Document:

Exhibit 10.3

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

SUPPLY AGREEMENT

 

This SUPPLY AGREEMENT (“Agreement”) is made as of this 23rd day of July, 2014 (the “Effective Date”), by and between Pro-Tech Design and Manufacturing, Inc., a California S corporation, having its principal place of business at 14561 Marquardt Ave., Santa Fe Springs, CA 90670 (“Pro-Tech”) and Nevro Corporation, a Delaware corporation, having its principal place of business at 4040 Campbell Avenue, Suite 210, Menlo Park, CA 94025 (“Nevro”).

 

WHEREAS, Pro-Tech provides contract manufacturing and packaging services to companies within the medical device industry;

 

WHEREAS, Nevro is engaged in the development of its proprietary implantable medical device for treating pain; and

 

WHEREAS, Nevro wishes to enter into a subsequent Supply Agreement for continued engagement with Pro-Tech to provide services relating to the inspection, labeling, packaging, and sterilization of Nevro’s medical device for use in Nevro’s commercial sale of Nevro’s medical device (“Purpose”), and Pro-Tech desires to provide such services.

 

NOW, THEREFORE, in consideration of the mutual covenants, terms and conditions set forth below, the parties agree as follows:

 

ARTICLE 1.
 DEFINITIONS

 

The following terms have the following meanings in this Agreement:

 

1.1                               “Accessory Components” means various Components packaged and supplied separately from a Product.

 

1.2                               “Affiliate(s)” means any corporation, firm, partnership or other entity, which controls, is controlled by or is under common control with a party.  For purposes of this definition, “control” shall mean the ownership of at least fifty percent (50%) of the voting share capital of such entity or any other comparable equity or ownership interest.

 

1.3                               “Applicable Laws” means all applicable laws, rules, regulations, standards and guidelines that apply to the performance of either party’s obligations under this Agreement, including without limitation current good manufacturing practice (“cGMP”) rules, regulations or standards promulgated by the FDA, international standards organizations, and any other governmental agency or any national industry association or governing body in any jurisdiction, including without limitation 21 C.F.R. § 802 et seq. and ISO 13485.

 

1.4                               “Component” means various components, pieces, or parts of the Product or the Accessory Components supplied to Nevro or its designee by Third Parties pursuant to Section 2.2 or manufactured by Pro-Tech pursuant to Section 2.1.

 

1.5                               “Confidential Information” has the meaning provided in Section 10.2.

 

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1.6                               “Defective Product” means any Product or Accessory Component that contains a Nonconformity or Latent Defect.

 

1.7                               “Facilities” means Pro-Tech’s facilities located in Santa Fe Springs, CA or such other facility as mutually agreed in writing by the parties.

 

1.8                               “FDA” means the United States Food and Drug Administration or any successor thereto.

 

1.9                               “Intellectual Property” means all patents, patent applications, know-how, trade secrets, copyrights, trademarks, designs, concepts, data, results, technical information, know-how, show-how, materials, prototypes, manuals, standard operating procedures, instructions or Specifications.

 

1.10                        “Latent Defect” means a Nonconformity that was not reasonably discoverable upon inspection pursuant to Article 4.1(b).

 

1.11                        “Losses” means suits, claims, losses, demands, liabilities, damages, costs and expenses (including reasonable attorneys’ fees) in connection with any suit, demand or action by any Third Party.

 

1.12                        “Nonconformity” means a characteristic, factor or circumstance of or relating to the Product or Accessory Component manufactured or supplied pursuant to this Agreement that renders Product or Accessory Component not to conform to the Specifications or not to have been made in accordance with Applicable Laws.

 

1.13                        “Packaging Supplies” include the Tray, retainer, lid, carton, and other packaging products that Pro-Tech will make or have made under this Agreement for packaging of Product or Accessory Components.

 

1.14                        “Product” means (i) an implantable pulse generator (an “IPG”), (ii) leads, and/or (iii) lead extenders (each packaged with a Tray) to be used in Nevro’s implantable medical device for treatment of chronic pain.

 

1.15                        “Regulatory Authority” means any governmental regulatory authority involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of Nevro’s Products or Accessory Components including, but not limited to, the FDA and any foreign equivalents thereof.

 

1.16                        “Services” means the services performed by Pro-Tech pursuant to Sections 2.1, 2.2, and 2.3 of this Agreement.

 

1.17                        “Specifications” means the specifications for the Product and any Accessory Components, as set forth in Exhibit A of this Agreement, including the Tray Specifications and any subsequent changes to the Specifications or Tray Specifications made in accordance with Article 7.  The Specifications shall be attached to Exhibit A within forty-five (45) days after the Effective Date.

 

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1.18                        “Third Party” means any person or entity other than Nevro, Pro-Tech, or an Affiliate of any of them.

 

ARTICLE 2.
 SERVICES

 

2.1                               Receipt and Inspection of Components.  Nevro will arrange for the supply to Pro-Tech of multiple Components by Third Parties.  Upon receipt of these Components so provided by or on behalf of Nevro, Pro-Tech shall inspect such Components for (i) damage, and (ii) compliance with other written requirements established by Nevro from time to time.  Pro-Tech shall notify Nevro of any damaged or non-compliant Components received within five (5) business days after receipt of such Components.  If Pro-Tech discovers any damaged or non-compliant Component pursuant to (i) or (ii) above, subsequent to the above described notification of Nevro, Pro-Tech shall (a) ship such Component to an address designated in writing by Nevro, if requested by Nevro, and (b) not use or include any such Component when assembling or making the Product or any Accessory Component without Nevro’s prior written consent.  Pro-Tech shall store all Components received by or on behalf of Nevro in a manner that will not adversely harm such Components and that will preserve the functionality and integrity of such Components.  Pro-Tech is not responsible for any damaged or non-compliant Components, but will make reasonable efforts to discover such defects prior to packaging by performing an inspection on all Components it receives pursuant to this Agreement.  Nonetheless, upon prior written consent from Nevro, Pro-Tech may procure necessary Components from Third Parties on behalf of Nevro solely for the Purpose.  All material costs and expenses resulting from procuring Components on behalf of Nevro shall be charged at cost plus [***]% and invoiced as a pass-through with all supporting documentation included.

 

2.2                               Environmental Monitoring Services. Pro-Tech will have systems in place to monitor the environment per Nevro’s requirement in which the products are manufactured and/or kitted and/or manufactured.

 

2.3                               Other Related Services.  Pro-Tech shall provide other services upon terms and conditions agreed to by the parties in writing from time to time.

 

2.4                               Performance by Pro-Tech.  Pro-Tech shall not delegate its responsibilities under this Agreement to any Third Parties or any Affiliates of Pro-Tech, without the prior written permission of Nevro, except that Pro-Tech may subcontract sterilization of Products or Accessory Components to a Third Party that Nevro approves in writing.  In the event Nevro agrees to such a delegation of Pro-Tech’s responsibilities under this Agreement, Pro-Tech shall ensure such Third Party or Affiliate complies with the terms and conditions of this Agreement.  Any such delegation shall not relieve Pro-Tech of its responsibilities under this Agreement.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

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ARTICLE 3.
 PURCHASE ORDERS & FORECASTS

 

3.1                               Purchase Orders.  From time to time, Nevro may issue to Pro-Tech specific purchase orders for Product or Accessory Components (each a “Purchase Order”).  Individual Purchase Orders issued by Nevro referencing this Agreement will be the only documents authorizing the supply of Products and Accessory Components to Nevro or its designee.  Each Purchase Order shall be in the form of a written or electronic communication and shall contain the following information: (i) a description of the Product and/or Accessory Components by item number and revision (ii) quantity and pricing of the Product and/or Accessory Components ordered; (iii) the required delivery date or shipping schedule; (iv) the location to which the Product and/or Accessory Components are to be shipped; and (v) at Nevro’s sole election, the method of transportation.

 

3.2                               Purchase Order Acceptance.  Pro-Tech shall acknowledge all Purchase Orders received from Nevro that are submitted in compliance with this Agreement in writing within five (5) days after Pro-Tech receives such Purchase Order.  Pro-Tech will deliver all Product and/or Accessory Components prior to or on the delivery dates set forth on Purchase Orders that are so acknowledged, in accordance with Section 3.1.  Pro-Tech shall have no obligation to acknowledge any Purchase Order that either does not conform to Section 3.1 or that requires delivery in any calendar quarter of more than [***] percent ([***]%) of amounts of Product forecasted in the most recent forecast for such calendar quarter pursuant to Section 3.4.

 

3.3                               Adjustments to Purchase Orders.  Nevro may adjust any Purchase Order within (30) calendar days after issuing a Purchase Order by changing the quantity of Products and/or Accessory Components ordered or rescheduling the delivery date. Subject to Section 2.2, Pro-Tech shall use commercially reasonable efforts to accommodate any other requested schedule changes.

 

3.4                               Forecast.  Nevro shall prepare and submit to Pro-Tech at least once per quarter a non-binding rolling six (6) month Product and Packaging Supplies demand forecast.  Each such forecast shall be non-binding and shall be used by Pro-Tech solely to plan for materials and production capacity.

 

ARTICLE 4.
 TESTING; SAMPLES; RELEASE

 

4.1                               Inspection; Acceptance.  Nevro shall be entitled to reject any portion or all of any shipment of Products or Accessory Components that are Defective Product.  Pro-Tech makes no claims for any Component of reliability, fitness of design, function, or compliance to the specifications for such Components, because such Components are procured by Nevro.

 

(a)                                 Pro-Tech shall maintain an inspection system adequate to ensure that all work performed and items delivered conform to the Specifications and that they comply with and are made in accordance with Applicable Laws and the terms of this Agreement.  Nevro may, at all reasonable times and places, inspect or test the work (including, without limitation,

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

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raw material, components, assemblies and end products) being performed under this Agreement, including without limitation Pro-Tech’s manufacturing or testing processes, equipment, and locations used for the performance of this Agreement.  If Nevro makes any inspection or test on the premises of the Pro-Tech, including the Facilities, or any permitted lower tier subcontractor pursuant to Section 2.5, all reasonable assistance for such inspection shall be provided by Pro-Tech without charge.  Nevro shall be allowed to inspect Pro-Tech’s Facilities at any time during the manufacturing process.  While on Pro-Tech’s premises, Nevro shall comply with Pro-Tech’s safety and security rules and regulations.

 

(b)                                 Within sixty (60) business days after delivery of a shipment of Products or Accessory Components, Nevro or its designee may inspect such shipment.  Nevro shall promptly, and in no event more than five (5) business days after the end of such inspection period, notify Pro-Tech if the shipment of Product or Accessory Components includes Defective Product.

 

(c)                                  If no such notice of Defective Product is provided by Nevro pursuant to Article 4.1(b), then Nevro shall be deemed to have accepted the shipment regardless of whether Nevro has actually performed any inspection or testing on such Product as set forth in Article 4.1(b), and Nevro shall be deemed to have waived any claims as to any Nonconformity, except as to Latent Defects as specified in Article 4.1(d).  Payment of invoice does not constitute acceptance of supplies covered by this Agreement and is without prejudice to any and all claims of Nevro against Pro-Tech.

 

(d)                                 If a shipment of Product has a Latent Defect, Nevro shall promptly, and in no event more than ten (10) business days after it becomes aware of such Latent Defect, notify Pro-Tech of such Latent Defect.

 

(e)                                  At Nevro’s sole option, Pro-Tech shall either repair or replace any such Defective Products, however Pro-Tech limits its liability to the purchase price of the Products or Accessory Components.  Pro-Tech shall promptly review the cause of rejection and upon confirmation take corrective action to address and correct the basis for any Nonconformity.  Pro-Tech shall bear freight, tax, and insurance costs incurred by Pro-Tech in transporting such replacement Product to Nevro or its designee provided such Nonconformity be directly related to the work performed by Pro-Tech.

 

(f)                                   If Pro-Tech disputes Nevro’s assertion that certain Product or Accessory Components are Defective Products, then at either party’s request an independent testing laboratory reasonably acceptable to both parties and subject to confidentiality provisions set forth in Article 10 below, shall be engaged to analyze a sample of the allegedly Defective Product and any samples as necessary to determine whether such rejected Product or Accessory Components are Defective Products.  Both parties shall be bound by the laboratory’s results of analysis, which, absent manifest error, shall be deemed final as to any dispute under this Article 4.  If such laboratory determines Product contains a Nonconformity, then Pro-Tech shall be responsible for the costs incurred by such laboratory.  Otherwise, Nevro shall be responsible for the costs incurred by such laboratory.

 

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4.2                               Chronic Defects.  Should a material number of Products or Accessory Component supplied by Pro-Tech pursuant to this Agreement in any given calendar quarter have Nonconformities, Pro-Tech shall promptly contact Nevro and provide information regarding the nature of the Nonconformities, the steps Pro-Tech plans to take to minimize the occurrence of such Nonconformities, and the frequency of occurrence of such Nonconformities.  Promptly after Nevro receives such notice, the parties shall meet to discuss the causes of such Nonconformities, develop a reasonable and mutually acceptable plan for minimizing occurrence of such Nonconformities, and use commercially reasonable efforts to perform their respective obligations under such plan.

 

ARTICLE 5.
 DELIVERY

 

5.1                               Storage and Delivery.  Pro-Tech shall segregate and properly store all Components provided by Nevro and Products and Accessory Components supplied by Pro-Tech until use or delivery.  Nevro shall be responsible for all costs and risk of loss associated with such storage of the Product and Components by Pro-Tech or any approved subcontractor.  Pro-Tech shall tender the Product or Accessory Components for delivery, FCA (Incoterms 2000) the Facilities.  Pro-Tech shall ship Product or Accessory Components in accordance with the Purchase Order, or if not described therein, as Nevro designates.  Pro-Tech shall insure all Product or Accessory Components shipped to Nevro or its designee pursuant to this Agreement, at the cost of Nevro, and designate Nevro as the loss payee.

 

5.2                               Certificate of Compliance. Pro-Tech will provide a written certificate of compliance to Nevro indicating the Product or Accessory Components meet Specifications and were manufactured in accordance with, and comply with, other requirements under Applicable Laws.  Pro-Tech shall provide such certificate of compliance to Nevro electronically (via scanned and emailed copies) within one (1) business day after each shipment of Product and in hard copy for the shipments during the preceding month within five (5) business days after such month’s end.  Pro-Tech shall also include together with the foregoing, certificates of compliance Pro-Tech receives from Third Party suppliers of any Components included in such shipment pursuant to Section 2.2.  Pro-Tech cannot certify the Components comply with the respective Component specifications although it will make reasonable efforts to discover Defects through an inspection of Components it receives pursuant to this Agreement.

 

ARTICLE 6.
 PRICING AND PAYMENT

 

6.1                               Pricing.  Prices for the Products, each Accessory Components, and Packaging Supplies are or shall be set forth in Exhibit C, as may be amended from time to time upon mutual written agreement of the parties.  Pro-Tech represents that the prices for the Products Accessory Components, or Packaging Supplies sold to Nevro under this Agreement are at least as favorable as the prices currently paid by any other customer of Pro-Tech for products or services substantially similar to Products, Packaging Supplies, or Services in equal or similar quantities.

 

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6.2                               Taxes; Duty.  All taxes, duties and other amounts assessed on the Packaging Supplies prior to or upon sale to Nevro are the responsibility of Pro-Tech and are included in the pricing set forth on Exhibit C.

 

6.3                               Invoice; Payment Terms.  Pro-Tech shall invoice Nevro for all Products, Packaging Supplies, or Accessory Components shipped upon or after shipment.  Payment for such invoices shall be due within thirty (30) days after shipment date.

 

ARTICLE 7.
 CHANGES TO SPECIFICATIONS

 

Any changes in the Specifications (“Changes”) from time to time shall be in writing, dated, and signed by the parties.  No Changes shall be implemented by Pro-Tech, whether requested by Nevro or requested or required by any Regulatory Authority, until the parties have mutually agreed in writing to such Change, the implementation date of such Change, and any increase or decrease in fees associated with such Change.  Pro-Tech shall respond promptly to any request made by Nevro for a Change and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such Change in a timely manner.  As soon as possible after Nevro or a Regulatory Authority requests any Change, Pro-Tech shall notify Nevro of the increase or decrease in fees associated with such change and shall provide such supporting documentation as Nevro may reasonably require.  Nevro shall pay all fees associated with such agreed upon Changes and agreed upon by the parties in writing.  Notwithstanding the forgoing, Pro-Tech shall not unreasonably withhold consent to Changes.

 

ARTICLE 8.
 RECORDS; REGULATORY MATTERS

 

8.1                               Records.  Pro-Tech shall maintain true and accurate books, records, test and laboratory data, reports and all other information (“Records”) relating to Services and manufacture or supply of Products or Accessory Components under this Agreement, including, without limitation, all information required to be maintained by Applicable Laws and any Regulatory Authority.  Pro-Tech shall provide Nevro with a copy of all Records and any documents related to the Services or the supply or manufacture of Product or Accessory Components at Nevro’s request or upon expiration or termination of this Agreement.  The Records shall be Confidential Information of Nevro.  Pro-Tech shall retain copies of all Records for a period of at least ten (10) years after date of final payment under this Agreement.

 

8.2                               Regulatory Compliance.  Pro-Tech shall be solely responsible for all permits and licenses required by any Regulatory Authority or Applicable Laws to enable Pro-Tech to perform Services under this Agreement.  Pro-Tech will maintain ISO13485 certification.  For clarity, Nevro is responsible for all other permits and licenses required.  Pro-Tech will accommodate Nevro’s requests to perform periodic onsite audits.

 

8.3                               Quality Audits.  Inspection System and Quality Assurance Requirements for supplies and/or Services provided under this Agreement shall be in accordance with Pro-Tech’s standard quality system, which shall meet or exceed industry standards.  All Products

 

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and Accessory Components shall conform to the Specifications and shall be manufactured in accordance, and comply, with Applicable Laws and this Agreement.

 

8.4                               Regulatory Inspection.  Pro-Tech shall cooperate reasonably with Nevro’s efforts to obtain regulatory approval of Products. Without limiting the foregoing, if a Regulatory Authority makes an inquiry or otherwise requests information or assistance relating to Products or Accessory Components, whether to Nevro or Pro-Tech, Pro-Tech shall provide access to, and coordinate and make available, applicable personnel, facilities, materials, and documents as necessary to respond to such inquiries.  In the event of any such inquiry, request, or other communication relating to Product or Accessory Components, Pro-Tech will promptly notify and provide information regarding such inquiry, request, or communication to Nevro.  Pro-Tech will promptly forward to Nevro copies of any findings that Pro-Tech receives from a government authority or Regulatory Authority in connection with Services, Product, or Accessory Components.  Pro-Tech will also provide Nevro an opportunity to comment prospectively on any Pro-Tech responses to a government authority regarding Product or Accessory Components.

 

8.5                               Ownership of Regulatory Filings.  As between the parties, Nevro will own all regulatory filings for Nevro products.  Pro-Tech shall cooperate reasonably with Nevro to draft and file applications and other materials with any Regulatory Authority relevant to Products or Accessory Components, and to seek approval of Products by such Regulatory Authorities

 

ARTICLE 9.
 REPRESENTATIONS, WARRANTIES, AND COVENANTS

 

9.1                               Pro-Tech.  Pro-Tech represents, warrants and covenants to Nevro that:

 

(a)                                 In providing services under this Agreement, Pro-Tech shall comply with the Specifications, Applicable Laws and this Agreement;

 

(b)                                 neither Pro-Tech, its Affiliates, members of their respective staffs, nor any of their approved subcontractors or members of their respective staffs are or shall be, at the time of performance of under this Agreement, disqualified or debarred by any Regulatory Authorities or any other governmental authority for any purpose;

 

(c)                                  any Services provided hereunder by Pro-Tech will be provided in a workman-like and professional manner by personnel of Pro-Tech having a level of skill in the area commensurate with the requirements of the scope of work to be performed;

 

(d)                                 to its knowledge, its performance under this Agreement will not infringe or misappropriate any patent rights and other Intellectual Property rights;

 

(e)                                  all Product and Accessory Components shall comply with Specifications; and

 

(f)                                   it has not received any warnings from any Regulatory Authority relating to services it has provided to Third Parties.

 

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9.2                               Mutual.  Each party hereby represents and warrants to the other party that:

 

(a)                                 Compliance with Laws.  Such party will comply with Applicable Laws relevant to such party’s performance under this Agreement.

 

(b)                                 Existence and Power.  Such party (i) is duly organized, validly existing and in good standing under the laws of the state in which it is organized and (ii) has the power and authority and the legal right to own and operate its property and assets, and to carry on its business as it is now being conducted.

 

(c)                                  Authorization and Enforcement of Obligations.  Such party (i) has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder and (ii) has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder.

 

(d)                                 Execution and Delivery.  This Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal, valid and binding obligation upon such party.

 

(e)                                  No Consents.  All necessary consents, approvals, and authorizations of all Regulatory Authorities and other persons required to be obtained by such party in connection with the Agreement have been obtained.

 

(f)                                   No Conflict.  The execution and delivery of this Agreement and the performance of such party’s obligations hereunder (i) do not conflict with or violate any requirement of Applicable Laws; and (ii) do not materially conflict with, or constitute a material default or require any consent under, any contractual obligation of such party.

 

9.3                               Limitations.  THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS AGREEMENT ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

 

ARTICLE 10.
 CONFIDENTIAL INFORMATION

 

10.1                        Mutual Obligation.  Pro-Tech and Nevro each agree that it will not disclose the Confidential Information (defined below) it receives from or on behalf of the other party pursuant to this Agreement to any Third Party without the prior written consent of the other party, or use such Confidential Information for any purpose other than as permitted in this Agreement or as necessary to perform its obligations or exercise its rights under this Agreement, except that Nevro may disclose this Agreement under confidentiality obligations to actual or potential outside investors, licensees, acquirers, corporate partners and advisors.  Notwithstanding the foregoing, each party may disclose the other party’s Confidential Information to any of its Affiliates, employees, consultants and other authorized

 

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representatives that (i) need to know such Confidential Information for the purpose of performing under this Agreement or exercising rights hereunder, (ii) are advised of the contents of this Article, and (iii) agree to be bound by the terms of this Article or confidentiality obligations commensurate with those set forth in this Article.

 

10.2                        Definition.  As used in this Agreement, the term “Confidential Information” includes all such information furnished by Pro-Tech or Nevro, or any of their respective authorized representatives, independent contractors or Affiliates, to the other or its authorized representatives, independent contractors or Affiliates, whether furnished in any form, including but not limited to written, verbal, visual, electronic or in any other media or manner.  Confidential Information includes without limitation all proprietary information (whether or not patented), any licensed technology, methods or materials, documents, analyses, compilations, business or technical information and other materials prepared by either party, or any of their respective representatives, containing or based in whole or in part on any such information furnished to a party by the other party or its representatives.  Records, Specifications, Product or Component specific documents, and all copies thereof shall be deemed Confidential Information disclosed by Nevro.  Confidential Information of each party also includes without limitation the existence of this Agreement and its terms.  All Confidential Information will remain the sole property of the party disclosing or deemed to have disclosed such information or data.

 

10.3                        Exclusions.  Notwithstanding Article 10.1, the restrictions set forth in Article 10.1 shall not apply to any information that (i) is or becomes generally available to the public other than as a result of a breach of this Agreement, (ii) is already known by the receiving party at the time of disclosure, as evidenced by the receiving party’s written records, (iii) becomes available to the receiving party without an obligation of confidentiality, or (iv) was or is independently developed by or for the receiving party without reference to the other party’s Confidential Information, as evidenced by the receiving party’s contemporaneous written records.  If the Confidential Information of a party is required to be disclosed pursuant to a requirement of law, government regulation, or court or administrative order, then the party being compelled to disclose such Confidential Information may disclose such Confidential Information, provided that such disclosing party (a) gives the other party prompt written notice regarding such required disclosure so that the other party may obtain a protective order or otherwise minimize any such disclosure; (b) cooperates fully with the other party and/or its Affiliates in connection with its efforts to obtain any such order or other remedy; (c) discloses, where disclosure is necessary, only the information legally required to be disclosed; and (d) uses its reasonable efforts to have confidential treatment accorded to the disclosed Confidential Information.

 

10.4                        Return of Confidential Information.  Upon termination of this Agreement, the receiving party shall, upon request of the disclosing party, promptly return within thirty (30) days all Confidential Information, including all copies thereof, and cease its use or, promptly destroy the same and certify such destruction to the disclosing party; except that the receiving party may retain a single copy thereof for the sole purpose of determining the scope of the obligations incurred under this Agreement.

 

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10.5                        Survival.  The obligations of this Article 10 will terminate ten (10) years from the expiration or termination of this Agreement.

 

ARTICLE 11.
 INTELLECTUAL PROPERTY

 

11.1                        Pro-Tech Intellectual Property.  Pro-Tech has certain intellectual property rights over processes developed and trade secrets used in the manufacturing of Product.  If at any time Pro-Tech is unwilling or unable to provide Products or Accessory Components under this Agreement or after this Agreement terminates or expires, Pro-Tech grants Nevro a non-exclusive license under any intellectual property and/or know how and manufacturing processes owned or otherwise licensable by Pro-Tech to enable Nevro to make, have made, and use and sell the affected Product.

 

11.2                        Nevro Intellectual Property Relating to Products.  If Nevro makes any know-how or trade secret available to Pro-Tech relative to the design or production of a Product or Accessory Component, Pro-Tech will have a non-exclusive, non-transferable, revocable license under such intellectual property solely to produce or have produced the Products or Accessory Components pursuant to this Agreement.

 

ARTICLE 12.
 INDEMNIFICATION

 

12.1                        Indemnification by Pro-Tech.  Pro-Tech shall indemnify, defend and hold harmless Nevro, its Affiliates, and their respective directors, officers, employees and agents (“Nevro Indemnitees”) from and against any and all Losses to the extent arising out of or resulting from (i) any breach of Pro-Tech’s representations, covenants, warranties or obligations set forth in this Agreement or any Pro-Tech Indemnitee’s violation of Applicable Law relevant to this Agreement, or (ii) any negligence or willful misconduct by any Pro-Tech Indemnitee, except to the extent that any of the foregoing arises out of or results from any Nevro Indemnitees’ negligence, willful misconduct or breach of this Agreement or violation of Applicable Law.

 

12.2                        Indemnification by Nevro.  Nevro shall indemnify, defend and hold harmless Pro-Tech, its Affiliates, and their respective directors, officers, employees and agents (“Pro-Tech Indemnitees”) from and against any and all Losses to the extent arising out of or resulting from (i) any breach of Nevro’s representations, covenants, warranties or obligations set forth in this Agreement or any Nevro Indemnitee’s violation of Applicable Law relevant to this Agreement, or (ii) any negligence or willful misconduct by any Nevro Indemnitee, except to the extent that any of the foregoing arises out of or results from any Pro-Tech Indemnitees’ negligence, willful misconduct or breach of this Agreement or violation of Applicable Law.

 

12.3                        Indemnification Procedures.  All indemnification obligations in this Agreement are conditioned upon the party seeking indemnification: (i) promptly notifying the indemnifying party in writing of any claim or liability of which the party seeking indemnification becomes aware (including a copy of any related complaint, summons, notice or other instrument); provided, however, that failure to provide such written notice within a

 

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reasonable period of time shall not relieve the indemnifying party of any of its obligations hereunder except to the extent the indemnifying party is prejudiced by such failure; (ii) cooperating with the indemnifying party in the defense of any such claim or liability (at the indemnifying party’s expense); and (iii) not compromising or settling any claim or liability without prior written consent of the indemnifying party.  The indemnifying party may be represented by counsel of its own choosing, such counsel to be reasonably acceptable to the indemnified party.

 

ARTICLE 13.
 INSURANCE

 

Pro-Tech shall procure and maintain general liability insurance in such amount as ordinary good business practice for its type of business would make advisable, but not less than one million dollars ($1,000,000).  Pro-Tech does not maintain insurance for Nevro’s products.  Nevro shall procure and maintain product liability and general liability insurance in such amount as ordinary good business practice for its type of business would make advisable, but not less than five million dollars ($5,000,000).

 

ARTICLE 14.
 TERM AND TERMINATION

 

14.1                        Term.  This Agreement shall commence on the Effective Date and shall continue for a period of five (5) years, unless earlier terminated under Article 14.2 or 14.3 below (the “Term”).

 

14.2                        Termination for Material Breach.  Either party may terminate this Agreement effective upon sixty (60) days prior written notice to the other party, if the other party commits a material breach of this Agreement and fails to cure such breach by the end of such thirty (30) day period.

 

14.3                        Termination Without Cause.  Without prejudice to any of its other rights conferred on it by this Agreement or by Applicable Law:

 

(a)                                 Nevro may terminate this Agreement six (6) months after giving Pro-Tech written notice to such effect; and

 

(b)                                 Pro-Tech may terminate this Agreement eighteen (18) months after giving Nevro written notice to such effect.

 

14.4                        Effect of Termination.

 

(a)                                 Expiration or termination of this Agreement shall be without prejudice to any rights or obligations that accrued to the benefit of either party prior to such expiration or termination.

 

(b)                                 In the event of any termination pursuant to Section 14.2 or 14.3, Pro-Tech shall promptly return to Nevro (i) any remaining inventory of materials or Components received from or on behalf of Nevro, (ii) all remaining inventories of Product, (iii) any other

 

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Product (or Components thereof or raw materials therefor) being stored for Nevro, and (iv) copies of Records used to produce Product or Accessory Components, and all associated completed release tests and certificates of compliance.

 

(c)                                  Upon termination or expiration of this Agreement, all prototype tooling and production tooling shall be returned to Nevro from the location of such tooling at the time of such expiration or termination of this Agreement.  Pro-Tech may ship or send such tooling to Nevro, at Nevro’s cost, or Nevro may collect such tooling itself.

 

14.5                        Survival.  The provisions set forth in Section 14.4 and 14.5 and Articles 8, 10, 11, 12, 15, and 17 shall survive termination or expiration of this Agreement, as will other terms that by their nature are intended to survive the expiration or termination of this Agreement.

 

ARTICLE 15.
 LIMITATIONS OF LIABILITY

 

EXCEPT IN CONNECTION WITH A BREACH OF A PARTY’S OBLIGATIONS UNDER ARTICLE 10 OR LIABILITY UNDER ARTICLE 12, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF OR RELATED TO THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, LOSS OF REVENUES, PROFITS OR DATA, WHETHER IN CONTRACT OR TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

ARTICLE 16.
 NOTICE

 

All notices and other communications hereunder shall be in writing to each party as set forth below and shall be deemed given: (i) when delivered personally; (ii) when delivered by facsimile transmission (receipt verified); (iii) when received or refused, if mailed by registered or certified mail (return receipt requested), postage prepaid; or (iv) when delivered if sent by express courier service, to the parties at the following addresses (or at such other address as specified by either party as described herein).

 

	
Nevro:
    	
 
    	
Nevro   Corporation
    	
 
    	
Pro-Tech:
    	
 
    	
Pro-Tech   Design & Manufacturing, Inc.
    
	
 
    	
 
    	
4040   Campbell Avenue,
   Suite 210
    	
 
    	
 
    	
 
    	
14561   Marquardt Ave.
    
	
 
    	
 
    	
Menlo   Park, CA 94025
    	
 
    	
 
    	
 
    	
Santa   Fe Springs, CA 90670
    
	
 
    	
 
    	
Tel:   650-251-0005
    	
 
    	
 
    	
 
    	
Tel:   562-207-1680
    
	
 
    	
 
    	
Facsimile:   650-251-9415
    	
 
    	
 
    	
 
    	
Facsimile:   562-207-1699
    

 

ARTICLE 17.
 MISCELLANEOUS

 

17.1                        Entire Agreement; Amendments.  This Agreement, the Exhibits thereto, and any amendments thereto constitute the entire understanding between the parties and supersede any contracts, agreements or understanding (oral or written) of the parties with respect to the

 

13

 

subject matter hereof.  No term of this Agreement may be amended except upon written agreement of both parties, unless otherwise provided in this Agreement.

 

17.2                        Captions.  The captions and headings in this Agreement are for convenience only and are not to be interpreted or construed as a substantive part of this Agreement.

 

17.3                        Further Assurances.  The parties agree to execute, acknowledge and deliver such further instruments and to take all such other incidental acts as may be reasonably necessary or appropriate to carry out the purpose and intent of this Agreement.

 

17.4                        No Waiver.  Failure by either party to insist upon strict compliance with any term of this Agreement in any one or more instances will not be deemed to be a waiver of its rights to insist upon such strict compliance with respect to any subsequent failure.

 

17.5                        Severability.  If a court or other body of competent jurisdiction declares any term of this Agreement invalid or unenforceable, the remaining terms of this Agreement will continue in full force and effect.

 

17.6                        Independent Contractors.  The relationship of the parties is that of independent contractors, and neither party will incur any debts or make any commitments for the other party except to the extent expressly provided in this Agreement.  Nothing in this Agreement is intended to create or will be construed as creating between the parties the relationship of joint ventures, co-partners, employer/employee or principal and agent.

 

17.7                        Successors and Assigns.  This Agreement will be binding upon and inure to the benefit of the parties, their successors and permitted assigns.  Neither party may assign this Agreement, in whole or in part, without the prior written consent of the other party, which shall not be unreasonably withheld, provided, however, that either party may, without the other party’s consent, assign this Agreement to an Affiliate or to an acquirer or successor of substantially all of the business or assets of the assigning company to which this Agreement relates.  Any assignment in violation of this Section 17.7 shall be null and void.

 

17.8                        Governing Law.  This Agreement shall be governed by and construed under the laws of the State of Delaware, excluding its conflicts of law provisions.  The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.

 

17.9                        Counterparts.  This Agreement may be executed in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument.  Any photocopy, facsimile or electronic reproduction of the executed Agreement shall constitute an original.

 

17.10                       Product Release and Distribution.  Pro-Tech does not design or commercially distribute medical devices, components, or primary packaging elements.  Pro-Tech does not guarantee the fitness of use or reliability of any designs.  Nevro is solely responsible for the commercial distribution of its Products.  Pro-Tech may ship to multiple sites as requested by Nevro however Pro-Tech is not distributing the Product for Nevro.

 

14

 

[THE REMAINDER OF THIS PAGE LEFT BLANK
 SIGNATURES TO FOLLOW]

 

15

 

IN WITNESS WHEREOF, the parties have caused their duly authorized representative to execute this Agreement effective as of the Effective Date.

 

	
PRO-TECH   DESIGN AND MANUFACTURING, INC.
    	
 
    	
NEVRO   CORPORATION
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/   Aaron Swanson
    	
 
    	
By:
    	
/s/   Konstantinos Alataris
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Aaron   Swanson
    	
 
    	
Name:
    	
Konstantinos   Alataris
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
VP,   Operations
    	
 
    	
Title:
    	
CEO
    

 

16

 

EXHIBIT A

 

SPECIFICATIONS

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-NIPG1500[C]
    
	
Title:
    	
 
    	
IPG Model IPG1500 Kit, NIPG1500
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
21-Jan-2014
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
R&DE_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
NIPG1500
    	
C
    	
Sheet 1 of 10
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Model IPG1500 Kit, NIPG1500
    

 

1.                          SCOPE

 

The NIPG1500 kit will include the implantable pulse generator, model IPG1500 and implant tools to aid the physician during the operating procedure.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                The NIPG1500 kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
NIPG1500
    	
C
    	
Sheet 2 of 10
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Model IPG1500 Kit, NIPG1500
    

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall be supplied in the inner and retainer trays for operating room (OR) use.

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  IPG kit shall be supplied ETO sterilized per manufacturing outline NIPG1500.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
NIPG1500
    	
C
    	
Sheet 3 of 10
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Model IPG1500 Kit, NIPG1500
    

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Components shall be visible while inside the trays.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both trays and pouches shall be sealed per ProTech’s manufacturing outline NIPG1500.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the trays and pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
NIPG1500
    	
C
    	
Sheet 4 of 10
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Model IPG1500 Kit, NIPG1500
    

 

4.6.                   Components shall be placed in the inner tray as shown in the image below:

 

[***]

 

Figure 1: Location of Nevro devices in the inner tray

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
NIPG1500
    	
C
    	
Sheet 5 of 10
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Model IPG1500 Kit, NIPG1500
    

 

4.7.                   The retainer tray will remain empty for the NIPG1500 kit. The retainer tray shall be placed on top of the Inner tray and shall snap into place.

 

4.8.                   A Tyvek lid shall be sealed to the top of the Inner tray while the Retainer tray sits inside.

 

4.9.                   The clear side of the inner tray shall be loaded into the outer pouch so that the contents of the tray are visible from the clear side of the outer pouch.

 

4.10.            A NIPG1500 Kit Label shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package and is placed in the same orientation as shown below. Place the supplementary label below the NIPG1500 Kit label on the Tyvek pouch (P/N 10253-16) as shown below

 

4.10.1.           A MR Conditional Label shall be placed on the open space of the NIPG1500 Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 4). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

[***]

 

Figure 2: Label placement on the outer pouch

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
NIPG1500
    	
C
    	
Sheet 6 of 10
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Model IPG1500 Kit, NIPG1500
    

 

4.11.            A NIPG1500 Kit Label shall be placed in the center of the shelf carton (P/N 10254-01) in the same orientation as shown below.  The orientation of the Lead Kit Label on the outer pouch and shelf carton should be the same. The label should be centered and placed between 4 1⁄2 to 5 1⁄2 inches from the top of the shelf carton and square to the front carton plane.

 

4.11.1.           A MR Conditional Label shall be placed on the open space of the NIPG1500 Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 4). The MR Conditional Label must not obscure any print or logo on the NIPG1500 Label. All edges must be pressed flat and exhibit zero label peel.

 

4.12.            The pouch with its contents shall then be loaded into the shelf carton in the same orientation as shown below:

 

[***]

 

Figure 3: Outer pouch insertion orientation

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
NIPG1500
    	
C
    	
Sheet 7 of 10
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Model IPG1500 Kit, NIPG1500
    

 

[***]

 

Figure 4: MR Conditional Label Placement

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
NIPG1500
    	
C
    	
Sheet 8 of 10
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Model IPG1500 Kit, NIPG1500
    

 

4.13.            Place labels on the shelf carton as shown below (Top View of shelf carton):

 

[***]

 

Figure 5: Location of labels on the shelf carton

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
NIPG1500
    	
C
    	
Sheet 9 of 10
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Model IPG1500 Kit, NIPG1500
    

 

4.14.            Place labels on the shelf carton as shown below (Side View of the shelf carton):

 

[***]

 

Figure 6: Location of labels on shelf carton (con’t)

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
NIPG1500
    	
C
    	
Sheet 10 of 10
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Model IPG1500 Kit, NIPG1500
    

 

4.15.            No more than 2 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline NIPG1500.

 

5.                          QUALITY SYSTEM

 

The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.1.                   Lot Traceability & Acceptance

 

5.1.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.1.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.2.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, manufacturing process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    
	
B
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    
	
C
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-10913[B]
    
	
Title:
    	
 
    	
CLPG2000 Programmer Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
09-May-2013
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DE_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
10913 (CLPG2000)
    	
B
    	
Sheet 1 of 2
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
CLPG2000 Programmer Kit
    

 

1.                          SCOPE

 

This specification establishes the receiving, packaging, shipping and quality system requirements for the Nevro CLPG2000 Programmer Kit.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The programmer kit will be stored and supplied by ProTECH

 

Santa Fe Springs, CA USA

 

14561 Marquardt Avenue

 

Santa Fe Springs, CA 90670

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

4.                          RECEIVING INSPECTION REQUIRMENTS

 

4.1.                   Packing list quantity matches delivered quantity.

 

4.2.                   Packing list serial numbers match delivered serial numbers on manufacturer packaging.

 

5.                          PACKAGING & SHIPPING REQUIREMENTS

 

5.1.                   Contents of package will be received and re-packaged in manufacturer’s packaging.

 

5.2.                   Surfaces of the manufacturer packaging shall be smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance.

 

5.3.                   Outer packaging shall be labeled with packaging label, P/N 10914 as shown in the image below:

 

[***]

 

Figure 2: Placement of label on top of manufacturer’s packaging box

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
10913 (CLPG2000)
    	
B
    	
Sheet 2 of   2
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
CLPG2000 Programmer Kit
    

 

6.                          QUALITY SYSTEM

 

6.1.                   Lot Traceability & Acceptance

 

6.1.1.                  Each lot shall be traceable to the material lot numbers used on packing list.  The lot number shall be printed on the packaging label P/N 10914.

 

6.1.2.                  Each lot supplied shall be inspected by the supplier using trained personnel to determine conformance to requirements if applicable.

 

6.2.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    
	
B
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
6/6/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-PTTK1000[E]
    
	
Title:
    	
 
    	
Patient Trial Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
06-Jun-2014
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
PTTK1000
    	
E
    	
Sheet 1 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Patient Trial Kit
    

 

1.                          SCOPE

 

The Patient Trial Kit will include the patient trial accessories and instructions needed during the patient’s trial.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The patient trial kit will be stored and supplied by ProTech Design & Manufacturing Inc, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
PTTK1000
    	
E
    	
Sheet 2 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Patient Trial Kit
    

 

4.                          FUNCTIONAL REQUIREMENTS

 

4.1.                   Patient Trial Kit packaging shall contain the patient trial kit cardboard insert, battery box, and patient trial kit outer box, as shown in Figure 1.

 

[***]

 

Figure 1: Subcomponents of Patient Trial Kit Packaging

 

4.2.                   Kit shall be easy to open.

 

4.3.                   Patient Trial Kit shall not be sterilized.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
PTTK1000
    	
E
    	
Sheet 3 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Patient Trial Kit
    

 

5.                          PACKAGING & SHIPPING REQUIREMENTS

 

5.1.                   Contents of package shall be free of contaminants and foreign objects.

 

5.2.                   Patient Trial Kit Cardboard insert, P/N 10254-11, shall be folded so that it looks like the image below:

 

[***]

 

Figure 2: Patient Trial Kit Cardboard Insert

 

5.3.                   The cardboard insert shall then be placed inside the Patient Trial Kit Outer Box, as show in Figure 3.

 

5.4.                   There are three main compartments in the Patient Trial Kit Outer Box as shown below:

 

[***]

 

Figure 3: Patient Trial Kit Outer Box Compartments

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
PTTK1000
    	
E
    	
Sheet 4 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Patient Trial Kit
    

 

5.5.                   The Trial Stimulator Belt, P/N 10202, shall be taken out of the plastic wrap, unfolded once and placed in compartment 1 of the Patient Trial Kit Outer Box as shown in Figure 5.

 

[***]

 

Figure 4: Trial Stimulator Belt

 

5.6.                   Four lithium AA batteries, P/N 10085, shall be placed inside the battery box, P/N 10254-12, all oriented in the same direction. The battery box shall then be placed in compartment 2 of the Patient Trial Kit Outer Box, as shown in Figure 5.

 

[***]

 

Figure 5: Placement of components inside the Patient Trial Kit Outer Box

 

5.7.                   The Flexible Boot, P/N 10485, shall be placed in compartment 3.

 

5.8.                   Place the USB Flash Drive with the loaded Patient Manual in compartment 3 along with the Flexible Boot.

 

5.9.                   Place the Patient Temporary ID Card (P/N 10288) on top of the filled compartments 2 and 3.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
PTTK1000
    	
E
    	
Sheet 5 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Patient Trial Kit
    

 

5.10.            Surfaces of the Patient Trial Kit Outer Box are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance.

 

5.11.            Place labels on the Patient Trial Kit Outer Box as shown below (isometric view of box):

 

[***]

 

Figure 6: Front side of Patient Trial Kit Outer Box

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
PTTK1000
    	
E
    	
Sheet 6 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Patient Trial Kit
    

 

5.12.            Ensure that an inventory label is placed on both the right side of the Patient Trial Kit Outer Box and on the binding of the outer box as show in Figure 7.

 

[***]

 

Figure 7: Back side of Patient Trial Kit Outer Box

 

5.13.            Place Patient Trial Kits into a shipping carton per ProTech’s manufacturing outline PTTK1000.

 

6.                          QUALITY SYSTEM

 

6.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

6.2.                   Lot Traceability & Acceptance

 

6.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

6.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements if applicable.

 

6.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
PTTK1000
    	
E
    	
Sheet 7 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Patient Trial Kit
    

 

REVISION HISTORY

 

	
Rev
    	
 
    	
Change Description
    	
 
    	
Release Date
    	
 
    
	
A
    	
 
    	
[***]
    	
 
    	
01/14/2010
    	
 
    
	
B
    	
 
    	
[***]
    	
 
    	
03/01/2011
    	
 
    
	
C
    	
 
    	
[***]
    	
 
    	
03/15/2011
    	
 
    
	
D
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    	
 
    
	
E
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    	
 
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-EXTS1000[D]
    
	
Title:
    	
 
    	
Trial Stimulator Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
30-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
EXTS1000
    	
D
    	
Sheet 1 of 2
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Trial Stimulator Kit
    

 

1.                          SCOPE

 

This part specification establishes the bill of materials, packaging, shipping and quality system requirements for the Nevro Trial Stimulator Kit EXTS1000.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The Trial Stimulator, flexible boot, and external box will be shipped from CCC.

 

3.2.                   The Trial Stimulator Kit will be stored and supplied by ProTech Design & Manufacturing Inc, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.3.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

4.                          FUNCTIONAL REQUIREMENTS

 

4.1.                   Kit shall be easy to open.

 

5.                          PACKAGING & SHIPPING REQUIREMENTS

 

5.1.                   Contents of package shall be free of contaminants and foreign objects.

 

5.2.                   Foam or bubble wrap shall surround the trial stimulator while inside the external box to protect the trial stimulator during shipping and storage.

 

5.3.                   Contents of Trial Stimulator kit will be packaged in an external box, manufacturer P/N 363, from CCC as detailed below:

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
EXTS1000
    	
D
    	
Sheet 2 of 2
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Trial Stimulator Kit
    

 

5.3.1.                  Base Material: White carton sheet 1.5mm thickness

 

5.3.2.                  Cover Material: Light blue Cellulose paper, 80 grams

 

5.3.3.                  Dimensions: 270 x 175 x 42 mm

 

5.4.  Kit will be packaged per Pro Tech’s manufacturing outline EXTS1000.

 

5.5.                   Surfaces of the Outer Box are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance

 

5.4                        Packaging shall be labeled with packaging label, P/N 10203-01

 

5.5                        A tamper indicator shall be placed on the Outer Box

 

6.                          QUALITY SYSTEM

 

6.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

6.2.                   Lot Traceability & Acceptance

 

6.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

6.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements if applicable.

 

6.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00280
    	
 
    	
[***]
    	
 
    	
05/21/2010
    
	
B
    	
 
    	
00283
    	
 
    	
[***]
    	
 
    	
06/04/2010
    
	
C
    	
 
    	
00489
    	
 
    	
[***]
    	
 
    	
06/02/2011
    
	
D
    	
 
    	
00546
    	
 
    	
[***]
    	
 
    	
08/11/2011
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-CLPW1000[B]
    
	
Title:
    	
 
    	
Programmer Wand Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
30-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
CLPW1000
    	
B
    	
Sheet 1 of 2
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Programmer Wand Kit
    

 

1.                          SCOPE

 

The Programmer Wand Kit will include the Programmer Wand needed to program the patient’s therapy.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The programmer wand and external box will be shipped from CCC.

 

3.2.                   The programmer wand kit will be stored and supplied by ProTech Design & Manufacturing Inc, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.3.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

4.                          FUNCTIONAL REQUIREMENTS

 

4.1.                   Kit shall be easy to open.

 

5.                          PACKAGING & SHIPPING REQUIREMENTS

 

5.1.                   Contents of package shall be free of contaminants and foreign objects.

 

5.2.                   Foam or bubble wrap shall surround the programmer wand inside the Outer Box to protect the programmer wand during shipping and storage.

 

5.3.                   Surfaces of the Programmer Wand Kit Outer Box are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance.

 

5.4.                   Contents of Programmer Wand kit will be packaged in an external box, manufacturer P/N 363, from CCC as detailed below:

 

5.4.1.                  Base Material: White carton sheet 1.5mm thickness

 

5.4.2.                  Cover Material: Light blue Cellulose paper, 80 grams

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
CLPW1000
    	
B
    	
Sheet 2 of 2
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Programmer Wand Kit
    

 

5.4.3.                  Dimensions: 270 x 175 x 42 mm

 

5.5.                   Kit will be packaged per Pro Tech’s manufacturing outline CLPW1000.

 

5.6.                   Packaging shall be labeled with packaging label, P/N 10270-01.

 

5.7.                   A tamper indicator sticker shall be placed on the Outer Box shipped from CCC.

 

6.                          QUALITY SYSTEM

 

6.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

6.2.                   Lot Traceability & Acceptance

 

6.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

6.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements if applicable.

 

6.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00280
    	
 
    	
[***]
    	
 
    	
05/21/2010
    
	
B
    	
 
    	
00642
    	
 
    	
[***]
    	
 
    	
03/28/2012
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-CHGR1000[G]
    
	
Title:
    	
 
    	
Charger kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
30-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
CHGR1000
    	
G
    	
Sheet 1 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Charger Kit
    

 

1.                          SCOPE

 

The Charger Kit will include the Nevro charger, power supply with US, EU, UK, and Australia power adaptor plugs, charger belt, charger holder pouch, and instructions for the patient. The Nevro charger will be compatible with the Nevro Implantable Pulse Generator (IPG).

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
CHGR1000
    	
G
    	
Sheet 2 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Charger Kit
    

 

3.                          REQUIREMENTS

 

3.1.                   The charger kit will be stored and supplied by Pro-Tech Design & Manufacturing Inc, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

4.                          FUNCTIONAL REQUIREMENTS

 

4.1.                   Kit shall contain all four US, EU, UK, and Australia power adaptor plugs.

 

4.2.                   Place the following contents on top of the charger and belt compartments in the following order from bottom to top (so that the smallest items are seen first when opening the Charger Kit Outer Box lid):

 

·                  Patient Registration Form

·                  Charger Kit Patient Chart Label (strip of 8 individual labels)

·                  Charger Kit Internal Tracking Label (strip of 8 individual labels)

·                  Patient Temporary ID Card

 

5.                          KIT SHALL BE EASY TO OPEN PACKAGING & SHIPPING REQUIREMENTS

 

5.1.                   Contents of package shall be free of contaminants and foreign objects.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
CHGR1000
    	
G
    	
Sheet 3 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Charger Kit
    

 

5.2.                   Foam shall surround the charger inside the Charger Kit Outer Box Shell to protect the charger during shipping and storage.

 

5.3.                   There are three main compartments in the Charger Kit Outer Box Shell as shown in the image below:

 

[***]

 

Figure 1: Charger Kit Outer Box Compartments

 

5.4.                   Place the charger, P/N 10187, in compartment 1, as shown in Figure 2.

 

5.5.                   Place the charger belt & pouch, P/N 10189, and the charger belt holder, P/N 10277, in compartment 2 as shown in Figure 2.

 

5.6.                   Place the AC/DC Power Supply, P/N 10188, with the US, EU, UK, and Australia charger power supply plugs (P/N 10390-01, -02, -03, and -04) in compartment 3. After placing contents into compartment 3 fold flap down so that it is tucked into box.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
CHGR1000
    	
G
    	
Sheet 4 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Charger Kit
    

 

5.7.                   Components shall be placed in the Charger Kit Outer Box Shell as shown in the image below:

 

[***]

 

Figure 2: Placement of Components in Charger Kit Outer Box (US, EU, and UK plug adaptors and USB flash drive are not shown)

 

5.8.                   Place the USB flash drive that is loaded with the patient manual (P/N 10443) into compartment 2.

 

5.9.                   Place the Patient Registration Form (P/N 10221), Patient Chart Labels (P/N 10243-02), Charger Kit Internal Tracking Labels (P/N 10244-02), and Patient Temporary ID Card (P/N 10288) on top of the items in compartments 1 and 2.

 

5.10.            Surfaces of the Charger Kit Outer Box Shell are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
CHGR1000
    	
G
    	
Sheet 5 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Charger Kit
    

 

5.11.            Place labels on the Charger Kit Outer Box Shell as shown in Figure 3 and 4.

 

[***]

 

Figure 3: Front side of Charger Kit Outer Box

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
CHGR1000
    	
G
    	
Sheet 6 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Charger Kit
    

 

5.12.            Ensure that an inventory label is placed on both the right side of the Charger Kit Outer Box and on the back side of the outer box as show in Figure 4.

 

[***]

 

Figure 4: Back side of Charger Kit Outer Box

 

6.                          QUALITY SYSTEM

 

6.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

6.2.                   Lot Traceability & Acceptance

 

6.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

6.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements if applicable.

 

6.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
CHGR1000
    	
G
    	
Sheet 7 of 7
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Charger Kit
    

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00193
    	
 
    	
[***]
    	
 
    	
01/14/2010
    
	
B
    	
 
    	
00275
    	
 
    	
[***]
    	
 
    	
05/20/2010
    
	
C
    	
 
    	
00283
    	
 
    	
[***]
    	
 
    	
06/04/2010
    
	
D
    	
 
    	
00394
    	
 
    	
[***]
    	
 
    	
02/11/2011
    
	
E
    	
 
    	
00489
    	
 
    	
[***]
    	
 
    	
06/02./2011
    
	
F
    	
 
    	
00547
    	
 
    	
[***]
    	
 
    	
08/15/2011
    
	
G
    	
 
    	
00665
    	
 
    	
[***]
    	
 
    	
04/11/12
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK9100[A]
    
	
Title:
    	
 
    	
Medical Adhesive kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
30-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK9100
    	
A
    	
Sheet 1 of 4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Medical Adhesive kit
    

 

1.         SCOPE

 

The Medical Adhesive kit will be supplied as a supplementary accessory for physicians upon request.

 

2.         APPLICABLE DOCUMENTS

 

[***]

 

3.         REQUIREMENTS

 

3.1.      The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.      Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.      Functional Requirements

 

3.3.1.      Component shall be supplied in a double layered pouch configuration for operating room (OR) use.

 

3.3.2.      Kit shall be easy to open with gloves on.

 

3.3.3.      Accessory kit will be supplied ETO sterilized per manufacturing outline ACCK9100.

 

4.         PACKAGING & SHIPPING REQUIREMENTS

 

4.1.      Component shall be visible while inside both pouches.

 

4.2.      Contents of package shall be free of contaminants and foreign objects.

 

4.3.      Both pouches shall be sealed per Protech’s manufacturing outline ACCK9100.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK9100
    	
A
    	
Sheet 2 of 4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Medical Adhesive kit
    

 

4.4.      Sterilization indicator must be green after sterilization.

 

4.5.      Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.6.      Component shall be placed in the pouches similar to the image below, where the component is shaded dark grey:

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK9100
    	
A
    	
Sheet 3 of 4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Medical Adhesive kit
    

 

4.7.      Accessory kit label with the supplementary label below shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

4.8.      No more than 25 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK9100.

 

5.         QUALITY SYSTEM

 

5.1.      The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.      Lot Traceability & Acceptance

 

5.2.1.      Each lot shall be traceable to the material lot numbers used.

 

5.2.2.      Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.      Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, manufacturing process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK9100
    	
A
    	
Sheet 4 of 4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Medical Adhesive kit
    

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00622
    	
 
    	
[***]
    	
 
    	
01/13/2012
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK9050[C]
    
	
Title:
    	
 
    	
Mx Trial Adaptor Cable Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
03-Jun-2013
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK9050
    	
C
    	
Sheet 1 of 3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Mx Trial Adaptor Cable Kit
    

 

1.                          SCOPE

 

The Mx Trial Adaptor Cable Kit will be supplied as an accessory to bridge the Medtronic Snap-Lid Connector Cable and Nevro external trial stimulator (ETS).

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.2.                   Functional Requirements

 

3.2.1.                  Components shall be supplied in a single (1) plastic bag.

 

3.2.2.                  Bag shall be easy to open.

 

3.2.3.                  Accessory kit shall be supplied per manufacturing outline ACCK9050.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Component shall be visible while inside the plastic bag.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Bag shall be cut to size and sealed per ProTech’s manufacturing outline ACCK9050.

 

4.4.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK9050
    	
C
    	
Sheet 2 of 3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Mx Trial Adaptor Cable Kit
    

 

4.5.                   Label shall be placed in the center of the pouch so as to ensure visibility of the contents of the package.

 

[***]

 

4.6.                   No more than 25 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK9050.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK9050
    	
C
    	
Sheet 3 of 3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Mx Trial Adaptor Cable Kit
    

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00175
    	
 
    	
[***]
    	
 
    	
12/23/09
    
	
B
    	
 
    	
CHO-271
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    
	
C
    	
 
    	
CHO-290
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/16/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK8012-90[A]
    
	
Title:
    	
 
    	
Stylet Kit, 90cm Length
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
21-Mar-2013
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-90
    	
A
    	
Sheet 1 of 3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, 90cm Length
    

 

1.                          SCOPE

 

This specification establishes the functional, packaging, shipping and quality system requirements for the Nevro 90cm stylet kit, ACCK8012-90.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall slide smoothly in place inside the stylet retainer.

 

3.3.2.                  Stylet handles shall be secured onto stylet retainer clip.

 

3.3.3.                  Loaded stylet retainer shall be supplied in a double layered pouch configuration for operating room (OR) use.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-90
    	
A
    	
Sheet 2 of 3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, 90cm Length
    

 

3.3.4.                  Kit shall be easy to open with gloves on.

 

3.3.5.                  Accessory kit shall be supplied ETO sterilized per manufacturing outline ACCK8012-90.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Component shall be visible while inside both pouches.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be cut to size and sealed per ProTech’s manufacturing outline ACCK8012-90.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.]

 

4.6.                   Component shall be placed in the pouches similar to the image below, where the component is the depicted hoop:

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-90
    	
A
    	
Sheet 3 of 3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, 90cm Length
    

 

4.7.                   Accesorry Kit Label with the supplementary label shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

4.8.                   No more than 25 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK8012-90.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements if applicable.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK8012-70[C]
    
	
Title:
    	
 
    	
Stylet Kit, .012” Diameter, 70cm Length
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
13-Sep-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-70
    	
C
    	
Sheet 1 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, .012” Diameter, 70cm Length
    

 

1.                          SCOPE

 

This specification establishes the functional, packaging, shipping and quality system requirements for the Nevro 70 cm length 0.012” diameter stylet kit, ACCK8012-70.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall slide smoothly in place inside the stylet retainer.

 

3.3.2.                  Stylet handles shall be secured onto stylet retainer clip.

 

3.3.3.                  Loaded stylet retainer shall be supplied in a double layered pouch configuration for operating room (OR) use.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-70
    	
C
    	
Sheet 2 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, .012” Diameter, 70cm Length
    

 

3.3.4.                  Kit shall be easy to open with gloves on.

 

3.3.5.                  Accessory kit shall be supplied ETO sterilized per manufacturing outline ACCK8012-70.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Component shall be visible while inside both pouches.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be cut to size and sealed per ProTech’s manufacturing outline ACCK8012-70.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.6.                   Component shall be placed in the pouches similar to the image below, where the component is the depicted hoop:

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-70
    	
C
    	
Sheet 3 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, .012” Diameter, 70cm Length
    

 

4.7.                   Accesorry Kit Label with the supplementary label shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

4.8.                   No more than 25 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK8012-70.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements if applicable.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-70
    	
C
    	
Sheet 4 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, .012” Diameter, 70cm Length
    

 

REVISION HISTORY

 

	
Rev
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
[***]
    	
 
    	
05/25/2010
    
	
B
    	
 
    	
[***]
    	
 
    	
03/22/2011
    
	
C
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK8012-50[D]
    
	
Title:
    	
 
    	
Stylet Kit, .012” Diameter, 50cm Length
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
25-Oct-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality   Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
REG_ROLE Regulatory   Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research   and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research   and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-50
    	
D
    	
Sheet 1 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, .012” Diameter, 50 cm Length
    

 

1.                          SCOPE

 

This specification establishes the functional, packaging, shipping and quality system requirements for the Nevro 50 cm length 0.012” diameter stylet kit, ACCK8012-50.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall slide smoothly in place inside the stylet retainer.

 

3.3.2.                  Stylet handles shall be secured onto stylet retainer clips.

 

3.3.3.                  Loaded stylet retainer shall be supplied in a double layered pouch configuration for operating room (OR) use.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-50
    	
D
    	
Sheet 2 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, .012” Diameter, 50 cm Length
    

 

3.3.4.                  Kit shall be easy to open with gloves on.

 

3.3.5.                  Accessory kit shall be supplied ETO sterilized per manufacturing outline ACCK8012-50.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Component shall be visible while inside both pouches.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be cut to size and sealed per ProTech’s manufacturing outline ACCK8012-50.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.6.                   Component shall be placed in the pouches similar to the image below, where the component is the depicted hoop:

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-50
    	
D
    	
Sheet 3 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, .012” Diameter, 50 cm Length
    

 

4.7.                   Accesorry Kit Label with the supplementary label shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

4.8.                   No more than 25 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK8012-50.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements if applicable.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-50
    	
D
    	
Sheet 4 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, .012” Diameter, 50 cm Length
    

 

REVISION HISTORY

 

	
Rev
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
[***]
    	
 
    	
09/17/2009
    
	
B
    	
 
    	
[***]
    	
 
    	
05/25/2010
    
	
C
    	
 
    	
[***]
    	
 
    	
02/22/2011
    
	
D
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK8012-30[C]
    
	
Title:
    	
 
    	
Stylet Kit, .012” Diameter, 30 cm Length
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
25-Oct-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-30
    	
C
    	
Sheet 1 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, .012” Diameter, 30cm Length
    

 

1.                          SCOPE

 

This specification establishes the functional, packaging, shipping and quality system requirements for the Nevro 30 cm length 0.012” diameter stylet kit, ACCK8012-30.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall slide smoothly in place inside the stylet retainer.

 

3.3.2.                  Stylet handles shall be secured onto stylet retainer clips.

 

3.3.3.                  Loaded stylet retainer shall be supplied in a double layered pouch configuration for operating room (OR) use.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-30
    	
C
    	
Sheet 2 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, .012” Diameter, 30cm Length
    

 

3.3.4.                  Kit shall be easy to open with gloves on.

 

3.3.5.                  Accessory kit shall be supplied ETO sterilized per manufacturing outline ACCK8012-30.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Component shall be visible while inside both pouches.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be cut to size and sealed per ProTech’s manufacturing outline ACCK8012-30.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.6.                   Component shall be placed in the pouches similar to the image below, where the component is the depicted hoop:

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-30
    	
C
    	
Sheet 3 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, .012” Diameter, 30cm Length
    

 

4.7.                   Accessory Kit Label with the supplementary label below shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

4.8.                   No more than 25 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK8012-30.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements if applicable.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK8012-30
    	
C
    	
Sheet 4 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Stylet Kit, .012” Diameter, 30cm Length
    

 

REVISION HISTORY

 

	
Rev
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
[***]
    	
 
    	
05/25/2010
    
	
B
    	
 
    	
[***]
    	
 
    	
02/22/2011
    
	
C
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK7100[B]
    
	
Title:
    	
 
    	
IPG Template Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
30-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK7100
    	
B
    	
Sheet 1 of   3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Template Kit
    

 

1.                          SCOPE

 

This part specification establishes the bill of materials, packaging, shipping and quality system requirements for the Nevro IPG Template Kit ACCK7100.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Component will be supplied in a double layered pouch configuration for operating room (OR) use.

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Accessory kit will be supplied ETO sterilized per manufacturing outline ACCK7100.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Component shall be visible while inside both pouches.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be sealed per ProTech’s manufacturing outline ACCK7100.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK7100
    	
B
    	
Sheet 2 of   3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Template Kit
    

 

4.6.                   Component shall be placed in the pouches similar to the image below, where the component is inside the inner pouch:

 

[***]

 

4.7.                   Accessory Kit Label with the supplementary label below shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK7100
    	
B
    	
Sheet 3 of   3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Template Kit
    

 

4.8.                   No more than 25 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK7100.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements if applicable.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00333
    	
 
    	
[***]
    	
 
    	
07/29/2010
    
	
B
    	
 
    	
00394
    	
 
    	
[***]
    	
 
    	
02/22/2011
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

 

The Point of Relief

 

	
 
    	
 
    	
5/15/2014
    
	
Document Detail
    	
 
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK7000[B]
    
	
Title:
    	
 
    	
IPG Port Plug Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
30-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK7000
    	
B
    	
Sheet 1 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Port Plug Kit
    

 

1.                          SCOPE

 

The IPG Port Plug kit will be supplied as a supplement device for physicians upon request.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall be supplied in a double layered pouch configuration for operating room (OR) use.

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Accessory kit shall be supplied ETO sterilized per manufacturing outline ACCK7000.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Components shall be visible while inside both pouches.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be sealed per ProTech’s manufacturing outline ACCK7000.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK7000
    	
B
    	
Sheet 2 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Port Plug Kit
    

 

4.6.                   Components shall be placed in the pouches similar to the image below, where the components are black and dark grey:

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK7000
    	
B
    	
Sheet 3 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Port Plug Kit
    

 

4.7.                   Accessory Kit Label with the supplementary label below shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

4.8.                   No more than 25 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK7000.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK7000
    	
B
    	
Sheet 4 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
IPG Port Plug Kit
    

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    	
 
    
	
A
    	
 
    	
00079
    	
 
    	
[***]
    	
 
    	
09/17/2009
    	
 
    
	
B
    	
 
    	
00394
    	
 
    	
[***]
    	
 
    	
02/22/2011
    	
 
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

 

The Point of Relief

	
 
    	
 
    	
5/15/2014
    
	
Document Detail
    	
 
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK6006[C]
    
	
Title:
    	
 
    	
Torque Wrench Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
02-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK6006
    	
C
    	
Sheet 1 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Torque Wrench Kit
    

 

1.                          SCOPE

 

The torque wrench accessory kit will be supplied as a supplement device for physicians upon request.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Component will be packaged in the backer card to eliminate the possibility of damaging the pouch.

 

3.3.2.                  The component inside the assembled backer card will be supplied in a double layered pouch configuration for operating room (OR) use.

 

3.3.3.                  Kit shall be easy to open with gloves on.

 

3.3.4.                  Accessory kit will be supplied ETO sterilized per manufacturing outline ACCK6006.

 

4.                         PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Component shall be visible while inside both pouches.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK6006
    	
C
    	
Sheet 2 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Torque Wrench Kit
    

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be sealed.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.6.                   Component shall be placed in the pouches similar to the image below, where the backer card is shaded dark grey:

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK6006
    	
C
    	
Sheet 3 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Torque Wrench Kit
    

 

4.7.                   Accessory kit label with the supplementary label below shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

4.8.                   No more than 25 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK6006.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK6006
    	
C
    	
Sheet 4 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Torque Wrench Kit
    

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    	
 
    
	
A
    	
 
    	
00079
    	
 
    	
[***]
    	
 
    	
09/17/2009
    	
 
    
	
B
    	
 
    	
00278
    	
 
    	
[***]
    	
 
    	
05/20/2010
    	
 
    
	
C
    	
 
    	
00394
    	
 
    	
[***]
    	
 
    	
02/22/2011
    	
 
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

 

The Point of Relief

	
 
    	
 
    	
5/15/2014
    
	
Document Detail
    	
 
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK5101[A]
    
	
Title:
    	
 
    	
N100 Lead Anchor Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
02-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK5101
    	
A
    	
Sheet 1 of   3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
N100 Lead Anchor Kit
    

 

1.                          SCOPE

 

This part specification establishes the bill of materials, packaging, shipping and quality system requirements for the Nevro N100 Lead Anchor Kit ACCK5101.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall be supplied in a double layered pouch configuration for operating room (OR) use.

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Accessory kit shall be supplied ETO sterilized per manufacturing outline ACCK5101.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Components shall be visible while inside both pouches.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be sealed per ProTech’s manufacturing outline ACCK5101.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK5101
    	
A
    	
Sheet 2 of   3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
N100 Lead Anchor Kit
    

 

4.6.                   Components shall be placed in the pouches similar to the image below, where the components are shaded dark grey:

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK5101
    	
A
    	
Sheet 3 of   3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
N100 Lead Anchor Kit
    

 

4.7.                   Label shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

4.8.                   No more than 25 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK5101.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements if applicable.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    	
 
    
	
A
    	
 
    	
00254
    	
 
    	
[***]
    	
 
    	
04/29/2010
    	
 
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

 

The Point of Relief

	
 
    	
 
    	
5/15/2014
    
	
Document Detail
    	
 
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK5000[C]
    
	
Title:
    	
 
    	
Lead Anchor Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
07-Feb-2014
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK5000
    	
C
    	
Sheet 1 of 6
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Anchor Kit
    

 

1.                          SCOPE

 

The Lead Anchor kit will be supplied as a supplement device for physicians upon request.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall be supplied in a double layered pouch configuration for operating room (OR) use.

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Accessory kit shall be supplied ETO sterilized per manufacturing outline ACCK5000.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Components shall be visible while inside both pouches.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK5000
    	
C
    	
Sheet 2 of   6
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Anchor Kit
    

 

4.3.                   Both pouches shall be sealed per ProTech’s manufacturing outline ACCK5000.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.6.                   Components shall be placed in the pouches similar to the image below, where the components are shaded dark grey:

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK5000
    	
C
    	
Sheet 3 of   6
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Anchor Kit
    

 

4.7.                   Accessory kit label with the supplementary label directly below shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package

 

4.7.1.                  MR Conditional Label shall be placed on the open space of the Accessory Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the two bar codes. The MR Conditional Label must not obscure any print or logo on the Accessory Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK5000
    	
C
    	
Sheet 4 of   6
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Anchor Kit
    

 

[***]

 

MR Conditional Label placement

 

4.8.                   No more than 25 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK5000.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK5000
    	
C
    	
Sheet 5 of   6
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Anchor Kit
    

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK5000
    	
C
    	
Sheet 6 of   6
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Anchor Kit
    

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    	
 
    
	
A
    	
 
    	
00079
    	
 
    	
[***]
    	
 
    	
09/17/2009
    	
 
    
	
B
    	
 
    	
00394
    	
 
    	
[***]
    	
 
    	
02/22/2011
    	
 
    
	
C
    	
 
    	
See Document Detail Page
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    	
 
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK4000[B]
    
	
Title:
    	
 
    	
OR Cable Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
02-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK4000
    	
B
    	
Sheet 1 of 4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
OR Cable Kit
    

 

1.                          SCOPE

 

The OR cable accessory kit will be supplied as a supplement device for physicians upon request.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
Qty
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Component will be supplied in a double layered pouch configuration for operating room (OR) use.

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Accessory kit will be supplied ETO sterilized per manufacturing outline ACCK4000.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Component shall be visible while inside both pouches.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be sealed.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK4000
    	
B
    	
Sheet 2 of 4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
OR Cable Kit
    

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.6.                   Component shall be placed in the pouches similar to the image below:

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK4000
    	
B
    	
Sheet 3 of 4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
OR Cable Kit
    

 

4.7.                   Accessory kit label with the supplementary label below shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

4.8.                   No more than 20 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK4000.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK4000
    	
B
    	
Sheet 4 of 4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
OR Cable Kit
    

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00079
    	
 
    	
[***]
    	
 
    	
09/17/2009
    
	
B
    	
 
    	
00394
    	
 
    	
[***]
    	
 
    	
02/22/2011
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK3050[D]
    
	
Title:
    	
 
    	
50 cm Tunneling Tool Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
02-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK3050
    	
D
    	
Sheet 1 of 5
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
50 cm Tunneling Tool Kit
    

 

1.                          SCOPE

 

The 50 cm Tunneling Tool Accessory Kit will be supplied as a supplement device for physicians upon request.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  The tunneling tool T-handle shall be loaded with the appropriate size passing straw per assembly drawing 10070.

 

3.3.2.                  The tunneling tips shall be loaded in the tunneling tip protector per assembly drawing 10070.

 

3.3.2.1.        Insert the tunneling tips inside the tunneling tip protector tubing so that the points are facing inward. Align each tunneling tip so that the edge of the flat is just inside the edge of the tip protector tubing. The total length should not 

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK3050
    	
D
    	
Sheet 2 of 5
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
50 cm Tunneling Tool Kit
    

 

be more than 2.1” in length, as show in assembly drawing 10070.  NOTE: There should be adequate amount of space between the two tunneling tips. See the picture below.

 

[***]

 

3.3.3.                  Kit shall be easy to open with gloves on.

 

3.3.4.                  Accessory kit will be supplied ETO sterilized per manufacturing outline ACCK3050.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Ensure that the passing straw is placed on the tunneling tool shaft before inserting the assembly onto the backer card.

 

4.2.                   The pouch integrity shall be maintained during shipping and handling by mounting the tunneling tool assembly onto a backer card.

 

4.3.                   Mount the tunneling tool assembly onto the backer card in the same arrangement as shown below:

 

[***]

 

4.4.                   The component inside the assembled backer card will be supplied in a double layered pouch configuration for operating room (OR) use.

 

4.5.                   Component shall be visible while inside both pouches.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK3050
    	
D
    	
Sheet 3 of 5
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
50 cm Tunneling Tool Kit
    

 

4.6.                   Contents of package shall be free of contaminants and foreign objects.

 

4.7.                   Both pouches shall be sealed per ProTech’s manufacturing outline ACCK3050.

 

4.8.                   Sterilization indicator must be green after sterilization.

 

4.9.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.10.            Component shall be placed in the pouches similar to the image below, where the component in the backer card is the grey shaded rectangle:

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK3050
    	
D
    	
Sheet 4 of 5
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
50 cm Tunneling Tool Kit
    

 

4.11.            Accessory kit label with the supplementary label below shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

4.12.            No more than 20 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK3050.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements if applicable.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK3050
    	
D
    	
Sheet 5 of 5
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
50 cm Tunneling Tool Kit
    

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00079
    	
 
    	
[***]
    	
 
    	
09/17/2009
    
	
B
    	
 
    	
00239
    	
 
    	
[***]
    	
 
    	
03/10/2010
    
	
C
    	
 
    	
00278
    	
 
    	
[***]
    	
 
    	
05/20/2010
    
	
D
    	
 
    	
00394
    	
 
    	
[***]
    	
 
    	
02/22/2011
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK3035[C]
    
	
Title:
    	
 
    	
35 cm Tunneling Tool Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
02-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK3035
    	
C
    	
Sheet 1 of   4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
35 cm Tunneling Tool Kit
    

 

1.                          SCOPE

 

The 35 cm Tunneling Tool Accessory Kit will be supplied as a supplement device for physicians upon request.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  The tunneling tool T-handle shall be loaded with the appropriate size passing straw per assembly drawing 10070.

 

3.3.2.                  The tunneling tips shall be loaded in the tunneling tip protector per assembly drawing 10070.

 

3.3.2.1.        Insert the tunneling tips inside the tunneling tip protector tubing so that the points are facing inward. Align each tunneling tip so that the edge of the flat is just inside the edge of the tip protector tubing. The total length should not be more than 2.1” in length, as show in assembly drawing

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK3035
    	
C
    	
Sheet 2 of 4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
35 cm Tunneling Tool Kit
    

 

10070.  NOTE: There should be adequate amount of space between the two tunneling tips. See the picture below.

 

[***]

 

3.3.3.                  Kit shall be easy to open with gloves on.

 

3.3.4.                  Accessory kit will be supplied ETO sterilized per manufacturing outline ACCK3035.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Ensure that the passing straw is placed on the tunneling tool shaft before inserting the assembly onto the backer card.

 

4.2.                   The pouch integrity shall be maintained during shipping and handling by mounting the tunneling tool assembly onto a backer card.

 

4.3.                   Mount the tunneling tool assembly onto the backer card in the same arrangement as shown below:

 

[***]

 

4.4.                   The component inside the assembled backer card will be supplied in a double layered pouch configuration for operating room (OR) use.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK3035
    	
C
    	
Sheet 3 of 4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
35 cm Tunneling Tool Kit
    

 

4.5.                   Component shall be visible while inside both pouches.

 

4.6.                   Contents of package shall be free of contaminants and foreign objects.

 

4.7.                   Both pouches shall be sealed per Pro-Tech’s manufacturing outline ACCK3035.

 

4.8.                   Sterilization indicator must be green after sterilization.

 

4.9.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.10.            Component shall be placed in the pouches similar to the image below, where the component in the backer card is the grey shaded rectangle:

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK3035
    	
C
    	
Sheet 4 of 4
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
35 cm Tunneling Tool Kit
    

 

4.11.            Accessory kit label with the supplementary label below shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

4.12.            No more than 20 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK3035.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements if applicable.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00079
    	
 
    	
[***]
    	
 
    	
09/17/2009
    
	
B
    	
 
    	
00239
    	
 
    	
[***]
    	
 
    	
03/10/2010
    
	
C
    	
 
    	
00394
    	
 
    	
[***]
    	
 
    	
02/22/2011
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK2000[B]
    
	
Title:
    	
 
    	
Coiled Lead Blank Kit
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
02-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK2000
    	
B
    	
Sheet 1 of 3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Coiled Lead Blank Kit
    

 

1.                          SCOPE

 

The coiled lead blank accessory kit will be supplied as a supplement device for physicians upon request.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
Qty
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Component will be supplied in a double layered pouch configuration for operating room (OR) use.

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Accessory kit will be supplied ETO sterilized per manufacturing outline ACCK2000.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Component shall be visible while inside both pouches.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be sealed.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK2000
    	
B
    	
Sheet 2 of 3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Coiled Lead Blank Kit
    

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.6.                   Component shall be placed in the pouches similar to the image below:

 

[***]

 

4.7.                   Accessory kit label with the supplementary label below shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK2000
    	
B
    	
Sheet 3 of 3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Coiled Lead Blank Kit
    

 

4.8.                   No more than 20 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK2000.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00079
    	
 
    	
[***]
    	
 
    	
09/17/2009
    
	
B
    	
 
    	
00394
    	
 
    	
[***]
    	
 
    	
02/22/2011
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

 

The Point of Relief

	
 
    	
 
    	
5/15/2014
    
	
Document Detail
    	
 
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK1015[C]
    
	
Title:
    	
 
    	
Insertion Needle Kit, 15 cm
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
02-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK1015
    	
C
    	
Sheet 1 of   3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Insertion Needle Kit, 15 cm
    

 

1.                          SCOPE

 

The 15 cm insertion needle accessory kit will be supplied as a supplement device for physicians upon request.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Component will be supplied in a double layered pouch configuration for operating room (OR) use.

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Accessory kit will be supplied ETO sterilized per manufacturing outline ACCK1015.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Component shall be visible while inside both pouches.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be sealed.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK1015
    	
C
    	
Sheet 2 of   3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Insertion Needle Kit, 15 cm
    

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.6.                   Component shall be assembled with protective tubing covering the stylet and cannula while attached to the hub of the cannula.

 

4.7.                   Component shall be placed in the pouches similar to the image below, where the component is in the center of the inner pouch:

 

[***]

 

4.8.                   Accessory kit label with the supplementary label below shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK1015
    	
C
    	
Sheet 3 of   3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Insertion Needle Kit, 15 cm
    

 

No more than 25 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK1015.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00079
    	
 
    	
[***]
    	
 
    	
09/17/2009
    
	
B
    	
 
    	
00394
    	
 
    	
[***]
    	
 
    	
02/22/2011
    
	
C
    	
 
    	
00622
    	
 
    	
[***]
    	
 
    	
01/13/2012
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

 

The Point of Relief

	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-ACCK1010[B]
    
	
Title:
    	
 
    	
Insertion Needle Kit, 10 cm
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
02-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK1010
    	
B
    	
Sheet 1 of   3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Insertion Needle Kit, 10 cm
    

 

1.                          SCOPE

 

The 10 cm insertion needle accessory kit will be supplied as a supplement device for physicians upon request.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The accessory kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    	
Supplier
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Component will be supplied in a double layered pouch configuration for operating room (OR) use.

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Accessory kit will be supplied ETO sterilized per manufacturing outline ACCK1010.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Component shall be visible while inside both pouches.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be sealed.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK1010
    	
B
    	
Sheet 2 of   3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Insertion Needle Kit, 10 cm
    

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.6.                   Component shall be assembled with protective tubing covering the stylet and cannula while attached to the hub of the cannula.

 

4.7.                   Component shall be placed in the pouches similar to the image below, where the component is in the center of the inner pouch:

 

[***]

 

4.8.                   Accessory kit label with the supplementary label below shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package.

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
ACCK1010
    	
B
    	
Sheet 3 of   3
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Insertion Needle Kit, 10 cm
    

 

4.9.                   No more than 25 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline ACCK1010.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00079
    	
 
    	
[***]
    	
 
    	
09/17/2009
    
	
B
    	
 
    	
00394
    	
 
    	
[***]
    	
 
    	
02/22/2011
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

 

The Point of Relief

	
 
    	
 
    	
5/15/2014
    
	
Document Detail
    	
 
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-SADP2008-25B[A]
    
	
Title:
    	
 
    	
S8 Blue Lead Adaptor Kit, 25cm long
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
08-Apr-2013
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
SADP2008-25B
    	
A
    	
Sheet 1 of   8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
S8 Blue Lead Adaptor Kit, 25cm long
    

 

1.                          SCOPE

 

The SADP2008-25B kit includes the 25cm Blue S8 Lead Adaptor and a Torque Wrench that is used to aid the physician intra-operatively.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The adaptor kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
SADP2008-25B
    	
A
    	
Sheet 2 of   8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
S8 Blue Lead Adaptor Kit, 25cm long
    

 

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

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall be supplied in the inner and retainer trays for use in the operating room (OR).

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Lead kit shall be supplied ETO sterilized per manufacturing outline SADP2008-25B.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Components shall be visible while inside the trays.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be sealed per ProTech’s manufacturing outline SADP2008-25B.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
SADP2008-25B
    	
A
    	
Sheet 3 of   8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
S8 Blue Lead Adaptor Kit, 25cm long
    

 

4.6.                   Components shall be placed in the inner tray as shown in the image below:

 

Note: Both ends of the Lead Extension shall be in the straight section of the channel.

 

[***]

 

Figure 1: Location of Nevro devices in the inner tray

 

4.7.                   Retaining tray will remain empty for SADP2008-25B. The retainer tray shall be placed on top of the Inner tray and shall snap into place.

 

4.8.                   A Tyvek lid shall be sealed to the top of the Inner tray while the Retainer tray sits inside.

 

4.9.                   The clear side of the Inner tray shall be loaded into the outer pouch so that the contents of the tray are visible from the clear side of the outer pouch.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
SADP2008-25B
    	
A
    	
Sheet 4 of   8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
S8 Blue Lead Adaptor Kit, 25cm long
    

 

4.10.            A Lead Extension Kit Label shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package in the same orientation as shown below. Place the supplementary label below the lead extension kit label on the tyvek pouch (P/N 10253-16) as shown below.

 

[***]

 

Figure 2: Label placement on the outer pouch

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
SADP2008-25B
    	
A
    	
Sheet 5 of   8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
S8 Blue Lead Adaptor Kit, 25cm long
    

 

4.11.            The pouch with its contents shall then be loaded into the shelf carton in the same orientation as shown below:

 

[***]

 

Figure 3: Outer pouch insertion orientation

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
SADP2008-25B
    	
A
    	
Sheet 6 of   8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
S8 Blue Lead Adaptor Kit, 25cm long
    

 

4.12.            Place labels on the shelf carton as shown below (Top View of shelf carton):

 

[***]

 

Figure 4: Location of labels on the shelf carton

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
SADP2008-25B
    	
A
    	
Sheet 7 of   8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
S8 Blue Lead Adaptor Kit, 25cm long
    

 

4.13.            Affix the Internal Tracking Labels (P/N 10514-02) and Patient Chart Labels (P/N 10513-02) on the outside of the Lead Kit pouch by peeling the first and last label partially and using the exposed adhesive to adhere to the label strips.

 

4.14.            Place the following between the Lead Kit pouch and shelf carton: Device Billing and Registration Form (P/N 10221-01), Patient Temporary ID Card (10288-01), and USB Flash Drive Loaded with the Implant Manual (P/N 10444).

 

4.15.            Place labels on the shelf carton as shown below (Side View of the shelf carton):

 

[***]

 

Figure 5: Location of labels on shelf carton (cont)

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
SADP2008-25B
    	
A
    	
Sheet 8 of   8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
S8 Blue Lead Adaptor Kit, 25cm long
    

 

4.16.            2 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline SADP2008-25B.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00477
    	
 
    	
[***]
    	
 
    	
07/29/2011
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document   Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document   No.:
    	
 
    	
PRTSPEC-MADP2008-25B[A]
    
	
Title:
    	
 
    	
Blue M8 Lead Adaptor   Kit, 25cm long
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective   Date:
    	
 
    	
17-Jul-2012
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
MADP2008-25B
    	
A
    	
Sheet 1 of 8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
M8 Blue Lead Adaptor Kit, 25cm long
    

 

1.                          SCOPE

 

The MADP2008-25B kit includes the 25cm Blue M8 Lead Adaptor and a Torque Wrench that is used to aid the physician intra-operatively.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The adaptor kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
MADP2008-25B
    	
A
    	
Sheet 2 of 8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
M8 Blue Lead Adaptor Kit, 25cm long
    

 

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

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall be supplied in the inner and retainer trays for use in the operating room (OR).

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Lead kit shall be supplied ETO sterilized per manufacturing outline MADP2008-25B.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Components shall be visible while inside the trays.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be sealed per ProTech’s manufacturing outline MADP2008-25B.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
MADP2008-25B
    	
A
    	
Sheet 3 of 8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
M8 Blue Lead Adaptor Kit, 25cm long
    

 

4.6.                   Components shall be placed in the inner tray as shown in the image below:

 

Note: Both ends of the Lead Extension shall be in the straight section of the channel.

 

[***]

 

Figure 1: Location of Nevro devices in the inner tray

 

4.7.                   Retaining tray will remain empty for MADP2008-25B. The retainer tray shall be placed on top of the Inner tray and shall snap into place.

 

4.8.                   A Tyvek lid shall be sealed to the top of the Inner tray while the Retainer tray sits inside.

 

4.9.                   The clear side of the Inner tray shall be loaded into the outer pouch so that the contents of the tray are visible from the clear side of the outer pouch.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
MADP2008-25B
    	
A
    	
Sheet 4 of 8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
M8 Blue Lead Adaptor Kit, 25cm long
    

 

4.10.            A Lead Extension Kit Label shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package in the same orientation as shown below. Place the supplementary label below the lead extension kit label on the tyvek pouch (P/N 10253-16) as shown below.

 

[***]

 

Figure 2: Label placement on the outer pouch

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
MADP2008-25B
    	
A
    	
Sheet 5 of 8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
M8 Blue Lead Adaptor Kit, 25cm long
    

 

4.11.            The pouch with its contents shall then be loaded into the shelf carton in the same orientation as shown below:

 

[***]

 

Figure 3: Outer pouch insertion orientation

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
MADP2008-25B
    	
A
    	
Sheet 6 of 8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
M8 Blue Lead Adaptor Kit, 25cm long
    

 

4.12.            Place labels on the shelf carton as shown below (Top View of shelf carton):

 

[***]

 

Figure 4: Location of labels on the shelf carton

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
MADP2008-25B
    	
A
    	
Sheet 7 of 8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
M8 Blue Lead Adaptor Kit, 25cm long
    

 

4.13.            Affix the Internal Tracking Labels (P/N 10509-02) and Patient Chart Labels (P/N 10508-02) on the outside of the Lead Kit pouch by peeling the first and last label partially and using the exposed adhesive to adhere to the label strips.

 

4.14.            Place the following between the Lead Kit pouch and shelf carton: Device Billing and Registration Form (P/N 10221-01), Patient Temporary ID Card (10288-01), and USB Flash Drive Loaded with the Implant Manual (P/N 10444).

 

4.15.            Place labels on the shelf carton as shown below (Side View of the shelf carton):

 

[***]

 

Figure 5: Location of labels on shelf carton (cont)

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
MADP2008-25B
    	
A
    	
Sheet 8 of 8
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
M8 Blue Lead Adaptor Kit, 25cm long
    

 

4.16.            2 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline MADP2008-25B.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00622
    	
 
    	
[***]
    	
 
    	
01/13/2012
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document   Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document   No.:
    	
 
    	
PRTSPEC-LEAD2008-60B[B]
    
	
Title:
    	
 
    	
Blue Lead Extension   Kit, 60cm
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective   Date:
    	
 
    	
07-Feb-2014
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-60B
    	
B
    	
Sheet 1 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 60cm
    

 

1.                          SCOPE

 

The LEAD2008-60B kit includes the 60cm Lead Extension and a Torque Wrench that is used to aid the physician intra-operatively.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The lead kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-60B
    	
B
    	
Sheet 2 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential &   Proprietary
    	
Blue Lead Extension Kit, 60cm
    

 

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

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall be supplied in the inner and retainer trays for use in the operating room (OR).

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Lead kit shall be supplied ETO sterilized per manufacturing outline LEAD2008-60B.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Components shall be visible while inside the trays.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be sealed per ProTech’s manufacturing outline LEAD2008-60B.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-60B
    	
B
    	
Sheet 3 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 60cm
    

 

4.6.                   Components shall be placed in the inner tray as shown in the image below:

 

Note: Both ends of the Lead Extension shall be in the straight section of the channel.

 

[***]

 

Figure 1: Location of Nevro devices in the inner tray

 

4.7.                   Retaining tray will remain empty for LEAD2008-60B. The retainer tray shall be placed on top of the Inner tray and shall snap into place.

 

4.8.                   A Tyvek lid shall be sealed to the top of the Inner tray while the Retainer tray sits inside.

 

4.9.                   The clear side of the Inner tray shall be loaded into the outer pouch so that the contents of the tray are visible from the clear side of the outer pouch.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-60B
    	
B
    	
Sheet 4 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 60cm
    

 

4.10.            A Lead Extension Kit Label shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package in the same orientation as shown below:

 

4.10.1.           A MR Conditional Label shall be placed on the open space of the Lead Extension Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 4). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

[***]

 

Figure 2: Label placement on the outer pouch

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-60B
    	
B
    	
Sheet 5 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 60cm
    

 

4.11.            A Lead Extension Kit Label shall be placed in the center of the shelf carton (P/N 10254-01) in the same orientation as shown below.  The orientation of the Lead Kit Label on the outer pouch and shelf carton should be the same. The label should be centered and placed between 4 1⁄2 to 5 1⁄2 inches from the top of the shelf carton and square to the front carton plane.

 

4.11.1.           A MR Conditional Label shall be placed on the open space of the Lead Extension Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 4). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

4.12.            The pouch with its contents shall then be loaded into the shelf carton in the same orientation as shown below:

 

[***]

 

Figure 3: Outer pouch insertion orientation

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-60B
    	
B
    	
Sheet 6 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 60cm
    

 

[***]

 

Figure 4: MR Conditional Label Placement

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-60B
    	
B
    	
Sheet 7 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 60cm
    

 

4.13.            Place labels on the shelf carton as shown below (Top View of shelf carton):

 

[***]

 

Figure 5: Location of labels on the shelf carton

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-60B
    	
B
    	
Sheet 8 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 60cm
    

 

4.14.            Place labels on the shelf carton as shown below (Side View of the shelf carton):

 

[***]

 

Figure 6: Location of labels on shelf carton (cont)

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-60B
    	
B
    	
Sheet 9 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 60cm
    

 

4.15.            2 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline LEAD2008-60B.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00448
    	
 
    	
[***]
    	
 
    	
03/16/11
    
	
B
    	
 
    	
See Document Detail Page
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/16/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-LEAD2008-35B[C]
    
	
Title:
    	
 
    	
Blue Lead Extension Kit, 35cm
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
07-Feb-2014
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development 
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-35B
    	
C
    	
Sheet 1 of   9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 35cm
    

 

1.                          SCOPE

 

The LEAD2008-35B kit includes the 35cm Lead Extension and a Torque Wrench that is used to aid the physician intra-operatively.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The lead kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-35B
    	
C
    	
Sheet 2 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 35cm
    

 

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

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall be supplied in the inner and retainer trays for use in the operating room (OR).

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Lead kit shall be supplied ETO sterilized per manufacturing outline LEAD2008-35B.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Components shall be visible while inside the trays.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be sealed per ProTech’s manufacturing outline LEAD2008-35B.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-35B
    	
C
    	
Sheet 3 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 35cm
    

 

4.6.                   Components shall be placed in the inner tray as shown in the image below:

 

Note: Both ends of the Lead Extension shall be in the straight section of the channel.

 

[***]

 

Figure 1: Location of Nevro devices in the inner tray

 

4.7.                   Retaining tray will remain empty for LEAD2008-35B. The retainer tray shall be placed on top of the Inner tray and shall snap into place.

 

4.8.                   A Tyvek lid shall be sealed to the top of the Inner tray while the Retainer tray sits inside.

 

4.9.                   The clear side of the Inner tray shall be loaded into the outer pouch so that the contents of the tray are visible from the clear side of the outer pouch.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-35B
    	
C
    	
Sheet 4 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 35cm
    

 

4.10.            A Lead Extension Kit Label shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package in the same orientation as shown below. Place the supplementary label below the lead extension kit label on the tyvek pouch (P/N 10253-16) as shown below

 

4.10.1.           A MR Conditional Label shall be placed on the open space of the Lead Extension Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 4). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

[***]

 

Figure 2: Label placement on the outer pouch

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-35B
    	
C
    	
Sheet 5 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 35cm
    

 

4.11.            A Lead Extension Kit Label shall be placed in the center of the shelf carton (P/N 10254-01) in the same orientation as shown below.  The orientation of the Lead Kit Label on the outer pouch and shelf carton should be the same. The label should be centered and placed between 4 1⁄2 to 5 1⁄2 inches from the top of the shelf carton and square to the front carton plane.

 

4.11.1.           A MR Conditional Label shall be placed on the open space of the Lead Extension Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 4). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

[***]

 

Figure 3: Outer pouch insertion orientation

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-35B
    	
C
    	
Sheet 6 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 35cm
    

 

[***]

 

Figure  4:  MR Conditional Label placement

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-35B
    	
C
    	
Sheet 7 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 35cm
    

 

4.12.            Place labels on the shelf carton as shown below (Top View of shelf carton):

 

[***]

 

Figure 5: Location of labels on the shelf carton

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-35B
    	
C
    	
Sheet 8 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 35cm
    

 

4.13.            Place labels on the shelf carton as shown below (Side View of the shelf carton):

 

[***]

 

Figure 6: Location of labels on shelf carton (cont)

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-35B
    	
C
    	
Sheet 9 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 35cm
    

 

4.14.            2 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline LEAD2008-35B.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00355
    	
 
    	
[***]
    	
 
    	
09/07/2010
    
	
B
    	
 
    	
00394
    	
 
    	
[***]
    	
 
    	
02/22/2011
    
	
C
    	
 
    	
See Document Detail Page
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/16/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-LEAD2008-25B[B]
    
	
Title:
    	
 
    	
Blue Lead Extension Kit, 25cm
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
07-Feb-2014
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development 
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-25B
    	
B
    	
Sheet 1 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 25cm
    

 

1.                          SCOPE

 

The LEAD2008-25B kit includes the 25cm Lead Extension and a Torque Wrench that is used to aid the physician intra-operatively.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

3.                          REQUIREMENTS

 

3.1.                   The lead kit will be stored and supplied by Pro-Tech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-25B
    	
B
    	
Sheet 2 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 25cm
    

 

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

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall be supplied in the inner and retainer trays for use in the operating room (OR).

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Lead kit shall be supplied ETO sterilized per manufacturing outline LEAD2008-25B.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Components shall be visible while inside the trays.

 

4.2.                   Contents of package shall be free of contaminants and foreign objects.

 

4.3.                   Both pouches shall be sealed per Pro-Tech’s manufacturing outline LEAD2008-25B.

 

4.4.                   Sterilization indicator must be green after sterilization.

 

4.5.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-25B
    	
B
    	
Sheet 3 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 25cm
    

 

4.6.                   Components shall be placed in the inner tray as shown in the image below:

 

Note: Both ends of the Lead Extension shall be in the straight section of the channel.

 

[***]

 

Figure 1: Location of Nevro devices in the inner tray

 

4.7.                   Retaining tray will remain empty for LEAD2008-25B. The retainer tray shall be placed on top of the Inner tray and shall snap into place.

 

4.8.                   A Tyvek lid shall be sealed to the top of the Inner tray while the Retainer tray sits inside.

 

4.9.                   The clear side of the Inner tray shall be loaded into the outer pouch so that the contents of the tray are visible from the clear side of the outer pouch.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-25B
    	
B
    	
Sheet 4 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 25cm
    

 

4.10.            A Lead Extension Kit Label shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package in the same orientation as shown below. Place the supplementary label below the lead extension kit label on the tyvek pouch (P/N 10253-16) as shown below

 

4.10.1.           A MR Conditional Label shall be placed on the open space of the Lead Extension Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 4). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

[***]

 

Figure 2: Label placement on the outer pouch

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-25B
    	
B
    	
Sheet 5 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 25cm
    

 

4.11.            A Lead Extension Kit Label shall be placed in the center of the shelf carton (P/N 10254-01) in the same orientation as shown below.  The orientation of the Lead Kit Label on the outer pouch and shelf carton should be the same. The label should be centered and placed between 4 1⁄2 to 5 1⁄2 inches from the top of the shelf carton and square to the front carton plane.

 

4.11.1.           A MR Conditional Label shall be placed on the open space of the Lead Extension Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 4). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

4.12.            The pouch with its contents shall then be loaded into the shelf carton in the same orientation as shown below:

 

[***]

 

Figure 3: Outer pouch insertion orientation

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-25B
    	
B
    	
Sheet 6 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 25cm
    

 

[***]

 

Figure 4: MR Conditional Label placement

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-25B
    	
B
    	
Sheet 7 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 25cm
    

 

4.13.            Place labels on the shelf carton as shown below (Top View of shelf carton):

 

[***]

 

Figure 5: Location of labels on the shelf carton

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-25B
    	
B
    	
Sheet 8 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 25cm
    

 

4.14.            Place labels on the shelf carton as shown below (Side View of the shelf carton):

 

[***]

 

Figure 6: Location of labels on shelf carton (cont)

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD2008-25B
    	
B
    	
Sheet 9 of 9
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Extension Kit, 25cm
    

 

4.15.            2 kits shall be packaged in a shipping carton per Pro-Tech’s manufacturing outline LEAD2008-25B.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
DCN
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
00441
    	
 
    	
[***]
    	
 
    	
003/09/2011
    
	
B
    	
 
    	
See Document Detail Page
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-LEAD1058-90B[B]
    
	
Title:
    	
 
    	
Lead Kit, 90cm with 5mm Spacing
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
24-Jan-2014
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-90B
    	
B
    	
Sheet 1 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 90cm with 5mm Spacing
    

 

1.                          SCOPE

 

The Lead kit will include the Percutaneous Lead and Implant Tools that are used to aid the physician intra-operatively.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-90B
    	
B
    	
Sheet 2 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 90cm with 5mm Spacing
    

 

3.                          REQUIREMENTS

 

3.1.                   The lead kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-90B
    	
B
    	
Sheet 3 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 90cm with 5mm Spacing
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall be supplied in the inner and retainer trays for operating room (OR) use.

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Lead kit shall be supplied ETO sterilized per manufacturing outline LEAD1058-90B.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Contents of package shall be free of contaminants and foreign objects.

 

4.2.                   Trays and pouch shall be sealed per ProTech’s manufacturing outline LEAD1058-90B.

 

4.3.                   Sterilization indicator must be green after sterilization.

 

4.4.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.5.                   Ensure the distal end of the Lead with the curved tip is lying as flat as possible before attaching the Retainer Tray to the Inner Tray so as not to damage the tip of the Lead.

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-90B
    	
B
    	
Sheet 4 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 90cm with 5mm Spacing
    

 

4.6.                   Components shall be placed in the inner tray as shown in the image below:

 

Note: The proximal and distal end shall be in the straight section of the channel.

 

[***]

 

Figure 1: Location of Nevro devices in the inner tray

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-90B
    	
B
    	
Sheet 5 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 90cm with 5mm Spacing
    

 

[***]

 

Figure 2: Percutaneous Lead

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-90B
    	
B
    	
Sheet 6 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 90cm with 5mm Spacing
    

 

4.7.                   Components shall be placed in the Retainer tray as shown in the image below:

 

[***]

 

Figure 3: Components assembled in the retainer tray

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-90B
    	
B
    	
Sheet 7 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 90cm with 5mm Spacing
    

 

4.8.                   The retainer tray shall snap into place inside the Inner tray.

 

4.9.                   A Tyvek lid shall be sealed to the top of the Inner tray while the Retainer tray sits inside.

 

4.10.            The clear side of the Inner tray shall be loaded into the Outer Pouch so that it touches the clear side of the outer pouch.

 

4.11.            A Lead Kit Label shall be placed in the center of the Tyvek side of the outer pouch (P/N 10253-16) so as to ensure visibility of the contents of the package in the same orientation as shown below. Place the supplementary label below the lead kit label on the tyvek pouch (P/N 10253-16) as shown below.

 

4.11.1.           A MR Conditional Label shall be placed on the open space of the Lead Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 6). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

[***]

 

Figure 4: Label placement on the outer pouch

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-90B
    	
B
    	
Sheet 8 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 90cm with 5mm Spacing
    

 

4.12.            A Lead Kit Label shall be placed in the center of the shelf carton (P/N 10254-01) in the same orientation as shown below.  The orientation of the Lead Kit Label on the outer pouch and shelf carton should be the same. The label should be centered and placed between 4 1⁄2 to 5 1⁄2 inches from the top of the shelf carton and square to the front carton plane.

 

4.12.1.           A MR Conditional Label shall be placed on the open space of the Lead Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 6). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

4.13.            The pouch with its contents shall then be loaded into the shelf carton (P/N 10254-01) in the same orientation as shown below:

 

[***]

 

Figure 5: Outer pouch insertion orientation

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-90B
    	
B
    	
Sheet 9 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 90cm with 5mm Spacing
    

 

[***]

 

Figure 6: MR Conditional Label Placement

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-90B
    	
B
    	
Sheet 10 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 90cm with 5mm Spacing
    

 

4.14.            Affix the Internal Tracking Labels and Patient Chart Labels on the outside of the Lead Kit pouch by peeling the first and last label partially and using the exposed adhesive to adhere to the label strips.

 

4.15.            Place the following between the Lead Kit pouch and shelf carton: Device Billing and Registration Form (P/N 10221-01), Patient Temporary ID Card (10288-01), and USB Flash Drive Loaded with the Implant Manual (P/N 10444).

 

4.16.            Place labels on the shelf carton as shown below (Top View of shelf carton):

 

[***]

 

Figure 7: Location of labels on the shelf carton

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-90B
    	
B
    	
Sheet 11 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 90cm with 5mm Spacing
    

 

4.17.            Place labels on the shelf carton as shown below (Side View):

 

[***]

 

Figure 8: Location of labels on shelf carton (con’t)

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-90B
    	
B
    	
Sheet 12 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 90cm with 5mm Spacing
    

 

4.18.            No more than 2 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline LEAD1058-90B.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, manufacturing process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
[***]
    	
 
    	
See   document detail page
    
	
B
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-LEAD1058-70B[F]
    
	
Title:
    	
 
    	
Blue Lead Kit, 70cm with 5mm Spacing
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
24-Jan-2014
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-70B
    	
F
    	
Sheet 1 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 70cm with 5mm Spacing
    

 

1.                          SCOPE

 

The Lead kit will include the Percutaneous Lead and Implant Tools that are used to aid the physician intra-operatively.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-70B
    	
F
    	
Sheet 2 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 70cm with 5mm Spacing
    

 

3.                          REQUIREMENTS

 

3.1.                   The lead kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-70B
    	
F
    	
Sheet 3 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 70cm with 5mm Spacing
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall be supplied in the inner and retainer trays for operating room (OR) use.

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Lead kit shall be supplied ETO sterilized per manufacturing outline LEAD1058-70B.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Contents of package shall be free of contaminants and foreign objects.

 

4.2.                   Trays and pouch shall be sealed per ProTech’s manufacturing outline LEAD1058-70B.

 

4.3.                   Sterilization indicator must be green after sterilization.

 

4.4.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.5.                   Ensure the distal end of the Lead with the curved tip is lying as flat as possible before attaching the Retainer Tray to the Inner Tray so as not to damage the tip of the Lead.

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-70B
    	
F
    	
Sheet 4 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 70cm with 5mm Spacing
    

 

4.6.                   Components shall be placed in the inner tray as shown in the image below:

 

Note: The proximal and distal end shall be in the straight section of the channel.

 

[***]

 

Figure 1: Location of Nevro devices in the inner tray

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-70B
    	
F
    	
Sheet 5 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 70cm with 5mm Spacing
    

 

[***]

 

Figure 2: Percutaneous Lead

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-70B
    	
F
    	
Sheet 6 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 70cm with 5mm Spacing
    

 

4.7.                   Components shall be placed in the Retainer tray as shown in the image below:

 

[***]

 

Figure 3: Components assembled in the retainer tray

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-70B
    	
F
    	
Sheet 7 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 70cm with 5mm Spacing
    

 

4.8.                   The retainer tray shall snap into place inside the Inner tray.

 

4.9.                   A Tyvek lid shall be sealed to the top of the Inner tray while the Retainer tray sits inside.

 

4.10.            The clear side of the Inner tray shall be loaded into the Outer Pouch so that it touches the clear side of the outer pouch.

 

4.11.            A Lead Kit Label shall be placed in the center of the Tyvek side of the outer pouch (P/N 10253-16) so as to ensure visibility of the contents of the package in the same orientation as shown below. Place the supplementary label below the lead kit label on the tyvek pouch (P/N 10253-16) as shown below

 

4.11.1.           A MR Conditional Label shall be placed on the open space of the Lead Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 6). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

[***]

 

Figure 4: Label placement on the outer pouch

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-70B
    	
F
    	
Sheet 8 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 70cm with 5mm Spacing
    

 

4.12.            A Lead Kit Label shall be placed in the center of the shelf carton (P/N 10254-01) in the same orientation as shown below.  The orientation of the Lead Kit Label on the outer pouch and shelf carton should be the same. The label should be centered and placed between 4 1⁄2 to 5 1⁄2 inches from the top of the shelf carton and square to the front carton plane.

 

4.12.1.           A MR Conditional Label shall be placed on the open space of the Lead Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 6). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

4.13.            The pouch with its contents shall then be loaded into the shelf carton (P/N 10254-01) in the same orientation as shown below:

 

[***]

 

Figure 5: Outer pouch insertion orientation

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-70B
    	
F
    	
Sheet 9 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 70cm with 5mm Spacing
    

 

[***]

 

Figure 6: MR Conditional Label placement

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-70B
    	
F
    	
Sheet 10 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 70cm with 5mm Spacing
    

 

4.14.            Affix the Internal Tracking Labels and Patient Chart Labels on the outside of the Lead Kit pouch by peeling the first and last label partially and using the exposed adhesive to adhere to the label strips.

 

4.15.            Place the following between the Lead Kit pouch and shelf carton: Device Billing and Registration Form (P/N 10221-01), Patient Temporary ID Card (10288-01), and USB Flash Drive Loaded with the Implant Manual (P/N 10444).

 

4.16.            Place labels on the shelf carton as shown below (Top View of shelf carton):

 

[***]

 

Figure 7: Location of labels on the shelf carton

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-70B
    	
F
    	
Sheet 11 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 70cm with 5mm Spacing
    

 

4.17.                                           Place labels on the shelf carton as shown below (Side View):

 

[***]

 

Figure 8: Location of labels on shelf carton (con’t)

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-70B
    	
F
    	
Sheet 12 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Lead Kit, 70cm with 5mm Spacing
    

 

4.18.            No more than 2 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline LEAD1058-70B.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, manufacturing process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
[***]
    	
 
    	
03/17/11
    
	
B
    	
 
    	
[***]
    	
 
    	
01/13/12
    
	
C
    	
 
    	
[***]
    	
 
    	
02/13/12
    
	
D
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    
	
E
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    
	
F
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-LEAD1058-50B[G]
    
	
Title:
    	
 
    	
Blue Lead Kit, 50cm with 5mm Spacing
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
24-Jan-2014
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-50B
    	
G
    	
Sheet 1 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 50cm with 5mm Spacing
    

 

1.                          SCOPE

 

The Lead kit will include the Percutaneous Lead and Implant Tools that are used to aid the physician intra-operatively.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-50B
    	
G
    	
Sheet 2 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 50cm with 5mm Spacing
    

 

3.                          REQUIREMENTS

 

3.1.                   The lead kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-50B
    	
G
    	
Sheet 3 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 50cm with 5mm Spacing
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall be supplied in the inner and retainer trays for operating room (OR) use.

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Lead kit shall be supplied ETO sterilized per manufacturing outline LEAD1058-50B.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Contents of package shall be free of contaminants and foreign objects.

 

4.2.                   Trays and pouch shall be sealed per ProTech’s manufacturing outline LEAD1058-50B.

 

4.3.                   Sterilization indicator must be green after sterilization.

 

4.4.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.5.                   Ensure the distal end of the Lead with the curved tip is lying as flat as possible before attaching the Retainer Tray to the Inner Tray so as not to damage the tip of the Lead.

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-50B
    	
G
    	
Sheet 4 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 50cm with 5mm Spacing
    

 

4.6.                   Components shall be placed in the inner tray as shown in the image below:

 

Note: The proximal and distal end shall be in the straight section of the channel.

 

[***]

 

Figure 1: Location of Nevro devices in the inner tray

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-50B
    	
G
    	
Sheet 5 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 50cm with 5mm Spacing
    

 

[***]

 

Figure 2: Percutaneous Lead

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-50B
    	
G
    	
Sheet 6 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 50cm with 5mm Spacing
    

 

4.7.                   Components shall be placed in the Retainer tray as shown in the image below:

 

[***]

 

Figure 3: Components assembled in the retainer tray

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-50B
    	
G
    	
Sheet 7 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 50cm with 5mm Spacing
    

 

4.8.                   The retainer tray shall snap into place inside the Inner tray.

 

4.9.                   A Tyvek lid shall be sealed to the top of the Inner tray while the Retainer tray sits inside.

 

4.10.            The clear side of the Inner tray shall be loaded into the Outer Pouch so that it touches the clear side of the outer pouch.

 

4.11.            A Lead Kit Label shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package in the same orientation as shown below. Place the supplementary label below the lead kit label on the tyvek pouch (P/N 10253-16) as shown below in figure 4.

 

4.11.1.           A MR Conditional Label shall be placed on the open space of the Lead Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 6). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

[***]

 

Figure 4: Label placement on the outer pouch

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-50B
    	
G
    	
Sheet 8 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 50cm with 5mm Spacing
    

 

4.12.            A Lead Kit Label shall be placed in the center of the shelf carton (P/N 10254-01) in the same orientation as shown below.  The orientation of the Lead Kit Label on the outer pouch and shelf carton should be the same. The label should be centered and placed between 4 1⁄2 to 5 1⁄2 inches from the top of the shelf carton and square to the front carton plane.

 

4.12.1.           A MR Conditional Label shall be placed on the open space of the Lead Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 6). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

4.13.            The pouch with its contents shall then be loaded into the shelf carton in the same orientation as shown below:

 

[***]

 

Figure 5: Outer pouch insertion orientation

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-50B
    	
G
    	
Sheet 9 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 50cm with 5mm Spacing
    

 

[***]

 

Figure 6: MR Conditional label placement

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-50B
    	
G
    	
Sheet 10 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 50cm with 5mm Spacing
    

 

4.14.            Affix the Internal Tracking Labels and Patient Chart Labels on the outside of the Lead Kit pouch by peeling the first and last label partially and using the exposed adhesive to adhere to the label strips.

 

4.15.            Place the following between the Lead Kit pouch and shelf carton: Device Billing and Registration Form (P/N 10221-01), Patient Temporary ID Card (10288-01), and USB Flash Drive Loaded with the Implant Manual (P/N 10444).

 

4.16.            Place labels on the shelf carton as shown below (Top View of shelf carton):

 

[***]

 

Figure 6: Location of labels on the shelf carton

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-50B
    	
G
    	
Sheet 11 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 50cm with 5mm Spacing
    

 

4.17.            Place labels on the shelf carton as shown below (Side View):

 

[***]

 

Figure 7: Location of labels on shelf carton (con’t)

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-50B
    	
G
    	
Sheet 12 of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 50cm with 5mm Spacing
    

 

4.18.            No more than 2 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline LEAD1058-50B.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
[***]
    	
 
    	
04/16/2010
    
	
B
    	
 
    	
[***]
    	
 
    	
05/10/2010
    
	
C
    	
 
    	
[***]
    	
 
    	
02/22/2011
    
	
D
    	
 
    	
[***]
    	
 
    	
1/13/2011
    
	
E
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    
	
F
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    
	
G
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
 
    
	
 
    	
 
    
	
The   Point of Relief
    	
 
    
	
 
    	
5/15/2014
    
	
Document Detail
    	
1
    

 

	
Type:
    	
 
    	
PRT_SPEC
    
	
Document No.:
    	
 
    	
PRTSPEC-LEAD1058-30B[H]
    
	
Title:
    	
 
    	
Blue Lead Kit, 30cm with 5mm Spacing
    
	
Owner:
    	
 
    	
[***]
    
	
Status:
    	
 
    	
RELEASED
    
	
Effective Date:
    	
 
    	
24-Jan-2014
    

 

	
Owner Role
    	
 
    	
Actor
    	
 
    	
Sign-off By
    
	
QUAL_ASSURANCE Quality Assurance
    	
 
    	
[***]
    	
 
    	
[***]
    
	
REG_ROLE Regulatory Affairs
    	
 
    	
[***]
    	
 
    	
[***]
    
	
R&DM_ROLE Research and Development
    	
 
    	
[***]
    	
 
    	
[***]
    
	
MAT_ROLE Materials
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-30B
    	
H
    	
Sheet 1 of   12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 30cm with 5mm Spacing
    

 

1.                          SCOPE

 

The Lead kit will include the Percutaneous Lead and Implant Tools that are used to aid the physician intra-operatively.

 

2.                          APPLICABLE DOCUMENTS

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-30B
    	
H
    	
Sheet 2 of   12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 30cm with 5mm Spacing
    

 

3.                          REQUIREMENTS

 

3.1.                   The lead kit will be stored and supplied by ProTech Design, located at 14561 Marquardt Avenue, Santa Fe Springs, CA 90670.

 

3.2.                   Accessory kit bill of materials (BOM):

 

	
Nevro P/N
    	
 
    	
Supplier P/N
    	
 
    	
QTY
    	
 
    	
Description
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-30B
    	
H
    	
Sheet 3 of   12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 30cm with 5mm Spacing
    

 

3.3.                   Functional Requirements

 

3.3.1.                  Components shall be supplied in the inner and retainer trays for operating room (OR) use.

 

3.3.2.                  Kit shall be easy to open with gloves on.

 

3.3.3.                  Lead kit shall be supplied ETO sterilized per manufacturing outline LEAD1058-30B.

 

4.                          PACKAGING & SHIPPING REQUIREMENTS

 

4.1.                   Contents of package shall be free of contaminants and foreign objects.

 

4.2.                   Trays and pouch shall be sealed per ProTech’s manufacturing outline LEAD1058-30B.

 

4.3.                   Sterilization indicator must be green after sterilization.

 

4.4.                   Surfaces of the pouches are smooth and free of obvious scratches, tears, holes and other defects affecting function or appearance before and after sterilization.

 

4.5.                   Ensure the distal end of the Lead with the curved tip is lying as flat as possible before attaching the Retainer Tray to the Inner Tray so as not to damage the tip of the Lead.

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-30B
    	
H
    	
Sheet 4 of   12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 30cm with 5mm Spacing
    

 

4.6.                   Components shall be placed in the inner tray as shown in the image below:

 

Note: The proximal and distal end shall be in the straight section of the channel.

 

[***]

 

Figure 1: Location of Nevro devices in the inner tray

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-30B
    	
H
    	
Sheet 5 of   12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 30cm with 5mm Spacing
    

 

[***]

 

Figure 2: Percutaneous Lead

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-30B
    	
H
    	
Sheet 6 of   12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 30cm with 5mm Spacing
    

 

4.7.                   Components shall be placed in the Retainer tray as shown in the image below:

 

[***]

 

Figure 3: Components assembled in the retainer tray

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-30B
    	
H
    	
Sheet 7 of   12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 30cm with 5mm Spacing
    

 

4.8.                   The retainer tray shall snap into place inside the Inner tray.

 

4.9.                   A Tyvek lid shall be sealed to the top of the Inner tray while the Retainer tray sits inside.

 

4.10.            The clear side of the Inner tray shall be loaded into the Outer Pouch so that it touches the clear side of the outer pouch.

 

4.11.            A Lead Kit Label shall be placed in the center of the Tyvek side of the outer pouch so as to ensure visibility of the contents of the package in the same orientation as shown below. Place the supplementary label below the lead kit label on the tyvek pouch (P/N 10253-16) as shown below in figure 4.

 

4.11.1.           A MR Conditional Label shall be placed on the open space of the Lead Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 6). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

[***]

 

Figure 4: Label placement on the outer pouch

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-30B
    	
H
    	
Sheet 8 of   12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 30cm with 5mm Spacing
    

 

4.12.            A Lead Kit Label shall be placed in the center of the shelf carton (P/N 10254-01) in the same orientation as shown below.  The orientation of the Lead Kit Label on the outer pouch and shelf carton should be the same. The label should be centered and placed between 4 1⁄2 to 5 1⁄2 inches from the top of the shelf carton and square to the front carton plane.

 

4.12.1.           A MR Conditional Label shall be placed on the open space of the Lead Kit Label, beneath bottom right of the rectangle box containing “Sterile” and “Lot: XXXXXXX” and to the right of the “Australian Sponsor” paragraph text box (refer figure 6). The MR Conditional Label must not obscure any print or logo on the Lead Kit Label. All edges must be pressed flat and exhibit zero label peel.

 

4.13.            The pouch with its contents shall then be loaded into the shelf carton in the same orientation as shown below:

 

[***]

 

Figure 5: Outer pouch insertion orientation

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-30B
    	
H
    	
Sheet 9 of   12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 30cm with 5mm Spacing
    

 

[***]

 

Figure 6: MR Conditional label placement

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-30B
    	
H
    	
Sheet 10   of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 30cm with 5mm Spacing
    

 

4.14.            Affix the Internal Tracking Labels and Patient Chart Labels on the outside of the Lead Kit pouch by peeling the first and last label partially and using the exposed adhesive to adhere to the label strips.

 

4.15.            Place the following between the Lead Kit pouch and shelf carton: Device Billing and Registration Form (P/N 10221-01), Patient Temporary ID Card (10288-01), and USB Flash Drive Loaded with the Implant Manual (P/N 10444).

 

4.16.            Place labels on the shelf carton as shown below (Top View of shelf carton):

 

[***]

 

Figure 6: Location of labels on the shelf carton

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-30B
    	
H
    	
Sheet 11   of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 30cm with 5mm Spacing
    

 

4.17.                                           Place labels on the shelf carton as shown below (Side View):

 

[***]

 

Figure 7: Location of labels on shelf carton (con’t)

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

	

    	
Document   number
    	
Rev
    	
 
    
	
LEAD1058-30B
    	
H
    	
Sheet 12   of 12
    
	
 
    	
 
    	
 
    
	
PART SPECIFICATION
    	
Title
    	
 
    	
 
    
	
Confidential & Proprietary
    	
Blue Lead Kit, 30cm with 5mm Spacing
    

 

4.18.            No more than 2 kits shall be packaged in a shipping carton per ProTech’s manufacturing outline LEAD1058-30B.

 

5.                          QUALITY SYSTEM

 

5.1.                   The supplier shall allow customer to perform pre-scheduled manufacturing facility audits, including review of applicable documentation.

 

5.2.                   Lot Traceability & Acceptance

 

5.2.1.                  Each lot shall be traceable to the material lot numbers used.

 

5.2.2.                  Each lot supplied shall be inspected by the supplier using calibrated equipment and trained personnel to determine conformance to requirements.

 

5.3.                   Notification of Changes

 

The supplier shall notify Nevro in writing prior to any change in the raw materials, manufacturing process or place of manufacture.  Nevro must approve all changes in writing before implementation.

 

REVISION HISTORY

 

	
Rev
    	
 
    	
Change Description
    	
 
    	
Release Date
    
	
A
    	
 
    	
[***]
    	
 
    	
04/16/2010
    
	
B
    	
 
    	
[***]
    	
 
    	
05/10/2010
    
	
C
    	
 
    	
[***]
    	
 
    	
05/19/2010
    
	
D
    	
 
    	
[***]
    	
 
    	
02/22/2011
    
	
E
    	
 
    	
[***]
    	
 
    	
1/13/2011
    
	
F
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    
	
G
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    
	
H
    	
 
    	
[***]
    	
 
    	
See   Document Detail Page
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

 

EXHIBIT B

 

QUALITY AGREEMENT

 

 

Supplier Quality Agreement

 

This Quality Agreement is made and entered into as of 10 Jul 2013 (“Effective Date”) by Pro-Tech and Manufacturing Inc.  145561 Marquardt Avenue Santa Fe Springs, CA 90670 and Nevro Corp (“Nevro”), with its headquarters at 4040 Campbell Avenue, Menlo Park, CA 94025.

 

This Quality Agreement defines the duties of Supplier and Nevro in the Quality System for the contract manufacture of the Product(s) set forth below:

 

Pro-Tech and Manufacturing Inc is the assembly and packaging supplier for Nevro.

 

SCOPE:

 

This Quality Agreement applies to all Products and their associated Specifications and requirements supplied on or after its Effective Date.

 

Responsibility for each activity is assigned to either “Supplier” or “Nevro” in the appropriate box.

 

This Quality Agreement is intended to define the responsibilities as set forth minimally by ISO13485:2003 and FDA Quality System Regulations (QSR) 21 CFR Part 820.

 

DEFINITIONS:

 

For purposes of this Quality Agreement, the following definitions shall apply:

 

A.                        “Adverse Event Report” means the written report to the appropriate Regulatory Authority from a device manufacturer required whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices: (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that the device or any other device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

 

B.                        “Applicable Laws” means the laws within a political entity that govern any aspect of the development, manufacture, market, approval, sale, distribution, packaging or use of the Product.

 

 

C.                        “Regulatory Authority” means any government regulatory authority, in the United States or other countries, where Supplier manufactures Products, or mutually agreed upon additional countries in which Supplier has responsibility to ensure compliance with applicable requirements, responsible for granting approvals for the performance of services under this Quality Agreement or for the Manufacturing, use, marketing, sale, pricing and/or other disposition of Nevro product(s) in which the Product(s) are used.

 

D.                        “CAPA” means a corrective action and preventive action system for identifying and preventing or eliminating the cause of an existing or potential nonconformity, defect, or other undesirable situation in order to prevent occurrence or recurrence.

 

E.                         “Certificate of Conformance”, “Certification of Compliance” or “Certification of Analysis” means a document, signed by an authorized representative of Supplier, attesting that a particular Product is Manufactured or serviced in accordance with applicable Quality Management System requirements, the Specifications and this Quality Agreement.

 

F.                          “Component” means any raw material, substance, piece, part, software, firmware, labeling or assembly which is intended to be included as part of the Product(s) or consumed during the Manufacture of the Product(s).

 

G.                        “Correction(s)” means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.

 

H.                       “Device Master Record” means the compilation of records containing the procedures and specifications for the Product.

 

I.                            “Device History Record” or “DHR” means a compilation of Records containing the production history of the Product(s).

 

J.                            “Field Action” means an activity outlining the steps for management of and/or communication regarding the performance of distributed clinical, custom, and/or market released Product currently in use by the customer.  These activities may include educational briefs, health safety alerts, notifications, Corrections or Recall of Product(s) in any Nevro product(s).

 

K.                       “Finished Device” means any Product that constitutes a device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled or sterilized.

 

L.                         “Good Manufacturing Practice” or “GMP” means FDA regulations and guidelines regarding manufacturing practices and quality systems.

 

M.                     “ISO 13485:2003” means the “ISO Quality Management Systems - Medical Devices - System Requirements for Regulatory Purposes” standard.

 

N.                        “Lot” means one or more Products Manufactured under essentially the same conditions that are intended to have uniform characteristics and quality within specified limits.

 

O.                        “Lot History Record” or “LHR” means the document that authorizes and controls the production of a single lot of components or finished devices. When completed, the LHRs required to manufacture a finished device comprise the DHR.

 

P.                          “Manufacture(d)” or “Manufacturing” means all steps, processes and activities necessary to produce Product(s), including without limitation, the design, to the extent that Supplier is responsible for the design, manufacturing, processing, quality control testing, release and storage of Product(s) by Supplier in accordance with the terms and conditions of this Agreement.

 

Q.                        “Nonconforming Product” means product that does not meet Specifications.  Examples include, but are not limited to:

 

·            Product built to an incorrect configuration,

·            Product built not in conformance with the validated process, or

·            Product built with unapproved Components, counterfeit Components, or Components not

 

 

meeting Specification.

 

R.                        “Notified Body” means a government agency in a member state of the European Union that carries out conformity assessment procedures for some classes of medical devices.

 

S.                          “Qualification” or “Qualify” means activity and analysis performed to demonstrate adherence to predetermined criteria. Qualification for a Product means Product testing or inspection conducted according to an approved and controlled protocol to ensure the Product meets Specifications.

 

T.                         “Quality System”, “Quality Management System” or “QSR” means the regulatory requirements under the Applicable Laws of an Regulatory Authority for the methods used in, and the facilities and controls used for, the design, Manufacture, packing, labeling, storage, installation and servicing of Product.

 

U.                        “Recall” means a firm’s removal or correction of a marketed product that Regulatory Authorities considers to be in violation of the laws it administers, and against which the agency would initiate legal action (e.g., seizure).

 

V.                        “Records” means written or electronic accounts, notes, data, record of, and information and results obtained from performance of Services of all work done under this Quality Agreement.

 

W.                     “Specification(s)” means all applicable specifications, protocols and other documents relevant to the design, physical characteristics, function, performance, Manufacture, packaging, labeling and quality of the Product(s) communicated in writing by Nevro or mutually agreed upon in writing by the parties.

 

X.                        “Standard Operating Procedure” means the standard operating procedures in effect at the Supplier which have been approved by the Supplier’s quality department and which are applicable to the processing of the product.

 

Y.                        “Sub-tier Supplier” means any supplier that either directly or indirectly provides product or Services to the Supplier in connection with any Product.

 

Z.                         “Validation” (or “Validate”) means confirmation by examination and provision of objective evidence that the applicable requirements can consistently be fulfilled.

 

 

Responsibilities Table

 

Table Key: N/A = Not Applicable

 

	
Section
    	
 
    	
Responsibilities
    	
 
    	
N/A
    	
 
    	
Supplier
    	
 
    	
Nevro
    
	
1.0
    	
 
    	
Regulatory   Compliance
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.1
    	
 
    	
Maintain all licenses, registrations and   other authorizations as are required under the Applicable Laws.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.2
    	
 
    	
Maintain and operate the facility in   compliance with this Quality Agreement.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.3
    	
 
    	
Manufacture the Product in accordance with   this Quality Agreement.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.4
    	
 
    	
Product Clearances   and Approvals. Supplier   shall provide reasonably necessary assistance to Nevro in obtaining all   necessary regulatory approvals for the Manufacturing, marketing, sale and   distribution of the Product(s).
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.5
    	
 
    	
Regulatory Approval   of Product Modifications. Nevro shall be responsible for making the final determination   as to whether proposed Product modifications require regulatory approval   prior to implementation and shall be responsible for filing and obtaining any   required approvals, clearances and/or supplements.
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.6
    	
 
    	
Compliance History. Supplier shall provide Nevro with a review of Supplier’s   regulatory compliance history related to the Products or related to the   manufacturing processes used to manufacture the Products.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2.0
    	
 
    	
Management   Responsibility 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2.1
    	
 
    	
Supplier shall have personnel with executive responsibility to   oversee its Quality System. Supplier also shall maintain an organizational   structure which ensures the Product(s) are designed, developed and/or   Manufactured in accordance with this Quality Agreement. 
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2.2
    	
 
    	
Supplier shall assign a person or person(s) with executive   responsibility, or who report(s) directly to a person with executive   responsibility, to serve as a contact for Nevro under this Quality Agreement,   and to oversee compliance with this Quality Agreement. 
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2.3
    	
 
    	
Quality Plan. Supplier shall have a   quality plan and/or quality system manual that defines the elements of the   Quality System relevant to the design, development and/or Manufacture of the   Product(s), and shall establish how the quality requirements shall be met.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2.4
    	
 
    	
Identification. Supplier   shall ensure that Product(s) and Components are identified during all stages   of receipt, production and distribution.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2.5
    	
 
    	
Traceability. Supplier shall be responsible for setting up and maintaining   controlled documentation of Product and Component traceability during all   stages of receipt, production and distribution.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
3.0
    	
 
    	
Corrective and Preventive   Actions/Performance
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

 

	
Section
    	
 
    	
Responsibilities
    	
 
    	
N/A
    	
 
    	
Supplier
    	
 
    	
Nevro
    
	
3.1
    	
 
    	
Standard Operating Procedures. Supplier shall establish and maintain procedures for   implementing a CAPA system in compliance with the industry standards and   Quality Management System requirements.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
3.2
    	
 
    	
Resolution. Supplier shall implement the CAPA system with regard to any   quality, Manufacturing or performance issue raised by Supplier or Nevro   related to Product(s).
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
3.3
    	
 
    	
Field Actions. Nevro has the sole authority for decisions related to any   Product(s) in the field, including any Field Action. Suppler shall   support Nevro by providing access to necessary Product information and   quality records.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.0
    	
 
    	
Nonconforming Product
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.1
    	
 
    	
Supplier shall establish and maintain   procedures to control Product that does not conform to specified requirements   in compliance with the Quality Management System requirements.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.2
    	
 
    	
Control of Nonconforming Product. Supplier   shall have Standard   Operating Procedures to control Product that does not conform to Nevro   Specifications. The procedures shall address the identification,   documentation, evaluation, segregation, and disposition of Nonconforming   Product, including a determination of a need for an investigation, which   shall be documented.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.3
    	
 
    	
Product   Performance. Nonconforming Products may be returned to   Supplier for investigation and analysis.    
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.4
    	
 
    	
Disposition of Nonconforming Product. Supplier   shall have Standard   Operating Procedures covering disposition of Nonconforming Product,   including review and documentation of decisions. The parties shall jointly   determine the procedures for rework, retest and reevaluation of Nonconforming   Product to ensure the Product(s) meet Specifications. Supplier shall   document rework activities in the DHR, and provide report of rework   activities to Nevro upon request.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
5.0
    	
 
    	
Document   Control
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
5.1
    	
 
    	
The Supplier shall establish a process for document   control and document changes related to Product(s). 
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
5.2
    	
 
    	
Supplier   shall not, modify Product Specifications or process specifications without   Nevro written approval. Supplier shall maintain records of changes to   documents related to the Product(s), which shall include a description of the   change, identification of the affected documents, the signature of the   approving individual(s), the approval date, and the effective date.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
6.0
    	
 
    	
Purchasing   Controls
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
6.1
    	
 
    	
For   Components not supplied by Nevro, Supplier shall establish and maintain   controls on the purchase of Components to ensure conformance to specified   requirements, including visual inspection of packaging, labeling, or shipping   containers, and dimensional inspection or analytical testing. Supplier shall   maintain documentation that clearly describes the quality requirements for   Components, and shall require Component sources to notify Supplier of any   proposed changes in the Manufacturing of the Components prior 
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    

 

 

	
Section
    	
 
    	
Responsibilities
    	
 
    	
N/A
    	
 
    	
Supplier
    	
 
    	
Nevro
    
	
 
    	
 
    	
to   making any change. 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
6.2
    	
 
    	
For Components not supplied by Nevro,   the Supplier shall establish and maintain acceptance procedures with respect   to the Manufacture of the Products.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
7.0
    	
 
    	
Design   Controls
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
7.1
    	
 
    	
Nevro shall collaborate with the Supplier to ensure that the design   requirements for the Product(s) are appropriate and address the intended   use of the Product(s) including the needs of the user and patient, in   compliance with the Quality Management System requirements. 
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
7.2
    	
 
    	
Nevro has the sole authority to make design changes.  Supplier shall not implement design change   unless it receives updated Specifications from Nevro.  
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
8.0
    	
 
    	
Preventive   Maintenance and Calibration
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
8.1
    	
 
    	
Maintain   calibration and preventive maintenance procedures and schedules for   equipment/instruments used in the manufacture, packaging, testing and   Validation/qualification of the Product.    Include calibration tagging where appropriate.  
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
8.2
    	
 
    	
Document   and review preventive maintenance and calibration performed for equipment and   make available to Nevro designee for onsite review upon request.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9.0
    	
 
    	
Packaging   and Labeling
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9.1
    	
 
    	
Compliance with   Specifications. All Products shall be packaged and labeled in accordance with any   applicable Specifications.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9.2
    	
 
    	
Procedures. Supplier shall establish and maintain   Standard Operating Procedures to control labeling activities in compliance   with the Quality Management System requirements.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9.3
    	
 
    	
Labeling Mix-Ups.   Supplier shall store labels and labeling in a way that prevents an incorrect   label from being used with a Product. Supplier shall control labeling and   packaging operations to prevent labeling mistakes, and shall document the   label and labeling used for each production unit, Lot or batch in the DHR.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.0
    	
 
    	
Audits
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.1
    	
 
    	
Nevro retains the right to audit   Supplier Manufacturing and Quality Systems.
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.2
    	
 
    	
Nevro   or an approved designee has the right to audit the Supplier’s facilities and   systems for a time period not to exceed three working days, as they relate to   the manufacture and testing of Product, at mutually agreed upon time and   date.  Nevro or an approved designee   retains the right to conduct “for cause” audits as necessary upon agreement   with Supplier.
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.3
    	
 
    	
Issue   responses to all observations in writing to Nevro or approved designee within   thirty (30) days of receipt.  Responses   are to include timelines and plans for closure of all commitments.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    

 

 

	
Section
    	
 
    	
Responsibilities
    	
 
    	
N/A
    	
 
    	
Supplier
    	
 
    	
Nevro
    
	
10.4
    	
 
    	
Management   of Sub-tier Suppliers. Supplier is responsible for management of   Supplier’s Sub-tier Suppliers based upon risk as determined per Supplier’s   own internal procedures.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.5
    	
 
    	
The Supplier is   responsible for qualifying, monitoring and maintaining the list of Sub-Tier   Suppliers used for this Product in accordance with the Suppliers internal   procedures.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.6
    	
 
    	
Regulatory Audits and Inspections. Supplier agrees that Regulatory Authorities shall have access   to and the right to inspect or audit any pertinent Product(s) design,   Manufacturing, or quality processes, and associated documentation or Records.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.7
    	
 
    	
Third Party Audits. Supplier shall promptly notify Nevro when an Authority   inspection of its facilities (or an inspection by third parties in accordance   with FDA regulations or inspection by another governmental authority such as   a Notified Body) is expected and/or underway.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.8
    	
 
    	
Regulatory Correspondence. Supplier shall promptly provide Nevro  with copies of all regulatory   correspondence, including without limitation Form FDA 483s and FDA   warning letters and any correspondence with the FDA or any other Authority   related to processes, Components or equipment which are the same or similar   to those used in the Manufacture of the Products.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.9
    	
 
    	
Regulatory Commitments. Supplier   shall secure Nevro’s written agreement prior to making any commitment to a   regulatory agency regarding the Product. Nevro shall be provided with draft   responses to regulatory observations that involve the Product and its   Manufacture prior to submission to any Regulatory Authority and Supplier   shall permit Nevro’s input into responses and corrective actions. Supplier   shall retain the final authority and responsibility for the content of the   responses to the Regulatory Authority related to a Finished Device.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11.0
    	
 
    	
Personnel   Training
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11.1
    	
 
    	
Personnel   and Training. Supplier shall have sufficient personnel with the   necessary education, background, training and experience to perform under   this Quality Agreement.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11.2
    	
 
    	
Provide adequate number of personnel qualified by   appropriate training and experience to perform and supervise the manufacture,   testing, packaging and disposition of the Product.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11.3
    	
 
    	
Assure training is regularly conducted, assessed   and documented by qualified individuals in accordance with Supplier’s   documented procedures.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11.4
    	
 
    	
Have written job descriptions for positions   responsible for performing GMP related activities.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11.5
    	
 
    	
Assure that non-employees, including consultants,   advising on the manufacture and control of the Product have sufficient   education, training, and experience to advise on the subject for which they   are retained.  
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12.0
    	
 
    	
Complaints/Adverse   Events
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12.1
    	
 
    	
Each party shall cooperate fully   with the other party in dealing with customer and third party complaints   concerning the Product(s) and shall take such action to promptly resolve   such complaints as may be reasonably requested by the other party.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    

 

 

	
Section
    	
 
    	
Responsibilities
    	
 
    	
N/A
    	
 
    	
Supplier
    	
 
    	
Nevro
    
	
12.2
    	
 
    	
Nevro shall have the sole   authority to correspond with all applicable regulatory authorities with   respect to complaints about the Product(s).
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12.3
    	
 
    	
Nevro is responsible for   complying with all applicable    Regulatory Authorities regulatory requirements pertaining Adverse   Event reporting.  Supplier shall   reasonably cooperate with Nevro to enable Nevro to fulfill such requirements.   If Supplier becomes aware of a potentially reportable event, notice of such   event shall be given to Nevro within two (2) business days.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
13.0
    	
 
    	
Field   Alerts and Recalls
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
13.1
    	
 
    	
If the Supplier becomes aware of any defect or problem with respect   to any Nevro Product, they shall notify Nevro no later than two   (2) business days after becoming aware of the issue.  If such issue may have caused or   contributed to death or serious injury, Supplier shall promptly notify Nevro,   and in any event no later than one business (1) day after becoming aware   of the issue.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
13.2
    	
 
    	
Notification. If either party in good faith determines that a Recall or   other action involving a Product(s) should be considered, such party   shall immediately notify the other party and shall advise such other party of   the reasons underlying its determination. 
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
13.3
    	
 
    	
Nevro Determination. Nevro has the sole authority to determine whether any action   such as a Recall or other action should be undertaken.
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
13.4
    	
 
    	
Analysis. Product returned related to Recall shall be analyzed by Nevro   or by the Supplier at Nevro’s request.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
14.0
    	
 
    	
Handling, Storage, Distribution and   Installation
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
14.1
    	
 
    	
Supplier shall establish and maintain procedures   for the handling, storage, distribution and installation of the Product(s).
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
14.2
    	
 
    	
Handling. Supplier shall have   systems in place to ensure that mix-ups, damage, deterioration, contamination   or other adverse effects do not occur during handling of the Product(s).
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
14.3
    	
 
    	
Storage. Supplier shall control   storage areas to prevent mix-ups, damage, deterioration, contamination or   other adverse effects pending distribution of the Product(s).
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
14.4
    	
 
    	
Distribution. Supplier shall have   systems in place to control distribution of Product(s) so that only   Product(s) approved for release are distributed. Supplier shall ensure   that no obsolete, rejected, expired or deteriorated Product(s) are   distributed, unless they are distributed to Nevro at its written request. 
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15.0
    	
 
    	
Production
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15.1
    	
 
    	
Process   Control-Generally. Supplier shall have systems in place to define   and maintain the Manufacturing process and associated controls so that all   Product(s) conform to their Specifications (ie. Device Master Records).
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15.2
    	
 
    	
Process Monitoring. Supplier shall monitor and control the Manufacturing process   using the industry standard tools such as in-process inspection, Validation   and statistical process control.  
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    

 

 

	
Section
    	
 
    	
Responsibilities
    	
 
    	
N/A
    	
 
    	
Supplier
    	
 
    	
Nevro
    
	
15.3
    	
 
    	
Environmental   Monitoring (CER): Supplier will have systems in place to monitor the   environmental per Nevro’s requirement in which the products are kitted and/or   manufactured.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15.4
    	
 
    	
Certificate of   Conformance. If requested   by Nevro, Supplier shall provide to Nevro a Certificate of Conformance   consistent with the Specifications for each Lot/batch of Product shipped.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15.5
    	
 
    	
Inspection,   Measurement, and Test Equipment. Supplier shall notify   Nevro in writing of any out-of-tolerance equipment that may affect the   testing or Manufacturing of any Product(s) or Component. The written   notification shall include identification of the affected Product(s) or   Component.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
16.0
    	
 
    	
Change   and Change Notification
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
16.1
    	
 
    	
Changes by Nevro. The Specifications may be revised by Nevro. Such revisions may   require additional Qualification. Nevro shall notify Supplier of all relevant   Specification revisions. Supplier shall implement all revisions by dates   specified by Nevro when possible and if such date cannot be met, then the   parties shall mutually agree to a date that is achievable.
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
16.2
    	
 
    	
Changes by Supplier. Upon approval by Nevro of the initial design, Component or   process changes, design changes or deviations considered by Supplier must be   submitted to Nevro in writing for review and approval prior to   making any changes.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
16.3
    	
 
    	
Change/Approval. Nevro  personnel shall review and approve changes   that may affect the Product(s)
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
17.0
    	
 
    	
Record   Retention
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
17.1
    	
 
    	
Creation and   Maintenance Quality System Record. Each party shall create and maintain Records for the activities   for which they are responsible under this Quality Agreement in compliance   with the Quality Management System requirements.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
17.2
    	
 
    	
Copies. Upon Nevro’s request, Supplier shall promptly provide Nevro   with copies of non-proprietary portions of Records and other documents   required to be maintained pursuant to this Quality Agreement.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
17.3
    	
 
    	
Retention. Supplier shall keep Records for 7 years minimally from date of   Record creation; thereafter, Supplier shall notify Nevro prior to disposing   of such Records and upon Nevro’s request, either (i) transfer custody of   the Records to Nevro or (ii) Nevro may elect to have such Records   retained in Supplier’s archives for an additional period of time at a   reasonable charge to Nevro. At any time upon written request, or termination   of this Quality Agreement, Supplier shall return all Records to Nevro.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    

 

XII.                         ATTACHMENTS

 

x  ISO 13485 Certificate

 

 

x  Organizational Chart

x  Quality Manual

o

o

 

Approval:

 

 

	
SUPPLIER   REPRESENTIVE
    	
 
    	
NEVRO   CORPORATION
    
	
 
    	
 
    	
QUALITY   REPRESENTATIVE
    
	
 
    	
 
    	
 
    
	
Aaron Swanson
    	
 
    	
Vis Ayer 
    	
Sr. Manager, QA
    
	
Print   (Name and Title)
    	
 
    	
Print   (Name and Title)
    
	
 
    	
 
    	
 
    
	
/s/ Aaron Swanson
    	
 
    	
/s/ Vis Ayer
    
	
Signature
    	
 
    	
Signature
    
	
 
    	
 
    	
 
    
	
7/16/13
    	
 
    	
23 Jul 2013
    
	
Date
    	
 
    	
Date
    

 

 

EXHIBIT C

 

PRICING

 

 

 

	

    	
PRO TECH Design & Mfg., Inc.
    	
 
    
	
14561 Marquardt Avenue
    	
 
    
	
Santa Fe Springs, CA 90670
    	
 
    
	
Phone:  (562) 207-1680
    	
 
    
	
Fax:  (562) 207-1698
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Quotation 10594
    	
 
    

 

	
Quote
    	
 
    	
Nevro   Corporation
    
	
To:
    	
 
    	
4040   Campbell Avenue
   Menlo Park, CA 94025
   United States
    

 

	
Quote Number:
    	
10594
    	
 
    	
Contact:
    	
[***]
    
	
Quote Date:
    	
07/21/14
    	
Expires: 08/20/14
    	
Inquiry:
    	
 
    
	
Customer:
    	
NEVRO
    	
 
    	
Terms:
    	
Net   30 Days
    
	
Salesman:
    	
[***]
    	
 
    	
Phone:
    	
[***]
    
	
Ship Via:
    	
Federal   Express
    	
 
    	
FAX:
    	
[***]
    
	
FOB:
    	
Santa   Fe Springs
    	
 
    	
Delivery:
    	
4   Weeks ARO
    

 

Notes:

 

1)             Prices includes all packaging materials, sterilization, labels, and labor to package.

 

2)             Prices do not include any device components.

 

	
Item
    	
 
    	
Part Number
   Descrition
    	
 
    	
Revision
    	
 
    	
Quantity
    	
 
    	
Price
    
	
1
    	
 
    	
NIPG1500
    	
 
    	
C
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   IPG, Model IPG1500, Nevro
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2
    	
 
    	
LEAD1058-30B
    	
 
    	
H
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Percutaneous Lead, 30cm,5mm, Blue, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
3
    	
 
    	
LEAD1058-50B
    	
 
    	
G
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Percutaneous Lead, 50cm, 5mm, Blue, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
4
    	
 
    	
LEAD1058-70B
    	
 
    	
F
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Percutaneous Lead, 70cm, 5mm, Blue, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

1

 

	
Item
    	
 
    	
Part Number
   Descrition
    	
 
    	
Revision
    	
 
    	
Quantity
    	
 
    	
Price
    
	
5
    	
 
    	
LEAD2008-25B
    	
 
    	
B
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Lead Extension, 25cm, EO, Blue
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
6
    	
 
    	
LEAD2008-35B
    	
 
    	
C
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Lead Extension, 35cm, EO, Blue
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
7
    	
 
    	
LEAD2008-60B
    	
 
    	
B
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Lead Extension, 60cm, EO, Blue
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
8
    	
 
    	
MADP2008-25B
    	
 
    	
A
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Lead Adaptor, Blue, M8, 25cm, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9
    	
 
    	
SADP2008-25B
    	
 
    	
A
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Lead Adaptor, Blue, S8, 25cm, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10
    	
 
    	
ACCK1010
    	
 
    	
B
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Needle, Insertion, 4”, Nevro, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11
    	
 
    	
ACCK1015
    	
 
    	
C
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Needle, Insertion, 6”, Nevro, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12
    	
 
    	
ACCK2000
    	
 
    	
B
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Lead Blank, Coiled, Nevro, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
13
    	
 
    	
ACCK3035
    	
 
    	
C
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Tool, Tunneling, 35cm, Nevro, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
14
    	
 
    	
ACCK3050
   Kit, Tool, Tunneling, 50cm, Nevro, EO
    	
 
    	
D
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

2

 

	
Item
    	
 
    	
Part Number
   Descrition
    	
 
    	
Revision
    	
 
    	
Quantity
    	
 
    	
Price
    
	
14
    	
 
    	
ACCK3050
    	
 
    	
D
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15
    	
 
    	
ACCK4000
    	
 
    	
B
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   OR Cable, Nevro, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
16
    	
 
    	
ACCK5000
    	
 
    	
B
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Anchor, Lead, Nevro, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
17
    	
 
    	
ACCK5101
    	
 
    	
A
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Lead Anchor, N100, Nevro
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
18
    	
 
    	
ACCK5200
    	
 
    	
B
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   N200 Lead Anchor, Nevro, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
19
    	
 
    	
ACCK5300
    	
 
    	
C
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   N300 Lead Anchor, Nevro, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
20
    	
 
    	
ACCK6006
    	
 
    	
C
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   IPG Port Plug, Nevro, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
21
    	
 
    	
ACCK7000
    	
 
    	
B
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   IPG Port Plug, Nevro, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
22
    	
 
    	
ACCK7100
    	
 
    	
B
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   IPG Template, Nevro
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
23
    	
 
    	
ACCK8012-90
    	
 
    	
A
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Stylet, 0.012”, 90cm, Nevro, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
24
    	
 
    	
ACCK9050
    	
 
    	
C
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Mx Trial Adaptor Cable, Nevro
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
25
    	
 
    	
ACCK9100
    	
 
    	
A
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Medical Adhesive, Nevro, EO
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

3

 

	
Item
    	
 
    	
Part Number
   Descrition
    	
 
    	
Revision
    	
 
    	
Quantity
    	
 
    	
Price
    
	
25
    	
 
    	
ACCK9100
    	
 
    	
A
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
26
    	
 
    	
CHGR1000
    	
 
    	
G
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Charger, Nevro
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
27
    	
 
    	
CLPG2000
    	
 
    	
B
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Programmer, Nevro
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
28
    	
 
    	
CLPW1000
    	
 
    	
B
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Programmer Wand, Nevro
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
29
    	
 
    	
EXTS1000
    	
 
    	
D
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Trial Stimulator, Nevro
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
30
    	
 
    	
PTTK1000
    	
 
    	
D
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
Kit,   Patient Trial, Nevro
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
$[***] /EA
    

 

1)                         Custom orders are subject to a quantity variance of ± 10% of the original order quantity. Orders requiring exact shipment quantities are subject to additional charges.

 

2)                         It is the customer’s responsibility to maintain objective evidence regarding label claims, including but not limited to shelf life, sterility, storage conditions, and CE marking.

 

3)                         Products contained within the same family can be combined to gain more favorable pricing provided they are run concurrently and sterilized at the same time.

 

4)                         PRO-TECH does not warrant the appropriateness of materials used in your product, the fitness of design, reliability, intended or unintended use, nor does PRO-TECH establish shelf life for your packaged product.

 

5)                         Sales are subject to PRO-TECH standard terms and conditions which can be reviewed at http://protechdesign.com/SitePages/Terms_of_Sale.aspx

 

6)                         This quotation is valid for a period of thirty (30) days.

 

7)                         Standard lead time is indicated on this quotation and is stated as weeks until shipment from our facility after arrival of all parts and materials you will supply, if any, but may vary based upon current production conditions.

 

8)                         OUS Orders - Orders for items produced in our offshore facilities are irrevocable . Delivery dates may be extended up to one (1) month provided such requests are received at least 45 days prior to scheduled delivery. Delivery of entire quantity ordered must be accepted within thirty (30) days after the initial delivery.

 

9)                         Price breaks applicable to this quotation consider producing the quantity indicated as one lot delivered with a maximum of two (2) releases no more than sixty (60) days apart. Scheduled deliveries exceeding the 60 day period will be quoted upon request.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

4

 

	
 
    	
 
    
	
 
    	
By Aaron Swanson
    
	
 
    	
PRO TECH Design & Mfg., Inc.
    

 

5Exhibit 10.4(a)

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

SUPPLY AGREEMENT

 

BETWEEN

 

C.C.C. DEL URUGUAY S.A.

 

AND

 

NEVRO CORP

 

April 1, 2012

 

1

 

TABLE OF CONTENTS

 

	
1.   Definitions
    	
 
    	
3
    	
 
    
	
2.   Program Management
    	
 
    	
5
    	
 
    
	
3.   Manufacture of Products
    	
 
    	
5
    	
 
    
	
4.   Product Training
    	
 
    	
5
    	
 
    
	
5.   Quality
    	
 
    	
5
    	
 
    
	
6.   Component Responsibilities
    	
 
    	
6
    	
 
    
	
7. Consigned Components
    	
 
    	
6
    	
 
    
	
8.   Engineering Change Order (ECO)
    	
 
    	
6
    	
 
    
	
9.   Yield Loss
    	
 
    	
7
    	
 
    
	
10.   Purchase Orders and Forecasts
    	
 
    	
7
    	
 
    
	
11.   Increase, Rescheduling and Cancellation of Purchase Orders
    	
 
    	
7
    	
 
    
	
12.   Price and Payment Terms
    	
 
    	
7
    	
 
    
	
13.   Shipment
    	
 
    	
7
    	
 
    
	
14.   CCC Warranties and Indemnification
    	
 
    	
8
    	
 
    
	
15.   Acceptance and RMA Process
    	
 
    	
8
    	
 
    
	
16.   Nevro Warranties and Indemnification
    	
 
    	
9
    	
 
    
	
17.   Nevro Property
    	
 
    	
9
    	
 
    
	
18.   Intellectual Property
    	
 
    	
9
    	
 
    
	
19.   Exclusivity/Non-Competition
    	
 
    	
10
    	
 
    
	
20.   Term
    	
 
    	
10
    	
 
    
	
21.   Termination
    	
 
    	
11
    	
 
    
	
22.   Effect of Termination
    	
 
    	
11
    	
 
    
	
23.   Liability Limitation
    	
 
    	
11
    	
 
    
	
24.   Relationship of Parties and Liability for Services Performed by Others
    	
 
    	
12
    	
 
    
	
25.   Confidentiality
    	
 
    	
12
    	
 
    
	
26.   Force Majeure
    	
 
    	
13
    	
 
    
	
27.   Governing Law and Arbitration
    	
 
    	
13
    	
 
    
	
28.   Compliance with Laws
    	
 
    	
13
    	
 
    
	
29.   Assignability
    	
 
    	
13
    	
 
    
	
30.   Notice
    	
 
    	
14
    	
 
    
	
31.   No Waiver
    	
 
    	
14
    	
 
    
	
32.   Severability
    	
 
    	
14
    	
 
    
	
33.   Entire Agreement
    	
 
    	
14
    	
 
    
	
34.   Construction
    	
 
    	
14
    	
 
    
	
35.   Counterparts
    	
 
    	
14
    	
 
    
	
EXHIBIT A — PRODUCTS
    	
 
    	
16
    	
 
    
	
EXHIBIT B — PROGRAM TEAM LIST
    	
 
    	
17
    	
 
    
	
EXHIBIT C — CONSIGNED TOOLING, EQUIPMENT AND SOFTWARE
    	
 
    	
18
    	
 
    
	
EXHIBIT D — QUALITY AGREEMENT
    	
 
    	
19
    	
 
    
	
EXHIBIT E — PRICE MODEL
    	
 
    	
30
    	
 
    

 

2

 

SUPPLY AGREEMENT

 

This supply agreement (“Agreement”) is entered into on April 1, 2012 (the “Effective Date”) by and between C.C.C. Del Uruguay S.A. (“CCC”), an Uruguay corporation with its principal place of business at General Paz 1371, Montevideo, Uruguay, CP 11400 and Nevro Corp (“Nevro”), a California corporation with its principal place of business at 4040 Campbell Avenue, Suite 210, Menlo Park, CA 94025.  CCC and Nevro are referred to collectively as the “Parties”, individually as a “Party”.

 

Whereas, Nevro conceived a Nevro System and engaged the services of CCC to develop the Nevro System under the Engineering Agreement; and

 

Whereas, Nevro desires to purchase certain Manufacturing Services from CCC; and

 

Whereas, CCC is in the business of providing engineering and Manufacturing Services; and

 

Whereas, the Parties desire to establish the terms and conditions that shall apply to Nevro’s purchase of certain Manufacturing Services from CCC.

 

In consideration of the foregoing and the agreements contained herein, CCC and Nevro hereby agree as follows:

 

1. Definitions

 

1.1                          “Approved Manufacturer List” shall mean the approved list of vendors in the Specifications for the supply of Components.

 

1.2                          “Bill of Materials” shall mean Nevro’s listing or reference for the Components included in or required for the manufacture/assembly of Products in accordance with the Specifications.

 

1.3                          “Change Order” shall mean a formal written request to increase, decrease, or reschedule deliveries in a Purchase Order.

 

1.4                          “Components” shall mean the parts, materials and supplies included in or required for each Product as stipulated in the Bill of Materials.

 

1.5                          “Confidential Information” shall mean all intellectual property, including software and other technical data, products and product designs, and information, materials and documents relating to products, product designs, product testing, markets, business plans, business opportunities and trade secrets, disclosed, orally or in any written form, by one party to another under the Agreement or the Engineering Agreement, but which is non public, private or proprietary in nature.  Confidential Information shall also include all summaries, analyses, documents, memoranda, notes and other writings, including all the terms, conditions and definitions of this agreement and any and all exhibits attached hereto, prepared by either party containing or based on other Confidential Information.

 

1.6                          “Days” shall mean calendar days, unless otherwise specified, including Saturdays, Sundays and United States Government recognized holidays. “Business Days” shall not include Saturdays, Sundays or United States and Uruguay Government recognized holidays.

 

1.7                          “Defect” or “Defective” shall mean a non-conformance to Nevro’s Specifications, Bills of Material, Approved Manufacturer List, or relevant workmanship standards as referenced in the Specifications or in this Agreement.

 

1.8                          “Device Master Record” shall mean the compilation of records containing the procedures and Specifications for the Product.

 

1.9                          “Disclosing Party” shall mean the Party disclosing its Confidential Information.

 

3

 

1.10                   “Engineering Agreement” shall mean the Engineering Agreement entered into between the parties on December 30, 2008, as amended.

 

1.11                   “Engineering Change Order” (ECO) shall mean the document that details a change in the Specifications and/or design of a Product.

 

1.12                   Ex Works (EXW) shall be as defined in Incoterms 2000 of the International Chamber of Commerce.

 

1.13                   “Facility” shall mean the manufacturing facility located at General Paz 1371, 11400 Montevideo, Uruguay.

 

1.14                   “Good Manufacturing Practice” (GMP) shall mean compliance with ISO13485:2003 and Quality System Regulations 21 CFR Part 820.

 

1.15                   “High Frequency Neurostimulator” shall mean a neurostimulator designed to deliver stimulation pulses in the epidural space at a pulse rate greater than [***]Hz.

 

1.16                   “Incorporated CCC Property” shall mean any Pre-existing Property of CCC or any improvements to or derivatives of the Pre-Existing Property of CCC that is or are incorporated in any manner into any Resulting Property or a Product.

 

1.17                   “Intellectual Property” shall mean all rights held by a party in its technology, products and business information, all or some of which may constitute Confidential Information, and including but not limited to:  patent rights, copyrights, trademark rights, goodwill, inventions, improvements, discoveries, designs, modifications, data, business information, financial information, clinical information and data, regulatory information, trade secret rights, mask work, know how rights and other intellectual property and proprietary rights.

 

1.18                   “Inventory” shall mean the store of Components held by CCC at the Facility.

 

1.19                   “Manufacturing Services” shall mean full turnkey assembly, including development and deployment of manufacturing, inspection and test processes, procurement of Components, assembly and test of Products to Specifications, quality control and quality improvement and value engineering.

 

1.20                   “Minimum Order Quantities” shall mean minimum order quantities required by Component vendors.

 

1.21                   “Nevro Controlled Components” shall mean Components for which Nevro shall manage price agreements with the vendors.

 

1.22                   “Nevro Property” shall mean any tooling, equipment or software provided by Nevro, or such tooling or equipment developed or procured by CCC at Nevro expense and Safety Stock.

 

1.23                   “Nevro System” shall mean an implantable system intended to be completely introduced to a living body by surgical intervention to apply electrical stimulation for treatment of chronic pain.

 

1.24                   “Pre-existing Property” shall mean all rights of a party to designs, inventions (whether patentable or not), copyrights, trade marks, trade secrets, processes, software, devices and other intellectual property and confidential information owned or held by a party immediately prior to the Effective Date.

 

1.25                   “Product” shall mean the products set forth in EXHIBIT A, as identified by the Nevro part number or assembly identification specified in each Purchase Order issued under this Agreement and as described in the Device Master Record. There can be multiple versions of a Product, based on differences provided for in the Bills of Material.

 

1.26                   “Purchase Order” shall mean the Nevro purchase order submitted to CCC detailing the Product(s), revision level, quantity, pricing, and requested Shipment Date(s).

 

1.27                   “Receiving Party” shall mean the Party receiving Confidential Information.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

4

 

1.28                   “Resulting Property” shall mean all designs, data, information, inventions, improvements, discoveries (whether patentable or not), processes, software, and devices and any intellectual property rights in any of the foregoing (including but not limited to copyrights, trade marks, trade secrets, and patent rights) developed by either party as a result of this Agreement.

 

1.29                   “Safety Stock” shall mean the Nevro requested level of Components to be purchased by CCC, and paid for by Nevro, in excess of the amount required to meet Nevro’s Purchase Orders, Minimum Order Quantities or Component lead times.

 

1.30                   “Shipment Date” shall mean the requested shipment date from the CCC manufacturing facility as specified in a Purchase Order, or as otherwise mutually agreed by the Parties.

 

1.31                   “Specifications” shall mean Nevro’s written specifications for the manufacture and testing of the Product including, but not limited to, the current revision number, Approved Manufacturer List (AML), Bills of Material, manufacturing procedures, schematics, testing procedures, drawings, and documentation.

 

1.32                   “Warranty Period” shall mean the period of one (1) year after acceptance by Nevro of Product.

 

2. Program Management

 

2.1                          Each Party shall appoint a program manager as the program liaison with the other Party in connection with the coordination and implementation of the manufacture of the Products and shall also provide ongoing support thereafter. The Parties agree to conduct periodic business reviews. The business reviews shall include, but shall not be limited to, quality, delivery, flexibility, service, and price. The program managers shall coordinate these reviews.

 

2.2                          Each Party shall provide a list of program team members. The list shall include name, title, phone number, and email address. The Program Team List is attached as EXHIBIT B.

 

3. Manufacture of Products

 

3.1                          During the term of this Agreement, CCC shall provide Nevro with Manufacturing Services at the Facility.

 

3.2                          CCC shall manufacture and build Products in accordance with the Specifications.

 

3.3                          CCC shall purchase all inventory as needed and standard production and test equipment as necessary to fulfill Purchase Orders.  Nevro may consign certain tooling, equipment and software that are unique to Products, attached as EXHIBIT C.

 

3.4                          CCC shall maintain manufacturing and test records in accordance with GMP.

 

4. Product Training

 

4.1                          During the term of this Agreement, CCC shall maintain a sufficient staff of trained personnel to adequately support all the requirements set forth in this Agreement.

 

5. Quality

 

5.1                          The Parties agree to the Quality Agreement attached as EXHIBIT D.

 

5.2                          Without limiting CCC’s other obligations under this Agreement, CCC agrees that the manufacture, test and quality control of the Products under the terms of this Agreement shall be in accordance with the standard CCC processes utilized for similar products manufactured by CCC, unless otherwise specified by the Quality Agreement.

 

5.3                          CCC agrees to maintain ISO 13485:2003 certification and comply with 21 CFR Part 820 in all Facilities producing Products.

 

5

 

6. Component Responsibilities

 

6.1                          CCC shall maintain and manage adequate Inventory in order to meet Nevro’s Purchase Orders and Component lead times. CCC shall immediately notify Nevro in the event of any potential material delays or shortages that may impact Shipment Date.

 

6.2                          CCC may order Components above the quantities required to satisfy Purchase Orders in order to meet Minimum Order Quantities.

 

6.3                          Nevro may request that CCC establish a Safety Stock. The amount of Safety Stock will be as mutually agreed by the Parties. Nevro will pay CCC for all Safety Stock purchases.  In the case that Safety Stock is used for a specified Product, Nevro will receive a commensurate change to the overall pricing for that Product.

 

6.4                          Nevro shall be responsible for any Inventory purchased by CCC under the terms of this Agreement, including Safety Stock, which becomes unusable due to reduction in demand or obsolescence due to Engineering Change Orders, provided that CCC has made a reasonable effort to return such Inventory.

 

6.5                          CCC will invoice Nevro for all of the costs of transporting Components to the Facility including but not limited to freight and customs charges.

 

7. Consigned Components

 

7.1                          Nevro will supply certain consigned Components to CCC. Such consigned Components shall be delivered to CCC in sufficient time and in sufficient quantities based on Purchase Orders and in accordance with this Agreement, including normal yield levels, to allow CCC to meet scheduled Shipment Dates for the applicable Products.  All consigned Components shall be in good condition and in good working order.  Nevro assumes complete liability for the quality of all consigned Components and CCC shall not be responsible for any Defects or deficiencies therein.  CCC shall, upon receipt of the consigned Components, perform all necessary inspections of the consigned Components, in accordance with its standard procedures and shall notify Nevro in writing, not later than seven (7) Days from the date of receipt of the consigned Components, of any Defects found or of any discrepancy in quantities. CCC reserves the right, after receipt of the consigned Components, to timely inform Nevro of additional Defects which may be discovered or revealed by further inspection by or through the manufacturing process that could not be discovered at incoming inspection by CCC.

 

7.2                          CCC will provide Nevro with a written statement of the Consigned Components used by CCC at the end of each calendar month.

 

8. Engineering Change Order (ECO)

 

8.1                          An ECO is required when the form, fit or function of the design of the Product and/or Specifications are affected by a related change by or on behalf of Nevro.  Nevro shall provide ECOs to CCC by way of e-mail, hard-copy, or fax.  CCC agrees to promptly implement any change in the Specifications or the design of a Product as reasonably requested by Nevro pursuant to an ECO. Nevro shall reimburse CCC’s reasonable costs of implementation.

 

8.2                          CCC shall provide a written response to Nevro if such changes affect the per-unit price and/or parameters related to the shipment of a Product.  The pricing model will be adjusted for the effect of the ECO when implemented.

 

8.3                          CCC shall not implement any changes to the design or Specifications (including any deviations from the Approved Manufacturer List or the Bill of Materials) of any Product or materials used to produce a Product, without Nevro’s prior written approval. CCC shall not implement any changes to equipment, manufacturing and quality assurance procedures, or methods and techniques used to produce a Product without notifying Nevro in writing prior to such change.

 

6

 

8.4                          Documentation reasonably supporting the unusability of any Inventory as a result of an ECO shall be provided by CCC; however, Nevro has the sole authority in its reasonable judgment to determine whether or not such Inventory is unusable.

 

9. Yield Loss

 

9.1                          Nevro shall be responsible for yield loss.  CCC’s sole responsibility with respect to yield loss shall be for those failures mutually determined by the Parties in good faith to be the direct fault of CCC.

 

9.2                          Following the end of each calendar quarter CCC will invoice Nevro for the cost of the yield loss. CCC will also provide a report on the steps that are being taken by CCC to address the causes of the yield loss to accompany such invoice.

 

10. Purchase Orders and Forecasts

 

10.1                   During the term of this Agreement, Nevro shall issue quarterly Purchase Order(s) by the last day of each calendar quarter for Shipment Dates in the quarter two quarters in the future. By way of example, on or before December 31st Purchase Orders will be issued for Shipment Dates in the third quarter starting July 1st.  Each successive quarter, Purchase Orders shall be issued for an additional quarter. The terms and conditions of this Agreement shall supersede printed terms on any Purchase Order, quotation, acknowledgement, confirmation or invoice.

 

10.2                   CCC shall provide written Purchase Order acceptance within three (3) business days of receipt of the Purchase Order.

 

10.3                   Nevro will pay a deposit for [***] percent ([***]%) of the amount set forth in Exhibit E as CCC BOM plus the LOP for a Product times the quantity ordered on the Purchase Order to CCC as a down payment deposit to be applied against the invoice issued upon shipment of the Product to Nevro. When CCC purchases Components as set forth in Exhibit E as BOM Nevro, Nevro will pay as a deposit the cost of the Components purchased by CCC to be applied against the invoice issued upon shipment of the Product to Nevro.

 

10.4                   Nevro shall issue quarterly rolling monthly forecast by the last day of each calendar quarter for the 3 quarters immediately following the Purchase Order coverage period. The forecast quantities for the last two quarters of the forecast are non-binding. When a Purchase order is issued for the first quarter of the forecast, CCC will accept such Purchase Order provided that the quantities ordered may not vary up or down from such forecast quantity by more than 25% unless otherwise agreed by the Parties.

 

11. Increase, Rescheduling and Cancellation of Purchase Orders

 

11.1                   CCC shall use its commercially reasonable efforts to accommodate increases, decreases or reschedules of the quantities in a Purchase Order requested by Nevro. Any additional costs of such change will be borne by Nevro.

 

12. Price and Payment Terms

 

12.1                   All prices are EXW at the Facility, provided that CCC agrees to be responsible for the loading of the Product on departure and delivery to the carrier and to bear the risk and all costs of such loading. The pricing model for the Products shall be as set forth in EXHIBIT E of this Agreement.

 

12.2                   All CCC invoices shall be in U.S. dollars and due and payable net thirty (30) days after the date of shipment.

 

13. Shipment

 

13.1                   CCC shall notify Nevro of shipments by CCC to Nevro.  Nevro may specify carrier and mode of transportation for each Shipping Order or provide a standing instruction; provided, if Nevro does not so specify, CCC may select the carrier and mode of transportation reasonably required to meet Nevro’s delivery requirements.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

7

 

13.2                   CCC shall ship all Products on the committed Shipment Date.  If circumstances arise that prevent CCC from such timely shipment of Products, CCC shall (i) immediately notify Nevro of the nature of the problem, the methods taken to overcome the problem and the estimated time of delay, (ii) expedite shipment of such Products when the problem is overcome.

 

13.3                   All Products shall be packaged and prepared for shipment in a manner which conforms to the Specifications and is acceptable to common carriers for shipment.  CCC shall mark the outside of each pallet per Specifications.  Each shipment shall be accompanied by a packing slip which shall include Nevro item/part numbers and Nevro’s Purchase Order number the shipment is against.

 

14. CCC Warranties and Indemnification

 

14.1                   CCC warrants that for the Warranty Period each Product will, when properly used, conform to all material respects with the relevant Specifications under this Agreement.  This warranty is made only to Nevro and CCC shall have no liability to any third party, directly or indirectly, with respect to any Product as a result of such warranty.  CCC shall have no obligation to Nevro under this warranty or otherwise, to the extent that (a) the Product is used in connection with an activity other than that for which Nevro is selling the Products; (b) the Product has been modified by any party other than CCC or its authorized agents; (c) the failure is due to incorrect use or handling of the Products by Nevro or third parties after Nevro accepts such Product; or (d) Nevro has not complied with Section 15.1.

 

14.2                   CCC further represents and warrants that (i) it has and shall transfer good and clear title to the Products, free and clear of all liens, claims and encumbrances, and the right to grant the rights granted hereunder, (ii) CCC , to its knowledge, does not and shall not infringe on any Intellectual Property of any third party in connection with its performance under this Agreement, and (iii) CCC has the right and power to enter into this Agreement.

 

14.3                   CCC agrees to indemnify Nevro and hold Nevro harmless from and against any and all claims, third party losses, liabilities, third party damages, expenses and costs (including reasonable attorney’s fees and court costs) finally awarded against Nevro, that results from or arises out of a breach or alleged breach of any of these representations and warranties in section 14.2 or incurred in the settlement or avoidance of any such claim. This indemnity shall not apply if (i) Nevro fails to give CCC prompt notice of any such claim or threatened claim and such failure materially prejudices CCC, or (ii) Nevro does not provide reasonable assistance to CCC at CCC’s expense with respect to such claim.

 

14.4                   CCC MAKES NO OTHER WARRANTIES, EXPRESSED OR IMPLIED, WITH RESPECT TO THE COMPONENTS, PRODUCTS OR ANY SERVICES PROVIDED UNDER THIS AGREEMENT, AND DISCLAIMS ALL OTHER WARRANTIES INCLUDING THE WARRANTIES OF MERCHANTABILITY, AND FITNESS FOR A PARTICULAR PURPOSE.

 

14.5                   The terms of Section 14 and Section 15 shall apply to all Products manufactured by CCC for Nevro, regardless of whether such Products were manufactured before or after the Effective Date, excluding any Products that CCC provided as non-verified Deliverables under the Engineering Agreement that were not intended for commercial distribution by Nevro.

 

15. Acceptance and RMA Process

 

15.1                   Notwithstanding any prior inspection or payment by Nevro, Nevro may reject all or any portion of any shipment of Products that are not conforming to the CCC Warranty as set forth herein, as determined by Nevro following quality control tests and inspection or as otherwise found to be Defective, provided such return is within the Warranty Period set forth in herein.  Any Defective Products may be returned to CCC and CCC will, upon their confirmation of the Product as Defective Product, at its sole expense (including shipping and handling expenses), either (i) repair the applicable Defective Products within a reasonable time; (ii) replace the applicable Defective Products within a reasonable time; and/or (iii) and if neither of (i) or (ii) is feasible within a reasonable time, CCC will refund the amount of the payments paid for the Product; provided that (i) Nevro obtains a return authorization from CCC prior to returning the Products (and CCC shall provide Nevro with an RMA number promptly upon request), and the failure analysis, or summary thereof, conducted by Nevro shall accompany the Product or shall otherwise be promptly be delivered to CCC. If the Product returned to CCC are not covered by the Warranty (because the return was outside the

 

8

 

Warranty period or was found not to be Defective Product) CCC may charge Nevro for any services performed on the Product.

 

16. Nevro Warranties and Indemnification

 

16.1                   Nevro represents and warrants to CCC that (i) to its knowledge, Nevro Intellectual Property provided to CCC hereunder does not infringe the proprietary rights of any third party, and (ii) Nevro has the right and power to enter into this Agreement.  As the sole remedy and liability for any breach of the foregoing representations and warranties,

 

16.2                   Nevro agrees to indemnify CCC and hold CCC harmless from and against any and all claims, third party losses, liabilities, third party damages, expenses and costs (including reasonable attorney’s fees and court costs) finally awarded to CCC, that result from a breach or alleged breach of any of third party Intellectual Property infringement claim in violation of this warranty.  This indemnity shall not apply (i) if CCC fails to give Nevro prompt notice of any such claim or threatened claim and such failure materially prejudices Nevro, or (ii) unless Nevro is not given the opportunity to assume control of the defense or settlement, and (iii) CCC does not provide reasonable assistance to Nevro at Nevro’s expense with respect to such claim.

 

16.3                   NEVRO MAKES NO OTHER WARRANTIES WITH RESPECT TO THE NEVRO INTELLECTUAL PROPERTY, NEVRO COMPONENTS, NEVRO PROPERTY, THE LICENSES GRANTED HEREUNDER OR OTHER MATERIALS OR DOCUMENTATION PROVIDED BY NEVRO HEREUNDER AND DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICE.

 

17. Nevro Property

 

17.1                   Any Nevro Property shall reside and/or remain the property of Nevro and shall (i) be clearly marked or tagged as the Property of Nevro, (ii) be and remain personal property, and not become a fixture to real property, (iii) be subject to inspection by Nevro at any time, (iv) be used solely for the purpose of providing Manufacturing Services to Nevro, (v) be kept free by CCC from any and all liens and encumbrances, (vi) not be modified in any manner by CCC without the prior written approval of Nevro, and (vii) be maintained by CCC in accordance with Nevro’s maintenance procedures and guidelines, including, if applicable, but not limited to periodic calibration procedures.  Nevro will pay all maintenance costs of Nevro Property.  Nevro shall retain all rights, title and interest in Nevro’s Property and CCC agrees to treat and maintain the Nevro’s Property with the same degree of care as CCC uses with respect to its own property, but no less care than reasonable care.  CCC shall bear all risk of loss or damage to Nevro’s Property until it is returned or delivered to Nevro. Upon Nevro’s request, CCC shall deliver all of Nevro’s Property to Nevro in good condition, normal wear and tear excepted, without cost to Nevro (except freight costs); Nevro shall determine the manner and procedure for returning the Nevro’s Property, and shall pay the corresponding freight costs.  CCC agrees to execute all documents, or instruments evidencing Nevro’s ownership of Nevro’s Property as Nevro may require from time to time.

 

18. Intellectual Property

 

18.1                   The parties acknowledge and agree that all Pre-existing Property is the property of the respective party or its licensors and that, except as expressly set out herein, nothing in this Agreement shall convey or otherwise grant any rights in or to any Pre-existing Property from one party to the other.

 

18.2                   CCC hereby grants to Nevro, its successors and assigns, a perpetual, fully paid, world-wide, sublicensable, non-exclusive license under the Incorporated CCC Property and all intellectual property rights therein, to make, use, sell, offer for sale, and import the Incorporated CCC Property and all intellectual property rights therein, in connection with such Resulting Property, the “Resulting Property” as defined under the Engineering Agreement (which shall be deemed for purposes of this Agreement to include any designs, data, information, inventions, improvements, discoveries (whether patentable or not), processes, software, and devices and any intellectual property rights in any of the foregoing (including copyrights, trade marks, trade secrets, and patent rights) developed in connection with the development or manufacture of Products by CCC before the Effective Date, collectively, “EA Resulting Property”), or Product, and any improvements, derivatives or successor works of or to any of the foregoing, as Nevro considers

 

9

 

appropriate including, without limitation, to use, manufacture, sell, offer for sale, import, display, copy, perform, modify, alter and support the Incorporated CCC Property.  The license granted to Nevro includes the rights to future improvements to or derivatives of the Incorporated CCC Property, but unless otherwise specified in this Agreement (including any exhibits thereto) or otherwise agreed by the Parties, it does not require CCC to take any actions or perform any activities to incorporate it to any Product in connection with the Resulting Property or Products, and any improvements, derivatives or successor works thereof or thereto. Nothing in this Agreement will be deemed to grant Nevro the right to market, sub-license or otherwise use the Pre-Existing Property of CCC other than in connection with one or more Products or the Resulting Property, the EA Resulting Property, or any improvements, derivatives or successor works of any of the foregoing.

 

18.3                   The parties acknowledge and agree that all Resulting Property, the EA Resulting Property and all intellectual property rights therein, excluding the Incorporated CCC Property and the changes or improvements incorporated to it during the term of this Agreement or the Engineering Agreement, are and shall be solely owned by Nevro. CCC shall promptly disclose any such items to Nevro.  CCC hereby assigns, and shall cause all of its employees, agents, affiliates, subcontractors and other authorized representatives to assign, to Nevro any interest it or they may have in any such Resulting Property, EA Resulting Property (to the extent not already assigned under the Engineering Agreement) and all intellectual property rights therein.  CCC agrees to cooperate with Nevro for the purpose of filing and prosecuting patent applications, including the execution of any and all legal papers which are necessary or desirable to affect the intent of this Section.

 

18.4                   The rights and obligations of the parties under this section shall survive the termination of this Agreement and shall remain in full force and effect thereafter.

 

18.5                   Upon request by Nevro, CCC will cooperate to transfer to Nevro or its designee all documents, information, data, prototypes, and other technology, and will grant to Nevro and its designee all rights, in each case necessary for Nevro or its designee to manufacture and sell Products or improvements to or derivatives thereof, and will make its personnel reasonably available to Nevro or its designee, as necessary to enable Nevro or its designee to manufacture the Products in the manner CCC manufactured the Products during the term of and pursuant to this Agreement.  Nevro shall reimburse CCC’s reasonable cost of providing any services requested by Nevro and described in the previous sentence.

 

18.6                   Nothing in this Section 18 or otherwise in this Agreement negates, modifies or otherwise adversely affects any assignment of or grant of license to Intellectual Property by CCC to Nevro under the Engineering Agreement.

 

19. Exclusivity/Non-Competition

 

19.1                   CCC agrees that it shall not, directly or indirectly, through its affiliated companies, distributors, resellers or agents of any type or nature or otherwise, develop, manufacture, market, distribute or sell any products that utilize any Resulting Property, the “Resulting Property” as defined under the Engineering Agreement, or any Intellectual Property gained directly or indirectly from Nevro during the performance of this Agreement or the Engineering Agreement unless specifically authorized in writing by Nevro.

 

19.2                   If Nevro issues forecasts for Product in 2012 for quantities greater or equal to [***] IPG units, or [***] IPG units per year thereafter, and provided that Nevro takes delivery of at least [***] IPG units in 2012 and [***] IPG units thereafter, CCC agrees that it shall not, at any time during such years, directly or indirectly, through its affiliated companies, distributors, resellers or agents of any type or nature or otherwise, develop, manufacture, market, distribute or sell any High Frequency Neurostimulator.

 

20. Term

 

20.1                   This Agreement shall become effective on the Effective Date and shall continue for a period of 3 years unless terminated at an earlier date in accordance with the provisions herein set forth. Thereafter, this Agreement shall automatically be renewed for additional one (1) year terms, unless terminated by either Party upon written notice delivered to the other Party not later than ninety (90) days prior to the last day of the applicable term   The Parties

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

10

 

agree that, notwithstanding the number of renewals, the Parties do not intend to convert this Agreement into a contract of indefinite duration.

 

21. Termination

 

21.1                   Either Party may immediately terminate this Agreement by providing written notice to the other Party, upon the occurrence of any of the following events:

 

(a)                                 if the other Party ceases to do business, or otherwise terminates its business operations, excluding any situation where all or substantially all of such other Party’s assets, stock or business to which this Agreement relates are acquired by a third party (whether by sale, acquisition, merger, operation of law or otherwise);

 

(b)                                 if the other Party breaches any material provision of this Agreement and fails to cure such breach within sixty (60) days of written notice describing the breach;

 

(c)                                  if the other becomes insolvent, makes an assignment for the benefit of creditors, files a petition in bankruptcy, permits a petition in bankruptcy to be filed against it, presents a petition or has a petition presented by a creditor for its winding up, or enters into any liquidation or call any meeting of its creditors, or admits in writing that it is unable to pay its debts as they mature, or if a receiver or examiner is appointed for a substantial part of its assets; or

 

(d)                                 as mutually agreed in writing by the Parties.

 

22. Effect of Termination

 

22.1                   Expiration or termination of this Agreement shall be without prejudice to any rights or obligations that accrued to the benefit of either party prior to such expiration or termination.  Upon expiration or termination without cause or by mutual agreement, CCC shall continue to fulfill, subject to the terms of this Agreement, all Purchase Orders and ECOs placed by Nevro and accepted by CCC in accordance with this Agreement prior to the effective date of termination.  Upon expiration or termination of this Agreement for any reason, CCC shall promptly turn over to Nevro all Products and related documentation, whether or not completed, and both Parties shall promptly turn over to the respective Party the Confidential Information. All Components remaining at the conclusion of Purchase Order fulfillment will be invoiced to Nevro and returned to Nevro with any remaining Consigned Components. Any remaining balance of Nevro deposits with CCC will be offset against amounts owing to CCC.  The obligations under sections 14, 16, 17, 18, 19.1, 22, 23, 24, 28, 29, 30, 31, 32, 33, 34 and 35 shall survive the termination or expiration of this Agreement.

 

22.2                   In case of termination due to breach by CCC all remaining Purchase Order deposits paid by Nevro will be returned by CCC within ten (10) business days.

 

22.3                   In case of termination due to breach by Nevro all remaining Purchase Order deposits paid by Nevro can be applied to future shipments but are otherwise forfeit.

 

22.4                   The Parties agree to make every effort to complete the final transfer of Products, Inventory, Confidential Information and complete all financial transactions within forty-five (45) days from the date of termination.

 

23. Liability Limitation

 

23.1                   EXCEPT FOR LIABILITY UNDER THE WARRANTIES HEREIN, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR THE LOSS OF, OR DAMAGE TO, OR LOSS OF USE OF, FACILITIES OR OTHER PROPERTY, BUSINESS INTERRUPTION, LOSS OF REVENUE, LOSS OF PROFITS, LOSS OF DATA OR TRANSMISSIONS, OR OTHER SPECIAL OR PUNITIVE OR DAMAGES OF ANY KIND WHATSOEVER, RESULTING OR ARISING FROM OR RELATING TO THIS AGREEMENT AND WHETHER OR NOT THE OTHER PARTY IS ADVISED OF THE POSSIBILITY OF ANY OF THE FOREGOING.

 

11

 

24. Relationship of Parties and Liability for Services Performed by Others

 

24.1                   CCC and its subcontractor(s) shall be deemed to be independent contractors of Nevro, and this Agreement does not create a general agency, joint venture, partnership, employment relationship, or franchise between CCC and Nevro.  Each Party assumes full responsibility for the actions and negligence of its employees, agents or other personnel assigned by it to perform work pursuant to this Agreement, regardless of their place of work, and shall be solely responsible for payment of salary, including withholding of federal and state income taxes, social security, workers’ compensation and the like.

 

25. Confidentiality

 

25.1                   The parties acknowledge and agree that, from time to time, either of the parties may disclose Confidential Information only to the other for the purpose of better carrying out their obligations or to allow the receiving party to better carry out its obligations hereunder.  The parties shall only use Confidential Information for the purposes of this Agreement and shall otherwise keep confidential and not disclose to any other person any of the Confidential Information except as expressly permitted hereof.

 

25.2                   The parties may disclose Confidential Information to their respective directors, officers, employees, authorized agents and professional advisers to the extent such persons have a need to know such information for the purpose of performing each party’s duties and obligations hereunder, provided that party advises each such individual of the terms of this Agreement and ensures that each such individual receives and hold such information as if that individual were a party to this Agreement.  A party may, from time to time, designate in writing individuals as authorized representatives of that party to whom Confidential Information may be provided directly by the disclosing party, and any Confidential Information so provided will be deemed to have been provided to the other party and be subject to this Agreement.  A Disclosing Party may, from time to time, require the Receiving Party to provide evidence to its reasonable satisfaction that all persons permitted by this paragraph to have access to the Disclosing Party’s Confidential Information have executed Agreements, the terms of which are reasonably satisfactory to the Disclosing Party, are consistent with the terms of this Agreement and which may be enforced by the Disclosing Party providing for the assignment of intellectual and other property rights to the Receiving Party or Disclosing Party, as appropriate and non-disclosure of Confidential Information.

 

25.3                   The obligations of a party concerning the other party’s Confidential Information shall not apply to information which:

 

(a)                                 is or becomes widely known (defined as being published in industry/medical journals or literature), other than by reason of a breach of this Agreement or, to the knowledge of the Receiving Party, a breach of a similar Agreement;

 

(b)                                 is or has been independently developed by the Receiving Party without reference to or based upon the other party’s Confidential Information;

 

(c)                                  the Disclosing Party agrees in writing need not be kept confidential;

 

(d)                                 is required by law or court of competent jurisdiction to be disclosed by the Receiving Party provided such party first gives prompt notice of the requirement to disclose to the Disclosing Party to allow that party to obtain an appropriate order or other protection against the publication of such information; or

 

(e)                                  is required by any regulatory authority or notified body.

 

25.4                   All Confidential Information provided hereunder shall remain the property of the Disclosing Party.  The Receiving Party shall, within ten days of a written request to do so, return to the Disclosing Party all Confidential Information that has been provided in tangible form and shall, unless prohibited by law, destroy or otherwise render unintelligible all other Confidential Information. Notwithstanding the foregoing, each party will be allowed to keep one copy of the Confidential Information in order to ensure continued compliance with the terms of this Agreement.

 

12

 

25.5                   The parties acknowledge that monetary damages would not be sufficient remedy for a breach of obligation of confidentiality in this Agreement and agree that each party shall be entitled to seek and obtain appropriate equitable remedies, including injunctive relief, to prevent the unauthorized use or disclosure of any Confidential Information.

 

25.6                   The obligations under this Section shall continue for a period of five years following the last day on which CCC performs any services under this Agreement.

 

26. Force Majeure

 

26.1                   The failure or delay of either party to perform fully any of its obligations under this Agreement solely by reason of acts of God; acts of civil or military authority; civil disturbance; war; embargo; strikes or other labor disputes (excluding those related to a Party’s workforce); fire; a delay or default caused by common carriers; or similar circumstance beyond its reasonable control which cannot reasonably be foreseen or provided against (“Force Majeure”) will be deemed not to be a breach of this Agreement so long as the Party so prevented from complying with this Agreement has not contributed to such Force Majeure, has used its best efforts to avoid such Force Majeure or to ameliorate its effects, and continues to take all actions within its power to comply as fully as possible with the terms of this Agreement.  In the event of any such Force Majeure, full performance of the obligations affected will be deferred until the Force Majeure ceases.  This section will not apply to excuse a failure to comply with the terms of this Agreement arising from any commercial dispute between a party and a third party or the failure by a party to secure any materials, supplies, labor or other input for any reason not caused by Force Majeure.

 

27. Governing Law and Arbitration

 

27.1                   This Agreement shall be governed by and construed under the laws of the State of New York, U.S.A., without regard for conflict of laws principles.  Any controversy or claim arising out of or relating to this Agreement, or its breach, shall be subject to binding arbitration in New York, New York, under the Commercial Arbitration Rules of the American Arbitration Association by one arbitrator appointed in accordance with such Rules, provided, however, that neither party shall be precluded from seeking injunctive relief or other provisional relief in any court of law. The language of the arbitration shall be English. Judgment on the award rendered by the arbitrator may be entered in any court having jurisdiction. The federal and state courts within the State of New York, U.S.A., shall have exclusive jurisdiction and venue to adjudicate any action for injunction or other provisional relief arising out of this Agreement.  However, Nevro may, in its sole discretion, seek to adjudicate in a court in any other jurisdiction any permitted dispute for injunction or other provisional relief arising out of this Agreement.  CCC hereby expressly consents to (i) binding arbitration as described above; (ii) the personal jurisdiction of the federal and state courts within New York, (iii) service of process being effected upon it by major rapid delivery courier service sent to the address set forth at the beginning of this Agreement, and (iv) the uncontested enforcement of a final judgment from such arbitrator or court in any other jurisdiction wherein CCC or any of its assets are present.  The parties expressly exclude the application of the United Nations Convention on Contracts for the International Sale of Goods.  It is not intended that any third party should be a beneficiary under this Agreement pursuant to the Contracts (Rights of Third Parties) Act 1999.

 

28. Compliance with Laws

 

28.1                   CCC shall comply with all applicable laws and regulations in the performance of its duties and tasks under this Agreement.

 

29. Assignability

 

29.1                   CCC shall not have any right or ability to assign, transfer, or sublicense any obligation or benefit under this Agreement by operation of law or otherwise, without Nevro’s prior written consent.  Nevro may assign this Agreement to any of Nevro’s affiliated companies or to an entity that succeeds to all or substantially all of its business or assets to which this Agreement relates, provided Nevro delivers CCC a prompt, written notice of such assignment.

 

13

 

30. Notice

 

30.1                   Notices under this Agreement shall be sufficient only if personally delivered by a major rapid delivery courier service return receipt requested to a Party at its addresses first set forth herein or as amended by notice pursuant to this subsection.

 

31. No Waiver

 

31.1                   No waiver of any term or condition of this Agreement shall be valid or binding on either Party.  The failure of either Party to enforce at any time any of the provisions of the Agreement, or the failure to require at any time performance by the other Party of any of the provisions of this Agreement, shall in no way be construed to be a present or future waiver of such provisions, nor in any way affect the validity of either Party to enforce each and every such provision thereafter.

 

32. Severability

 

32.1                   In the event that any provision of this Agreement is found to be entirely or partially invalid, illegal, or unenforceable, the validity, legality, and enforceability of any of the remaining provisions shall not in any way be affected or impaired and a valid, legal, and enforceable provision of similar intent and economic impact shall be substituted therefore.

 

33. Entire Agreement

 

33.1                   This Agreement consists of the terms and conditions stated above, including the Exhibits, is the entire Agreement between the Parties, and supersedes all proposals, oral or written, all negotiations, conversations, or discussions between or among Parties relating to the subject matter of this Agreement and all past dealing or industry custom.  Any term, condition or other provision in any Purchase Order, quotation, confirmation, invoice, document, or other oral or written communication that is in any way inconsistent or in conflict with or in addition to the Agreement shall be void and is hereby expressly rejected by the Parties, unless it is clearly labeled and intended specifically as an amendment to this Agreement in particular and is agreed upon in writing and signed for and on behalf of both Parties.

 

34. Construction

 

34.1                   The headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.  The term “including” as used herein shall mean “including without limitation.”

 

35. Counterparts

 

35.1                   The Agreement may executed by facsimile, pdf, and in any number of counterparts, each of which shall be deemed an original but all of such together shall constitute one and the same instrument.

 

14

 

IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the Effective Date.

 

 

	
C.C.C. DEL URUGUAY S.A.
    	
 
    	
NEVRO CORP
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Julio Arzuaga
    	
 
    	
By:
    	
/s/ Andrew Galligan
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Julio Arzuaga
    	
 
    	
Name:
    	
Andrew Galligan
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
General Manager
    	
 
    	
Title: :
    	
CFO
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
March 15, 2012
    	
 
    	
Date:
    	
March 7, 2012
    

 

15

 

EXHIBIT A — PRODUCTS

 

Implantable Neurostimulator

 

External Neurostimulator

 

Patient & Clinical Communicator

 

Battery Charger

 

Programmer Wand

 

16

 

EXHIBIT B — PROGRAM TEAM LIST

 

CCC:

 

	
Name
    	
 
    	
Phone Number
    	
 
    	
E-mail Address
    	
 
    	
Title/Responsibility
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

Nevro:

 

	
Name
    	
 
    	
Phone Number
    	
 
    	
E-mail Address
    	
 
    	
Title/Responsibility
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

17

 

EXHIBIT C — CONSIGNED TOOLING, EQUIPMENT AND SOFTWARE

 

Special Test Equipment:

 

·                           None

 

18

 

EXHIBIT D — QUALITY AGREEMENT

 

19

 

 

Supplier Quality Agreement

 

This Quality Agreement is made and entered into as of 3 October 2012 (“Effective Date”) by CCC Medical General Paz 1371 (“CCC Medical”) and Nevro Corp (“Nevro”), with its headquarters at 4040 Campbell Avenue, Menlo Park, CA 94025.

 

This Quality Agreement defines the duties of Supplier and Nevro in the Quality System for the contract manufacture of the Product(s) set forth below:

 

CCC will manufacture and perform assembly operations of the Impulse generator (IPG) and Externals for Nevro

 

SCOPE:

 

This Quality Agreement applies to all Products and their associated Specifications and requirements supplied on or after its Effective Date.

 

Responsibility for each activity is assigned to either “Supplier” or “Nevro” in the appropriate box.

 

This Quality Agreement is intended to define the responsibilities as set forth minimally by ISO13485:2003 and FDA Quality System Regulations (QSR) 21 CFR Part 820.

 

DEFINITIONS:

 

For purposes of this Quality Agreement, the following definitions shall apply:

 

A.                        “Adverse Event Report” means the written report to the appropriate Regulatory Authority from a device manufacturer required whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices: (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that the device or any other device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

 

B.                        “Applicable Laws” means the laws within a political entity that govern any aspect of the development, manufacture, market, approval, sale, distribution, packaging or use of the Product.

 

C.                        “Regulatory Authority” means any government regulatory authority, in the United States or other countries, where Supplier manufactures Products, or mutually agreed upon additional countries in which Supplier has responsibility to ensure compliance with applicable requirements, responsible for granting approvals for the performance of services under this Quality Agreement or for the Manufacturing, use, marketing, sale, pricing and/or other disposition of Nevro product(s) in which the Product(s) are used.

 

D.                        “CAPA” means a corrective action and preventive action system for identifying and preventing or eliminating the cause of an existing or potential nonconformity, defect, or other undesirable situation in order to prevent occurrence or recurrence.

 

E.                        “Certificate of Conformance”, “Certification of Compliance” or “Certification of Analysis” means a document, signed by an authorized representative of Supplier, attesting that a particular Product is Manufactured or serviced in accordance with applicable Quality Management System requirements, the Specifications and this Quality Agreement.

 

F.                          “Component” means any raw material, substance, piece, part, software, firmware, labeling or assembly which is intended to be included as part of the Product(s) or consumed during the Manufacture of the Product(s).

 

G.                        “Correction(s)” means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.

 

20

 

H.                       “Device Master Record” means the compilation of records containing the procedures and specifications for the Product.

 

I.                            “Device History Record” or “DHR” means a compilation of Records containing the production history of the Product(s).

 

J.                            “Field Action” means an activity outlining the steps for management of and/or communication regarding the performance of distributed clinical, custom, and/or market released Product currently in use by the customer.  These activities may include educational briefs, health safety alerts, notifications, Corrections or Recall of Product(s) in any Nevro product(s).

 

K.                       “Finished Device” means any Product that constitutes a device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled or sterilized.

 

L.                        “Good Manufacturing Practice” or “GMP” means FDA regulations and guidelines regarding manufacturing practices and quality systems.

 

M.                     “ISO 13485:2003” means the “ISO Quality Management Systems - Medical Devices - System Requirements for Regulatory Purposes” standard.

 

N.                        “Lot” means one or more Products Manufactured under essentially the same conditions that are intended to have uniform characteristics and quality within specified limits.

 

O.                        “Lot History Record” or “LHR” means the document that authorizes and controls the production of a single lot of components or finished devices. When completed, the LHRs required to manufacture a finished device comprise the DHR.

 

P.                         “Manufacture(d)” or “Manufacturing” means all steps, processes and activities necessary to produce Product(s), including without limitation, the design, to the extent that Supplier is responsible for the design, manufacturing, processing, quality control testing, release and storage of Product(s) by Supplier in accordance with the  terms and conditions of this Agreement.

 

Q.                        “Nonconforming Product” means product that does not meet Specifications.  Examples include, but are not limited to:

 

·            Product built to an incorrect configuration,

·            Product built not in conformance with the validated process, or

·            Product built with unapproved Components, counterfeit Components, or Components not meeting Specification.

 

R.                        “Notified Body” means a government agency in a member state of the European Union that carries out conformity assessment procedures for some classes of medical devices.

 

S.                          “Qualification” or “Qualify” means activity and analysis performed to demonstrate adherence to predetermined criteria. Qualification for a Product means Product testing or inspection conducted according to an approved and controlled protocol to ensure the Product meets Specifications.

 

T.                         “Quality System”, “Quality Management System” or “QSR” means the regulatory requirements under the Applicable Laws of an Regulatory Authority for the methods used in, and the facilities and controls used for, the design, Manufacture, packing, labeling, storage, installation and servicing of Product.

 

U.                        “Recall” means a firm’s removal or correction of a marketed product that Regulatory Authorities considers to be in violation of the laws it administers, and against which the agency would initiate legal action (e.g., seizure).

 

V.                        “Records” means written or electronic accounts, notes, data, record of, and information and results obtained from performance of Services of all work done under this Quality Agreement.

 

W.                     “Specification(s)” means all applicable specifications, protocols and other documents relevant to the design, physical characteristics, function, performance, Manufacture, packaging, labeling and quality of the Product(s) communicated in writing by Nevro  or mutually agreed upon in writing by the parties.

 

X.                        “Standard Operating Procedure” means the standard operating procedures in effect at the Supplier which have been approved by the Supplier’s quality department and which are applicable to the processing of the product.

 

Y.                        “Sub-tier Supplier” means any supplier that either directly or indirectly provides product or Services to the Supplier in connection with any Product.

 

21

 

Z.                        “Validation” (or “Validate”) means confirmation by examination and provision of objective evidence that the applicable requirements can consistently be fulfilled.

 

22

 

Responsibilities Table

 

Table Key: N/A = Not Applicable

 

	
Section
    	
 
    	
Responsibilities
    	
 
    	
N/A
    	
 
    	
Supplier
    	
 
    	
Nevro
    
	
1.0
    	
 
    	
Regulatory   Compliance
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.1
    	
 
    	
Maintain all licenses, registrations and   other authorizations as are required under the Applicable Laws. Facility   (CCC). Product (Nevro)
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.2
    	
 
    	
Maintain and operate the facility in   compliance with this Quality Agreement.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.3
    	
 
    	
Manufacture the Product in accordance with   this Quality Agreement.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.4
    	
 
    	
Product Clearances and   Approvals. Supplier shall   provide reasonably necessary assistance to Nevro in obtaining all necessary   regulatory approvals for the Manufacturing, marketing, sale and distribution   of the Product(s).
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.5
    	
 
    	
Regulatory Approval of   Product Modifications. Nevro shall be responsible for making the final determination as to   whether proposed Product modifications require regulatory approval prior to   implementation and shall be responsible for filing and obtaining any required   approvals, clearances and/or supplements.
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.6
    	
 
    	
Compliance History. Supplier shall provide Nevro with a review   of Supplier’s regulatory compliance history related to Nevro Products or   manufacturing processes upon request or receipt of a non-conformance   observation.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2.0
    	
 
    	
Management Responsibility
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2.1
    	
 
    	
Supplier   shall have personnel with executive responsibility to oversee its Quality   System. Supplier also shall maintain an organizational structure which   ensures the Product(s) are designed, developed and/or Manufactured in   accordance with this Quality Agreement.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2.2
    	
 
    	
Supplier   shall assign a person or person(s) with executive responsibility, or who   report(s) directly to a person with executive responsibility, to serve   as a contact for Nevro under this Quality Agreement, and to oversee   compliance with this Quality Agreement.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2.3
    	
 
    	
Quality   Plan. Supplier shall have a quality plan and/or quality system manual that   defines the elements of the Quality System relevant to the design,   development and/or Manufacture of the Product(s), and shall establish how the   quality requirements shall be met.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2.4
    	
 
    	
Identification. Supplier   shall ensure that Product(s) and Components are identified during all   stages of receipt, production and distribution.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2.5
    	
 
    	
Traceability. Supplier shall be responsible for setting up and maintaining   controlled documentation of Product and Component traceability during all   stages of receipt, production and distribution.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
3.0
    	
 
    	
Corrective and Preventive   Actions/Performance
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
3.1
    	
 
    	
Standard Operating Procedures. Supplier shall establish and maintain procedures for   implementing a CAPA system in compliance with the industry standards and   Quality Management System requirements.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
3.2
    	
 
    	
Resolution. Supplier shall implement the CAPA system with regard to any   quality, Manufacturing or performance issue raised by Supplier or Nevro related   to Product(s).
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
3.3
    	
 
    	
Field Actions. Nevro has the sole authority for decisions   related to any Product(s) in the field, including any Field Action.   Suppler shall support Nevro by providing access to necessary Product   information and quality records.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    

 

23

 

	
Section
    	
 
    	
Responsibilities
    	
 
    	
N/A
    	
 
    	
Supplier
    	
 
    	
Nevro
    
	
4.0
    	
 
    	
Nonconforming Product
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.1
    	
 
    	
Supplier shall establish and maintain   procedures to control Product that does not conform to specified requirements   in compliance with the Quality Management System requirements.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.2
    	
 
    	
Control   of Nonconforming Product. Supplier shall have Standard Operating Procedures to control Product that   does not conform to Nevro Specifications. The procedures shall address the   identification, documentation, evaluation, segregation, and disposition of   Nonconforming Product, including a determination of a need for an   investigation, which shall be documented.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.3
    	
 
    	
Product   Performance. Nonconforming Products may be returned to   Supplier for investigation and analysis.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.4
    	
 
    	
Disposition   of Nonconforming Product. Supplier shall have Standard Operating Procedures covering disposition of   Nonconforming Product, including review and documentation of decisions. CCC   determines the procedures for rework, retest and reevaluation of   Nonconforming Product to ensure the Product(s) meet Specifications.   Supplier shall document rework activities in the DHR, and provide report of   rework activities to Nevro upon request. Dispositions requiring acceptance or   rework beyond specifications requires prior Nevro approval.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
5.0
    	
 
    	
Document Control
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
5.1
    	
 
    	
The Supplier shall establish a process for document   control and document changes related to Product(s).
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
5.2
    	
 
    	
Approvals   for the Change Request of Nevro affected product specification or specific   manufacturing process are required. Change Requests that do not specifically   affect a Nevro product specification or process do not require neither   Nevro’s approval nor notification . Supplier shall maintain records of   changes to documents related to the Nevro product(s), which shall include a   description of the change, identification of the affected documents, the   signature of the approving individual(s), the approval date, and the   effective date.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
5.3
    	
 
    	
Approval   for Nevro affected product specifications or specific manufacturing process   prior to Supplier product release are required.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
5.4
    	
 
    	
Upon   request copies of final released documents related to new or revised Nevro   product or processes shall be forwarded to Nevro. At the supplier’s   discretion, documents may be redacted to preserve the confidentiality of   unrelated product, specification, processes, or customers.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
6.0
    	
 
    	
Purchasing Controls
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
6.1
    	
 
    	
For   Components not supplied by Nevro, Supplier shall establish   and maintain controls on the purchase of Components to ensure conformance to   specified requirements. Supplier shall maintain documentation that clearly   describes the quality requirements for Components, and shall require   Component sources to notify Supplier of any proposed changes in the   Manufacturing of the Components prior to making any change.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
6.2
    	
 
    	
For Components not supplied by Nevro, the   Supplier shall establish and maintain acceptance procedures with respect to   the Manufacture of the Products.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
6.3
    	
 
    	
For Components supplied by Nevro, a   predetermination between the supplier and Nevro for inspection and release   shall be documented.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
7.0
    	
 
    	
Design Controls
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
7.1
    	
 
    	
Nevro   shall collaborate with the Supplier to ensure that the design requirements   for the Product(s) are appropriate and address the intended use of the   Product(s) including the needs of the user and patient, in compliance   with the Quality Management System requirements.
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    

 

24

 

	
Section
    	
 
    	
Responsibilities
    	
 
    	
N/A
    	
 
    	
Supplier
    	
 
    	
Nevro
    
	
7.2
    	
 
    	
Nevro   has the sole authority to make design changes. Supplier   shall not release products implementing a design change unless it receives   final approval from Nevro. See also 16.0 “Change and Change Notification”.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
7.3
    	
 
    	
Maintain   the Product Master Design History File
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
7.4
    	
 
    	
Responsible   for marketing authorization updates related to product specification and   maintenance updates.
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
8.0
    	
 
    	
Preventive Maintenance and   Calibration
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
8.1
    	
 
    	
Maintain   calibration and preventive maintenance procedures and schedules for   equipment/instruments used in the manufacture, packaging, testing and   Validation/qualification of the Product. Include calibration tagging where   appropriate.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
8.2
    	
 
    	
Document   and review preventive maintenance and calibration performed for equipment and   make available to Nevro designee for onsite review upon request.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9.0
    	
 
    	
Packaging and Labeling
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9.1
    	
 
    	
Compliance   with Specifications. All Products shall be packaged and labeled in   accordance with any applicable Specifications.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9.2
    	
 
    	
Procedures. Supplier shall establish   and maintain Standard Operating Procedures to control labeling activities in   compliance with the Quality Management System requirements.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9.3
    	
 
    	
Labeling Mix-Ups.   Supplier shall store labels and labeling in a way that prevents an incorrect   label from being used with a Product. Supplier shall control labeling and   packaging operations to prevent labeling mistakes, and shall document the   label and labeling used for each production unit, Lot or batch in the DHR.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9.4
    	
 
    	
Define and approve label content and requirements in   accordance with applicable laws
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9.5
    	
 
    	
Define and approve all artwork, inserts, labeling   and packaging and notify CCC
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.0
    	
 
    	
Audits
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.1
    	
 
    	
Nevro retains the right to audit   Supplier Manufacturing and Quality Systems.
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.2
    	
 
    	
Nevro   or an approved designee has the right to audit the Supplier’s facilities and   systems as they relate to the manufacture and testing of Product, at mutually   agreed upon time and date. Nevro or an approved designee retains the right to   conduct “for cause” audits as necessary upon agreement with Supplier.
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.3
    	
 
    	
Issue   responses to all observations in writing to Nevro or approved designee within   a period specified in the observation. Responses are to include timelines and   plans for closure of all commitments.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.4
    	
 
    	
Management   of Sub-tier Suppliers. Nevro is responsible the management of   Nevro dictated suppliers unless otherwise specified. Supplier is responsible   for the management of all other sub-tier suppliers. Supplier expressly   managed by Nevro shall be identified.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.5
    	
 
    	
Approved   Supplier List. The Supplier is responsible for qualifying,   monitoring, managing and listing the approved Sub-Tier Suppliers which are   used for Nevro Product in accordance with the Suppliers internal procedures   with the exception of those identified as expressly managed by Nevro (par.   10.4)
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.6
    	
 
    	
Regulatory Audits and Inspections. Supplier agrees that Regulatory Authorities shall have access   to and the right to inspect or audit any pertinent Product(s) design,   Manufacturing, or quality processes, and associated documentation or Records.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.7
    	
 
    	
Third Party Audits. Supplier shall promptly notify Nevro when an Authority   inspection of its facilities (or an inspection by third parties in accordance   with FDA regulations or inspection by another governmental authority such as   a Notified Body) is expected and/or underway for affected Nevro product or   processes.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    

 

25

 

	
Section
    	
 
    	
Responsibilities
    	
 
    	
N/A
    	
 
    	
Supplier
    	
 
    	
Nevro
    
	
10.8
    	
 
    	
Regulatory Correspondence. Supplier shall promptly provide Nevro with copies of all   regulatory correspondence, including without limitation Form FDA 483s   and FDA warning letters and any correspondence with the FDA or any other   Authority related to processes, components or equipment which are the same or   similar to those used in the manufacture of affected Nevro product or   processes. Nevro will likewise inform supplier of same.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10.9
    	
 
    	
Regulatory   Commitments. Supplier shall secure Nevro’s written agreement   prior to making any commitment to a regulatory agency regarding the Product.   Nevro shall be provided with draft responses to regulatory observations that   involve the Product and its Manufacture prior to submission to any Regulatory   Authority and Supplier shall permit Nevro’s input into responses and   corrective actions. Supplier shall retain the final authority and responsibility   for the content of the responses to the Regulatory Authority related to a   Finished Device.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11.0
    	
 
    	
Personnel Training
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11.1
    	
 
    	
Personnel   and Training. Supplier shall have sufficient personnel with the   necessary education, background, training and experience to perform under   this Quality Agreement.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11.2
    	
 
    	
Provide adequate number of personnel qualified by   appropriate training and experience to perform and supervise the manufacture,   testing, packaging and disposition of the Product.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11.3
    	
 
    	
Assure training is regularly conducted, assessed   and documented by qualified individuals in accordance with Supplier’s   documented procedures.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11.4
    	
 
    	
Have written job descriptions for positions   responsible for performing GMP related activities.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11.5
    	
 
    	
Assure that non-employees, including consultants,   advising on the manufacture and control of the Product have sufficient   education, training, and experience to advise on the subject for which they   are retained.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12.0
    	
 
    	
Complaints/Adverse Events
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12.1
    	
 
    	
Each party shall cooperate fully with the   other party in dealing with customer and third party complaints concerning   the Product(s) and shall take such action to promptly resolve such   complaints as may be reasonably requested by the other party.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12.2
    	
 
    	
Nevro shall have the sole authority to   correspond with all applicable regulatory authorities with respect to   complaints about the Product(s).
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12.3
    	
 
    	
Nevro is responsible for complying with all   applicable Regulatory Authorities regulatory requirements pertaining Adverse   Event reporting. Supplier shall reasonably cooperate with Nevro to enable   Nevro to fulfill such requirements. If Supplier becomes aware of a   potentially reportable event, notice of such event shall be given to Nevro   within two (2) business days.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
13.0
    	
 
    	
Field Alerts and Recalls
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
13.1
    	
 
    	
If   the Supplier becomes aware of any defect or problem with respect to any Nevro   Product, they shall notify Nevro no later than two (2) business days   after becoming aware of the issue. If such issue may have caused or   contributed to death or serious injury, Supplier shall promptly notify Nevro,   and in any event no later than one business (1) day after becoming aware   of the issue.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
13.2
    	
 
    	
Notification. If either party in good faith determines   that a Recall or other action involving a Product(s) should be considered,   such party shall immediately notify the other party and shall advise such   other party of the reasons underlying its determination.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
13.3
    	
 
    	
Nevro Determination. Nevro has the sole authority to determine   and manage whether 
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    

 

26

 

	
Section
    	
 
    	
Responsibilities
    	
 
    	
N/A
    	
 
    	
Supplier
    	
 
    	
Nevro
    
	
 
    	
 
    	
any action such as a Recall or other action   should be undertaken.
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
13.4
    	
 
    	
Analysis. Product returned related to Recall shall   be analyzed by Nevro or by the Supplier at Nevro’s request.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
14.0
    	
 
    	
Handling, Storage, Distribution and Installation
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
14.1
    	
 
    	
Supplier shall establish and maintain   procedures, as it applies for the handling, storage, distribution and installation   of the Product(s).
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
14.2
    	
 
    	
Handling. Supplier   shall have systems in place to ensure that mix-ups, damage, deterioration,   contamination or other adverse effects do not occur during handling of the   Product(s).
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
14.3
    	
 
    	
Storage. Supplier   shall control storage areas to prevent mix-ups, damage, deterioration,   contamination or other adverse effects pending distribution of the   Product(s).
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
14.4
    	
 
    	
Distribution. Supplier   shall have systems in place to control distribution of Product(s) so   that only Product(s) approved for release are distributed. Supplier   shall ensure that no obsolete, rejected, expired or deteriorated   Product(s) are distributed, unless they are distributed to Nevro at its   written request.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15.0
    	
 
    	
Production
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15.1
    	
 
    	
Process   Control-Generally. Supplier shall have systems in place to define   and maintain the Manufacturing process and associated controls so that all   Product(s) conform to their Specifications (ie. Device Master Records).
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15.2
    	
 
    	
Process Monitoring. Supplier shall monitor and control the Manufacturing process   using the industry standard tools such as in-process inspection, Validation   and statistical process control.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15.3
    	
 
    	
Certificate of   Conformance. If requested   by Nevro, Supplier shall provide to Nevro a Certificate of Conformance   consistent with the Specifications for each Lot/batch of Product shipped.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15.4
    	
 
    	
Inspection,   Measurement, and Test Equipment. Supplier shall notify   Nevro in writing of any out-of-tolerance equipment if it affects the testing   or Manufacturing of any Product(s) or Component. The written   notification shall include identification of the affected Product(s) or   Component.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15.5
    	
 
    	
Production   Release. Release product in accordance with the DMR
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15.6
    	
 
    	
Product   Release. Authorize product release to market
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15.7
    	
 
    	
Servicing   (as applicable). Manage and document product servicing.
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
16.0
    	
 
    	
Change and Change Notification
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
16.1
    	
 
    	
Changes by Nevro. The Specifications may be revised by Nevro. Such revisions may   require additional Qualification. Nevro shall notify Supplier of all relevant   Specification revisions. Supplier shall implement all revisions by dates   specified by Nevro when possible and/or according to conditions set forth in   the supplier/Nevro commercial agreement
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
16.2
    	
 
    	
Changes by Supplier. Changes process to the specification or the process are outline   in ATTACHMENT 1
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
16.3
    	
 
    	
Change/Approval. Nevro   personnel shall review and approve changes that may affect the Product(s)
    	
 
    	
o
    	
 
    	
o
    	
 
    	
x
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
17.0
    	
 
    	
Record Retention
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
17.1
    	
 
    	
Creation and Maintenance   Quality System Record. Each party shall create and maintain Records for the activities for   which they are responsible under this Quality Agreement in compliance with   the Quality Management System requirements.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
x
    

 

27

 

	
Section
    	
 
    	
Responsibilities
    	
 
    	
N/A
    	
 
    	
Supplier
    	
 
    	
Nevro
    
	
17.2
    	
 
    	
Copies. Upon Nevro’s request, Supplier shall   promptly provide Nevro with copies of non-proprietary portions of Records and   other documents required to be maintained pursuant to this Quality Agreement.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
17.3
    	
 
    	
Retention. Supplier shall keep original Records for 15   years minimally from date of Record creation; thereafter, Supplier shall   notify Nevro prior to disposing of such Records and upon Nevro’s request,   either (i) transfer custody of the original Record to Nevro or   (ii) Nevro may elect to have such Records retained in Supplier’s   archives for an additional period of time at a reasonable charge to Nevro. At any time upon written request, or termination of this Quality   Agreement, Supplier shall return all original Records to Nevro.
    	
 
    	
o
    	
 
    	
x
    	
 
    	
o
    

 

XII.                         SUPPLIER ATTACHMENTS

 

x  ISO 13485 Certificate

x  Organizational Chart

x  Quality Manual

o

o

 

Approval:

 

 

	
SUPPLIER   REPRESENTIVE
    	
 
    	
NEVRO   CORPORATION
    
	
 
    	
 
    	
QUALITY   REPRESENTATIVE
    
	
 
    	
 
    	
 
    
	
Alicia   Fiandra
    	
 
    	
Edwin   Lee, QA Director
    
	
Print   (Name and Title)
    	
 
    	
Print   (Name and Title)
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
/s/   Alicia Fiandra
    	
 
    	
/s/   Edwin Lee
    
	
Signature
    	
 
    	
Signature
    
	
 
    	
 
    	
 
    
	
November 20,   2012
    	
 
    	
19   November 2012
    
	
Date
    	
 
    	
Date
    

 

28

 

ATTACHMENT 1

 

[***]

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

29

 

EXHIBIT E — PRICE MODEL

 

The price for the Product will be calculated as follows:

 

Step 1 Material component

 

No later than the last day of a calendar quarter CCC will provide Nevro with a priced Bill of Materials where each item of the Bill of Materials has the most recent purchase price of the item. Items priced in local currency will be translated at a recent exchange rate for inclusion in the priced Bill of Materials. The total amount of the priced Bill of Materials will be the Component price per unit of the Product that will be invoiced to Nevro for the following quarter.

 

At the end of each quarter CCC will calculate any purchase price variance between the amount actually paid by CC for the items and the amount used in the priced Bill of Materials. Any currency variances on items priced in local currency in the bill of Materials will also be calculated. CCC will issue an invoice or a credit memo for the variances to Nevro.

 

Step 2 Labor, Overhead and Profit (“LOP”)

 

The amount of the LOP charge per unit will be as set forth herein.

 

	
 
    	
 
    	
BOM Nevro
    	
 
    	
BOM CCC
    	
 
    	
LOP
    	
 
    	
Total
    
	
Implantable Neurostimulator (IPG)
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    
	
External Neurostimulator (TSM)
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    
	
Patient & Clinical Communicator (PTR)
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    
	
Battery Charger (CRG)
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    
	
Programmer Wand (PW)
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    	
 
    	
$
    	
[***]
    

 

At the end of each quarter CCC will adjust the amount of the LOP by the amount of the change, if any,  to the salary index published by the Uruguay Government agency responsible for the index. (Private Sector Gross Salary Index (IMSPr for its acronym in Spanish) provided by the National Statistics Institute of Uruguay (INE for its acronym in Spanish www.ine.gub.uy)).

 

At the end of each quarter CCC will calculate the dollar amount of the LOP translated at a recent exchange rate. The US dollar amount will be the LOP price per unit of the Product that will be invoiced to Nevro for the following quarter.

 

If the currency rate between the Uruguayan pesos and US dollar varies by more than 5% in any quarter then CCC will calculate a currency variance amount. CCC will issue an invoice or a credit memo for the variances to Nevro.

 

Step 3 Price per Product Purchased

 

The addition of Step 1 and Step 2 will be the price per unit of Product for the upcoming quarter.

 

Step 4 Invoices

 

CCC will invoice Nevro using the price per product calculated herein. Nevro shall pay the invoice less the amount of any deposits paid by Nevro for the Products.

 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION

 

30

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