UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K/A
(Amendment No.1)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended: December 31, 2017
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _____________ to _____________
Commission File No. 000-52545
Wize Pharma, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 88-0445167 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
24 Hanagar Street, Hod Hasharon, Israel, 4527708
(Address of principal executive offices)
Issuer’s telephone number: +972 (72) 260-0536
Securities Registered pursuant to Section 12(b) of the Act: None
Securities Registered pursuant to Section 12(g) of the Exchange Act: Common Stock, $0.001 Par Value
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.
Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes ☒ No ☐
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer: ☐ | Accelerated filer: ☐ |
Non-accelerated filer: ☐ | Smaller reporting company: ☒ |
(Do not check if a smaller reporting company) | 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 ☒
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).
Yes ☐ No ☒
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant was $945,458 computed by reference to the average bid and asked price of the Common Stock as of the last business day of the registrant’s most recently completed second fiscal quarter.
As of June 5, 2018, there were 5,069,095 shares of the registrant’s Common Stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE: NONE
EXPLANATORY NOTE
This Amendment No. 1 on Form 10-K/A (this “Amendment”) to Wize Pharma, Inc.’s (the “Company,” “we” or “our”) Annual Report on Form 10-K (the “Initial Form 10-K”), for the year ended December 31, 2017, originally filed with the Securities and Exchange Commission (the “SEC”), on March 29, 2018 (SEC File No. 000-52545), is being filed solely for the purpose of including an updated version of Exhibit 10.44 which now includes an unredacted Section 1.6 of such exhibit and a partially redacted Section 1.7 of such exhibit which were previously fully omitted in the exhibit filed with the Initial Form 10-K.
This Amendment does not reflect events occurring after the filing of the Initial Form 10-K or modify or update the disclosures contained in the Initial Form 10-K in any way other than as discussed above. In connection with the filing of this Amendment and pursuant to the rules of the SEC, we are including with this Amendment certain new certifications by our principal executive officer and principal financial officer.
We hereby amend and restate Item 15(b) of the Initial Form 10-K as follows:
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES.
(b) Exhibits
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2
3
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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.
Wize Pharma, Inc. | ||
Date: June 5, 2018 | By: | /s/ Or Eisenberg |
Or Eisenberg Acting Chief Executive Officer, Chief Financial Officer, Treasurer and Secretary (Principal Executive Officer, Principal Financial and Accounting Officer) |
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
NAME | TITLE | DATE | ||
/s/ Or Eisenberg | Acting Chief Executive Officer, Chief Financial Officer, | June 5, 2018 | ||
Or Eisenberg | Treasurer and Secretary (Principal Executive Officer, Principal Financial and Accounting Officer) | |||
/s/ Ron Mayron | Chairman of the Board | June 5, 2018 | ||
Ron Mayron | ||||
/s/ Yossi Keret | Director | June 5, 2018 | ||
Yossi Keret | ||||
/s/ Franck Amouyal | Director | June 5, 2018 | ||
Franck Amouyal | ||||
/s/ Joseph Zarzewsky | Director | June 5, 2018 | ||
Joseph Zarzewsky | ||||
/s/ Michael Belkin | Director | June 5, 2018 | ||
Michael Belkin |
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Exhibit 10.44
CONFIDENTIAL TREATMENT
[***] DENOTES OMISSIONS
Memorandum Of Understandings
This memorandum of understanding (this " MOU ") is entered this January 8, 2018 and is intended to reflect our mutual agreement concerning the contemplated assignment of distribution rights and a license from Resdevco Research and Development Ltd. (Private Company 510422223, hereinafter " Resdevco ") to Wize Pharma Ltd. of Hanagr 5b Hod Hasharon, Israel (“ Wize ”).
In this document the following terms will have the meaning corresponding to them as follows:
“ Product ” shall mean Resdevco’s LO2A unit dose Eye Drops and all indications relating thereto, as described in Appendix C of the Agreement.
“ Current Territories ” shall mean Switzerland, Germany, Holland, Israel, Ukraine and the USA.
“ Additional Territories ” shall mean all territories other than Current Territories, excluding the People’s Republic of China
“ Net Sales ” shall mean the income actually received by Wize from sales of the Product from the first fully independent market organization in a sales chain to consumers, less commissions paid (by Wize) to third parties in connection with the production and sale of the Product.
The business understandings which we have reached are as follows:
1. | Worldwide License |
1.1 | The existing license agreement between the parties, including without limitation that certain Exclusive Distribution and Licensing Agreement dated May 1, 2015 between the parties attached hereto as Appendix A (the “License Agreement”) shall continue to be in full force and effect, and its continuing effect shall be a condition precedent to the effect of the undertakings in this MOU, and to the continuing effect of all agreements entered thereunder. |
1.2 | Resdevco will grant Wize an exclusive license to sell and distribute the Product in Additional Territories - in return for royalties as set forth in Appendix B enclosed hereto for the Term of this Agreement. The license set forth herein shall not cover Current Territories (“ License ”). |
1.3 | The License granted to Wize shall be conditioned, in each Additional Territory, on reaching minimum sales targets within the time frame stipulated for each such Additional Territory, in a specific license agreement which will need to be signed per each new Additional Territory, based on the general terms and conditions set forth herein, and as setforth in Appendix B enclosed hereto. |
1.4 | In every Additional Territory in which the Products shall be sold - Resdevco shall be entitled to a minimum per Product as per the formula detailed in APPENDIX B, payable jointly and severally from Wize and the distributor appointed by it, and the agreement with each distributor, agent, or reseller of whatever form or structure, in each Additional Territory - shall require Resdevco's prior written approval for above said territory. Subject to compliance with obligations stipulated in Appendix B, Resdevco’s prior written approval shall not be unreasonably withheld. |
1.5 | The License hereunder will be granted for 5 years, and shall be automatically renewed for each additional term of 5 years, subject to full compliance with the terms herein, and the continuing effect of the License Agreement. |
1.6 | If Resdevco introduces to Wize a distributor in any new Additional Territory, Wize will negotiate in good faith the terms of a distribution agreement with such distributor, on terms and conditions customary with other distributors, and subject always to the requirement for minimum targets and milestones as described in 1.2 above. |
1.7 | If Wize fails to reach an agreement with a distributor which has been introduced by Resdevco within [***] months, Resdevco, at its sole discretion, may grant Wize another period of [***] months to reach an agreement with said distributor or to conclude an agreement with such distributor directly. In case Wize fails to conclude an agreement as stated above and an agreement is reached with said distributors directly by Resdevco, Wize will abide by its terms and will provide the distributor and Resdevco with the services provided in other cases (where the distributor was engaged by Wize). For these services under this Section 1.6 Wize will be entitled to the lower of $[***] per 30 unit dose box, or [***]% of royalties Resdevco will receive from Products sold to such distributor in said territory. |
Wize being entitled to such sharing in the royalty shall be conditioned on Wize providing such services to the distributor, and on Wize fulfilling the conditions outlined in Appendix A hereof (referred to in section 1.9 hereunder), provided Resdevco signs an agreement with said introduced distributor.
2 |
1.8 | Regardless of the party that initiated or finalized the deal with the distributor, Wize will be responsible for overseeing the registration process and enabling the relationship between the distributor and the Manufacturer in a timely manner and Wize shall use best efforts to enable the distribution of the Product |
[***]
The existing engagements of distributors in Current Territories shall continue to be in place, and shall continue to be managed by Resdevco. The Parties will act to maintain business continuity in the Current Territories.
The License Agreement shall be assigned to Wize Pharma Ltd, and shall inure to the benefit of the parties hereof. The distribution agreement between the parties for Israel, Ukraine and China shall remain in place.
Wize may assign this agreement to a third party providing Resdevco a written prior written notice and guaranteeing the compliance of such assignee with the terms thereof. Such assignment shall require the prior written consent of Resdevco given in good faith, and not to be unreasonably withheld.
2. | Additional Terms and Conditions |
The term of this MOU is in effect until a definitive agreement is signed in respect of the subject matter hereof. The parties are committed and will do their utmost effort to complete such a definitive agreement within three months.
If Wize becomes insolvent, is dissolved or liquidated, makes a general assignment for the benefit of its creditors, files or has filed against it a petition which is not reversed within 60 days of filing thereof, or institution of voluntary proceedings in bankruptcy, liquidation, dismantling – all its rights under this MOU and all agreements entered subject thereto shall terminate and be of no force and effect.
Resdevco may freely assign and transfer its rights under this agreement or any of the agreements related therein to third parties.
Neither Party hereto shall be liable for non-fulfillment of its obligations or for any failure or delay caused by force majeure, provided such force majeure occurrence shall immediately be notified to the other party. So far as reasonable the activities held up by force majeure shall be taken up as soon as adequately possible after the respective cause no longer prevails. In the event of any delay resulting from such causes, the time for performance under this Agreement shall be extended on a day to day basis.
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Except as required by applicable law, none of the parties hereto (nor any of their respective affiliates, officers, directors, associates, shareholders, advisors, agents or representatives) shall issue any press release or make any other public disclosure relating to, or connected with, this letter or the matters contained herein (including, without limitation, the fact that this letter has been executed or that the negotiations contemplated hereby have commenced) without obtaining the prior approval of the other party, except for the disclosure by each of the parties hereto of this letter to its officers, directors and advisors on a need-to-know basis provided such parties keep this letter and its content confidential, or as may be required under law, including without limitation any regulated reporting requirements of Wize. Each party hereto agrees to maintain the confidentiality of this MOU and the transactions contemplated hereby. This provision shall be binding on the parties, whether definitive agreements are entered or not.
This MOU shall be governed by, and construed in accordance with, the laws of the State of Israel, and without regard to its conflict of law provisions. The place
of any legal proceedings is Jerusalem, Israel
Any legal action or proceeding with respect to any of the obligations arising under or relating to this MOU will be brought to the competent courts in Jerusalem which shall have an exclusive jurisdiction in respect thereof.
No reliance may be made on the agreement reflected herein by any person, including the parties hereof, and no liability or rescission or change in the terms hereof shall be assumed by either party.
Confirmed and agreed as of the date first set forth above.
Wize Pharma Ltd. | Resdevco Ltd. | ||||
By | /s/ Or Eisenberg | By | /s/ Prof. S. Dikstein | ||
Name: | Or Eisenberg | Name: | Prof. S. Dikstein | ||
Title: | CFO & Acting CEO | Title: | CEO |
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Appendix A
Commitments by Wize Pharma
Wize is committed to completing two double-blind clinical trials, according to a Protocol prepared under the supervision of Wize and applicable Ethics Committee (IRB) Approvals and other regulatory approvals, as may be required. The duration of the clinical trial will be dependent on the number of participants recruited. Wize shall extend best efforts to recruit the required number of patients in the designated timeframe, but if recruitment is low, the parties will extend the time frame for completion of the clinical trials accordingly.
The first will test the efficacy of the Product for treating Conjunctivochalasis
The Second will test the efficacy of the Product for treating Sjogren’s Syndrome Dry Eyes
Both the above clinical trials should be completed by [***].
Wize is committed to complete the Pre-IND process vis a vis the FDA for the the indications: “treating Conjunctivochalasis” and/or the indication “treating Sjogren’s Syndrome Dry Eyes”, as per regulatory specialist recommendations, and receive the said recommendations and plan by [***]
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Appendix B
The royalties for sales in Additional Territories and in the USA will be the higher of $[***] or [***]% from Net Sales for the duration of the local distribution agreement signed separately with each local distributor.
Minimum annual sales target formula is [***].
If it is less than $[***] per year, then the minimum sales target is prorated by the GDP.
[***]
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Appendix C
PRODUCT description and formula
1. Unit dose or any other future dose or packaging eye drops to treat dry eye and/or Conjunctivochalasis currently sold in Hungary as Conheal ® (in Germany as Hylan ® ) The product is currently manufactured by PharmaStulln GmbH in Germany and by Excel Vision in France currently sold in Switzerland as Lacrycon ® . In the future, the Product may be produced by another contract manufacturer approved by Resdevco.
3. The expenses involving the box design for the Territory are paid by LICENSEE.
4. As far as RESDEVCO knows the ex factory= ex works price of Conheal ® (containing 2x5x3 =30 unit dose) is [***] euro.
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Exhibit 31.1
Certification
I, Or Eisenberg, certify that:
1. | I have reviewed this amendment no. 1 to the Annual Report on Form 10-K of Wize Pharma, Inc. for the year ended December 31, 2017; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: June 5, 2018
/s/ Or Eisenberg | |
Or Eisenberg,
Acting Chief Executive Officer |
|
(Principal Executive Officer) |
Exhibit 31.2
Certification
I, Or Eisenberg, certify that:
1. | I have reviewed this amendment no. 1 to the Annual Report on Form 10-K of Wize Pharma, Inc. for the year ended December 31, 2017; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: June 5, 2018
/s/ Or Eisenberg | |
Or Eisenberg,
Chief Financial Officer |
|
(Principal Financial and Accounting Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the amendment no. 1 to the Annual Report of Wize Pharma, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2017, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned principal executive officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (“SOX”), that:
(1) | the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"); and |
(2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
This certification accompanies the Report pursuant to Section 906 of SOX and shall not, except to the extent required by such Act, be deemed filed by the Company for purposes of Section 18 of the Exchange Act. Such certification will not be deemed to be incorporated by reference into any filling under the Securities Act of 1993, as amended, or the Exchange Act, except to the extent that the Company specifically incorporates it by reference.
A signed original of this written statement required by Rule 13a-14(b) or 15d-14(b) of the Exchange Act and Section 906 of SOX has been provided by the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
Date: June 5, 2018
/s/ Or Eisenberg | |
Or Eisenberg,
Acting Chief Executive Officer |
|
(Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the amendment no. 1 to the Annual Report of Wize Pharma, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2017, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned principal financial and accounting officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (“SOX”), that:
(1) | the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"); and |
(2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
This certification accompanies this Report pursuant to Section 906 of SOX and shall not, except to the extent required by such Act, be deemed filed by the Company for purposes of Section 18 of the Exchange Act. Such certification will not be deemed to be incorporated by reference into any filling under the Securities Act of 1993, as amended, or the Exchange Act, except to the extent that the Company specifically incorporates it by reference.
A signed original of this written statement required by Rule 13a-14(b) or 15d-14(b) of the Exchange Act and Section 906 of SOX has been provided by the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
Date: June 5, 2018
/s/ Or Eisenberg | |
Or Eisenberg,
Chief Financial Officer |
|
(Principal Financial and Accounting Officer) |