Form 8-K Gi Dynamics, Inc.

Current report, items 5.02, 7.01, and 9.01

Published: 2019-09-20 09:25:40
Submitted: 2019-09-20
Period Ending In: 2019-09-19
d805170d8k.htm 8-K


> ENT> 8-K 1 d805170d8k.htm 8-K

8-K

 

 

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): September 19, 2019

 

 


GI DYNAMICS, INC.

(Exact name of registrant as specified in its charter)

 

 


 

Delaware   000-55195   84-1621425

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

P.O. Box 51915

Boston, MA 02205

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (781) 357-3300

(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 obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

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))

 

Title of each class

  

Trading

symbol(s)

  

Name of each exchange

on which registered

Common Stock, par value US$0.01    GID.ASX    Australia Securities Exchange

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  ☒

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 5.02

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

Amended and Restated Offer Letter Agreement for Chief Executive Officer

Effective as of September 16, 2019, on September 19, 2019, GI Dynamics, Inc. (the “Company”) entered into an amended and restated offer letter agreement (the “Amended and Restated Offer Letter Agreement”) with Scott Schorer, the Company’s Chief Executive Officer. Pursuant to the Amended and Restated Offer Letter Agreement, Mr. Schorer will receive a base salary at the annual rate of $450,000, payable in accordance with the Company’s standard payroll schedule, be eligible for an annual incentive bonus of up to 50% his annual salary, and stock options to purchase up to 1,169,545 shares of the Company’s common stock, par value $0.01 per share (the “Common Stock”), under the Company’s 2011 Employee, Director and Consultant Equity Incentive Plan (the “2011 Plan”), exercisable at a price equal to the closing price on the grant date. The stock options will vest over a four (4) year period, with one quarter (1/4) of the shares subject to the stock options vesting on the one (1) year anniversary of the grant date, and the remaining shares vesting on a quarterly basis over the following three (3) years of continuous service. In addition, Mr. Schorer will also receive a performance stock unit equal to 1,106,058 shares of Common Stock (the “PSU”), which is subject to the formal approval of the board of directors of the Company. The PSU will provide for the issuance of: (i) 250,000 shares subject to the PSU upon completion of enrollment in Stage 1 of the STEP-1 Clinical Trial in the U.S.; (ii) 428,029 of the shares subject to the PSU upon receipt of approval from the U.S. Food and Drug Administration (the “FDA”) to continue enrollment in the STEP-1 Clinical Trial after a successful Stage 1 safety review with the FDA; and (iii) 428,029 of the shares subject to the PSU upon attainment of $5,000,000 in cumulative amounts received from any of the following sources: (1) revenue measured in accordance with generally accepted accounting principles in the U.S.; (2) distributions to the Company from a joint venture to be formed with Apollo Sugar; and/or (3) transfer fee income from a joint venture to be formed with Apollo Sugar.

The Amended and Restated Offer Letter Agreement provides that if Mr. Schorer’s employment with the Company is terminated by the Company without Cause (as defined in the Amended and Restated Offer Letter Agreement) or by Mr. Schorer for Good Reason (as defined in the Amended and Restated Offer Letter Agreement), subject to his execution of a release of claims agreement acceptable to the Company and the application of the ASX Listing Rules and other applicable laws, he will be entitled to continuation of salary for up to 12 months, and payment of health insurance premiums necessary to continue health insurance coverage under COBRA for up to 12 months. In addition, Mr. Schorer may also be entitled to a pro-rata portion of the performance bonus then in effect.

In addition, if a Change of Control (as defined in the Amended and Restated Offer Letter Agreement) takes place, upon the consummation of such Change of Control, 100% of Mr. Schorer’s unvested stock options and PSUs will vest and become immediately exercisable.

The foregoing description of the Amended and Restated Offer Letter Agreement is qualified in its entirety by reference to the text of such agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.

Offer Letter Agreement for Chief Financial Officer

Effective as of September 16, 2019, on September 19, 2019, the Company entered into an offer letter agreement with, Charles Carter, the Company’s Chief Financial Officer (the “CFO Offer Letter Agreement”). Pursuant to the CFO Offer Letter Agreement, Mr. Carter will be employed by the Company on a full-time basis and will receive a base salary at the annual rate of $300,000, payable in accordance with the Company’s standard payroll schedule, be eligible for an annual incentive bonus of up to 35% his annual salary, and stock options to purchase up to 385,226 shares of Common Stock under the 2011 Plan, exercisable at a price equal to the closing price on the grant date. The stock options will vest over a four (4) year period, with one quarter (1/4) of the shares subject to the stock options vesting on the one (1) year anniversary of the grant date, and the remaining shares vesting on a quarterly basis over the following three (3) years of continuous service.



The Offer Letter Agreement provides that if Mr. Carter’s employment with the Company is terminated by the Company without Cause (as defined in the CFO Offer Letter Agreement) or by Mr. Carter for Good Reason (as defined in the CFO Offer Letter Agreement), subject to his execution of a release of claims agreement acceptable to the Company and the application of the ASX Listing Rules and other applicable laws, he will be entitled to continuation of salary for up to six months, and payment of health insurance premiums necessary to continue health insurance coverage under COBRA for up to six months. In addition, Mr. Carter may also be entitled to a pro-rata portion of the performance bonus then in effect.

In addition, if a Change of Control (as defined in the CFO Offer Letter Agreement) takes place, upon the consummation of such Change of Control, 100% of Mr. Carter’s unvested stock options will vest and become immediately exercisable.

Mr. Carter, 52, has served as the Company’s Chief Financial Officer and Secretary on a part-time consulting basis through Danforth Advisors, LLC (“Danforth”) since December 2018. Mr. Carter has served as a consulting senior finance executive for Marina Biotech (NASDAQ: MRNA), Interleukin Genetics (NASDAQ: ILGN) and numerous private life science companies. From 2015 to February 2018, Mr. Carter was CFO of The Guild for Human Services, a not-for-profit community-based residential school and program for special needs students and adults. Prior to the Guild, Mr. Carter consulted with Danforth from 2012 to 2015. Before joining Danforth, Mr. Carter held positions as CFO for Aeris Therapeutics, Inc., and Intelligent Medical Devices, Inc. and served various other companies as an independent consultant. From 2003 to 2005, Mr. Carter was Vice President of Finance for Adnexus Therapeutics, Inc., and from 2001 to 2003, he was Senior Director, Financial Planning and Analysis for Transkaryotic Therapies, Inc./Shire, PLC. (NASDAQ: TKT; NASDAQ: SHPG). Prior to TKT, Mr. Carter was a partner with Mercer Management Consulting, Inc. Mr. Carter holds an M.B.A. and an M.S. in Molecular Genetics from the University of Chicago and a B.A. in Biology from Colgate University.

There are no family relationships between Mr. Carter and any director or executive officer of the Company that are required to be disclosed pursuant to Item 401(d) of Regulation S-K. There are no related party transactions involving the Company that are required to be disclosed pursuant to Item 404(a) of Regulation S-K related to Mr. Carter.

The foregoing description of the CFO Offer Letter Agreement is qualified in its entirety by reference to the text of such agreement, which is filed as Exhibit 10.2 to this Current Report on Form 8-K and incorporated herein by reference.

 

Item 7.01

Regulation FD Disclosure.

On September 19, 2019, the Company made available an updated investor presentation on its website, which it may use from time to time in presentations to investors and other interested parties. The presentation is furnished herewith for the purposes of Regulation FD as Exhibit 99.1.

The information set forth in this Item 7.01, including Exhibit 99.1, is being furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly provided by specific reference in such a filing.

By filing this Current Report on Form 8-K and furnishing the information in this Item 7.01, the Company makes no admission as to the materiality of Item 7.01 in this report or the presentation attached hereto as Exhibit 99.1. The information contained in the presentation is summary information that is intended to be considered in the context of the Company’s filings with the Securities and Exchange Commission (the “SEC”) and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this Item, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.



The Company cautions you that the presentation attached hereto as Exhibit 99.1 contains forward-looking statements. These forward-looking statements are based on our management’s current estimates and expectations of future events as of the date of the date of the presentation and the announcement, respectively. Furthermore, the estimates are subject to several risks and uncertainties that could cause actual results to differ materially and adversely from those indicated in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with our ability to continue to operate as a going concern, our ability to maintain compliance with our obligations under the loan documents with Crystal Amber Fund Limited, obtaining and maintaining regulatory approvals required to market and sell our products; obtaining funding from third parties; the consequences of stopping the ENDO trial and the possibility that future clinical trials will not be successful or confirm earlier results; the timing and costs of clinical trials; the timing of regulatory submissions; the timing, receipt and maintenance of regulatory approvals; the timing and amount of other expenses; the timing and extent of third-party reimbursement; risks related to excess inventory; and risks related to assumptions regarding the size of the available market, the benefits of our products, product pricing, timing of product launches, future financial results and other factors, including those described in our filings with the SEC. Given these uncertainties, one should not place undue reliance on these forward-looking statements. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information or future events or otherwise, unless we are required to do so by law.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)

Exhibits

 

Exhibit
No.

  

Description

10.1    Amended and Restated Offer Letter Agreement, dated September 19, 2019, by and between Scott Schorer and the Company.
10.2    Offer Letter Agreement, dated September 19, 2019, by and between Charles Carter and the Company.
99.1    Presentation of the Company issued on September 19, 2019 (furnished herewith).


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 hereunto duly authorized.

 

 

GI DYNAMICS, INC.

Dated:  September 20, 2019

 

/s/ Charles Carter

 

Charles Carter

 

Chief Financial Officer


d805170dex101.htm EX-10.1


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EX-10.1

Exhibit 10.1    

 

LOGO

September 19, 2019

Scott Schorer

[Address]

 

  Re:

Amended and Restated Offer Letter Agreement

Dear Scott:

The purpose of this document (the “Amended and Restated Offer Letter Agreement”) is to amend and restate the offer letter agreement entered into on March 23, 2016, and later amended on January 30, 2017, between you and GI Dynamics, Inc. (the “Company”), in order to reflect negotiated and mutually acceptable new provisions pertaining to your continued employment with the Company. In consideration of the mutual covenants contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree to the following terms, effective as of September 16, 2019:

 

1.

Start Date; Term.  Your employment will continue until terminated by either party in accordance with Section 7 (such period of employment referred to herein as the “Term”).

 

2.

Title and Duties.  During the Term, you will serve as the Chief Executive Officer of the Company, reporting to the Board of Directors of the Company (the “Board”). You will devote your best efforts and full business time, skill and attention to the performance of your duties, subject to the direction of the Board. You will perform such executive, managerial, administrative and professional duties as are normally associated with those positions and customarily performed by those holding such offices at businesses similar to the Company. You will be expected to adhere to the written employment policies and practices of the Company that may be in effect from time to time, except that when the terms of this Amended and Restated Offer Letter conflict with the Company’s written employment policies or practices, this Amended and Restated Offer Letter will control. You will be expected to comply with the Company’s corporate governance policies and charters that may be in effect from time to time.

 

3.

Base Compensation.  You will be paid an annual base salary of four hundred fifty thousand dollars ($450,000) (the “Base Salary”), less applicable deductions and withholdings, to be paid each month in accordance with the Company’s payroll practices as may be in effect from time to time. Your total compensation will be reviewed by the Compensation Committee of the Board (the “Compensation Committee”) at least annually, and you will be entitled to such increases in Base Salary and/or Performance Bonus (as defined below) during your employment as will be recommended by the Compensation Committee and approved by the Board, in its sole discretion, taking into account your performance and that of the Company, and other factors considered relevant by the Board.

 

4.

Performance Bonus.  Each calendar year, you will be eligible to earn an annual incentive bonus of up to fifty percent (50%) of your annual Base Salary (the “Performance Bonus”). Whether you receive such a Performance Bonus, and the amount of any such Performance Bonus, will be determined by recommendations from the Compensation Committee and approval from the

 

GI Dynamics, Inc.    ●    320 Congress St    ●    Boston, Massachusetts    ●    02210



  Board, and will be based upon achievement of performance objectives to be provided to you by the Compensation Committee following initial recommendation of proposed objectives to you, discussion of such objectives with you, and consideration of your input regarding such objectives. The amount, if any, of such earned Performance Bonus will be paid to you within forty-five (45) days following the close of the calendar year to which it relates, and in no event later than March 15th of the calendar year immediately following the calendar year in which it was earned. You must be employed on the last day of the calendar year to which it relates in order to earn any Performance Bonus.

 

5.

Benefits.

 

  (a)

You will be eligible to participate in the Company’s standard benefit programs made available to senior executives, subject to the terms and conditions of such plans. The Company may, from time to time, change these benefits in its discretion. Additional information regarding these benefits is available for your review upon request.

 

  (b)

The Company will reimburse you for all normal, usual and necessary expenses incurred by you in furtherance of the business and affairs of the Company, including reasonable travel and entertainment, upon timely receipt by the Company of appropriate vouchers or other proof of your expenditures and in accordance with the Company’s policies with respect thereto as in effect from time to time. You must submit any request for reimbursement no later than thirty (30) days following the date that such business expense is incurred. All reimbursements provided under this Amended and Restated Offer Letter will be made or provided in accordance with the requirements of Section 409A of the Internal Revenue Code (“Code Section 409A”) including, where applicable, the requirement that (i) any reimbursement is for expenses incurred during your lifetime (or during a shorter period of time specified in this Amended and Restated Offer Letter); (ii) the amount of expenses eligible for reimbursement during a calendar year may not affect the expenses eligible for reimbursement in any other calendar year; (iii) the reimbursement of an eligible expense will be made no later than the last day of the calendar year following the year in which the expense is incurred; and (iv) the right to reimbursement or in kind benefits is not subject to liquidation or exchange for another benefit.

 

  (c)

You will, during each calendar year of your employment, be entitled to four (4) weeks of vacation, in addition to nationally recognized holidays.

 

6.

Equity.

 

  (a)

The Company will grant you an option (the “Option”) to purchase 1,169,545 shares of the Company’s common stock, at a per share exercise price equal to the Fair Market Value (as defined in the Company’s 2011 Employee, Director and Consultant Equity Incentive Plan (the “2011 Plan”)) of the Company’s common stock on the date of grant. The Option will vest over a four (4) year period, with one quarter (1/4) of the shares subject to the Option vesting on the one (1) year anniversary of the date of grant, and the remaining shares vesting on a quarterly basis over the following three (3) years of continuous service, provided that you are providing services to the Company as an employee or consultant on such vesting dates (no vesting will occur following the termination of employment or consulting services). The Option will be, to the

 

2



  maximum extent permissible, treated as an “incentive stock option” within the meaning of Section 422 of the Internal Revenue Code. The Option will be formally granted by the Board and will be evidenced in writing by, and subject to the terms and conditions of, the 2011 Plan and the Company’s standard form of stock option agreement, which agreement will expire ten (10) years from the date of grant except as otherwise provided in the stock option agreement or the Plan.

 

  (b)

The Company will grant you a performance stock unit (the “PSU”) in the Company equal to 1,106,058 shares of the Company’s common stock. The PSU will provide for the issuance of: (i) 250,000 shares subject to the PSU upon completion of enrollment in Stage 1 of the STEP-1 Clinical Trial in the U.S.; (ii) 428,029 of the shares subject to the PSU upon receipt of approval from the U.S. Food and Drug Administration (the “FDA”) to continue enrollment in the STEP-1 Clinical Trial after a successful Stage 1 safety review with the FDA; and (iii) 428,029 of the shares subject to the PSU upon attainment of $5,000,000 in cumulative amounts received from any of the following sources: (1) revenue measured in accordance with generally accepted accounting principles in the U.S.; (2) distributions to the Company from a joint venture to be formed with Apollo Sugar; and/or (3) transfer fee income from a joint venture to be formed with Apollo Sugar, provided that, in each case, you are providing services to the Company as an employee or consultant on such issuance date (no issuance will occur following the termination of employment or consulting services). If the PSU has not vested prior to 1 January, 2023 then the PSU will lapse on that date. The PSU will be formally granted by the Board and will be evidenced in writing by, and subject to the terms and conditions of, the 2011 Plan and the Company’s standard form of restricted stock unit agreement, which agreement will expire ten (10) years from the date of grant except as otherwise provided in the restricted stock unit agreement or the Plan. The PSU is intended to replace your current PSU for 250,000 shares (the “Existing PSU”). For the avoidance of doubt, the restricted stock unit agreement for the new PSU shall cancel the Existing PSU.

 

  (c)

As described in the applicable stock option or restricted stock unit agreement(s) and subject to the terms and conditions thereof, if there is a Change of Control (as defined in each such agreement) involving the Company, then one hundred percent (100%) of all of your unvested options and performance stock units will vest and become immediately exercisable as of the consummation of the Change of Control. The parties acknowledge and agree that to the extent that this Section 6(c) conflicts with any term of an option agreement or grant document listed above (including but not limited to any term of such option agreement or grant document that permits or requires that a termination without “Cause” or as a result of a “Good Reason” occur following a Change of Control in order for unvested options to become vested and fully exercisable) then the terms of this Section 6(c) will govern.

 

7.

Termination; Severance.  Your employment will continue during the Term until terminated in accordance with this Section 7. You and the Company each will be entitled to terminate your employment for any reason at any time, subject to the provisions of this Section 7.

 

  (a)

Termination for Cause; Resignation without Good Reason.  If, at any time, the Company terminates your employment for Cause (as defined herein), or you resign without Good Reason (as defined herein), subject to any restrictions contained in the

 

3



  Australian Stock Exchange Listing Rules or other applicable laws, you will receive your Base Salary accrued through your last day of employment, any unused vacation (if applicable) accrued through your last day of employment, and any properly incurred business expenses through your last day of employment that remain unreimbursed. Under these circumstances, you will not be entitled to any other form of compensation from the Company, including any severance benefits.

 

  (b)

Termination without Cause; Resignation for Good Reason; Death or Disability.  If your employment is terminated by the Company without Cause (as defined below) or by you for Good Reason (as defined below) or due to your death or Disability (as defined below) (collectively, such reasons for separation, an “Involuntary Termination”), then, subject to any restrictions contained in the Australian Stock Exchange Listing Rules or other applicable laws, in addition to the payments and benefits described in Section 7(a) (which you will receive irrespective of the reason for termination), and subject to the conditions set forth in Section 7(c), you will be entitled to receive the following severance benefits (collectively, the “Severance Benefits”):

 

  (i)

an amount equal to twelve (12) months of your then current Base Salary, less all applicable withholdings and deductions, paid over such twelve (12) month period on the schedule described below (the “Salary Continuation”); and

 

  (ii)

a pro-rata portion of your at-target Performance Bonus as then in effect for the calendar year in which the termination occurs, which, for the avoidance of doubt, shall be determined without regard to whether any performance objectives required to be satisfied for such calendar year have been achieved, adjusted based on the period worked by you during such calendar year prior to termination; and

 

  (iii)

if you timely elect continued coverage under COBRA for yourself and your covered dependents under the Company’s group health plans following the Involuntary Termination, then the Company will pay the COBRA premiums necessary to continue your health insurance coverage in effect for yourself and your eligible dependents on the termination date until the earliest of (A) the close of the twelve (12) month period following the termination of your employment, (B) the expiration of your eligibility for the continuation coverage under COBRA, or (C) the date when you become eligible for substantially equivalent health insurance coverage in connection with new employment or self-employment (such period from the termination date through the earliest of (A) through (C), the “COBRA Payment Period”).

Notwithstanding the foregoing, if the Company determines, in its sole but good faith discretion, that the payment of the above-described COBRA premiums could result in a violation of the nondiscrimination rules of Section 105(h)(2) of the Code or any statute or regulation of similar effect (including but not limited to the 2010 Patient Protection and Affordable Care Act, as amended by the 2010 Health Care and Education Reconciliation Act), then in lieu of providing the COBRA premiums, the

 

4



Company, in its sole discretion, may elect to instead pay you on the first day of each month of the COBRA Payment Period, a fully taxable cash payment equal to the COBRA premiums for that month, subject to applicable tax withholdings (such amount, the “Special Severance Payment”), for the remainder of the COBRA Payment Period. You may, but are not obligated to, use such Special Severance Payment toward the cost of COBRA premiums. On the sixtieth (60th) day following your Separation from Service, the Company will make the first payment under this clause equal to the aggregate amount of payments that the Company would have paid through such date had such payments commenced on the Separation from Service through such sixtieth (60th) day, with the balance of the payments paid thereafter on the schedule described above. If you become eligible for coverage under another employer’s group health plan or otherwise cease to be eligible for COBRA during the period provided in this clause, you must immediately notify the Company of such event, and all payments and obligations under this clause will cease.”

 

  (c)

Conditions to Receive Severance Benefits.  The Severance Benefits are conditional upon (i) your continuing to comply with your obligations under your Nondisclosure, Nonsolicitation and Noncompete Agreement; (ii) your delivering to the Company of an effective separation agreement and general release of claims in favor of the Company in a mutually acceptable form within sixty (60) days following your termination date; and (iii) your compliance with all reasonable requests for transition assistance from the Company. The Salary Continuation will be paid in equal installments on the Company’s regular payroll schedule over the applicable period following your termination date, and will be subject to applicable tax withholdings, provided that no payments will be made prior to the sixtieth (60th) day following your separation from service. On the 60th day following your separation from service, the Company will pay you in a lump sum the Salary Continuation and other Severance Benefits that you would have received on or prior to such date under the original schedule but for the delay while waiting for the 60th day in compliance with Code Section 409A and the effectiveness of the release, with the balance of the Salary Continuation and other Severance Benefits being paid as originally scheduled.

 

  (d)

Definition of Cause.  For purposes of this Amended and Restated Offer Letter, “Cause” will mean one or more of the following: (i) your willful failure or refusal to abide in all material respects by lawful directions received from the Board; (ii) your commission of any act of fraud, embezzlement or any other willful misconduct that has caused or is reasonably expected to result in material injury to the Company; (iii) your unauthorized use or disclosure of any proprietary information or trade secrets of the Company or any other party to whom you owe an obligation of nondisclosure as a result of your relationship with the Company; or (iv) your willful breach of any of your material obligations under any written agreement or written covenant with the Company. Cause will not exist under this Amended and Restated Offer Letter unless the Company gives written notice to you describing with particularity the alleged act(s) at issue. The foregoing definition does not in any way limit the Company’s ability to terminate your employment at any time.

 

5



  (e)

Definition of Good Reason.  For purposes of this Amended and Restated Offer Letter, “Good Reason” will mean your resignation from all positions you then hold with the Company based on an event described below, provided you give written notice of such event within ten (10) days after the first occurrence of such event and that you assert that grounds for a resignation for Good Reason exist as a result of such event, and provided such event is not corrected within thirty (30) days after the Company (or any successor thereto) receives written notice from you of: (A) a material reduction in your base compensation or target annual bonus eligibility (unless you are treated proportionately similarly to all other employees); (B) a change in your position with the Company that materially reduces your title, level of authority, responsibilities and/or duties; (C) a requirement that you relocate more than fifty (50) miles from the Company’s principal place of business; or (D) any material breach of this Amended and Restated Offer Letter by the Company.

 

  (f)

Definition of Disability.  For purposes of this Amended and Restated Offer Letter, “Disability” will mean your failure to perform your normal required services hereunder for a period of three (3) consecutive months during any calendar year by reason of your mental or physical disability, as determined by an independent physician reasonably satisfactory to you and the Company.

 

8.

Non-Competition; Confidentiality.  As a condition of employment hereunder, you will be required to sign and abide by the Company’s standard Nondisclosure, Nonsolicitation and Noncompete Agreement. By signing this Amended and Restated Offer Letter and accepting the consideration provided for herein, you expressly reaffirm your obligations under such Nondisclosure, Nonsolicitation and Noncompete Agreement.

 

9.

At-Will Employment.  Your employment with Company will be “at-will.” This means that either you or the Company may terminate your employment at any time, with or without Cause or Good Reason, and with or without advance notice. Notwithstanding the foregoing, you will be entitled to receive the Severance Benefits under this Agreement pursuant to the terms hereof.

 

10.

Code Section 409A.

 

  (a)

It is intended that all of the severance benefits and other payments payable under this Amended and Restated Offer Letter satisfy, to the greatest extent possible, the exemptions from the application of Code Section 409A provided under Treasury Regulations 1.409A-1(b)(4), 1.409A-1(b)(5) and 1.409A-1(b)(9), and this letter will be construed to the greatest extent possible as consistent with those provisions.

 

  (b)

Any termination of your employment triggering payment of benefits under Section 7 must constitute a “separation from service” under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h) before distribution of such benefits can commence. To the extent that the termination of your employment does not constitute a separation of service under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h) (as the result of further services that are reasonably anticipated to be provided by you to the Company at the time your employment terminates), any such payments under Section 7 that constitute deferred compensation under Code Section 409A will be delayed until after the date of a subsequent event constituting a separation of service under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h). For purposes of clarification, this section will not cause any forfeiture of benefits on your part, but will only act as a delay until such time as a “separation from service” occurs.

 

6



  (c)

For purposes of Code Section 409A (including, without limitation, for purposes of Treasury Regulation Section 1.409A-2(b)(2)(iii)), your right to receive any installment payments under this Amended and Restated Offer Letter (whether severance payments, reimbursements or otherwise) will be treated as a right to receive a series of separate payments and, accordingly, each installment payment hereunder will at all times be considered a separate and distinct payment. Notwithstanding any provision to the contrary in this Amended and Restated Offer Letter, if you are deemed by the Company at the time of your separation from service to be a “specified employee” for purposes of Code Section 409A(a)(2)(B)(i), and if any of the payments upon separation from service set forth herein and/or under any other agreement with the Company are deemed to be “deferred compensation,” then to the extent delayed commencement of any portion of such payments is required in order to avoid a prohibited distribution under Code Section 409A(a)(2)(B)(i) and the related adverse taxation under Code Section 409A, such payments will not be provided to you prior to the earliest of (i) the expiration of the six-month period measured from the date of your separation from service with the Company, (ii) the date of your death, or (iii) such earlier date as permitted under Code Section 409A without the imposition of adverse taxation. Upon the first business day following the expiration of such applicable Code Section 409A(a)(2)(B)(i) period, all payments deferred pursuant to this paragraph will be paid in a lump sum to you, and any remaining payments due will be paid as otherwise provided herein or in the applicable agreement. No interest will be due on any amounts so deferred.

 

  (d)

Notwithstanding any other provision herein to the contrary, in the event of any ambiguity in the terms of this Amended and Restated Offer Letter, such term(s) will be interpreted and at all times administered in a manner that avoids the inclusion of compensation in income under Code Section 409A, or the payment of increased taxes, excise taxes or other penalties under Code Section 409A.

 

  (e)

The parties intend all payments and benefits hereunder to be in compliance with Code Section 409A; however, you acknowledge and agree that the Company does not guarantee the tax treatment or tax consequences associated with any payment or benefit arising under this Amended and Restated Offer Letter, including but not limited to consequences related to Code Section 409A.

 

11.

Arbitration.  To ensure the rapid and economical resolution of disputes that may arise in connection with your employment with the Company, you and the Company agree that any and all disputes, claims, or causes of action, in law or equity, arising from or relating to the enforcement, breach, performance, or interpretation of this Amended and Restated Offer Letter, your employment with the Company, or the termination of your employment, will be resolved, to the fullest extent permitted by law, by final, binding and confidential arbitration in Boston, Massachusetts by JAMS, Inc. (“JAMS”) or its successor, under JAMS’ then applicable rules and procedures. You acknowledge that by agreeing to this arbitration procedure, both you and the Company waive the right to resolve any such dispute through a trial by jury or judge or administrative proceeding. You will have the right to be represented by legal counsel at any arbitration proceeding. The arbitrator will: (a) have the authority to compel adequate

 

7



  discovery for the resolution of the dispute and to award such relief as would otherwise be permitted by law; and (b) issue a written statement signed by the arbitrator regarding the disposition of each claim and the relief, if any, awarded as to each claim, the reasons for the award, and the arbitrator’s essential findings and conclusions on which the award is based. Each party will bear its own attorneys’ fees and litigation costs, except to the extent the underlying law upon which any claim is based provides for the award of attorneys’ fees, in which case such fees will be recoverable as provided by law. The arbitrator will be authorized to award all relief that you or the Company would be entitled to seek in a court of law, including, but not limited to, allocating in the arbitrator’s discretion, between the parties, all costs of the arbitration, including facility fees and the fees and expenses of the arbitrator and reasonable attorneys’ fees, costs and expert witness fees of the parties, if permitted by applicable law. Nothing in this Amended and Restated Offer Letter is intended to prevent either you or the Company from obtaining injunctive relief in court to prevent irreparable harm pending the conclusion of any such arbitration. The parties further agree that this Section 11 may be specifically enforced in court.

 

12.

Indemnification.  The Company acknowledges and agrees that you will be entitled to indemnification under the Company’s standard form of indemnification agreement.

 

13.

Notices.  Any notice to be given hereunder will be in writing and delivered or sent by certified mail, postage prepaid, return receipt requested, addressed to the party concerned at the address indicated below or at such other address as such party may subsequently be designated by like notice:

If to the Company:

320 Congress Street

3rd Floor

Boston, MA 02210

Attention: Chairman of the Board

With a copy to:

Mitchell Silberberg & Knupp LLP

437 Madison Avenue

25th Floor

New York, NY 10022

Attn: Melanie Figueroa

If to you:

Scott Schorer

[Address]

 

14.

Survivorship.  The respective rights and obligations of the parties hereunder will survive any termination of this Amended and Restated Offer Letter to the extent necessary to the intended preservation of such rights and obligations.

 

15.

Miscellaneous.  This Amended and Restated Offer Letter and the other agreements specifically mentioned herein are the complete and exclusive statement of all of the terms and conditions of your employment with the Company, and supersede and replace any and all prior agreements

 

8



  or representations with regard to the subject matter hereof and thereof, whether written or oral. This Amended and Restated Offer Letter is entered into without reliance on any promise or representation other than those expressly contained herein, and it cannot be modified, amended or extended except in a writing signed by you and a duly authorized member of the Board. This Amended and Restated Offer Letter is intended to bind and inure to the benefit of and be enforceable by you and the Company, and our respective successors, assigns, heirs, executors and administrators, except that you may not assign any of your duties or rights hereunder without the express written consent of the Company. Whenever possible, each provision of this Amended and Restated Offer Letter will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Amended and Restated Offer Letter is held to be invalid, illegal or unenforceable in any respect under any applicable law or rule in any jurisdiction, such invalidity, illegality or unenforceability will not affect any other provision or any other jurisdiction, but this Amended and Restated Offer Letter will be reformed, construed and enforced as if such invalid, illegal or unenforceable provisions had never been contained herein. This Amended and Restated Offer Letter and the terms of your employment with the Company will be governed in all aspects by the laws of the Commonwealth of Massachusetts.

[Signature Page Follows]

 

9



If the foregoing correctly sets forth our agreement and understanding, please indicate your acceptance of this offer by signing and returning to me a copy of this Amended and Restated Offer Letter.

 

Very truly yours,
GI DYNAMICS, INC.
By:    /s/ Daniel Moore

Daniel Moore

Chairman

 

Accepted and Agreed:
Name:    /s/Scott Schorer
  SCOTT SCHORER
Date:   September 19, 2019

 

10


d805170dex102.htm EX-10.2


> ENT> EX-10.2 3 d805170dex102.htm EX-10.2

EX-10.2

Exhibit 10.2    

 

LOGO

September 19, 2019

Charles R. Carter

[Address]

 

  Re:

Offer Letter Agreement

Dear Charles:

On behalf of GI Dynamics, Inc. (the “Company”) I am pleased to offer you employment with the Company on the terms and conditions set forth below.

 

1.

Start Date; Term.  Your full-time employment will commence on September 16, 2019 and will continue until terminated by either party in accordance with Section 7 (such period of employment referred to herein as the “Term”).

 

2.

Title and Duties.  During the Term, you will serve as the Chief Financial Officer of the Company, reporting to the Chief Executive Officer of the Company (the “CEO”). You will devote your best efforts and full business time, skill and attention to the performance of your duties, subject to the direction of the CEO. You will perform such executive, managerial, administrative and professional duties as are normally associated with those positions and customarily performed by those holding such offices at businesses similar to the Company. You will be expected to adhere to the written employment policies and practices of the Company that may be in effect from time to time, except that when the terms of this Offer Letter conflict with the Company’s written employment policies or practices, this Offer Letter will control. You will be expected to comply with the Company’s corporate governance policies and charters that may be in effect from time to time.

 

3.

Base Compensation.  You will be paid an annual base salary of three hundred thousand dollars ($300,000) (the “Base Salary”), less applicable deductions and withholdings, to be paid each month in accordance with the Company’s payroll practices as may be in effect from time to time. Your total compensation will be reviewed by the Compensation Committee of the Board of Directors (the “Compensation Committee”) at least annually, and you will be entitled to such increases in Base Salary and/or Performance Bonus (as defined below) during your employment as will be recommended by the Compensation Committee and approved by the Board of Directors, in its sole discretion, taking into account your performance and that of the Company, and other factors considered relevant by the Board of Directors.

 

4.

Performance Bonus.  Each calendar year, you will be eligible to earn an annual incentive bonus of up to thirty-five percent (35%) of your annual Base Salary (the “Performance Bonus”). Whether you receive such a Performance Bonus and the amount of any such Performance Bonus will be determined by recommendations from the Compensation Committee and approval from the Board of Directors, and will be based upon achievement of performance objectives to be provided to you by the Compensation Committee following initial recommendation of proposed objectives to you, discussion of such objectives with you, and

 

GI Dynamics, Inc.    ●    320 Congress St    ●    Boston, Massachusetts    ●    02210



  consideration of your input regarding such objectives. The amount, if any, of such earned Performance Bonus will be paid to you within forty five (45) days following the close of the calendar year to which it relates, and in no event later than March 15th of the calendar year immediately following the calendar year in which it was earned. You must be employed on the last day of the calendar year to which it relates in order to earn any Performance Bonus.

 

5.

Benefits.

 

  (a)

You will be eligible to participate in the Company’s standard benefit programs made available to senior executives, subject to the terms and conditions of such plans. The Company may, from time to time, change these benefits in its discretion. Additional information regarding these benefits is available for your review upon request.

 

  (b)

The Company will reimburse you for all normal, usual and necessary expenses incurred by you in furtherance of the business and affairs of the Company, including reasonable travel and entertainment, upon timely receipt by the Company of appropriate vouchers or other proof of your expenditures and in accordance with the Company’s policies with respect thereto as in effect from time to time. You must submit any request for reimbursement no later than thirty (30) days following the date that such business expense is incurred. All reimbursements provided under this Offer Letter will be made or provided in accordance with the requirements of Section 409A of the Internal Revenue Code (“Code Section 409A”) including, where applicable, the requirement that (i) any reimbursement is for expenses incurred during your lifetime (or during a shorter period of time specified in this Offer Letter); (ii) the amount of expenses eligible for reimbursement during a calendar year may not affect the expenses eligible for reimbursement in any other calendar year; (iii) the reimbursement of an eligible expense will be made no later than the last day of the calendar year following the year in which the expense is incurred; and (iv) the right to reimbursement or in kind benefits is not subject to liquidation or exchange for another benefit.

 

  (c)

You will, during each calendar year of your employment, be entitled to four (4) weeks of vacation, in addition to nationally recognized holidays.

 

6.

Equity.

 

  (a)

The Company will grant you an option (the “Option”) to purchase 385,226 shares of the Company’s common stock, at a per share exercise price equal to the Fair Market Value (as defined in the Company’s 2011 Employee, Director and Consultant Equity Incentive Plan (the “2011 Plan”)) of the Company’s common stock on the date of grant. The Option will vest over a four (4) year period, with one quarter (1/4) of the shares subject to the Option vesting on the one (1) year anniversary of the date of grant, and the remaining shares vesting on a quarterly basis over the following three (3) years of continuous service, provided that you are providing services to the Company as an employee or consultant on such vesting dates (no vesting will occur following the termination of employment or consulting services). The Option will be, to the maximum extent permissible, treated as an “incentive stock option” within the meaning of Section 422 of the Internal Revenue Code. The Option will be formally approved by the Board of Directors and will be evidenced in writing by, and subject to the terms and conditions of, the 2011 Plan and the Company’s standard form of stock option agreement, which agreement will expire ten (10) years from the date of grant except as otherwise provided in the stock option agreement or the Plan.

 

2



  (b)

As described in the applicable stock option agreement and subject to the terms and conditions thereof, if there is a Change of Control (as defined in each such agreement) involving the Company, then one hundred percent (100%) of all of your unvested options will vest and become immediately exercisable as of the consummation of the Change of Control. The parties acknowledge and agree that to the extent that this Section 6(b) conflicts with any term of an option agreement listed above (including but not limited to any term of such option agreement or grant document that permits or requires that a termination without “Cause” or as a result of a “Good Reason” occur following a Change of Control in order for unvested options to become vested and fully exercisable) then the terms of this Section 6(b) will govern.

 

7.

Termination; Severance.  Your employment will continue during the Term until terminated in accordance with this Section 7. You and the Company each will be entitled to terminate your employment for any reason at any time, subject to the provisions of this Section 7.

 

  (a)

Termination for Cause; Resignation without Good Reason.  If, at any time, the Company terminates your employment for Cause (as defined herein), or you resign without Good Reason (as defined herein), subject to any restrictions contained in the Australian Stock Exchange Listing Rules or other applicable laws, you will receive your Base Salary accrued through your last day of employment, any unused vacation (if applicable) accrued through your last day of employment, and any properly incurred business expenses through your last day of employment that remain unreimbursed. Under these circumstances, you will not be entitled to any other form of compensation from the Company, including any severance benefits.

 

  (b)

Termination without Cause; Resignation for Good Reason; Death or Disability.  If your employment is terminated by the Company without Cause (as defined below) or by you for Good Reason (as defined below) or due to your death or Disability (as defined below) (collectively, such reasons for separation, an “Involuntary Termination”), then, subject to any restrictions contained in the Australian Stock Exchange Listing Rules or other applicable laws, in addition to the payments and benefits described in Section 7(a) (which you will receive irrespective of the reason for termination), and subject to the conditions set forth in Section 7(c), you will be entitled to receive the following severance benefits (collectively, the “Severance Benefits”):

 

  (i)

an amount equal to six (6) months of your then current Base Salary, less all applicable withholdings and deductions, paid over such six (6) month period on the schedule described below (the “Salary Continuation”); and

 

  (ii)

a pro-rata portion of your at-target Performance Bonus as then in effect for the calendar year in which the termination occurs, which, for the avoidance of doubt, shall be determined without regard to whether any performance objectives required to be satisfied for such calendar year have been achieved, adjusted based on the period worked by you during such calendar year prior to termination; and

 

3



  (iii)

if you timely elect continued coverage under COBRA for yourself and your covered dependents under the Company’s group health plans following the Involuntary Termination, then the Company will pay the COBRA premiums necessary to continue your health insurance coverage in effect for yourself and your eligible dependents on the termination date until the earliest of (A) the close of the six (6) month period following the termination of your employment, (B) the expiration of your eligibility for the continuation coverage under COBRA, or (C) the date when you become eligible for substantially equivalent health insurance coverage in connection with new employment or self-employment (such period from the termination date through the earliest of (A) through (C), the “COBRA Payment Period”).

Notwithstanding the foregoing, if the Company determines, in its sole but good faith discretion, that the payment of the above-described COBRA premiums could result in a violation of the nondiscrimination rules of Section 105(h)(2) of the Code or any statute or regulation of similar effect (including but not limited to the 2010 Patient Protection and Affordable Care Act, as amended by the 2010 Health Care and Education Reconciliation Act), then in lieu of providing the COBRA premiums, the Company, in its sole discretion, may elect to instead pay you on the first day of each month of the COBRA Payment Period, a fully taxable cash payment equal to the COBRA premiums for that month, subject to applicable tax withholdings (such amount, the “Special Severance Payment”), for the remainder of the COBRA Payment Period. You may, but are not obligated to, use such Special Severance Payment toward the cost of COBRA premiums. On the sixtieth (60th) day following your Separation from Service, the Company will make the first payment under this clause equal to the aggregate amount of payments that the Company would have paid through such date had such payments commenced on the Separation from Service through such sixtieth (60th) day, with the balance of the payments paid thereafter on the schedule described above. If you become eligible for coverage under another employer’s group health plan or otherwise cease to be eligible for COBRA during the period provided in this clause, you must immediately notify the Company of such event, and all payments and obligations under this clause will cease.

 

  (c)

Conditions to Receive Severance Benefits.  The Severance Benefits are conditional upon (i) your continuing to comply with your obligations under your Nondisclosure, Nonsolicitation and Noncompete Agreement; (ii) your delivering to the Company of an effective separation agreement and general release of claims in favor of the Company in a mutually acceptable form within sixty (60) days following your termination date; and (iii) your compliance with all reasonable requests for transition assistance from the Company. The Salary Continuation will be paid in equal installments on the Company’s regular payroll schedule over the applicable period following your termination date, and will be subject to applicable tax withholdings, provided that no payments will be made prior to the sixtieth (60th) day following your separation from service. On the 60th day following your separation from service, the Company will pay you in a lump sum the Salary Continuation and other Severance Benefits that you would have received on or prior to such date under the original schedule but for the delay while waiting for the 60th day in compliance with Code Section 409A and the effectiveness of the release, with the balance of the Salary Continuation and other Severance Benefits being paid as originally scheduled.

 

4



  (d)

Definition of Cause.  For purposes of this Offer Letter, “Cause” will mean one or more of the following: (i) your willful failure or refusal to abide in all material respects by lawful directions received from the CEO; (ii) your commission of any act of fraud, embezzlement or any other willful misconduct that has caused or is reasonably expected to result in material injury to the Company; (iii) your unauthorized use or disclosure of any proprietary information or trade secrets of the Company or any other party to whom you owe an obligation of nondisclosure as a result of your relationship with the Company; or (iv) your willful breach of any of your material obligations under any written agreement or written covenant with the Company. Cause will not exist under this Offer Letter unless the Company gives written notice to you describing with particularity the alleged act(s) at issue. The foregoing definition does not in any way limit the Company’s ability to terminate your employment at any time.

 

  (e)

Definition of Good Reason.  For purposes of this Offer Letter, “Good Reason” will mean your resignation from all positions you then hold with the Company based on an event described below, provided you give written notice of such event within ten (10) days after the first occurrence of such event and that you assert that grounds for a resignation for Good Reason exist as a result of such event, and provided such event is not corrected within thirty (30) days after the Company (or any successor thereto) receives written notice from you of: (A) a material reduction in your base compensation or target annual bonus eligibility (unless you are treated proportionately similarly to all other employees); (B) a change in your position with the Company that materially reduces your title, level of authority, responsibilities and/or duties; (C) a requirement that you relocate more than fifty (50) miles from the Company’s principal place of business; or (D) any material breach of this Offer Letter by the Company.

 

  (f)

Definition of Disability.  For purposes of this Offer Letter, “Disability” will mean your failure to perform your normal required services hereunder for a period of three (3) consecutive months during any calendar year by reason of your mental or physical disability, as determined by an independent physician reasonably satisfactory to you and the Company.

 

8.

Non-Competition; Confidentiality.  As a condition of employment hereunder, you will be required to sign and abide by the Company’s standard Nondisclosure, Nonsolicitation and Noncompete Agreement. By signing this Offer Letter and accepting the consideration provided for herein, you expressly reaffirm your obligations under such Nondisclosure, Nonsolicitation and Noncompete Agreement.

 

9.

At-Will Employment.  Your employment with Company will be “at-will.” This means that either you or the Company may terminate your employment at any time, with or without Cause or Good Reason, and with or without advance notice. Notwithstanding the foregoing, you will be entitled to receive the Severance Benefits under this Agreement pursuant to the terms hereof.

 

5



10.

Code Section 409A.

 

  (a)

It is intended that all of the severance benefits and other payments payable under this Offer Letter satisfy, to the greatest extent possible, the exemptions from the application of Code Section 409A provided under Treasury Regulations 1.409A-1(b)(4), 1.409A-1(b)(5) and 1.409A-1(b)(9), and this letter will be construed to the greatest extent possible as consistent with those provisions.

 

  (b)

Any termination of your employment triggering payment of benefits under Section 7 must constitute a “separation from service” under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h) before distribution of such benefits can commence. To the extent that the termination of your employment does not constitute a separation of service under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h) (as the result of further services that are reasonably anticipated to be provided by you to the Company at the time your employment terminates), any such payments under Section 7 that constitute deferred compensation under Code Section 409A will be delayed until after the date of a subsequent event constituting a separation of service under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h). For purposes of clarification, this section will not cause any forfeiture of benefits on your part, but will only act as a delay until such time as a “separation from service” occurs.

 

  (c)

For purposes of Code Section 409A (including, without limitation, for purposes of Treasury Regulation Section 1.409A-2(b)(2)(iii)), your right to receive any installment payments under this Offer Letter (whether severance payments, reimbursements or otherwise) will be treated as a right to receive a series of separate payments and, accordingly, each installment payment hereunder will at all times be considered a separate and distinct payment. Notwithstanding any provision to the contrary in this Offer Letter, if you are deemed by the Company at the time of your separation from service to be a “specified employee” for purposes of Code Section 409A(a)(2)(B)(i), and if any of the payments upon separation from service set forth herein and/or under any other agreement with the Company are deemed to be “deferred compensation,” then to the extent delayed commencement of any portion of such payments is required in order to avoid a prohibited distribution under Code Section 409A(a)(2)(B)(i) and the related adverse taxation under Code Section 409A, such payments will not be provided to you prior to the earliest of (i) the expiration of the six-month period measured from the date of your separation from service with the Company, (ii) the date of your death, or (iii) such earlier date as permitted under Code Section 409A without the imposition of adverse taxation. Upon the first business day following the expiration of such applicable Code Section 409A(a)(2)(B)(i) period, all payments deferred pursuant to this paragraph will be paid in a lump sum to you, and any remaining payments due will be paid as otherwise provided herein or in the applicable agreement. No interest will be due on any amounts so deferred.

 

  (d)

Notwithstanding any other provision herein to the contrary, in the event of any ambiguity in the terms of this Offer Letter, such term(s) will be interpreted and at all times administered in a manner that avoids the inclusion of compensation in income under Code Section 409A, or the payment of increased taxes, excise taxes or other penalties under Code Section 409A.

 

  (e)

The parties intend all payments and benefits hereunder to be in compliance with Code Section 409A; however, you acknowledge and agree that the Company does not guarantee the tax treatment or tax consequences associated with any payment or benefit arising under this Offer Letter, including but not limited to consequences related to Code Section 409A.

 

6



11.

Arbitration.  To ensure the rapid and economical resolution of disputes that may arise in connection with your employment with the Company, you and the Company agree that any and all disputes, claims, or causes of action, in law or equity, arising from or relating to the enforcement, breach, performance, or interpretation of this Offer Letter, your employment with the Company, or the termination of your employment, will be resolved, to the fullest extent permitted by law, by final, binding and confidential arbitration in Boston, Massachusetts by JAMS, Inc. (“JAMS”) or its successor, under JAMS’ then applicable rules and procedures. You acknowledge that by agreeing to this arbitration procedure, both you and the Company waive the right to resolve any such dispute through a trial by jury or judge or administrative proceeding. You will have the right to be represented by legal counsel at any arbitration proceeding. The arbitrator will: (a) have the authority to compel adequate discovery for the resolution of the dispute and to award such relief as would otherwise be permitted by law; and (b) issue a written statement signed by the arbitrator regarding the disposition of each claim and the relief, if any, awarded as to each claim, the reasons for the award, and the arbitrator’s essential findings and conclusions on which the award is based. Each party will bear its own attorneys’ fees and litigation costs, except to the extent the underlying law upon which any claim is based provides for the award of attorneys’ fees, in which case such fees will be recoverable as provided by law. The arbitrator will be authorized to award all relief that you or the Company would be entitled to seek in a court of law, including, but not limited to, allocating in the arbitrator’s discretion, between the parties, all costs of the arbitration, including facility fees and the fees and expenses of the arbitrator and reasonable attorneys’ fees, costs and expert witness fees of the parties, if permitted by applicable law. Nothing in this Offer Letter is intended to prevent either you or the Company from obtaining injunctive relief in court to prevent irreparable harm pending the conclusion of any such arbitration. The parties further agree that this Section 11 may be specifically enforced in court.

 

12.

Indemnification.  The Company acknowledges and agrees that you will be entitled to indemnification under the Company’s standard form of indemnification agreement.

 

13.

Notices.  Any notice to be given hereunder will be in writing and delivered or sent by certified mail, postage prepaid, return receipt requested, addressed to the party concerned at the address indicated below or at such other address as such party may subsequently be designated by like notice:

If to the Company:

GI Dynamics, Inc.

745 Atlantic Avenue

Office No. 708

Boston, MA 02111

Attention: Chief Executive Officer

With a copy to:

Melanie Figueroa, Esq.

Mitchell Silberberg & Knupp LLP

437 Madison Avenue, 25th Floor

New York, NY 10022

 

7



If to you:

Charles R. Carter

[Address]

 

14.

Survivorship.  The respective rights and obligations of the parties hereunder will survive any termination of this Offer Letter to the extent necessary to the intended preservation of such rights and obligations.

 

15.

Miscellaneous.  This Offer Letter and the other agreements specifically mentioned herein are the complete and exclusive statement of all of the terms and conditions of your employment with the Company, and supersede and replace any and all prior agreements or representations with regard to the subject matter hereof and thereof, whether written or oral. This Offer Letter is entered into without reliance on any promise or representation other than those expressly contained herein, and it cannot be modified, amended or extended except in a writing signed by you and the CEO. This Offer Letter is intended to bind and inure to the benefit of and be enforceable by you and the Company, and our respective successors, assigns, heirs, executors and administrators, except that you may not assign any of your duties or rights hereunder without the express written consent of the Company. Whenever possible, each provision of this Offer Letter will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Offer Letter is held to be invalid, illegal or unenforceable in any respect under any applicable law or rule in any jurisdiction, such invalidity, illegality or unenforceability will not affect any other provision or any other jurisdiction, but this Offer Letter will be reformed, construed and enforced as if such invalid, illegal or unenforceable provisions had never been contained herein. This Offer Letter and the terms of your employment with the Company will be governed in all aspects by the laws of the Commonwealth of Massachusetts.

This offer is subject to satisfactory proof of your right to work in the United States and satisfactory completion of a Company-required background check. Please sign and date this Offer Letter, and the enclosed Nondisclosure, Nonsolicitation and Noncompete Agreement, if you wish to accept employment at the Company under the terms described above.

[Signature Page Follows]

 

8



If the foregoing correctly sets forth our agreement and understanding, please indicate your acceptance of this offer by signing and returning to me a copy of this Offer Letter.

 

Very truly yours,
GI DYNAMICS, INC.
By:    /s/Scott Schorer
 

Scott Schorer

Chief Executive Officer

 

Accepted and Agreed:
Name:    /s/ Charles R. Carter
  CHARLES R. CARTER
Date:   September 19, 2019

 

9


d805170dex991.htm EX-99.1


> ENT> EX-99.1 4 d805170dex991.htm EX-99.1

EX-99.1

Slide 1

Corporate Presentation Q3 2019 Exhibit 99.1


Slide 2

Important Notice EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. Currency References Financial amounts in this presentation are expressed in U.S. Dollars, except where specifically noted. Forward-Looking Statements This presentation may contain forward-looking statements. These statements are based on GI Dynamics management’s current estimates and expectations of future events as of the date of this announcement. Furthermore, the estimates are subject to several risks and uncertainties that could cause actual results to differ materially and adversely from those indicated in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with our ability to continue to operate as a going concern; our ability to obtain stockholder approval of the conversion feature of the August 2019 Note and issuance of the August 2019 Warrant, our ability to raise sufficient additional funds to continue operations and to conduct the planned pivotal trial of EndoBarrier in the United States (STEP-1); our ability to execute STEP-1 under FDA’s Investigational Device Exemption; our ability to enlist clinical trial sites and enroll patients in accordance with STEP-1; the risk that the FDA stops STEP-1 early as a result of the occurrence of certain safety events or does not approve an expansion of STEP-1; our ability to enroll patients in accordance with I-STEP; our ability to secure a CE Mark; our ability to maintain compliance with our obligations under our existing convertible note and warrant agreements executed with Crystal Amber, including our obligations to make payment on the Note that is due on 31 March 2020 and our ability to restructure the terms of the Note with Crystal Amber that is due on 31 March 2020 if we are unable to raise sufficient funds to enable us to fully repay such Note when due; obtaining and maintaining regulatory approvals required to market and sell our products; the possibility that future clinical trials will not be successful or confirm earlier results; the timing and costs of clinical trials; the timing of regulatory submissions; the timing, receipt and maintenance of regulatory approvals; the timing and amount of other expenses; the timing and extent of third-party reimbursement; intellectual-property risk; risks related to excess inventory; risks related to assumptions regarding the size of the available market; the benefits of our products; product pricing; timing of product launches; future financial results; and other factors, including those described in our filings with the U.S. Securities and Exchange Commission. Given these uncertainties, one should not place undue reliance on these forward-looking statements. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information or future events or otherwise, unless we are required to do so by law.


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Executive Summary EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. 380m people WW with diabetes, creating an economic cost of $2.5 Trillion by 2030 Obesity #1 risk factor for type 2 diabetes, both are risk factors for cardiovascular disease Weight loss procedures have significant complications incl. death, do not address diabetes PROBLEM TREATMENT GAP IN T2D & OBESITY FUNDRAISE Completed USD $10m raise LARGE MARKET OPPORTUNITY HIGH ROI POTENTIAL SOLUTION ENDOBARRIER® Minimally invasive, reversible, 20 minute procedure uniquely targeting intestinal mechanisms Demonstrated efficacy in lowering HbA1c, BMI, and insulin use in ~4,000 implants OUS FDA IDE and IRB approval for U.S. pivotal study – enrolling EndoBarrier potentially fills a major treatment gap, addressing global metabolic disorder pandemic High value to health systems in reducing significant costs of diabetes and related care High margin, scalable, single-use implant Complete Stage 1 of U.S. pivotal trial (STEP-1) – enrolling Initiate enrollment in I-STEP trial with Apollo Sugar in India à joint venture distribution with Apollo Achieve CE Mark and select re-commercialization in Europe & Middle East


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Diabetes: High & Growing Cost U.S. and Worldwide EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. CDC 2017: http://www.diabetes.org/assets/pdfs/basics/cdc-statistics-report-2017.pdf Global Diabetes Population in 2045 ‘03 ‘05 ‘07 ‘09 ‘11 ‘13 ‘15 ‘17 $500 B –––––––––––––––––––––––––––––––––– $1 TRILLION –––––––––––––––––––––––––––––– Rising Economic Costs of Diabetes $327 B $622 B $1.3 T $2.5 T 2017 2030 2017 2030 United States Worldwide 20m U.S. adults with T2D 61.3% with diabetes have BMI >30 15.6% have an HbA1C >9% Average medical expenditures for people with diagnosed diabetes ~ $13,700 per year. ~ $7,900 directly attributed to diabetes Average medical expenditures among people diagnosed with diabetes were about 2.3 times higher than expenditures for people without diabetes IDF Diabetes Atlas 8th Edition 2017 Country Reports 2017 National Diabetes Statistics Report Estimates of Diabetes & its Burden in the U.S.


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Type 2 Diabetes & Obesity Treatment Gap Treatment Gap SURGERY $30K Significant complications Mortality Not reversible 98% of eligible patients elect not to undergo the procedure Per Patient Costs (US) & Health Risks Obesity & Pre-diabetes MEDICATIONS $2.7K / YEAR 1 T2D + Obesity Treatment with Favorable Risk/Benefit Profile for Earlier Intervention All costs “up to” the amount shown and in USD Khan et al, Medical Care Expenditures for Individuals with Prediabetes, Population Health Management, Oct 2017. Economic Costs of Diabetes in the US 2017, American Diabetes Association KFF, Medicare Part D Spending on Insulin Increased 840 Percent Between 2007 and 2017 Doble et al, What are Real Costs of Bariatric Surgery?, Obesity Surgery, May 2017 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3889324/ $4K / YEAR 3 INSULIN 1) Avoid Insulin 2) Reduce/ Eliminate Insulin $6K / YEAR 2 TYPE 2 DIABETES MEDICATIONS Treatment Gap exists because despite concurrent medication usage including insulin for many Type 2 diabetics, <50% of patients achieve glycemic control5 4 3) Avoid gastric bypass


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EndoBarrier® Minimally Invasive Solution for Type 2 Diabetes EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. Thin, flexible EndoBarrier implant lines the proximal intestine: food bypasses duodenum + upper intestine EndoBarrier is removed after 12 months of treatment EndoBarrier placed and removed through a gastroscope in a 20 minute outpatient procedure


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EndoBarrier® Mechanism of Action Mimics Gastric Bypass EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. VAGUS NERVE GUT HORMONES Similar to Roux-en-Y Gastric Bypass (RYGB), EndoBarrier harnesses metabolic effects, utilizing the body’s own blood glucose control mechanisms*: Gut Hormones Neural Circuits Bile Acids Glucose Transport “Conclusions: Duodenal-Jejunal Bypass Liner (DJBL) improves glycemic control and insulin resistance in T2D patients with obesity. DJBL also appears to induce significant weight loss in this population. Additionally, changes in gut hormones suggest mechanisms similar to RYGB.” *Mechanism of Action currently under investigation


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Demonstrated Clinical Effect on HbA1c and Weight EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. PI Study Title Subjects Type Presented HbA1c Weight EB Control Benes The duodenal-jejunal bypass liner (EndoBarrier) for the treatment of type 2 diabetes mellitus in obese patients – efficacy and factors predicting optimal effects 45 24 RCT DDW 2016 ↓ 4.3% EWL: 15% Cinkajzlova   Circulating lipopolysaccharide and gut permeability in obese patients with type 2 diabetes: the influence of surgical and endoscopic interventions 15 15 (gastric) 10 (ctrl) RCT EASD 2017 ↓1.7% BMI: ↓ 3.7 Guenthert   Improvement in Glucose Metabolism After Bariatric Surgery: Comparison of Laparoscopic Roux-en-Y Gastric Bypass and Duodenal-Jejunal Bypass Liner 27 27 (RYGB) RCT DDW 2017 ↓1.7% BMI: ↓ 6.2 Holtmann Improvement of Liver and Glycemic Parameters After Duodenal-Jejunal Bypass Sleeve (DJBS) Insertion 20 10 RCT DDW 2017 n/a ↓11.3 kg Jirapinyo The effect of the duodenal-jejunal bypass liner on glycemic control in type-2 diabetic patients with obesity: a meta-analysis with secondary analysis on weight loss and hormonal changes 431 54 Meta-Analysis DDW 2017 Diabetes Care 2018 ↓1.3% (↓1.4%) ↓12.6kg EWL: 36.9% TWL: 18.9% Ryder, Sen Gupta REVISE-Diabesity Study: One Year Efficacy, Safety and Tolerability Outcomes of Endoscopic Duodenal Exclusion Using EndoBarrier® as an Adjunct to GLP-1 48 24 RCT ADA 2017 ↓2.1% ↓11.3 kg Laubner Comparative Efficacy & Safety of the Duodenal-jejunal Bypass Liner in Obese Patients with T2DM 111 222 Case Control ADA 2017 ↓1.3% ↓14.7kg Endpoint Change # Studies # Patients HbA1c reduction at explant 1.3%* (15.5%) 14 431 Reduction v Control 0.9%* (10.8%) 4 123 HbA1c reduction 6 months post explant 1.0%* (11.9%) 2 99 Total body weight reduction 12.6kg (18.9%) 10 395 ADA Diabetes Care: EndoBarrier Meta-Analysis * absolute %-point drop in A1Cs > 1,000 patients in recent trials / analyses


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EndoBarrier® Positive Patient Impact* EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. “Patients included here are typical of our EndoBarrier treated patients, with some demonstrating additional benefits over and above weight and HbA1c.” – Dr. Robert Ryder, PI for EndoBarrier® Trials Sandwell and West Birmingham, UK Hospital NHS Trust • View online: ABCD REVISE Study ~4,000 EndoBarrier Implants Begin Treatment Post Removal (30 mos.) Begin Treatment Post Removal (30 mos.) Begin Treatment Post Removal (42 mos.) Insulin 42 units daily No Insulin Needed ALT = 86 U/L (Fatty liver) ALT = 11 U/L (Normal) Insulin 260 units daily No Insulin Needed A1c ↓2.1% A1c ↓6.4% A1c ↓2.6% Watch Video: Patient Testimonials *OUS patients and data shown


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Strong Safety Profile, Improving with Time & Experience EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. EndoBarrier adverse event rates have declined significantly over time due to numerous refinements, including clinician training and patient selection EndoBarrier risk is associated with implanted time only; no long-term sequelae or risks have been identified post removal In August 2018, FDA approved IDE for the U.S. pivotal study Implant totals by period: n=600 n=2,672 n=514 30 day SAE rate for RYGB = 5%, incl. death2 In February 2019, IRB approval received for U.S. pivotal study 2. Aterbern et al, Comparative Effectiveness and Safety of Bariatric Procedures for Weight Loss: A PCORnet Cohort Study, Annals of Internal Medicine, 4 December 2018 1. GI Dynamics, Inc. Internal Complaint Handling System OUS data


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U.S. Pivotal Study Design & Target Timeline EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. Property of GI Dynamics, Inc. Primary Endpoint Reduction of HbA1c at 12 month implant removal Secondary Endpoints Weight, HOMA-IR, NAFLD / NASH, CV risk, CKD, Insulin avoidance (at 12 & 24 months) Randomization 3 EndoBarrier : 1 Control Control Double-blinded sham procedure Stages Stage 1: 50 EndoBarrier / ~17 control Stage 2: 130 EndoBarrier / ~43 control U.S. Pivotal Trial, STEP-1: Single Therapy Euglycemic Procedure 2020 Q1 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q2 Q3 Q4 2019 Site Selection complete – IRB Approval – Stage 1 Enrollment Start – Stage 1 Enrollment End – Stage 1 Safety Review – Stage 2 Approval – Stage 2 Enrollment Start – Stage 1 Implants Removed – 2021 Q1 Q2 Q3 Q4 IDE Approval–


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Apollo Sugar Clinical Trial and Planned Partnership EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. Apollo Sugar Study in Collaboration with GI Dynamics: I-STEP India Single Therapy Euglycemic Procedure Primary Endpoint Reduction in HbA1c at 12 month implant removal Secondary Endpoints Weight, HOMA-IR, NAFLD / NASH, CV risk, Insulin avoidance Study Size 100 at 5 leading Apollo Sugar clinical sites Randomization 3 EndoBarrier : 1 Control GI Dynamics Cost ~$1-1.5 m over life of study Apollo HospitalsLargest private hospital system in India, >65m patients in 141 countries Apollo SugarApollo Hospitals & Sanofi partnership focused on treatment of diabetes “We believe EndoBarrier can provide a novel and powerful clinical tool for our clinicians, and we look forward to studying EndoBarrier in our hospitals for patients based in India and Southeast Asia.” – Gagan Bhalla, CEO of Apollo Sugar Enrollment Start – Enrollment End – Implants Removed – Trial Data Apollo Sugar Partnership – 2020 Q1 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q2 Q3 Q4 2019 2021 Q1 Q2 Q3 Q4


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Anticipated Commercial Milestones and Estimated Revenue EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. I-STEP Start - CE Mark - India CE Mark I-STEP Trial Data - India Commercialization w/Apollo Sugar JV Select EU/ME country commercialization (UK, Germany, Saudi Arabia, UAE, Qatar) CDSCO Submission / Approval 2019 2020 2021 2022 2023 2024 2025 Combined peak sales in these markets could exceed $2.4 billion by 2029 With successful completion of Stage 1 of U.S. pivotal trial and near-term revenue, liquidity options could materialize within 5 years US FDA Submission STEP-1 Stage 1 Safety Review - STEP-1 Stage 2 US Commercialization PMA


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Scientific Advisory Board EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. Gastroenterology Manoel Galvao Neto, MD Sao Paulo, Brazil Thomas Rösch, MD Hamburg, Germany Gerald Holtmann, MD Brisbane, Australia David Cummings, MD Seattle, WA, USA Carel le Roux, MD, PhD Dublin, Ireland Endocrinology Judith Korner, MD New York, NY USA Ricardo Cohen, MD Sao Paulo, Brazil Jan Willem Greve, MD, PhD Heerlen, Netherlands Francesco Rubino, MD London, UK Philip Schauer, MD Cleveland, OH USA Metabolic Surgery Allon Friedman, MD Indianapolis, IN USA Infectious Disease Steven Opal, MD Providence, RI USA Renal Disorders


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Experienced Leadership – Healthcare, Operations, M&A EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. Janell Shields – Manager Marketing & I.R. Steve Linhares – VP of Clinical & Regulatory Scott Schorer– President & CEO Charley Carter – Chief Financial Officer Paul Pelletier – Director of Quality Scott Schorer President & CEO 20+ years as executive in medical device, biologics, healthcare IT companies Significant early-stage, new product experience Raised >$120m through private equity, public equity and debt financings Systagenix Wound Management; IST; CentriMed/Global Healthcare Exchange (GHX) US Army, Airborne Ranger Executive Dan Moore Chairman Juliet Thompson Oern Stuge, MD Tim Barberich 20+ years experience healthcare banking Nomura Code: Founder, Head Corporate Finance: executed >150 life sciences transactions, including 40 IPOs raising more than €4bn NED: Nexstim (NXTMH.HE), Novacyt (NYCT.L), Vectura PLC (VEC.L) 40+ years in medical device and pharmaceutical companies Sepracor: Founder & CEO (NASDAQ: SEPR) Sold to Dainippon for $2.6Bn NED: BioNevia, Verastem (NASDAQ: VSTM), TScan Therapeutics, Frequency Therapeutics Physician with 30+ years in medical device, health care and life sciences companies Medtronic: 12 years in multiple senior management roles NED: Lumenis, Mainstay Medical (MSTY.PA), Balt Extrusion, Pulmonx, Phagenesis, OrthoD Ltd, EchoSens SA 30+ years in medical device companies Boston Scientific: 18 years in domestic and inter-national sales, operations and executive management in global medical device manufacturing. Served as CEO of Cyberonics, Inc. NED: LivaNova (NASDAQ: LIVN), ViewRay (NASDAQ: VRAY), Epilepsy Foundation of America, BioHouston, Weldon School of Bio-engineering, BrainScope Non Executive Directors Leadership Team Over 90 years experience in medical devices


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US Intellectual Property 76 issued and pending U.S. and non-U.S. patents 38 issued U.S. patents and maintain 7 pending U.S. patent applications OUS Intellectual Property 10 issued patents in the European Patent Convention region (including Germany and the United Kingdom) 5 pending PCT applications and 15 pending foreign patent applications across Europe, China, Hong Kong, India, and Israel. Coverage Our patents and patent applications cover, but are not limited to, the following areas: Implant: Liner and anchor Systems: Delivery and removal systems Device placement Treatment alternatives Our current issued patents expire between 2023 and 2031 Pending applications – if/when issued – expire 2039 - 2041 Expanded Intellectual Property Portfolio EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc.


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Corporate Lines of Effort EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. Stage 1: 50 EndoBarrier / ~17 Control (3:1) Clinical systems ready, IRB: approval by WIRB & Brigham & Women’s, 5 clinical sites qualified Currently enrolling Target enrollment completion: Q1 2020 STEP-1 Clinical Trial US Pivotal RCT Additional CE Mark I-STEP Clinical Trial India Pivotal RCT with Apollo Sugar 100: 75 EndoBarrier / 25 Control (3:1) IRB, CDSCO reviews underway Target enrollment initiation: Q4 2019 Target enrollment completion: Q2 2020 Technical File and Quality Management System:Preparing for audit Notified Body activities: Scheduling inspections Target completion: Q1 2020 Market access / revenue preparation: reimbursement in Europe, pricing optimization Intellectual Property: continuing to develop IP and add to IP portfolio Financing US$10m investment: Warrant Conversion: US$5.4m / Potential new Note: US$4.6m Cash out projection: first half March 2020 ASX listing maintained


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Conclusion EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. Turnaround efforts have largely been completed with much success New leadership has shown consistent execution while maintaining lean expenditures FDA approved Stage 1 of U.S. pivotal trial: STEP-1 Partnership with Apollo Sugar to further study EndoBarrier in India: I-STEP Unique implant with a well characterized Benefit : Risk Profile with significant clinician support Company is laser-focused on execution of clinical trials and CE Mark efforts Committed current investors Company history and current pricing provide significant upside opportunity Entire team fully committed to treating patients diagnosed with type 2 diabetes/obesity, bringing EndoBarrier to market while maximizing shareholder value


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EndoBarrier is not approved for sale and is limited by federal law to investigational use only; Property of GI Dynamics, Inc. Thank you

Additional Files
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0001193125-19-250158.txt   Complete submission text file   8692772
$MRNA $ILGN $TKT $SHPG $SEPR $VSTM $LIVN $VRAY

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