Exhibit 10.1

 

ASSIGNMENT AND LICENSE AGREEMENT

 

THIS AGREEMENT (this “Agreement”) is made and entered into as of November 28, 2007, by and between Inspire Medical Systems, Inc. (“Inspire”), a Delaware corporation, and Medtronic, Inc., a Minnesota corporation (“Medtronic”).

 

WITNESSETH:

 

WHEREAS, Medtronic and Inspire have agreed that in order to enable Inspire to develop and distribute products in the Field, as defined below, on a world-wide basis, Medtronic will transfer to Inspire certain assets for Inspire’s use in connection with the Field (such transfer and related transactions between Medtronic and Inspire, to be known herein as the “Spin-Out”).

 

WHEREAS, in connection with the Spin-Out, Medtronic and Inspire have entered into an investment agreement of even date herewith whereby Medtronic shall make certain investments in Inspire (the “Investment Agreement”); and

 

WHEREAS, in connection with the Spin-Out, Medtronic agrees to assign to Inspire, the Assigned Patents (as defined herein) and Trademarks (as defined herein) and to license to Inspire the Technical Information and Licensed Patents (all as defined herein) in the Field (as defined herein), subject to the terms and conditions of this Agreement.

 

AGREEMENTS:

 

NOW THEREFORE, in consideration of the representations, warranties, covenants and agreements contained herein, and for other valuable consideration, the receipt and adequacy of which is hereby acknowledged, the parties mutually agree as follows:

 

ARTICLE 1
 DEFINITIONS

 

1.1)                           Specific Definitions. As used in this Agreement, the following definitions and terms shall have the designated meanings:

 

“Affiliate” has the meaning set forth in the Investment Agreement.

 

“Agreement” means this Agreement and all Exhibits attached hereto.

 

“Assigned Patents” means (a) the patents listed on Exhibit A; and (b) all continuation, divisional , re-issue or re-examination applications that may be filed based on the patents listed on Exhibit A.

 

“Base IP” means Intellectual Property owned by, or licensed to (with the right to sublicense), Inspire that has application in the Field. For the avoidance of doubt, Base IP includes the Assigned Patents and the Licensed Patents.

 

“Closing” has the meaning set forth in the Investment Agreement.

 











 

“Confidential Information” has the meaning set forth in the Investment Agreement.

 

“Field” means the electrical stimulation of the upper airway for the treatment of obstructive sleep apnea.

 

“Grant-Back Base IP” means any Base IP that is owned by, or licensed to (with the right to sublicense), Inspire at any time during the period beginning on the Initial Closing Date and ending on the date that the Noncompetition Period ends.

 

“IDEA Disclosures” means the IDEA disclosures identified on Exhibit B-1.

 

“IDEA Disclosure Patents” means: (a) any patent applications filed by, or on behalf of, Inspire, or its Affiliates, that are based upon, or that contain subject matter that is related to the subject matter of, any IDEA Disclosures; (b) any patents which issue from any of the patent applications of subpart (a); and (c) all continuation, divisional, re-issue or re-examination applications that may be filed based on the patents and patent applications of subparts (a) and (b), together with any patents that may issue based thereon.

 

“Improvement Patents” means any patent or patent application included in the Base IP: (a) that claims, or could claim, priority, either directly or indirectly, from any of the patents or patent applications included in the Assigned Patents or Licensed Patents; or (b) from which any of the patents or patent applications included in the Assigned Patents or Licensed Patents claims, or could claim, priority, either directly or indirectly.

 

“Initial Closing Date” has the meaning set forth in the Investment Agreement.

 

“Insolvent” with respect to a party means that such party, makes an assignment for the benefit of creditors, files, or has filed against it involuntarily, a petition for relief under any applicable code, or goes into receivership.

 

“Intellectual Property” has the meaning set forth in the Investment Agreement.

 

“Indemnifiable Losses” has the meaning set forth in Section 5.1.

 

“Knowledge” has the meaning set forth in the Investment Agreement.

 

“L169 IC” means the integrated circuit that is assembled onto the hybrid assembly and further assembled into the 3024 Implantable Pulse Generator as defined in the Development Agreement.

 

“Licensed Patents” means (a) the patents and patent applications listed on Exhibit B; (b) any patents which issue from the patent applications listed on Exhibit B; (c) all continuation, divisional, re-issue or re-examination applications that may be filed based on the patents and patent applications listed on Exhibit B, together with any patents that may issue based thereon; and (d) any IDEA Disclosure Patents.

 

“Product Liability” has the meaning set forth in the Investment Agreement.

 

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“Products” mean the products set forth in the Development Agreement.

 

“Sale Transaction” has the meaning set forth in the Investment Agreement.

 

“Software” means software designs necessary to drive the functions of the physician and patient programmers as well as software necessary to drive the test equipment that evaluates the functionality of the Products.

 

“System” means a device for use in the Field that includes a 3024 Implantable Pulse Generator (as defined in the Development Agreement), a 3063 Stimulation Lead, and a Pressure Sensor Capsule (as defined in the Development Agreement).

 

“Technical Information” means the information specifically set forth on Exhibit C as it relates to the 3063 Stimulation Lead, the L169 IC, and the Software, and only to the extent such information is required to develop, manufacture, and market products for use in the Field, as well as to ensure compliance to Food and Drug Administrative (FDA) Quality System Regulations and specifically, 21 C.F.R. Part 820, Sections 820.180, 820.181 and 180.184. Technical Information specifically excludes any information relating to Medtronic’s chronicle lead. All Technical Information disclosed under this Agreement shall be considered Confidential Information.

 

“3063 Stimulation Lead” means the stimulation lead incorporating a full cuff with three electrodes in a guarded bi-polar configuration with a lead body and connector to interface with the 3024 Implantable Pulse Generator.

 

“Trademarks” means the trademark and trademark applications, together with any registrations that may issue based thereon, set forth in Exhibit D.

 

1.2)                           Definitional Provisions.

 

(a)                                 The words “hereof,” “herein,” and “hereunder” and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provisions of this Agreement.

 

(b)                                 The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa. Terms referring to a masculine gender shall be deemed to refer to the feminine or neuter genders, as applicable.

 

(c)                                  The term “including” is not limiting and, unless preceded by the word “not,” has the meaning “including, without limitation.”

 

(d)                                 References to an “Exhibit” or to a “Schedule” are, unless otherwise specified, to one of the Exhibits or Schedules attached to or referenced in this Agreement, and references to an “Article” or a “Section” are, unless otherwise specified, to one of the Articles or Sections of this Agreement.

 

(e)                                  The term “person” means any individual, partnership, firm, corporation, limited liability company, association, trust, unincorporated organization, governmental department or agency, or other entity, as well as any syndicate or group that would be

 

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deemed to be a person under Section 13(d)(3) of the Securities Exchange Act of 1934, as amended.

 

(f)                                   The term “dollars” or “$” shall refer to the currency of the United States of America.

 

(g)                                  All references to time shall refer to Minneapolis, Minnesota time.

 

1.3)                           Other Terms. Other terms may be defined elsewhere in the text of this Agreement and shall have the meaning indicated throughout this Agreement.

 

ARTICLE 2
 ASSIGNMENT AND LICENSE

 

2.1)                           Assignment. Subject to the terms and conditions of this Agreement, Medtronic hereby assigns to Inspire the Assigned Patents, the Trademarks and the goodwill associated with the Trademarks. Medtronic will execute the recordable assignment forms provided in Exhibit E on the Initial Closing Date.

 

2.2)                           Technical Information License Grant. Subject to the terms and conditions of this Agreement, Medtronic agrees to grant, and hereby grants, to Inspire a co-exclusive, worldwide, royalty-free, perpetual, irrevocable, non-sublicensable and non-transferable (except as set forth below) license to the Technical Information to make, have made, use, import, offer to sell and sell products in the Field, and to practice methods in the Field. Medtronic agrees that the co-exclusive license rights granted to Inspire under this Section 2.2 shall be exclusive to Inspire unless and until Inspire becomes Insolvent at which point Medtronic may also exercise its co-exclusive rights to practice in the Field. Inspire may not transfer Technical Information except as provided for as part of a Sales Transaction. Nothing set forth herein shall prevent Inspire from granting rights to distribute its products through all standard commercial means, including granting distribution rights to dealers, distributors, agents and other third parties who are in the business of distributing products such as those developed by Inspire.

 

2.3)                           Patent License Grant. Subject to the terms and conditions of this Agreement, Medtronic agrees to grant, and hereby grants, to Inspire a co-exclusive, worldwide, royalty-free, perpetual, irrevocable, non-sublicensable and non-transferable (except as set forth below) license to the Licensed Patents to make, have made, use, import, offer to sell and sell products in the Field, and to practice methods in the Field. Medtronic agrees that the co-exclusive license rights granted to Inspire under this Section 2.3 shall be exclusive to Inspire unless and until Inspire becomes Insolvent at which point Medtronic may also exercise its co-exclusive rights to practice in the Field. Inspire may not transfer the license granted to it under this Section 2.3 except as provided for as part of a Sales Transaction. The parties acknowledge that as part of its license grant under this Section 2.3, Inspire shall have the right, but not the obligation, to prepare and file, or have prepared and filed on its behalf, at Inspire’s sole cost, IDEA Disclosure Patents.

 

2.4)                           Co-Exclusive Licenses. The licenses granted to Inspire under Section 2.2 and Section 2.3 shall be co-exclusive licenses, meaning that Medtronic shall also have the worldwide right under the Technical Information and Licensed Patents to make, have made, use, market, import, offer for sale and sell products in the Field, and to practice methods in the Field, but

 

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Medtronic shall not have the right to grant any further licenses to such Technical Information and Licensed Patents in the Field. Medtronic agrees that it shall not exercise its license rights in such Technical Information and Licensed Patents in the Field unless and until Inspire becomes Insolvent.

 

2.5)                           License Restrictions.

 

(a)                                 During the term of the Supply Agreement, Inspire shall not exercise its rights under the license granted in Section 2.3 with respect to having Products made in the Field except as permitted under the Supply Agreement.

 

(b)                                 The license granted pursuant to Section 2.3 shall not be used in such a way as to manufacture Products on an original equipment manufacturer basis (“OEM basis”) for any person or entity without the prior written approval of Medtronic, which may not be unreasonably withheld. The term “OEM basis” includes, without limitation, the manufacture and sale of a product to any person or entity for (i) incorporation into or sale with or as such other person’s or entity’s product, or (ii) the resale of such product by such person or entity under trademarks other than those owned by Inspire. It is the intent of the parties that the licenses granted herein be used for the sole and exclusive benefit of Inspire and that all licensing of third parties shall be the sole right of Medtronic in its sole and absolute discretion.

 

2.6)                           Restrictions on Use. Inspire will use reasonable efforts to ensure that all Products manufactured by or for Inspire or sold by Inspire are not used outside of the Field. Without limiting the foregoing, if Inspire has Knowledge that the manufacture, use, sale, import, or other distribution of products manufactured by or for Inspire or sold by Inspire are, or likely will be, in violation of the licenses granted herein, or if Medtronic notifies Inspire of any such violation, then Inspire shall immediately, at Inspire’s sole expense, take reasonable steps to attempt to prohibit or terminate such violation.

 

2.7)                           Medtronic Licenses to Intellectual Property.

 

(a)                                 Inspire agrees to grant, and hereby grants, to Medtronic and its Affiliates an exclusive, worldwide, royalty-free, perpetual, irrevocable, sublicensable and transferable license to the Assigned Patents to make, have made, use, import, offer to sell and sell products outside of the Field, and to practice methods outside of the Field.

 

(b)                                 Inspire agrees to grant, and hereby grants, to Medtronic and its Affiliates an exclusive, worldwide, royalty-free, perpetual, irrevocable, sublicensable and transferable license to any: (a) Improvement Patents; (b) Base IP covering the System; and (c) Grant-Back Base IP; each of (a), (b) and (c) to make, have made, use, import, offer to sell and sell products outside of the Field, and to practice methods outside of the Field.

 

(c)                                  Inspire agrees to grant, and hereby grants, to Medtronic and its Affiliates a co-exclusive, worldwide, royalty-free, perpetual, and irrevocable license to the Assigned Patents to make, have made, use, import, offer to sell and sell products in the Field, and to practice methods in the Field. Medtronic agrees that it shall not exercise its license rights granted it under this Section 2.7(c) unless and until Inspire becomes Insolvent.

 

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(d)                                 Inspire agrees to grant, and hereby grants, to Medtronic and its Affiliates a co-exclusive, worldwide, royalty-free, perpetual, and irrevocable license to the Licensed Patents to make, have made, use, market, import, offer for sale and sell products in the Field, and to practice methods in the Field. Medtronic agrees that it shall not exercise its license rights granted it under this Section 2.7(d) unless and until Inspire becomes Insolvent.

 

(e)                                  Inspire agrees to grant, and hereby grants, to Medtronic and its Affiliates a co-exclusive worldwide, royalty-free, perpetual, and irrevocable license to any Base IP (other than the Base IP which is licensed to Medtronic under Section 2.7(c) and 2.7(d)) to make, have made, use, import, offer to sell and sell products in the Field, and to practice methods in the Field. Medtronic agrees that it shall not exercise its license rights granted it under this Section 2.7(e) unless and until Inspire becomes Insolvent.

 

(f)                                   The licenses granted to Medtronic under Sections 2.7(c), 2.7(d) and 2.7(e) shall be co-exclusive, meaning that Inspire shall also have the worldwide right to make, have made, use, market, import, offer for sale and sell products in the Field, and to practice methods in the Field, but Inspire shall not have the right to grant any further licenses to such Intellectual Property in the Field.

 

2.8)                           No Other Rights. Inspire acknowledges and agrees that, as between the parties, Medtronic owns all right, title and interest, including all Intellectual Property Rights, in and to the Licensed Patent Rights, Technical Information and Medtronic’s Confidential Information, and that under this Agreement, Inspire shall acquire no right, title, or interest in or to any of the foregoing, or to any other Intellectual Property Rights of Medtronic, by implication, estoppel or otherwise, other than the license rights expressly granted herein.

 

2.9)                           Non-Compete.

 

(a)                                 Except as Medtronic is otherwise permitted or required to perform certain obligations to the benefit of Inspire as set forth herein or in any of the other agreements entered into between Medtronic and Inspire in connection with the Spin-Out (the “Spin-Out Documents”), for a period commencing on the Initial Closing Date and ending on the fifth (5th) anniversary of the Initial Closing Date (the “Noncompetition Period”), neither Medtronic nor its Affiliates shall: (i) market, sell or have sold for it a Competing Product (defined below) anywhere in the United States or in any country where Inspire conducts business; (ii) fund any clinical study that enrolls patients for the sole purpose of obtaining regulatory approval in the United States of a Competing Product for Medtronic or an Affiliate of Medtronic; or (iii) make a direct equity investment (including investment in convertible securities) in excess of One Million Dollars ($1,000,000) in Apnex Medical, any other Person that at the time of the investment markets, sells or has sold for it any Competing Product, or any other Person that at the time of the investment is solely engaged in developing a Competing Product and has enrolled patients in any clinical study for the sole purpose of obtaining regulatory approval in the United States of a Competing Product for such Person.

 

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(b)                                 For the purposes of this Section 2.9, a “Competing Product” shall mean a product with the primary and regulatory approved purpose of utilizing electrical stimulation of the Hypoglossal Nerve for the treatment (as opposed to diagnosis) of obstructive sleep apnea.

 

(c)                                  Notwithstanding the foregoing, the restrictions in this Section 2.9 shall not apply: (i) with respect to any Person that becomes an Affiliate of Medtronic or assets that are acquired by Medtronic or an Affiliate of Medtronic after the date of this Agreement if 10% or less of the annual revenues of such Person or of revenues generated by such acquired assets relate to sales of Competing Products at the time such Person first becomes an Affiliate of Medtronic or such assets are acquired by Medtronic; (ii) from and after a Sale Transaction; and (iii) from and after the time that Inspire is Insolvent. Except as explicitly set forth in (a)(iii) above, Inspire acknowledges and agrees that the restrictions in this Section 2.10 shall not apply to any Person in which Medtronic or an Affiliate of Medtronic has an investment unless and until such Person becomes an Affiliate of Medtronic.

 

(d)                                 The restrictions set forth in this Section 2.9 are for the personal benefit of Inspire only. Inspire’s rights and benefits pursuant to this Section 2.9 shall not be assignable by Inspire and any attempted assignment of Inspire’s rights and benefits under this Section 2.9 shall be void.

 

(e)                                  Inpire’s sole right and remedy with respect to a violation of this Section 2.9 shall be to seek injunctive relief against Medtronic or an Affiliate of Medtronic to enjoin the activities that are in violation of this Section 2.9. In no event shall Inspire be entitled to money damages (under any theory or cause of action) from Medtronic or an Affiliate of Medtronic with respect to a violation of this Section 2.9 and Inspire hereby waives any and all rights to money damages that may result from a violation of this Section 2.9 as a result of a breach hereof by Medtronic or an Affiliate of Medtronic. Notwithstanding anything to the contrary herein, in the event any Person becomes an Affiliate of Medtronic after the date of this Agreement, or Medtronic or an Affiliate acquires assets that include Competing Products from a Person, and at such time more than 10% of such Person’s annual revenues or revenues of such Person that are generated by such acquired assets relate to sales of Competing Products (a “Prohibited Acquisition”), Medtronic shall have the right to continue to sell such Competing Products for up to 3 months after the date of the Prohibited Acquisition; provided that if Medtronic continues to sell Competing Products after such 3 month period, Inspire’s sole right and remedy shall be to require Medtronic to divest the portion of such Person or acquired assets by the date that is twelve (12) months after the date of the Prohibited Acquisition if such date is within the Noncompetition Period.

 

ARTICLE 3
 INTELLECTUAL PROPERTY

 

3.1)                           Control of Patents by Inspire.

 

(a)                                 Inspire shall have the right, through counsel of its choice and at its expense, to prepare, file and prosecute all patent applications and cause the issuance of and maintain

 

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any patents awarded thereby worldwide (including provisionals, non provisionals, continuations, divisions, continuations in part, PCT applications, national phase applications, reissues and reexaminations) for the Assigned Patents and any IDEA Disclosure Patents. Further, Inspire shall have the right to manage any interference that might be declared with respect to the Assigned Patents and any IDEA Disclosure Patents.

 

(b)                                 If Inspire does not prosecute or maintain any patent or patent application within the Assigned Patents, Inspire shall so notify Medtronic prior to any relevant deadline and Medtronic shall have the right, but not the obligation, to undertake the prosecution or maintenance of such Assigned Patents. If Medtronic exercises this option, Inspire shall assign such Assigned Patents to Medtronic and Inspire shall execute a recordable assignment form. Any such patents assigned to Medtronic will thereafter be subject to the license grant in Section 2.3.

 

(c)                                  Medtronic shall have the right to review and comment on any IDEA Disclosure Patent and any filing or other correspondence related to the prosecution of any IDEA Disclosure Patent (“Patent Documents”). Inspire shall provide Medtronic with a copy of any Patent Documents that Inspire intends to file in a patent office prior to such filing (including any patent application that would be an IDEA Disclosure Patent) or that is received from a patent office. Provided that Medtronic’s comments are received within thirty (30) days following receipt of the relevant information by the Medtronic employee responsible for reviewing such Patent Documents from Inspire, Inspire shall incorporate any reasonable comments requested by Medtronic into such Patent Document.

 

3.2)                           Control of Patents by Medtronic.

 

(a)                                 Medtronic shall have the right, through counsel of its choice and at its expense, to prepare, file and prosecute all patent applications and cause the issuance of and maintain any patents awarded thereby worldwide (including provisionals, non provisionals, continuations, divisions, continuations in part, PCT applications, national phase applications, reissues and reexaminations) for the Licensed Patents. Further, Medtronic shall have the right to manage any interference that might be declared with respect to the Licensed Patents.

 

(b)                                 If Medtronic does not prosecute or maintain any patent or patent application within the Licensed Patents in the Field, Medtronic shall so notify Inspire prior to any relevant deadline and Inspire shall have the right, but not the obligation, to undertake the prosecution or maintenance of such Licensed Patents.

 

3.3)                           Notice of Alleged Infringement or Misappropriation. Inspire shall promptly report in writing to Medtronic during the term of this Agreement any known or suspected infringement of any of the Licensed Patents or Assigned Patents, or any misappropriation of the Technical Information by a third party. Medtronic shall promptly report in writing to Inspire during the term of this Agreement any known or suspected infringement of any of the Licensed Patents in the Field or Assigned Patents in the Field, or any misappropriation of the Technical Information in the Field by a third party.

 

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3.4)                           Intellectual Property Enforcement.

 

(a)                                 As between the parties hereto, Inspire reserves the right, and shall have the exclusive first right, to commence, defend, compromise, settle and control (by way of license or otherwise) (collectively, “Actions”) any and all claims, actions or proceedings for infringement, unauthorized use, misappropriation or violation of any of the Licensed Patents or Assigned Patents involving third parties (collectively, “Claims”) in the Field, but shall not have the obligation to do so. Inspire shall promptly notify Medtronic of any Action Inspire intends to take with respect to such Claim during the term of this Agreement, and Medtronic shall provide Inspire with all reasonable cooperation and assistance at Inspire’s expense. Medtronic consents to being joined as a party-plaintiff in any Action hereunder if, and to the extent, such joiner is required by law for standing. If Inspire undertakes any such Action, Inspire shall be entitled to receive any recovery from the Action for damages and other awards to the extent such recovery relates to a Claim in the Field, and Medtronic shall be entitled to receive any recovery from the Action for damages and other awards to the extent such recovery relates to a Claim outside of the Field. Notwithstanding the above, Inspire shall not settle any Action if such settlement would materially adversely impact Medtronic’s rights under this Agreement.

 

(b)                                 If Inspire does not undertake any Action within (90) days after notice of a Claim in the Field has been sent pursuant to Section 3.3 above, then Medtronic shall have the right to commence, defend, compromise, settle and control (by way of license or otherwise) any and all Actions with respect to such Claim, but shall not have the obligation to do so. Medtronic shall promptly notify Inspire of any Action Medtronic intends to take with respect to a Claim during the term of this Agreement and Inspire shall provide Medtronic with all reasonable cooperation and assistance at Inspire’s expense. Inspire consents to being joined as a party-plaintiff in any Action hereunder if, and to the extent, such joiner is required by law for standing. If Medtronic undertakes any such Action, Medtronic shall be entitled to receive any recovery from the Action for damages and other awards to the extent such recovery relates to a Claim outside of the Field, and Inspire shall be entitled to receive any recovery from the Action for damages and other awards to the extent such recovery relates to a Claim in the Field. Notwithstanding the above, Medtronic shall not settle any Action if such settlement would materially adversely impact Inspire’s rights under this Agreement.

 

3.5)                           Trademark. Nothing in this Agreement shall confer in Inspire any rights, whether by way of ownership , license or right to use, in the trademark “Medtronic,” the Medtronic corporate logo, or any other trademark, service mark, trade name, trade dress, logotype or similar right owned by Medtronic or its Affiliates.

 

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ARTICLE 4
 REPRESENTATIONS & WARRANTIES

 

4.1)                           Representations of Inspire. Inspire represents, warrants and covenants to Medtronic that:

 

(a)                                 Inspire has the skills and resources to conduct due diligence on Medtronic’s published patent portfolio and is entering this Agreement based on its independent evaluation thereof. Inspire acknowledges that it has studied the questions of validity and enforceability of the Assigned Patents and Licensed Patents and believes such rights to be valid and enforceable.

 

(b)                                 Neither the execution and delivery of this Agreement nor the consummation of the transactions contemplated herein will violate any provision of the articles and bylaws of Inspire or any law, rule, regulation, writ, judgment, injunction, decree, determination, award or other order of any court or governmental agency or instrumentality, domestic or foreign.

 

4.2)                           Representations of Medtronic. Medtronic represents, warrants and covenants to Inspire that it has the right to grant the assignment and licenses granted under this Agreement. To Medtronic’s knowledge, as of immediately prior to the Initial Closing, Medtronic owns title to the Assigned Patents free and clear of all security interests. For purposes of clarification only, and without limiting in any way the disclaimers set forth in this Article 4, Medtronic make no representations with respect to the validity of the Assigned Patents or Licensed Patents and makes no representations with respect to non-infringement of third party proprietary rights by the Assigned Patents or Licensed Patents. OTHER THAN THE WARRANTIES EXPRESSLY GIVEN IN THIS SECTION 4.2, MEDTRONIC MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE ASSIGNED PATENTS, LICENSED PATENTS OR ANY PRODUCTS MANUFACTURED, USED OR SOLD (OTHER THAN AS MAY BE MADE UNDER THE SUPPLY AGREEMENT BETWEEN THE PARTIES) UNDER THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, PATENTABILITY, PATENT VALIDITY, NON-INFRINGEMENT , OR WARRANTIES ARISING FROM COURSE OF DEALING OR USAGE OF TRADE.

 

4.3)                           Disclaimers of Representations. EXCEPT AS EXPRESSLY SET FORTH IN SECTION 4.2, EACH PARTY HERETO (AS “DISCLAIMING PARTY”) DISCLAIMS, AND THE OTHER PARTY HEREBY WAIVES, ANY AND ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, ARISING BY LAW OR OTHERWISE WITH REGARD TO THIS AGREEMENT. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, THE DISCLAIMING PARTY DISCLAIMS (A) ANY AND ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE SCOPE, COVERAGE, VALIDITY OR ENFORCEABILITY OF ANY OF THE ASSIGNED PATENTS, LICENSED PATENTS, BASE IP AND ANY OTHER INTELLECTUAL PROPERTY RIGHTS ASSIGNED OR LICENSED HEREUNDER (COLLECTIVELY, “CONTRACT IP”); AND (B) ANY AND ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, WITH REGARD TO ANY PRODUCT DEVELOPED OR

 

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DISTRIBUTED THAT IS BASED UPON OR INCLUDES ANY CONTRACT IP (INCLUDING, BUT NOT LIMITED TO, ANY INFRINGEMENT, MISAPPROPRIATION OR VIOLATION OF ANY INTELLECTUAL PROPERTY RIGHT OF ANY THIRD PARTY AND ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE).

 

4.4)                           Limitations of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, CONSEQUENTIAL, INDIRECT, INCIDENTAL OR PUNITIVE DAMAGES OR LOST PROFITS OR LOST BUSINESS, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY (INCLUDING NEGLIGENCE) ARISING IN ANY WAY OUT OF THIS AGREEMENT, WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

ARTICLE 5
 INDEMNIFICATION

 

5.1)                           Indemnification of Medtronic. Inspire shall indemnify, defend and hold harmless Medtronic and its officers, directors, stockholders and Affiliates (such indemnitees referred to in this Article 5 as “Medtronic”) from and against and in respect of any and all demands, claims, actions or causes of action, assessments, losses, damages, liabilities, interest and penalties, costs and expenses (including, without limitation, reasonable legal fees and disbursements incurred in connection therewith and in seeking indemnification therefor, and any amounts or expenses required to be paid or incurred in connection with any action, suit, proceeding, claim, appeal, demand, assessment or judgment) (“Indemnifiable Losses”), resulting from, arising out of, or imposed upon or incurred by any person to be indemnified hereunder by reason of any of the following:

 

(a)                                 Any breach of any representation, warranty, covenant or agreement of Inspire contained in this Agreement; and

 

(b)                                 Any act or omission of Inspire or any of its agents, employees or suppliers arising out of or in connection with the development, commercialization, sale or other use of the Licensed Patents, Assigned Patents or any products licensed by, or developed by or for, Inspire, including but not limited to Product Liability Claim except with respect to Losses arising out of matters for which Medtronic has an obligation to indemnify Inspire pursuant to this Agreement.

 

5.2)                           Indemnification of Inspire. Medtronic shall indemnify, defend and hold harmless Inspire and each of its subsidiaries, officers, directors and stockholders (such indemnitees referred to in this Article 5 as “Inspire”) from and against and in respect of any and all Indemnifiable Losses, resulting from, arising out of, or imposed upon or incurred by any person to be indemnified hereunder by reason of any breach of any representation, warranty, covenant or agreement of Medtronic contained in this Agreement.

 

5.3)                           Third-Party Claims. If a claim by a third party is made against an indemnified party and if the indemnified party intends to seek indemnity with respect thereto under this Article 8, such indemnified party shall promptly notify the indemnifying party of such claim; provided,

 

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however, that failure to give timely notice shall not affect the rights of the indemnified party so long as the failure to give timely notice does not adversely affect the indemnifying party’s ability to defend such claim against a third party. The indemnified party shall not settle such claim without the consent of the indemnifying party, which consent shall not be unreasonably withheld or delayed. If the indemnifying party acknowledges in writing its indemnity obligations for Indemnifiable Losses resulting therefrom, the indemnifying party may participate at its own cost and expense in the settlement or defense of any claim for which indemnification is sought.

 

5.4)                           Cooperation as to Indemnified Liability. Each party hereto shall cooperate fully with the other parties with respect to access to books, records, or other documentation within such party’s control, if deemed reasonably necessary or appropriate by any party in the defense of any claim which may give rise to indemnification hereunder.

 

ARTICLE 6
 CONFIDENTIAL INFORMATION — INSOLVENCY

 

In the event that Inspire becomes Insolvent, all Confidential Information, other than the Technical Information, shall immediately be returned to Medtronic.

 

ARTICLE 7
 OTHER PROVISIONS

 

7.1)                           Non-Disclosure. Each party agrees not to disclose or use (except as permitted or required for performance by the party receiving such Confidential Information of its rights or duties hereunder) any Confidential Information of the other party obtained during the term of this Agreement and for as long as such information is maintained as confidential by the disclosing party, but in any event, not less than a period of three (3) years after the receiving party’s receipt of such Confidential Information. Each party further agrees to take appropriate measures to prevent any such prohibited disclosure by its present and future employees, officers, agents, subsidiaries, or consultants during such period.

 

7.2)                           Complete Agreement. The Investment Agreement, the Supply Agreement, the Development Agreement, the Transaction Documents, and Exhibits to this Agreement shall be construed as an integral part of this Agreement to the same extent as if they had been set forth verbatim herein. This Agreement and the exhibits hereto constitutes the entire agreement between Inspire and Medtronic with respect to the subject matter of this Agreement and supersedes any prior agreements or understandings. This Agreement does not supersede any terms in the Development Agreement and Supply Agreement and terms in such agreements shall co-exist with this Agreement.

 

7.3)                           Survival of Representations, Warranties and Agreements. The representations, warranties, covenant and agreements contained herein shall survive the Closing and remain in full force and effect; provided however, the representations and warranties shall expire on the third anniversary of the date of the last Closing hereunder. No independent investigation of Inspire by Medtronic, its counsel, or any of its agents or employees shall in any way limit or restrict the scope of the representations and warranties made by Inspire in this Agreement.

 

12











 

7.4)                           Waiver, Discharge, Amendment, Etc. The exercise by either party of any remedy or recourse available to it hereunder shall not deprive such party of any other remedy or recourse available to it under applicable law. Any waiver by either party of a breach of any term of this Agreement shall not be considered as a waiver of any subsequent breach of the same or other terms or condition hereof. This Agreement may be amended by Inspire and Medtronic by mutual action approved by their respective Boards of Directors or their respective officers authorized by such Board of Directors. Any amendment to this Agreement shall be in writing and signed by Inspire and Medtronic.

 

7.5)                           Notices. All notices or other communications to a party required or permitted hereunder or under the Certificate of Incorporation, as amended, shall be in writing and shall be delivered personally or by facsimile (receipt confirmed electronically) to such party (or, in the case of an entity, to an executive officer of such party) or shall be sent by a reputable express delivery service or by certified mail, postage prepaid with return receipt requested, addressed as follows:

 

if to Medtronic to:

 

Medtronic, Inc.

World Headquarters

710 Medtronic Parkway, N.E.

Minneapolis, MN 55432-5604

Attention: General Counsel

FAX (###) ###-####

 

with a copy to:

 

Medtronic, Inc.

World Headquarters

710 Medtronic Parkway, N.E.

Minneapolis, MN 55432-5604

Attention: Vice President and Chief Development Officer

FAX (###) ###-####

 

if to Inspire to:

 

Inspire Medical Systems, Inc.

7100 Northland Circle North, Suite 304

Brooklyn Park, MN 55428

ATTN: President and CEO

FAX: (###)-###-####

 

13











 

with a copy to:

 

Wiese Law Offices

33 South 6th Street, Suite 4100

Minneapolis, MN 55402

Attn: ####### #####

FAX: (###)-###-####

 

Any party may change the above-specified recipient and/or mailing address by notice to all other parties given in the manner herein prescribed. All notices shall be deemed given on the day when actually delivered as provided above (if delivered personally or by facsimile) or on the day shown on the return receipt (if delivered by mail or delivery service).

 

7.6)                           Public Announcement. Public Announcements shall be governed as set forth in the Investment Agreement.

 

7.7)                           Expenses. Except as expressly provided herein, Inspire and Medtronic shall each pay their own expenses incident to this Agreement and the preparation for, and consummation of, the transactions provided for herein.

 

7.8)                           Notice of Dispute. The parties shall attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiation between executives of each party who have authority to settle the controversy and who are at a higher level of management than the persons with direct responsibility for administration of this Agreement. Either party may give the other party written notice of any dispute not resolved in the normal course of business (“Notice of Dispute”), which Notice of Dispute shall include (i) a statement of that party’s position and a summary of arguments supporting that position, (ii) the dollar amount of the dispute, if known, and the section(s) of the Agreement to which the dispute relates and (iii) the name and title of the executive who will represent that party and of any other person who will accompany the executive. Within 10 days after delivery of the Notice of Dispute, the receiving party shall submit to the other a written response (the “Response to Dispute”). The Response to Dispute shall include (iv) a statement of that party’s position and a summary of arguments including references to any section(s) of the Agreement, if applicable, supporting that position and (v) the name and title of the executive who will represent that party and of any other person who will accompany the executive. Within ten (10) days after delivery of the Response to Dispute, the designated executives of both parties shall meet at a mutually acceptable time and place or by conference telephone, and thereafter as often as they reasonably deem necessary, to attempt to resolve the dispute. All negotiations pursuant to this clause are confidential and shall be treated as compromise and settlement negotiations for purposes of applicable rules of evidence.

 

7.9)                           Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Minnesota, without reference to the choice of law principles thereof.

 

7.10)                    Titles and Headings; Construction. The titles and headings to articles and sections herein are inserted for the convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement. Inspire acknowledges that Medtronic and Inspire have jointly participated in the negotiation and drafting of this Agreement, and the parties

 

14











 

agree that 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.

 

7.11)                    Benefit. Nothing in this Agreement, expressed or implied, is intended to confer on any person other than the parties hereto or their respective successors or assigns, any rights, remedies, obligations or liabilities under or by reason of this Agreement.

 

7.12)                    Counterparts. This Agreement may be executed in one or more counterparts, all of which shall be considered one and the same agreement, and shall become a binding agreement when one or more counterparts have been signed by each party and delivered to the other party. Copies of this Agreement with signatures transmitted by facsimile shall be deemed to be original signed versions of this Agreement.

 

7.13)                    Parties in Interest. All representations, covenants and agreements contained in this Agreement by or on behalf of any of the parties hereto shall bind and inure to the benefit of the respective successors and assigns of the parties hereto whether so expressed or not.

 

7.14)                    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.

 

7.15)                    No Joint Venture. Nothing contained in this Agreement shall be deemed to create a joint venture, partnership, agency or similar endeavor between the parties hereto. Each party shall act solely as an independent contractor and neither party shall have any power or authority to direct or indirectly bind or act on behalf of the other.

 

[Remainder of page intentionally left blank]

 

15











 

IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed in the manner appropriate to each, effective as of the date first above written.

 

 

	
 
    	
INSPIRE   MEDICAL SYSTEMS, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Timothy P. Herbert
    
	
 
    	
By:   Timothy P. Herbert
    
	
 
    	
Its:    President & CEO
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
MEDTRONIC, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Robert S. White
    
	
 
    	
By:
    	
Robert   S. White
    
	
 
    	
Its:
    	
 
    


 









 

Exhibit A: Assigned Patents

 

	
US Patent/Application
    	
 
    	
Title
    
	
5,158,080
    	
 
    	
Muscle tone
    
	
International Patents
    	
 
    	
None
    
	
5,540,731
    	
 
    	
Method and apparatus for pressure detecting and   treating obstructive airway disorders
    
	
International Patents
    	
 
    	
DE69532740D1 20040429
    
	
 
    	
 
    	
DE69532740T2 20050428
    
	
 
    	
 
    	
EP0702979B1 20040324
    
	
 
    	
 
    	
EP0702979A3 19970319
    
	
 
    	
 
    	
EP0702979A2 19960327
    
	
5,540,732
    	
 
    	
Method and apparatus for impedance detecting and   treating obstructive airway disorders
    
	
International Patents
    	
 
    	
DE69529951D1 20030424
    
	
 
    	
 
    	
DE69529951T2 20040205
    
	
 
    	
 
    	
EP0702977B1 20030319
    
	
 
    	
 
    	
EP0702977A3 19970319
    
	
 
    	
 
    	
EP0702977A2 19960327
    
	
 
    	
 
    	
JP3733555B2 20060111
    
	
 
    	
 
    	
JP3733555B2 20060111
    
	
 
    	
 
    	
JP8224318A 19960903
    
	
5,540,733
    	
 
    	
Method and apparatus for detecting and treating   obstructive sleep apnea
    
	
International Patents
    	
 
    	
None
    
	
5,549,655
    	
 
    	
Method and apparatus for synchronized treatment of   obstructive sleep apnea
    
	
International Patents
    	
 
    	
DE69526767D1 20020627
    
	
 
    	
 
    	
DE69526767T2 20030102
    
	
 
    	
 
    	
DE69532514D1 20040304
    
	
 
    	
 
    	
DE69532514T2 20041014
    
	
 
    	
 
    	
EP1175919B1 20040128
    
	
 
    	
 
    	
EP1 175919A1 20020130
    
	
 
    	
 
    	
EP1277491A1 20030122
    
	
 
    	
 
    	
EP0706808B1 20020522
    
	
 
    	
 
    	
EP0706808A1 19960417
    
	
 
    	
 
    	
JP3733556B2 20060111
    
	
 
    	
 
    	
JP3733556B2 20060111
    
	
 
    	
 
    	
JP9187521A 19970722
    
	
5,591,216
    	
 
    	
Method for treatment of sleep apnea by electrical   stimulation
    
	
International Patents
    	
 
    	
DE69629238D1 20030904
    
	
 
    	
 
    	
DE69629238T2 20040527
    
	
 
    	
 
    	
DE69636883D1 20070322
    
	
 
    	
 
    	
EP1306104B120070131
    
	
 
    	
 
    	
EP1306104A3 20040811
    
	
 
    	
 
    	
EP1306104A2 20030502
    
	
 
    	
 
    	
EP0743076B1 20030730
    
	
 
    	
 
    	
EP0743076A1 19961120
    
	
6,251,126
    	
 
    	
Method and apparatus for synchronized treatment of   obstructive sleep apnea
    
	
International Patents
    	
 
    	
None
    
	
6,269,269
    	
 
    	
Method and apparatus for synchronized treatment of   obstructive sleep apnea
    
	
International Patents
    	
 
    	
None
    


 

17











 

Exhibit B: Licensed Patents

 

	
US Patent/ 
   Application
    	
 
    	
Title
    
	
4,967,755
    	
 
    	
Electromedical lead with pressure sensor
    
	
International Patents
    	
 
    	
None
    
	
5,133,354
    	
 
    	
Method and apparatus for improving muscle tone
    
	
International Patents
    	
 
    	
AU659200B2 19950511
    
	
 
    	
 
    	
AU2322092A 19931021
    
	
 
    	
 
    	
CA2109429A1 19930925
    
	
 
    	
 
    	
DE69224388D1 19980312
    
	
 
    	
 
    	
DE69224388T2 19981001
    
	
 
    	
 
    	
EP0597891B1 19980204
    
	
 
    	
 
    	
EP0597891A1 19940525
    
	
 
    	
 
    	
JP6508288T 19940922
    
	
 
    	
 
    	
WO9318820A1 19930930
    
	
5,344,438
    	
 
    	
Cuff electrode
    
	
International Patents
    	
 
    	
DE4413065B4 20061130
    
	
 
    	
 
    	
DE4413065A1 19941027
    
	
5,353,800
    	
 
    	
Implantable pressure sensor lead
    
	
International Patents
    	
 
    	
AU5449794A 19940704
    
	
 
    	
 
    	
WO9413200A1 19940623
    
	
5,546,952
    	
 
    	
Method and apparatus for detection of a respiratory   waveform
    
	
International Patents
    	
 
    	
None
    
	
5,895,360
    	
 
    	
Gain control for a periodic signal and method   regarding same
    
	
International Patents
    	
 
    	
AT276792T 20041015
    
	
 
    	
 
    	
AU717044B2 20000316
    
	
 
    	
 
    	
AU3410697A 19980114
    
	
 
    	
 
    	
CA2258757C 20020514
    
	
 
    	
 
    	
CA2258757A1 19971231
    
	
 
    	
 
    	
DE69730836D1 20041028
    
	
 
    	
 
    	
DE69730836T2 20051006
    
	
 
    	
 
    	
EP0914179B1 20040922
    
	
 
    	
 
    	
EP0914179A1 19990512
    
	
 
    	
 
    	
ES2229368T3 20050416
    
	
 
    	
 
    	
JP11514553T 19991214
    
	
 
    	
 
    	
JP3568126B2 20040922
    
	
 
    	
 
    	
WO9749451A1 19971231
    
	
5,919,221
    	
 
    	
Method and apparatus for calibrating pacemaker   pressure sensor lead prior to chronic implant
    
	
International Patents
    	
 
    	
None
    
	
5,944,680
    	
 
    	
Respiratory effort detection method and apparatus
    
	
International Patents
    	
 
    	
AT233004T 20030315
    
	
 
    	
 
    	
AU716513B2 20000224
    
	
 
    	
 
    	
AU3580197A 19980114
    
	
 
    	
 
    	
CA2258759C 20021203
    
	
 
    	
 
    	
CA2258759A1 19971231
    
	
 
    	
 
    	
DE69719185D1 20030327
    
	
 
    	
 
    	
DE69719185T2 20031127
    
	
 
    	
 
    	
EP0907926B1 20030219
    
	
 
    	
 
    	
EP0907926A1 19990414
    
	
 
    	
 
    	
JP11514556T 19991214
    
	
 
    	
 
    	
JP3194968B2 20010806
    


 

18











 

	
 
    	
 
    	
WO9750049A1 19971231
    
	
6,021,352
    	
 
    	
Diagnostic testing methods and apparatus for   implantable therapy devices
    
	
International Patents
    	
 
    	
AT301490T 20050815
    
	
 
    	
 
    	
AU727327B2 20001207
    
	
 
    	
 
    	
AU3649797A 19980114
    
	
 
    	
 
    	
CA2259155C 20020409
    
	
 
    	
 
    	
CA2259155A1 19971231
    
	
 
    	
 
    	
DE69733954D1 20050915
    
	
 
    	
 
    	
DE69733954T2 20060518
    
	
 
    	
 
    	
DK0917486T3 20051212
    
	
 
    	
 
    	
EP0917486B1 20050810
    
	
 
    	
 
    	
EP0917486A1 19990526
    
	
 
    	
 
    	
ES2246516T3 20060216
    
	
 
    	
 
    	
JP2004167211A 20040617
    
	
 
    	
 
    	
JP11514557T 19991214
    
	
 
    	
 
    	
WO9749455A1 19971231
    
	
6,099,479
    	
 
    	
Method and apparatus for operating therapy system
    
	
International Patents
    	
 
    	
AT216906T 20020515
    
	
 
    	
 
    	
AU768822B2 20040108
    
	
 
    	
 
    	
AU1836001A 20010412
    
	
 
    	
 
    	
AU3503197A 19980114
    
	
 
    	
 
    	
CA2258812C 20020409
    
	
 
    	
 
    	
CA2258812A1 19971231
    
	
 
    	
 
    	
DE69712369D1 20020606
    
	
 
    	
 
    	
DE69712369T2 20021128
    
	
 
    	
 
    	
EP0957983B1 20020502
    
	
 
    	
 
    	
EP0957983A1 19991124
    
	
 
    	
 
    	
JP2003190303A 20030708
    
	
 
    	
 
    	
JP11514554T 19991214
    
	
 
    	
 
    	
WO9749452A1 19971231
    
	
6,641,542
    	
 
    	
Method and apparatus to detect and treat sleep   respiratory events
    
	
International Patents
    	
 
    	
CA2445709A1 20021107
    
	
 
    	
 
    	
EP1385425A1 20040204
    
	
 
    	
 
    	
JP2004529707T 20040930
    
	
 
    	
 
    	
WO2002087433A9 20030327
    
	
 
    	
 
    	
WO2002087433A1 20021107
    
	
6,731,984
    	
 
    	
Method for providing a therapy to a patient   involving modifying the therapy after detecting an onset of sleep in the   patient, and implantable medical device embodying same
    
	
International Patents
    	
 
    	
None
    
	
6,752,765
    	
 
    	
Method and apparatus for monitoring heart rate and   abnormal respiration
    
	
International Patents
    	
 
    	
CA2429237A1 20020523
    
	
 
    	
 
    	
DE60035719D1 20070906
    
	
 
    	
 
    	
EP1337296B1 20070725
    
	
 
    	
 
    	
EP1337296A1 20030827
    
	
 
    	
 
    	
JP2004513713T 20040513
    
	
 
    	
 
    	
WO2002040096A1 20020523
    
	
6,964,641
    	
 
    	
Implantable medical device with sleep disordered   breathing monitoring
    
	
International Patents
    	
 
    	
CN1897872A 20070117
    
	
 
    	
 
    	
EP1706023A1 20061004
    
	
 
    	
 
    	
WO2005065536A1 20050721
    
	
20030120161
    	
 
    	
Automatic pressure range and sensitivity adjustment
    
	
International Patents
    	
 
    	
None
    


 

19











 

	
20040059240
    	
 
    	
Method and apparatus to detect and treat sleep   respiratory events (Impedance Sensing for OSA)
    
	
International Patents
    	
 
    	
None
    
	
5,215,082
    	
 
    	
Implantable apnea generator with ramp on generator
    
	
International Patents
    	
 
    	
DE69212520D1 19960905
    
	
 
    	
 
    	
DE69212520T2 19970306
    
	
 
    	
 
    	
EP0507580B1 19960731
    
	
 
    	
 
    	
EP0507580A3 19930324
    
	
 
    	
 
    	
EP0507580A2 19921007
    
	
5,233,983
    	
 
    	
Method and apparatus for apnea patient screening
    
	
International Patents
    	
 
    	
None
    
	
5,238,006
    	
 
    	
Apnea stimulation lead
    
	
International Patents
    	
 
    	
None
    
	
5,281,219
    	
 
    	
Multiple stimulation electrodes
    
	
International Patents
    	
 
    	
None
    
	
5,483,969
    	
 
    	
Method and apparatus for providing a respiratory   effort waveform for the treatment of obstructive sleep apnea
    
	
International Patents
    	
 
    	
None
    
	
5,522,862
    	
 
    	
Method and apparatus for treating obstructive sleep   apnea
    
	
International Patents
    	
 
    	
DE69527903D1 20021002
    
	
 
    	
 
    	
DE69527903T2 20030528
    
	
 
    	
 
    	
EP0702978B1 20020828
    
	
 
    	
 
    	
EP0702978A3 19980506
    
	
 
    	
 
    	
EP0702978A2 19960327
    
	
 
    	
 
    	
JP3684514B2 20050817
    
	
 
    	
 
    	
JP8224317A 19960903
    
	
6,132,384
    	
 
    	
Sensor, method of sensor implant and system for   treatment of respiratory disorders
    
	
International Patents
    	
 
    	
None
    
	
6,572,543
    	
 
    	
Sensor, method of sensor implant and system for   treatment of respiratory disorders
    
	
International Patents
    	
 
    	
AT276793T 20041015
    
	
 
    	
 
    	
AU3580097A 19980114
    
	
 
    	
 
    	
CA2258289A1 19971231
    
	
 
    	
 
    	
DE69730842D1 20041028
    
	
 
    	
 
    	
DE69730842T2 20050929
    
	
 
    	
 
    	
EP0917485B1 20040922
    
	
 
    	
 
    	
EP0917485A1 19990526
    
	
 
    	
 
    	
ES2229374T3 20050416
    
	
 
    	
 
    	
JP11514555T 19991214
    
	
 
    	
 
    	
JP3249826B2 20020121
    
	
 
    	
 
    	
US6132384A 20001017
    
	
 
    	
 
    	
WO9749454A1 19971231
    
	
20040176809
    	
 
    	
Method and apparatus for modifying delivery of a   therapy in response to onset of sleep
    
	
International Patents
    	
 
    	
CA2549489A1 20050707
    
	
 
    	
 
    	
DE60203902D1 20050602
    
	
 
    	
 
    	
DE60203902T2 20060524
    
	
 
    	
 
    	
EP1395336B1 20050427
    
	
 
    	
 
    	
EP1395336A2 20040310
    
	
 
    	
 
    	
EP1706174A2 20061004
    
	
 
    	
 
    	
WO2002100482A3 20030320
    
	
 
    	
 
    	
WO2002100482A2 20021219
    
	
 
    	
 
    	
WO2005061046A3 20070524
    
	
 
    	
 
    	
WO2005061046A2 20050707
    


 

20











 

Exhibit B-1: IDEA Disclosures

 

	
IDEA Disclosure   P0028998.00
    	
 
    	
Submitted by Mark Christopherson
    
	
IDEA Disclosure P0029000.00
    	
 
    	
Submitted by Mark Christopherson
    
	
IDEA Disclosure P0029002.00
    	
 
    	
Submitted by Mark Christopherson
    
	
IDEA Disclosure P0029003.00
    	
 
    	
Submitted by Mark Christopherson
    
	
IDEA Disclosure P0029004.00
    	
 
    	
Submitted by Mark Christopherson
    
	
IDEA Disclosure P0030197.00
    	
 
    	
3063 Stimulation Lead — Inventor is Eric Bonde, MDT employee
    


 

21









 

Exhibit C

 

Technical Information

 

3063 Lead

 

	
BOM
   Part
   Number
    	
 
    	
Item Type
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT
   mfg
    
	
 
    	
 
    	
 
    	
 
    	
Tunneling Tool: believe this is 210459, 800283,   168025, 404214, 210171.
    	
 
    	
 
    	
 
    	
 
    
	
198244001
    	
 
    	
Manual
    	
 
    	
MANUAL-TECH,LEAD,PERIPHERAL NERVE,3063(EUROPEAN   CLINICAL)
    	
 
    	
X
    	
 
    	
X
    
	
210459001
    	
 
    	
Catheter
    	
 
    	
GUIDE-TUNNELING,SST.3990/3990A,PASSIVATED
    	
 
    	
X
    	
 
    	
X
    
	
800283001
    	
 
    	
Catheter
    	
 
    	
GUIDE-TUNNELING,WEDGE TIP
    	
 
    	
X
    	
 
    	
X
    
	
168025001
    	
 
    	
Miscellaneous Component
    	
 
    	
RUBBER-SILICONE,MOLDING,BIOCOMP,HARDNESS 45-55 SHORE   A
    	
 
    	
X
    	
 
    	
X
    
	
404214001
    	
 
    	
Ferrule
    	
 
    	
COLLET ASSY-4322 (Sensitive information will be   redacted)
    	
 
    	
X
    	
 
    	
X
    
	
210171001
    	
 
    	
Miscellaneous Component
    	
 
    	
ROD-CLAMPING,MOLDED,.185ODX2.36LG,4750 (Sensitive   information will be redacted)
    	
 
    	
X
    	
 
    	
X
    
	
152753001
    	
 
    	
Cable
    	
 
    	
CABLE-OR.2 COND,ALIGATOR,3861
    	
 
    	
X
    	
 
    	
X
    
	
141889001
    	
 
    	
SAM
    	
 
    	
SAM-STERILE PACKAGE,UNIVERSAL,LONG
    	
 
    	
X
    	
 
    	
X
    
	
119943002
    	
 
    	
Cover
    	
 
    	
COVER-TRAY,INNER,STERILE PACKAGE,UNIVERSAL
    	
 
    	
X
    	
 
    	
X
    
	
101045001
    	
 
    	
Sheet
    	
 
    	
SHEET-VINYL,CLEAR WIDTH,LENGTH, AND TFIK PER PO
    	
 
    	
X
    	
 
    	
X
    
	
119951001
    	
 
    	
Closure
    	
 
    	
LID-OUTER TRAY,STANDARD LEAD
    	
 
    	
X
    	
 
    	
X
    
	
119942001
    	
 
    	
Tray
    	
 
    	
TRAY-OUTER,STERILE PACKAGE,LONG UNIVERSAL
    	
 
    	
X
    	
 
    	
X
    
	
101045001
    	
 
    	
Sheet
    	
 
    	
SHEET-VINYL,CLEAR WIDTH,LENGTH, AND THK PER PO
    	
 
    	
X
    	
 
    	
X
    
	
119941002
    	
 
    	
Tray
    	
 
    	
TRAY-INNER,STERILE PACKAGE,LONG UNIVERSAL
    	
 
    	
X
    	
 
    	
X
    
	
101045001
    	
 
    	
Sheet
    	
 
    	
SHEET-VINYL,CLEAR WIDTH,LENGTH, AND THK PER PO
    	
 
    	
X
    	
 
    	
X
    
	
194117004
    	
 
    	
Label
    	
 
    	
LABEL-BAR CODE,BLANK,THERMAL TRANSFER, 2.00 IN. X   0.50 IN.
    	
 
    	
X
    	
 
    	
X
    
	
082059002
    	
 
    	
SAM
    	
 
    	
SAM-FNL PKG,UNVRSL,LNG,APS,STD
    	
 
    	
X
    	
 
    	
X
    
	
193364002
    	
 
    	
Label
    	
 
    	
LABEL-SEAL,TEAR TAB,MEDTRONIC
    	
 
    	
X
    	
 
    	
X
    
	
119957001
    	
 
    	
Box
    	
 
    	
CARTON-FOLDING,SHIPPING(WHITE)
    	
 
    	
X
    	
 
    	
X
    
	
187947002
    	
 
    	
Sheet
    	
 
    	
SHEET-INSTRUCTION,OPENING,LEADTRAY
    	
 
    	
X
    	
 
    	
X
    
	
220290001
    	
 
    	
Label
    	
 
    	
TEMPLATE-LABEL SET,STIM GENERIC,(DIE B)
    	
 
    	
X
    	
 
    	
X
    
	
‘82012003
    	
 
    	
Form
    	
 
    	
FORM-REGISTRATION,DEVICE TRACKING(LEAD/CATHETER)   (Sensitive information will be redacted)
    	
 
    	
X
    	
 
    	
X
    
	
82731001
    	
 
    	
Sheet
    	
 
    	
SHEET-ADDENDUM,DIATHERMY,PHYSICIAN MANUAL
    	
 
    	
X
    	
 
    	
X
    
	
502668001
    	
 
    	
Lead
    	
 
    	
LEAD ASSY-NERVE,PERIPHERAL,SELF SIZING,   3063(45CM,3MM CUFF) (Sensitive information will be redacted)
    	
 
    	
X
    	
 
    	
X
    
	
206360001
    	
 
    	
Electrode
    	
 
    	
ELECTRODE-TAB,HALF (Sensitive information will be   redacted)
    	
 
    	
X
    	
 
    	
X
    
	
141588001
    	
 
    	
Label
    	
 
    	
LABEL-SERIAL NO
    	
 
    	
X
    	
 
    	
X
    
	
105872001
    	
 
    	
Sleeve
    	
 
    	
ANCHORING SLEEVE-DOUBLE SUTURE (Sensitive   information will be redacted)
    	
 
    	
X
    	
 
    	
X
    


 

22











 

3063 Lead

 

	
Model No.
    	
 
    	
Document
   No.
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT
   mfg
    
	
3063
    	
 
    	
600000
    	
 
    	
Project Charter
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600001
    	
 
    	
Project Initiation Form
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600002
    	
 
    	
Concept Phase Design Review Minutes System Design   Plan or re-titled as 3063
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600003
    	
 
    	
Program Plan
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600004
    	
 
    	
Marketing Plan (Sensitive information will be   redacted)
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600005
    	
 
    	
Risk Analysis
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600006
    	
 
    	
Standards Assessment
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600007
    	
 
    	
Planning and Specification Phase Design Review   Minutes
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600008
    	
 
    	
Design Verification Plan (Sensitive information will   be redacted)
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600009
    	
 
    	
Design Verif. Report (Sensitive information will be   redacted)
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600010
    	
 
    	
Clinical Manag. Plan
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600011
    	
 
    	
Clinical Protocol (Sensitive information will be   redacted)
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600012
    	
 
    	
Clinical Readiness Review
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600015
    	
 
    	
Labeling Validation Report (manuals/labels)   Material/Supplier Qualification Plan/Report
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600016
    	
 
    	
(NA)
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600017
    	
 
    	
Supplier / Materials Assessment
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600018
    	
 
    	
Classification of Characteristics Report
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600019
    	
 
    	
Design FMEA
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600020
    	
 
    	
User FMEA
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600023
    	
 
    	
Mfg Process Characterization
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600024
    	
 
    	
Mfg Equip Installation Plan/Report
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600025
    	
 
    	
Reliability Assessment
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600026
    	
 
    	
Safety Assessment
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600027
    	
 
    	
Technical File/Design Dossier (for CE mark)
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600028
    	
 
    	
Regulatory Submissions
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600029
    	
 
    	
Regulatory Approvals for Clinical
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600030
    	
 
    	
Standards Compliance Report& Certificates
    	
 
    	
X
    	
 
    	
X
    
	
3063
    	
 
    	
600031
    	
 
    	
Development Phase Design Review Minutes (Sensitive   information will be redacted)
    	
 
    	
X
    	
 
    	
X
    


 

23











 

3024 IPG

 

	
BOM
   Part
   Number
    	
 
    	
Item Type
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT mfg
    
	
120110001
    	
 
    	
Label Software
    	
 
    	
JETFORM FILE NEURO IPG
    	
 
    	
X
    	
 
    	
 
    
	
502040002
    	
 
    	
IPG
    	
 
    	
IPG ASSY-INSPIRE II,3024,K
    	
 
    	
X
    	
 
    	
 
    
	
404827004
    	
 
    	
EMA
    	
 
    	
EMA ASSY-INSPIRE II,3024,T/K(DESICCANT)
    	
 
    	
X
    	
 
    	
 
    
	
404754001
    	
 
    	
Shield Assy
    	
 
    	
LH SHIELD ASSY-(IN-LINE)ITREL 3,7425(EMA),T
    	
 
    	
X
    	
 
    	
 
    
	
211088001
    	
 
    	
Shield
    	
 
    	
SHIELD HALF-LEFT,ITREL 3
    	
 
    	
X
    	
 
    	
 
    
	
101291001
    	
 
    	
Alloy
    	
 
    	
TITANIUM-SHEET,BEAD BLASTED,.012+-,0005THK,   GRD 1
    	
 
    	
X
    	
 
    	
 
    
	
210329001
    	
 
    	
Bead
    	
 
    	
BEADS-STAINLESS STEEL
    	
 
    	
X
    	
 
    	
 
    
	
103725001
    	
 
    	
Insulator
    	
 
    	
INSULATOR-BATTERY,ITREL 3,(PET,POLYESTER W/ADHES.),   1.3X1.48
    	
 
    	
X
    	
 
    	
 
    
	
101060009
    	
 
    	
Film
    	
 
    	
STRIP-POLYESTER,.005THK TS=25000PSI,W AND LG PER PO
    	
 
    	
X
    	
 
    	
 
    
	
404752001
    	
 
    	
Battery
    	
 
    	
BATTERY ASSEMBLY-IPG,7425(EMA),T
    	
 
    	
X
    	
 
    	
 
    
	
161177001
    	
 
    	
Battery
    	
 
    	
CELL-LITHIUM/THIONYL CHLORIDE,3.7V,2.7AH@2MA,1.34WX.324TX1.5
    	
 
    	
X
    	
 
    	
 
    
	
199004001
    	
 
    	
Power Source
    	
 
    	
QA REQT-POWER CELLS AND BATTERIES
    	
 
    	
X
    	
 
    	
 
    
	
211212002
    	
 
    	
Contact
    	
 
    	
CONTACT-B PLUS,T-BLOCK,KOVAR,PLATED
    	
 
    	
X
    	
 
    	
 
    
	
211212001
    	
 
    	
Contact
    	
 
    	
CONTACT-B PLUS,T-BLOCK,KOVAR
    	
 
    	
X
    	
 
    	
 
    
	
210862002
    	
 
    	
Contact
    	
 
    	
CONTACT-BLOCK,7960,PLATED
    	
 
    	
X
    	
 
    	
 
    
	
153212010
    	
 
    	
Tubing
    	
 
    	
TUBING-PTFE,TRANSPARENT .042 ODX.020X.004 LIGHT WALL
    	
 
    	
X
    	
 
    	
 
    
	
181637005
    	
 
    	
Hybrid
    	
 
    	
HYBRID-MULTIPROGRAMMABLE,INSPIRE II,3024
    	
 
    	
X
    	
 
    	
X
    
	
404787002
    	
 
    	
Shield Assy
    	
 
    	
RH SHIELD ASSY-ITREL 3,7425(EMA),T
    	
 
    	
X
    	
 
    	
 
    
	
404786001
    	
 
    	
Shield Assy
    	
 
    	
SHIELD SUBASSEMBLY-RH,7425(EMA)T
    	
 
    	
X
    	
 
    	
 
    
	
206588001
    	
 
    	
Shield
    	
 
    	
SHIELD HALF/MATRIX ID,7425
    	
 
    	
X
    	
 
    	
 
    
	
211087004
    	
 
    	
Shield
    	
 
    	
SHIELD HALF-RIGHT HAND,ITREL 3 (WITH HOLES AND   RECESS)TALL U
    	
 
    	
X
    	
 
    	
 
    
	
103772001
    	
 
    	
Insulator
    	
 
    	
INSULATOR CUP-ITREL 3,POLYPROPYLENE (INCLUDED   FEATURE)
    	
 
    	
X
    	
 
    	
 
    
	
171093001
    	
 
    	
Adhesive
    	
 
    	
MOLDING-POLYPROPYLENE RESIN HARDNESS 8696 ROCKWELL R
    	
 
    	
X
    	
 
    	
 
    
	
210862002
    	
 
    	
Contact
    	
 
    	
CONTACT-BLOCK,7960,PLATED
    	
 
    	
X
    	
 
    	
 
    
	
140089002
    	
 
    	
Feedthru
    	
 
    	
FEEDTHRU ASSY-TOPHAT,8081
    	
 
    	
X
    	
 
    	
 
    
	
140081002
    	
 
    	
Feedthru
    	
 
    	
TERMINAL-FEEDTHRU.FLAT TOP.IPGTITANIUM
    	
 
    	
X
    	
 
    	
 
    
	
151071001
    	
 
    	
Contact
    	
 
    	
CONTACT-DISK,GOLD-PLATED KOVAR,.073-.075 DIAX   .025-.027
    	
 
    	
X
    	
 
    	
 
    
	
168188001
    	
 
    	
Preform
    	
 
    	
PREFORM-SOLDER,GOLD/TIN,.070 DIA X .002 THK   (0108564A006)
    	
 
    	
X
    	
 
    	
 
    
	
211048004
    	
 
    	
Desiccant
    	
 
    	
DESICCANT-ITREL 3,CLEANED
    	
 
    	
X
    	
 
    	
 
    
	
211048002
    	
 
    	
Desiccant
    	
 
    	
DESICCANT-ITREL 3
    	
 
    	
X
    	
 
    	
 
    
	
163021002
    	
 
    	
Powder
    	
 
    	
POWDER-DESICCANT,7960
    	
 
    	
X
    	
 
    	
 
    
	
163022001
    	
 
    	
Polymer
    	
 
    	
RUBBER-SILICONE,LSR,2 PART
    	
 
    	
X
    	
 
    	
 
    
	
101293001
    	
 
    	
Wire
    	
 
    	
WIRE-UNINSULATED,8081,WIREBOND
    	
 
    	
X
    	
 
    	
 
    
	
101292003
    	
 
    	
Adhesive
    	
 
    	
ADHESIVE-ELECT MOD COMP,RESIN,1 GALLON
    	
 
    	
X
    	
 
    	
 
    
	
101292004
    	
 
    	
Adhesive
    	
 
    	
ADHESIVE-ELECT MOD COMP,CATALYST,1 GALLON
    	
 
    	
X
    	
 
    	
 
    
	
210635002
    	
 
    	
Fastener
    	
 
    	
FASTENER-BARBED,MULTIPLE,G2,3 BARBS
    	
 
    	
X
    	
 
    	
 
    


 

24











 

3024 IPG

 

	
BOM
   Part
   Number
    	
 
    	
Item Type
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT mfg
    
	
101038008
    	
 
    	
Alloy
    	
 
    	
TITANIUM-SHT,ARGON ANNEAL,.010THK,+-.001,GRD1
    	
 
    	
X
    	
 
    	
 
    
	
210624020
    	
 
    	
Radiopaque
    	
 
    	
SYMBOL-IDENT,RADIOPAQUE,INSPIRE II,NCR,3024
    	
 
    	
X
    	
 
    	
 
    
	
101231001
    	
 
    	
Sheet
    	
 
    	
SHEET-TUNGSTEN,PER FED STD 151ANSI-B46.1,ASTM-E92
    	
 
    	
X
    	
 
    	
 
    
	
410274001
    	
 
    	
Grommet
    	
 
    	
SEAL ASSY-COMPRESSION,7074/75
    	
 
    	
X
    	
 
    	
 
    
	
104605001
    	
 
    	
Grommet
    	
 
    	
GROMMET-SPLIT,SI RBR,.090 ODX   0.30IDX.103T,GRV=.1500DX.068W
    	
 
    	
X
    	
 
    	
 
    
	
168588001
    	
 
    	
Polymer
    	
 
    	
MOLDING-SILICONE RUBBER 2-PARTMEDICAL GRD,HARDNESS   30-40 DUR
    	
 
    	
X
    	
 
    	
 
    
	
104585001
    	
 
    	
Ring
    	
 
    	
RING-COMPRESSION,SILICON .140ODX.100IDX.060THK
    	
 
    	
X
    	
 
    	
 
    
	
153191014
    	
 
    	
Tubing
    	
 
    	
TUBING-SILICONE RUBBER,TRANS .140 ODX.100X.015   WALL,DUR 50A
    	
 
    	
X
    	
 
    	
 
    
	
110941002
    	
 
    	
Screw
    	
 
    	
SCREW-MACH,SET,HEX SKT,CUP PT   TITANIUM,2-56X.125,CLASS 2A
    	
 
    	
X
    	
 
    	
 
    
	
101227001
    	
 
    	
Alloy
    	
 
    	
TITANIUM ALLOY-ROD,TS=135K PSI.125 TO 4.5 IN   OD,(6AL-4V)
    	
 
    	
X
    	
 
    	
 
    
	
149460001
    	
 
    	
Connector
    	
 
    	
CONNECTOR MODULE-ITREL 3,OPEN SLOTS
    	
 
    	
X
    	
 
    	
 
    
	
168166003
    	
 
    	
Polymer
    	
 
    	
RESIN-POLYETHER URETHANE,YEL,74 SHORE D,5000PSI,200%   ELONG
    	
 
    	
X
    	
 
    	
 
    
	
149121001
    	
 
    	
Connector
    	
 
    	
CONNECTOR BODY-IMPL,SLIMLINE 8420/21
    	
 
    	
X
    	
 
    	
 
    
	
101031004
    	
 
    	
Sheet
    	
 
    	
TI-GRD4,TS=80KSI,AVAIL   FORM SHEET/STRIP/PLATE/BAR/BILLETS
    	
 
    	
X
    	
 
    	
 
    
	
101031003
    	
 
    	
Sheet
    	
 
    	
TI-GRD3,TS=60KSI, AVAIL   FORM SHEET/STRIP/PLATE/BAR/BILLETS
    	
 
    	
X
    	
 
    	
 
    
	
101031002
    	
 
    	
Sheet
    	
 
    	
TI-GRD2,TS=50KSI,AVAIL FORM SHEET/STRIP/PLATE/BAR/BILLETS
    	
 
    	
X
    	
 
    	
 
    
	
149120001
    	
 
    	
Connector
    	
 
    	
CONNECTOR BODY-IMPL,SLMLN,8420
    	
 
    	
X
    	
 
    	
 
    
	
101031004
    	
 
    	
Sheet
    	
 
    	
TI-GRD4,TS=80KSI,AVAIL   FORM SHEET/STRIP/PLATE/BAR/BILLETS
    	
 
    	
X
    	
 
    	
 
    
	
101031003
    	
 
    	
Sheet
    	
 
    	
TI-GRD3,TS=60KSI, AVAIL FORM SHEET/STRIP/PLATE/BAR/BILLETS
    	
 
    	
X
    	
 
    	
 
    
	
101031002
    	
 
    	
Sheet
    	
 
    	
TI-GRD2,TS=50KSI,AVAIL   FORM SHEET/STRIP/PLATE/BAR/BILLETS
    	
 
    	
X
    	
 
    	
 
    
	
117988001
    	
 
    	
Seal
    	
 
    	
SEAL-INNER,DUAL BIPOLAR
    	
 
    	
X
    	
 
    	
 
    
	
168588002
    	
 
    	
Silicon
    	
 
    	
MOLDING-SILICONE RUBBER,2-PARTMEDICAL GRD,HARDNESS   45-55 DUR
    	
 
    	
X
    	
 
    	
 
    
	
104597001
    	
 
    	
Seal
    	
 
    	
OUTER SEAL-CONNECTOR
    	
 
    	
X
    	
 
    	
 
    
	
168588002
    	
 
    	
Silicon
    	
 
    	
MOLDING-SILICONE RUBBER,2-PARTMEDICAL GRD,HARDNESS   45-55 DUR
    	
 
    	
X
    	
 
    	
 
    
	
168171003
    	
 
    	
Adhesive
    	
 
    	
ADHESIVE-RTV,SILICONE RUBBER,1 PART,TRANSLUCENT,6   OZ(170 G)
    	
 
    	
X
    	
 
    	
 
    
	
168079001
    	
 
    	
Coating
    	
 
    	
COATING-PARYLENE-C
    	
 
    	
X
    	
 
    	
 
    
	
171506991
    	
 
    	
Dadet
    	
 
    	
ENCAPSULANT-EPOXY RESIN KIT,SIZE 1 OZ ENCAP AND   HARDENER
    	
 
    	
X
    	
 
    	
 
    
	
152284005
    	
 
    	
Wire
    	
 
    	
WIRE-UNINS,NIOBIUM,.015DIA +-.001, TS=18,000
    	
 
    	
X
    	
 
    	
 
    
	
168064002
    	
 
    	
Primer
    	
 
    	
PRIMER-GAMA-METHACRYLOXYPROPYLTRIMETHOXYSILANE,CLEAR   LIQUID
    	
 
    	
X
    	
 
    	
 
    


 

25











 

3024 IPG

 

	
BOM
   Part
   Number
    	
 
    	
Item Type
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT mfg
    
	
19679001
    	
 
    	
Tray
    	
 
    	
TRAY-PACKAGING,IPG,OUTER,THERA,7940
    	
 
    	
X
    	
 
    	
 
    
	
101271001
    	
 
    	
Film
    	
 
    	
FILM-PETG COPOLYESTER,PKG,UNCOATED
    	
 
    	
X
    	
 
    	
 
    
	
50007001
    	
 
    	
Tray
    	
 
    	
TRAY-PACKAGING,INNER
    	
 
    	
X
    	
 
    	
 
    
	
119708001
    	
 
    	
Lid
    	
 
    	
LID-PACKAGING,IPG,OUTER,THERA
    	
 
    	
X
    	
 
    	
 
    
	
101168002
    	
 
    	
Sheet
    	
 
    	
SHEET-POLYETHYLENE FIBER,.0073THK.CTD,OLIVER 18B
    	
 
    	
X
    	
 
    	
 
    
	
119707001
    	
 
    	
Lid
    	
 
    	
LID-PACKAGING,IPG,INNER,THERA
    	
 
    	
X
    	
 
    	
 
    
	
101168002
    	
 
    	
Sheet
    	
 
    	
SHEET-POLYETHYLENE FIBER,.0073THK.CTD,OLIVER 18B
    	
 
    	
X
    	
 
    	
 
    
	
800242001
    	
 
    	
Wrench
    	
 
    	
WRENCH-HEX #2
    	
 
    	
X
    	
 
    	
 
    
	
101029006
    	
 
    	
Alloy
    	
 
    	
SST-420 TYPE1,AVAILABLE FORM BAR/WIRE
    	
 
    	
X
    	
 
    	
 
    
	
119718002
    	
 
    	
Box
    	
 
    	
BOX-SHELF,IPG,6.63 X 5.25 X 2.44
    	
 
    	
X
    	
 
    	
 
    
	
119968001
    	
 
    	
Cushion
    	
 
    	
FOAM-INSERT,7223
    	
 
    	
X
    	
 
    	
 
    
	
119724003
    	
 
    	
Bag
    	
 
    	
POUCH-IPG,LITERATURE,FOLDING
    	
 
    	
X
    	
 
    	
 
    
	
100477001
    	
 
    	
Film
    	
 
    	
FILM-POLYETHYLENE,LOW DENSITY DIMENSIONS PER PO
    	
 
    	
X
    	
 
    	
 
    
	
197615001
    	
 
    	
Manual
    	
 
    	
MANUAL-TECH,MODEL 3024,PHYSICIAN’S MANUAL,EN
    	
 
    	
X
    	
 
    	
X
    
	
197552001
    	
 
    	
Manual
    	
 
    	
MAUNAL-TECH,3024,INSPIRE,PATIENT,US
    	
 
    	
X
    	
 
    	
X
    
	
186193004
    	
 
    	
Form
    	
 
    	
FORM-REGISTRATION,IPG SYSTEM
    	
 
    	
X
    	
 
    	
X
    
	
103334001
    	
 
    	
Bag
    	
 
    	
POUCH-PLASTIC,ID CARD,ITREL IIITREL   3,TRANSFORM REGIST FORM
    	
 
    	
X
    	
 
    	
X
    
	
187380025
    	
 
    	
Transformer
    	
 
    	
TRANSFORM-PATIENT ID CARD,CARDIOMYOSTM,4710,E/EF/EG/ES/EI/EN
    	
 
    	
X
    	
 
    	
X
    
	
187222025
    	
 
    	
Card
    	
 
    	
CARD-PATIENT ID,ITREL,7424/25 E/EF/EG/ES/EI/EN
    	
 
    	
X
    	
 
    	
X
    
	
194642001
    	
 
    	
Label
    	
 
    	
LABEL SET-UNIVERSAL,SMALL,TACHY
    	
 
    	
X
    	
 
    	
X
    
	
193364002
    	
 
    	
Label
    	
 
    	
LABEL-SEAL,TEAR TAB,MEDTRONIC
    	
 
    	
X
    	
 
    	
X
    
	
86198002
    	
 
    	
Envelope
    	
 
    	
ENVELOPE-ITREL
    	
 
    	
X
    	
 
    	
X
    
	
L169
    	
 
    	
Inspire L169
    	
 
    	
Inspire L169 IC Specification (Design files, IC   Verilog/Verifault VHDL simulations)
    	
 
    	
X
    	
 
    	
X
    
	
L169
    	
 
    	
Inspire L169 IC
    	
 
    	
Layout Files
    	
 
    	
X
    	
 
    	
X
    
	
L169
    	
 
    	
Inspire L169 IC
    	
 
    	
Verification and Validation Plans / Reports
    	
 
    	
X
    	
 
    	
X
    
	
L169
    	
 
    	
Inspire L169 IC
    	
 
    	
Inspire L169 IC Test Specification
    	
 
    	
X
    	
 
    	
X
    
	
181637
    	
 
    	
Inspire Hybrid
    	
 
    	
Electrical Specification
    	
 
    	
X
    	
 
    	
X
    
	
601601
    	
 
    	
Inspire Hybrid
    	
 
    	
Electrical Schematic, Inspire Hybrid
    	
 
    	
X
    	
 
    	
X
    
	
2125229
    	
 
    	
Inspire Hybrid
    	
 
    	
Inspire Hybrid Test Specification
    	
 
    	
X
    	
 
    	
X
    


 

26









 

3024 IPG

 

	
Model No.
    	
 
    	
Document
   Number
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT
   mfg
    
	
3024
    	
 
    	
2841-3079
    	
 
    	
2841 Hybrid FMEA
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
2841-3104
    	
 
    	
Upper Airway Stimulation (UAS) System Hazard   Analysis
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3000
    	
 
    	
Reliability Development Plan for UAS Inspire   (II)IPG, Model 3024.
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3004
    	
 
    	
Chargeback for UAS Project
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3006
    	
 
    	
Initial Hazard Analysis
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3006
    	
 
    	
Upper Airway Stimulation System Hazard Analysis
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3008
    	
 
    	
UAS Commitment Phase Review Summary
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3009
    	
 
    	
Upper Airway Stimulation (UAS) Development Plan
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3010 and 3024-3051
    	
 
    	
Memo Hans Neisz from Donald Erickson Aug 2, 1998 and   3024- “Upper Airway IPG”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3011
    	
 
    	
Product Specification Ventor IPG Model 3024
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3012
    	
 
    	
Patent Review for IPG UAS
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3013
    	
 
    	
Business Plan “Obstructive Sleep Apnea Upper Airway   Stimulation”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3018
    	
 
    	
Cstim Slew Rate Measurements
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3020
    	
 
    	
STIM Waveform (Recharge Investigation)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3024
    	
 
    	
Medical Advisory Board Meeting, July 16, 1997,   Summary
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3035
    	
 
    	
ECO Release Model 3024 Inspire II Product Specification
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3035
    	
 
    	
Inspire II Product Specification (083553)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3038
    	
 
    	
Memo to John Hammargren from Mark Christopherson Oct   25, 1994 Preliminary 60hz Testing of the 4322 Sensor and the Phase I System
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3153
    	
 
    	
Memo to John Hammargren, Hans Neisz from Mark   Christopherson, October 25, 1995 “L169 Verilog Verification Stimulations”   with Test Plan
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3155
    	
 
    	
Memo to John Hammargren from Mark Christopherson
   Nov 21, 1995 “Summary of Inspire II Test Strategy”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3157
    	
 
    	
083553 Model 3024 Inspire II IPG Product   Specification Rev A
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3161
    	
 
    	
Qual Plan: Qualification of Inspire II IPG (Model   3024) (L169-004)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3162
    	
 
    	
Verification Plan: Inspire II (Model 3024) Hybrid   Test Plan, Detection Algorithm Specific L169 Verification Plan (L169-004)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3162-1
    	
 
    	
Test Report: Memo to Inspire II Team from Mark   Christopherson “Functionality of First Hybrids”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3178
    	
 
    	
Design Verification of the Rev 2 Hybrid (Inspire II   IPG) Status
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3201
    	
 
    	
Inspire II Manufacturing Plan Rev B
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3204
    	
 
    	
Memo to Distribution from Dan Pyne “Inspire II Phase   2 CDR Minutes”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
 
    	
 
    	
1) Memo to File from Mark Christopherson “Summary of   Rev 2 Hybrid Evaluation (L169 IC/lnspire II, Model 3024)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
 
    	
 
    	
2) Memo to Inspire II Team from Mark Christopherson   “Testing of the Analog Front End and Vref”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
 
    	
 
    	
3) Memo to Inspire II from Mark Christopherson   “Status of L169 Following Trip to Micro-Rel
    	
 
    	
X
    	
 
    	
 
    


 

27











 

3024 IPG

 

	
Model No.
    	
 
    	
Document
   Number
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT
   mfg
    
	
3024
    	
 
    	
3024-3228
    	
 
    	
4) Memo to Mark Christopherson from Dan Pyne   “Inspire II Network/topo Changes Reply”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
 
    	
 
    	
5) Memo to Distribution from Dan Pyne “Inspire II   Phase 2 CDR Minutes”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
 
    	
 
    	
6) Memo to John Hammargren/Todd Kallmyer from Mark   Christopherson “Design Verification of the Rev 2 Hybrid (Inspire II IPG)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3229
    	
 
    	
Lab Notebook Inspire II Hybrid Verification Rev 2   March 1996 (Mark Christopherson )
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3235
    	
 
    	
Lab Notebook Documentation and Qualification of the   Inspire II Stimulus Tester (Labview)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3249
    	
 
    	
Memo to Todd Kallmyer from Mark Christopherson   “Inspire II Hybrid Evaluations Summary (Rev 3)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3257
    	
 
    	
Lab Notebook UAS Algorithm Verification April, 1994   (Mark Christopherson)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3288
    	
 
    	
Inspire II Product Transfer Plan Rice Creek to ESTC   Rev A
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3289
    	
 
    	
Inspire II Manufacturing Plan rev C
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3291
    	
 
    	
Memo to Inspire II Team from Mark Christopherson   “Longevity Calculations”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3301
    	
 
    	
Memo to Project File from Mark Christopherson “Rev 4   Telemetry Frequency”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3316
    	
 
    	
Memo to Distribution from Mark Christopherson   “Inspire II Telemetry Frequency”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3321
    	
 
    	
Qual Plan: QE%-115: H1637-003 and L169-001 for   Inspire II (Micro-Rel L169-001 Qual)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3330
    	
 
    	
Hybrid Operations Development Portfolio: Phase II of   the Inspire I Project (Renamed Inspire II) September 14, 1995
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3345
    	
 
    	
Qual Plan: System Testing and Production   Qualification of Model 3024 Inspire II IPG Nov 13, 1997 (L169-004)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3349
    	
 
    	
Report: Inspire II Model 3024 Hybrid Test Report,   Detection Algorithm Specific
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3350
    	
 
    	
Memo to Inspire II Team from Mark Christopherson   “Net DC Measurements” [Draft] (L169-004)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3351
    	
 
    	
Memo to Inspire II Team from Mark Christopherson   “Inspire II Rev 4 Design Verification Report Summary”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3353
    	
 
    	
L169 Verification Plan Rev F
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3353
    	
 
    	
Micro-Rel L169 Verification Plan (169-004)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3354
    	
 
    	
Hybrid Inspire II L169-4 CDR October 28, 1996
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3355
    	
 
    	
ECO Specification 215124 Model 3024 Inspire II IPG   Test Specification Rev A
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3357
    	
 
    	
Micro-Rel Validation Plan: Inspire II Electronic   Module Manufacturing Processes Validation Document
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3358
    	
 
    	
Micro-Rel Report Memo to Distribution from Dawn   Sokol “Inspire II Electronic Module Mechanical Qualification Acceptance”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3362
    	
 
    	
Inspire II Hybrid FMEA
    	
 
    	
X
    	
 
    	
 
    


 

28











 

3024 IPG

 

	
Model No.
    	
 
    	
Document
   Number
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT
   mfg
    
	
3024
    	
 
    	
3024-3363
    	
 
    	
Micro-Rel Report Memo to Distribution from Dawn   Sokol “Inspire II Electronic Module Mechanical Qualification”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3376
    	
 
    	
Micro-Rel Qual Report “Electrical Qualification of   the Inspire II Hybrid and L169 IC (L169-001)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3377
    	
 
    	
Medical Advisory Board Meeting Total System Implant   Project July 16, 1997
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3383
    	
 
    	
Inspire II Model 3024 Rev 4 Design Verification Lab   Book Dec ‘96-Jan ‘97
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3387
    	
 
    	
Inspire II L169 Rev 4 Qualification Test Data   June-Aug ‘97
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3388
    	
 
    	
Report: System Testing and Production Qualification   of Model 3024 Inspire II IPG August ‘97 (L169-004)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3392
    	
 
    	
Design Verification Report Inspire II (Model 3024)   Hybrid Test Report, Detection May 97 Algorithm Specific (L169-004)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3393
    	
 
    	
Memo to Roy Testerman/Todd Kallmyer from Mark Christopherson   “Inspire II AGC Change for Rev 5
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3403
    	
 
    	
Report “Electrical Qualification of the Inspire II   Hybrid and L169IC with Corrections (L169-003)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3404
    	
 
    	
Memo to Project File from Mark Christopherson Oct   13, 1997 L169 Rev 5 (Inspire II ) Review Meetings
   1) Memo to H1637-003/L169-001 Qualification File (QE-5- 115) from Dawn Sokol   “H1637-003 1000 Hour Life Test
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3408
    	
 
    	
Characterization Delta Analysis” Sept 18, 1997   [3404] Memo to Distribution from Dawn Sokol “Correction to Inspire II Delta   Analysis Report
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3411
    	
 
    	
Memo to Inspire II Team from Mark Christopherson   Sept 29, 1997 “Inspire II Telemetry Status”
   1) Memo to Distribution from Dawn Sokol June 24, 1997 “Inspire II Electronic   Module Mechanical Qualification”
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3412
    	
 
    	
2) Report Inspire II Electronic Module Process   Validation Document
   3) Memo to Distribution from Dawn Sokol “Inspire II Electronic Module   Mechanical Qualification Acceptance” June 25, 1997
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3416
    	
 
    	
System Testing and Production Qualification of Model   3024 Inspire II IPG, L169-007
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3417
    	
 
    	
Inspire II (Model 3024) Hybrid Test Plan (Design   Verification) L169-007
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3422
    	
 
    	
Memo to Inspire II Development Team from Todd   Kallmyer “Inspire II Fix-it List
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3439
    	
 
    	
Memo to Project File from Mark Christopherson   Inspire II Design Summary: Rev-006/-007 May, 1998 Memo: Design Verification   and Design Qualification of the Rev 7 L169 Inspire II IPG
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3446
    	
 
    	
Design Review Meeting Minutes (Inspire System   Review), July 30, 1998
    	
 
    	
X
    	
 
    	
 
    


 

29











 

3024 IPG

 

	
Model No.
    	
 
    	
Document
   Number
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT
   mfg
    
	
3024
    	
 
    	
3024-3451
    	
 
    	
Model 3024 Inspire II UAS IPG Safety Requirements.   (Updated UAS System Hazard Analysis)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3452
    	
 
    	
Inspire II, Upper Airway System, Safety Assessment
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3453
    	
 
    	
Inspire II Model 3024 FMEA
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3454
    	
 
    	
Model 3024 Inspire II Customer Use FMEA
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3456
    	
 
    	
Report: System Testing and Production Qualification   of Model 3024 Inspire II IPG Sept. 1998 (L169-007)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3457
    	
 
    	
Micro-Rel Product Qualification Plan (H1637-003&   L169- 001) and (H1637-004 and L169-007)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3458
    	
 
    	
Hybrid Test Report (Design Verification) L169-007
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3460
    	
 
    	
AIMD Conformity Assessment Checklist/Essential   Requirements (Initial Draft)
    	
 
    	
 
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3462
    	
 
    	
Design Verification Test Data,Inspire II (3024)   (L169-007)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3463
    	
 
    	
4322 dp/dt Sensor Capsule: Inspire II System Bias   Voltage Drift Test Plan
    	
 
    	
 
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3465
    	
 
    	
Comparison of Inspire I vs. Inspire II
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3466
    	
 
    	
Materials Availability for the Inspire II System
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3470
    	
 
    	
Inspire II System Phase I Review
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3473
    	
 
    	
Early Product Description, UAS IPG System
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3475
    	
 
    	
Investigators Meeting, October 16, 1995
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3479
    	
 
    	
Micro-Rel Inspire II Verification Results
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3480
    	
 
    	
Net DC Measurements on Inspire II
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3481
    	
 
    	
Itrel 3 Packaging (and Sterilization) Qualification
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3482
    	
 
    	
ITREL 3 Model 7425 Reliability Assessment (Failure   Rate Prediction) 1100-94-161
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3483
    	
 
    	
Itrel 3 Process File List
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3484
    	
 
    	
Final Customer Use FMEA for Itrel 3 System
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3485
    	
 
    	
Itrel 3 IPG FMEA
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3486
    	
 
    	
Itrel 3 EMA FMEA
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3487
    	
 
    	
Itrel 3 IPG EMA Product Qualification Test Plan and   Report
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3488
    	
 
    	
Itrel 3 Mechanical Qualification Plan and Report
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3489
    	
 
    	
Risk Assessment for the Upper Airway Stimulation   (UAS) System
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3491
    	
 
    	
Inspire Controlled Release Plan, September 15, 1998
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3492
    	
 
    	
Itrel 3 EMC Qualification Plans and Reports
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3493
    	
 
    	
Inspire II System Manuals Audit
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3494
    	
 
    	
Inspire II Clinical Protocol and Overview
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3024-3496
    	
 
    	
Inspire II IDE Submission, September 25, 1998
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3026-3223
    	
 
    	
Inspire I Product Specification (083543)
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
3026-3326
    	
 
    	
2841/3026 Hybrid FMEA
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
 
    	
 
    	
Latest ECO of Specs and Drawings
    	
 
    	
X
    	
 
    	
 
    
	
3024
    	
 
    	
215214
    	
 
    	
Inspire II IPG Final Test Specification
    	
 
    	
X
    	
 
    	
 
    


 

30











 

4322 Pressure Senior Lead

 

	
BOM Part
   Number
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT
   mfg
    
	
404180001
    	
 
    	
Inspire dp/dt Sensor (original design)
    	
 
    	
X
    	
 
    	
X
    
	
404180
    	
 
    	
Mechanical Specification
    	
 
    	
X
    	
 
    	
X
    
	
180808003
    	
 
    	
Hybrid
    	
 
    	
X
    	
 
    	
X
    
	
180808
    	
 
    	
Electrical Specification
    	
 
    	
X
    	
 
    	
X
    
	
083444/083846
    	
 
    	
Product Specification
    	
 
    	
X
    	
 
    	
X
    
	
140058002
    	
 
    	
Feedthru
    	
 
    	
X
    	
 
    	
X
    
	
140058
    	
 
    	
Mechanical Specification
    	
 
    	
X
    	
 
    	
X
    
	
180779001
    	
 
    	
Hybrid
    	
 
    	
X
    	
 
    	
X
    
	
200945
    	
 
    	
Miscellaneous Document
    	
 
    	
X
    	
 
    	
X
    
	
200428
    	
 
    	
Test Specification
    	
 
    	
X
    	
 
    	
X
    
	
200068
    	
 
    	
Electrical Specification
    	
 
    	
X
    	
 
    	
X
    
	
180779
    	
 
    	
Electrical Specification
    	
 
    	
X
    	
 
    	
X
    
	
200112
    	
 
    	
Product Specification
    	
 
    	
X
    	
 
    	
X
    
	
200068
    	
 
    	
Electrical Specification
    	
 
    	
X
    	
 
    	
X
    
	
200070
    	
 
    	
Product Specification
    	
 
    	
X
    	
 
    	
X
    
	
200113
    	
 
    	
Miscellaneous Document
    	
 
    	
X
    	
 
    	
X
    
	
201173, 201172
    	
 
    	
Test Specifications
    	
 
    	
X
    	
 
    	
X
    
	
117600001
    	
 
    	
Connector
    	
 
    	
X
    	
 
    	
X
    
	
168626001
    	
 
    	
Miscellaneous Component
    	
 
    	
X
    	
 
    	
X
    
	
124132
    	
 
    	
Inspire dp/dt crystal specification
    	
 
    	
X
    	
 
    	
X
    
	
108999
    	
 
    	
Inspire dp/dt crystal assembly
    	
 
    	
X
    	
 
    	
X
    
	
605488
    	
 
    	
Inspire dp/dt D46 final acceptance
    	
 
    	
X
    	
 
    	
X
    
	
0107074, 0104778
    	
 
    	
Inspire dp/dt D46 DHF, specs, and design files   (layout, schematic)
    	
 
    	
X
    	
 
    	
X
    
	
2507077
    	
 
    	
Inspire dp/dt D46 reticles/mask
    	
 
    	
X
    	
 
    	
X
    
	
605658
    	
 
    	
Inspire dp/dt D46 Visual Specification
    	
 
    	
X
    	
 
    	
X
    
	
 
    	
 
    	
Inspire dp/dt Sensor (collaboration design)
    	
 
    	
X
    	
 
    	
X
    
	
Collab - new
    	
 
    	
Inspire dp/dt Sensor DHF (specifications,   verification and validation plans / reports)
    	
 
    	
X
    	
 
    	
X
    
	
Collab - new
    	
 
    	
Inspire dp/dt Sensor DMR (BOM, electrical and   mechanical drawings)
    	
 
    	
X
    	
 
    	
X
    
	
Collab - new
    	
 
    	
Inspire dp/dt Test System Specification
    	
 
    	
X
    	
 
    	
X
    
	
Collab - new
    	
 
    	
Inspire dp/dt Test System Mechanical and Electrical   Drawings
    	
 
    	
X
    	
 
    	
X
    
	
Collab - new
    	
 
    	
Inspire dp/dt Test System verification and   validation plans and reports
    	
 
    	
X
    	
 
    	
X
    
	
Collab - new
    	
 
    	
Inspire dp/dt Test System Software specification
    	
 
    	
X
    	
 
    	
X
    
	
Collab - new
    	
 
    	
Inspire dp/dt Test System Software source code
    	
 
    	
X
    	
 
    	
X
    
	
Collab - new
    	
 
    	
Inspire dp/dt Test System Software Verification and   Validation Plans/Reports
    	
 
    	
X
    	
 
    	
X
    
	
Collab - new
    	
 
    	
Inspire dp/dt Test System User Manual
    	
 
    	
X
    	
 
    	
X
    
	
4322T00
    	
 
    	
Package Specification
    	
 
    	
X
    	
 
    	
 
    
	
193176017
    	
 
    	
Label
    	
 
    	
X
    	
 
    	
X
    
	
186341001
    	
 
    	
Form
    	
 
    	
X
    	
 
    	
X
    
	
197755001
    	
 
    	
Manual
    	
 
    	
X
    	
 
    	
X
    
	
192339001
    	
 
    	
Label
    	
 
    	
X
    	
 
    	
X
    
	
119562001
    	
 
    	
Box
    	
 
    	
X
    	
 
    	
X
    


 

31









 

4322 Pressure Senior Lead

 

	
BOM Part
   Number
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT
   mfg
    
	
119562
    	
 
    	
Package Specification
    	
 
    	
X
    	
 
    	
X
    
	
502608002
    	
 
    	
Lead (Sensitive information will be redacted)
    	
 
    	
X
    	
 
    	
X
    
	
119551001
    	
 
    	
Closure
    	
 
    	
X
    	
 
    	
 
    
	
101168002
    	
 
    	
Sheet
    	
 
    	
X
    	
 
    	
 
    
	
119858001
    	
 
    	
Tray
    	
 
    	
X
    	
 
    	
 
    
	
119858
    	
 
    	
Package Specification
    	
 
    	
X
    	
 
    	
 
    
	
119431005
    	
 
    	
Disk
    	
 
    	
X
    	
 
    	
 
    
	
119550001
    	
 
    	
Closure
    	
 
    	
X
    	
 
    	
 
    
	
141566001
    	
 
    	
Label
    	
 
    	
X
    	
 
    	
 
    


 

4322 Pressure Sensor Lead

 

	
Model No.
    	
 
    	
Document
   Number
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT
   mfg
    
	
4322
    	
 
    	
4322-A002
    	
 
    	
4322 Product Description and Development Plan
    	
 
    	
X
    	
 
    	
X
    
	
4322
    	
 
    	
4322-B004
    	
 
    	
4322 Sensor and Test Requirements: Frequency   Response and Pressure Levels (Sensitive information will be redacted)
    	
 
    	
X
    	
 
    	
X
    
	
4322
    	
 
    	
4322-B005
    	
 
    	
ESD and Cautery Testing on the 4322 Sensor/Lead
    	
 
    	
X
    	
 
    	
X
    
	
4322
    	
 
    	
4322-C004
    	
 
    	
Design Review 4322 Comments
    	
 
    	
X
    	
 
    	
X
    
	
4322
    	
 
    	
4322-C007
    	
 
    	
Electrical Test Requirements for the 4322 Respiratory   Pressure Sensor
    	
 
    	
X
    	
 
    	
X
    
	
4322
    	
 
    	
4322-C011
    	
 
    	
4322 Test Specifications (Supersedes Memo:   Electrical Test Requirements for 4322 Respiratory Pressure Sensor,   Dec. 20, 1994
    	
 
    	
X
    	
 
    	
X
    
	
4322
    	
 
    	
4322-C018
    	
 
    	
Test Setup Files and Associated Files for Capsule   and Lead Testing Inspire I Devices (Model 4322) Qualification Plan (Sensitive   information will be redacted)
    	
 
    	
X
    	
 
    	
X
    
	
4322
    	
 
    	
4322-C024
    	
 
    	
Chronic Monitor: Week #12 - 4322 Data Results (First   Two Canines)
    	
 
    	
X
    	
 
    	
X
    
	
4322
    	
 
    	
4322-C025
    	
 
    	
Model 4322 Sleep Apnea Lead Qualification Test Plan   (Sensitive information will be redacted)
    	
 
    	
X
    	
 
    	
X
    
	
4322
    	
 
    	
4322-C025A
    	
 
    	
Model 4322 Sleep Apnea Lead Qualification Test Plan   Rev A (Sensitive information will be redacted)
    	
 
    	
X
    	
 
    	
X
    
	
4322
    	
 
    	
4322-C027
    	
 
    	
Sterilization of Model 4322 Lead (Sensitive   information will be redacted)
    	
 
    	
X
    	
 
    	
X
    


 

32











 

	
4322
    	
 
    	
4322-C033
    	
 
    	
Observations from the 4322 Human Cadaver Study   (2/09/96)
    	
 
    	
X
    	
 
    	
X
    
	
4322
    	
 
    	
4322-C034
    	
 
    	
My Notes from the Cadaver Lab
    	
 
    	
X
    	
 
    	
X
    
	
4322
    	
 
    	
4322-C040
    	
 
    	
4322T Human Acute Study Qualification Report
    	
 
    	
X
    	
 
    	
X
    


 

2032 Inspire Patient Programmer

 

	
BOM Part
   Number
    	
 
    	
Item Type
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT
   mfg
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    


 

8840 Physician Programmer

 

	
BOM Part
   Number
    	
 
    	
Item Type
    	
 
    	
Description
    	
 
    	
 
    	
 
    	
 
    
	
411326003
    	
 
    	
Miscellaneous Component
    	
 
    	
TELEMETRY MODULE SUBASSEMBLY- PROGRAMMER
    	
 
    	
X
    	
 
    	
X
    
	
177848002
    	
 
    	
Closure
    	
 
    	
HOUSING-BOTTOM,TELEMETRY,8840 WITH EMI SPRAYCOAT
    	
 
    	
X
    	
 
    	
X
    
	
177949002
    	
 
    	
Antenna
    	
 
    	
ANTENNA-TELEMETRY MODULE,8840 VARNISHED
    	
 
    	
X
    	
 
    	
X
    
	
411214005
    	
 
    	
Miscellaneous Component
    	
 
    	
ASSEMBLY - PWB, 8840 TELEMETRY MODULE
    	
 
    	
X
    	
 
    	
X
    
	
170681001
    	
 
    	
Shield
    	
 
    	
SHIELD-TM, H FIELD
    	
 
    	
X
    	
 
    	
X
    
	
183764001
    	
 
    	
Tape
    	
 
    	
FOAM TAPE -DIECUT SET, TM
    	
 
    	
X
    	
 
    	
X
    
	
411327002
    	
 
    	
Miscellaneous Component
    	
 
    	
REEL ASSEMBLY-PROGRAMMER, 8840
    	
 
    	
X
    	
 
    	
X
    
	
170394002
    	
 
    	
Cable
    	
 
    	
CABLE-TELEMETRY MODULE,POLYPROPYLENE PRIMARIES   INSULATION
    	
 
    	
X
    	
 
    	
X
    
	
177910001
    	
 
    	
Strain Relief
    	
 
    	
STRAIN RELIEF-CABLE
    	
 
    	
X
    	
 
    	
X
    
	
77850001
    	
 
    	
Cable
    	
 
    	
REEL-CABLE, TOP,8840
    	
 
    	
X
    	
 
    	
X
    
	
177851001
    	
 
    	
Cable
    	
 
    	
REEL-CABLE, BOTTOM,8840
    	
 
    	
X
    	
 
    	
X
    
	
149785001
    	
 
    	
Connector
    	
 
    	
HOUSING-CONNECTOR, 1.25MM
    	
 
    	
X
    	
 
    	
X
    
	
149786001
    	
 
    	
Connector
    	
 
    	
CONTACT-CONNECTOR, 1.25MM
    	
 
    	
X
    	
 
    	
X
    
	
170395002
    	
 
    	
Flex
    	
 
    	
CABLE-FLEX,PCB-TM,COPPER STRENGTH MEMBER,.025-.030.
    	
 
    	
X
    	
 
    	
X
    
	
177911001
    	
 
    	
Strain Relief
    	
 
    	
STRAIN RELIEF-REEL
    	
 
    	
X
    	
 
    	
X
    
	
161367001
    	
 
    	
Battery
    	
 
    	
BATTERY - LITHUIM, POLY-CARBONMONOFLUORIDE, 3 VOLT,   BR1225
    	
 
    	
X
    	
 
    	
X
    
	
177853001
    	
 
    	
Miscellaneous Component
    	
 
    	
RETAINER-CORD,8840
    	
 
    	
X
    	
 
    	
X
    
	
186034001
    	
 
    	
Label
    	
 
    	
COLOR CHIP-SLATE MEDIUM GRAY
    	
 
    	
X
    	
 
    	
X
    
	
177849001
    	
 
    	
Closure
    	
 
    	
HOUSING-TOP,TELEMETRY,8840
    	
 
    	
X
    	
 
    	
X
    
	
186034001
    	
 
    	
Label
    	
 
    	
COLOR CHIP-SLATE MEDIUM GRAY
    	
 
    	
X
    	
 
    	
X
    
	
220344001
    	
 
    	
Label
    	
 
    	
LABEL-TELEMETRY MODULE,8840
    	
 
    	
X
    	
 
    	
X
    
	
186034001
    	
 
    	
Label
    	
 
    	
COLOR CHIP-SLATE MEDIUM GRAY
    	
 
    	
X
    	
 
    	
X
    
	
110778002
    	
 
    	
Screw
    	
 
    	
SCREW-PCB,8840,#2-28X3/8
    	
 
    	
X
    	
 
    	
X
    
	
220371001
    	
 
    	
Label
    	
 
    	
LABEL-BATTERY COMPARTMENT,INSIDE,8840
    	
 
    	
X
    	
 
    	
X
    


 

33











 

8840 Physician Programmer

 

	
BOM Part
   Number
    	
 
    	
Item Type
    	
 
    	
Description
    	
 
    	
 
    	
 
    	
 
    
	
177836001
    	
 
    	
Cover
    	
 
    	
COVER-BATTERY,8840
    	
 
    	
X
    	
 
    	
X
    
	
186034001
    	
 
    	
Label
    	
 
    	
COLOR CHIP-SLATE MEDIUM GRAY
    	
 
    	
X
    	
 
    	
X
    
	
119000008
    	
 
    	
Bag
    	
 
    	
BAG-POLYETHYLENE,5WX12LGX.003THK
    	
 
    	
X
    	
 
    	
X
    
	
100477001
    	
 
    	
Film
    	
 
    	
FILM-POLYETHYLENE,LOW DENSITY DIMENSIONS PER PO
    	
 
    	
X
    	
 
    	
X
    
	
165145001
    	
 
    	
Tape
    	
 
    	
TAPE-SEALING,BOX,TRANSPARENT W=36MM
    	
 
    	
X
    	
 
    	
X
    
	
168836001
    	
 
    	
Oil
    	
 
    	
GREASE-PTFE
    	
 
    	
X
    	
 
    	
X
    
	
350209001
    	
 
    	
Miscellaneous Assembly
    	
 
    	
CARTON-SHELF,CORRUGATED,PHY PROGRAMMER,8840
    	
 
    	
X
    	
 
    	
X
    
	
101170101
    	
 
    	
Sheet
    	
 
    	
SHEET-FIBERBOARD CORR, SGL WALLMIN BURSTING   TEST=200LBS/SQ IN
    	
 
    	
X
    	
 
    	
X
    
	
161076001
    	
 
    	
Battery
    	
 
    	
BATTERY-ALKALINE MN,1.5V,2.7MAH@300MA,SIZE AA FLAT   CONTACT
    	
 
    	
X
    	
 
    	
X
    
	
198311001
    	
 
    	
Manual
    	
 
    	
MANUAL-PHYSICIAN,PROGRAMMER,PLATFORM,8840
    	
 
    	
X
    	
 
    	
X
    
	
182599001
    	
 
    	
Sheet
    	
 
    	
CARD-QUICK REFERENCE,PHYSICIAN PROGRAMMER,8840
    	
 
    	
X
    	
 
    	
X
    
	
170192001
    	
 
    	
Box
    	
 
    	
CASE-CARRYING,8840
    	
 
    	
X
    	
 
    	
X
    
	
220352001
    	
 
    	
Label
    	
 
    	
LABEL SET-GENERIC, OEM, EXTERNALS, 8840
    	
 
    	
X
    	
 
    	
X
    
	
170285001
    	
 
    	
Die Cutter
    	
 
    	
DIE CUT-LABEL SET, OEM-EXTERNALS, 8840
    	
 
    	
X
    	
 
    	
X
    
	
633708002
    	
 
    	
Firmware
    	
 
    	
FIRMWARE FORMAT, LABEL, SHIPPING, PROGRAMMER,   8840(DOMESTIC), Rx Only
    	
 
    	
X
    	
 
    	
X
    
	
165145001
    	
 
    	
Tape
    	
 
    	
TAPE-SEALING,BOX,TRANSPARENT W=36MM
    	
 
    	
X
    	
 
    	
X
    
	
198960001
    	
 
    	
Magnet
    	
 
    	
INSERT - PLACEMENT, PROGRAMMER AND MAGNET, 8840
    	
 
    	
X
    	
 
    	
X
    
	
Software
    	
 
    	
Drivers/base s/w
    	
 
    	
8840 Itrel 3 driver level source software and Itrel   3 application/source code.
    	
 
    	
X
    	
 
    	
X
    
	
Software DHR
    	
 
    	
Software DHF
    	
 
    	
8840 Itrel 3 driver and application DHR reference
    	
 
    	
X
    	
 
    	
X
    
	
Software Tools
    	
 
    	
S/W tools
    	
 
    	
Software tools sufficient to compile and build the   Itrel 3 drivers and application
    	
 
    	
X
    	
 
    	
X
    


 

4328 RTD Research Programmer (Inspire II Research Programmer)

 

	
BOM Part
   Number
    	
 
    	
Item
   Type
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg

with

MDT
    	
 
    	
Transfer

with
   Inspire,
   beyond
   MDT
   mfg
    
	
4328RTD
    	
 
    	
DMR
    	
 
    	
 
    	
 
    	
X
    	
 
    	
X
    


 

34











 

7432AE Physician Programmer/ 3052 Memmod (Inspire II Physician Programmer - very outdated)

 

	
BOM Part
   Number
    	
 
    	
Item
   Type
    	
 
    	
Description
    	
 
    	
License

for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with

Inspire,

beyond
   MDT
   mfg
    
	
4328RTD
    	
 
    	
DMR
    	
 
    	
 
    	
 
    	
X
    	
 
    	
X
    


 

3032 Patient Programmer DHF

 

	
Model No.
    	
 
    	
Document
   Number
    	
 
    	
Description
    	
 
    	
License

for use
   while

Mfg
   with
   MDT
    	
 
    	
Transfer

with
   Inspire,
   beyond
   MDT
   mfg
    
	
3032 DHF
    	
 
    	
 
    	
 
    	
Right of Reference to 3031 lnterstim Patient   Programmer
    	
 
    	
X
    	
 
    	
X
    


 

8840 Physician Programmer DHF

 

	
Model No.
    	
 
    	
Document
   Number
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT
   mfg
    
	
8840 DHF
    	
 
    	
 
    	
 
    	
Right of Reference to 8840 Physician Programmer
    	
 
    	
X
    	
 
    	
X
    
	
8840 DHF
    	
 
    	
 
    	
 
    	
Right of Reference to 8848 Physician Programmer   Software
    	
 
    	
X
    	
 
    	
X
    


 

4328 RTD Research Programmer DHF

 

	
Model No.
    	
 
    	
Document
   Number
    	
 
    	
Description
    	
 
    	
License
   for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT
   mfg
    
	
4328 RTD   Research Programmer DHF
    	
 
    	
 
    	
 
    	
 
    


 

35











 

7432AE Physician Programmer DHF

 

	
Model
   No.
    	
 
    	
Document
   Number
    	
 
    	
Description
    	
 
    	
License

for use
   while
   Mfg
   with
   MDT
    	
 
    	
Transfer
   with
   Inspire,
   beyond
   MDT
   mfg
    
	
3052
    	
 
    	
3052-3001
    	
 
    	
3052 Product Specification #083482-001, Rev A
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3029
    	
 
    	
3052 Memory Module Software Hazard List,   Analysis & Report
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3030
    	
 
    	
3052 Memmod Planning Phase Review Report
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3032
    	
 
    	
3052 Memmod Prototype Phase Review Report
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3054
    	
 
    	
3052 Memmod Concept Phase Review Report
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3169
    	
 
    	
UAS Model 3052 Memory Module & Model   2841 & 3024 IPG Software Development, Configuration Mgmt, &   Verification & Validation Plans
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3206
    	
 
    	
Release of Memmod Model 3052 Revision NDR03
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3209
    	
 
    	
Inspire I System for the Treatment of Obstructive   Sleep Apnea
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3225
    	
 
    	
3052 Version Description Document Software Specification   #217364-001, Rev B
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3314
    	
 
    	
Changes in the 3052 Memmod for Inspire II
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3315
    	
 
    	
3052 Memory Module Software Test Plan, Rev B
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3317
    	
 
    	
3052 Memmod Traceability Map, Rev B
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3361
    	
 
    	
Completion of Functional Testing Phase for 3052   Memmod
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3410
    	
 
    	
3052 Memmod Version Description Document Software   Specification #217364
    	
 
    	
X
    	
 
    	
X
    
	
3052
    	
 
    	
3052-3450
    	
 
    	
Model 3052 Version NDR05 Test Report
    	
 
    	
X
    	
 
    	
X
    


 

36









 

Exhibit D

 

Trademarks

 

- NONE -

 

37











 

PATENT ASSIGNMENT

 

WHEREAS, Medtronic, Inc. (“Assignor”), is the owner of the United States and foreign patents and patent applications identified on the attached Exhibit A; and

 

WHEREAS, Inspire Medical Systems, Inc. (“Assignee”), desires to acquire the entire right, title and interest in and to the United States and foreign patents and patent applications identified on the attached Exhibit A and in and to the inventions described and claimed therein (hereinafter “Patents”);

 

In exchange for good and valuable consideration, the receipt of which is hereby acknowledged, Assignor hereby assigns to Assignee all of Assignor’s right, title and interest in and to the Patents, and all rights to seek and collect damages and other relief for infringement of the Patents, and all proceeds thereof.

 

This Agreement may be executed in one or more counterparts, all of which shall be considered one and the same agreement. The signatures from each counterpart may be combined with a copy of the Agreement to constitute the entire Agreement.

 

	
 
    	
MEDTRONIC, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/
    
	
 
    	
Name:
    	
 
    
	
 
    	
Title:
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
STATE   OF
    	
)
    
	
 
    	
)   ss.
    
	
COUNTY   OF
    	
)
    


 

On this day of                  , 2007, before me, a notary public in and for said county, appeared                 of Medtronic, Inc., the person who signed this instrument, who acknowledged that he or she signed it as a :free act on behalf of said company with authority to do so.

 

38