SECOND AMENDMENT TO PRIVATE LABEL DISTRIBUTION AGREEMENT

Exhibit 10.1

 

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. INFORMATION THAT HAS BEEN OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE ▇▇▇▇ “[***]”.

SECOND AMENDMENT TO PRIVATE LABEL DISTRIBUTION AGREEMENT

 

THIS SECOND AMENDMENT TO PRIVATE LABEL DISTRIBUTION AGREEMENT (this “Amendment”) is made and entered as of March 1, 2019 (“Second Amendment Effective Date”), by and between Inogen, Inc., a Delaware corporation (the “Company”) and OxyGo HQ, LLC, formerly known as Applied Home Healthcare Equipment, LLC, an Ohio limited liability company (the “Distributor”).

 

WHEREAS, the Company and the Distributor are parties to that certain Private Label Distribution Agreement dated November 12, 2014 (the “Agreement”);

 

WHEREAS, the Company and the Distributor have previously modified the Agreement in certain respects by way of Addendum dated November 12, 2014, attached hereto as Exhibit A, Addendum dated December 22, 2015, attached hereto as Exhibit B, Addendum dated February 17, 2016, attached hereto as Exhibit C, First Amendment dated February 21, 2018, attached hereto as Exhibit D (collectively, the “Prior Addenda”); and

 

WHEREAS, the Company and the Distributor wish to confirm and ratify the Prior Addenda and further to amend the Agreement as set forth below.  

 

NOW, THEREFORE, in consideration of the foregoing premises, the mutual covenants and promises contained in this Amendment and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and the Distributor agree as follows:

 

1.Ratification of the Prior Addenda.  The Company and the Distributor hereby confirm and ratify the Prior Addenda, and agree that the provisions of the Prior Addenda have been incorporated into and made an integral part of the Agreement.

2.Amendments to the First Amendment to Private Label Distribution Agreement.  

2.1Special Terms for Certain [***] Sales.  The Company and the Distributor hereby agree on the special pricing terms applicable solely to the sales of the Subject Products (as defined on Exhibit D) by the Distributor to [***] effective as of March 1, 2019, as set forth on Exhibit E attached hereto.  The pricing terms set forth on Exhibit D shall supersede any conflicting provisions of the Agreement solely with respect to sales of the Subject Products by the Distributor to [***] on or after March 1, 2019.

3.No Other Modifications.  Except as specifically provided in this Amendment, the terms and conditions of the Agreement remain in full force and effect. No provisions of this Amendment may be modified or amended except expressly in a writing signed by both parties, nor shall any terms be waived except expressly in a writing signed by the party charged therewith.

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

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4.Counterparts.  This Amendment may be executed in any number of counterparts, each of which shall be deemed to be an original, but all of which together shall constitute one and the same instrument.  

 

IN WITNESS WHEREOF, the parties hereto have duly executed this Amendment as of the First Amendment Effective Date.

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

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EXHIBIT A

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

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Addendum to Private Label Distribution Agreement Between Applied Home
Health Equipment and Inogen

This addendum to the private label agreement, entered into on November 12, 2014, documents changes in the warranty coverage for the OxyGo devices.

Inogen extends the warranty on the OxyGo devices to [***] on the concentrator only for the following customers, effective on the following dates:

 

The [***] warranty covers the concentrator only.  All accessories, including sieve beds, batteries, power supplies and carry bags remain at [***].

 

Agreed and acknowledged:

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

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EXHIBIT B

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

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Addendum to PRIVATE LABEL DISTRIBUTION AGREEMENT (“Addendum”)

 

5.1.1Export Restrictions. Distributor agrees to comply with all applicable export and re-export control laws and regulations, including the Export Administration Regulations (“EAR”) maintained by the U.S. Department of Commerce, trade and economic sanctions maintained by the Treasury Department’s Office of Foreign Assets Control, and the International Traffic in Arms Regulations (“ITAR”) maintained by the Department of State. Specifically, Distributor covenants that it shall not -- directly or indirectly -- sell, export, re-export, transfer, divert, or otherwise dispose of any products received from Inogen under this Agreement to any destination, entity, or person prohibited by the laws or regulations of the United States, without obtaining prior authorization from the competent government authorities as required by those laws and regulations. Distributor agrees to indemnify, to the fullest extent permitted by law, Inogen from and against any fines or penalties that may arise as a result of Distributor’s breach of this provision. This export control clause shall survive termination or cancellation of this Agreement.

 

10.1Initial Term; Renewal Terms. The initial term (the “Initial Term”) of this Agreement shall be [***] from the date of this Addendum. The Initial Term shall be automatically extended and renewed for successive [***] periods (each a “Renewal Term”) prior to the expiration of the Initial Term and each Renewal Term unless either party gives the other written notice of its election to terminate this Agreement at least [***] prior to the expiration of the then current term of this Agreement.

 

EXHIBIT B

TERRITORY

Updated Authorized Territory for Inogen/Applied Home Healthcare Distribution Agreement

 

[***]

 

[***]

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

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IN WITNESS WHEREOF, each of the undersigned has caused this Distribution Agreement to be duly executed as of the date first written above.

 

 

 

12/22/15

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

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EXHIBIT C

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

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EXHIBIT A: PRODUCTS

For purposes of this Agreement, the term “Products” includes all oxygen systems, accessories and other oxygen goods and services offered for sale by Inogen.

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

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EXHIBIT B: TERRITORY

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

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Signature Page

 

 

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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EXHIBIT D

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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FIRST AMENDMENT TO PRIVATE LABEL DISTRIBUTION AGREEMENT

THIS FIRST AMENDMENT TO PRIVATE LABEL DISTRIBUTION AGREEMENT (this “Amendment”) is made and entered as of February 21, 2018 (“First Amendment Effective Date”), by and between Inogen, Inc., a Delaware corporation (the “Company”) and Applied Home Healthcare Equipment, LLC, an Ohio limited liability company (the “Distributor”).

WHEREAS, the Company and the Distributor are parties to that certain Private Label Distribution Agreement dated November 12, 2014 (the “Agreement”);

WHEREAS, the Company and the Distributor have previously modified the Agreement in certain respects by way of Addendum dated November 12, 2014, attached hereto as Exhibit A, Addendum dated December 22, 2015, attached hereto as Exhibit B, and Addendum dated February 17, 2016, attached hereto as Exhibit C (collectively, the “Prior Addenda”); and

WHEREAS, the Company and the Distributor wish to confirm and ratify the Prior Addenda and further to amend the Agreement as set forth below.

NOW, THEREFORE, in consideration of the foregoing premises, the mutual covenants and promises contained in this Amendment and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and the Distributor agree as follows:

Ratification of the Prior Addenda.  The Company and the Distributor hereby confirm and ratify the Prior Addenda, and agree that the provisions of the Prior Addenda have been incorporated into and made an integral part of the Agreement.

Amendments to the Agreement.

Section 5.13(a) (Change in Control) of the Agreement is hereby renumbered as Section 5.14.

Section 6 (Additional Obligations of the Company) of the Agreement is hereby amended as follows:

Section 6.4 of the Agreement is replaced with the following:

“6.4ISO 13485 and CE ▇▇▇▇.  The Company shall implement such quality control systems and procedures as shall be appropriate to (a) ensure compliance with the requirements of International Standards Organization 13485, as applicable to the Company as the manufacturer and supplier of the

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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Products, and (b) place the ▇▇ ▇▇▇▇▇ (and/or other regulatory markings as may be applicable) on the Products in accordance with applicable law.  Company will provide to Distributor current copies of ISO 13485, CE and DoC certificates for all Company products.”

Section 6.5 is added to the Agreement as follows:

“6.5Regulatory Compliance Requirements.  Distributor shall meet all regulatory requirements as outlined in this section:

a.Distributor will market the Products only in countries where regulatory compliance has been confirmed.

b.Distributor will determine requirements for sale of the Products as prescriptive devices in targeted markets.  Distributor will document these requirements and inform Company prior to distribution into each country.

c.Distributor will maintain shipping records of all the Products that are distributed.

d.All customer complaints will be informed immediately to Company.

e.In case of adverse medical events involving the Products, Distributor will submit to Company all information to evaluate applicable regulatory reporting requirements.  All complaints shall be reviewed by Company and filed by Company should the results of Company’s complaint investigation deem the complaint to meet the criteria of a reportable event.  Company shall have sole responsibility for reporting of any complaints or incidents to competent governmental authorities and Distributor shall not make any such report without the Company’s prior written approval.

f.Distributor will comply with Company instructions in case of a need for product advisory product recall of the Products.

g.Distributor will maintain all documentation and records referred above for at least seven years.  Record will be made available to Company upon request.”

Section 6.6 is added to the Agreement as follows:

“6.6U.S. Foreign Corrupt Practices Act.  Without limiting any other provision in this Agreement, Distributor hereby represents, warrants and covenants that it shall comply with the requirements of the U.S. Foreign Corrupt Practices Act, U.S. and any other applicable foreign or domestic anti-bribery and anti-corruption laws, and other laws governing improper

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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payments.  Specifically, Distributor further represents, warrants, and covenants that, in connection with its activities under this Agreement, it will not offer, promise, authorize or otherwise act in furtherance or, or pay, anything of value, directly or indirectly, to a Government Official (as such term is hereinafter defined), or political party or party official, candidate for political office, or official of a public international organization.  For purposes of this Agreement, the term “Government Official” shall mean and include any official or employee of a foreign (i.e., not the United States of America) national, local, provincial, or state government department, agency, or instrumentality, as well as an official in the judicial, legislative, or military, anyone acting in an official capacity for any foreign government, or any immediate family member (i.e., a spouse, sibling, child or parent) of such persons.  Any such offer, promise, authorization, act in furtherance, or payment shall constitute a default by Distributor, and, to the extent, if any, required by law, the Company shall may immediately terminate this Agreement if Distributor breaches any of the representations and warranties set forth in this Section or if the Company learns that improper payments are being or have been made to any Government Official or private party by Distributor or its employees, subsidiaries or subcontractors.”

Section 8 (Confidentiality and Property Rights) of the Agreement is hereby amended by adding a new Section 8.7 as follows:

“8.7SEC or Similar Filings.  The Company may disclose the terms of this Agreement to the extent reasonably required to comply with the rules and regulations promulgated by the United States Securities and Exchange Commission, comparable foreign regulators and self-regulatory organizations (such as securities exchanges).”

Section 10.2 (Termination of the Agreement) of the Agreement is hereby amended as follows:

Section 10.2(c) of the Agreement is replaced with the following:

“(c)The Company may terminate this Agreement, upon written notice, as set forth in Sections 3.5, 5.3, 5.9, 5.14 and 6.6.”

Section 10.2(g) is added to the Agreement as follows:

“(g)The Company may terminate this Agreement if the Distributor is in material breach of the Company’s Code of Conduct and fails to remedy any such breach within sixty (60) days after written notification of the breach by the Company.”

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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Special Terms for [***] Sales.  The Company and the Distributor hereby agree on the special pricing terms applicable solely to the sales of the Subject Products (as defined on Exhibit D) by the Distributor to [***] effective as of February 1, 2018, as set forth on Exhibit D attached hereto.  The pricing terms set forth on Exhibit D shall supersede any conflicting provisions of the Agreement solely with respect to sales of the Subject Products by the Distributor to [***] on or after February 1, 2018.

No Other Modifications.  Except as specifically provided in this Amendment, the terms and conditions of the Agreement remain in full force and effect.  No provisions of this Amendment may be modified or amended except expressly in a writing signed by both parties, nor shall any terms be waived except expressly in a writing signed by the party charged therewith.

Counterparts.  This Amendment may be executed in any number of counterparts, each of which shall be deemed to be an original, but all of which together shall constitute one and the same instrument.

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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IN WITNESS WHEREOF, the parties hereto have duly executed this Amendment as of the First Amendment Effective Date.

 

 

 

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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EXHIBIT A

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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Addendum to Private Label Distribution Agreement Between Applied Home
Health Equipment and Inogen

This addendum to the private label agreement, entered into on November 12, 2014, documents changes in the warranty coverage for the OxyGo devices.

Inogen extends the warranty on the OxyGo devices to [***] on the concentrator only for the following customers, effective on the following dates:

 

The [***] warranty covers the concentrator only.  All accessories, including sieve beds, batteries, power supplies and carry bags remain at [***].

 

 

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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EXHIBIT B

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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Addendum to PRIVATE LABEL DISTRIBUTION AGREEMENT (“Addendum”)

5.1.1Export Restrictions.  Distributor agrees to comply with all applicable export and re-export control laws and regulations, including the Export Administration Regulations (“EAR”) maintained by the U.S. Department of Commerce, trade and economic sanctions maintained by the Treasury Department’s Office of Foreign Assets Control, and the International Traffic in Arms Regulations (“ITAR”) maintained by the Department of State.  Specifically, Distributor covenants that it shall not -- directly or indirectly -- sell, export, re-export, transfer, divert, or otherwise dispose of any products received from Inogen under this Agreement to any destination, entity, or person prohibited by the laws or regulations of the United States, without obtaining prior authorization from the competent government authorities as required by those laws and regulations.  Distributor agrees to indemnify, to the fullest extent permitted by law, Inogen from and against any fines or penalties that may arise as a result of Distributor’s breach of this provision.  This export control clause shall survive termination or cancellation of this Agreement.

 

10.1Initial Term; Renewal Terms.  The initial term (the “Initial Term”) of this Agreement shall be [***] from the date of this Addendum.  The Initial Term shall be automatically extended and renewed for successive [***] periods (each a “Renewal Term”) prior to the expiration of the Initial Term and each Renewal Term unless either party gives the other written notice of its election to terminate this Agreement at least [***] prior to the expiration of the then current term of this Agreement.

EXHIBIT B

TERRITORY

Updated Authorized Territory for Inogen/Applied Home Healthcare Distribution Agreement

 

[***]

 

[***]

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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IN WITNESS WHEREOF, each of the undersigned has caused this Distribution Agreement to be duly executed as of the date first written above.

 

 

12/22/15

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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EXHIBIT C

 

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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EXHIBIT A: PRODUCTS

For purposes of this Agreement, the term “Products” includes all oxygen systems, accessories and other oxygen goods and services offered for sale by Inogen.

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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EXHIBIT B: TERRITORY

 

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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Signature Page

 

 

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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EXHIBIT D

[***] PROGRAM

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

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EXHIBIT E

 

[***] PRICING

 

 

 

 

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.