIAL | Proposal No. 356 Rev. C |
Page 6 of 6
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Quallion LLC
Terms and Conditions of Sale
Applicable Terms and Conditions
All Quallion products and services are furnished only on the temp and conditions stated herein and on the face of the applicable Quallion quotation to the exclusion of any Buyer terms and conditions in any specific order documentation, preprinted or otherwise, except as to identification and quantity of products and services. Quallion's performance on an contract is expressly conditioned on Buyers acceptance of Quallion's terms and conditions of sale. In the absence of such an agreement, performance shall be for the convenience of the Buyer only and shall not create any contractual obligation or constitute acceptance by Quallion of any terms and conditions of the Buyer, printed or stated in its order. Buyer's acceptance of any product or service shall constitute acceptance of Quallion's terms and conditions as stated herein.
Orders, Quotations and Prices
Quallion's prices, quotations, and contracts for products and services are subject to the following unless otherwise slated in the applicable Quallion quotation or other writing signed by an authorized representative of Quallion. In case of contradictory terms slated herein and on the face hereof; the latter shall control.
- a.
- All purchase orders are subject to written acceptance by Quallion.
- b.
- Acceptance of purchase orders are expressly conditioned on compliance with all applicable laws, codes and regulations affecting the products and services
- c.
- Unless otherwise stated on the applicable quotation, all quotations shall be considered solicitations for offers to purchase and shall neither constitute firm pricing or obligate Quallion in any way.
- d.
- All prices quoted are for products and services only, and shall exclude, and Buyer shall be responsible for, ordinary and necessary charges inured by Quallion and billed to Buyer. These include, but are not limited to any and all applicable taxes, shipping charges, special packaging or insurance, incurred on Buyers instructions.
- e.
- Prices quoted are for products and services only, and do not include rights to intellectual property, know-how, technology, patents, trademarks, copyrights, or other proprietary rights
- f.
- Products and services provided in accordance with Buyer's specifications, which are then changed by Buyer after quotation by Quallion or order placement, will be subject to corresponding changes in price and delivery as determined by Quallion.
Terms of Payment
Unless different terms of payment are stipulated on the Quallion quotation, payment of any services, engineering charges or tooling charges is due at the time of order placement. Payment for products is due on shipment. Partial shipments if requested or authorized by the Buyer will be billed as a percent completion, which payment will be due on the partial shipment.
Transportation and Risk of Loss
All shipping will be FOB Quallion's plant, and risk of loss or damage to products shall pass upon delivery to the transportation company. Quallion may, but is not obligated to insure to full value of product shipped at Buyers expense and declare full value to the transportation company at time of shipment. Buyer shall inspect all products upon receipt and file all claims with the transportation company and with Quallion when there is damage, external or concealed.
Performance
Quallion shall not be liable for any delay in delivery or other performance which is due to unforeseen circumstances or to causes beyond its control, including, but not limited to strike, lockout, riot, war, fire, flood, earthquake, acts of God, accident, failure or breakdown of components necessary to order completion, supplier, subcontractor, inability to obtain or substantial increases in the cost of labor, materials or manufacturing facilities, curtailment of or failure to obtain sufficient electrical or other energy supplies; technical difficulties, or compliance with any governmental law, regulation or order, including but not limited to US Export Administration Regulations or Buyer caused delays. Provided any such delay is not indefinite, performance shall be deemed suspended during and extended for such a time as it is so delayed, and thereafter the Buyer shall accept performance. Delay in performance shall not be considered indefinite unless it exceeds or is reasonably estimated to exceed six (6) months.
Acceptance
The furnishing of a product or service by Quallion to the Buyer shall constitute acceptance of that product by Buyer, unless notice of defect or nonconformity is received by Quallion within thirty (30) days of delivery of product at Buyers designated delivery address. Notwithstanding the above, any use, sale or other disposition of a product by Buyer, its agents, employees, contractors or licensees, for any purpose after its receipt, shall constitute acceptance of the product by the Buyer.
Assignments and Terminations
No order accepted by Quallion may be terminated, cancelled, modified or assigned except through mutual agreement in writing. Any attempt to do so without Quallion's written consent shall be void.
Warranty
All products are warranted to meet Quallion's specifications, including Buyer's specifications, if any, which have been agreed upon in writing by Quallion. Products are not warranted to meet Buyer's specifications or changes to specifications not agreed upon in writing by Quallion. Products are not warranted unless Quallion receives written notice within 30 says after shipment describing the products' failure to meet specifications, in which event, Quallion will decide whether to replace the products or refund any payment received for the product. Quallion makes no warranties except as herein specified, and all other warranties are expressly excluded.
Damages and Liability
QUALLION'S TOTAL LIABILITY IN DAMAGES OR OTHERWISE SHALL NOT EXCEED THE PAYMENT, IF ANY, RECEIVED BY QUALLION FOR THE UNIT OR PRODUCT OR SERVICE FURNISHED OR TO BE FURNISHED, AS THE CASE MAY BY, RESULTING IN THE LOSS OR DAMAGE CLAIM. IN NO EVENT SHALL QUALLION BE LIABLE FOR INCIDENTAL. CONSEQUENTIAL, INDIRECT, PUNITIVE OR SPECIAL LOSS OR DAMAGES OF ANY KIND, SUCH AS, BUT NOT LIMITED TO, LOST BUSINESS REVENUE, LOST PROFITS OR COSTS OF DOWNTIME RESULTING FROM QUALLION'S PRODUCTS OR SERVICES, HOWEVER CAUSED, WHETHER BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE) OR ANY OTHER LEGAL THEORY.
Indemnities
Notwithstanding any fault or negligence attributable to Quallion, Quallion shall have no responsibility whatsoever for, and Buyer shall indemnify, defend, and hold Quallion harmless from any and all damage or injury to persons or property which may arise from or relate to 1) any use, operation, or service of any product contrary to any written warning or instruction given by Quallion with respect to such product, including, but not limited to unauthorized use and/or modification of said product by the user, or 2) an liability for Buyer with respect to OSHA toxic substances, air quality, water quality, hazardous waste, Superfund for other environmental liability including, but not limited t fines, penalties, cleanup costs or tort related, to the use, operation, or service or any product, or 3) the design. manufacture, purchase. sale use or reuse of any Product provided as convenience to the Buyer but not manufactured by Quallion and not listed as a Quallion product in a sales quotation or other official Quallion documentation.
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Revision | Description | DAR Number | Prepared By | Release Date | ||||
---|---|---|---|---|---|---|---|---|
1 | PROTOTYPE RELEASE | B1365 | KG | [*****] | ||||
2 | SEE DAR | B |
CUSTOMER REQUIREMENT OF QC0025B FOR DEXCOM
Prepared By: | [*****] | Date: | [*****] | [QUALLION LOGO] | ||||||
Checked By: | [*****] | Date: | [*****] | |||||||
Approved By: | [*****] | Date: | [*****] | Number | 300456 | |||||
Next Assy: | Model No. | QC0025B | Sheet | 1 of 3 |
This document, and any attachment, contains CONFIDENTIAL and PROPRIETARY information that is the property of Quallion LLC. This document and the information herein may not, in whole or in part, be duplicated, disclosed, or used for design, manufacturing, or other purposes without the prior written permission of Quallion LLC
300181, Rev. A
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
1.0 PURPOSE
This document defines the requirements for a lithium primary cell to be shipped to DexCom by Quallion LLC.
2.0 SCOPE
This document applies to the QC0025B product.
3.0 REFERENCE DOCUMENTS
PS 0013 Product Specification, QC0025B
4.0 DEFINITIONS
[*****]
[QUALLION LOGO] | Doc. No. 300456 | Sheet 2 of 4 | Rev. 2 |
This document, and any attachment, contains CONFIDENTIAL and PROPRIETARY information that is the property of Quallion LLC. This document and the information herein may not, in whole or in part, be duplicated, disclosed, or used for design, manufacturing, or other purposes without the prior written permission of Quallion LLC
300181, Rev. A
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
[*****]
5.0 RESPONSIBILITIES
[*****]
6.0 GENERAL REQUIREMENTS
[*****]
[QUALLION LOGO] | Doc. No. 300456 | Sheet 3 of 4 | Rev. 2 |
This document, and any attachment, contains CONFIDENTIAL and PROPRIETARY information that is the property of Quallion LLC. This document and the information herein may not, in whole or in part, be duplicated, disclosed, or used for design, manufacturing, or other purposes without the prior written permission of Quallion LLC
300181, Rev. A
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
[*****]
[QUALLION LOGO] | Doc. No. 300456 | Sheet 4 of 4 | Rev. 2 |
This document, and any attachment, contains CONFIDENTIAL and PROPRIETARY information that is the property of Quallion LLC. This document and the information herein may not, in whole or in part, be duplicated, disclosed, or used for design, manufacturing, or other purposes without the prior written permission of Quallion LLC
300181, Rev. A
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Revision | Description | DAR Number | Prepared By | Release Date | ||||
---|---|---|---|---|---|---|---|---|
1 | PROTOTYPE RELEASE | B1364 | KG | [*****] | ||||
2 | SEE DAR | B |
PRODUCT SPECIFICATION,
QC0025B
Prepared By: | [*****] | Date: | [*****] | [QUALLION LOGO] | ||||||
Checked By: | [*****] | Date: | [*****] | |||||||
Approved By: | [*****] | Date: | [*****] | Number | PS 0013 | |||||
Next Assy: | Model No. | QC0025B | Sheet | 1 of 10 |
This document, and any attachment, contains CONFIDENTIAL and PROPRIETARY information that is the property of Quallion LLC. This document and the information herein may not, in whole or in part, be duplicated, disclosed, or used for design, manufacturing, or other purposes without the prior written permission of Quallion LLC
300181, Rev. A
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
1.0 PURPOSE
This specification defines the requirements for a custom lithium primary cell to be shipped to the customer by Quallion LLC.
2.0 SCOPE
This document applies to the QC0025B product.
3.0 REFERENCE DOCUMENTS
3.1. MIL-STD-883 | Test Methods Stand: Microcircuits | ||
3.2. ISTA | International Safe Transit Association | ||
3.3. I50-9000 | International Organization for Standardization: Quality Management | ||
3.4. MIL-STD-202F | Test Method for Electrical and Electronic Component Parts | ||
3.5. EN45502-1 | Active Implantable Medical Devices, Part 1 | ||
3.6. TM 0006 | Micronail Penetration Test, Quallion LLC | ||
3.7. UL1642 | Standard for Safety: Lithium Batteries, 3rd edition |
[QUALLION LOGO] | Doc. No. PS 0013 | Sheet 2 of 10 | Rev. 2 |
This document, and any attachment, contains CONFIDENTIAL and PROPRIETARY information that is the property of Quallion LLC. This document and the information herein may not, in whole or in part, be duplicated, disclosed, or used for design, manufacturing, or other purposes without the prior written permission of Quallion LLC
300181, Rev. A
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
4.0 DEFINITIONS
[*****]
[QUALLION LOGO] | Doc. No. PS 0013 | Sheet 3 of 10 | Rev. 2 |
This document, and any attachment, contains CONFIDENTIAL and PROPRIETARY information that is the property of Quallion LLC. This document and the information herein may not, in whole or in part, be duplicated, disclosed, or used for design, manufacturing, or other purposes without the prior written permission of Quallion LLC
300181, Rev. A
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
5.0 CELL REQUIREMENTS
- 5.2.
- Mechanical
[*****]
PROPERTIES | Conditions | REQUIREMENT | ||
---|---|---|---|---|
Dimensions | [*****] | [*****] | ||
Weight | [*****] | [*****] | ||
Case Material | [*****] | [*****] | ||
Case Polarity | [*****] | [*****] | ||
Positive Feedthru Material | [*****] | [*****] | ||
Negative Feedthru Material | [*****] | [*****] | ||
Cell Marking | [*****] | [*****] | ||
Cell Hermeticity | [*****] | [*****] | ||
Feedthru Pin Strength | [*****] | [*****] |
[QUALLION LOGO] | Doc. No. PS 0013 | Sheet 4 of 10 | Rev. 2 |
This document, and any attachment, contains CONFIDENTIAL and PROPRIETARY information that is the property of Quallion LLC. This document and the information herein may not, in whole or in part, be duplicated, disclosed, or used for design, manufacturing, or other purposes without the prior written permission of Quallion LLC
300181, Rev. A
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
5.3. Electrochemical
PROPERTIES | CONDITIONS | REQUIREMENT | ||
---|---|---|---|---|
Capacity | [*****] | [*****] | ||
Average Voltage | [*****] | [*****] | ||
Normal Operating Voltage Range | [*****] | [*****] | ||
Operating Discharge Temperature | [*****] | [*****] | ||
Preferred Storage Temperature | [*****] | [*****] | ||
Discharge Current | [*****] | [*****] | ||
Discharge Pulse Current | [*****] | [*****] | ||
AC Impedance | [*****] | [*****] |
[QUALLION LOGO] | Doc. No. PS 0013 | Sheet 5 of 10 | Rev. 2 |
This document, and any attachment, contains CONFIDENTIAL and PROPRIETARY information that is the property of Quallion LLC. This document and the information herein may not, in whole or in part, be duplicated, disclosed, or used for design, manufacturing, or other purposes without the prior written permission of Quallion LLC
300181, Rev. A
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
5.4. Environment
PROPERTIES | CONDITION | REQUIREMENT | ||
---|---|---|---|---|
Vibration Test | [*****] | |||
Mechanical Shock Test | [*****] | |||
Drop Test | [*****] | |||
Altitude Test | [*****] | [*****] | ||
Temperature Shock Test | [*****] | |||
Humidity Test | [*****] | |||
High Temperature Storage | [*****] | |||
Low Temperature Storage | [*****] |
5.5. Safety
PROPERTIES | CONDITION | REQUIREMENT | ||
---|---|---|---|---|
External Short | [*****] | [*****] | ||
Over Discharge | [*****] | [*****] | ||
Crush | [*****] | [*****] | ||
Impact | [*****] | [*****] | ||
Hot Box | [*****] | [*****] | ||
Nail Penetration | [*****] | [*****] |
[QUALLION LOGO] | Doc. No. PS 0013 | Sheet 6 of 10 | Rev. 2 |
This document, and any attachment, contains CONFIDENTIAL and PROPRIETARY information that is the property of Quallion LLC. This document and the information herein may not, in whole or in part, be duplicated, disclosed, or used for design, manufacturing, or other purposes without the prior written permission of Quallion LLC
300181, Rev. A
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
6.0 SHIPPING AND STORAGE
[*****]
7.0 NOTIFICATION OF CHANGES
- 7.1.
- Quallion LLC shall notify Customer of any changes in manufacturing processes, testing, raw materials, or design that affect form, interchangeability, reliability, packaging, labeling, storage condition, fit or function so that the customer is able to evaluate the possible effects of such changes in its application. None of the changes specified above shall be made without prior written permission from the customer.
8.0 QUALITY ASSURANCE SYSTEM REQUIREMENT
- 8.1.
- The cell is to be manufactured within a documented system in general accordance with the requirements of ISO-9000. The Customer has the right to periodically audit Quallion LLC for compliance to this requirement
9.0 PACKAGING
- 9.1.
- Each cell shall be packaged in such a manner as to be protected from physical damage, contamination, or short-circuiting when subjected to ISTA procedure 1A.
- 9.2.
- The cell shall be free of oils, grease, or ionic contamination.
- 9.3.
- The feedthrus shall be protected from damage by means of plastic covers.
10.0 RETAINED SAMPLES
- 10.1.
- [*****]
- 10.2.
- [*****]
- 10.3.
- [*****]
11.0 DATA PACKAGE REQUIREMENT
- 11.1.
- [*****]
[QUALLION LOGO] | Doc. No. PS 0013 | Sheet 7 of 10 | Rev. 2 |
This document, and any attachment, contains CONFIDENTIAL and PROPRIETARY information that is the property of Quallion LLC. This document and the information herein may not, in whole or in part, be duplicated, disclosed, or used for design, manufacturing, or other purposes without the prior written permission of Quallion LLC
300181, Rev. A
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appendix I
Test Procedures
[*****]
[QUALLION LOGO] | Doc. No. PS 0013 | Sheet 8 of 10 | Rev. 2 |
This document, and any attachment, contains CONFIDENTIAL and PROPRIETARY information that is the property of Quallion LLC. This document and the information herein may not, in whole or in part, be duplicated, disclosed, or used for design, manufacturing, or other purposes without the prior written permission of Quallion LLC
300181, Rev. A
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appendix II
Customer Requirement
DOCUMENT #
300456
[QUALLION LOGO] | Doc. No. PS 0013 | Sheet 9 of 10 | Rev. 2 |
This document, and any attachment, contains CONFIDENTIAL and PROPRIETARY information that is the property of Quallion LLC. This document and the information herein may not, in whole or in part, be duplicated, disclosed, or used for design, manufacturing, or other purposes without the prior written permission of Quallion LLC
300181, Rev. A
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
[*****]
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
QUALIFICATION PLAN
Date: | May 21st, 2003 | |||
Customer Name | DexCom Inc. | |||
Product:. | QC0025B | |||
Revision: | C | |||
Reference Document: | Product Specification for QC0025B, Doc. PS0013 Customer Requirement, Doc. 300456 |
STANDARD TESTING (per PS 0013)
REF | SPECIFICATION | [*****] | [*****] | [*****] | Other | |||||
---|---|---|---|---|---|---|---|---|---|---|
5.2 | Mechanical | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
5.3 | Electrochemical | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
5.4 | Environment | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X |
CONFIDENTIAL
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* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
5.5 | Safety | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
[*****] | X | |||||||||
6.0. | Shelf Life | X | ||||||||
9.0 | Packaging (ISTA)(3) | X |
CONFIDENTIAL
Page 2 of 3
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
STANDARD TESTING (per 300456)
REF | SPECIFICATION | 6/9/2003 | 9/9/2003 | 12/9/2003 | Other | |||||
---|---|---|---|---|---|---|---|---|---|---|
[*****] | [*****] | |||||||||
[*****] | [*****] | |||||||||
[*****] | [*****] | |||||||||
[*****] | [*****] |
CONFIDENTIAL
Page 3 of 3
* CERTAIN INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
QuickLinks
- Exhibit 10.11