UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 19 , 2017
Nuvectra Corporation
(Exact Name of Registrant as Specified in its Charter)
Delaware |
001-37525 |
30-0513847 |
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
5830 Granite Parkway, Suite 1100,
Plano, Texas 75024
(Address of principal executive offices, including zip code)
(214) 474-3103
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 1.01 |
Entry into a Material Definitive Agreement . |
Effective June 19, 2017, Nuvectra Corporation (“Nuvectra”) entered into a Second Amendment to the Development Agreement (the “Amendment”) with Aleva Neurotherapeutics, S.A., a Swiss share company (“Aleva”) to amend the Development Agreement between Aleva and Nuvectra, dated January 29, 2016 (the “Development Agreement”). Under the terms of the Amendment, Aleva and Nuvectra agreed to modify the payment schedule and the timing of certain payments as set forth on Exhibit A of the Development Agreement and that any additional work performed by Nuvectra will be paid on a monthly basis.
The foregoing description is not complete and is qualified in its entirety by reference to the full text of the Amendment to the Development Agreement, which is filed as Exhibit 10.1 to this Current Report and incorporated by reference into this Item 1.01.
Item 9.01 |
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Financial Statements and Exhibits. |
(d) Exhibits.
10.1 |
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Amendment to the Development Agreement, dated June 19, 2017, between Nuvectra Corporation and Aleva Neurotherapeutics SA. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
June 21, 2017 |
NUVECTRA CORPORATION |
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By: /s/ Walter Z. Berger |
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Name: Walter Z. Berger |
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Title: Chief Operating Officer and Chief Financial Officer |
Exhibit 10.1
SECOND AMENDMENT TO THE
DEVELOPMENT AGREEMENT
This Second Amendment (the “Amendment No. 2”) dated as of June 19, 2017 (the “Amendment Effective Date”) to the Development Agreement, is by and between Nuvectra Corporation (f/k/a QIG Group, LLC), located at 5830 Granite Parkway, Suite 1100, Plano, TX 75223 (“Nuvectra”), and Aleva Neurotherapeutics S.A., located at EPFL Innovation Park, Building D, 1015 Lausanne, Switzerland (“Aleva”).
WHEREAS, Nuvectra and Aleva previously have entered into a Development Agreement dated as of January 29, 2016, which was amended on March 30, 2017 (as amended, the “Development Agreement”);
WHEREAS, the Project Plan (as defined in the Development Agreement) which is attached to the Development Agreement as its Exhibit A and is a full part thereto contains, among other elements, a payment schedule;
WHEREAS, according to Section 1.9 of the Development Agreement, the Project Plan may be modified by the parties in writing;
WHEREAS, the parties, i.e., Aleva and Nuvectra, hereby agree to amend the Project Plan initially agreed in the Development Agreement.
NOW, THEREFORE , the parties hereto agree as follows:
ARTICLE 1
Amendment to the Project Plan
1.1 |
The Project Plan attached to this Amendment No. 2 as its Exhibit A fully cancels and supersedes the Project Plan attached to the Development Agreement as its Exhibit A. |
1.2 |
Aleva agrees that as of the Amendment Effective Date, Nuvectra has completed all work and deliverables due to Aleva that were required to be completed by the Amendment Effective Date. The parties further agree that Nuvectra has no obligation to complete any further work or deliverables under the Project Plan until it receives payment in accordance with the payment schedule set forth on Exhibit A, as amended and attached hereto. |
ARTICLE 2
Other Provisions of the Development Agreement
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2.1 |
For the sake of clarity, all provisions and exhibits of the Development Agreement other than the one replaced by the above Article 1.1 to this Amendment No. 2 (i.e., Exhibit A) remain unchanged. |
[ Remainder of page left intentionally blank .]
IN WITNESS WHEREOF, each of the parties has caused this Amendment No. 2 dated as of March 30, 2017 to the Development Agreement to be executed below in the manner appropriate to each.
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Nuvectra Corporation
By: /s/ Scott F Drees
Name: Scott F. Drees
Title: CEO
Aleva Neurotherapeutics S.A.
By: /s/ Andre Mercanzini
Name: Andre Mercanzini
Title: CTO |
EXHIBIT A
PRO DUCTS AND PROJECT PLAN
DEVICES OF THE ALEVA directSTIM NEUROSTIMULATION MEDICAL DEVICE
The Aleva directSTIM Deep Brain Stimulation System to be developed by Nuvectra is a rechargeable, 24-channel, deep brain stimulation system for the treatment of Movement Disorders (i.e. Parkinson’s Disease and/or Essential Tremor). The main devices of the Aleva directSTIM Deep Brain Stimulation System include the following:
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Rechargeable, 24-channel implantable pulse generator (IPG or Stimulator) in one main configuration |
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2 ports x 12 independent channels (2 leads, each with 12-electrodes) |
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Extensions in 1x12 configuration and lengths |
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Clinician programmer (CP) |
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Programmer charger (PPC) |
Work Package, Products and Deliverables :
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Design Changes to Clinician and Patient Programmer Software |
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Changes to Extension Cable Design for a low-profile 12 contact extension |
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Material for Design Verification and Testing of DBS System (12 implantable IPGs, 12 EPGs, 100 12-contact extension cables, and other testing material as required) |
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Material for European Clinical Study in 2017 (IPG, 12 contact Extensions, Tunneling tool, Patient Programmer; for 60 patients) |
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Regulatory Guidance and Consulting for CE-Mark Submission and FDA IDE submission |
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Post-Market FDA regulatory preparation consulting |
Fees :
Aleva will pay $6,000,000 for the services provided by Nuvectra under this Agreement in accordance with the Payment Schedule set forth below.
Payment Schedule :
1. |
On the Effective Date - Payment of $500,000 |
2. |
2/15/16 – Payment of $500,000 |
3. |
6/30/16 – Payment of $1,500,000 |
4. |
3/31/17 – Payment of $750,000 |
5. |
6/21/2017 – Payment of $132,167 |
6. |
6/30/2017 – Payment of $243,035 |
7. |
9/30/17 – Payment of $2,374,798 |
Aleva agrees that in addition to the above payments, it will pay Nuvectra monthly for all work completed and billed by Nuvectra up to and through September 30, 2017.
Project Plan :
Nuvectra and Aleva will work together in good faith to promptly finalize the Project Plan in writing after the Effective Date.