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As filed with the Securities and Exchange Commission on October 15, 2014.

Registration No. 333-199156


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



AMENDMENT NO. 2
TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933



Nevro Corp.
(Exact name of Registrant as specified in its charter)

Delaware
(State or other jurisdiction of
incorporation or organization)
  3841
(Primary Standard Industrial
Classification Code Number)
  56-2568057
(I.R.S. Employer
Identification Number)

4040 Campbell Avenue
Menlo Park, CA 94025
(650) 251-0005

(Address, including zip code, and telephone number, including
area code, of Registrant's principal executive offices)



Michael DeMane
Chief Executive Officer
Nevro Corp.
4040 Campbell Avenue
Menlo Park, CA 94025
(650) 251-0005
(Name, address, including zip code, and telephone number, including area code, of agent for service)



Copies to:

Michael W. Hall, Esq.
Anthony J. Richmond, Esq.
Brian J. Cuneo, Esq.
Latham & Watkins LLP
140 Scott Drive
Menlo Park, CA 94025
Telephone: (650) 328-4600
Facsimile: (650) 463-2600

 

Andrew H. Galligan
Vice President of Finance,
Chief Financial Officer
Nevro Corp.
4040 Campbell Avenue
Menlo Park, CA 94025
Telephone: (650) 251-0005
Facsimile: (650) 251-9415

 

Alan F. Denenberg, Esq.
Davis Polk & Wardwell LLP
1600 El Camino Real
Menlo Park, CA 94025
Telephone: (650) 752-2000
Facsimile: (650) 752-2111



Approximate date of commencement of proposed sale to the public:
As soon as practicable after the effective date of this Registration Statement.

         If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.     o

         If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.     o

         If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.     o

         If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.     o

         Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer  o   Accelerated filer  o   Non-accelerated filer  ý
(Do not check if a
smaller reporting company)
  Smaller reporting company  o

          The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

   



EXPLANATORY NOTE

         This Amendment No. 2 to the Registration Statement on Form S-1 (Registration No. 333-199156) of Nevro Corp. is being filed solely to include exhibits to the Registration Statement. Accordingly, Part I, the form of prospectus, has been omitted from this filing.



PART II
Information Not Required in Prospectus

Item 13. Other Expenses of Issuance and Distribution.

        The following table sets forth the costs and expenses, other than the underwriting discounts and commissions, payable by the registrant in connection with the sale of Common Stock being registered. All amounts are estimates except for the Securities and Exchange Commission, or SEC, registration fee, the FINRA filing fee and the New York Stock Exchange listing fee.

Item
  Amount to
be paid
 

SEC registration fee

  $ 13,363  

FINRA filing fee

    17,750  

The New York Stock Exchange listing fee

             *

Printing and engraving expenses

             *

Legal fees and expenses

             *

Accounting fees and expenses

             *

Blue Sky, qualification fees and expenses

             *

Transfer Agent fees and expenses

             *

Miscellaneous expenses

             *
       

Total

  $   *
       
       

*
To be completed by amendment.

Item 14. Indemnification of Directors and Officers.

        As permitted by Section 102 of the Delaware General Corporation Law, we have adopted provisions in our amended and restated certificate of incorporation and bylaws that limit or eliminate the personal liability of our directors for a breach of their fiduciary duty of care as a director. The duty of care generally requires that, when acting on behalf of the corporation, directors exercise an informed business judgment based on all material information reasonably available to them. Consequently, a director will not be personally liable to us or our stockholders for monetary damages for breach of fiduciary duty as a director, except for liability for:

    any breach of the director's duty of loyalty to us or our stockholders;

    any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

    any act related to unlawful stock repurchases, redemptions or other distributions or payment of dividends; or

    any transaction from which the director derived an improper personal benefit.

        These limitations of liability do not affect the availability of equitable remedies such as injunctive relief or rescission. Our amended and restated certificate of incorporation also authorizes us to indemnify our officers, directors and other agents to the fullest extent permitted under Delaware law.

        As permitted by Section 145 of the Delaware General Corporation Law, our amended and restated bylaws provide that:

    we may indemnify our directors, officers, and employees to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions;

II-1


    we may advance expenses to our directors, officers and employees in connection with a legal proceeding to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions; and

    the rights provided in our amended and restated bylaws are not exclusive.

        Our amended and restated certificate of incorporation, to be attached as Exhibit 3.3 hereto, and our amended and restated bylaws, to be attached as Exhibit 3.5 hereto, provide for the indemnification provisions described above and elsewhere herein. We intend to enter into separate indemnification agreements with our directors and officers which may be broader than the specific indemnification provisions contained in the Delaware General Corporation Law. These indemnification agreements generally require us, among other things, to indemnify our officers and directors against liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from willful misconduct. These indemnification agreements also generally require us to advance any expenses incurred by the directors or officers as a result of any proceeding against them as to which they could be indemnified. In addition, we have purchased a policy of directors' and officers' liability insurance that insures our directors and officers against the cost of defense, settlement or payment of a judgment in some circumstances. These indemnification provisions and the indemnification agreements may be sufficiently broad to permit indemnification of our officers and directors for liabilities, including reimbursement of expenses incurred, arising under the Securities Act of 1933, as amended, or the Securities Act.

        The form of Underwriting Agreement, to be attached as Exhibit 1.1 hereto, provides for indemnification by the underwriters of us and our officers who sign this Registration Statement and directors for specified liabilities, including matters arising under the Securities Act.

Item 15. Recent Sales of Unregistered Securities.

        The following list sets forth information as to all securities we have sold since January 1, 2011, which were not registered under the Securities Act.

    1.
    In February and March 2013, we issued an aggregate of 103,671,704 shares of our Series C convertible preferred stock solely to accredited investors at a price per share of $0.463, for aggregate gross consideration of approximately $48.0 million.

    2.
    In July 2011, we issued an aggregate of 130,814,045 shares of our Series B convertible preferred stock solely to accredited investors at a price per share of $0.448, for aggregate gross consideration of approximately $58.6 million.

    3.
    We granted stock options and stock awards to employees, directors and consultants under our 2007 Stock Incentive Plan, as amended, covering an aggregate of 85,360,424 shares of common stock, at a weighted average average exercise price of $0.1384 per share. Of these, options covering an aggregate of 7,008,312 shares were cancelled without being exercised.

    4.
    We sold an aggregate of 34,070,559 shares of common stock to employees, directors and consultants for cash consideration in the aggregate amount of $3.4 million upon the exercise of stock options and stock awards.

        We claimed exemption from registration under the Securities Act for the sale and issuance of securities in the transactions described in paragraph (1) by virtue of Section 4(a)(2) and in paragraph (2) by virtue of Section 4(a)(2) and/or Regulation D promulgated thereunder as transactions not involving any public offering. All of the purchasers of unregistered securities for which we relied on Section 4(a)(2) and/or Regulation D represented that they were accredited investors as defined under the Securities Act. We claimed such exemption on the basis that (a) the purchasers in each case represented that they intended to acquire the securities for investment only and not with a view to the distribution thereof and that they either received adequate information about the registrant or had

II-2


access, through employment or other relationships, to such information and (b) appropriate legends were affixed to the stock certificates issued in such transactions.

        We claimed exemption from registration under the Securities Act for the sales and issuances of securities in the transactions described in paragraphs (3)-(4) above under Section 4(a)(2) of the Securities Act in that such sales and issuances did not involve a public offering or under Rule 701 promulgated under the Securities Act, in that they were offered and sold either pursuant to written compensatory plans or pursuant to a written contract relating to compensation, as provided by Rule 701.

Item 16. Exhibits and Financial Statement Schedules.

         (a)    Exhibits.     See the Exhibit Index attached to this registration statement, which is incorporated by reference herein.

         (b)    Financial Statement Schedules.     Schedules not listed above have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements or notes thereto.

Item 17. Undertakings.

        Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act, and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer, or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

        The undersigned Registrant hereby undertakes that:

    1.
    For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this Registration Statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this Registration Statement as of the time it was declared effective.

    2.
    For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

        The undersigned Registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreement certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.

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Signatures

        Pursuant to the requirements of the Securities Act of 1933, as amended, the Registrant has duly caused this Amendment No. 2 to the Registration Statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, in Menlo Park, California, on October 15, 2014.

    NEVRO CORP.

 

 

By:

 

/s/ MICHAEL DEMANE

Michael DeMane
Chief Executive Officer

        Pursuant to the requirements of the Securities Act, this Amendment No. 2 to the Registration Statement has been signed by the following persons in the capacities and on the dates indicated.

Signature
 
Title
 
Date

 

 

 

 

 

 

 
/s/ MICHAEL DEMANE

Michael DeMane
  Chief Executive Officer and
Chairman of the Board
(Principal Executive Officer)
  October 15, 2014

/s/ ANDREW H. GALLIGAN

Andrew H. Galligan

 

Vice President of Finance and
Chief Financial Officer
(Principal Financial and Accounting Officer)

 

October 15, 2014

*

Ali Behbahani, M.D.

 

Director

 

October 15, 2014

*

Peter T. Bisgaard

 

Director

 

October 15, 2014

*

Frank Fischer

 

Director

 

October 15, 2014

*

Wilfred E. Jaeger, M.D.

 

Director

 

October 15, 2014

*

Shawn T McCormick

 

Director

 

October 15, 2014

*

Nathan B. Pliam, M.D.

 

Director

 

October 15, 2014

*By:

 

/s/ ANDREW H. GALLIGAN


Andrew H. Galligan

Attorney-in-Fact

 

 

 

October 15, 2014

II-4



Exhibit Index

 
   
  Incorporated by
Reference
   
 
   
  Filed
Herewith
Exhibit
Number
  Exhibit Description   Form   Date   Number
  1.1*   Form of Underwriting Agreement.                

  3.1(a)

 

Amended and Restated Certificate of Incorporation, currently in effect.

 

S-1

 

10/03/2014

 

3.1(a)

 

 

  3.1(b)

 

Amendment to Amended and Restated Certificate of Incorporation, currently in effect.

 

S-1

 

10/03/2014

 

3.1(b)

 

 

  3.2*

 

Form of Amended and Restated Certificate of Incorporation, effecting a stock split, to be in effect prior to the consummation of this offering.

 

 

 

 

 

 

 

 

  3.3

 

Form of Amended and Restated Certificate of Incorporation, to be in effect prior to the consummation of this offering.

 

S-1/A

 

10/10/2014

 

3.3

 

 

  3.4

 

Bylaws, currently in effect.

 

S-1

 

10/03/2014

 

3.4

 

 

  3.5

 

Form of Amended and Restated Bylaws, to be in effect prior to the consummation of this offering.

 

S-1/A

 

10/10/2014

 

3.5

 

 

  4.1

 

Reference is made to exhibits 3.1 through 3.5.

 

 

 

 

 

 

 

 

  4.2*

 

Form of Common Stock Certificate.

 

 

 

 

 

 

 

 

  5.1*

 

Opinion of Latham & Watkins LLP.

 

 

 

 

 

 

 

 

10.1†

 

Amended and Restated License Agreement, dated October 2, 2006, by and among the Company and Mayo Foundation for Medical Education and Research, Venturi Group, LLC.

 

 

 

 

 

 

 

X

10.2(a)†

 

Stellar Manufacturing Agreement, dated as of July 1, 2009, by and between the Company and Stellar Technologies, Inc.

 

 

 

 

 

 

 

X

10.2(b)†

 

First Amendment to Stellar Manufacturing Agreement, dated as of July 1, 2014, by and between the Company and Stellar Technologies, Inc.

 

 

 

 

 

 

 

X

10.3†

 

Supply Agreement, dated as of July 23, 2014 by and between the Company and Pro-Tech Design and Manufacturing, Inc.

 

 

 

 

 

 

 

X

10.4(a)†

 

Supply Agreement, dated April 1, 2012, by and between the Company and CCC del Uruguay S.A.

 

 

 

 

 

 

 

X

10.4(b)†

 

Amendment to Supply Agreement, dated as of March 20, 2013, by and between the Company and CCC del Uruguay S.A.

 

 

 

 

 

 

 

X

10.5†

 

Product Supply and Development Agreement, dated as of April 15, 2009, by and between the Company and EaglePicher Medical Power LLC.

 

 

 

 

 

 

 

X

 
   
  Incorporated by
Reference
   
 
   
  Filed
Herewith
Exhibit
Number
  Exhibit Description   Form   Date   Number
10.6(a)   Amended and Restated Registration Rights Agreement, dated February 8, 2013, by and among the Company and the investors listed therein.   S-1   10/03/2014   10.6(a)    

10.6(b)

 

Amendment to Amended and Restated Registration Rights Agreement, dated March 5, 2013, by and among the Company and the investors listed therein.

 

S-1

 

10/03/2014

 

10.6(b)

 

 

10.7(a)

 

Multi-Tenant Space Lease, dated as of March 15, 2010, by and between Deerfield Campbell LLC and the Company.

 

S-1

 

10/03/2014

 

10.7(a)

 

 

10.7(b)

 

First Amendment to Lease, dated as of October 18, 2012, by and between Deerfield Campbell LLC and the Company.

 

S-1

 

10/03/2014

 

10.7(b)

 

 

10.8(a)#

 

Nevro Corp. 2007 Stock Incentive Plan, as amended as of March 5, 2013.

 

S-1

 

10/03/2014

 

10.8(a)

 

 

10.8(b)#

 

Form of Incentive Stock Option Agreement (ISO) under the 2007 Stock Incentive Plan, as amended.

 

S-1

 

10/03/2014

 

10.8(b)

 

 

10.8(c)#

 

Form of Non-Incentive Stock Option Agreement (NSO) under the 2007 Stock Incentive Plan, as amended.

 

S-1

 

10/03/2014

 

10.8(c)

 

 

10.8(d)#

 

Form of Stock Purchase Right Grant Notice and Restricted Stock Purchase Agreement under the 2007 Stock Incentive Plan, as amended.

 

S-1

 

10/03/2014

 

10.8(d)

 

 

10.9(a)#

 

Nevro Corp. 2014 Equity Incentive Award Plan.

 

S-1/A

 

10/10/2014

 

10.9(a)

 

 

10.9(b)#

 

Form of Stock Option Grant Notice and Stock Option Agreement under the 2014 Equity Incentive Award Plan.

 

S-1/A

 

10/10/2014

 

10.9(b)

 

 

10.9(c)#

 

Form of Restricted Stock Award Agreement and Restricted Stock Award Grant Notice under the 2014 Equity Incentive Award Plan.

 

S-1/A

 

10/10/2014

 

10.9(c)

 

 

10.9(d)#

 

Form of Restricted Stock Unit Award Agreement and Restricted Stock Unit Award Grant Notice under the 2014 Equity Incentive Award Plan.

 

S-1/A

 

10/10/2014

 

10.9(d)

 

 

10.10#

 

Nevro Corp. 2014 Employee Stock Purchase Plan.

 

S-1/A

 

10/10/2014

 

10.10

 

 

10.11#

 

Form of Indemnification Agreement for directors and officers.

 

S-1/A

 

10/10/2014

 

10.11

 

 

10.12(a)#

 

Offer Letter, dated as of March 8, 2011, by and between Michael DeMane and the Company.

 

S-1/A

 

10/10/2014

 

10.12(a)

 

 

10.12(b)#

 

Form of Employment Agreement by and between Michael DeMane and the Company.

 

S-1/A

 

10/10/2014

 

10.12(b)

 

 

 
   
  Incorporated by
Reference
   
 
   
  Filed
Herewith
Exhibit
Number
  Exhibit Description   Form   Date   Number
10.13#   Offer Letter, dated as of October 9, 2012, by and between Rami Elghandour and the Company.   S-1   10/03/2014   10.13    

10.14#

 

Offer Letter, dated as of May 12, 2010, by and between Andrew H. Galligan and the Company.

 

S-1

 

10/03/2014

 

10.14

 

 

10.15#

 

Offer Letter, dated as of November 1, 2012, by and between Michael Enxing and the Company.

 

S-1/A

 

10/10/2014

 

10.15

 

 

10.16#

 

Offer Letter, dated as of February 27, 2014, by and between Balakrishnan Shankar and the Company.

 

S-1/A

 

10/10/2014

 

10.16

 

 

10.17#

 

Offer Letter, dated as of January 16, 2007, by and between Andre Walker and the Company.

 

S-1/A

 

10/10/2014

 

10.17

 

 

10.18(a)

 

Amended and Restated Stockholders' Agreement, dated February 8, 2013, by and among the Company and the stockholders listed therein.

 

S-1

 

10/03/2014

 

10.15(a)

 

 

10.18(b)

 

Amendment to Amended and Restated Stockholders' Agreement, dated March 5, 2013, by and among the Company and the stockholders listed therein.

 

S-1

 

10/03/2014

 

10.15(b)

 

 

10.19#

 

Nevro Corp. Non-Employee Director Compensation Program.

 

S-1/A

 

10/10/2014

 

10.19

 

 

10.20#

 

Form of Change in Control Severance Agreement.

 

S-1/A

 

10/10/2014

 

10.20

 

 

21.1

 

List of Subsidiaries.

 

S-1

 

10/03/2014

 

21.1

 

 

23.1*

 

Consent of independent registered public accounting firm.

 

S-1/A

 

10/10/2014

 

23.1

 

 

23.2*

 

Consent of Latham & Watkins LLP (included in Exhibit 5.1).

 

 

 

 

 

 

 

 

24.1

 

Power of Attorney. Reference is made to the signature page to the Registration Statement.

 

S-1

 

10/03/2014

 

24.1

 

 

*
To be filed by amendment.
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and this exhibit has been filed separately with the SEC.
#
Indicates management contract or compensatory plan.



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EXPLANATORY NOTE
PART II Information Not Required in Prospectus
Signatures
Exhibit Index

Exhibit 10.1

 

[***] 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

 

AMENDED AND RESTATED LICENSE AGREEMENT

 

This Amended and Restated License Agreement (the “Agreement”) is by and among Mayo Foundation for Medical Education and Research, a Minnesota charitable corporation, located at 200 First Street SW, Rochester, Minnesota  55905-0001 (“MAYO”), Venturi Group, LLC, located at 2800 Patton Road, St. Paul, Minnesota  55113 (“VGL,” and, together with MAYO, the “FOUNDERS”), and NBI Development, Inc., a private for-profit company, located at 2800 Patton Road, St. Paul, Minnesota  55113 (“COMPANY”).

 

WHEREAS, MAYO desires to make certain patent rights and know-how available for the development and commercialization of medical devices for public use and benefit; and

 

WHEREAS, VGL desires to make certain patent rights and know-how available for the development and commercialization of medical devices for public use and benefit; and

 

WHEREAS, COMPANY represents itself as being knowledgeable in developing medical devices, and such knowledge is applicable in the treatment of disorders in the Field; and

 

WHEREAS, FOUNDERS are willing to grant and COMPANY is willing to accept an exclusive license under certain patent rights and a license to certain know-how and are willing to confer with COMPANY on development of such devices as set forth below; and

 

WHEREAS, COMPANY will be solely responsible for regulatory compliance, marketing and selling any products in accordance with the grant of rights hereunder.

 

NOW THEREFORE, in consideration of the foregoing and the promises and covenants set forth below, the parties hereby agree as follows:

 

Article 1.00 - Definitions

 

For purposes of this Agreement, the terms defined in this Article 1.00 will have the meaning specified and will be applicable both to the singular and plural forms:

 

1.01                         “Affiliate”:  shall mean any corporation or other entity within the same “controlled group of corporations” as MAYO or its parent Mayo Foundation.  For purposes of this definition, the term “controlled group of corporations” will have the same definition as Section 1563 of the Internal Revenue Code as of November 10, 1998, but will include corporations or other entities which, if not a stock corporation, more than 50% of the board of directors or other governing body of such corporation or other entity is controlled by a corporation within the controlled group of corporations of MAYO or Mayo Foundation.   MAYO’s Affiliates include, but are not limited to: Mayo Foundation; Mayo Collaborative Services, Inc.; Rochester Methodist Hospital; Saint Mary’s Hospital; Mayo Clinic Rochester; Mayo Clinic Jacksonville, Florida; St. Luke’s Hospital, Jacksonville, Florida; Mayo Clinic Arizona; Mayo Clinic Hospital, Arizona; Mayo Regional Practices, P.C., Decorah, Iowa; Mayo Health System West Central Wisconsin; and controlled or wholly-owned subsidiary corporations of all of the above.

 

Confidential -Page 1 of 26 -

 



 

1.02                         “COMPANY Product(s)”:  shall mean any product or service that is covered by a Valid Claim within the Licensed Patents or Jointly Owned Patents or that incorporates, uses or is manufactured using or is developed using (including testing) Licensed Know-How.

 

1.03                         “COMPANY Sublicense Revenue”: shall mean all revenue (including but not limited to upfront fees, milestone payments, royalties and other consideration) received by COMPANY or its affiliate from the sublicensing of its licenses under Sections 2.01 and 2.02 under the Licensed Patents, Jointly Owned Patents and Licensed Know-How to third parties per the terms of this Agreement.

 

1.04                         “Effective Date”: shall mean March 21, 2006.

 

1.05                         “Field”: shall mean the treatment of central, autonomic and peripheral nervous system disorders, including pain, using devices to modulate nerve signaling.  For avoidance of doubt, “Field” shall not include the treatment of obesity or other gastrointestinal disorders or treatment of cardiac indication using devices on or within the pericardium or heart.

 

1.06                         “First Commercial Sale”: shall mean the first sale of a COMPANY Product.

 

1.07                         “Founders”:  shall mean MAYO and VGL.

 

1.08                         “Jointly Owned Patents”: shall mean (i) any patent application claiming inventions arising out of Product Development or Product Testing activities conducted for COMPANY by the Mayo Neurological Device Group and/or the VGL Neurological Device Group pursuant to this Agreement that has as inventors (a) employees of MAYO and/or employees or members of VGL and (b) employees of COMPANY, (ii) all patents issuing from any of the foregoing, (iii) all continuations, divisions, continuations in part, substitutions, reissues, or reexaminations of any of the foregoing patents or patent applications, as applicable, and (iv) all foreign counterparts of any of the foregoing.

 

1.09                         “License Year”: shall mean, for the year beginning on the Effective Date, the period from the Effective Date to December 31, and thereafter each calendar year during the Term.

 

1.10                         “Licensed Know-How”:  shall mean information, whether patentable or not, that (i) is developed for and provided to COMPANY by the Mayo Neurological Device Group or the VGL Neurological Device Group through Product Development or Product Testing activities, (ii) is contained in Mayo Medical Ventures disclosure, [***] and [***], or (iii) arises from meetings held between the Mayo Neurological Device Group and the VGL Neurological Device Group beginning January 24, 2006.

 

1.11                         “Licensed Patents”: shall mean (i) all patent applications (including without limitation those claiming methods) owned solely by MAYO that claim inventions arising out of Product Development or Product Testing activities conducted for COMPANY pursuant to this Agreement by the Mayo Neurological Device Group, (ii) U.S. patent application Ser. No. [***], filed [***], entitled [***], (iii) all patent applications (including without limitation those claiming methods) owned solely by VGL that claim inventions arising out of Product Testing or Product Development activities conducted for COMPANY by the VGL Neurological Device Group, (iv) all patent applications owned jointly by MAYO and VGL claiming inventions arising out of Product Development or Product Testing activities conducted by the Mayo Neurological Device Group and the VGL Neurological Device Group for COMPANY, (v) all patents issuing from any of the

 


[***] 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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foregoing, (vi) all continuations, divisions, continuations in part, substitutions, reissues, or reexaminations of any of the foregoing patents or patent applications, as applicable, and (vii) all foreign counterparts of any of the foregoing.  Licensed Patents shall not be interpreted to include Jointly Owned Patents.

 

1.12                         “Net Sales”:  shall mean the amount invoiced by COMPANY or its affiliates for sales of COMPANY Products to third parties, less the following:  (a) normal and customary trade and/or quantity discounts, chargebacks, rebates and allowances actually allowed or taken; (b) sales, use, value added and excise taxes, import and customs duties, or tariffs to the extent actually invoiced by the selling entity; (c) freight, insurance, packaging costs and other transportation charges to the extent separately invoiced and paid by the selling entity; (d) amounts repaid or credits taken by reason of rejections, outdating, defects or returns or because of retroactive price reductions or due to recalls or government laws or regulations requiring rebate; and (e) a reasonable allowance for bad debts or uncollectible amounts.  “Net Sales” shall exclude amounts received for any COMPANY Product furnished to a third party for which payment is not intended to be received, including but not limited to COMPANY Products used in clinical trials and COMPANY. Products distributed as promotional and free goods, in reasonable quantities.  Net Sales will be determined in accordance with GAAP.

 

For Combination Products, royalties will be calculated based on Combination Net Sales.  If, on a country-by-country basis, a COMPANY Product is sold in the form of a combination product containing one (1) or more active ingredients or devices in addition to COMPANY Product (a “Combination Product”), then Net Sales for such Combination Product (“Combination Net Sales”) will be adjusted by multiplying actual Net Sales of such Combination Product by the fraction A/(A + B), where A is the average invoice price of COMPANY Product, if sold separately, and B is the average invoice price of any other active ingredient or device in the combination, if sold separately.  If, on a country-by-country basis, the other active ingredient or device in the combination is not sold separately, then Net Sales shall be calculated by multiplying actual Net Sales of such Combination Product in such country by the fraction A/C, where A is the invoice price of COMPANY Product, if sold separately, in such country and C is the invoice price of the Combination Product in such country. If, on a country-by-country basis, neither COMPANY Product nor the other active ingredient or device of the Combination Product is sold separately, then Net Sales shall be determined by COMPANY in good faith, in consultation with MAYO.

 

1.13                         “Mayo Neurological Device Group” or “MNDG”:  shall mean the Mayo Neurological Device Group (MNDG), which shall include the following members:

 

[***]

 


[***] 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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1.14                         “Product Development”: shall mean the research (other than preclinical or clinical Product Testing), clinical or preclinical development, design and/or enhancement of devices.

 

1.15                         “Product Testing”:  shall mean the design and development of preclinical or clinical test or study protocols, assays and/or measurement tools or methods, and the conduct of preclinical and clinical testing and/or validation activities, in each case relating to devices.

 

1.16                         “Term”: shall have the meaning set forth in Section 6.01.

 

1.17                         “Valid Claim”: shall mean a claim of an unexpired, issued patent that has not lapsed or been abandoned or determined by a court from which no further appeal can be taken or has been taken within the time allowed for appeal to be invalid or unenforceable.

 

1.18                         “VGL Neurological Device Group” or “VNDG”: shall mean the VGL Neurological Device Group (VNDG), which shall include the following members:

 

[***]

 

Article 2.00- Grant of Rights

 

2.01                         FOUNDERS’ GRANT.  Subject to the reservation of rights set forth in Section 2.03, FOUNDERS grant COMPANY a worldwide, royalty-bearing, exclusive (even as to MAYO and VGL, subject to Section 2.03) license under the Licensed Patents and their interests in the Jointly Owned Patents to develop, make, have made, use, offer for sale, sell and import COMPANY Products, in the Field.

 

COMPANY shall have the right to sublicense the Licensed Patents and the Jointly Owned Patents in the Field. Any such sublicense will include obligations of confidentiality, name use, warranties, waivers and indemnification for the benefit of FOUNDERS of the same scope as set forth herein. COMPANY will be responsible for the performance of its sublicensees under any such sublicense. COMPANY will notify FOUNDERS of any sublicense within thirty (30) days after execution thereof and provide FOUNDERS a copy of the same.  If COMPANY receives any non-cash consideration for the grant of a sublicense under the Licensed Patents and Jointly Owned Patents in the Field (e.g., in the form of services, products or technology in lieu of cash consideration for such sublicense), it shall include in COMPANY Sublicense Revenue the fair market value of such non-cash consideration, and COMPANY shall owe MAYO payments on such fair market value pursuant to Section 3.08.

 

2.02                         LICENSED KNOW-HOW COMMITMENT.  For a period of five (5) years from January 24, 2006, unless terminated earlier by either COMPANY or FOUNDERS as provided for in this Agreement, FOUNDERS commit to the following:

 

(a)                                  Subject to existing obligations to third parties, MAYO policies and for so long as its members are employees of MAYO, the MNDG would confer with COMPANY in the Field exclusively for Product Development and non-exclusively for Product Testing.  The VNDG would confer

 


[***] 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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with COMPANY in the Field exclusively for Product Development and non-exclusively for Product Testing.  For avoidance of doubt, in no event would the foregoing commitment to confer exclusively for Product Development be deemed to prevent MAYO from conducting preclinical or clinical Product Testing for third parties.

 

(b)                                  Subject to existing obligations to third parties and MAYO policies, FOUNDERS hereby grant COMPANY a royalty-bearing, worldwide license to use the Licensed Know-How in the Field to develop, make, use, sell, offer for sale and import COMPANY Products as provided below:

 

1. for Product Development, such license shall be exclusive; and

 

2. for Product Testing, such license shall be non-exclusive.

 

COMPANY shall have the right to sublicense such Licensed Know-How, but not any obligation of MAYO or VGL to confer, on the same terms and conditions as set forth above with respect to Licensed Patents.

 

MAYO represents and warrants that to the best of its internal patent counsel’s knowledge as of the Effective Date and without a duty to inquire, MAYO is not aware of any existing third-party obligations that will materially interfere with the MNDG conferring with COMPANY under this Agreement.   VGL represents and warrants that to the best of its internal counsel’s knowledge as of the Effective Date and without a duty to inquire, VGL is not aware of any existing third-party obligations that will materially interfere with the VNDG conferring with COMPANY under this Section 2.02, in accordance with the terms and conditions of this Agreement.

 

Each member of the MNDG shall use reasonable efforts to attend meetings, achieve specific Product Development objectives and milestones, and conduct Product Testing, contributing on average among the individuals of the groups between 3-6 hours per member per month to achieve an intended aggregate contribution of 15-25 person-hours per month as requested by COMPANY.  Any time credited under this Section 2.02 shall not also be subject to compensation under any other agreement including any agreement referenced under Section 3.13.

 

Certain members of the VNDG are employees of EnteroMedics, Inc., developing gastrointestinal products including products for using neural blocking for treatment of obesity.  VGL and such individuals represent they will not use any equipment, supplies, facilities or trade secret information of EnteroMedics, Inc. for the benefit of COMPANY, and any development contributions for COMPANY will be developed entirely on their own time, and (1) will not relate (a) directly to the businesses of EnteroMedics, Inc. and (b) to EnteroMedics,  Inc. actual or demonstrably anticipated research or development, and (2) will not result from any work performed by them for EnteroMedics, Inc..  COMPANY will not require of such individuals any work or transfer of rights inconsistent with the foregoing.

 

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2.03                         RESERVATION OF RIGHTS.   The grant of rights in Sections 2.01 and 2.02 are subject to the rights of the United States government,  if any, in the Licensed Patents, the Jointly Owned Patents and Licensed Know-How and MAYO’s and its Affiliates’   reserved,  irrevocable and royalty-free right under the Licensed Patents and Jointly Owned Patents to make, have made, use,  offer for sale and sell, solely for the benefit of MAYO and its Affiliate’s internal programs, including research, any product or service and to use the Licensed Know-How for the same.  For avoidance of doubt, MAYO reserves the right to conduct Product Testing with third parties.

 

2.04                         ALL OTHER RIGHTS RESERVED. This Agreement does not grant a license to any patent or patent application (i) not defined in the Licensed Patents or the Jointly Owned Patents or Licensed Know-How that exists prior to the Effective Date or (ii) arising outside of FOUNDERS’ Product Development or FOUNDERS’ Product Testing.  Except as granted in Sections 2.01 and 2.02, no other license is granted by FOUNDERS under any intellectual property rights owned or controlled by FOUNDERS, including any patents, know-how, copyrights, proprietary information and trademarks.  All such rights are expressly reserved by FOUNDERS.  COMPANY acknowledges that in no event will this Agreement be construed as an assignment by MAYO or VGL to COMPANY of any intellectual property rights.  During the term of the obligation to confer under Section 2.02, subject to any obligations to third parties and MAYO policies, if MAYO, through Mayo Medical Ventures, becomes aware of any MAYO owned patent or patent application in the Field that is required for COMPANY to make, use or sell a COMPANY Product in the Field, and such patent or patent application is not otherwise licensed under this Agreement, MAYO will make its best efforts to so notify COMPANY to permit COMPANY to consider negotiating rights thereto before any third parties.

 

2.05                         CONFIDENTIALITY.  During the Term, and for a period of five (5) years thereafter, the parties agree to keep confidential by not disclosing to any third party any information (i) relating to this Agreement, including the terms and conditions thereof, except COMPANY may disclose the terms and conditions of this Agreement to its confidential advisors and agents and its existing or potential sublicensees or distributors, shareholders, investors or lenders, provided that if any such party refuses to sign a confidentiality agreement with terms at least as restrictive as those in this Section 2.05, COMPANY shall first notify FOUNDERS and obtain FOUNDERS written consent (including electronic correspondence) which will not be unreasonably withheld,  or (ii) other confidential information transmitted to one or two of the parties by another party. Each party may use this information solely as necessary for complying with the terms and conditions of this Agreement.  The obligations of non-disclosure and non-use will not apply when and to the extent such information:

 

(a)                                  becomes part of the public domain through no action or fault of the receiving party; or

 

(b)                                  was in the receiving party’s possession before disclosure, as demonstrated by the receiving party’s written records, and was not acquired, directly or indirectly, from the disclosing party; or

 

(c)                                   was received by the receiving party from a third party having a legal right to transmit such information.

 

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At a party’s request, the other party will cooperate fully in any legal actions taken by the requesting party to protect its rights in the information disclosed hereunder, and each party shall bear its own costs of any such action.

 

2.06                         PURCHASE [***].  MAYO may, at its sole option, purchase COMPANY Products in any quantity for use within MAYO’s and its Affiliates’ own programs [***] available to MAYO from COMPANY.  This [***].

 

Article 3.00 - Condition Precedent, Consideration and Royalties.

 

3.01                         SHARE ISSUANCE.  Concurrent with the execution of this Agreement, COMPANY has issued (i) to MAYO one million (1,000,000) shares of its fully-diluted common stock in partial consideration for MAYO’s obligations under this Agreement and (ii) to VGL one million (1,000,000) shares of its fully-diluted common stock in consideration for a cash payment of one thousand dollars (US$1,000).  This initial issuance is not an advance or creditable against any payments otherwise due under this Agreement.

 

3.02                         EARNED ROYALTIES.  COMPANY will pay MAYO, on behalf of FOUNDERS, a [***] percent ([***]%) earned royalty on Net Sales of those COMPANY Products that are covered by a Valid Claim within the Licensed Patents and Jointly Owned Patents in the country in which such products are sold, and a [***] percent ([***]%) earned royalty on Net Sales of any other Company Product (such royalties, the “Earned Royalties”).   MAYO will distribute one half (1/2) of all amounts it actually receives under Sections 3.02, 3.03, 3.08 and 7.02 to VGL, except as provided in Section 6.04.

 

The obligation to pay worldwide royalties on a COMPANY Product not covered by a Valid Claim within the Licensed Patents and Jointly Owned Patents shall, on a product-by-product and country-by-country basis, commence upon the First Commercial Sale of such COMPANY Product in a country and cease on December 31st of the fifth calendar year after the year within which the First Commercial Sale occurred in such country, unless such COMPANY Product becomes covered by a Valid Claim.  Thereafter, the obligation for COMPANY to pay royalties on a COMPANY Product that is not covered by a Valid Claim shall be considered paid-up.  The obligation to pay Earned Royalties under this Section 3.02 for a COMPANY Product covered by a Valid Claim shall run on a product-by-product and country-by-country basis until the last to expire of the Valid Claims within the Licensed Patents and Jointly Owned Patents covering such COMPANY Product in such country.

 

3.03                         MINIMUM ROYAL TIES.  In order for COMPANY to maintain its license, COMPANY will pay MAYO a minimum annual royalty of two hundred thousand dollars (US$200,000) for each of the second and third License Years after the First Commercial Sale in the United States or Europe of a COMPANY Product.  The Earned Royalties due and accrued under Section 3.02 within a given License Year are fully creditable against such minimum annual royalty due only for that License Year.  If the Earned Royalty does not equal or exceed the minimum annual royalty due, COMPANY will pay the difference.  Payment must be made within (30) thirty days after the last relevant License Year, and failure to do so constitutes a material breach of 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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3.04                         ROYALTY STACKING.  If COMPANY or its affiliate is a party to a license agreement with any third party under which COMPANY or its affiliate obtains a license for technology required for the manufacture, use or sale of a COMPANY Product and the total royalty due in the aggregate to one or more third parties exceeds [***] percent ([***]%), then COMPANY may reduce the Earned Royalties due to MAYO pursuant to Section 3.02 on such COMPANY Product (on a product-by-product basis) by [***] percent ([***]%) of the royalties that are payable to such third party; provided, however, that in no event will the Earned Royalties otherwise due under Section 3.02 be reduced to less than [***] percent ([***]%) of the Earned Royalties that would otherwise be payable to MAYO pursuant to Section 3.02 by operation of the foregoing reduction.

 

3.05                         KNOW-HOW RETAINER FEES. COMPANY shall pay MAYO a quarterly retainer fee of thirty-one thousand two hundred and fifty dollars (US$31,250) for the MNDG as partial compensation for its Licensed Know-How. The initial payment shall be due within thirty (30) days after April 1, 2006 and the following payments are due on a quarterly basis: July 1, October 1, January 1, and April 1 during the term of the commitment under Section 2.02. For avoidance of doubt, the last quarterly retainer fee payment shall be due on January 1, 2011.

 

3.06                         KNOW-HOW MILESTONE PAYMENTS. As partial compensation for providing the Licensed Know-How, COMPANY shall have a pool of five hundred thousand (500,000) COMPANY common shares which it shall issue to MAYO within ninety (90) days after FDA approval of the first COMPANY Product.

 

3.07                         CERTAIN COMMON STOCK PROVISIONS.   In connection with COMPANY’s obligation to issue shares of its common stock to FOUNDERS under Section 3.01 and to MAYO under Section 3.06, COMPANY and FOUNDERS hereby covenant and agree as follows:

 

(a)                                  COMPANY hereby represents and warrants that the terms of this Agreement have been duly and validly approved and authorized by all requisite corporate action of the Board of Directors of COMPANY, and that the performance of COMPANY’s obligations under this Agreement will not result in the violation of the terms or provisions of any other agreements to which COMPANY is a party or is otherwise bound.

 

(b)                                  COMPANY represents and warrants that a sufficient number of shares of COMPANY common stock for performance of COMPANY’s obligations under this Agreement have been and will continue to be duly and validly reserved for issuance by all requisite corporate action of the Board of Directors of COMPANY, and upon the issuance of the common stock in accordance with this Agreement such shares of common stock will be duly and validly issued and fully paid and non-assessable shares of capital stock of COMPANY.

 

(c)                                   COMPANY and FOUNDERS covenant and agree that the number of shares of COMPANY common stock that may be issued from time to time to MAYO in the future pursuant to the Section 3.06 shall be equitably adjusted to give effect to all stock combinations or stock splits affecting COMPANY common stock and all dividend distributions payable to holders of COMPANY common stock in shares of additional COMPANY common stock.

 

(d)                                  COMPANY agrees that, simultaneous with the occurrence of a Liquidation Event or simultaneous with the initial closing in an arrangement involving COMPANY’s first firm commitment underwritten public offering of its common stock under the Securities Act of 1933,

 


[***] 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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as amended, (the “Act”) MAYO shall automatically, and without need for further action, be entitled to receive, and shall be deemed the beneficial owner of, all shares of COMPANY common stock issuable pursuant to Section 3.06, regardless of whether the conditions precedent to such issuance as set forth in each Section 3.06 have theretofore been achieved or satisfied.  If at any time there is a recapitalization of COMPANY common stock (other than as contemplated upon the occurrence of a Liquidation Event), COMPANY agrees that MAYO shall automatically, and without need for further action, be entitled to receive the number of shares of capital stock or other securities or property to which a holder of an aggregate number of shares of COMPANY common stock equal to the maximum number of shares which MAYO may have become entitled to receive in the future pursuant to Section 3.06 would be entitled to receive in connection with such recapitalization, regardless of whether the conditions precedent to such issuances as set forth in Section 3.06 have theretofore been achieved or satisfied.  Upon issuance of common stock, capital stock or other securities pursuant to this Section 3.07(d), COMPANY shall have no further obligation to issue common stock to MAYO pursuant to the terms of this Agreement.  For the avoidance of doubt, this Section 3.07(d) does not apply to any type of financing transaction that COMPANY may undertake in the furtherance of its business, e.g., venture equity, venture debt, lease-line undertakings, etc.  For this purpose, “Liquidation Event” shall include (A) the closing of the sale, lease, exchange, exclusive licensing or other disposition of all or substantially all of COMPANY’s assets or intellectual property (whether in one transaction of a series of related transactions), (B) the consummation of the merger, business combination, reorganization or consolidation of COMPANY with or into another entity (except a merger or consolidation in which the holders of capital stock of COMPANY immediately prior to such merger or consolidation continue to hold at least 50% of the voting power of the capital stock of COMPANY or the surviving or acquiring entity), (C) the closing of the transfer (whether by merger, consolidation or otherwise), in one transaction or a series of related transactions, to a person or group of affiliated persons (other than an underwriter of COMPANY’s securities or in connection with an equity, debt or other financial transaction whose principal purpose is the financing of COMPANY), of COMPANY’s securities if, after such closing, such person or group of affiliated persons would hold 50% or more of the outstanding voting stock of COMPANY (or the surviving or acquiring entity) or (D) a liquidation, dissolution or winding up of COMPANY; provided, however, that a transaction shall not constitute a Liquidation Event if its sole purpose is to change the state of COMPANY’s incorporation or to create a holding company that will have substantially similar series and classes of shares with the same terms as existed immediately prior to such transaction and be owned in substantially the same proportions by the persons who held COMPANY’s securities immediately prior to such transaction.

 

(e)                                   FOUNDERS hereby represent and warrant that they are investors in securities of companies in the development stage and acknowledges that they are able to fend for themselves, can bear the economic risk of its investment, and have such knowledge and experience in financial or business matters that they are capable of evaluating the merits and risks of the investment in the common stock of COMPANY.  FOUNDERS also represent they have not been organized for the purpose of acquiring the common stock of COMPANY.

 

(f)                                    FOUNDERS hereby represent and warrant that they are “accredited investors” within the meaning of SEC Rule 501 of Regulation D, as presently in effect.

 

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(g)                                   FOUNDERS understand that the common stock of COMPANY will be characterized as “restricted securities” under the federal securities laws inasmuch as they are being acquired from COMPANY in a transaction not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration under the Act only in certain limited circumstances.  In this connection, FOUNDERS represent that they are familiar with SEC Rule 144, as presently in effect, and understand the resale limitations imposed thereby and by the Act.

 

(h)                                  Without in any way limiting the representations set forth above, FOUNDERS further agree not to make any disposition of all or any portion of the shares of common stock of COMPANY unless and until:

 

(1)                                  There is then in effect a registration statement under the Act covering such proposed disposition and such disposition is made in accordance with such registration statement; or

 

(2)                                  If requested by COMPANY, FOUNDERS shall have furnished COMPANY with an opinion of counsel, reasonably satisfactory to COMPANY, that such disposition will not require registration of such shares under the Act.   It is agreed that COMPANY will not require opinions of counsel for transactions made in reliance upon Rule 144 except in unusual circumstances.

 

Notwithstanding the provisions of subsections (1) and (2) above, no such registration statement or opinion of counsel shall be necessary for a transfer by FOUNDERS to any of their “affiliates,” as that term is defined under the Act, so long as such affiliate is an “accredited investor” (within the meaning of Regulation D under the Act).

 

(i)                                      It is understood that the certificates evidencing the common stock of COMPANY may bear a legend that refers to the shareholders agreement between the shareholders of COMPANY and states:

 

“These securities have not been registered under the Securities Act of 1933, as amended. They may not be sold, offered for sale, pledged or hypothecated in the absence of a registration statement in effect with respect to the securities under such Act or an opinion of counsel satisfactory to COMPANY that such registration is not required or unless sold pursuant to Rule 144 of such Act.”

 

3.08                         SUBLICENSE REVENUE:

 

(a)                                  COMPANY shall pay MAYO on behalf of FOUNDERS forty percent (40%) of all COMPANY Sublicense Revenue it receives during the Term for sublicenses executed within the first three (3) years after the Effective Date.  COMPANY shall pay MAYO on behalf of FOUNDERS twenty-five percent (25%) of all COMPANY Sublicense Revenue it receives during the Term for sublicenses executed thereafter.

 

(b)                                  Payments due with respect to COMPANY Sublicense Revenue are payable as described

 

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in Section 4.01.

 

3.09                         TAXES.  COMPANY is responsible for all taxes (other than net income taxes), duties, import deposits, assessments and other governmental charges, however designated, which are now or hereafter will be imposed by any authority on COMPANY (a) by reason of the performance by a FOUNDER of its obligations under this Agreement, or the payment of any amounts by COMPANY to a FOUNDER under this Agreement; or (b) based on the Licensed Patents, Joint Owned Patents, Licensed Know-How or use or sale of COMPANY Product.

 

3.10                         NO DEDUCTIONS.  All payments to be made by COMPANY to MAYO and/or FOUNDERS under this Agreement represent net amounts MAYO and/or FOUNDERS are entitled to receive, and will not be subject to any deductions or offsets for any reason whatsoever; provided, however, that COMPANY shall be entitled to deduct from payments due to FOUNDERS (as applicable) under this Agreement any taxes imposed upon MAYO and/or FOUNDERS with respect to such payments, if COMPANY is required to withhold such amounts under law.

 

3.11                         U.S. CURRENCY.  All payments to MAYO or FOUNDERS under this Agreement will be made by draft drawn on a United States bank, and payable in United States dollars.

 

3.12                         DISTRIBUTION OF CONSIDERATION WITHIN MAYO.  MAYO may distribute any of its funds received by reason of this Article 3.00 and Section 7.02 to individuals within the MNDG as MAYO, in its sole discretion, deems advisable and will hold COMPANY harmless from any claims by any person that any such distribution or related allocation is inadequate or unreasonable.

 

3.13                         RESEARCH AND CLINICAL TRIALS.   The parties acknowledge that any COMPANY-sponsored research or clinical trial at MAYO related to COMPANY Products will be subject to a separate agreement consisting of a defined protocol, associated budget and any terms and conditions that may be required by law or MAYO policy; however, all intellectual property arising from such research or trial shall be included in Licensed Patents, Jointly Owned Patents or Licensed Know-How, as applicable, and licensed to COMPANY pursuant to the provisions of this Agreement.  Any such separate agreement will not require any compensation beyond the mutually agreed upon costs for conducting the research or clinical trial.

 

3.14                         MAYO RESEARCH FUNDING.  MAYO shall have the right but not the obligation to propose that it provide to COMPANY research funding for Product Development and Product Testing efforts to be conducted at COMPANY’s direction.  COMPANY shall have the right, in its sole discretion, to accept or reject such proposal.  If it accepts such proposal, then if the parties mutually agree upon the scope of the research, the amount of the research funding, and the equity interest in COMPANY or other consideration that MAYO would receive for its provision of such funding, then the parties shall negotiate the terms of an agreement pursuant to which MAYO would provide such funding, COMPANY would direct such research, and MAYO would receive such mutually agreed consideration.

 

Article 4.00 - Accounting and Reports.

 

4.01                         PAYMENT.  COMPANY will deliver to FOUNDERS on or before February 1 of

 

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 each License Year a detailed written report stating Net Sales on which Earned Royalties are based, COMPANY Sublicense Revenue on which payment is due FOUNDERS and all activities for all other payments due under Article 3.00 for the preceding License Year.  Each such report will be accompanied by the payment(s) to MAYO due to FOUNDERS for such License Year.  In the event no royalties are due, COMPANY shall submit a detailed written report on the progress of the development of COMPANY Products and a timeline for commercialization of the same, including a description of activities conducted as set forth in Section 7.02.

 

4.02                         ACCOUNTING.  COMPANY will keep complete, true and accurate books of accounts and records sufficient to support calculation of Net Sales, COMPANY Sublicense Revenue and all other payment payable to FOUNDERS under this Agreement.  Such books and records will be kept at COMPANY’s principal place of business for at least three (3) years after the end of the License Year to which they pertain, and will be open at all reasonable times for inspection by a representative of FOUNDERS for verification of payments.  The FOUNDERS’ representative will treat as confidential all relevant matters and will be a person or firm reasonably acceptable to COMPANY.  In the event such audit reveals an underpayment by COMPANY, COMPANY will within thirty (30) days pay the amount due in excess of the payments actually paid.  In the event the audit reveals an underpayment by COMPANY of more than [***] percent ([***]%) of the amount due, COMPANY will pay interest on the amount due in excess of the amount actually paid at the highest rate then permitted by law.  In the latter event, COMPANY will pay all of FOUNDERS’ costs in conducting the audit.

 

Article 5.00- Warranties and Indemnification.

 

5.01                         USE OF NAME AND LOGO.  COMPANY and VGL will not use publicly for publicity, promotion or otherwise, any logo, name, trade name, service mark or trademark of MAYO or its Affiliates, including, but not limited to, the terms “MAYO®,” “MAYO Clinic®” and the triple shield MAYO logo, or any simulation, abbreviation or adaptation of the same, or the name of any MAYO employee or agent, without MAYO’s prior, written, express consent, which MAYO may withhold in its absolute discretion.  Upon MAYO’s prior written consent, COMPANY may disclose that it has obtained a license under certain patents and know-how from MAYO related to products in the Field, and that MAYO has an equity interest in COMPANY, where required for COMPANY to comply with laws, rules, regulations or rules of any securities exchange, which consent shall not be unreasonably withheld or delayed.

 

5.02                         DISCLAIMER.   Except as expressly set forth in Section 5.08, nothing in this Agreement will be construed as:

 

(a)                                  a warranty or representation by MAYO or VGL as to the validity or scope of any of the Licensed Patents, Jointly Owned Patents and Licensed Know-How; or

 

(b)                                  an obligation to bring or to prosecute actions against third parties for infringement of the Licensed Patents, Jointly Owned Patents or Licensed Know-How; or

 

(c)                                   a warranty or representation that the manufacture, use, sale, offer for sale or importation

 


[***] 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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of any COMPANY Product or the use or practice of any of the Licensed Patents, Jointly Owned Patents or Licensed Know-How are free from infringement or misappropriation of a third party’s intellectual property rights.

 

5.03                         DISCLAIMER.  EXCEPT AS PROVIDED HEREIN, MAYO AND VGL HAVE NOT MADE AND PRESENTLY MAKE NO PROMISES, GUARANTEES, REPRESENTATIONS OR WARRANTIES OF ANY NATURE, DIRECTLY OR INDIRECTLY, EXPRESS OR IMPLIED, REGARDING THE MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT FOR THE COMPANY PRODUCTS, LICENSED PATENTS, JOINTLY OWNED PATENTS OR LICENSED KNOW-HOW.   EXCEPT AS EXPRESSLY PROVIDED IN SECTION 5.02 OR 5.08, THE LICENSED KNOW-HOW, JOINTLY OWNED PATENTS AND LICENSED PATENTS WHICH ARE LICENSED UNDER THIS AGREEMENT ARE PROVIDED “AS IS,” “WITH ALL FAULTS” AND “WITH ALL DEFECTS.”  COMPANY IS SOLELY RESPONSIBLE FOR DETERMINING WHETHER THE LICENSED PATENTS, JOINTLY OWNED PATENTS AND LICENSED KNOW-HOW HEREUNDER HAVE APPLICABILITY OR UTILITY IN COMPANY’S MANUFACTURING, DESIGN, MARKETING AND SALES ACTIVITIES.  COMPANY ASSUMES ALL RISK AND LIABILITY IN CONNECTION WITH SUCH DETERMINATION.

 

5.04                         INDEMNIFICATION.   COMPANY will defend, indemnify and hold harmless FOUNDERS and MAYO’s Affiliates from any and all claims, actions, demands, judgments, losses, costs, expenses, damages and liabilities (including but not limited to attorneys’ fees and other expenses of litigation) (“Claim”), regardless of the legal theory asserted, arising out of or connected with:  (a) practice by COMPANY of inventions claimed in the Licensed Patents or Jointly Owned Patents or of the Licensed Know-How furnished or licensed under this Agreement; (b) design, manufacture, distribution, use, sale or other disposition of COMPANY Products by COMPANY, or its transferees or sublicensees; and (c) the Product Development and Product Testing to be conducted for COMPANY hereunder.  The foregoing obligations of COMPANY to indemnify are contingent upon FOUNDERS or MAYO’s Affiliates giving COMPANY prompt and timely notice of any claim requiring indemnification, granting to COMPANY the right to control the defense of any such claim including selection of counsel and the right to settle any such claim (including the right to grant sublicenses, without royalty to FOUNDERS) of any right licensed under this Agreement.  Notwithstanding the foregoing, COMPANY shall not, without MAYO’s prior written consent, settle or compromise any Claim in a manner that would require MAYO to admit liability or incur financial obligation.  MAYO and VGL may be represented by counsel of their own choosing, at their own expense.

 

5.05                         INSURANCE.  As used in Sections 5.04 and 5.05, MAYO and its Affiliates include the trustees, officers, agents, and employees of MAYO and its Affiliates.  COMPANY will, during the Term, carry claim-based liability insurance, including products liability and contractual liability, in an amount and for a time period sufficient to cover the liability assumed by COMPANY hereunder, such amount being at least two million dollars ($2,000,000).  In addition, such policy will name MAYO and VGL as an additional-named insured.  COMPANY may not settle any Claim in a manner that would require an admission of liability or incur financial obligation on the part of MAYO, without MAYO’s prior written consent.

 

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5.06                         WAIVER OF SUBROGATION.   COMPANY expressly waives any right of subrogation that it may have against VGL or MAYO resulting from any claim, demand, liability, judgment,  settlement, costs, fees (including attorneys’  fees) and expenses for which COMPANY has agreed to indemnify VGL, MAYO and its Affiliates or hold VGL, MAYO and its Affiliates harmless under this Agreement.

 

5.07                         ADDITIONAL WAIVERS.   SUBJECT TO COMPANY’S OBLIGATION TO INDEMNIFY FOUNDERS HEREUNDER,  IN NO EVENT WILL ANY PARTY’S LIABILITY TO THE OTHER PARTY OR PARTIES INCLUDE ANY SPECIAL, INDIRECT, INCIDENTAL,  CONSEQUENTIAL OR PUNITIVE LOSSES OR DAMAGES, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.   IN NO CASE WILL A FOUNDER’S LIABILITY OF ANY KIND EXCEED THE TOTAL PAYMENTS WHICH HAVE ACTUALLY BEEN PAID BY COMPANY UNDER THIS AGREEMENT AS OF THEDA TE OF FILING OF THE ACTION AGAINST MAYO, VGL, OR FOUNDERS WHICH RESULTS IN THE SETTLEMENT OR AWARD OF DAMAGES.

 

COMPANY ACKNOWLEDGES AND AGREES THAT MAYO WILL NOT LIABLE OR RESPONSIBLE FOR ANY ACTIONS OR OMISSIONS OF VGL UNDER THIS AGREEMENT AND VGL SHALL NOT BE LIABLE OR RESPONSIBLE FOR ANY ACTIONS OR OMISSIONS OF MAYO UNDER THIS AGREEMENT.

 

5.08                         REPRESENTATIONS AND WARRANTY.   MAYO and VGL represent and warrant (each individually only as to itself) that, in the Field, the employees of MAYO are under an obligation to assign their rights to MAYO and the VGL members or employees are under an obligation to assign their rights to VGL, that, to the best of their internal counsel’s knowledge as of the Effective Date and without a duty to inquire, MAYO and VGL are otherwise the lawful owners of their respective Licensed Patent rights licensed hereunder and the patent rights licensed hereunder are provided free and clear of any third-party ownership rights.  MAYO and VGL represent and warrant (each individually only as to itself) that this Agreement is binding upon it and that it has all rights necessary to grant the rights it purports to grant hereunder.  VGL represents and warrants that, to the best of its knowledge, no license will be required from EnteroMedics, Inc. for COMPANY and FOUNDERS’ research and commercialization efforts contemplated under this Agreement.  Notwithstanding the foregoing, nothing herein shall be construed as an express or implied representation or warranty of non-infringement, and COMPANY acknowledges that it may require rights to third-party intellectual property in order to practice the licenses granted hereunder.  VGL represents and warrants that no members or employees who owe their intellectual property rights in the Field to a third party will be permitted to participate in any activities of COMPANY or with MAYO, unless COMPANY or MAYO, as applicable, has given its prior written consent.

 

Article 6.00- Term and Termination.

 

6.01                         TERM.  This Agreement will commence on the Effective Date and, unless terminated earlier hereunder, will terminate upon the last to expire patent application or Valid Claim within the

 

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Patent Rights or COMPANY’s last obligation to make payments under Article 3.00, whichever occurs last (the “Term”).

 

6.02                         TERMINATION FOR BREACH .  If any party commits a material breach of this Agreement, including without limitation for COMPANY the failure to make any required payments hereunder, either of the other parties may notify the breaching party in writing of such breach and the breaching party will have sixty (60) days after such notice becomes effective as set forth in Section 9.07 to cure such breach, or this Agreement will automatically terminate; provided that, if this Agreement is terminated hereunder by COMPANY for material breach committed by MAYO or VGL, then this Agreement shall remain in effect except as set forth in Section 6.05(b).

 

6.03                         INSOLVENCY OF COMPANY.  MAYO or VGL may terminate this Agreement by transmitting a notice of termination to COMPANY in the event COMPANY ceases conducting business in the normal course, becomes insolvent or bankrupt, makes a general assignment for the benefit of creditors, admits in writing its inability to pay its debts as they are due, permits the appointment of a receiver for its business or assets, or avails itself of or becomes subject to any proceeding under any statute of any governing authority relating to insolvency or the protection of rights of creditors.

 

6.04                         EARLY TERMINATION OF CONFERENCE RIGHTS.  Starting three (3) years after the Effective Date of this Agreement, MAYO or VGL, at its discretion and without a showing of cause, may terminate the obligations to confer under Sections 2.02(a) and 2.02(b) by giving notice of such election to COMPANY.

 

(a)                                  If MAYO so terminates, then, upon such notice:

 

(1) COMPANY’s obligation to pay Earned Royalties under Section 3.02 to MAYO, on behalf of the FOUNDERS, shall be reduced from [***] percent ([***]%) of Net Sales of COMPANY Products that are covered by a Valid Claim within the Licensed Patents and Jointly Owned Patents in the country in which such COMPANY Products are sold to [***] percent ([***]%) on Net Sales for each such COMPANY Product, and from [***] percent ([***]%) on Net Sales of any other COMPANY Product to [***] percent ([***]%) on Net Sales of each such COMPANY Product; COMPANY’s obligation to pay amounts due pursuant to Section 3.08 with respect to COMPANY Sublicense Revenue shall be reduced to from forty percent (40%) of all such COMPANY Sublicense Revenue it receives during the Term for sublicenses executed within the first three (3) years after the Effective Date to twenty percent (20%) of all such COMPANY Sublicense Revenue, and from twenty five percent (25%) of all such COMPANY Sublicense Revenue it receives during the Term for sublicenses executed thereafter to twelve and one half percent (12.5%) of all such COMPANY Sublicense Revenue; and MAYO will distribute two-thirds (2/3) of all amounts it receives under this section to VGL;

 

(2)  any Licensed Know-How retainer fee obligations under Section 3.05 that have not accrued shall expire;

 

(3)  any Know-How milestone payment obligations under Section 3.06 that have 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

 

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accrued shall expire; and

 

(4)  the grant of licenses from MAYO for its Licensed Know-How to COMPANY shall become non-exclusive.

 

(b)                                  If VGL so terminates, then, upon such notice:

 

(1)          COMPANY’s obligation to pay Earned Royalties under Section 3.02 to MAYO, on behalf of FOUNDERS, shall be reduced from [***] percent ([***]%) of Net Sales of COMPANY Products that are covered by a Valid Claim within the Licensed Patents and Jointly Owned Patents in the country in which such COMPANY Products are sold to one and [***] percent ([***]%) on Net Sales for each such COMPANY Product, and from [***] percent ([***]%) on Net Sales of any other COMPANY Product to [***] percent ([***]%) on Net Sales of each such COMPANY Product; COMPANY’s obligation to pay amounts due pursuant to Section 3.08 with respect to COMPANY Sublicense Revenue shall be reduced to from forty percent (40%) of all such COMPANY Sublicense Revenue it receives during the Term for sublicenses executed within the first three (3) years after the Effective Date to twenty percent (20%) of all such COMPANY Sublicense Revenue, and from twenty five percent (25%) of all such COMPANY Sublicense Revenue it receives during the Term for sublicenses executed thereafter to twelve and one half percent (12.5%) of all such COMPANY Sublicense Revenue; and MAYO will distribute one-third (1/3) of all amounts it receives under this section to VGL; and

 

(2)  the grant of licenses from VGL for its Licensed Know-How to COMPANY shall become non-exclusive.

 

6.05                         CONSEQUENCES OF TERMINATION.

 

(a)          In the event of termination under Section 6.02 of this Agreement for COMPANY’s breach, the licenses to Licensed Patents and Jointly Owned Patents from FOUNDERS to COMPANY shall immediately terminate.   All licenses to Licensed Know-How shall become non-exclusive and any obligation to confer shall immediately terminate.

 

(b)          In the event of termination under Section 6.02 of this Agreement for breach by MAYO or VGL:

 

(1)          the licenses to COMPANY of Licensed Patents of that breaching FOUNDER and to that breaching FOUNDER’s interest in Jointly Owned Patents shall continue;

 

(2)          All licenses to Licensed Know-How of that breaching FOUNDER shall continue on a non-exclusive basis;

 

(3)          Any obligation of that breaching FOUNDER to confer shall immediately terminate.

 

(4)          Such termination will trigger the provisions of Section 6.04(a) if the breach is by MAYO or of Section 6.04(b) if the breach is by VGL.

 

(c)           In the event of termination of this Agreement under Section 6.03, all licenses granted

 


[***] 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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hereunder shall immediately terminate.

 

(d)          Subject to Section 6.05(a)-(c), nothing in this Agreement shall be construed to prohibit or enjoin COMPANY from continuing to use Licensed Know-How licensed from FOUNDERS for any reason.  In the event of any claim of breach, except as set forth in this Section 6.05, above, FOUNDERS waive any remedy that would otherwise enjoin COMPANY from using Licensed Know-How as licensed hereunder.   In the event MAYO or VGL terminates this Agreement under Section 6.02, COMPANY’s license under such Licensed Know-How shall not be terminated and COMPANY’s license to such Licensed Know-How (and obligation to make payments therefor) shall continue, but only on a non-exclusive basis.  In any arbitration or court proceeding involving this Agreement, it is the intention of the parties that the relief for FOUNDERS and the effect on COMPANY be as least as significant as FOUNDERS having the right to terminate the Licensed Know-How license and, in this regard, an arbitrator or court may grant FOUNDERS such additional relief as such arbitrator or court deems equitable to compensate FOUNDERS.

 

6.06                         Survival. Subject to the foregoing, the following sections survive any termination or expiration of this Agreement, per their terms: 2.05; 2.06 (except if this Agreement is terminated for breach by MAYO under Section 6.02); any payment obligations that accrued or are accruable up to the date of termination and thereafter as may be set forth in Article 3.00; 3.07(g), (h) and (i); Article 4.00 (solely as to payments accruing during the term of the Agreement); Article 5.00; Article 6.00; all payment obligations of COMPANY that accrued or are accruable under Article 8.00; and Article 9.00.

 

Article 7.00- Representation and Warranties.

 

7.01                         REPRESENTATIONS OF COMPANY.  COMPANY represents and warrants to FOUNDERS that it has independently evaluated the Licensed Patents, Jointly Owned Patents and Licensed Know-How and is entering into this Agreement on the basis of its own evaluation and not in reliance of any representation by FOUNDERS. COMPANY represents and warrants that it shall have a minimum of one hundred thousand dollars (US$100,000) of available funding by April 28, 2006 and shall raise, at a minimum, financing of five hundred thousand dollars (US$500,000) for COMPANY purposes, including COMPANY Product research and development, by January 31, 2007.

 

7.02                         COMMERCIALIZATION EFFORTS. COMPANY will use commercially reasonable efforts to research, develop and commercialize COMPANY Product(s). If COMPANY has not submitted an application for IDE to the FDA for a COMPANY Product within seven (7) years after the Effective Date, the license to COMPANY for Licensed Patents and Licensed Know- How shall terminate unless COMPANY pays FOUNDERS an annual license maintenance fee of five hundred thousand dollars (US$500,000) per year for each year such trial is not started. The first such payment is due within thirty (30) days of the seventh (7th) anniversary of the Effective Date, and subsequent maintenance fees are due within thirty (30) days of subsequent anniversary dates of the Effective Date.

 

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Article 8.00- Patents

 

8.01                         Patent Filing, Prosecution, Maintenance and Enforcement. All patent applications filed within the Licensed Patents shall be assigned as follows:

 

(a)          to MAYO for all inventions invented solely by one or more employees of Mayo;

 

(b)          to VGL for all inventions invented solely by one or more employees of VGL; and

 

(c)           jointly to the respective parties for all inventions invented jointly by one or more employees of such parties.

 

COMPANY shall have control and authority to direct prosecution of the Licensed Patents and Jointly Owned Patents, including the right to amend such patent applications and file new patent applications which shall be considered within the definition of Licensed Patents and/or Jointly Owned Patents, and FOUNDERS will be afforded the opportunity to advise and consult on all such filings and the prosecution.  In addition, COMPANY will provide FOUNDERS with copies of all papers submitted to or received from the United States Patent and Trademark Office on a timely basis.  For so long as the license to Licensed Patents and Jointly Owned Patents remains exclusive, COMPANY shall have control and authority to direct the enforcement and defense of the Licensed Patents in the Field and the Jointly Owned Patents.  COMPANY shall be responsible for all costs and expenses related to prosecution, maintenance, enforcement and defense of the Licensed Patents after the Effective Date and reimbursement of Licensed Patents invoice costs incurred prior to the Effective Date (such invoice costs to be limited to thirty thousand dollars (US$30,000) in total).  COMPANY shall be responsible for all costs and expenses related to prosecution, maintenance, enforcement and defense of the Jointly Owned Patents.  FOUNDERS agree to take such actions as are reasonably necessary for COMPANY to file, prosecute, maintain, enforce and defend the Licensed Patents and Jointly Owned Patents,  and will cooperate with COMPANY in any such matters except financially.  MAYO may not be joined as a party to any litigation, unless deemed a necessary party by law.  If MAYO is joined, COMPANY will pay all costs on a monthly basis, including attorneys’ fees, incurred by MAYO with respect thereto and will indemnify MAYO for any damages that may result from such litigation.  MAYO may be represented by counsel of its own choosing.  Any recoveries will first be used to reimburse each party’s out-of-pocket costs incurred in connection with such action (including, if applicable, under Section 5.04), and thereafter will be shared equally by the parties.

 

If COMPANY determines in its sole discretion to abandon any patent application or not to file any continuation patent application with claims suggested by FOUNDERS within the Licensed Patents or Jointly Owned Patent Rights that are assigned or co-assigned to MAYO and/or VGL, COMPANY will provide FOUNDERS with thirty (30) days prior written notice of such determination and provide FOUNDER assignee(s) with the opportunity to prosecute, enforce, defend and maintain such patent or patent application at FOUNDER assignee(s)’ sole expense, and the license granted to COMPANY with respect to such patent or patent application shall convert to a non-exclusive license.  This conversion of rights to non-exclusive shall not apply to any decision by COMPANY not to file in any country other than the United States.  COMPANY shall have the sole discretion, without penalty, to opt to forego any foreign filing, provided that upon COMPANY’s making such a decision, FOUNDERS shall be entitled to

 

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pursue the foreign tiling at their own expense. Upon termination of this Agreement, the parties shall confer as to the responsibility of prosecution, maintenance, enforcement and defense of Jointly-Owned Patents; MAYO and VGL shall retain their sole rights to prosecute, maintain, enforce and defend any Licensed Patents assigned exclusively to either MAYO or VGL; and MAYO and VGL shall confer as to the responsibility of prosecution, maintenance, enforcement and defense of Licensed Patent that are co-assigned to MAYO and VGL.

 

8.02                         THIRD PARTY LITIGATION.  In the event a third party institutes a suit against COMPANY for patent infringement involving a COMPANY Product, COMPANY will promptly inform FOUNDERS and keep FOUNDERS regularly informed of the proceedings.  In the event the third party sues or joins FOUNDERS, COMPANY will defend FOUNDERS pursuant to the indemnification obligation in Section 5.04.  Any recoveries will first be used to reimburse each party’s out-of-pocket costs incurred in connection with such action (including, if applicable, under Section 5.04), and thereafter will be shared by the parties such that COMPANY shall pay to MAYO royalties on such amount as if such recovered amount were Net Sales of COMPANY Products, and MAYO shall share its portion of such recovery with VGL as if such amount were royalties on Net Sales of COMPANY Products.

 

8.03                         KEY PATENT OWNERSHIP.  Prior to the submission of an IDE for a COMPANY Product, the parties will meet to discuss whether any Jointly Owned Patents are Key Patent(s) for such COMPANY Product.  “Key Patent(s)” shall mean one or more patents or applications within the Jointly Owned Patents that claim inventions material to the manufacture, use,  operation or other aspect of such COMPANY Product, and that are not then licensed to any third party.  MAYO and VGL (to the extent either such party holds any rights in such Key Patent), shall assign all right, title and interest in and to such Key Patent to COMPANY, subject to COMPANY’s continuing obligations to pay royalties on sales of COMPANY Products covered by a Valid Claim within such Key Patent as if such Key Patent were still a Jointly Owned Patent, in accordance with the terms and conditions of this Agreement.  COMPANY shall grant to MAYO and/or VGL, whichever has assigned its interest therein to COMPANY, a fully paid up, fully sublicensable right and license under such Key Patent to make, have made, use, offer for sale, sell and import products and services outside the Field.  The Key Patent shall remain subject to the terms and conditions of this Agreement, including FOUNDERS’ retained rights to use the inventions claimed therein internally as provided in Section 2.03.

 

Article 9.00 - General Provisions.

 

9.01                         AMENDMENTS.  This Agreement may not be amended or modified except by a writing signed by the parties and identified as an amendment to this Agreement.

 

9.02                         ASSIGNMENT. A party may not assign its rights hereunder to any third party without the prior written consent of the other parties; provided that a party may assign its rights without the prior written consent of the other parties to any affiliate or other entity that controls, is controlled by or is under common control with such party.  Notwithstanding the foregoing, COMPANY is free to transfer or assign this Agreement (or any rights granted under this Agreement) to its successor, whether by way of merger, consolidation, reorganization or acquisition of stock or sale of substantially all of its assets relating to the subject matter of this

 

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Agreement.  COMPANY will promptly notify FOUNDERS of any such assignment.  Any purported assignment in violation of this clause is void.  Any assignment shall not in any manner relieve the assignor from liability for the performance of this Agreement by its assignee.  The assignee shall agree to be fully bound by the terms and conditions of this Agreement.  If COMPANY assigns this Agreement in accordance with this Section 9.02, MAYO’s and VGL’s obligations under Sections 2.02(a) and 2.02(b) shall terminate, unless, within sixty (60) days after an assignment pursuant to this Section 9.02, MAYO, in its sole discretion, provides notice that it desires to continue to confer per the terms of this Agreement.  If MAYO fails to provide such notice within sixty (60) days of notification of assignment in writing by COMPANY, (1) no Know-How retainer fees under Section 3.05 shall thereafter accrue and be payable; and (2) no Know-How milestone payments under Section 3.06 shall thereafter accrue and be payable.

 

9.03                         BINDING EFFECT.  This Agreement shall be binding upon and inure to the benefit of the parties, their heirs, legal representatives, successors and permitted assigns.

 

9.04                         ENTIRE AGREEMENT.  This Agreement, including Exhibit A, constitutes the final, complete and exclusive agreement between the parties with respect to its subject matter and supersedes all past and contemporaneous agreements, promises and understandings, whether oral or written, between the parties.

 

9.05                         INDEPENDENT CONTRACTOR. It is mutually understood and agreed that the relationship between the parties is that of independent contractors. Neither party is the agent, employee, or servant of the other. Except as specifically set forth herein, neither party shall have nor exercise any control or direction over the methods by which the other party performs work or obligations under this Agreement. Further, nothing in this Agreement is intended to create any partnership, joint venture, lease or equity relationship, expressly or by implication, between the parties. Neither VGL nor Mayo shall have the right to bind or otherwise obligate the other to any commitment or contract or act on the other’s behalf under this Agreement.

 

9.06                         ARBITRATION.  Any disputes as described in Exhibit A will be arbitrated as set forth therein.

 

9.07                         NOTICES.  All notices and other business communications between the parties related to this Agreement shall be in writing, sent by certified mail, addressed as follows:

 

If to COMPANY:                                                                          NBI Development,  Inc.

Attn: Robert Nickoloff: CEO

2800 Patton Road

St. Paul, MN 55113

Facsimile:  (651) 634-3212

 

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with a copy to:

Latham & Watkins LLP

Attn: Michael Pucker

Sears Tower, Suite 5800

233 South Wacker Drive

Chicago, IL 60606

Facsimile:  (312) 993-9767

 

If to VGL:                                                                                                                VenturiGroup, LLC

2800 Patton Road

St. Paul, MN 55113

Facsimile:  (651) 634-3212

 

If to MAYO:                                                                                                   Mayo Medical Ventures

Attn: Leif Nelson

200 First Street SW

Rochester, MN  55905

Facsimile:  (507) 284-5410

 

with a copy to:

MAYO Legal Department

Attn: General Counsel

200 First Street SW

Rochester, MN 55905

Facsimile:  (507) 284-0929

 

Notices sent by certified mail shall be deemed delivered on the third day following the date of mailing. Either party may change its address or facsimile number by giving written notice in compliance with this Section 9.07.

 

9.08                         SEVERABILITY.  In the event any provision of this Agreement is held to be invalid or unenforceable, the remainder of this Agreement shall remain in full force and effect as if the invalid or unenforceable provision had never been a part of this Agreement.

 

9.09                         WAIVER. The failure of either party to complain of any default by the other party or to enforce any of such party’s rights, no matter how long such failure may continue, will not constitute a waiver of the party’s rights under this Agreement. The waiver by either party of any breach of any provision of this Agreement shall not be construed as a waiver of any subsequent breach of the same or any other provision. No part of this Agreement may be waived except by the further written agreement of the parties.

 

9.10                         LIMITATION OF RIGHTS.   Subject to Section 9.03, this Agreement is intended only to benefit the parties hereto.  They have no intention to create any interests for any other party. Specifically, no interests are intended to be created for any customer, patient, research subjects or other persons (or their relatives, heirs, dependents or personal representatives) by or upon whom COMPANY Products may be used.

 

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9.11                         CONSTRUCTION.  The parties agree to all of the terms of this Agreement and have executed it only after reviewing it thoroughly. That one party may have drafted all or a part of this Agreement will not cause this Agreement to be read more strictly against the drafting party. This Agreement, and any changes to it, will be interpreted on the basis that the parties contributed equally to the drafting of each of its parts.

 

9.12                         FORCE MAJEURE.  Neither party shall be responsible for the non-performance of its obligations under this Agreement if such non-performance is caused directly or indirectly by acts of God, acts of civil or military authority, civil disturbance, war, terrorism, fires, or strikes. The party so affected shall give notice to the other party and shall do everything reasonably possible to resume performance.

 

9.13                         GOVERNING LAW.  This Agreement shall be governed by the laws of the State of Minnesota, without giving effect to its conflict of laws principles.

 

[Signature Page Follows]

 

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MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH:

 

 

 

Signed:

/s/ Steven P. VanNurden

 

 

 

 

Printed Name:

Steven P. VanNurden

 

 

 

 

Title:

Assistant Treasurer

 

 

 

 

Date:

10/02/2006

 

 

 

 

VENTURI GROUP, LLC

 

 

 

 

Signed:

/s/ Mark. B. Knudson

 

 

 

 

Printed Name:

Mark B. Knudson

 

 

 

 

Title:

Managing Member

 

 

 

 

Date:

10/02/2006

 

 

 

 

COMPANY

 

 

 

 

Signed:

/s/ Robert S. Nickoloff

 

 

 

 

Printed Name:

Robert S. Nickoloff

 

 

 

 

Title:

President

 

 

 

 

Date:

10/02/2006

 

 

[A/R License Agreement]

 



 

EXHIBIT A

 

MANDATORY MEDIATION AND BINDING ARBITRATION

 

1.                                       NOTICE OF DISPUTE.   Any dispute related to this Agreement between the parties, including its formation, performance, or termination, which cannot be resolved by the parties themselves within thirty (30) days after written notice by one party to another of the existence of a dispute, may be referred by either of the parties to mandatory mediation and binding arbitration under the terms of this Exhibit A.  The parties intend the mediation/arbitration procedure described in this Exhibit A to substitute in all cases for litigation related to any such dispute, subject only to Section 7 of this Exhibit A, and this agreement to submit all such disputes to mandatory mediation and binding arbitration is irrevocable.

 

2.                                       LIMITATION PERIOD. No demand for mediation/arbitration may be made regarding any claim more than one hundred eighty (180) days after written notice by one party to the other of the existence of a dispute, regardless of any otherwise applicable statute of limitations.

 

3.                                       MEDIA TOR/ARBITRATOR.  If the parties cannot agree upon a single mediator/arbitrator within fourteen (14) days after written demand by either of them for mediation/arbitration, then a single mediator/arbitrator shall be chosen by the American Arbitration Association office in Minneapolis, Minnesota, within thirty (30) additional days after the fourteen (14) day period. The mediator/arbitrator shall be generally experienced in the legal and technical matters related to the dispute.

 

4.                                       MEDIATION.   Within thirty (30) days after the appointment of the mediator/arbitrator, the parties must attend a mediation session at which the mediator/arbitrator personally shall attempt to guide the parties to a settlement.  Each party may be represented by counsel at the mediation, but each party must attend through an officer having authority to agree to a settlement at the mediation.  The mediation session shall occur in Minneapolis or in St. Paul, Minnesota, and shall extend no longer than a single day.  Statements or offers made at the mediation session shall not be admissible in any later arbitration hearing.

 

5.                                       ARBITRATION .   If such mediation has not resulted in a mutually-executed settlement agreement (or withdrawal of claim) within five (5) business days after the date of mediation, then the parties shall proceed to arbitration as described below.   Such arbitration, which the parties intend to be final and to substitute for litigation, shall occur in Minneapolis or in St. Paul, Minnesota, and the arbitration results may be entered as a final judgment in any court with jurisdiction.   The decision of the arbitrator shall be final and binding upon the parties both as to law and fact.

 

(a)                                  Initial Disclosures.   Within twenty-one (21) days after the date of mediation, the parties shall exchange written disclosures listing with reasonable specificity: (i) all exhibits expected to be used by the party at arbitration, and complete copies of such exhibits, (ii) all witnesses expected to be called by the party at arbitration, and (iii) the substance of the testimony of each witness.  Copies of such disclosures shall be sent to the arbitrator. No exhibit or witness may be called if the same does not appear on such disclosure, and

 

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no witness may testify as to matters not described in such disclosure, except for rebuttal testimony as may be permitted by the arbitrator.

 

(b)                                  Discovery Period.  Within fourteen (14) days after exchange of the disclosure notices, the parties shall make specific discovery requests to the arbitrator, and within an additional fourteen (14) days the arbitrator shall issue to both parties a joint discovery order.  The discovery period preceding the arbitration hearing shall not exceed sixty (60) days from the issuance of the discovery order by the arbitrator.

 

(c)                                   Scope of Discovery.  Discovery shall be limited to that ordered by the arbitrator as being reasonable and necessary, and in no case shall exceed the deposition of two (2) witnesses for each party, and/or the exchange of more than a total of twenty-five (25) specific and non-compound interrogatories by each party, and/or two specific requests by each party for the production of documents considered by the arbitrator to be reasonably relevant and not unduly burdensome.

 

(d)                                  Hearing.  The arbitration hearing, which shall be confidential to the parties and not open to the public, shall not exceed two (2) separate days, and shall be completed within thirty (30) days after the close of discovery.  The arbitrator may admit any testimony or other evidence which the arbitrator decides is reasonably relevant to the issues of the arbitration, but excluding statements or offers made by either party at the mediation session.

 

(e)                                   Final Decision.  The arbitrator shall issue a final written decision no later than sixty (60) days following the end of the arbitration hearing, stating findings as to law and fact.  In any final decision, the arbitrator shall be free to grant a continuing license to COMPANY to any Licensed Know- How or Licensed Patents on terms deemed by the arbitrator to be just and equitable (such terms to include subject matter or geographic scope of any continuing license, royalty rate, degree of exclusivity).  The decision shall be confidential to the parties.  The arbitrator shall be limited to determining and ordering the payment of actual and direct damages if any, and may order the payment of indirect, special, incidental, or consequential damages only where bad faith has been shown and/or to the extent required to fulfill any obligations under Article 7.00 of the .  The arbitrator shall not order the payment of punitive or exemplary damages in any case.

 

6.                                       COSTS AND FEES.  Each party shall be responsible for its own costs and fees (including attorney’s fees), and shall divide common costs and fees equally; however, if the arbitrator specifically finds bad faith on the part of a party, then the arbitrator may order a different division of costs and fees.

 

7.                                       EQUITABLE RELIEF.  Nothing in this Exhibit A prohibits a party from seeking equitable relief to protect its rights to the extent that irreparable harm may occur and damages would not be a sufficient remedy, except that a party shall not seek to enjoin mediation/arbitration as described in this Exhibit A.

 

(a)                                  Specific Performance.  Among the equitable remedies that a party may seek under this Section 7 of this Exhibit A, either party may petition a court for specific performance of

 

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the terms of this Exhibit A, including following the failure of either party without good cause to adhere to the time limits set out in this Exhibit A.  A party securing an order for specific performance under this Section 7(a) of this Exhibit A is entitled to recover costs and reasonable attorneys’ fees in connection with such petition for specific performance and any related hearings.

 

8.                                       SURVIVAL.  The rights and obligations of the parties described in this Exhibit A survive the termination, expiration, non-renewal, or rescission of this Agreement.

 

9.                                       GOVERNING RULES AND LAW.  To the extent not inconsistent with the terms of this Exhibit A, the mediation and arbitration are governed by the rules of the American Arbitration Association, the Minnesota Arbitration Act, and the Federal Arbitration Act (9 U.S.C § I, et seq.).

 

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Exhibit 10.2(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

 

STELLAR MANUFACTURING AGREEMENT

 

This Stellar Manufacturing Agreement (“Agreement”), effective the 1st day of July, 2009 (the “Effective Date”) , by and between Stellar Technologies, Inc., a Minnesota corporation (“Stellar”) and Nevro Corp., a Delaware corporation, having a place of business at 411 Acacia Avenue, Palo Alto, CA 94306 (“Customer”) (Stellar and Customer are the “Party[ies]”).

 

In consideration of the mutual covenants contained in this Agreement, the receipt and sufficiency of which are hereby acknowledged, Customer and Stellar agree as follows:

 

1.)                                   Appointment.  Customer hereby appoints Stellar as its supplier of all percutaneous leads and percutaneous lead extenders for neurological stimulation and related services that Customer orders from Stellar during the Contract Term.  All plans, designs and specifications used by Stellar in manufacturing or providing any Products and Services are designed solely by Customer and are owned exclusively by Customer.  Customer agrees to indemnify and hold Stellar harmless from any claims, judgments, penalties, recalls and attorney fees arising from any third-party allegations that Customer’s plans, designs and specifications for the Products infringe on or violate any third party’s patents, trade secrets, proprietary rights or other intellectual property rights.  Stellar will cooperate with Customer’s efforts to obtain regulatory approval for its Products from governmental authorities (“Regulatory Approvals”) without conveying to Customer or any governmental authorities any right, title or interest in its Confidential Information and Intellectual Property as defined herein.

 

2.)                                   Definitions.  For purposes of this Agreement, “Product(s)” means percutaneous leads and percutaneous lead extenders for neurological stimulation, including parts, components, supplies and finished devices, manufactured by Stellar for Customer.  “Service(s)” means any work or other services performed by Stellar for Customer, including without limitation any process and any work that may increase the effectiveness, efficiency or safety of any Products.  “Purchase Order Acknowledgment” refers to Stellar’s Purchase Order Acknowledgment as defined in Section 5; it does not refer to any of Customer’s Purchase Orders, requests for proposal, requests for quotations, shipping documents and other Customer documents relating to the Products and Services (collectively, “Customer Records”).  “Subcontractor” refers to Customer’s subassembly contractors or other subcontractors; “Subcontractor” does not include any buyer, licensee or other transferee of Customer or Customer’s assets, including without limitation a successor, assignee or transferee under a Customer Sale or Product/Service Transfer as defined in Section 22.  “Buyer” refers to a successor, assignee or transferee under a Customer Sale or Product/Service Transfer as defined in Section 22.  Buyer is deemed to assume all of Customer’s obligations under this Agreement, subject to the provisions of Section 25.

 

3.)                                   Term of Agreement.  This Agreement is for a term of five (5) years, beginning the Effective Date, and will automatically renew for an additional year on each subsequent annual anniversary date, unless terminated by either party in writing at least thirty (30) days prior to the expiration of the then-current term (“Contract Term”).  All Purchase Orders issued or approved by Stellar prior to the expiration date of the then-current Contract Term shall remain in effect

 



 

through the date of Stellar’s last scheduled shipment made under that Purchase Order, even if manufacturing and shipment occur after the expiration or other termination of this Agreement (“Last Shipment”).  The terms of this Agreement shall also remain in effect through the Last Shipment.  In addition, Customer’s Indemnity described in Section 17 and the Continuation Charge described in Section 24 shall survive the expiration or termination of this Agreement, subject to the terms hereof.

 

4.)                                   Voluntary Termination by Stellar or Customer.  Stellar may terminate this Agreement at-will at any time on six (6) months’ notice (“Stellar Voluntary Termination”), without incurring any liability or obligation to Customer, except Customer’s right to a Last Time Buy under Section 12.  Customer may make a Last Time Buy at any time through the last day of the six (6)-month notice period.  In the event of a Stellar Voluntary Termination, Customer is not liable for the Continuation Charge.

 

Customer may also terminate this Agreement at-will at any time (“Customer Voluntary Termination”), provided Customer pays Stellar all amounts due or to become due under this Agreement, together with the Continuation Charge, immediately upon receipt of Stellar’s invoices for such amounts.  The amounts due or to become due include, without limitation: (a) the Price and other sums due under Section 10; (b) any costs under Section 11; (c) any remedies for Customer’s Default under Sections 22 and 23; (d) the Continuation Charge; and (e) any Adjustments and other costs under Exhibit A, Price Terms.

 

If Customer or Buyer is unable to obtain FDA approval of the Products, this shall also be deemed a Customer Voluntary Termination and Customer and Buyer shall remain liable for all amounts due or to become under this Agreement, except for the Continuation Charge.

 

5.)                                   Preferred Supplier Clause, Purchase Orders and Purchase Order Acknowledgments.  Customer designates Stellar as its preferred supplier of the Products and Services throughout the Contract Term.  Customer will in good faith negotiate exclusively with Stellar for a period of thirty (30) days after giving Stellar written notice of its interest in negotiations before engaging any other suppliers or vendors of the Products and Services.

 

During the Contract Term, Customer or its Subcontractor(s) shall submit its own purchase orders or other requests for Products and Services to Stellar (“collectively, “Purchase Order(s)”).  Customer’s Purchase Orders may include such terms as components, price, quantity, delivery schedule (including proposed shipping dates and quantities), whether the Products will be delivered to the Customer or Subcontractor, plans, drawings, material specifications, process specifications, and other Customer specifications and requirements (“Terms”).

 

Within five (5) business days after receipt of a Purchase Order, Stellar will issue a Purchase Order Acknowledgment signed by Stellar (“Purchase Order Acknowledgment”) accepting the Terms of the Purchase Order, except the price and delivery schedules and deadlines.  Stellar may amend (a) the price to conform to the Price Terms, Exhibit A, attached, and (b) the delivery schedules and deadlines for the Products and Services if the Purchase Order requests substantially more Products and Services than the forecasted amount .   Any such revisions to the price and delivery schedules and deadlines shall be incorporated into, and become a Term of, the Purchase Order.  Customer may not revise Stellar’s price and revised

 

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delivery and deadline Term except upon prior written consent of Stellar’s Chief Executive Officer.  All Purchase Orders are subject to the terms of this Agreement.

 

6.)                                   Right to Reject.  Stellar is only obligated to provide Products and Services under the Terms of Purchase Orders that it has approved in writing, subject to Changes, as defined in Section 7.  Stellar may reject any Change proposed by Customer, in Stellar’s discretion.

 

7.)                                   Changes.  For purposes of this Agreement and any Purchase Order, “Change” means a change in materials, process, procedures or facilities that materially affects the Product or Service.  “Change” does not include alterations in the Product or Service characteristics that fit within the Customer’s specifications that are in effect on the date Stellar performs such work, and it does not include “Variations” as defined below.  Furthermore, Stellar does not make any Changes or Variations to Customer’s plans, designs and specifications for any Products or Services.

 

Stellar agrees to inform Customer of any process change that affects the fit, form or function of the Products.  Stellar agrees to notify Customer of any Changes in advance so that Customer may determine whether the Changes could affect the quality of a finished Product or Service.  Such notification shall be made in sufficient detail to allow the Customer to determine the impact of such Changes, if any, upon the affected finished Product or Service.

 

Stellar is not required to provide Customer prior notice in connection with the following variations in the following manufacturing processes, materials and other activities, provided Stellar complies with all specifications, drawings, material specifications, process specifications, and other Customer requirements as specifically set forth in the Purchase Orders (collectively, “Variations”):

 

(a)                                  Stellar may purchase materials, tools and any other items which it deemsappropriate for performance of any Purchase Order from multiple vendors, provided such purchases meet the applicable Customer specifications;

 

(b)                                  Stellar may use one or more pieces of equipment for material processing provided the relevant processing method does not change.  For example, and not by way of limitation, Stellar may use different machines for cutting, laser-cutting, EDM, grinding and any other processing method.  The material processing will be verified by inspection and certified to Customer’s written specifications.  Part numbers are not machine-specific;

 

(c)                                   Stellar may incorporate secondary processes as required in Stellar’s discretion, including, for example, manufacturing to meet Customer specifications for the removal of burrs, lot to lot.  Such secondary processes may include, without limitation, tumbling, bead-blasting, cryo-tumbling, slurry process, and other secondary processes; and

 

(d)                                  Stellar may use one or more methods and chemicals to remove foreign matter from any Products during the manufacturing process, lot to lot.  All chemicals used must be on Stellar’s Approved Chemical List, available upon request.

 

8.)                                   Certificate of Conformance.  Stellar shall provide a written Certificate of Conformance with each delivery of Products or Services.

 

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9.)                                   Delivery.  Stellar shall deliver Products and Services to Customer, F.O.B., Stellar Technologies, Inc. warehouse, Brooklyn Park, Minnesota.  Packaging and delivery shall be made in accordance with Stellar’s policies in effect on the date of delivery.  Title to, and all risk of loss or damage with respect to, the Products and Services shall pass to Customer upon delivery for shipment at Stellar’s warehouse.  Delivery is subject to Stellar’s receipt of all necessary information and documentation from Customer, including all required certificates, licenses and documents required for export of the Products and Services.  Stellar is not liable for any delays in delivery beyond the reasonable control of Stellar and Stellar’s suppliers, including but not limited to:  (a) delays caused by unavailability or shortages of labor, fuel, power, materials, Products and Services, at customary and reasonable prices, rates and times; (b) natural disasters, acts of war, fire, flood or other casualty, strike, riot, or governmental interference; (c) failure or destruction of plant or equipment arising from any cause whatsoever; or (d) transportation delays.  Stellar will inform Customer or its Subcontractor(s) of any delays in delivery of Product within five (5) days after knowledge of the delays.  Stellar will not charge increased unit prices under Exhibit A, Section 7, for its own delays.  Stellar is not responsible for purchasing insurance for any shipments unless specified in the Purchase Order, in which event such insurance shall be based on Customer’s valuation and purchased at Customer’s sole expense.  Regardless of whether Stellar purchases such insurance, Stellar is not liable for any damage or loss to the Products and Services, and Customer waives all claims for such damage or loss against Stellar, and instead assumes all liability for such damage or loss.

 

10.)                            Price and Payment.  Customer shall remit payment to Stellar for all Products and Services within thirty (30) days after the date of Stellar’s delivery, regardless of the circumstances.  Customer agrees to pay Stellar the full amount of the price of the Products and Services set forth in each Purchase Order and any Schedules and Addenda referenced therein, plus any sums payable to Stellar under this Agreement (collectively, “Price”), as they accrue.  All of Stellar’s invoices shall be due within thirty (30) days after the date of the invoice except invoices for (a) deliveries of Products and Services (which are due and payable within thirty (30) days after the date of delivery) and (b) amounts immediately due and payable under this Agreement.  Invoices due within 30 days after the date of the invoice include, without limitation, invoices for modifications, revisions and cancellations under Section 11 and invoices for BAL seals under Exhibit A, Price Terms, Section 6.  If there is any inconsistency between the payment terms of any documents, the payment terms contained in this Section 10 govern.  However, if Customer is in Default, all Purchase Orders and invoices shall be immediately due and payable.  Customer shall pay all federal, state, municipal and other government taxes (such as sales, use, and similar taxes), as well as import or customs duties, license fees and similar charges relating to all sales.  Exemption certificates must be presented by Customer prior to delivery if they are to be honored.  Stellar may charge interest on all unpaid invoices at a rate equal to the lesser of (a) one and one-half percent (1-1/2%) per month on the unpaid balance, calculated from the date due; or (b) the highest rate allowed by law.  If Stellar accepts payment by check, Customer agrees to pay Stellar an administrative fee of $100.00 for each check that is dishonored, returned “NSF”, or which is subject to a “stop payment” order, plus any penalty or other costs incurred by Stellar as a result of such nonpayment.

 

11.)                            Purchase Order Modification or Cancellation by Customer or Stellar.  Customer may modify or cancel a Purchase Order within thirty (30) days after the date of the Purchase Order (“30-Day Period”).  Such modification or cancellation must be in writing and received by Stellar within the 30-Day Period or it is void.

 

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Upon receipt of such timely notice (that is, within the 30-Day Period), if Customer notifies Stellar that it is only delaying delivery for up to 90 days after the date specified in the Purchase Order (“Delayed Delivery”), Customer will pay the cost of (a) all finished Products and Services manufactured by Stellar, including without limitation Products and Services in Stellar’s and Customer’s inventory and in shipment and (b) Stellar’s losses relating in any way to precious metals materials that Stellar returns to its precious metals suppliers, plus the related costs of shipping, handling and any losses due to fluctuations in currency exchange rates.

 

Alternatively, upon receipt of such timely notice (that is, within the 30-Day Period), if (i) Customer modifies any Terms other than a Delayed Delivery (for example but not by way of limitation, by changing any revisions to the drawings and specifications), or (ii) Customer cancels the Purchase Order, or (iii) Customer fails to order delivery within the Delayed Delivery period, Stellar will calculate, and Customer will immediately pay Stellar, the cost of all (x) finished Products and Services manufactured or provided by Stellar, including without limitation Products and Services in Stellar’s and Customer’s inventory and in shipment, (y) all work in process (including Products and Services) and (z) all raw materials purchased by Stellar for that Purchase Order, including without limitation Stellar’s losses relating in any way to raw materials that Stellar returns to its raw materials suppliers, plus Stellar’s costs for shipping and handling and any losses due to fluctuations in currency exchange rates.

 

If Customer delays delivery of any part of a Purchase Order more than six months after the date of the Purchase Order (regardless of the reason), the unit price shall also be recalculated and added to the Price, as provided in Exhibit A, Price Terms, Section 7.

 

If Customer makes any modification or other revision to the drawings and specifications for a Product or Service, Customer shall pay all of Stellar’s costs for undertaking or making such modification or revision.  These costs are in addition to: (A) the amounts referenced in the preceding paragraphs of Section 11 and (B) any Adjustment to the unit price under Exhibit A, Price Terms, Section 2.  Customer is liable for these costs regardless of whether such modification or revision is made with timely notice under Section 11.

 

The amounts due under Section 11 will be determined by Stellar in its sole discretion and shall be payable as provided in Section 10.

 

Stellar reserves the right to cancel any Purchase Order and any delivery thereunder, at any time , as a result of Customer’s Default (as defined in Section 22) without incurring any liability or obligation to Customer, subject to the Last Time Buy, as defined in Section 12.

 

The remedies contained in Section 11 are in addition to all other remedies available to Stellar for Customer’s Default.

 

12.)                            Last Time Buys Upon Expiration or Termination of Agreement or Termination of Purchase Order by Stellar.  Upon expiration or termination of this Agreement, or upon termination of a Purchase Order by Stellar, Stellar shall take reasonable measures to cease any ongoing Services or production of Product(s) and limit further expenses associated with such ongoing production, except for the Last Time Buy.  Notwithstanding the foregoing, upon expiration or termination of this Agreement, or upon termination of a Purchase Order by Stellar, then unless such termination is the result of Customer’s Default under Section 22, Customer

 

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shall have the right to place a last Purchase Order with multiple delivery dates (the “Last Time Buy”).  The last delivery date under any Last Time Buy shall not to exceed six (6) months from the date of the Last Time Buy.  Any credit remaining on Customer’s account upon expiration or termination of this Agreement shall be refunded to Customer within thirty (30) days after the latest of the expiration, termination or last delivery of Product pursuant to the Last Time Buy.  Any credit remaining on Customer’s account upon termination of any Purchase Order under Section 12 shall be refunded to Customer within thirty (30) days after the later of the termination of the Purchase Order or last delivery of Product ordered pursuant to the Last Time Buy.

 

13.)                            Confidential Information.  During the Contract Term, Stellar and Customer may provide confidential and proprietary information and trade secrets regarding their respective products, processes, know-how, work and business to the other party.  Such information shall be deemed the confidential and proprietary information, or trade secrets, of the disclosing party, provided the disclosing party designates the information as “CONFIDENTIAL” in writing at the time of disclosure or within seven (7) days after disclosure to the receiving party (“Confidential Information”).  Any Confidential Information disclosed by either party will remain the sole property of the disclosing party unless it (i) was rightfully known to the receiving party (without any restriction on disclosure or use) prior to its receipt from the disclosing party, or (ii) becomes part of the public domain or (iii) is disclosed to the receiving party by a third party not in violation of the disclosing party’s rights.  Each party shall take all necessary precautions to protect the other party’s Confidential Information.  Both parties agree, on behalf of themselves and their respective employees, agents, successors and assigns, that the receiving party will not, directly or indirectly: (a) reproduce, publish or disclose the disclosing party’s Confidential Information to any third party, or (b) use the disclosing party’s Confidential Information for any purpose except to perform this Agreement and any Purchase Order, without the prior written consent of the disclosing party.  The Chief Executive Officer of Stellar is the only person authorized to grant such written consent on behalf of Stellar.  Each party agrees to not disclose the other party’s Confidential Information under any court or other governmental order without giving immediate written notice of the order to the disclosing party so that the disclosing party may take legal action to prevent the disclosure.  On request, each party will return the other party’s Confidential Information and certify the return or destruction of all copies thereof, regardless of the medium in which it is maintained.  Either party may obtain a temporary restraining order and temporary and permanent injunctions to enforce Section 13 and to prevent or prohibit the imminent or actual disclosure or use of its Confidential Information.  The receiving party shall pay all of the disclosing party’s damages, attorneys’ fees, costs and disbursements arising from the receiving party’s imminent or actual violation of any term of Section 13.  Each party shall have the right to review and approve the other party’s procedures for handling records and Confidential Information, and may make such inspections as the disclosing party deems necessary to insure that the other party is properly safeguarding the disclosing party’s records and Confidential Information.  Each party’s obligations under Section 13 shall survive the termination or expiration of this Agreement and all Purchase Orders except as to information that does not qualify, or no longer qualifies, as Confidential Information under the terms of Section 13 (i-iii).  Customer further agrees that all information and records that it received from Stellar on or before the date of this Agreement is Stellar’s Confidential Information.

 

14.)                            Intellectual Property.  Stellar retains sole and exclusive right, title and interest in its Confidential Information, trade secrets, proprietary information, patents, trademarks,

 

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servicemarks and all other intellectual property (“Intellectual Property”).  Customer retains sole and exclusive right, title and interest in its Intellectual Property.  All Intellectual Property that Stellar uses or develops in connection with performing this Agreement relating in any manner to manufacturing operations, processes and know-how is and remains the sole property of Stellar.  Stellar does not grant Customer a license, or convey or transfer any right, title or interest, in its Intellectual Property to Customer.  All changes and improvements to the Products’ designs and specifications (excluding manufacturing operations, processes and know-how that Stellar uses or develops in connection with performing this Agreement) is and remains the sole property of Customer.  If Stellar and Customer develop new Intellectual Property while working together (unrelated to manufacturing operations, processes and know-how that Stellar uses or develops in connection with performing this Agreement, and unrelated to changes and improvements to the Products’ designs and specifications) (“Other IP”), Customer is the owner of the Other IP and Customer hereby grants to Stellar an irrevocable, worldwide, nonexclusive license to use such Other IP at no cost to Stellar.  Stellar and Customer agree to cooperate with each other in effecting assignments of and registering any Intellectual Property and Other IP to effect the foregoing, subject to their respective rights in their own Confidential Information and Intellectual Property.  This duty to cooperate shall survive the expiration or termination of this Agreement.

 

15.)                            Customer’s Right to Inspect Records.  Stellar agrees to provide records confirming Stellar’s compliance with an appropriate quality system for Customer’s review upon reasonable request.  Stellar should allow Customer, upon reasonable notice, to perform quality system audits at Stellar’s facility, including the review of applicable documentation.  These records may include the following quality controls:

 

(a)                                  Process controls;

 

(b)                                  Inspection records confirming appropriate calibrated measuring equipment and statistically valid sampling plans;

 

(c)                                   Records tracing Products and Services to the materials and processes used, and the dates of manufacture;

 

(d)                                  Products and Services labeled to insure proper identification and packed for shipment in accordance with packing and shipping requirements set forth in the Purchase Order; and

 

(e)                                   Stellar will maintain a Device Master File (“DMF”) for Products manufactured by Stellar.  Stellar hereby grants Customer a right of reference for such DMF solely for the purpose of developing and obtaining regulatory approval of Customer’s products incorporating Products.  Such right of reference does not allow Customer to access directly the DMF or to review and read the DMF.  Stellar shall retain records for each batch of Product manufactured pursuant to this Agreement for three (3) years after the last delivery of such Product.

 

16.)                            Limited Warranty.  Stellar makes no warranty except as specifically set forth in Stellar’s Certificate of Conformance for the Products and Services listed in the Certificate of Conformance (“Limited Warranty”).  STELLAR MAKES NO OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING WARRANTY OF TITLE AND IMPLIED

 

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WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

 

17.)                            Indemnification.  If Customer or any third party: (i) performs any operation, procedure or process involving any Products or Services, or (ii) assembles, installs, uses or manufactures any Products or Services, or (iii) transports or delivers any Products to any third party, Customer immediately assumes all liability for, and agrees to indemnify and hold Stellar harmless from all claims, damages, recalls, penalties and attorneys’ fees relating to, or arising from, the Products and Services.  In addition, Stellar is not liable for: (a) Customer’s designs, plans and specifications for the Products and Services; (b) Customer-supplied goods, including without limitation material, components, assemblies, and services, whether conforming or non-conforming, while in Stellar’s possession (“Customer Materials”); (c) non-conformities in any Products or Services created or occurring during Stellar’s handling, development, set-up, production, inspection, or provision of Services; and (d) non-conformities in any Products or Services created or occurring while in the possession of any third parties (collectively, (c-d), “Non-Conformities”).  Customer assumes all liability for, and agrees to indemnify and hold Stellar harmless from all claims, damages, recalls, penalties and attorneys’ fees relating to, or arising from, Customer’s designs, plans and specifications, Customer Materials and Non-Conformities (collectively, Section 17, “Customer’s Indemnity”).

 

18.)                            Remedy and Limitation of Damages.  Customer or Subcontractor shall inspect each shipment of Products and Services within thirty (30) days after delivery (“Inspection Period”).  If any Products or Services do not conform to the Certificate of Conformance (collectively, “Defect[s]”, “Product Defect” or “Service Defect”), Customer or Subcontractor shall notify Stellar of such Defects within five (5) days after the expiration of the Inspection Period or the Defects are waived.  There is no exception for latent Defects.  Subject to Customer’s Indemnity, in the event of a Product Defect, Stellar’s exclusive obligation and Customer’s sole remedy shall be as follows: (a) that Stellar repair or replace the defective Products (or any defective part thereof) without charge; OR (b) that Stellar credit the Price of the defective Products (or any defective part thereof) to future Purchase Orders; OR (c) that Stellar refund the Price of the defective Products (or any defective part thereof), which alternative remedy (a, b, or c) shall be selected by Stellar in Stellar’s sole discretion.  Stellar will issue a Return Material Acceptance (RMA) number for the return and replacement, repair or refund of the defective Product.  Defective Products will be repaired or scrapped and Customer will receive a credit for those that are scrapped.  IN NO EVENT SHALL STELLAR BE LIABLE FOR ANY CLAIM OR DAMAGE IN EXCESS OF THE PURCHASE PRICE OF THE DEFECTIVE PRODUCTS (OR ANY DEFECTIVE PARTS THEREOF) UNDER THE RELATED PURCHASE ORDER.  STELLAR IS NOT LIABLE FOR ANY OTHER CLAIMS OR DAMAGES, INCLUDING WITHOUT LIMITATION, DIRECT, INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE OR INCIDENTAL DAMAGES , RECALL OR ATTORNEYS’ FEES.  Subject to Customer’s Indemnity, in the event of a Service Defect, Stellar’s exclusive obligation and Customer’s sole remedy shall be as follows: (a) that Stellar repair or replace without charge defective Services provided by Stellar; OR (b) that Stellar credit the Price of defective Services provided by Stellar to future Purchase Orders; OR (c) that Stellar refund to Customer the Price of defective Services provided by Stellar, which alternative remedy (a, b, or c) shall be selected by Stellar in Stellar’s sole discretion.  IN NO EVENT SHALL STELLAR BE LIABLE FOR ANY CLAIM OR DAMAGE IN EXCESS OF THE PURCHASE PRICE OF THE DEFECTIVE SERVICES PROVIDED BY STELLAR UNDER THE

 

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RELATED PURCHASE ORDER.  STELLAR IS NOT LIABLE FOR ANY OTHER CLAIMS OR DAMAGES, INCLUDING WITHOUT LIMITATION, DIRECT, INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE OR INCIDENTAL DAMAGES, RECALL OR ATTORNEYS’ FEES.

 

If there is a dispute as to whether any of Stellar’s Products or Services contain Defects, Customer and Stellar agree to submit the dispute to an independent inspection laboratory for a determination (“Inspection Lab”).  If Customer and Stellar do not agree on the selection or decision of the Inspection Lab, each of them shall hire its own Inspection Lab and the decision whether Defects exist shall be determined by the Courts in the Exclusive Venue.

 

19.)                            Exclusions of Consequential Damages.  STELLAR AGREES THAT CUSTOMER IS NOT LIABLE TO STELLAR FOR ANY CONSEQUENTIAL, PUNITIVE OR INCIDENTAL DAMAGES ARISING FROM CUSTOMER’S BREACH OF THIS AGREEMENT, EXCEPT THOSE CLAIMED BY A THIRD PARTY AGAINST STELLAR.

 

20.)                            Stellar’s Inability to Perform.  If Stellar ceases business operations or cannot conduct business operations for sixty (60) days or more, or if Stellar refuses to perform this Agreement, Customer may terminate this Agreement after giving Stellar sixty (60) days’ written notice to cure.  If Stellar fails to cure within such time period, Customer may terminate this Agreement for cause.  Stellar is not liable to Customer for any claims arising from such termination and Customer is not liable for the Continuation Charge.

 

21.)                            Customer’s Obligations.  Until Customer has paid the Price in full, Customer shall fulfill all of its duties with respect to the Products and, in addition, shall:  (a) keep the Products insured for their full value against loss by fire, theft, or other casualty or hazard, and provide proof of such insurance to Stellar upon Stellar’s request; and (b) permit all payments for loss relating to the Products and Services under such insurance policies to be applied first to all indebtedness owed by Customer to Stellar, and for such purpose Customer does hereby assign all such payments to Stellar (up to the amount of the Price).  Customer warrants that all information that it provides Stellar at any time regarding its creditworthiness and ability to perform this Agreement is true and accurate.

 

22.)                            Customer’s Default.  If Customer engages in any of the following, such action shall constitute a default by Customer under this Agreement (each, a “Default”):  (a) fails to make any payment when due; (b) materially violates any warranty or any other term of this Agreement or any Term contained in any Purchase Order or Purchase Order Acknowledgement (except for nonpayment of amounts due, which is governed by Section 22(a)); (c) materially violates any Laws, as defined in Section 28; (d) violates the terms of any other contract or agreement between Customer and Stellar (collectively “Other Contract[s]”); (e) becomes insolvent or makes an assignment for the benefit of creditors, is named as the debtor in any voluntary or involuntary bankruptcy proceeding, or has a receiver, liquidator or similar officer appointed to take charge of all or part of Customer’s assets, and such event is not cured or removed, to Stellar’s satisfaction, within sixty (60) days thereafter; or (f) attempts to assign or delegate any of its rights or obligations under this Agreement or any Purchase Order to any third party, except in the case of a Customer Sale or Product/Service Transfer.  For purposes of this Agreement, (A) a “Customer Sale” occurs if Customer merges with or is acquired by a third party, or transfers or assigns (i) control of its business to any third party or (ii) fifty percent

 

9



 

(50%) or more of its assets, capital stock, voting stock or rights to profits to a third party, or intends to engage in any such activities and (B) a “Product/Service Transfer”occurs if Customer sells, licenses, transfers or assigns ownership of, or its right to manufacture or sell, any Products or Services (or any items which contain or use Products or Services), to a third party, or intends to engage in any such activity.  A Customer Sale and Product/Service Transfer is further governed by the terms of Sections 24 and 25.

 

23.)                            Remedies.  In the event of Default, Stellar is entitled to all remedies available at law and in equity and all other remedies provided in this Agreement.  Such remedies shall be cumulative and not exclusive and include, without limitation:  (a) obtaining temporary restraining orders and temporary and permanent injunctions to compel performance, or to prevent or stop any violation; (b) an award of money damages, including the Price, all other damages, and all costs and expenses incurred by Stellar in exercising any of its rights and remedies, including its attorneys’ fees, costs, disbursements and collection agency fees, regardless of whether a lawsuit is commenced; (c) the immediate acceleration of all amounts due or that will become due under this Agreement, any Purchase Orders and any Other Contracts; (d) Stellar’s revocation of credit, delay or cessation of future deliveries, cancellations of any or all Purchase Orders and repossession of delivered or undelivered goods; (e) Stellar’s termination of this Agreement, any Purchase Orders and any Other Contracts, in Stellar’s discretion; and (f) the payment of the Continuation Charge.  However, the Continuation Charge shall only be payable under Section 22(a) (that is, for Customer’s nonpayment of amounts due) if such Default is not cured within sixty (60) days after the due date.  Any termination shall be without prejudice to any claims, damages or other rights that Stellar has or may have against Customer and any third party.  Stellar may exercise any combination of remedies without incurring any liability to Customer or any third party.  Customer agrees to indemnify and hold Stellar harmless from all claims by any third party arising from Stellar’s exercise of any of its remedies against Customer, and agrees to pay all of Stellar’s attorneys’ fees, costs and disbursements incurred in defending against any such third-party claims.

 

24.)                            Continuation Charge and Triggering Events.  Customer agrees to pay Stellar a Continuation Charge for each Product upon the earliest of the following:  (a) upon Customer’s failure to pay any amount when due under this Agreement if such Default is not cured within sixty (60) days thereafter; (b) at the time of a Customer Sale or Product/Service Transfer (however, a Customer Sale or Product/Service Transfer is not a Triggering Event if Buyer assumes Customer’s obligations under this Agreement, including the Continuation Charge); (c) at the time Customer no longer uses, markets, or manufactures any Product (unless Customer or Buyer fails to obtain FDA approval for such Product); (d) at the time Customer no longer orders or purchases any Product from Stellar (unless Customer or Buyer fails to obtain FDA approval for such Product); (e) at the time Stellar terminates this Agreement based upon Customer’s Default (subject to the provisions of Section 24(a)); (f) at the time Customer terminates this Agreement, including without limitation at the time of a Customer Voluntary Termination (excluding, however, a termination under Section 20); (g) upon the expiration of the first five-year Contract Term, unless Customer or Buyer failed to obtain FDA approval for any Product(s) and demonstrates that it is diligently pursuing FDA approval of the Product(s) at that time, in which case the Continuation Charge shall be payable at the earliest of (1) the first alternative grounds under Section 24(a-f and h), (2) the expiration of the Contract Term, or (3) three (3) years after the date of FDA approval; and (h) upon the occurrence of any other event that constitutes a termination of this Agreement, a transfer or assignment of Customer’s obligations

 

10



 

under this Agreement, or the termination, transfer or assignment of Customer’s obligations with respect to any Product (each, (a-h), a “Triggering Event”).

 

The Continuation Charge is calculated and defined as follows:

 

Regardless of any other term of this Agreement, Customer, on behalf of itself and any Buyer, agrees that under all circumstances Customer and any Buyer shall pay, and have a continuing duty to pay, Stellar the following continuing obligation for each Product, beginning the Effective Date:

 

·                   Percutaneous leads:  $[***], minus $[***] per lead purchased after the first [***] leads

 

·                   Percutaneous lead extenders:  $[***], minus $[***] per lead extender purchased after the first [***] lead extenders

 

The continuing obligation payable for each Product is referred to as the “Continuation Charge” for that Product.  The Continuation Charge for each Product is incurred as of the Effective Date.  The Continuation Charge is calculated for each Product separately.  Customer may not credit its purchases of one Product to the Continuation Charge for the other Product at any time.

 

For example, if Customer purchases only [***] percutaneous leads from Stellar during the Contract Term, it must pay Stellar $[***] as a Continuation Charge for percutaneous leads as provided below.  If Customer purchases [***] percutaneous leads from Stellar, it must pay Stellar $[***] as a Continuation Charge for percutaneous leads as provided below.  This Continuation Charge is calculated as follows:  $[***] - ([***] x $[***]).  If Customer purchases [***] percutaneous leads during the Contract Term, it owes Stellar no Continuation Charge for the percutaneous leads; however, Customer would owe Stellar the Continuation Charge for percutaneous lead extenders until its purchases of percutaneous lead extenders exceed the Continuation Charge for that Product.  Customer may not credit any purchases of percutaneous leads to the Continuation Charge for percutaneous lead extenders.

 

The Continuation Charge for each Product shall be immediately due and payable upon the occurrence of the earliest Triggering Event.  The Continuation Charge shall survive each of the events referenced in Section 24(a-h).

 

Customer agrees that the Continuation Charge is reasonable in all respects.  Customer agrees that Stellar has made and will make valuable and material investments in order to provide the Customer with the Products and Services referenced in this Agreement and in all Purchase Orders, including without limitation labor, skills, know-how, machinery and manufacturing processes.  Stellar has factored these investments and its expectation of the Continuation Charges into the Price of the Products.  Customer agrees that the value of Stellar’s investments cannot be adequately compensated except by the Continuation Charges, and that Customer’s failure to purchase the amount of Products covered by the Continuation Charges will cause damage to Stellar in an amount that cannot be precisely determined, including without limitation loss of prospective economic advantage, lost

 


[***] 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

 

11



 

sales and contracts, lost profits and its investments.  The Continuation Charge is not a penalty.  Stellar and Customer have entered this Agreement only because of Customer’s agreement to the Continuation Charge.

 

25.)                            Customer Sale and Product/Service Transfer(s).  In the event of a Customer Sale or Product/Service Transfer, Buyer may (in Customer’s and Buyer’s judgment) assume all of Customer’s obligations under this Agreement.  However, if Buyer refuses to assume any of the following obligations at the time of a Customer Sale or Product/Service Transfer, Customer shall remain liable for those amounts and shall pay Stellar such amount(s) immediately upon receipt of Stellar’s invoice: (a) the Continuation Charge; (b) the cost of all (i) outstanding invoices; (ii) all finished Products and Services manufactured or provided by Stellar, including without limitation Products and Services in Stellar’s and Customer’s inventory and in shipment, (iii) all work in process (including Products and Services) and (iv) all raw materials purchased by Stellar, including without limitation Stellar’s losses relating in any way to raw materials that Stellar returns to its raw materials suppliers, plus Stellar’s costs for shipping and handling and any losses due to fluctuations in currency exchange rates; (c) all other sums owed by Customer under this Agreement and any Purchase Orders, including without limitation any damages for any Default under Section 23; and (d) in the event of a Customer Sale, all other sums owed by Customer under any Other Contracts, all of which (that is, (a-d)) shall be accelerated and become immediately due and payable.  In the event of a Customer Sale, Product/Service Transfer or other transfer approved under Section 26, the parties to such transactions shall include terms in the related agreements that prevent Stellar’s competitors from obtaining or using Stellar’s Confidential Information and Intellectual Property as a result of such transactions, which terms must be approved in advance and in writing by the Chief Executive Officer of Stellar, in Stellar’s discretion.  All of Customer’s duties and obligations that survive this Agreement upon termination or expiration shall survive a Customer Sale and Product/Service Transfer.

 

26.)                            Binding Effect and Limitations on Assignability.  This Agreement binds each of the parties, their successors and assigns.  Notwithstanding any other term of this Agreement, Customer may not license, transfer or assign any of its rights or obligations under this Agreement or any Purchase Orders to any licensees, successors, transferees or assigns, including without limitation any subsidiaries, affiliates, parents or any third party, except pursuant to a Customer Sale or Product/Service Transfer, unless approved in advance and in writing by Stellar’s Chief Executive Officer, in Stellar’s sole discretion.

 

27.)                            Governing Law, Jurisdiction and Venue.  This Agreement and all Purchase Orders, and all rights and obligations arising thereunder, shall be governed exclusively by the laws of the State of Minnesota, without regard to Minnesota’s choice of law or conflict-of-law rules.  Customer consents to personal jurisdiction in the State and Federal Courts of Minnesota.  Any dispute relating to this Agreement shall only be filed and venued in the State Courts or Federal Courts of Minnesota (“Exclusive Venue”) and Customer waives all objections to venue in the Exclusive Venue, including forum non conveniens.  If Customer institutes an action in any other jurisdiction or venue, Stellar shall have the right to dismiss the action in the other jurisdiction or venue and remove it to the Exclusive Venue.

 

28.)                            Governmental Approvals and Warrants.  Customer agrees to comply with all international, foreign, federal (i.e., United States), State, municipal and local statutes, laws, regulations, ordinance and codes that apply to the Products and Services and to the performance

 

12



 

of all or any part of this Agreement, with respect to the Products and Services (collectively, “Laws”).  Customer agrees to defend, indemnify and hold Stellar harmless from and against any and all claims (including civil damages, recalls, fines, awards, attorneys’ fees, costs and disbursements) arising from any violation of such Laws.  Customer warrants that this Agreement and all information, records, prototypes and other items furnished to Stellar do not violate any Laws or the rights of any third party.  Customer agrees to indemnify and hold Stellar harmless from and against all damages, recalls, penalties, costs, disbursements and attorneys’ fees resulting from its violation of the covenants in Section 28.

 

Stellar is only responsible for complying with Laws that relate specifically to the Products and Services if Customer identifies the Products and Services to which those Laws apply and include a complete copy, verbatim , of such Laws in the specifications for those Products.  Stellar’s failure to comply with any Laws contained in any specifications shall be deemed a violation of Stellar’s Certificate of Conformance and Limited Warranty, and its liability shall be limited to the remedies provided to Customer under Section 18.

 

Stellar agrees to comply with all ISO certification requirements and State and federal laws governing its general business operations, including without limitation environmental laws (“General Business Laws”).  General Business Laws do not include the Laws that apply specifically to the Products and Services, as described in the first two paragraphs of this Section 28.  Stellar warrants that it will not employ any person who is debarred by the United States Food and Drug Administration (“FDA”) during the Contract Term.

 

29.)                            Severability and Waiver.  If any provision of this Agreement is held to be invalid or unenforceable by a court of competent jurisdiction, the enforceability of all remaining provisions of this Agreement will not be impaired and will remain in full force and effect.  If either Party fails to exercise, or delays its exercise of, any right, remedy, power or privilege under this Agreement, such failure or delay shall not operate as a waiver thereof in any later instance.  No waiver shall be effective unless it is in writing and is signed by an authorized officer of Stellar.

 

30.)                            Joint Signatures.  If more than one party signs this Agreement on behalf of Customer, including without limitation any personal guarantor or business guarantor, the term “Customer” shall mean all signing parties and guarantors, and all such parties shall be bound by all terms of this Agreement and shall be jointly and severally obligated hereunder.  All rights of Stellar shall inure to the benefit of its successors and assigns, and all obligations of Customer shall bind Customer’s permitted successors and assigns.

 

31.)                            Integration.  This Agreement including any Purchase Orders, Exhibits and Addenda contains the entire agreement between the parties concerning its subject matter and supersedes: (a) all other written and oral statements and agreements between the parties; (b) any prior course of dealing or industry practice; (c) any prior Confidentiality Agreement or Non-Disclosure Agreement between Stellar and Customer; and (d) any Customer Records (except Purchase Orders).  This Agreement may not be modified except in writing signed by the Chief Executive Officer of Stellar.

 

13



 

32.)                            No Joint Venture.  This Agreement does not create a joint venture or other business relationship between Stellar and Customer.  Stellar and Customer are, and at all times remain, separate and independent business entities.

 

STELLAR TECHNOLOGIES, INC.

 

NEVRO CORP., a Delaware corporation

 

 

 

 

 

 

By:

/s/ Estelle Forcelle

 

By:

/s/ Konstantinos Alataris

 

Estelle Forcelle,

 

 

Konstantinos Alataris, Ph.D.

 

Its: Chief Executive Offifcer

 

 

Its: Chief Executive Offifcer

 

 

 

 

 

Date:

7/13/09

 

Date:

7/10/09

 

14



 

EXHIBIT A

 

PRICE TERMS

 

This Exhibit A (“Exhibit”) is incorporated into that certain Stellar Manufacturing Agreement (“Agreement”), by and between Stellar Technologies, Inc. (“Stellar”) and Nevro Corp. (“Customer”).  All terms defined in the Agreement shall have the same meaning in this Exhibit.  The terms of this Exhibit supersede any inconsistent terms of the Quotations, as defined below.

 

1.                                       The Agreement incorporates Stellar Quotation #006821-00, dated May 6, 2009 (“May 6 Quotation”), and Stellar Quotation #006836-01, dated May 12, 2009 (“May 12 Quotation”) (collectively, the May 6 Quotation and May 12 Quotation, the “Quotation[s]”).  The May 6 Quotation is attached as Exhibit A-1 and the May 12 Quotation is attached as Exhibit A-2.

 

2.                                       The Quotations list the unit price of the Products based on Stellar’s general understanding of Customer’s current designs and specifications for each Product.  If the final designs and specifications for the Products increase Stellar’s cost of raw materials or Stellar’s cost to manufacture or provide Products and Services, Stellar will provide the related cost information to Customer and the Parties will negotiate an adjustment to the unit prices of the Products (“Adjustment[s]”).  Similarly, if Customer modifies the drawings and specifications of any Products, the Parties will negotiate an Adjustment to the unit prices of that Product.  Finally, if the unit prices for any Products are not included in the Quotations and are later agreed upon by the Parties, the new unit prices are deemed an Adjustment.  This would occur, for example, (a) if Stellar provides the cable for orders of [***] or more percutaneous leads; or (b) if Stellar provides the BAL seals for orders of [***] or more percutaneous lead extenders.  For purposes of this Exhibit and the Agreement, any Adjustments supersede the unit price of the Products listed in the Quotations.

 

3.                                       For each Product, the unit prices listed in the Quotations, subject to Adjustments, are valid through the earlier of:  (a) June 30, 2010, or (b) the date Stellar delivers the first [***] units of that Product.  The [***] unit threshold does not include the first [***] percutaneous leads or the first [***] percutaneous lead extenders.  If Stellar attains the [***] unit threshold with a Purchase Order that, when delivered within 6 months, results in Customer’s purchasing more than [***] units of either Product, the original unit price applies to all of those Products

 

4.                                       Stellar will provide all materials for percutaneous leads under Item 001 of both Quotations.

 

5.                                       Stellar will provide all materials for percutaneous lead extenders, including BAL seals, under Item 003 of the May 12 Quotation.

 

6.                                       Stellar will not provide BAL seals for percutaneous lead extenders under Item 002 of the May 6 Quotation or under Item 004 of the May 12 Quotation.  Instead Stellar will purchase the BAL seals at then-current market rates from the manufacturer and immediately charge Customer the sum of Stellar’s purchase price plus a processing charge.

 

7.                                       If Customer orders a certain number of units of either Product at the related unit price, but then requests delivery more than 6 months after the date of the Purchase Order, Customer will pay the unit cost for that order based on the actual amount delivered during each

 


[***] 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

 

15



 

6-month period beginning the date of the Purchase Order.  For example, if Customer orders [***] percutaneous lead extenders under Item 002 of the May 6 Quotation but then requests delivery of [***] in the first 6 calendar months after the date of Purchase Order, and the remaining [***] in the next 6 calendar months, Customer will pay the unit price of the first [***] under Item 4 of the May 12 Quotation ($[***] per unit) and the last [***] under Item 4 of the May 12 Quotation ($[***] per unit), subject to Adjustments.  Customer will not pay the unit price of [***] percutaneous lead extenders under Item 002 of the May 6 Quotation ($[***] per unit).

 

EXHIBITS A-1 and A-2 follow

 


[***] 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

 

16


 

Our Quotation #006821-00

05/06/2009

 

9200 Xylon Avenue North
Brooklyn Park, MN  55445
763-493-8556  FAX 763-493-8507

 

 

To:

Andre Walker

 

 

 

Nevro Corporation

 

Quotation Valid Thru : 05/06/2010

 

411 Acacia Avenue

 

Terms : NET 30, FOB Our Dock

 

Palo Alto CA 94306

 

 

 

US

 

 

 

 

 

 

 

(650)251-0005

 

 

 

We are pleased to quote your requirements as shown below. Our company has a reputation for delivering quality products on time and we look forward to the opportunity of serving you. CONFIDENTIAL NOTICE: The information contained in this document and all attached documents is strictly confidential and contains proprietary information. It may only be used by the named addressee(s) and is also subject to the terms of any other confidentiality or nondisclosure agreement between parties. All other use is strictly prohibited.

 

Item

 

Part/Rev/Description/Details

 

Quantity Quoted

 

Unit Price $USD

001

 

10160-XXXX

U/M EA

 

[***]

 

US$ [***]

 

 

 

 

 

 

 

 

 

 

Percutaneous Lead

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pricing assumes a minimum of [***]pcs is ordered at any one time, with deliveries not extending past 6 months from order date. Pricing will be reviewed in one year or after [***] leads are delivered which ever is sooner.

 

 

 

 

 

 

 

Customer Part: 10160-XXXX        Rev C

 

 

 

 

 

 

 

 

 

 

 

 

 

002

 

Perc. Lead Extender

U/M EA

 

[***]

 

US$ [***]

 

 

 

 

 

 

 

 

 

 

Lead Extension for Percutaneous lead

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Assumes a minimum order of [***] pcs, with deliveries not to extend past 6 months of original order date. Pricing does NOT include the cost of the 8 BAl Seals needed to manufacture this product complete.  Stellar will purchase the Bal Seals on Nevro’s behalf and invoice Nevro for them directly as Stellar receives the components. Pricing will be reviewed in one year or after [***] extenders have been manufactured, which ever is sooner.

 

 

 

 

 

 

 

 

 

 

Quoted prices are based upon acceptance of shipments up to 10% above quantity quoted.  Delivery as quoted is based on current machine load, and will be finalized at time of order placement. This quotation is based on the use of Mil-Std-105D C=O sampling plan to verify part acceptability.

 

 

 

 

 

Thank you for your interest in Stellar Technologies as one of your suppliers.

 

 

 

 

 

With best regards,

 

 

 

 

 

Todd Latterell

 

 

 

 

 

Terms and Conditions of Sale:

 

 

 

 

 

General Terms: All sales subject exclusively to Stellar Technologies, Inc. (“Stellar”) terms and conditions of sales listed herein. Limited Warranty: Stellar makes no warranty except as set forth in the Certificate of Conformance for the products listed herein (“Limited Warranty”).  STELLAR MAKES NO OTHER WARRANTY, EXPRESSED OR IMPLIED, Including implied warranties of merchantability and fitness for a particular purpose.

 

 

 

 

 

Indemnification: Upon Customers installation, use, manufacture, or an other operation involving the components listed herein, Customer assumes all liability for, and agrees to indemnify Stellar against, any and all claims and damages relating to, or arising from, the parts (“Customers Indemnity”).  Remedy: Subject to Customers indemnity, in the event of a breach of Stellar’s Limited Warranty, Stellar’s exclusive obligation and remedy shall be as follows: (a) that Stellar repair or replace the defective part without charge; OR (b) that Stellar credit the purchase price of the defective part to future Customer orders; OR (c) that Stellar refund the purchase price to Customer, which alternative remedy (a, b, or c) shall be

 

***STELLAR NOW OFFERS CLEAN ROOM ASSEMBLY, MOLDING, COIL WINDING AND LASER MARKING/CUTTING/WELDING***

 

Customer

Dennis Forcelle

 

Authorized Signature

 


[***] 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



 

Our Quotation #006821-00

05/06/2009

 

9200 Xylon Avenue North
Brooklyn Park, MN  55445
763-493-8556  FAX 763-493-8507

 

 

 

To:

Andre Walker

 

 

 

Nevro Corporation

 

Quotation Valid Thru : 05/06/2010

 

411 Acacia Avenue

 

 

 

Palo Alto CA 94306

 

 

 

US

 

 

 

Item

 

Part/Rev/Description/Details

 

Quantity Quoted

 

Unit Price $USD

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

selected by Stellar in Stellar’s discretion. In no event shall Stellar be liable for any claim or damage in excess of the purchase price of the defective part. STELLAR IS NOT LIABLE FOR ANY OTHER CLAIMS OR DAMAGES, including without limitation, direct, indirect, special, consequential or incidental damages. Stellar is not responsible for customer supplied goads (material, components, assemblies, etc.) that are non-conforming while in Stellar’s possession including non-conformances created during handling, development, set-up, production, outside services, inspection, or other services. Stellar’s exclusive obligation and remedy shall be as follows: (a) that Stellar repair or replace only Stellar rendered services without charge; OR (b) that Stellar credit the purchase price of only Stellar rendered services to future Customer orders; OR (c) that Stellar refund the purchase price of only Stellar rendered services to Customer, which alternative remedy (a, b, or c) shall be selected by Stellar is Stellar’s discretion. In no event shall Stellar be liable for any claim or damage in excess of the purchase price of Stellar rendered services of the defective part. STELLAR IS NOT LIABLE FOR ANY OTHER CLAIMS OR DAMAGES, including without limitation, direct, indirect, special, consequential or incidental damages.

 

***STELLAR NOW OFFERS CLEAN ROOM ASSEMBLY, MOLDING, COIL WINDING AND LASER MARKING/CUTTING/WELDING***

 

Customer

Dennis Forcelle

 

Authorized Signature

 

2



 

Our Quotation  #006836-01

05/12/2009

 

9200 Xylon Avenue North
Brooklyn Park, MN  55445
763-493-8556  FAX 763-493-8507

 

 

 

To:

Andre Walker

 

 

 

Nevro Corporation

 

Quotation Valid Thru : 09/12/2009

 

411 Acacia Avenue

 

Terms : NET 30, FOB Our Dock

 

Palo Alto CA 94306

 

 

 

US

 

 

 

 

 

 

 

(650) 251-0005

 

 

 

We are pleased to quote your requirements as shown below. Our company has a reputation for delivering quality products on time and we look forward to the opportunity of serving you. CONFIDENTIAL NOTICE: The information contained in this document and all attached documents is strictly confidential and contains proprietary information. It may only be used by the named addressee(s) and is also subject to the terms of any other confidentiality or nondisclosure agreement between parties. All other use is strictly prohibited.

 

Item

 

Part/Rev/Description/Details

 

Quantity Quoted

 

Unit Price $USD

001

 

10160-XXXX

U/M EA

 

[***]

 

US$   [***]

 

 

 

 

 

[***]

 

US$   [***]

 

 

Percutaneous Lead (Stellar supplied Cable)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pricing goes into affect after the initial [***] leads are purchased per quote, 006690. Pricing assumes [***] leads are ordered at any one time at the [***] price or [***] are ordered at the [***] price, with deliveries not extending past 6 months from order date.

 

 

 

 

 

 

 

Customer Part:  10160-XXXX            Rev C

 

 

 

 

 

 

 

 

 

 

 

 

 

002

 

10160-XXXX

U/M EA

 

[***]

 

US$   [***]

 

 

 

 

 

[***]

 

US$   [***]

 

 

Percutaneous Lead (Stellar not supplying cable)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pricing goes into affect after the initial [***] leads are purchased per quote, 006690. Pricing assumes [***] leads are ordered at any one time at the [***] price or [***] are ordered at the [***] price, with deliveries not extending past 6 months from order date. Nevro to provide raw coated cable needed +10%.

 

 

 

 

 

 

 

Customer Part:  10160-XXXX            Rev C

 

 

 

 

 

 

 

 

 

 

 

 

 

003

 

Perc. Lead Extender

U/M EA

 

[***]

 

US$   [***]

 

 

 

 

 

[***]

 

US$   [***]

 

 

Lead Extension for Perc. Lead (Stellar Providing Bal Seals)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pricing assumes [***] extenders are ordered at any one time at the [***] price or [***] are ordered at the [***] price, with deliveries not extending past 6 months from order date.

 

 

 

 

 

 

 

 

 

 

 

 

 

004

 

Perc. Lead Extender

U/M EA

 

[***]

 

US$   [***]

 

 

 

 

 

[***]

 

US$   [***]

 

 

Lead Extension for Perc. Lead (Stellar NOT Providing Bal Seals)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pricing assumes [***] extenders are ordered at any one time at the [***] price or [***] are ordered at the [***] price, with deliveries not extending past 6 months from order date. Nevro to supply needed Bal Seals, Extender Boots, Header Seal, & Header Strain relief +10% over.

 

 

 

 

 

 

***STELLAR NOW OFFERS CLEAN ROOM ASSEMBLY, MOLDING, COIL WINDING AND LASER MARKING/CUTTING/WELDING***

 

Customer

Dennis Forcelle

 

Authorized Signature

 


[***] 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



 

Our Quotation  #006836-01

05/12/2009

 

9200 Xylon Avenue North
Brooklyn Park, MN  55445
763-493-8556  FAX 763-493-8507

 

 

 

To:

Andre Walker

 

 

 

Nevro Corporation

 

Quotation Valid Thru : 09/12/2009

 

411 Acacia Avenue

 

 

 

Palo Alto CA 94306

 

 

 

US

 

 

 

Item

 

Part/Rev/Description/Details

 

Quantity Quoted

 

Unit Price $USD

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Quoted prices are based upon acceptance of shipments up to 10% above quantity quoted. Delivery as quoted is based on current machine load, and will be finalized at time of order placement, This quotation is based on the use of Mil-Std-105D C=O sampling plan to verify part acceptability.

 

 

 

 

 

Thank you for your interest in Stellar Technologies as one of your suppliers.

 

 

 

 

 

With best regards,

 

 

 

 

 

Todd Latterell

 

 

 

 

 

Terms and Conditions of Sale:

 

 

 

 

 

General Terms: All sales subject exclusively to Stellar Technologies, Inc. (“Stellar”) terms and conditions of sales listed herein. Limited Warranty: Stellar makes no warranty except as set forth in the Certificate of Conformance for the products listed herein (“Limited Warranty”). STELLAR MAKES NO OTHER WARRANTY, EXPRESSED OR IMPLIED, including implied warranties of merchantability and fitness for a particular purpose.

 

 

 

 

 

Indemnification: Upon Customer’s installation, use, manufacture, or an other operation involving the components listed herein, Customer assumes all liability for, and agrees to indemnify Stellar against, any and all claims and damages relating to, or arising from, the parts (“Customer’s indemnity”). Remedy: Subject to Customer’s indemnity, in the event of a breach of Stellar’s Limited Warranty, Stellar’s exclusive obligation and remedy shall be as follows: (a) that Stellar repair or replace the defective part without charge; OR (b) that Stellar credit the purchase price of the defective part to future Customer orders; OR (c) that Stellar refund the purchase price to Customer, which alternative remedy (a, b, or c) shall be selected by Stellar in Stellar’s discretion. In no event shall Stellar be liable for any claim or damage in excess of the purchase price of the defective part. STELLAR IS NOT LIABLE FOR ANY OTHER CLAIMS OR DAMAGES, including without limitation, direct, indirect, special, consequential or incidental damages. Stellar is not responsible for customer supplied goods (material, components, assemblies, etc.) that are non-conforming while in Stellar’s possession including non-conformances created during handling, development, set-up, production, outside services, inspection, or other service.  Stellar’s exclusive obligation and remedy shall be as follows: (a) that Stellar repair or replace only Stellar rendered services without charge; OR (b) that Stellar credit the purchase price of only Stellar rendered services to future Customer orders; OR (c) that Stellar refund the purchase price of only Stellar rendered services to Customer, which alternative remedy (a, b, or c) shall be selected by Stellar is Stellar’s discretion. In no event shall Stellar be liable for any claim or damage in excess of the purchase price of Stellar rendered services of the defective part. STELLAR IS NOT LIABLE FOR ANY OTHER CLAIMS OR DAMAGES, including without limitation, direct, indirect, special, consequential or incidental damages.

 

***STELLAR NOW OFFERS CLEAN ROOM ASSEMBLY, MOLDING, COIL WINDING AND LASER MARKING/CUTTING/WELDING***

 

Customer

Dennis Forcelle

 

Authorized Signature

 

2




Exhibit 10.2(b)

 

[***] 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

 

FIRST AMENDMENT TO STELLAR MANUFACTURING AGREEMENT

 

This First Amendment to Stellar Manufacturing Agreement (“First Amendment”) is entered into effective as of July 1, 2014  (“Effective Date”), by and between Stellar Technologies, Inc., a Minnesota corporation (“Stellar”) and Nevro Corp., a Delaware corporation, having a place of business at 4040 Campbell Ave., Suite 210, Menlo Park, CA 94025 (“Customer”) (Stellar and Customer are the “Party[ies]”), relating to the Stellar Manufacturing Agreement entered into between the Parties, dated July 1, 2009 (“Agreement”).

 

In consideration of the mutual covenants contained in this Agreement, the receipt and sufficiency of which are hereby acknowledged, Customer and Stellar agree as follows:

 

1.)                                   Defined Terms .  Except as otherwise defined in this First Amendment, all defined terms in the Agreement shall have the same meaning in this First Amendment.

 

2.)                                   Section 1 of the Agreement .  Section 1 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“Customer hereby appoints Stellar as its primary supplier of all Products listed in Exhibit A, attached, and all related Services that Customer orders from Stellar during the Contract Term.”  All pricing related to the Products will be listed in the Price Schedule listed in the attached Exhibit B.  All plans, designs and specifications used by Stellar in providing any Products, which are designed solely by Customer, are owned exclusively by Customer. Customer agrees to indemnify and hold Stellar harmless from any claims, judgments, penalties, recalls and attorney fees arising from any third-party allegations that Customer’s plans, designs and specifications for the Products infringe on or violate any third party’s patents, trade secrets, proprietary rights or other intellectual property rights. Stellar agrees to indemnify and hold Customer harmless from any claims, judgments, penalties, recalls, and/or attorney fees and costs arising from any third-party allegations that any of Stellar’s manufacturing operations, processes, know-how, plans, designs, and/or specifications for the Products or Services infringe on or violate any third party’s patents, trade secrets, proprietary rights or other intellectual property rights.  Such “Intellectual Property Indemnification Rights” shall survive the expiration or termination of this Agreement.  Stellar will cooperate with Customer’s efforts to obtain regulatory approval for its Products from governmental authorities (“Regulatory Approvals”) without conveying to Customer or any governmental authorities any right, title or interest in its Confidential Information and Intellectual Property as defined herein.

 

3.)                                   Section 3 of the Agreement .  The first sentence of Section 3 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“This Agreement is for a term of five (5) years beginning July 1, 2014, and will automatically renew for an additional year on each subsequent annual anniversary date (beginning July 1, 2019), unless terminated by either Party in writing at least thirty (30) days prior to the expiration of the then-current term (“Contract Term”).  The Contract Term is divided into five (5) consecutive years (each, a “Contract Year”) beginning July 1 and ending June 30 of the subsequent calendar year.”

 



 

All other terms of Section 3 remain unchanged.

 

4.)                                   Section 4 of the Agreement .  Section 4 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“4.                                 Voluntary Termination by Stellar or Customer .  Either party may terminate this Agreement at-will at any time prior to the expiration of the then-current Contract Term on one (1) year’s advance notice (“Voluntary Termination”), without incurring any liability or obligation to the other Party, except as follows:

 

(a)                                  Subject to the terms of Section 12 of the Agreement, Customer may make a Last Time Buy at any time through the last day of the one (1)-year notice period.

 

(b)                                  In the event of a Voluntary Termination by Customer (“Customer Voluntary Termination”), Customer shall pay Stellar all amounts due or to become due under this Agreement, together with the Early Cancellation Fee, immediately upon receipt of Stellar’s invoices for such amounts.  The amounts due or to become due include, without limitation:  (i) the Price and other sums due under Section 10; (ii) any costs under Section 11; (iii) any remedies for Customer’s Default under Sections 22 and 23; (iv) the Early Cancellation Fee; and (v) Adjustments and other costs under Exhibit A.”

 

(c)                                   In the event of a Voluntary Termination by Stellar (“Stellar Voluntary Termination”), during (i) the initial five (5)-year Contract Term and (ii) thereafter, but only if Stellar gives less than one (1) year’s advance written notice of termination: (1) Customer is not liable for the Early Cancellation Fee and (2) Stellar shall provide Customer necessary assistance to transfer the manufacturing of the Key Products to another Nevro owned facility or another manufacturer selected by Nevro (“Second Source”). This assistance will include, but is not limited to, the following

 

(A)           a copy of the manufacturing processes, including the specific parameters used at Stellar to produce Key Products

 

(B)           details of the equipment, including Make, Model and any pertinent drawings, used at Stellar to manufacture the Key Products

 

(C)           drawing of fixtures and tooling used at Stellar to manufacture the key products

 

(D)           such engineering consulting services (“Manufacturing Transition Services”) as are necessary to enable Customer to undertake such Manufacturing Transition Services, which hourly rates are defined in Exhibit C. These services will include, but is not limited to, the following:

 

·                   Assistance and support for the design, characterization and validation of the processes used during manufacturing of the key products at the Second Source.

 

·                   Training of manufacturing personnel at the second source.

 

2



 

Stellar’s agreement to provide assistance under Section 4(c)(2) does not make Stellar liable or responsible for the Second Source’s ability or inability to manufacture the Products, perform its contract(s) with Customer, or meet the requirements of Customer or any third party with respect to the Products.

 

This Section 4 (c) supersedes all inconsistent terms of Section 14.

 

5.)                                   Section 5 of the Agreement .  The first paragraph of Section 5 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

Minimum Purchase Requirement, Purchase Orders and Purchase Order Acknowledgements .  During each of the following Contract Years, Customer shall purchase from Stellar the following percentages of its requirements for each of the Key Products (collectively, “Minimum Purchase Requirement”):

 

Contract Year

 

Minimum Purchase
Requirement (%)

First Contract Year

 

[***]%

Second Contract Year

 

[***]%

Third Contract Year

 

[***]%

Fourth Contract Year

 

[***]%

Fifth Contract Year

 

[***]%

 

If Customer makes any modifications, revisions, changes, variations or improvements to Key Products (collectively, “Revisions”), all of such Revisions are included in the definition of Key Products and are subject to the Minimum Purchase Requirement.”

 

All other terms of Section 5 remain unchanged.

 

6.)                                   Section 13 of the Agreement .  Section 13 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“Confidential Information. During the Contract Term, Stellar and Customer may provide confidential and proprietary information and trade secrets regarding their respective products, processes, know-how, work and business to the other patty. Such information shall be deemed the confidential and proprietary information, or trade secrets, of the disclosing party, provided the disclosing party designates the information as “CONFIDENTIAL” in writing at the time of disclosure, or if such information is disclosed in such a way as to reasonably be understood to be confidential in nature (hereby referred to as “Confidential Information”).  Any Confidential Information disclosed by either party will remain the sole property of the disclosing party unless it (i) was rightfully known to the receiving party (without any restriction on disclosure or use) prior to its receipt from the disclosing party, or (ii) becomes part of the public domain by no fault of the receiving party, or (iii) is disclosed to the receiving party by a third party not in violation of the

 


[***] 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



 

disclosing party’s rights. Each party shall take all necessary precautions to protect the other party’s Confidential Information. Both parties agree, on behalf of themselves and their respective employees, agents, successors and assigns, that the receiving party will not, directly or indirectly: (a) reproduce, publish or disclose the disclosing party’s Confidential Information to any third party, or (b) use the disclosing party’s Confidential Information for any purpose except to perform this Agreement and any Purchase Order, without the prior written consent of the disclosing party. The Chief Executive Officer of Stellar is the only person authorized to grant such written consent on behalf of Stellar. Each party agrees to not disclose the other party’s Confidential Information under any court or other governmental order without giving immediate written notice of the order to the disclosing party so that the disclosing party may take legal action to prevent the disclosure. On request, each party will return the other party’s Confidential Information and certify the return or destruction of all copies thereof, regardless of the medium in which it is maintained. Either party may obtain a temporary restraining order and temporary and permanent injunctions to enforce Section 13 and to prevent or prohibit the imminent or actual disclosure or use of its Confidential Information. The receiving party shall pay all of the disclosing party’s damages, attorneys’ fees, costs, and disbursements arising from the receiving party’s actual violation of any term of Section 13. Each party shall have the right to review and approve the other party’s procedures for handling records and Confidential Information, and may make such inspections as the disclosing party deems necessary to insure that the other party is properly safeguarding the disclosing party’s records and Confidential Information. Each party’s obligations under Section 13 shall survive the termination or expiration of this Agreement and all Purchase Orders, except as to information that does not qualify, or no longer qualifies, as Confidential Information under the terms of Section 13 (i-iii). Customer further agrees that all information and records that it received from Stellar on or before the date of this Agreement is Stellar’s Confidential Information.”

 

7.)                                   Section 14 of the Agreement . Section 14 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“Intellectual Property.  Stellar retains sole and exclusive right, title and interest in its Confidential Information, trade secrets, proprietary information, patents, trademarks, servicemarks and all other intellectual property (“Intellectual Property”).  Customer retains sole and exclusive right, title and interest in its Intellectual Property.  All Intellectual Property that Stellar uses or develops in connection with performing this Agreement relating in any manner to manufacturing operations, processes and know-how is and remains the sole property of Stellar.  Stellar does not grant Customer a license, or convey or transfer any right, title or interest, in its Intellectual Property to Customer.  All changes and improvements to the Products’ designs and specifications (excluding manufacturing operations, processes and know-how that Stellar uses or develops in connection with performing this Agreement) is and remains the sole property of Customer.  If Stellar and Customer develop new Intellectual Property while working together (unrelated to manufacturing operations, processes and know-how that Stellar uses or develops in connection with performing this Agreement, and unrelated to changes and improvements to the Products’ designs and specifications) (“Other IP”), Customer is the owner of the Other IP, and Stellar hereby assigns all right, title, and interest in Other IP to Customer.  Stellar and Customer agree to cooperate with each other in effecting assignments of and registering any Intellectual Property and Other IP to effect the foregoing, subject to their respective rights in their own Confidential Information and Intellectual Property.  This duty to cooperate shall survive the expiration or termination of this Agreement.”

 

4



 

8.)                                   Section 17 of the Agreement .  Section 17 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“Indemnification. Notwithstanding the Intellectual Property Indemnification Rights outlined in Section 1, if Customer or any third party: (i) performs any operation, procedure or process involving any Products or Services, or (ii) assembles, installs, uses or manufactures any Products or Services, or (iii) transports or delivers any Products to any third party, Customer immediately assumes all liability for, and agrees to indemnify and hold Stellar harmless from all claims, damages, recalls, penalties and attorneys’ fees relating to, or arising from, the Products and Services. In addition, Stellar is not liable for: (a) Customer’s designs, plans and specifications for the Products and Services; (b) Customer-supplied goods, including without limitation material, components, assemblies, and services, whether conforming or nonconforming, while in Stellar’s possession (“Customer Materials”); (c) non-conformities in any Products or Services created or occurring during Stellar’s handling, development, set-up, production, inspection, or provision of Services; and (d) non-conformities in any Products or Services created or occurring while in the possession of any third parties (collectively, ( c-d), “Non-Conformities”). Customer assumes all liability for, and agrees to indemnity and hold Stellar harmless from all claims, damages, recalls, penalties and attorneys’ fees relating to, or arising from, Customer’s designs, plans and specifications, Customer Materials and Nonconformities (collectively, Section 17, “Customer’s Indemnity”).  Section 17 Customer’s Indemnity does not alter the parties’ Intellectual Property Indemnification Rights and obligations under Section 1.”

 

9.)                                   Section 23 of the Agreement .  The following sentence is added as a new second paragraph of Section 23 of the Agreement:

 

“Customer further agrees that the terms of Section 3, mandating the Minimum Purchase Requirement for all Products and Services, and Revisions thereof, are subject to all remedies set forth in the first paragraph of Section 23.”

 

All other terms of Section 23 remain unchanged.

 

10.)                            Conditional Cancellation of Remaining Continuation Charge .  If Customer signs this First Amendment and agrees to the Early Cancellation Fee as defined in Section 8 of this First Amendment, Stellar agrees to waive Customer’s obligation to pay the balance of the Continuation Charge under Section 24 of the Agreement.

 

11.)                            Section 24 of the Agreement .  Section 24 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“24.                          Early Cancellation Fee and Triggering Events .  Customer agrees to pay Stellar an Early Cancellation Fee of [***] Dollars ($[***]) (“Early Cancellation Fee”) upon the earliest of the following:  (a) upon Customer’s failure to pay any amount when due under the Agreement or this First Amendment if such Default is not cured within sixty (60) days thereafter; (b) at the time of a Customer Sale or Product/Service Transfer (however, a Customer Sale or Product/Service Transfer is not a Triggering Event if Buyer assumes Customer’s obligations under the Agreement and this First Amendment, including the Early Cancellation Fee); (c) at the time Customer no longer uses, markets, or manufactures any

 


[***] 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

 

5



 

Products; (d) at the time Customer no longer orders or purchases any Products from Stellar; (e) at the time Stellar terminates this Agreement based upon Customer’s Default (subject to the provisions of Section 24(a) hereof); (f) at the time Customer terminates the Agreement or this First Amendment, if such termination occurs at any time prior to the expiration of the Contract Term, including, without limitation, at the time of a Customer Voluntary Termination (excluding, however, a termination under Section 20); and (g) upon the occurrence of any other event that constitutes a termination of the Agreement or this First Amendment, a transfer or assignment of Customer’s obligations under the Agreement or this First Amendment, or the termination, transfer or assignment of Customer’s obligations with respect to all Products (each, (a-g), a “Triggering Event”).

 

The Early Cancellation Fee shall be immediately due and payable upon the occurrence of the earliest Triggering Event.  The Early Cancellation Fee shall survive each of the events referenced in Section 24 (a-g).

 

Customer agrees that the Early Cancellation Fee is reasonable in all respects.  Customer agrees that Stellar will make substantial investments in space, scheduling, equipment and labor in order to accommodate Customer’s Product and Services requirements.  Customer agrees that Stellar has made and will make valuable and material investments in order to provide Customer with the Products and Services referenced in the Agreement and First Amendment, and in all Purchase Orders, including without limitation labor, skills, know-how, machinery and manufacturing processes.  Stellar has factored these investments and its expectation of the Early Cancellation Fee into the Price of the Products.  Customer agrees that the value of Stellar’s investments cannot be adequately compensated except by the Early Cancellation Fee, and that Customer’s failure to purchase Products for the full duration of the Contract Term (as defined in Section 3 of this First Amendment), or the occurrence of any other Triggering Event, will cause damage to Stellar in an amount that cannot be precisely determined, including, without limitation, loss of prospective economic advantage, lost sales and contracts, increased overhead costs, lost profits and the loss and impairment of its investments.  The Early Cancellation Fee is not a penalty.  Stellar and Customer have entered into this Agreement only because of Customer’s agreement to the Early Cancellation Fee.”

 

12.)                            Redefinition .  All references to the “Continuation Charge(s)” in the Agreement are hereby replaced with the term “Early Cancellation Fee.”

 

13.)                            Governing Law .  All references to “Minnesota” in Section 27 of the Agreement are hereby replaced with “Delaware”.

 

All other terms of Section 27 remain unchanged

 

14.)                            Exhibit A of the Agreement .  Exhibit A, Price Terms , of the Agreement is deleted in its entirety and replaced with Exhibit A, Price Terms of First Amendment , attached.

 

15.)                            Scope of First Amendment .  Subject only to the modifications of the Agreement pursuant to this First Amendment, the remainder of the Agreement has not been modified and otherwise remains in full force and effect.

 

6



 

IN WITNESS WHEREOF, Customer and Stellar have executed this First Amendment as of the Effective Date.

 

 

STELLAR TECHNOLOGIES, INC.,

NEVRO CORP., a Delaware corporation

a Minnesota corporation

 

 

 

 

 

 

 

 

By:

/s/ Estelle Forcelle

 

By:

/s/ Andrew Galligan

 

Estelle Forcelle

 

 

Print Name: Andrew Galligan

 

Its: Chief Executive Officer

 

 

Title: Chief Financial Officer

 

 

 

 

 

Date:

9-26-14

 

Date:

10/2/2014

 

7



 

EXHIBIT A

 

PRICE TERMS OF FIRST AMENDMENT

 

This Exhibit A (“Exhibit”) is incorporated into that certain First Amendment to Stellar Manufacturing Agreement (“First Amendment”), dated July 1, 2014, by and between Stellar Technologies, Inc. (“Stellar”) and Nevro Corp. (“Customer”) (Stellar and Nevro are the “Party[ies])”, relating to the Stellar Manufacturing Agreement, by and between the Parties, dated July 1, 2009 (“Agreement”).

 

1.                                       Adoption of Terms .  All terms defined in the Agreement and First Amendment shall have the same meaning in this Exhibit.  The terms of this Exhibit supersede any inconsistent terms of the Quotations, as defined below.

 

2.                                       Cancellation of Exhibit A of Agreement .  Exhibit A of the Agreement is cancelled in its entirety and superseded by this Exhibit A, Price Terms of First Amendment .

 

3.                                       Definitions .  For purposes of this Agreement:

 

(a)                                  “Key Product(s)” means percutaneous leads, lead extensions, S8 lead adaptors, M8 lead adaptors and lead proximal and sub-assembly for paddle leads; and

 

(b)                                  “Products” means all Key Products together with active anchor inserts and other machined components, including, without limitation, set screw housings, set screws and IPG header caps.

 

4.                                       Price Schedule .  The Parties hereby adopt the Price Schedule, Exhibit B, attached for all Products.  For purposes of the Price Schedule, the Key Product Volumes refer to the combined sum of all Key Products delivered during each Contract Year.

 

Additionally, no later than the last day of every calendar quarter following the Effective Date of this First Amendment, Stellar will provide Customer with an updated Price Schedule for the next calendar quarter (“Projection”), which will account for any changes, and Adjustments including, but not limited to, changes in vendor costs, pricing for raw materials, and/or labor costs required for the manufacturing of the Products listed in Exhibit B.  Furthermore, Stellar will issue Customer an invoice or a credit memo accounting for any variances resulting from changes to this Price Schedule during the calendar quarter directly preceding the Projection.

 

5.                                       Price Adjustments .  The Price Schedule and any related Quotations list the unit price of the Products based on Customer’s current designs and specifications for each Product and the current price of raw materials and all components purchased by Stellar.  If, at any time, (a) Customer makes any revisions to the designs, drawings and specifications of the Products that increase the cost to Stellar with respect to the cost of raw materials or components purchased by Stellar, or that result in additional cost to Stellar in any other way, including, without limitation, additional engineering costs, labor or Services, or (b) the price of raw materials or components purchased by Stellar fluctuate from the current price, regardless of the reason, Stellar will provide the related cost information to Customer and the unit prices of the Products shall be adjusted accordingly by Stellar (“Adjustment[s]”).  Stellar may issue invoices for certain costs, including,

 

A-1



 

without limitation, engineering costs, labor and Services, separately, and such invoices are due upon receipt.  For purposes of this Exhibit, the Agreement and the First Amendment, any Adjustments supersede the unit price of the Products listed in the Price Schedule and any Quotation.

 

6.                                       Key Product Discounts and Recovery of Deficiency Payment .  The following terms govern the prices set forth in the Price Schedule and any Quotations.

 

(a)                                  The Price Schedule and Quotations refer, at various times, to volume pricing.  All volume pricing is based on the combined volume of all Key Products delivered during each Contract Year (“Key Product Volume”).

 

Within sixty (60) to ninety (90) days prior to the beginning of each Contract Year, Customer will provide Stellar a forecast of the Key Product Volume for the next Contract Year (“Forecast”).  Stellar will compute the Price of each Key Product for the next Contract Year based on the Forecast.

 

(b)                                  Within sixty (60) to ninety (90) days after the end of each Contract Year, Stellar will calculate the actual Key Product Volume that it delivered during that Contract Year and adjust the Price of all Key Products based on that amount.  If the Forecast overestimated the actual Key Product Volume for any Contract Year, and Stellar is entitled to an increased Price based on the actual Key Product Volume, Stellar shall recalculate the unit Price of each and every Key Product based on the delivered amount and charge Customer, retroactively , the difference between the Forecast Price and actual Price for each unit of Key Products delivered during the Contract Year (“Deficiency”).  Stellar’s invoice for the Deficiency is due and payable immediately upon receipt by Customer.

 

However, if the Forecast underestimated the actual Key Product Volume for any Contract Year, and Customer is eligible for a reduced Price based on the actual Key Product Volume, Stellar shall recalculate the unit Price for each and every Key Product based on the delivered amount and credit, retroactively , the difference between the Forecast Price and actual Price for each unit of Key Products delivered during that Contract Year (“Credit”).  The Credit shall be applied to the invoices subsequently issued by Stellar to Customer until satisfied in full.

 

7.                                       Product Materials .  The Price includes the cost of all known materials, components and products known as of the date of this Amendment, except BAL seals.  Customer shall negotiate the price of all materials, components and products for all Products and the Parties shall arrange shipment and payment for all materials.  If Stellar (a) makes any payments for materials, components and products that are not clearly addressed in their existing documentation or (b) if Stellar pays more for any materials, components and products than the price agreed upon by the Parties at the time of this Amendment or any Quotations, Customer shall be liable for those amounts.  Stellar shall issue invoices to Customer for the price of such materials, components and products (including, without limitation, transportation, insurance, costs and expenses), which invoices are immediately due and payable upon receipt by Customer.

 

A-2



 

As of the date of this Agreement, Customer has not negotiated the price of BAL seals with its supplier.  The cost of BAL seals is not included in the Price Schedule or Quotations, and shall be charged to Customer as a separate item.  The price of BAL seals shall include a reasonable premium or increase for BAL seals lost in the manufacturing process that cannot be reclaimed.

 

8.                                       Material Price Subject to Actual Delivery Schedule .  If Customer orders a certain number of units of any Product under a Purchase Order Acknowledgement, but then requests delivery more than six (6) months after the date of the Purchase Order Acknowledgment, Customer will pay the unit cost for each order based on the actual amount delivered during each 6-month period.  Stellar may change the material cost of each Product at the end of each 6-month period.  The first 6-month period begins the date of the related Purchase Order Acknowledgment.  This 6-month price change is in addition to any Adjustments, Deficiency or other price changes provided in the Projections, this Agreement or this First Amendment.

 

END

 

A-3



 

EXHIBIT B

 

PRICE SCHEDULE

 

 

 

Key Product Volume*

Key Product

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

Percutaneous Lead, Part Nos.:

·    10160-3050B

·    10160-5050B

·    10160-7050B

·    10160-9050B

 

N/A

 

 

[***]

[***]

[***]

[***]

 

N/A

 

 

 

 

 

 

 

Lead Extensions, Part Nos.:

·    10169-25B

·    10169-35B

·    10169-60B

 

N/A

 

 

[***]

[***]

[***]

 

N/A

 

 

 

 

 

 

 

S8 Lead Adaptors, Part Nos.:

·    10433-25B

 

N/A

 

 

[***]

 

N/A

 

 

 

 

 

 

 

M8 Lead Adaptors, Part Nos.:

·    10428-25B

 

N/A

 

 

[***]

 

N/A

 

 

 

 

 

 

 

Lead Proximal and Sub-Assembly for Paddle Leads, Part Nos.:

·   

 

N/A

 

 

 

N/A

 


*  Based on the combined number of all Key Products delivered during any Contract Year.  All prices quoted and paid in USD.

 

NOTE:  Prices do not include price of BAL seals.  BAL seals to be charged to Nevro as a separate item.  The price of BAL seals shall include a reasonable premium or increase for BAL seals lost in the manufacturing process that cannot be reclaimed.

 

NOTE:  The prices listed in Stellar Quotation #012366-00, dated 9/04/2014, are only for Leads, Lead Extensions, S8 Lead Adaptors and M8 Lead Adaptors in the cumulative amount of [***] units in 2015.

 

[***] 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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EXHIBIT C

 

MANUFACTURING TRANSITION SERVICES

 

Stellar agrees to perform the Manufacturing Transition Services as defined in Section 4(D) for the compensation as set forth below.

 

During the initial five (5)-year Contract Term, Stellar’s Manufacturing Transition Services for Key Products will be paid by Customer at the rate of $[***] per hour for engineering services and $[***] per hour for technician services (collectively, the “Hourly Services”).

 

The parties will negotiate the hourly rates for all Hourly Services provided by Stellar after the expiration of the initial five (5) year Contract Term.

 

In addition to paying for the Hourly Services, Customer shall reimburse Stellar for all reasonable out of pocket costs for air travel, food, lodging and ground transportation.

 


[***] 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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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 R elating 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

 

11



 

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

 

12



 

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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.

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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 ½ to 5 ½ 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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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.

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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 ½ to 5 ½ 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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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 ½ to 5 ½ 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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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 ½ to 5 ½ 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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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.

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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 ½ to 5 ½ 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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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.

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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 ½ to 5 ½ 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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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.

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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 ½ to 5 ½ 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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 


 

GRAPHIC

 

 

 

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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.

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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 ½ to 5 ½ 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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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

 



 

GRAPHIC

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.

 

5




Exhibit 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



 

T ABLE 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.

 

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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

 

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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.

 

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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.

 

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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

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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

 

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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

 

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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

 

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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.

 

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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



 

GRAPHIC

 

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 (IMS Pr  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




Exhibit 10.4(b)

 

[***] 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

 

AMENDMENT TO SUPPLY AGREEMENT

 

This Amendment to Supply Agreement (“Amendment”) is entered into as of March 20, 2013 (“Amendment 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 Delaware 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, the Parties entered into a Supply Agreement dated effective April 1, 2012 (“Agreement”);

 

WHEREAS, that Agreement, among other things, provided in Section 18 that CCC granted to Nevro a perpetual, fully paid, world-wide, sublicenseable non-exclusive license to all “Incorporated CCC Property” (as defined in the Agreement), and agreed to cooperate to transfer to Nevro or its designee all information necessary for Nevro or its designee to manufacture Products in the same manner as CCC manufactures Products;

 

WHEREAS, Nevro now wishes to exercise its rights under the Supply Agreement to sublicense its rights to a second source, to have that second source manufacture Products;

 

WHEREAS, Nevro has requested CCC’s support and assistance to transfer the manufacturing IP, technology and know-how necessary to complete manufacture the Implantable Neurostimulator, and the Parties have agreed to execute an Agreement for Manufacturing Conversion as of on or about the Amendment Effective Date;

 

WHEREAS, the Parties now wish to amend the Agreement as follows:

 

NOW, THEREFORE, in consideration of the foregoing and the agreements contained herein, the Parties hereby agree as follows:

 

1.                         Section 18.5 shall be amended by inserting, after the end of the last sentence in that section, the additional sentence:  “Any and all consideration that may be due or become payable to CCC under this section shall be deemed satisfied and fully paid-up through the payments defined in the Agreement for Manufacturing Conversion and the additional Purchase Commitment consideration provided for in section 19.2 as amended.”

 

2.                         The title of section 19 shall be amended by adding “/Purchase Commitment” thereto.

 

3.                         Section 19.2 of the Agreement shall be replaced in its entirety by the following provisions:

 

(a)(i) If Nevro issues orders to CCC (according to the terms of the Agreement) for quantities greater or equal to [***] IPG units per full calendar year for calendar years 2013 and 2014 (the “Purchase Commitment”), then the parties agree that Nevro and its Second Source (as that term is defined in the Agreement for Manufacturing Conversion) will have the transferable (whether by sublicense or assignment) right, including as provided for in Section 18 of the

 


[***] 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

 



 

Agreement, to practice any and all Confidential Information (as that term is defined in the Agreement for Manufacturing Conversion) that was and will be transferred by CCC to the Second Source, to manufacture and sell the Device (as that term is defined in the Agreement for Manufacturing Conversion) or its successors; and provided further that if Nevro fulfills the Purchase Commitment as set forth herein, unless excused under subsection (b), then the right to practice all Confidential Information as provided for in this subsection will also be fully paid-up, perpetual and non-terminable.

 

(a)(ii)  If Nevro issues orders to CCC (according to the terms of the Agreement) for quantities greater or equal to [***] IPG units per full calendar year in calendar year 2013 and thereafter (the “Exclusivity Undertaking”), then CCC 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 High Frequency Neurostimulator.

 

(b) The foregoing rights in subsection (a)(i) shall terminate if Nevro does not fulfill the Purchase Commitment, and the foregoing rights in subsection (a)(ii) shall terminate if Nevro does not fulfill the Exclusivity Undertaking; provided, however, that non-compliance by Nevro with the Purchase Commitment and Exclusivity Undertaking shall be excused if the failure to fulfill for any particular calendar year is due to (1) a recall, field action, regulatory, licensing or quality issue concerning Nevro IPGs manufactured by CCC or concerning CCC as a manufacturing entity that does not allow CCC to manufacture and/or delivery the minimum quantities required by the Purchase Commitment or Exclusivity Undertaking, or (2) force majeure.

 

(c)(i) If Nevro does not meet the Purchase Commitment for each year as specified in subsection (a)(i), unless excused pursuant to subsection (b), and if Nevro nonetheless wishes to continue to exercise and benefit from the rights described in subsection (a)(i), then Nevro shall pay to CCC an amount, in cash, equal to (1) $[***], multiplied by (2) the difference between (A) the annual Purchase Commitment in section (a)(i), minus (B) the number of units Nevro orders from CCC during the year in question.

 

(c)(ii) If Nevro does not meet the Exclusivity Undertaking for each year as specified in subsection (a)(ii),  unless excused pursuant to subsection (b), and if Nevro nonetheless wishes to continue to exercise and benefit from the rights described in subsection (a)(ii), then Nevro shall pay to CCC an amount, in cash, equal to (1) $[***], multiplied by (2) the difference between (A) the annual Exclusivity Undertaking in section (a)(ii), minus (B) the number of units Nevro orders from CCC during the year in question.

 

(d) The Parties agree that Nevro’s satisfaction of the Purchase Commitment for a particular calendar year shall also be deemed to satisfy the Exclusivity Undertaking for that same calendar year; and vice versa.

 

4.                                       Unless otherwise defined herein, all defined or capitalized terms in this Amendment shall have the meanings defined within the Supply Agreement or Agreement for Manufacturing Conversion.

 


[***] 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

 



 

5.                                       Other than as amended herein, all other terms of the Supply Agreement shall remain in full force and effect.

 

6.                                       This Amendment 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.

 

IN WITNESS WHEREOF, the Parties hereto have executed this Amendment as of the Amendment 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:

Vice President, Finance and CFO

 

 

 

 

 

Date:

March 21, 2013

 

Date:

March 21, 2013

 




Exhibit 10.5

 

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

 

PRODUCT SUPPLY AND DEVELOPMENT AGREEMENT

 

This PRODUCT SUPPLY AND DEVELOPMENT AGREEMENT (“Agreement”), effective as of April 15, 2009 (the “Effective Date”), is by and between EaglePicher Medical Power LLC (“EPMP LLC”), a Delaware Corporation having an address of “C” and Porter Streets, Joplin, MO 64801 and Nevro Corporation (“Buyer”), a Delaware Corporation, having its principal place of business at 411 Acacia Avenue, Palo Alto, CA 94306.

 

WHEREAS, Buyer wishes to purchase batteries and related products for use in preclinical status and clinical trials of its proprietary medical implantable devices;

 

WHEREAS, EPMP LLC agrees to manufacture and sell such batteries and related products to Buyer in accordance with, and subject to, the specifications, delivery schedules and other terms and conditions set forth in this Agreement; and

 

WHEREAS, at a future date, if Buyer desires to develop a custom battery, the parties will cooperate in the development of such custom battery pursuant to this Agreement.

 

NOW, THEREFORE, EPMP LLC and Buyer hereby agree as follows:

 

1.                                      DEFINITIONS . As used in this Agreement, the following defined terms shall have the meanings provided for in this Article 1:

 

1.1.                             Affiliate ” means with respect to either party, any Person controlling, controlled by or under common control with such party, for so long as such control exists.  For purposes of this Section 1.1, “control” means (a) direct or indirect ownership of fifty percent (50%) or more (or, if less than fifty percent (50%), the maximum ownership interest permitted by applicable law) of the stock or shares having the right to vote for the election of directors of such corporate entity or (b) the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such entity, whether through the ownership of voting securities, by contract or otherwise

 

1.2.                             “Battery Technology” means all inventions, know-how, processes, chemistry, data, test results, formulas, trade secrets, non-public specifications, and other proprietary information relating to the composition, article of manufacture, or methods of making or using batteries, whether or not patentable.

 

1.3.                             “Buyer Technology ” means any invention, know-how, design, plan, idea, technique, discovery, technical, trade secret or other proprietary information, whether or not patentable or copyrightable, including but not

 

PRODUCT DEVELOPMENT AND SUPPLY AGREEMENT EAGLEPICHER-NEVRO

 

1



 

limited to manufacturing technology and processes, either Controlled by Buyer or one of its Affiliates as of the Effective Date, or by Buyer or one of its Affiliates during the term of but outside the scope of this Agreement or thereafter, and any Improvements thereto.

 

1.4.                             Control ” means, with respect to an item or intellectual property rights, the ability and authority of a party or its Affiliate, whether arising by ownership, possession, or pursuant to a license or sublicense, to grant licenses, sublicenses, or other rights to the other party under or to the subject item or intellectual property rights as provided for in this Agreement, without breaching the terms of any agreement between such party and any third party.

 

1.5.                             Development Phase ” means the period beginning from initiation of the creation of a Modified Product pursuant to Article 3 and continuing until completion of the design and prototype tasks relating to such Modified Product, also referred to as “Phase 1” development, as set forth in the relevant Development Plan.

 

1.6.                             Development Plan ” means a development plan to be created by the parties at a later date if the parties agree to develop a Modified Product pursuant to Article 3, under which EPMP LLC will perform its obligations to develop a Modified Product, including time lines and deliverables for the Development Phase for any Modified Product.  Any future Development Plan will be attached hereto as Exhibit D.

 

1.7.                             “EPMP LLC Technology ” means any invention, know-how, design, plan, idea, technique, discovery, technical, trade secret or other proprietary information, whether or not patentable or copyrightable, including but not limited to manufacturing technology and processes, either owned by or licensed to EPMP LLC or one of its Affiliates as of the Effective Date, or solely developed or licensed by EPMP LLC or one of its Affiliates during the term of but outside the scope of this Agreement or thereafter, and any Improvements thereto.

 

1.8.                             Improvement ” means any modification, enhancement, inventions or other desirable change to the respective technology (Buyer Technology, Battery Technology, or EPMP LLC Technology) developed by either party hereto pursuant to this Agreement.

 

1.9.                             Interface Invention ” means any Invention relating to connections to, interfaces with, or attachments to batteries or Product.

 

1.10.                      “Pre-Production Phase ” means, for any Modified Product developed pursuant to Article 3 below, the period immediately after the Development Phase and immediately prior to the Production Phase during

 

PRODUCT DEVELOPMENT AND SUPPLY AGREEMENT EAGLEPICHER-NEVRO

 

2



 

which all preparations are completed for final approval by Buyer or its designee and production readiness of such Modified Product.

 

1.11.                      Production Phase ” means, for any Modified Product developed pursuant to Article 3 below, the period beginning when all Product designs for such Modified Product have been completed and approved in writing by both parties and continuing for the term of this Agreement.

 

1.12.                      Person ” means any individual and any corporation, partnership, limited liability company, business or other trust, governmental agency or authority, association or other entity.

 

1.13.                      Product ” means any cell or battery, whether those being made as of the Effective Date by EPMP LLC or specifically designed to meet Buyer’s specifications pursuant to a Development Plan, for use in Buyer’s implantable medical devices.  Products include without limitation any Modified Products that the parties develop pursuant to Article 3.

 

1.14.                      Specifications ” means the specifications for the Product set forth in Exhibit A, which may be modified from time to time by written agreement of the parties.

 

2.0                               SCOPE OF AGREEMENT.    EPMP LLC shall use its best efforts during the term of this Agreement to supply Products to Buyer in the quantities ordered by Buyer from time to time and in accordance with the Specifications and with the schedules for deliveries thereof established pursuant to this Agreement. If requested by Buyer, EPMP LLC shall develop Modified Products as provided in Article 3.  It is understood that Buyer shall be free to enter into cooperation, development, and supply agreements with third parties with respect to other batteries and related products.

 

3.0                               NEW PRODUCT DEVELOPMENT .

 

3.1                                If Buyer desires to have EPMP LLC conduct development of a modified version of Product to have specific characteristics of use to Buyer (a “Modified Product”), it shall so notify EPMP LLC in writing.  Within thirty (30) days after Buyer makes such request, the parties shall agree upon a Development Plan for developing such Modified Product, including timelines and related budgets for such activities.

 

3.2                                Without limiting Section 3.1, EPMP LLC agrees that it will dedicate sufficient personnel, materials and facilities to diligently develop Modified Products under this Agreement in accordance with the relevant Development Plan.

 

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3.3                                During the Development Phase, EPMP LLC will use its best efforts to develop Modified Products (i) to comply with all of the relevant Specifications, and (ii) in accordance with the relevant Development Plan.

 

3.4                                During the Development Phase, periodic meetings or conference calls, as necessary, will be held to coordinate and verify progress during the relevant Development Phase and the relevant Pre-Production Phase at times mutually agreed upon by the parties.

 

3.5                                Buyer may, from time to time, request modifications to the project objectives under any Development Plan, specifications or tasks, which EPMP LLC will consider in good faith, but which EPMP LLC reserves the right to approve in its reasonable discretion.  EPMP LLC will promptly provide Buyer in writing with notice of any projected resulting change in costs associated with Buyer’s requested modifications to project objectives, specifications, or tasks.  Buyer shall be obligated to pay such change in cost only if Buyer accepts such changes in cost in writing.  Buyer and EPMP LLC will mutually agree in writing upon such timetable changes as are necessitated by such modifications, and any other implications of such modifications, and update the relevant Development Plan to reflect such agreed changes.

 

3.6                                Each of EPMP LLC and Buyer will cooperate fully and closely with the other to facilitate the fastest possible development of any Modified Products, including but not limited to designating technical personnel to attend and participate in regularly scheduled design review meetings.  Each of EPMP LLC and Buyer will designate in writing from time to time a Project Engineer to act as liaison with the other party to coordinate and respond to questions and inquiries regarding technical matters, personnel and intellectual property matters.

 

4.                                       ORDER AND DELIVERY .

 

4.1                                Purchase Orders for Products, Forecasts, and Releases .

 

a.                     Within sixty (60) days prior to commencement of the Production Phase for any Modified Product, or within sixty (60) days after the Effective Date for other Products, Buyer shall submit to EPMP LLC in writing, whether by mail, telecopy, facsimile, or electronic data interchange format approved by EPMP LLC, a purchase order for Product for a time period of not less than three (3) months commencing from the beginning of the Production Phase for any Modified Product, or commencing from sixty (60) days after the Effective Date for other Products.  Each such purchase order shall represent and constitute a “Purchase Order.”  At least one (1) calendar month prior to the expiration of each Purchase Order, Buyer shall issue a Purchase Order for the

 

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contiguous time period of not less than three (3) months immediately following expiration of such prior Purchase Order.  Buyer may, at its discretion, satisfy this objective by extending the time period covered by the existing Purchase Order.  All Purchase Orders shall at a minimum: (i) identify Products ordered, (ii) state Product price, (iii) state Product quantity ordered with intended delivery schedule, (iv) state the location to which the Product is to be shipped, (v) state the shipping schedule for the period of the Purchase Order, and (iv) state that this Agreement shall govern and control all purchase orders.

 

b.                     Within sixty (60) days prior to commencement of the Production Phase for any Modified Product, or within sixty (60) days after the Effective Date for other Products, Buyer will provide EPMP LLC with an initial twelve (12) calendar month forecast indicating Buyer’s forecasted purchases of Products from EPMP LLC during that period (the “Initial Twelve (12) Calendar Month Forecast”). Subsequent to Buyer providing EPMP LLC the Initial Twelve (12) Calendar Month Forecast, by the first day of the first month in each of January, April, July, and September thereafter, Buyer shall provide EPMP LLC with an updated rolling twelve (12) calendar month forecast indicating Buyer’s forecast purchases of Products from EPMP LLC during the immediately following twelve (12) month period (each such forecast being a “Twelve Month Forecast”).  The Initial Twelve (12) Calendar Month Forecast and the Twelve Month Forecasts shall be used for purposes of facilitating each party’s planning and in order to meet the lead times required by certain of EPMP LLC’s suppliers.  The first three (3) months of each Twelve Month Forecast will be firm.

 

4.2                                Changes and Cancellations . Purchase Orders may be modified or canceled by Buyer by giving forty-five (45) days prior written notice.  Modifications must be approved in writing by EPMP.  In the event of a cancellation, Buyer will be responsible for purchasing finished product and work-in-progress according to quantities in the firm three (3) month period of the Initial Twelve (12) Calendar Month Forecast or the Twelve Month Forecast, as applicable, and for the cost of raw material purchased by EPMP LLC based on the most recent six months of either the Initial Twelve (12) Calendar Month Forecast or a Twelve Month Forecast, as applicable.

 

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4.3                                Order Limitations . An “Excess Product Quantity” is those quantities of Product ordered in a Purchase Order for delivery within a certain month that are greater than one hundred fifty percent (150%) of the quantities of Product forecasted by Buyer for that month. EPMP LLC shall not be obligated to supply Excess Product Quantities; however, EPMP LLC shall use all commercially reasonable efforts to supply Excess Product Quantities, it being understood that in the supply of any such excess beyond the permitted coverage EPMP LLC may take into account its then existing delivery commitments to other customers.  Buyer shall reimburse EPMP LLC for any reasonable costs actually paid by EPMP LLC in order to facilitate the production of Excess Product Quantities, but only costs directly related to the Excess Product Quantities actually delivered to Buyer and only if EPMP LLC obtains prior approval in writing from Buyer to commence such excess production at such increased cost.

 

4.4                                Packaging . EPMP LLC will mark all containers with necessary lifting, handling, storage, and shipping information and with Purchase Order numbers, date of shipment, and the names of the Buyer and EPMP LLC. EPMP’s standard Certificate of Compliance and an itemized packing list, which shall include (i) the Purchase Order number, and (ii) the description, part number, revision level, and quantity of the Product(s) so shipped, must accompany each shipment.

 

4.5                                Shipping . All deliveries of Products shall be FCA (Incoterms 2000) EPMP LLC’s manufacturing facility in either Surrey, B.C. Canada or Joplin, MO, USA. Title to the Products and all risk of damage to or loss or delay of Products purchased under this Agreement shall pass to Buyer upon their delivery to Buyer.

 

4.6                                Cancellation Costs in General . Production cancellation costs will not be in excess of the purchase price of the Products actually cancelled in a purchase order. EPMP LLC shall use best efforts to mitigate all cancellation costs. Upon Buyer’s request, EPMP LLC shall deliver to Buyer any materials or unfinished Products for which full reimbursement was received by EPMP LLC.

 

5.0                                PRODUCT ACCEPTANCE.

 

5.1                                Inspections . Any inspection by Buyer or its designee of Products purchased under this Agreement shall be made at Buyer’s or its designee’s facility and at Buyer’s expense. Buyer shall notify EPMP LLC in writing within thirty (30) calendar days after receipt at Buyer’s or its designee’s facility (the “Acceptance Period”) of any Product rejections based on damage, discrepancy, or nonconformity with the Specifications. Buyer’s failure to inspect or failure to notify EPMP LLC

 

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of any rejection of Product in writing due to any damage, discrepancy, or nonconformity with the Specifications during the Acceptance Period shall be deemed acceptance of the Products. In the event of any nonconformity with the Specifications discovered after acceptance, EPMP LLC’s sole obligation and liability, and Buyer’s sole remedy, shall be limited to the provisions set forth in Article 10, Warranty, below.

 

5.2                                Return Procedure . In the event that Buyer rejects a Product pursuant to Section 5.1, Buyer may, at Buyer’s option, return any rejected Product to EPMP LLC.

 

a. Buyer may return any Products rejected pursuant to Section 5.1 to EPMP LLC at EPMP LLC’s risk and cost unless EPMP LLC acknowledges any defect or non-conformance in writing and requests Buyer to not return such rejected Products within ten (10) days after receipt of the written rejection.  In such cases, EPMP LLC shall reimburse buyer’s costs of disposing of such Product.  EPMP LLC may issue a RA number (Return Authorization number) which is procedural only and is no way an admission that the Products are defective or nonconforming.

 

b. At Buyer’s option, EPMP LLC shall then either replace the rejected Products or credit Buyer for the rejected Products. In the case of either replacement or credit, title to the rejected Product shall pass to EPMP LLC on return shipment by Buyer of the rejected Products to EPMP LLC pursuant to Section 5.2(a).

 

c. If EPMP LLC is to replace the product(s), EPMP LLC shall transport the replacement products at EPMP LLC’s cost to an air freight or overnight carrier within ten (10) days after receipt of Buyer’s replacement request.

 

5.3                                EPMP LLC’s Quality Assurance . EPMP LLC will maintain and use in manufacturing Products quality assurance systems of at least industry standard for the control of material quality, processing, assembly, testing, packing, and shipping in accordance with its usual policies and practices. The parties will endeavor to meet quarterly to discuss and resolve any issues, which may have arisen with respect to quality assurance, including those relating to quality, performance, engineering changes, industry changes, or surpluses.

 

6.                                       PRICE .

 

6.1                                Pricing . The initial prices for Products that are not Modified Products are

 

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set out on Exhibit C hereto, and are subject to adjustment as provided for in Section 6.3.

 

6.2                                Production Payment Terms . Payment terms are net thirty (30) days from date of the invoice. Except in the case of good faith disagreements about amounts invoiced, EPMP LLC may charge interest in the amount of ten percent (10%) per annum, or the maximum amount permitted by law, whichever is less, on any unpaid balance after the net thirty (30) day payment term, until such balance is paid in full.

 

6.3                                Price Adjustments . If EPMP LLC incurs increases or decreases in its direct cost of materials for use in manufacturing the Product of [***] percent ([***]%) or more per Product unit during the term of this Agreement, EPMP LLC shall send a notice to Buyer detailing such change. The parties agree to negotiate in good faith after delivery of such notice with respect to an adjustment to Product pricing in view of such increase or decreases, but no modification of such pricing shall occur unless and until the parties have both signed an amendment hereto.

 

6.4                                Taxes . Prices are in U.S. dollars and do not include any Canadian, U.S. federal or state sales taxes, duties, or export or import charges, which shall be paid solely by Buyer.

 

7.0                                INTELLECTUAL PROPERTY .

 

7.1                                Existing Technology . All Battery Technology rights Controlled by Buyer as of the Effective Date and Buyer Technology will continue to be Controlled by Buyer. All Battery Technology rights Controlled by EPMP LLC as of the Effective Date and EPMP LLC Technology will continue to be Controlled by EPMP LLC.

 

7.2                                New Intellectual Property Arising Under Agreement . Ownership of all discoveries, technology, and inventions arising during and in the course of the parties’ performance under the Agreement, and intellectual property rights therein (together, “Inventions”) shall be as follows: (i) any joint Invention solely related to Battery Technology (and not related to any Interface Inventions) shall be owned by EPMP LLC, and (ii) Nevro shall own all other Inventions.  Both parties shall cooperate with the other party to execute documents and take any actions necessary to effect the intent of the foregoing sentence in this Section 7.2.  EPMP LLC hereby grants to Buyer a nonexclusive, perpetual, irrevocable, sublicenseable, fully paid up, royalty-free, worldwide license under EPMP LLC Technology and any Inventions owned by EPMP LLC pursuant to this Section 7.2 to make, use, sell, offer for sale, import, copy, modify, distribute and otherwise exploit any

 

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medical devices developed, made, or sold by or on behalf of Buyer, its Affiliates, or sublicensees.

 

7.3                                No Other License . Subject to the right to use and sell the Products as integrated into Buyer’s products as set forth in Section 7.2, nothing in this Agreement grants or can be capable of granting to either party (whether directly or by implication, estoppel or otherwise) any rights to any Battery Technology Controlled by the other party or any Affiliate of the other party. Further, EPMP LLC grants no license of any EPMP LLC Technology to Buyer, except the right to use and sell the Products as integrated into Buyer’s products as set forth in Section 7.2.

 

8.                                       COMPLIANCE WITH LAWS .

 

8.1                                Compliance . EPMP LLC shall comply with all applicable laws, rules and regulations of Canada, the USA, Europe, and all other jurisdictions in which the Products are sold by Buyer and as to which Buyer notifies EPMP LLC in writing (“Applicable Laws”) in its performance under this Agreement.

 

8.2                                Reports . EPMP LLC shall cooperate with Buyer and provide any information reasonably requested or required by Buyer for Buyer’s compliance with regulatory approvals or actions for any products in which the Products will be incorporated.  EPMP LLC specifically agrees to cooperate with any inspection by the FDA or other regulatory authority.  EPMP LLC shall keep complete, accurate, and authentic accounts, notes, data, and records of the work performed under this Agreement (“Records”) and shall provide Buyer with a copy of all Records at Buyer’s request.

 

9.                                       PRODUCT SPECIFICATIONS; CHANGES .

 

9.1                                Specifications . The initial specifications for the Products are set forth in the specification for EPMP LLC Battery (Source Control Document Number) (see Exhibit A, attached hereto). Subject to written agreement between the parties as to Specifications and price for additional Products that may be developed pursuant to Article 3, this Agreement may be amended to include additional Products by attaching additional exhibits, but only upon written mutual consent of both parties.

 

9.2                                Changes . In the event Buyer wishes to make any changes to the Specification or the Product, Buyer shall inform EPMP LLC in writing, and EPMP LLC shall advise Buyer within forty five (45) days after receiving such notice of the likely impact of such change on scheduling, pricing and manufacturing of Products, and whether such changes are feasible. EPMP LLC shall have the right to review and approve such changes to the

 

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Specifications, in order to determine whether EPMP LLC can reasonably comply with any requirement contained in such change. The parties may thereafter meet to discuss incorporating such change into the manufacturing process, including the allocation between the parties of additional costs related to such changes, however, EPMP LLC may, without breaching this Agreement, reject any change to the Specifications, which EPMP LLC believes it reasonably and in good faith cannot meet.

 

9.3                                Engineering Change Approval . EPMP LLC shall not make any changes to any manufacturing source, production process, controlled process parameters or sources, or types or grade classifications of materials used, which may alter the form, fit, or function of any Product, without first obtaining from Buyer an engineering change approval in writing.

 

9.4                                Cost of Engineering Changes . The parties shall mutually agree in writing upon the allocation of cost of engineering changes not necessary to remedy defects in the Products or nonconformities with the Specifications before such changes are made. All engineering changes to remedy defects in the Products or nonconformities with the Specifications shall be implemented at the sole expense of EPMP LLC, unless the defect in the Products or nonconformities with the Specifications is caused by Buyer’s own actions including, but not limited to, providing defective functional Specifications, in which case Buyer shall be solely responsible for such expenses. However, EPMP LLC shall examine Buyer’s Specifications and any other actions or instructions provided by Buyer to apply EPMP LLC’s own knowledge and expertise to such Specifications and EPMP LLC shall advise Buyer of any shortcomings of such Specifications in writing.

 

10.                                WARRANTY AND LIMITATION OF LIABILITY .

 

10.1                         Warranty . EPMP LLC represents and warrants to Buyer that: (i) the Product shall be free and clear from all liens and encumbrances, (ii) the manufacture, sale, lease, transfer or use of the Product will not infringe any intellectual property rights of a third party, and no action, suit or claim has been, or will have been, initiated or threatened against EPMP LLC with respect to the Products or EPMP LLC’s right to enter into and perform its obligations under this Agreement, (iii) the Products will meet the Specifications (for Modified Products, after such time as the Specifications are established for such Products), (iv) the manufacturing process and all materials used to manufacture the Products shall comply with all applicable Restriction of Hazardous Substance (“RoHS”) provisions, (v) EPMP LLC is not now nor has in the past been using in any capacity the services of any individual, corporation, partnership or association which has been debarred under 21 U.S.C. § 335a; (vi) the manufacturing process and all materials used in the manufacture of the Products will comply with all use

 

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restrictions, labeling requirements, inventory registration requirements and all other health and safety requirements imposed under Applicable Laws, and (vii) the Products will be free from defects in material and workmanship for a period of twelve (12) months after the date of delivery to Buyer (the “Warranty Period”); provided, however, that Buyer gives notice to EPMP LLC of any defect within thirty (30) days after discovering the defect within the Warranty Period. The return procedure outlined in Section 5.2 will be used with the exception that, in some cases, it may be impractical to return suspect Product to EPMP LLC for evaluation. In this case, following issuance of an RA by EPMP LLC, Buyer and EPMP LLC will work together to determine the appropriate means to make the suspect Product available for evaluation to determine the validity of the warranty claim, provided in this Section 10.1.  EPMP LLC covenants that it will not use in any capacity the services of any individual, corporation, partnership or association which is debarred or becomes debarred during the term of this Agreement, under 21 U.S.C. § 335a.

 

10.2                         Exceptions . EPMP LLC’s obligation under the warranties in Section 10.1 shall not apply to any Product or part thereof, if the alleged defect or other problem with the Product has been caused by: (a) Buyer’s improper storage, installation, use, maintenance, or modifications not complying with EPMP LLC’s written instructions, or Buyer’s improper testing not approved in writing by EPMP LLC, or (b) physical damage to Product after receipt by Buyer.

 

10.3                         Epidemic Failure . For the purpose of this Agreement, “Epidemic Failure” will be deemed to have occurred if more than [***] percent ([***]%) of Product units shipped pursuant to Article 4 in any 360 day period should fail to meet the relevant Specifications, whether occurring inside or outside any Warranty Period. Buyer and EPMP LLC acknowledge the common goal and expectation that the failure rate should decrease over the [***] quarters subsequent to any Epidemic Failure.

 

Epidemic Failure Policy . In the case of Epidemic Failure, Buyer and EPMP LLC will cooperate to implement the following procedure:

 

a. Buyer will promptly notify EPMP LLC in writing upon discovery of the Epidemic Failure.

 

b. Within two (2) working days, EPMP LLC will give an initial written response indicating its preliminary plan for diagnosing the problem.

 

c. EPMP LLC and Buyer will jointly exert all commercially reasonable efforts to diagnose the problem and plan a work-around as an interim solution if one is needed, and a permanent solution.

 


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d. EPMP LLC will apply its engineering change procedure, described in Section 9.3, in appropriate circumstances for hardware problems related to the design of the Product, or originating in the manufacturing process.

 

e. EPMP LLC will prepare and consult with Buyer regarding an appropriate recovery plan as well as an appropriate work-around, as an interim solution, if one is needed. EPMP LLC will any time upon Buyer’s request report in writing on the progress made.

 

f. EPMP LLC and Buyer will mutually agree on a recovery plan to cure or prevent Epidemic Failures. If such plan is not effected within 6 (six) months after an Epidemic Failure has been reported by Buyer, Buyer shall have the right to terminate this Agreement with immediate effect without liability so long as the failure was solely or partially a result of acts or omissions by EPMP LLC.

 

10.4                         Limited Warranty . THE WARRANTIES SET FORTH ABOVE ARE IN LIEU OF ALL OTHER WARRANTIES, AND EACH PARTY MAKES NO OTHER WARRANTIES WHETHER WRITTEN ORAL, WRITTEN, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE.

 

10.5                         Remedies for Breach of Warranty .  EPMP LLC’s sole obligation and liability under the warranties in Section 10.1 shall be limited to the replacement of the Product with a Product that meets Specifications or the refund of the purchase price at the Buyer’s sole option. Replacement Products will have a new Warranty Period based on their delivery date.

 

10.6                         Limitation of liability . Except for a breach of Sections 11 (Indemnification) and 12 (Confidentiality), the liability of each party is limited as follows:

 

a. The total liability of EPMP LLC for any and all claims by Buyer arising under this Agreement, including but not limited to claims based on tort, breach of contract, warranty, or any other theory of recovery, shall not exceed the cumulative value of the purchase orders in a continuous prior twelve (12) calendar month period containing the Product(s) giving rise to the claim and any such liability shall terminate upon the expiration of the Warranty Period.

 

b. The total liability of Buyer for any and all claims by EPMP LLC arising under this Agreement, including but not limited to claims based on tort, breach of contract, warranty, or any other theory of recovery, shall not exceed twice the purchase price of the Product which gives rise to the

 

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claim, and any such liability shall terminate upon the expiration of the Warranty Period.

 

c. In no event, however with the exception of grossly negligent or intentional acts or omissions, shall either party be liable for special,  indirect, incidental, exemplary, punitive or consequential damages including, but not limited to, loss of profits or revenue, even if warned of the possibility of such damages and notwithstanding the failure of essential purpose of any remedy.

 

10.7                         EPMP LLC Liability Insurance . EPMP LLC shall procure and maintain product liability and general liability insurance in such amounts as ordinary good business practice for its type of business would make advisable, but not less than one million dollars, and EPMP LLC shall provide Buyer with written evidence of this coverage within ten business (10) days after the Effective Date.

 

11.                                      INDEMNIFICATION

 

11.1                         Buyer’s Indemnification . Buyer shall indemnify, defend and hold harmless EPMP LLC and its Affiliates, agents, officers, directors and employees (“EPMP Indemnitees”) from and against any and all claims, losses, damages, liabilities, legal actions, settlements, or expenses (including reasonable legal expenses), to the extent resulting from or arising out of any third party claims (“Losses”) that result in any way from (a) any breach by Buyer of this Agreement, or (b) Buyer’s use of the Products in such a way that constitutes or may constitute an infringement of any patent, trade secret, trademark, service mark, copyright, or related application, or other intellectual property or confidential and proprietary information infringement, except in each case to the extent caused by EPMP LLC’s or any EPMP Indemnitee’s gross negligence or willful misconduct or the Products as delivered to Buyer, breach of this Agreement by EPMP LLC or any action for which EPMP LLC must indemnify Buyer under Section 11.2; provided, however, that EPMP LLC: (i) promptly notifies Buyer in writing of any such notice or claim, and (ii) permits Buyer to control, in a manner not adverse to EPMP LLC, the defense, settlement, adjustment or compromise of any such claim using counsel of Buyer’s own choice. EPMP LLC may employ counsel, at its own expense (provided that, if such counsel is necessary because of a conflict of interest of either Buyer or its counsel, or because Buyer does not assume control, in which case Buyer will bear such expense), to assist it with respect to any such claim. Buyer shall not enter into any settlement for any intellectual property infringement claim that affects EPMP LLC’s rights or interest without EPMP LLC’s prior written approval.

 

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11.2                         EPMP LLC’s Indemnification . EPMP LLC shall indemnify, defend and hold harmless Buyer and its Affiliates, agents, officers, directors, employees and  direct and indirect customers (“Buyer Indemnitees”) from and against any and all Losses that result in any way from (a) infringement or misappropriation of the Products provided by EPMP LLC to Buyer under this Agreement of any patent, copyright, trademark, trade secret or other intellectual property right, private right, or any other proprietary or personal interest of any third party, (b) defects or nonconformity with the Specifications of the Products that are not solely the result of any acts or omissions by Buyer, (c) any breach by EPMP LLC of this Agreement, except in each case to the extent caused by Buyer’s or any Buyer Indemnitee’s gross negligence or willful misconduct or breach of this Agreement by Buyer; provided, however, that Buyer: (i) promptly notifies EPMP LLC in writing of any such notice or claim, and (ii) permits EPMP LLC to control, in a manner not adverse to Buyer, the defense, settlement, adjustment or compromise of any such claim using counsel of EPMP LLC’s own choice. Buyer may employ counsel, at its own expense (provided that, if such counsel is necessary because of a conflict of interest of either EPMP LLC or its counsel, or because EPMP LLC does not assume control, in which case EPMP LLC will bear such expense), to assist it with respect to any such claim. EPMP LLC shall not enter into any settlement that affects Buyer’s rights or interest without Buyer’s prior written approval.

 

12.                                CONFIDENTIALITY .

 

Confidentiality Agreement. The parties agree that the terms of the Mutual Nondisclosure Agreement between EPMP LLC and Nevro (the “NDA,” as attached at Exhibit B), shall continue in effect during the term of this Agreement, apply to all information disclosed under this Agreement, apply thereafter as provided for in the NDA, and the Purpose (as defined in the NDA) is hereby expanded to include the performance of obligations and exercise of rights pursuant to this Agreement.  Furthermore, Section 4 of the NDA is hereby amended so that the following language is added at the end of Section 4: “If a court or government authority requires the Receiving Party to disclose any Proprietary Information, the Receiving Party may disclose such Proprietary Information only to the extent required by law or requirement and will use reasonable efforts to seek confidential treatment of any information so required to be disclosed.”  Permitted use and disclosure of Proprietary Information is limited to each party’s ability to use Proprietary Information only as necessary on a need to know basis to exercise its rights and fulfill its obligations under this Agreement and only in compliance with the standards and safeguards set forth in the NDA .

 

13.                          TERM AND TERMINATION

 

13.1                         Term . This Agreement shall commence on the Effective Date and have an initial term ending on November 1, 2010 (the “Initial Term”).  After the

 

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Initial Term, this Agreement will automatically renew for period of one year unless a Party notifies the other Party in writing of its intent to terminate the Agreement at least sixty (60) days prior to the end of the renewal term.

 

13.2                         Termination . Notwithstanding the provisions of Section 13.1, this Agreement may be terminated in accordance with any of the following provisions:

 

13.3                         Default . A party may terminate this Agreement upon giving written notice to the other party in the event that the other party is in breach of any material provision of this Agreement and shall have failed to cure such breach within sixty (60) days after receipt of written notice describing such material breach from the non-breaching party. A non-breaching party shall be entitled to an extension of time for performance of its obligations equaling the period of time of the breaching party’s default, to the extent such default affects the non-breaching party’s ability to perform hereunder.

 

13.4                         Bankruptcy, Insolvency. and Cessation . Either party may terminate this Agreement without liability by giving advance written notice to the other party, which termination shall be effective if such condition is not cured within sixty (60) days after any: (i) imminent filing of a bankruptcy petition of any type by the other party, (ii) declaration by the other party that it has or will become bankrupt or insolvent, (iii) assignment for the benefit of creditors of the other party, liquidation or receivership; or (iv) cessation of business or proof of the other party’s intent to cease to do business.

 

13.5                         Force Majeure . If an event of Force Majeure continues for more than ninety (90) consecutive days as provided in Article 14, then either party may terminate this Agreement, without liability to the other, immediately upon written notice. Each Party shall exercise commercially reasonable efforts to abate or remedy a condition of Force Majeure.

 

13.6                         Termination for Convenience . Either party may terminate this Agreement for convenience, in whole or in part and without liability for such termination, other than (for termination by Buyer) raw materials already purchased, finished Product, and work-in-progress as described in Section 4.2, by giving three(3) months prior written notice to the other party. In such event all terms and conditions of this Agreement shall remain in full force and effect until the termination takes effect three (3) months after notice.

 

13.7                         Rights and Obligations on Termination. If a party does not terminate for cause, termination of this Agreement shall not release that party from its obligation under this agreement. Any Purchase Orders pending or being effectively placed, pursuant to Section 4.1(b) during the notice period are to be fulfilled by EPMP LLC.

 

PRODUCT DEVELOPMENT AND SUPPLY AGREEMENT EAGLEPICHER-NEVRO

 

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14.                                FORCE MAJEURE .

 

“Force Majeure” shall mean any event or condition, not existing as of the date of signature of this Agreement, not reasonably foreseeable as of such date or thereafter, and not reasonably within the control of either party, which prevents in whole or in material part the performance by one of the parties of its obligations hereunder, including, but not limited to, flood, storm, earthquake, embargoes, and acts of God, acts of government (other than government business), war, and/or public enemy. Force Majeure does not necessarily include the business dealings of government, but does include acts of government outside the course of ordinary business that legally prohibit or mandate certain business and manufacturing activities by EPMP LLC. If a party wishes to declare Force Majeure, it shall notify the other party immediately. Such notice shall include information with respect to the actual hindrance and, where possible, the duration of such hindrance. Upon giving notice to the other party, a party affected by an event of Force Majeure shall be suspended without any liability on its part from the performance of its obligations under this Agreement provided it uses reasonable efforts to overcome such delay or failure, except that it may not suspend any obligation to pay any amounts due and owing hereunder, but only to the extent and only for the period that its performance of such obligations is prevented by the event of Force Majeure. During the period that the performance by one of the parties of its obligations under this Agreement has been suspended by reason of an event of Force Majeure, the other party may likewise suspend the performance of all or part of its obligations hereunder to the extent that such suspension is commercially reasonable and such other party may take provisional precautions which would otherwise have constituted a violation of this Agreement for the purpose of limiting its losses caused by the Force Majeure.

 

15.                          MISCELLANEOUS .

 

15.1                         Governing Law . The rights and obligations of the parties shall not be governed by the UN Convention of Contracts for the International Sale of Goods (“CISG”). Rather, this Agreement shall be interpreted, construed and governed by and in accordance with the laws of the state of Delaware without regard to its conflict of law provisions, and jurisdiction shall lie exclusively therein.

 

15.2                         Assignment . Neither party shall, without the prior written consent of the other party, which shall not be unreasonably withheld, assign this Agreement or any part hereof, or sell, offer for sale, transfer, divest, or otherwise dispose of its rights hereunder, to a third party, except that either party may assign this Agreement to its affiliate or to a third party which succeeds to substantially all of its assets to which this Agreement relates or equity, unless such successor is a

 

PRODUCT DEVELOPMENT AND SUPPLY AGREEMENT EAGLEPICHER-NEVRO

 

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Direct Competitor of the other party. For the purpose of this clause, a “Direct Competitor” of EPMP LLC is a company that derives a substantial portion of its revenues from manufacturing electro-chemical cells or batteries for non-affiliated third parties, some of which are medical device companies and a “Direct Competitor” of Buyer is a company that derives a substantial portion of its revenues from development and sales of medical devices for the treatment of pain.  Nonetheless, in the event of an assignment of this Agreement, the assignment shall be subject to the assigning party requiring that: (a) its successors, heirs or assigns assume all of its obligations and responsibilities under this Agreement, and (b) this Agreement and all of its terms and conditions shall inure to benefit of and be binding on any such successor, heir or assign. The respective rights of the parties under this Agreement shall survive transfer of title and possession of any assets of the transferring or assigning party, except to the extent that the non-transferring party may otherwise specifically waive in writing.

 

15.3                         Integration. This Agreement, the NDA, and all Exhibits attached hereto, constitute the entire understanding and agreement of the parties with respect to the subject matter hereof and supersede all previous agreements or proposals, oral or written, and all negotiations, conversations or discussions heretofore had between the parties related to the subject matter of this Agreement.

 

15.4                         Survival. The obligations described in Sections 7.2, 7.3, 10.1 (for the period described therein), 13.7, 15.1, 15.2, and Articles 11 and 12 shall survive termination of this Agreement and continue thereafter in full force and effect, subject to applicable statute of limitations.

 

15.5                         Amendment Waiver . This Agreement may not be released, discharged, abandoned, changed or modified in any manner, except by an instrument in writing signed on behalf of each of the parties to this Agreement by their duly authorized representative.  The failure of either party to enforce at any time any of the provisions of this Agreement shall in no way be construed to be a waiver of any such provision, nor in any way to affect the validity of this Agreement or any part of it or the right of either party after any such failure to enforce to enforce each and every such provision.  No waiver of any breach of this Agreement shall be held to be a waiver of any other or subsequent breach.

 

15.6                         Counterparts . This Agreement may be executed in one or more counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same agreement.  This Agreement shall become a binding agreement when one or more counterparts have been signed by each party and delivered to the other party pursuant to Section 15.9.

 

15.7                         Headings. The titles and headings to Articles and Sections herein are inserted for

 

PRODUCT DEVELOPMENT AND SUPPLY AGREEMENT EAGLEPICHER-NEVRO

 

17



 

the convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement. This Agreement shall be construed without regard to any presumption or other rule requiring construction hereof against the party causing this Agreement to be drafted.

 

15.8                         No Third Party Beneficiaries . Nothing in this Agreement, expressed or implied, is intended to confer on any person other than the parties to this Agreement, or their respective successors or assigns, any rights, remedies, obligations or liabilities under or by reason of this Agreement.

 

15.9                         Notices . Any notice or other communication hereunder must be given in writing and either (a) delivered in person, (b) transmitted by telex, facsimile or telecopy mechanism, provided that any notice so given is also mailed as provided in clause (c), or (c) mailed, postage prepaid, receipt requested as follows:

 

If to EPMP LLC:

EaglePicher Medical Power LLC

13136-82A Avenue,

Surrey, B.C., Canada V3W 9Y6.

Facsimile: 604 597-0814

Attention: Director of Marketing

 

If to Buyer:

Nevro Corporation
411 Acacia Avenue
Palo Alto, CA 94306
Attention: Andre Walker

 

or to such other address or to such other person as either party shall have last designated by such notice to the other party. Each such notice or other communication shall be effective (i) if given by telecommunication, when transmitted to applicable number so specified in (or pursuant to) this Section 15.9 and an appropriate receipt is received, (ii) if given by mail, three (3) days after such communication is deposited in the mail with first class or priority postage prepaid, addressed as aforesaid or (iii) if given by any other means, when actually received at such address.

 

15.10      Severability. If any provision of this Agreement is held invalid by a court of competent jurisdiction, the remaining provisions shall nonetheless be enforceable according to their terms. Further, if any provision is held to be overbroad as written, such provision shall be deemed amended to narrow its application to the extent necessary to make the provision enforceable according to Applicable Law and shall be enforced as amended.

 

PRODUCT DEVELOPMENT AND SUPPLY AGREEMENT EAGLEPICHER-NEVRO

 

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15.11      Relationship . This Agreement does not make either party the employee, agent or legal representative of the other for any purpose whatsoever. Neither party is granted any right or authority to assume or to create any obligation or responsibility, express or implied, on behalf of or in the name of the other party. In fulfilling its obligations pursuant to this Agreement, each party shall be acting as an independent contractor.

 

15.12      Effective Terms and Precedence . Should there be a conflict between the language of this Agreement and the language contained in any Purchase Order, the language of this Agreement shall control.

 

IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed by their authorized representatives.

 

 

EAGLE PICHER MEDICAL POWER LLC

 

 

 

 

By:

/s/ Emily Russell

 

 

 

 

Title:

Senior Counsel

 

 

 

 

 

 

 

NEVRO CORPORATION

 

 

 

 

By:

/s/ Konstantinos Alataris

 

 

 

 

Title:

CEO

 

 

PRODUCT DEVELOPMENT AND SUPPLY AGREEMENT EAGLEPICHER-NEVRO

 

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Exhibit A

 

Specifications

 

PRODUCT DEVELOPMENT AND SUPPLY AGREEMENT EAGLEPICHER-NEVRO

 


 

[***]

 


[***] 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

 

Non-Disclosure Agreement

 



 

MUTUAL NON-DISCLOSURE AGREEMENT

 

This Mutual Non-Disclosure Agreement (“Agreement”) is made and entered into on November 24th 2008     as by and between EaglePicher Medical Power , a division of EPEP UCL (“Vendor”) and having principal offices at 13136-82A-Ave, Surrey, BC, V3W 9Y6, CANADA and Nevro Corporation     (the “Company”) having principal offices at 411 Acacia ave Palo Alto CA 94306        USA    .

 

For and in consideration of the disclosures to be made hereunder, and for other good and valuable consideration, the receipt and sufficiency of which are hereby expressly acknowledged, the parties agree as follows:

 

1.                                       In connection with discussions regarding the Purpose (defined below), the Company and the Vendor may each disclose Proprietary Information (defined below) to the other party.  The party disclosing Proprietary Information hereunder shall be referred to herein as the “Disclosing Party” and the party receiving such Proprietary Information shall be referred to herein as the “Receiving Party”.  The Receiving Party acknowledges and agrees that the Proprietary Information of the Disclosing Party is the sole and exclusive property of the Disclosing Party (or a third party providing such information to the Disclosing Party) and that the Disclosing Party owns all worldwide copyrights, patents, trade secret rights, confidential and proprietary information rights, and all other property rights therein.

 

2.                                       The Receiving Party shall use the Proprietary Information solely for the Purpose and for no other purpose whatsoever.  The disclosure of the Proprietary Information of the Disclosing Party to the Receiving Party does not confer upon The Receiving Party any license, interest, rights or residuals of any kind in or to the Proprietary Information.

 

3.                                       The Receiving Party will hold in confidence and not disclose, reproduce, distribute, transmit, reverse engineer, disassemble, or transfer, directly or indirectly, in any form, by any means, or for any purpose, the Proprietary Information or any portion thereof.  The Receiving Party may disclose the Proprietary information only to its attorneys, accountants and employees to the extent, and only to the extent, such persons have a need to know such information for the Purpose; provided each such employee shall be obligated in writing to comply with the terms and conditions of this Agreement and each such attorney or accountant shall either be legally bound to comply with the terms and conditions of this Agreement or so obligated in writing.

 

4.                                       The Receiving Party acknowledges that its obligations under this Agreement with regards to the Trade Secrets (defined below) of the Disclosing Party shall remain in effect for as long as such information shall remain a trade secret under applicable law or shall be protected by other intellectual property rights.  The Receiving Party acknowledges that its obligations under this Agreement with regards to the Confidential Information (defined below) of the Disclosing Party shall remain in effect for five (5) years after the termination of this Agreement.  The foregoing obligations shall not apply if and to the extent that the Receiving Party establishes that the information communicated was:  (a) already

 



 

known to the Receiving Party, without obligation to keep it confidential, at the time of its receipt from the Disclosing Party; (b) received by such party in good faith from a third party lawfully in possession thereof and having no obligation to keep such information confidential; or (c) publicly known at the time of its receipt by the Receiving Party or has become publicly known other than by a breach of this Agreement or other action by the Receiving Party.

 

5.                                       The Receiving Party agrees to return to the Disclosing Party, upon request by the Disclosing Party, the Proprietary Information and all materials relating thereto, disclosed to the Receiving Party by the Disclosing Party, provided however that the Receiving Party may retain one (1) copy of such materials solely for archival and other regulatory compliance purposes.

 

6.                                       The Receiving Party understands and acknowledges that neither the Disclosing Party nor any of the Disclosing Party’s representatives make any representation, warranty or condition, express or implied, as to the accuracy or completeness of the Proprietary Information.  The Receiving Party agrees that neither the Disclosing Party nor any of the Disclosing Party’s representatives shall have any liability to the Receiving Party relating to or resulting from the use of the Proprietary Information or any errors therein or omissions therefrom.

 

7.                                       The Receiving Party understands and agrees that no contract or agreement providing for any transaction involving the Disclosing Party shall be deemed to exist between the Receiving Party and the Disclosing Party unless and until a final definitive agreement has been executed and delivered.

 

8.                                       The Receiving Party acknowledges that any breach of the covenants contained in this Agreement will cause the Disclosing Party immediate and irreparable harm, and remedies at law for any such breach are inadequate.  Accordingly, the Disclosing Party shall be entitled to seek to obtain a restraining order, injunction, or other similar remedy (without any requirement to post bond as a condition of such relief) for any breach or threatened breach of this Agreement by the Receiving Party.  Nothing contained herein shall be construed as limiting the Disclosing Party’s right to any other remedies at law including the recovery of damages for breach of this Agreement.  In the event that the Disclosing Party prevails in an action against the Receiving Party, the Receiving Party agrees to pay all court costs and attorney’s fees.

 

9.                                       As used herein, “Confidential Information” means information, other than Trade Secrets, that is of value to its owner and is treated as confidential, including without limitation any information disclosed by the Disclosing Party regarding its current products and services, its products and services under development and any Disclosing Party financial information.  As used herein, “Trade Secrets” means information constituting a trade secret under applicable law.  As used herein, “Proprietary Information” means Trade Secrets and Confidential Information.

 

10.                                This Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors, assigns, heirs, and legal representatives.  A waiver by either of the parties hereto of any breach by the other party of any of the terms, provisions or conditions of this Agreement or the acquiescence of either party hereto in any act (whether commission or omission) which but for such acquiescence would be a

 

24



 

breach as aforesaid, shall not constitute a general waiver of such term, provision or condition of any subsequent act contrary thereto.  This Agreement represents the entire understanding between the parties with respect to the subject matter hereof and supersedes all other written or oral agreements heretofore made by or on behalf of the Disclosing Party or the Receiving Party with respect to the subject matter hereof and may be changed only by agreements in writing signed by the authorized representatives of the parties.  If any provision of this Agreement is declared invalid by a court of competent jurisdiction, such provision shall be ineffective only to the extent of such invalidity, so that the remainder of that provision and all remaining provisions of this Agreement will continue in full force and effect.

 

11.                                This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but which together shall constitute the same instrument.  Each party agrees to be bound by its own telecopied or facsimiled signature, and agrees that it accepts the telecopied or facsimiled signature of the other party hereto.

 

12.                                This Agreement shall be governed by and construed and interpreted in accordance with the laws of New York, without giving effect to its conflict of laws.

 

25



 

For the purpose of this Agreement, “Purpose” means the evaluation of a business relationship between the Company and the Vendor whereby the Vendor may provide products and services to the Company, including without limitation, relating to batteries for implantable medical devices.

 

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives effective as of the date first above written.

 

Company:

 

Vendor:

 

 

 

 

 

 

Nevro

 

EAGLEPICHER MEDICAL POWER

 

 

 

Print Name:

Andre Walker

 

 

 

 

 

 

Print Name:

Cheryl Moll

Signature:

/s/ Andre Walker

 

 

 

 

 

 

Signature:

/s/ Cheryl Moll

Title:

Sr. VP Engineering

 

 

 

 

 

Title:

Program Manager

 

 

 

 

 

 

 

11/25/2008

 

26



 

Exhibit C

 

Pricing Terms

 

Product Description

 

Quantity

 

Unit Price

 

325mAh

 

[***]

 

$

[***]

 

325mAh

 

[***]

 

$

[***]

 

325mAh

 

[***]

 

$

[***]

 

325mAh

 

[***]

 

$

[***]

 

 

PRODUCT DEVELOPMENT AND SUPPLY AGREEMENT EAGLEPICHER-NEVRO

 


[***] 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 D

 

Development Plan(s)

 

[Never executed]

 

PRODUCT DEVELOPMENT AND SUPPLY AGREEMENT EAGLEPICHER-NEVRO