As filed with the Securities and Exchange Commission on February 5, 2019.
Registration No. 333-229155​
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No. 2 to
Form F-1
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
Anchiano Therapeutics Ltd.
(Exact Name of Registrant as Specified in its Charter)
Not Applicable
(Translation of Registrant’s Name to English)
State of Israel
2834
Not Applicable
(State or Other Jurisdiction of
Incorporation or Organization)
(Primary Standard Industrial
Classification Code Number)
(I.R.S. Employer Identification No.)
Anchiano Therapeutics Ltd.
1/3 High-Tech Village, Givat Ram, P.O. Box 39264
Jerusalem, 9139102 Israel
+972 (2) 548-6555
(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)
Anchiano Therapeutics, Inc.
One Kendall Square, Building 600, Suite 6-106
Cambridge, MA 02139
+1 (857) 259-4622
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
Anna T. Pinedo
Mayer Brown LLP
1221 Avenue of the Americas
New York, NY 10020-1001
Tel: (212) 506-2500
Aaron M. Lampert
Goldfarb Seligman & Co.
98 Yigal Alon Street
Tel Aviv 6789141, Israel
Tel: +972 (3) 608-9999
Ivan K. Blumenthal
Cliff M. Silverman
Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo, P.C.
Chrysler Center, 666 Third Avenue
New York, NY 10017
Tel: (212) 935-3000
Oded Har-Even
Shy S. Baranov
Zysman, Aharoni, Gayer & Co.
41-45 Rothschild Boulevard
Tel Aviv 6578401, Israel
Tel: +972 (3) 795-5555
Approximate date of commencement of proposed sale to the public: As soon as practicable after effectiveness of this registration statement.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☐
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933. ☒
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, 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 7(a)(2)(B) of the Securities Act. ☐

The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
CALCULATION OF REGISTRATION FEE
Title of each class of securities to be registered
Proposed maximum aggregate
offering price (1)(2)(3)
Amount of
registration fee (4)
Ordinary shares, no par value, as represented by American Depositary Shares
$ 40,213,200 $ 4,873.84
(1)
Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended.
(2)
Includes shares granted pursuant to the underwriters’ over-allotment option.
(3)
American Depositary Shares, or ADSs, issuable upon deposit of ordinary shares registered hereby will be registered under a separate registration statement on Form F-6. Each ADS represents five (5) ordinary shares.
(4)
Previously paid.
The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission acting pursuant to said Section 8(a), may determine.

EXPLANATORY NOTE
This Amendment No. 2 to the Registration Statement on Form F-1 is being filed for the sole purpose of filing additional exhibits to the Registration Statement. Accordingly, this amendment consists only of the facing page, this explanatory note and Part II of the Registration Statement. No changes are being made hereby to the Prospectus constituting Part I of the Registration Statement (not included herein) or to Items 6, 7 or 9 of Part II of the Registration Statement.

PART II

Information Not Required in Prospectus
Item 6.   Indemnification of Office Holders (including Directors).
Under the Companies Law, a company may not exculpate an office holder from liability for a breach of a fiduciary duty. An Israeli company may exculpate an office holder in advance from liability to the company, in whole or in part, for damages caused to the company as a result of a breach of duty of care but only if a provision authorizing such exculpation is included in its articles of association. Our articles of association include such a provision. The company may not exculpate in advance a director from liability arising out of a prohibited dividend or distribution to shareholders. We also do not exculpate our directors in advance from liability for damages caused to the company as a result of a breach of duty of care in connection with a transaction in which a controlling shareholder or any office holder has a personal interest.
Under the Companies Law, the Securities Law, 5728-1968 (the “Securities Law”) and the Restrictive Trade Practices Law, 5748-1988 (the “Antitrust Law”), a company may indemnify an office holder in respect of the following liabilities, payments and expenses incurred for acts performed by him or her as an office holder, either in advance of an event or following an event, provided its articles of association include a provision authorizing such indemnification:

a monetary liability incurred by or imposed on the office holder in favor of another person pursuant to a court judgment, including pursuant to a settlement confirmed as judgment or arbitrator’s decision approved by a competent court. However, if an undertaking to indemnify an office holder with respect to such liability is provided in advance, then such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen based on the company’s activities when the undertaking to indemnify is given, and to an amount or according to criteria determined by the board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned foreseen events and amount or criteria;

reasonable litigation expenses, including reasonable attorneys’ fees, which were incurred by the office holder as a result of an investigation or proceeding filed against the office holder by an authority authorized to conduct such investigation or proceeding, provided that such investigation or proceeding was either (i) concluded without the filing of an indictment against such office holder and without the imposition on him of any monetary obligation in lieu of a criminal proceeding; (ii) concluded without the filing of an indictment against the office holder but with the imposition of a monetary obligation on the office holder in lieu of criminal proceedings for an offense that does not require proof of criminal intent; or (iii) in connection with a monetary sanction;

a monetary liability imposed on the office holder in favor of all the injured parties by the breach in an Administrative Proceeding (as defined below) as set forth in Section 52(54)(a)(1)(a) to the Securities Law;

expenses expended by the office holder with respect to an Administrative Proceeding under the Securities Law, including reasonable litigation expenses and reasonable attorneys’ fees;

reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or which were imposed on the office holder by a court (i) in a proceeding instituted against him or her by the company, on its behalf, or by a third party, or (ii) in connection with criminal indictment of which the office holder was acquitted, or (iii) in a criminal indictment which the office holder was convicted of an offense that does not require proof of criminal intent;

financial liability imposed on the office holder on behalf of all the victims of the breach in an Administrative Proceeding;

expenses incurred by an office holder in connection with a proceeding conducted with respect to the office holder under the Antitrust Law, including reasonable attorneys’ fees and other litigation expenses; and
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any other obligation or expense in respect of which it is permitted or will be permitted under applicable law to indemnify an office holder, including, without limitation, matters referenced in Section 56H(b)(1) of the Securities Law.
An “Administrative Proceeding” is defined as a proceeding pursuant to chapters H3 (Monetary Sanction by the Israel Securities Authority), H4 (Administrative Enforcement Proceedings of the Administrative Enforcement Committee) or I1 (Arrangement to Conditionally Prevent Proceedings or Suspend Proceedings) of the Securities Law.

Under the Companies Law, the Securities Law and the Antitrust Law, a company may insure an office holder against the following liabilities incurred for acts performed by him or her as an office holder if and to the extent provided in the company’s articles of association:

a breach of the duty of loyalty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company;

a breach of duty of care to the company or to a third party, to the extent such a breach arises out of the negligent conduct of the office holder;

a monetary liability imposed on the office holder in favor of a third party;

a monetary liability imposed on the office holder in favor of an injured party in certain Administrative Proceedings under the Securities Law, including reasonable attorneys’ fees and other litigation expenses;

expenses incurred by an office holder in connection with an Administrative Proceeding, including reasonable attorneys’ fees and other litigation expenses; and

monetary liability imposed on the office holder in proceedings under or in connection with the Antitrust Law, including reasonable attorneys’ fees and other litigation expenses.
Under the Companies Law, a company may not indemnify, exculpate or insure an office holder against any of the following:

a breach of the duty of loyalty, except for indemnification and insurance for a breach of the duty of loyalty to the company to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company;

a breach of duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder;

an act or omission committed with intent to derive illegal personal benefit; or

a fine or forfeit levied against the office holder.
Under the Companies Law, exculpation, indemnification and insurance of office holders in a public company must be approved by the compensation committee and the board of directors and, with respect to directors or controlling shareholders, their relatives and third parties in which such controlling shareholders have a personal interest, also by the shareholders.
Our articles of association permit us to insure our office holders to the fullest extent permitted or to be permitted by law. Our office holders are currently covered by a directors’ and officers’ liability insurance policy. As of the date of this prospectus, no claims for directors’ and officers’ liability insurance have been filed under this policy and we are not aware of any pending or threatened litigation or proceeding involving any of our office holders, including our directors, in which indemnification is sought.
We have entered into agreements with each of our current office holders undertaking to indemnify them to the fullest extent permitted by law, subject to limited exceptions, including, with respect to liabilities resulting from this offering, to the extent that these liabilities are not covered by insurance. This indemnification is limited as follows: the maximum aggregate amount of indemnification that may be paid by the Company to all office holders entitled to indemnification, whether in advance or after the event, with
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respect to all indemnification undertakings by the Company to officer holders (including indemnification undertakings to office holders of companies held by the Company), if and to the extent that it grants them, based on the grounds specified above, shall not exceed the Maximum Indemnification Amount (defined below).
The term “Maximum Indemnification Amount” shall have the following meaning, which shall be determined on the date that any payment is made by virtue of an indemnification undertaking: (a) NIS 2.0 million ($0.5 million), if the Company’s shareholders’ equity is less than NIS 32.0 million ($8.75 million) (including if the Company’s shareholders’ equity is negative) and the Company’s working capital is negative; (b) NIS 8.0 million ($2.3 million), if the Company’s shareholders’ equity is less than NIS 32.0 million ($8.75 million) (including if the Company’s shareholders’ equity is negative) and the Company’s working capital is positive; or (c) 25% of the Company’s shareholders’ equity but in any event no more than NIS 40.0 million ($11.0 million), if the Company’s shareholders’ equity is NIS 32.0 million ($8.75 million) or more. Such indemnification amounts are in addition to any insurance amounts. However, in the opinion of the SEC, indemnification of office holders for liabilities arising under the Securities Act is against public policy and therefore unenforceable.
There is no pending litigation or proceeding against any of our office holders as to which indemnification is being sought, nor are we aware of any pending or threatened litigation that may result in claims for indemnification by any office holder.
Item 7.   Recent Sales of Unregistered Securities.
During the past three years, we issued securities which were not registered under the Securities Act as set forth below. We believe that each of such issuances was exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act, Rule 701 and/or Regulation S under the Securities Act.
The following is a summary of transactions during the preceding three years involving sales of our securities that were not registered under the Securities Act (all share numbers reflect the 1-for-10 reverse stock split effected in June 2018):

In June 2016, we issued 202,805 ordinary shares to the public in Israel pursuant to a rights offering to shareholders registered under the Israel Securities Law, 5728-1968, raising gross proceeds of approximately $5.3 million. Offering expenses were approximately $39 thousand.

Pursuant to a share purchase agreement, in October 2016 we issued 2,307,692 ordinary shares in a private placement to two investors, Palisade Medical Equity I, L.P. and Patata Beroa LLC, in return for an aggregate investment of  $6.0 million. Offering expenses were approximately $0.8 million.

In April 2017, we issued 2,213,430 ordinary shares to the public pursuant to a prospectus registered under the Israel Securities Law, 5728-1968, raising gross proceeds of approximately $5.7 million. Offering expenses were approximately $0.8 million.

Pursuant to a Securities Purchase Agreement between us and the investors identified therein (Shavit Capital Fund III (US), L.P., Shavit Capital Fund 3 (Israel), L.P., Shavit Capital Fund IV (US), L.P., Shavit Capital Fund 4 (Israel), L.P., Clal Biotechnology Industries Ltd., Meitav Dash Ltd., Sherfam Inc., Capital Point Ltd., ARC Group Holdings LLC, Tachlit Indices Ltd., James Tanenbaum, Anna Pinedo, Frank Haluska, Do-Tsach Ltd., Marc Joseph Irrevocable Trust, Collace Services Ltd., Neil Cohen, Harry Grynberg, Josh Weintraub, Gabriel Menaged, Gil Sudai, Adam Frieman, Gary Leibler, Erez Yuval, Roni Rosenheimer and David Frohmann), in June 2018 we issued 5,960,787 ordinary shares, and warrants to purchase an additional 4,768,629 shares. The gross proceeds from the sale of the shares amounted to $22.9 million. The warrants can be exercised for ordinary shares at an NIS-denominated price of NIS 16.20 per share (approximately $4.32 per share as of January 1, 2019); if all of the warrants are exercised, this would result in aggregate gross proceeds to us of approximately $20.6 million. Offering expenses were approximately $1.0 million.
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From January 1, 2016 through January 1, 2019, we granted share options to employees, directors and consultants under our stock option plans to purchase an aggregate of 2,531,633 shares, with exercise prices ranging from approximately $2.40 to $4.00 per share, of which, as of the date of this registration statement, options to purchase 140,000 shares have been forfeited or expired and cancelled without being exercised.
Other than as described above, no underwriter or underwriting discount or commission was involved in any of the transactions set forth in Item 7.
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Item 8.   Exhibits and Financial Statement Schedules.
Exhibit No.
Description
Form of Underwriting Agreement
Articles of Association of the Registrant (previously filed as Exhibit 3.1 of amendment no. 1 to our registration statement on Form F-1 (File No. 333-229155) as filed with the SEC on January 31, 2019 and incorporated by reference herein)
 3.2#*
Amended and Restated Articles of Association of the Registrant
Form of Deposit Agreement between the registrant, the Bank of New York Mellon as Depositary, and owners and holders from time to time of ADSs issued thereunder
Specimen American Depositary Receipt (included in Exhibit 4.1)
Specimen Certificate for ordinary shares (previously filed as Exhibit 4.3 of our registration statement on Form F-1 (File No. 333-229155) as filed with the SEC on January 7, 2019 and incorporated by reference herein)
Form of Opinion of Goldfarb Seligman & Co., Israeli counsel to the Registrant (including consent)
Form of Opinion of Mayer Brown LLP, U.S. counsel to the Registrant (including consent)
10.1*
Form of Indemnification Agreement
Amended and Restated Exclusive License Agreement between Yissum Research Development Company of the Hebrew University of Jerusalem and the Company, dated November 14, 2005, as amended by Amendment No. 1 dated November 22, 2005, Amendment No. 2 dated September 11, 2007, Amendment No. 3 dated January 24, 2011 and Amendment No. 4 dated November 6, 2013 (previously filed as Exhibit 10.2 of our registration statement on Form F-1 (File No. 333-229155) as filed with the SEC on January 7, 2019 and incorporated by reference herein)
Clinical Supply Agreement among BioCancell Therapeutics Israel Ltd., Boehringer Ingelheim Biopharmaceuticals GmbH and Boehringer Ingelheim RCV GmbH & Co KG, dated April 3, 2013
Rental Agreement between the Administration for Development and Management of Industrial Zones in Jerusalem Ltd. and BioCancell Therapeutics Israel Ltd. dated November 7, 2013 (previously filed as Exhibit 10.4 of amendment no. 1 to our registration statement on Form F-1 (File No. 333-229155) as filed with the SEC on January 31, 2019 and incorporated by reference herein)
Master Services Agreement between BioCancell Therapeutics Israel Ltd. and INC Research, LLC dated October 25, 2017 (previously filed as Exhibit 10.5 of our registration statement on Form F-1 (File No. 333-229155) as filed with the SEC on January 7, 2019 and incorporated by reference herein)
2011 Incentive Plan for Employees, Officers and Consultants (previously filed as Exhibit 10.6 of our registration statement on Form F-1 (File No. 333-229155) as filed with the SEC on January 7, 2019 and incorporated by reference herein)
Compensation Policy for Officers, dated February 2017 (previously filed as Exhibit 10.7 of our registration statement on Form F-1 (File No. 333-229155) as filed with the SEC on January 7, 2019 and incorporated by reference herein)
2017 Equity-Based Incentive Plan (previously filed as Exhibit 10.8 of our registration statement on Form F-1 (File No. 333-229155) as filed with the SEC on January 7, 2019 and incorporated by reference herein)
Information Rights Agreement between Anchiano Therapeutics Ltd. and Clal Biotechnology Industries Ltd., dated December 19, 2018 (previously filed as Exhibit 10.10 of our registration statement on Form F-1 (File No. 333-229155) as filed with the SEC on January 7, 2019 and incorporated by reference herein)
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Exhibit No.
Description
List of subsidiaries of the Registrant (previously filed as Exhibit 21.1 of our registration statement on Form F-1 (File No. 333-229155) as filed with the SEC on January 7, 2019 and incorporated by reference herein)
Consent of Somekh Chaikin, Member Firm of KPMG International, independent registered public accounting firm for the Registrant (previously filed as Exhibit 23.1 of our registration statement on Form F-1 (File No. 333-229155) as filed with the SEC on January 7, 2019 and incorporated by reference herein)
Consent of Goldfarb Seligman & Co., Israeli counsel to the Registrant (included in Exhibit 5.1)
Consent of Mayer Brown LLP, U.S. counsel to the Registrant (included in Exhibit 5.2)
Power of Attorney (previously included in the signature page of our registration statement on Form F-1 (File No. 333-229155) as filed with the SEC on January 7, 2019 and incorporated by reference herein)
*
To be filed by amendment.
**
Previously filed.
#
English translation of original Hebrew document.

Confidential treatment requested as to certain portions, which portions have been separately filed with the SEC.
II-6

Item 9.   Undertakings.
a.
The undersigned registrant hereby undertakes:
1.
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
i.
To include any prospectus required by section 10(a)(3) of the Securities Act of 1933;
ii.
To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
iii.
To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement.
2.
That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
3.
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
4.
To file a post-effective amendment to the registration statement to include any financial statements required by Item 8.A. of Form 20-F at the start of any delayed offering or throughout a continuous offering. Financial statements and information otherwise required by Section 10(a)(3) of the Act need not be furnished, provided that the registrant includes in the prospectus, by means of a post-effective amendment, financial statements required pursuant to this paragraph (a)(4) and other information necessary to ensure that all other information in the prospectus is at least as current as the date of those financial statements.
5.
That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser, each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.
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6.
That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities: The undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
i.
Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;
ii.
Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;
iii.
The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and
iv.
Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
b.
The undersigned registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreements certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.
c.
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
d.
The undersigned registrant hereby undertakes that:
1.
For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
2.
For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
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SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form F-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Cambridge, State of Massachusetts on February 5, 2019.
ANCHIANO THERAPEUTICS LTD.
By: 
/s/ Dr. Frank G. Haluska
Name: Dr. Frank G. Haluska
Title: Chief Executive Officer

Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statement has been signed by the following persons in the capacities and on the dates indicated.
Signatures
Title
Date
/s/ Dr. Frank G. Haluska
Dr. Frank G. Haluska
Chief Executive Officer and Director
(Principal Executive Officer)
February 5, 2019
*
Jonathan Burgin
Chief Financial Officer and
Chief Operating Officer
(Principal Financial Officer and Principal Accounting Officer)
February 5, 2019
*
Dr. Stephen Hoffman
Chairman of the Board of Directors
February 5, 2019
*
Ruth Alon
Director
February 5, 2019
*
Robert Connelly
Director
February 5, 2019
*
Reginald Hardy
Director
February 5, 2019
*
Dr. Lawrence Howard
Director
February 5, 2019
*
Isaac Kohlberg
Director
February 5, 2019
*
Efrat Makov
Director
February 5, 2019
*
Dennison Veru
Director
February 5, 2019
*By:
/s/ Dr. Frank G. Haluska
Dr. Frank G. Haluska
Attorney-in-Fact

Signature of authorized representative in the United States
Pursuant to the requirements of the Securities Act of 1933, as amended, the Registrant’s duly authorized representative has signed this registration statement on Form F-1 in the city of Cambridge, the State of Massachusetts, on February 5, 2019.
By:
ANCHIANO THERAPEUTICS, INC.
By:
/s/ Dr. Frank G. Haluska
Name: Dr. Frank G. Haluska
Title:   Chief Executive Officer

 

Exhibit 1.1

 

ANCHIANO THERAPEUTICS LTD.

 

[____] American Depositary Shares

 

Representing

 

[____] Ordinary Shares

 

UNDERWRITING AGREEMENT

 

________, 2019

 

Oppenheimer & Co. Inc.

85 Broad Street

New York, New York 10004

 

as Representative of the several

Underwriters named in Schedule I hereto

 

Ladies and Gentlemen:

 

Anchiano Therapeutics Ltd., a company organized under the laws of the State of Israel (the “Company”), proposes, subject to the terms and conditions contained herein, to sell to you and the other underwriters (the “Underwriters”) named on Schedule I to this Underwriting Agreement (the “Agreement”), for whom you are acting as Representative (the “Representative”), an aggregate of ________ American Depositary Shares (the “Firm Shares”), each representing _______ ordinary shares, no par value per share, of the Company (the “Ordinary Shares”) (“ADSs” shall mean the American Depositary Shares of the Company, each ADS representing _______ Ordinary Shares). The respective amounts of the Firm Shares to be purchased by each of the several Underwriters are set forth opposite their names on Schedule I hereto. In addition, the Company proposes to grant to the Underwriters an option to purchase up to an additional ___________ ADSs (the “Option Shares”) from the Company for the purpose of covering over-allotments in connection with the sale of the Firm Shares. The ADSs purchased by the Underwriters will be evidenced by American Depositary Receipts (“ADRs”) to be issued pursuant to a Deposit Agreement dated on or about the date hereof (the “Deposit Agreement”) entered into by and among the Company, The Bank of New York Mellon, as depository of the Company (the “Depository”), and all owners and beneficial owners from time to time of the ADSs. The Firm Shares and the Option Shares are collectively called the “Shares.”

 

 

 

 

The Company has prepared and filed in conformity with the requirements of the Securities Act of 1933, as amended (the “Securities Act”), and the published rules and regulations thereunder (the “Rules”) adopted by the Securities and Exchange Commission (the “Commission”), a registration statement on Form F-6 (No. 333-______) covering the registration of the ADSs under the Securities Act (the “ADS Registration Statement”), a Registration Statement (as hereinafter defined) on Form F-1 (No. 333-229155), including a preliminary prospectus, and such amendments thereof as may have been required to the date of this Agreement. Copies of such Registration Statement (including all amendments thereof) and of the related Preliminary Prospectus (as hereinafter defined) have heretofore been delivered by the Company to you. The term “Preliminary Prospectus” means any preliminary prospectus included at any time as a part of the Registration Statement or filed with the Commission by the Company pursuant to Rule 424(a) of the Rules. The term “Registration Statement” as used in this Agreement means the initial registration statement (including all exhibits and financial schedules), as amended at the time and on the date it becomes effective (the “Effective Date”), including the information (if any) contained in the form of final prospectus filed with the Commission pursuant to Rule 424(b) of the Rules and deemed to be part thereof at the time of effectiveness pursuant to Rule 430A of the Rules. If the Company has filed an abbreviated registration statement to register additional Shares pursuant to Rule 462(b) under the Rules (the “462(b) Registration Statement”), then any reference herein to the Registration Statement shall also be deemed to include such 462(b) Registration Statement. The term “Prospectus” as used in this Agreement means the prospectus in the form included in the Registration Statement at the time of effectiveness or, if Rule 430A of the Rules is relied on, the term Prospectus shall also include the final prospectus filed with the Commission pursuant to and within the time limits described in Rule 424(b) of the Rules.

 

The Company understands that the Underwriters propose to make a public offering of the Shares, as set forth in and pursuant to the Statutory Prospectus (as hereinafter defined) and the Prospectus, as soon after the Effective Date and the date of this Agreement as the Representative deems advisable. The Company hereby confirms that the Underwriters and dealers have been authorized to distribute or cause to be distributed each Preliminary Prospectus, and each Issuer Free Writing Prospectus (as hereinafter defined) and are authorized to distribute the Prospectus (as from time to time amended or supplemented if the Company furnishes amendments or supplements thereto to the Underwriters).

 

1.           Sale, Purchase, Delivery and Payment for the Shares . On the basis of the representations, warranties and agreements contained in, and subject to the terms and conditions of, this Agreement:

 

(a)          The Company agrees to issue and sell to each of the Underwriters, and each of the Underwriters agrees, severally and not jointly, to purchase from the Company, at a purchase price of $_____ per ADS (the “ADS Price”), the number of Firm Shares set forth opposite the name of such Underwriter under the column “Number of Firm Shares to be Purchased” on Schedule I to this Agreement, subject to adjustment in accordance with Section 8 hereof.

 

(b)          The Company hereby grants to the several Underwriters an option to purchase, severally and not jointly, all or any part of the Option Shares at the ADS Price. The number of Option Shares to be purchased by each Underwriter shall be the same percentage (adjusted by the Representative to eliminate fractions) of the total number of Option Shares to be purchased by the Underwriters as such Underwriter is purchasing of the Firm Shares. Such option may be exercised only to cover over-allotments in the sales of the Firm Shares by the Underwriters and may be exercised in whole or in part at any time on or before 12:00 noon, New York City time, on the business day before the Firm Shares Closing Date (as defined below), and from time to time thereafter within 30 days after the date of this Agreement, in each case upon written notice, or verbal or telephonic notice confirmed by written notice, by the Representative to the Company no later than 12:00 noon, New York City time, on the business day before the Firm Shares Closing Date or at least two business days before the Option Shares Closing Date (as defined below), as the case may be, setting forth the number of Option Shares to be purchased and the time and date (if other than the Firm Shares Closing Date) of such purchase.

 

 

 

  

(c)          Payment of the purchase price for, and delivery of certificates for, the Firm Shares shall be made at the offices of Oppenheimer & Co. Inc., 85 Broad Street, New York, New York 10004, at 10:00 a.m., New York City time, on the second business day following the date of this Agreement or at such time on such other date, not later than ten (10) business days after the date of this Agreement, as shall be agreed upon by the Company and the Representative (such time and date of delivery and payment are called the “Firm Shares Closing Date”). In addition, in the event that any or all of the Option Shares are purchased by the Underwriters, payment of the purchase price, and delivery of the certificates, for such Option Shares shall be made at the above-mentioned offices, or at such other place as shall be agreed upon by the Representative and the Company, on each date of delivery as specified in the notice from the Representative to the Company (such time and date of delivery and payment are called the “Option Shares Closing Date”). The Firm Shares Closing Date and any Option Shares Closing Date are called, individually, a “Closing Date” and, together, the “Closing Dates.”

 

(d)          Payment shall be made to the Company by wire transfer of immediately available funds against delivery of the respective certificates to the Representative for the respective accounts of the Underwriters of certificates for the Shares to be purchased by them.

 

(e)          The Shares shall be registered in such names and shall be in such denominations as the Representative shall request at least two full business days before the Firm Shares Closing Date or, in the case of Option Shares, on the day of notice of exercise of the option as described in Section 1(b), and shall be delivered by or on behalf of the Company to the Representative through the facilities of The Depository Trust Company (“DTC”) for the account of each Underwriter named in Schedule I hereto.

 

2.           Representations and Warranties of the Company . The Company represents and warrants to each Underwriter as of the date hereof, as of the Firm Shares Closing Date and as of each Option Shares Closing Date (if any), as follows:

 

 

 

 

(a)          On the Effective Date, the Registration Statement complied, and, on the date it became effective, the ADS Registration Statement complied, and on the date of the Prospectus, the date any post-effective amendment to the Registration Statement or the ADS Registration Statement becomes effective, the date any supplement or amendment to the Prospectus is filed with the Commission and each Closing Date, the Registration Statement, the Prospectus (and any amendment thereof or supplement thereto) and the ADS Registration Statement (and any amendment thereof or supplement thereto) will comply, in all material respects, with the requirements of the Securities Act and the Rules and the Securities and Exchange Act of 1934, as amended (the “Exchange Act”) and the rules and regulations of the Commission thereunder. Neither the Registration Statement nor the ADS Registration Statement, nor any amendments of either of the foregoing, as of the times they became effective, contained any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements therein not misleading; and on the Effective Date and the other dates referred to above neither the Registration Statement, the ADS Registration Statement nor the Prospectus, nor any amendment or supplement of either of the foregoing, will contain any untrue statement of a material fact or will omit to state any material fact required to be stated therein or necessary in order to make the statements therein not misleading. When any Preliminary Prospectus was first filed with the Commission (whether filed as part of the Registration Statement or any amendment thereto or pursuant to Rule 424(a) of the Rules) and when any amendment thereof or supplement thereto was first filed with the Commission, such Preliminary Prospectus as amended or supplemented complied in all material respects with the applicable provisions of the Securities Act and the Rules and did not contain an untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading. If applicable, each Preliminary Prospectus and the Prospectus delivered to the Underwriters for use in connection with this offering was identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T. Notwithstanding the foregoing, none of the representations and warranties in this Section 2(a) shall apply to statements in, or omissions from, the Registration Statement, any Preliminary Prospectus or the Prospectus made in reliance upon, and in conformity with, information herein or otherwise furnished in writing by the Representative on behalf of the several Underwriters specifically for use in the Registration Statement, any Preliminary Prospectus or the Prospectus, as the case may be. With respect to the preceding sentence, the Company acknowledges that the only information furnished in writing by the Representative on behalf of the several Underwriters for use in the Registration Statement, any Preliminary Prospectus or the Prospectus is the statements contained in the [   ] and [   ] paragraphs under the caption “Underwriting” in the Prospectus (collectively, the “Underwriter Information”).

 

(b)          As of the Applicable Time (as hereinafter defined), none of (i) the price to the public and the number of Shares sold, as indicated on the cover page of the Prospectus and the Statutory Prospectus (as hereinafter defined), considered together (collectively, the “General Disclosure Package”), (ii) any individual Issuer Free Writing Prospectus when considered together with the General Disclosure Package, (iii) any individual Written Testing-the Waters Communication (as defined herein), and (iv) the ADS Registration Statement or any amendments or supplements thereto, when considered together with the General Disclosure Package, included, includes or will include an untrue statement of a material fact or omitted, omits or will omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided, however, that this representation and warranty shall not apply to statements in or omissions in the General Disclosure Package made in reliance upon and in conformity with the Underwriter Information.

 

Each Issuer Free Writing Prospectus (as hereinafter defined) (i) is identified in Schedule III hereto and (ii) complied when issued, and complies, in all material respects with the requirements of the Securities Act and the Rules. The Company has made at least one version of a road show, as defined in Rule 433 under the Securities Act (a “Road Show”), available without restriction by means of graphic communication to any person, including any potential investor in the Shares (and if there is more than one version of a Road Show for the offering that is a written communication, the version available without restriction was made available no later than the other versions).

 

 

 

  

As used in this Section and elsewhere in this Agreement:

 

“Applicable Time” means [ ]:00 [a.m.]/[p.m.] (New York City time) on the date of this Agreement.

 

“Statutory Prospectus” as of any time means the Preliminary Prospectus relating to the Shares that is included in the Registration Statement immediately prior to the Applicable Time.

 

“Issuer Free Writing Prospectus” means each “free writing prospectus” (as defined in Rule 433 of the Rules) relating to the Shares.

 

(c)          The Registration Statement and the ADS Registration Statement are effective under the Securities Act and no stop order preventing or suspending the effectiveness of the Registration Statement or the ADS Registration Statement or suspending or preventing the use of any Preliminary Prospectus, the Prospectus or any “issuer free writing prospectus,” as defined in Rule 433 under the Rules, has been issued by the Commission and no proceedings for that purpose have been instituted or, to the Company’s knowledge, are threatened under the Securities Act. Any required filing of any Preliminary Prospectus and/or the Prospectus and any supplement thereto pursuant to Rule 424(b) of the Rules has been or will be made in the manner and within the time period required by such Rule 424(b). Any material required to be filed by the Company pursuant to Rule 433(d) or Rule 163(b)(2) of the Rules has been or will be made in the manner and within the time period required by such Rules.

 

(d)          Each Issuer Free Writing Prospectus listed in Schedule III hereto, when taken together with the General Disclosure Package, did not, as of the Applicable Time, contain an untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading, provided that no representation or warranty is made as to information contained or omitted from any Issuer Free Writing Prospectus in reliance upon and in conformity with written information furnished to the Company through the Representative by or on behalf of any Underwriter specifically for inclusion therein.

 

If at any time following issuance of an Issuer Free Writing Prospectus there occurred or occurs an event or development as a result of which such Issuer Free Writing Prospectus conflicted or would conflict with the information contained in the Registration Statement, the Statutory Prospectus or the Prospectus or included or would include an untrue statement of a material fact or omitted or would omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances prevailing at the subsequent time, not misleading, the Company has promptly notified or will promptly notify the Representative and has promptly amended or will promptly amend or supplement, at its own expense, such Issuer Free Writing Prospectus to eliminate or correct such conflict, untrue statement or omission.

 

 

 

 

(e)          The financial statements of the Company (including all notes and schedules thereto) included in the Registration Statement, the Statutory Prospectus and the Prospectus present fairly in all material respects the financial position of the Company and its consolidated subsidiaries at the dates indicated and the statement of operations, shareholders’ equity and cash flows of the Company and its consolidated subsidiaries for the periods specified; and such financial statements and related schedules and notes thereto, and the unaudited financial information filed with the Commission as part of the Registration Statement, have been prepared in conformity with International Financial Reporting Standards (“IFRS”) as adopted by International Accounting Standards Board, consistently applied throughout the periods involved. The summary and selected financial data included in the Statutory Prospectus and Prospectus present fairly the information shown therein as at the respective dates and for the respective periods specified. The Registration Statement, the Statutory Prospectus, and the Prospectus do not include any pro forma financial statements.

 

(f)          Somekh Chaikin, a member firm of KPMG International (the “Auditor”), whose reports are filed with the Commission as a part of the Registration Statement, are and, to the knowledge of the Company, during the periods covered by their reports, were independent public accountants as required by the Securities Act and the Rules.

 

(g)          The Company and each of its subsidiaries, including each entity (corporation, partnership, joint venture, association or other business organization) controlled directly or indirectly by the Company (each, a “subsidiary”), is duly organized, validly existing and (where such concept is applicable) in good standing under the laws of their respective jurisdictions of incorporation or organization, except where the failure to be in good standing could not in the aggregate reasonably be expected to have a material adverse effect on the assets, properties, condition, financial or otherwise, or in the results of operations, business affairs or business prospects of the Company and its subsidiaries considered as a whole (a “Material Adverse Effect”). Each such entity has all requisite power and authority to carry on its business as is currently being conducted as described in the Statutory Prospectus and the Prospectus, and to own, lease and operate its properties.

 

All of the issued shares of capital stock of, or other ownership interests in, each subsidiary have been duly and validly authorized and issued and are fully paid and non-assessable and are owned, directly or indirectly, by the Company, free and clear of any lien, charge, mortgage, pledge, security interest, claim, limitation on voting rights, equity, trust or other encumbrance, preferential arrangement, defect or restriction of any kind whatsoever. The Company and each of its subsidiaries is duly qualified to do business and (where such concept is applicable) is in good standing as a foreign corporation in each jurisdiction in which the nature of the business conducted by it or location of the assets or properties owned, leased or licensed by it requires such qualification, except for such jurisdictions where the failure to so qualify, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; and, to the Company’s knowledge, no proceeding has been instituted in any such jurisdiction revoking, limiting or curtailing, or seeking to revoke, limit or curtail, such power and authority or qualification.

 

(h)          (i) At the time of filing the Registration Statement and (ii) on the date hereof , the Company was not and is not an “ineligible issuer,” as defined in Rule 405 of the Rules.

 

 

 

 

(i)          The Company and each of its subsidiaries owns or possesses legally enforceable rights to use all patents, patent rights, inventions, trademarks, trademark applications, trade names, service marks, copyrights, copyright applications, licenses, know-how and other similar rights and proprietary knowledge (collectively, “Intangibles”) necessary for the conduct of its business. Neither the Company nor any of its subsidiaries has received any notice of, or is aware of, any infringement of or conflict with asserted rights of others with respect to any Intangibles, except for any of the foregoing that would not reasonably be expected to have a Material Adverse Effect.

 

(j)          The Company and each of its subsidiaries has good and marketable title in fee simple to all real property, and good and marketable title to all other property owned by it, in each case free and clear of all liens, encumbrances, claims, security interests and defects, except such as do not materially affect the value of such property and do not materially interfere with the use made or proposed to be made of such property by the Company and its subsidiaries. All property held under lease by the Company and its subsidiaries is held by them under valid, existing and enforceable leases, free and clear of all liens, encumbrances, claims, security interests and defects, except such as are not material and do not materially interfere with the use made or proposed to be made of such property by the Company and its subsidiaries.

 

(k)          Subsequent to the respective dates as of which information is given in the Registration Statement, the Statutory Prospectus and the Prospectus, (i) there has not been any event which could reasonably be expected to have a Material Adverse Effect; (ii) neither the Company nor any of its subsidiaries has sustained any loss or interference with its assets, businesses or properties (whether owned or leased) from fire, explosion, earthquake, flood or other calamity, whether or not covered by insurance, or from any labor dispute or any court or legislative or other governmental action, order or decree which would reasonably be expected to have a Material Adverse Effect; and (iii) since the date of the latest balance sheet included in the Registration Statement and the Prospectus and except as described in the Registration Statement and Prospectus, neither the Company nor its subsidiaries has (A) issued any securities other than Ordinary Shares issued pursuant to employee benefit plans, qualified stock option plans or other employee compensation plans or pursuant to outstanding options, (B) incurred any liability or obligation, direct or contingent, for borrowed money, except such liabilities or obligations incurred in the ordinary course of business, (C) entered into any material transaction not in the ordinary course of business or (D) declared or paid any dividend or made any distribution on any shares of its stock or redeemed, purchased or otherwise acquired or agreed to redeem, purchase or otherwise acquire any shares of its capital stock.

 

 

 

 

(l)          There is no document, contract or other agreement required to be described in the Registration Statement, the ADS Registration Statement, the Statutory Prospectus or the Prospectus or to be filed as an exhibit to the Registration Statement which is not described or filed as required by the Securities Act or Rules. Each description of a contract, document or other agreement in the Registration Statement, the ADS Registration Statement, the Statutory Prospectus or the Prospectus accurately reflects in all material respects the terms of the underlying contract, document or other agreement. Each contract, document or other agreement described in the Registration Statement, the ADS Registration Statement, the Statutory Prospectus or the Prospectus or listed in the exhibits to the Registration Statement or the ADS Registration Statement is in full force and effect and is valid and enforceable by and against the Company or its subsidiaries, as the case may be, in accordance with its terms. Neither the Company nor any of its subsidiaries, if a subsidiary is a party, nor to the Company’s knowledge, any other party, is in default in the observance or performance of any term or obligation to be performed by it under any such agreement, and no event has occurred which with notice or lapse of time or both would constitute such a default or result in the creation or imposition of any lien, charge, mortgage, pledge, security interest, claim, limitation on voting rights, equity, trust or other encumbrance, preferential arrangement, defect or restriction of any kind whatsoever, upon, any property or assets of the Company or any subsidiary pursuant to, any bond, debenture, note, indenture, mortgage, deed of trust, loan agreement or other agreement or instrument to which it is a party or by which it is bound or to which any of its properties or assets is subject, in any such case which default or event, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect. No default exists, and no event has occurred which with notice or lapse of time or both would constitute a default, in the due performance and observance of any term, covenant or condition, by the Company or its subsidiaries, if a subsidiary is a party thereto, of any other agreement or instrument to which the Company or any of its subsidiaries is a party or by which Company or its properties or business or a subsidiary or its properties or business may be bound or affected which default or event, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect.

 

(m)         The statistical and market related data included in the Registration Statement, the Statutory Prospectus or the Prospectus are based on or derived from sources that the Company believes to be reliable and accurate.

 

(n)          Neither the Company nor any subsidiary (i) is in violation of its certificate or articles of incorporation, articles of association, by-laws, certificate of formation, limited liability company agreement, partnership agreement or other organizational documents, (ii) is in violation of any instrument or approval granted to any of them by the Israel Innovation Authority (formerly the Office of the Chief Scientist) of the Israeli Ministry of Economy and Industry (the “IIA”), or (iii) is in violation of any statute, law, rule, regulation, ordinance, directive, judgment, decree or order of any judicial, regulatory or other legal or governmental agency or body, foreign or domestic, except in the case of clauses (ii) and (iii) to the extent such default or violation would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

 

(o)          This Agreement has been duly authorized, executed and delivered by the Company;

 

(p)          Neither the execution, delivery and performance of this Agreement by the Company nor the consummation of any of the transactions contemplated hereby (including, without limitation, the issuance and sale by the Company of the Shares) will give rise to a right to terminate or accelerate the due date of any payment due under, or conflict with or result in the breach of any term or provision of, or constitute a default (or an event which with notice or lapse of time or both would constitute a default) under, or require any consent or waiver under, or result in the execution or imposition of any lien, charge or encumbrance upon any properties or assets of the Company or its subsidiaries pursuant to the terms of, (i) any indenture, mortgage, deed of trust or other agreement or instrument to which the Company or any of its subsidiaries is a party or by which either the Company or its subsidiaries or any of their properties or businesses is bound, or (ii) any franchise, license, permit, judgment, decree, order, statute, rule or regulation applicable to the Company or any of its subsidiaries or (iii) violate any provision of the articles of association, charter or by-laws or other organizational documents of the Company or any of its subsidiaries; except for such consents or waivers which have already been obtained and are in full force and effect and except, with respect to clauses (i) and (ii), conflicts or violations that would not reasonably be expected to have a Material Adverse Effect.

 

 

 

  

(q)          The Company has authorized and outstanding share capital as set forth under the caption “Capitalization” in the Statutory Prospectus and the Prospectus. All of the issued and outstanding shares of the Company have been duly and validly issued and are fully paid and nonassessable and have been issued in compliance with all federal, state and local, including any applicable foreign (including Israeli), securities laws. There are no statutory preemptive or other similar rights to subscribe for or to purchase or acquire any shares of the Company or any of its subsidiaries, including Ordinary Shares or ADSs, or any such rights pursuant to its articles of association, charter, certificate of incorporation or by-laws or any other applicable organization documents or any agreement or instrument to or by which the Company or any of its subsidiaries is a party or bound. The Shares (including the underlying Ordinary Shares) have been duly authorized for issuance and sale pursuant to this Agreement and when issued and sold pursuant to this Agreement, will be duly and validly issued, fully paid and nonassessable and none of them will be issued in violation of any preemptive or other similar right. Except as disclosed in the Registration Statement, the Statutory Prospectus and the Prospectus, there is no outstanding option, warrant or other right calling for the issuance of, and there is no commitment, plan or arrangement to issue, any shares of the Company or any of its subsidiaries or any security convertible into, or exercisable or exchangeable for, such shares. Except for certain options to acquire Ordinary Shares issued to officers, employees and other service providers of the Company with an exercise price equal to the average closing price during the month preceding their respective dates of grant (which exercise price was consistent with Israeli practice and the requirements of Israeli tax law at the time of grant), the exercise price of each option to acquire Ordinary Shares (each, a “Company Stock Option”) is no less than the fair market value of an Ordinary Share as determined on the date of grant of such Company Stock Option. All grants of Company Stock Options were validly issued and properly approved by the Board of Directors of the Company (and, if required, by a committee of the Board of Directors of the Company and/or the shareholders of the Company) in material compliance with all applicable laws and the terms of the plans under which such Company Stock Options were issued and were recorded on the Company’s financial statements, in accordance with IFRS as issued by the International Accounting Standards Board, and no such grants involved any “back dating,” “forward dating,” “spring loading” or similar practices with respect to the effective date of grant. The Ordinary Shares and the Shares conform in all material respects to all statements in relation thereto contained in the Registration Statement and the Statutory Prospectus and the Prospectus.

 

(r)          No holder of any security of the Company has any right, which has not been waived, to have any security owned by such holder included in the Registration Statement or to demand registration of any security owned by such holder for a period of 180 days after the date of this Agreement. Each director and executive officer of the Company and each shareholder of the Company listed on Schedule II hereto has delivered to the Representative a lock-up agreement in the form attached to this Agreement as Exhibit A hereto (“Lock-Up Agreement”).

 

(s)          There are no legal or governmental proceedings pending to which the Company or any of its subsidiaries is a party or of which any property of the Company or any of its subsidiaries is the subject which, if determined adversely to the Company or any of its subsidiaries could, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and, to the knowledge of the Company, no such proceedings are threatened or contemplated by governmental authorities or threatened by others.

 

 

 

  

(t)          All necessary corporate action has been duly and validly taken by the Company to authorize the execution, delivery and performance of this Agreement and the issuance and sale of the Shares by the Company, including, if applicable, such corporate approvals on the part of the Company under Chapter 5 of Part VI of the Israeli Companies Law.

 

(u)          Neither the Company nor any of its subsidiaries is involved in any labor dispute nor, to the knowledge of the Company, is any such dispute threatened, which dispute would reasonably be expected to have a Material Adverse Effect. The Company is not aware of any existing or imminent labor disturbance by the employees of any of its principal suppliers or contractors which would reasonably be expected to have a Material Adverse Effect. The Company is not aware of any threatened or pending litigation between the Company or its subsidiaries and any of its executive officers which, if adversely determined, could reasonably be expected to have a Material Adverse Effect and has no reason to believe that such officers will not remain in the employment of the Company.

 

(v)         No transaction has occurred between or among the Company and any of its officers or directors, shareholders or any affiliate or affiliates of any such officer or director or shareholder that is required to be described in and is not described in the Registration Statement, the Statutory Prospectus and the Prospectus.

 

(w)          The Company has not taken, nor will it take, directly or indirectly, any action designed to, or which might reasonably be expected to cause or result in, or which has constituted or which might reasonably be expected to constitute, the stabilization or manipulation of the price of the Ordinary Shares or any security of the Company to facilitate the sale or resale of any of the Shares.

 

(x)          The Company and each of its subsidiaries has filed all federal, state, local and foreign tax returns which are required to be filed through the date hereof (except in any case in which the failure to so file would not result in a Material Adverse Effect), which returns are true and correct in all material respects or has received timely extensions thereof, and has paid all taxes shown on such returns and all assessments received by it to the extent that the same are material and have become due. There are no tax audits or investigations pending, which if adversely determined would reasonably be expected to have a Material Adverse Effect; nor are there any material proposed additional tax assessments against the Company or any of its subsidiaries.

 

(y)          The ADSs have been duly authorized for quotation on the National Association of Securities Dealers Automated Quotation (“Nasdaq”) Capital Market System, subject to official Notice of Issuance. A registration statement for the ADSs has been filed on Form 8-A pursuant to Section 12 of the Exchange Act, which registration statement complies in all material respects with the Exchange Act.

 

(z)          The Company has taken no action designed to, or likely to have the effect of, terminating the registration of the ADSs under the Exchange Act or the quotation of the ADSs on the Nasdaq Capital Market, nor has the Company received any notification that the Commission or the Nasdaq Capital Market is contemplating terminating such registration or quotation.

 

 

 

  

(aa)         The Company and its subsidiaries maintain a system of internal accounting controls sufficient to provide reasonable assurances that (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in accordance with IFRS and to maintain asset accountability, (iii) access to assets is permitted only in accordance with management’s general or specific authorization and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences.

 

(bb)         The Company maintains disclosure controls and procedures (as such term is defined in Rule 13a-15 under the Exchange Act), which: (i) are designed to ensure that material information relating to the Company is made known to the Company’s principal executive officer and its principal financial officer by others within the Company, particularly during the periods in which the periodic reports required under the Exchange Act are required to be prepared; (ii) provide for the periodic evaluation of the effectiveness of such disclosure controls and procedures at the end of the periods in which the periodic reports are required to be prepared; and (iii) are effective in all material respects to perform the functions for which they were established.

 

(cc)         Based on the evaluation of its disclosure controls and procedures, the Company is not aware of (i) any material weakness or significant deficiency in the design or operation of internal controls which could adversely affect the Company’s ability to record, process, summarize and report financial data or any material weaknesses in internal controls; or (ii) any fraud, whether or not material, that involves management or other employees who have a role in the Company’s internal controls.

 

(dd)         Except as described in the Statutory Prospectus and the Prospectus and as preapproved in accordance with the requirements set forth in Section 10A of the Exchange Act, the Auditor has not been engaged by the Company to perform any “prohibited activities” (as defined in Section 10A of the Exchange Act).

 

(ee)          Except as described in the Statutory Prospectus and the Prospectus, there are no material off-balance sheet arrangements (as defined in Item 303 of Regulation S-K) that have or are reasonably likely to have a material current or future effect on the Company’s financial condition, revenues or expenses, changes in financial condition, results of operations, liquidity, capital expenditures or capital resources.

 

(ff)         The Company is in compliance with all applicable provisions of the Sarbanes-Oxley Act of 2002, as amended (the “Sarbanes-Oxley Act”), any related rules and regulations promulgated by the Commission and corporate governance requirements under applicable Nasdaq regulations upon the effectiveness of such provisions and has no reason to believe that it will not be able to comply with such provisions at the time of effectiveness.

 

 

 

 

(gg)         The Company and its subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as are customary in the businesses in which they are engaged or propose to engage after giving effect to the transactions described in the Statutory Prospectus and the Prospectus; all policies of insurance and fidelity or surety bonds insuring the Company or any of its subsidiaries or the Company’s or its subsidiaries’ respective businesses, assets, employees, officers and directors are in full force and effect; the Company and each of its subsidiaries are in compliance with the terms of such policies and instruments in all material respects; and neither the Company nor any subsidiary has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business at a cost that is not materially greater than the current cost. Neither the Company nor any of its subsidiaries has been denied any insurance coverage which it has sought or for which it has applied.

 

(hh)         Each approval, consent, order, authorization, designation, declaration or filing of, by or with any regulatory, administrative or other governmental body necessary in connection with the execution and delivery by the Company of this Agreement and the consummation of the transactions herein contemplated required to be obtained or performed by the Company (except for (i) such additional steps as may be required by the Financial Industry Regulatory Authority (“FINRA”); (ii) as may be necessary to qualify the Shares for public offering by the Underwriters under the state securities or Blue Sky laws; (iii) the approval by the Nasdaq Capital Market for the listing of the Shares on the Nasdaq Capital Market; and (iv) the filing of a notice of the Offering with the IIA has been obtained or made and is in full force and effect. Assuming the Underwriters have not offered the Shares in Israel, or otherwise engaged in a solicitation, advertising or any other action in Israel constituting an offer under the Israeli Securities Law, 5728-1968, as amended, and the regulations promulgated thereunder, other than an offer that does not constitute an offering to the public, the Company is not required to publish a prospectus in the State of Israel under the laws of the State of Israel with respect to the offer or sale of the Shares.

 

(ii)          There are no affiliations with FINRA among the Company’s officers, directors or, to the best of the knowledge of the Company, any five percent or greater shareholder of the Company, except as set forth in the Registration Statement or otherwise disclosed in writing to the Representative.

 

(jj)          Except as described in the Registration Statement and except as would not be reasonably expected, individually or in the aggregate, to have a Material Adverse Effect, (i) each of the Company and each of its subsidiaries is in compliance in all respects with all rules, laws and regulation relating to the use, treatment, storage and disposal of toxic substances and protection of health or the environment (each such law, an “Environmental Law”) which are applicable to its business; (ii) neither the Company nor its subsidiaries has received any notice from any governmental authority or third party of an asserted claim under Environmental Laws; (iii) each of the Company and each of its subsidiaries has received all permits, licenses or other approvals required of it under applicable Environmental Laws to conduct its business and is in compliance with all terms and conditions of any such permit, license or approval; (iv) to the Company’s knowledge, no facts currently exist that will require the Company or any of its subsidiaries to make future material capital expenditures to comply with Environmental Laws; and (v) no property which is or has been owned, leased or occupied by the Company or its subsidiaries has been designated as a Superfund site pursuant to the Comprehensive Environmental Response, Compensation of Liability Act of 1980, as amended (42 U.S.C. Section 9601, et. seq.) or otherwise designated as a contaminated site under other Environmental Laws. Neither the Company nor any of its subsidiaries has been named as a “potentially responsible party” under the CERCLA 1980.

 

 

 

 

(kk)         The Company is not and, after giving effect to the offering and sale of the Shares and the application of proceeds thereof as described in the Statutory Prospectus and the Prospectus, will not be an “investment company” within the meaning of the Investment Company Act of 1940, as amended (the “Investment Company Act”).

 

(ll)          Neither the Company, nor, to the Company's knowledge, any director, officer, agent or employee of the Company or its subsidiaries, has not, directly or indirectly, while acting on behalf of the Company or its subsidiaries (i) used any corporate funds for unlawful contributions, gifts, entertainment or other unlawful expenses relating to political activity; (ii) made any unlawful payment to foreign or domestic government officials or employees or to foreign or domestic political parties or campaigns from corporate funds; (iii) violated any provision of the Foreign Corrupt Practices Act of 1977, as amended, or any provision of any applicable non-U.S. anti-bribery or anti-corruption law or regulation; or (iv) made any other unlawful payment.

 

(mm)       The operations of the Company and its subsidiaries are and have been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of all applicable jurisdictions, the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the “Money Laundering Laws”) and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any of its subsidiaries with respect to the Money Laundering Laws is pending, or to the best knowledge of the Company, threatened.

 

(nn)         Neither the Company nor any of its subsidiaries nor, to the knowledge of the Company, any director or officer of the Company or any of its subsidiaries, is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Treasury Department (“OFAC”); and the Company will not directly or indirectly use the proceeds of the offering, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity, for the purpose of financing the activities of any person currently subject to any U.S. sanctions administered by OFAC.

 

(oo)        The Company has fulfilled its obligations, if any, under the minimum funding standards of Section 302 of the U.S. Employee Retirement Income Security Act of 1974 (“ERISA”) and the regulations and published interpretations thereunder with respect to each “plan” as defined in Section 3(3) of ERISA and such regulations and published interpretations in which its employees are eligible to participate and each such plan is in compliance in all material respects with the presently applicable provisions of ERISA and such regulations and published interpretations. No “Reportable Event” (as defined in 12 ERISA) has occurred with respect to any “Pension Plan” (as defined in ERISA) for which the Company could have any liability.

 

(pp)        None of the Company, its directors or its officers has distributed nor will distribute prior to the later of (i) the Firm Shares Closing Date, or the Option Shares Closing Date, and (ii) completion of the distribution of the Shares, any offering material in connection with the offering and sale of the Shares other than any Preliminary Prospectus, the Prospectus, the Registration Statement and other materials, if any, permitted by the Securities Act and consistent with the terms of this Agreement.

 

 

 

  

(qq)         Since the date of the preliminary prospectus included in the Registration Statement filed with the Commission on _________ (or, if earlier, the first date on which the Company engaged directly or through any Person authorized to act on its behalf in any Testing-the-Waters Communication (as defined herein)) through the date hereof, the Company has been and is an “emerging growth company,” as defined in Section 2(a) of the Securities Act (an “Emerging Growth Company”). “Testing-the-Waters Communication” means any oral or written communication with potential investors undertaken in reliance on Section 5(d) of the Securities Act.

 

(rr)         The Company (a) has not alone engaged in any Testing-the-Waters Communication other than Testing-the-Waters Communications with the consent of the Representative with entities that are qualified institutional buyers within the meaning of Rule 144A under the Securities Act or institutions that are accredited investors within the meaning of Rule 501 under the Securities Act, and (b) has not authorized anyone other than the Representative to engage in Testing-the-Waters Communications. The Company reconfirms that the Representative has been authorized to act on its behalf in undertaking Testing-the-Waters Communications. The Company has not distributed any Written Testing-the-Waters Communications. “Written Testing-the-Waters Communication” means any Testing-the-Waters Communication that is a written communication within the meaning of Rule 405 under the Securities Act.

 

(ss)         The Company has the power to submit, and pursuant to Section 9 of this Agreement, has legally, validly, effectively and irrevocably submitted, to the personal jurisdiction of each United States federal court and New York state court located in the Borough of Manhattan, in the City of New York, New York, U.S.A. (each, a “New York Court”), and the Company has the power to designate, appoint and authorize, and pursuant to Section 9 of this Agreement, has legally, validly, effectively and irrevocably designated, appointed and authorized an agent for service of process in any action arising out of or relating to this Agreement in any New York Court, and service of process effected on such authorized agent will be effective to confer valid personal jurisdiction over the Company as provided in Section 10 hereof.

 

(tt)         The Company is a “foreign private issuer” within the meaning of Rule 405 under the Securities Act.

 

(uu)       The Company and each of its subsidiaries has all requisite corporate power and authority, and all necessary authorizations, approvals, consents, orders, licenses, certificates and permits of and from all governmental or regulatory bodies or any other person or entity (collectively, the “Permits”), to own, lease and license its assets and properties and conduct its business, all of which are valid and in full force and effect, except where the lack of such Permits, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company and each of its subsidiaries has fulfilled and performed all of its obligations with respect to such Permits and no event has occurred that allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the Company thereunder, except for any of the foregoing that would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. Except as may be required under the Securities Act and state and foreign Blue Sky laws, no other Permits are required to enter into, deliver and perform this Agreement and to issue and sell the Shares.

 

 

 

  

(vv)        The Deposit Agreement has been duly authorized by the Company, and when executed and delivered by the Company will, assuming due authorization, execution and delivery by the Depository, constitute a valid and legally binding obligation of the Company, enforceable against the Company in accordance with its terms, except as may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or other similar laws relating to or affecting creditors’ rights generally or general equitable principles. Upon the issuance, sale and payment for the underlying Ordinary Shares in accordance with the terms hereof and the due issuance by the Depository of the ADSs against the deposit of the underlying Ordinary Shares in respect thereof in accordance with the provisions of the Deposit Agreement, such Shares will be duly and validly issued, and the persons in whose names the ADSs are registered will be entitled to the rights specified in the Deposit Agreement; and the Deposit Agreement and the ADRs conform in all material respects to the descriptions thereof contained in the Registration Statement and the Prospectus.

 

(ww)        No transaction, stamp or other issuance or transfer taxes or duties, and, assuming that the Underwriters are not otherwise subject to taxation in Israel, no capital gain, income, or other tax or duty is payable in the State of Israel by or on behalf of the Underwriters to any taxing authority thereof or therein in connection with (i) the issuance, sale and delivery of the Shares by the Company; (ii) the purchase from the Company, and the initial sale and delivery by the Underwriters of the Shares to purchasers thereof; (iii) the holding or transfer of the Shares in connection with (ii) above; or (iv) the execution and delivery of this Agreement or any other document to be furnished hereunder.

 

3.            Conditions of the Underwriters’ Obligations . The obligations of the Underwriters under this Agreement are several and not joint. The respective obligations of the Underwriters to purchase the Shares are subject to each of the following terms and conditions:

 

(a)          Notification that each of the Registration Statement and the ADS Registration Statement has become effective shall have been received by the Representative and the Prospectus shall have been timely filed with the Commission in accordance with Section 4(a) of this Agreement and any material required to be filed by the Company pursuant to Rule 433(d) of the Rules shall have been timely filed with the Commission in accordance with such rule.

 

(b)          No order preventing or suspending the use of any Preliminary Prospectus, the Prospectus or any Issuer Free Writing Prospectus shall have been or shall be in effect and no order suspending the effectiveness of the Registration Statement shall be in effect and no proceedings for such purpose shall be pending before or, to the Company’s knowledge, threatened by the Commission, and any requests for additional information on the part of the Commission (to be included in the Registration Statement or the Prospectus or otherwise) shall have been complied with to the satisfaction of the Commission and the Representative. If the Company has elected to rely upon Rule 430A, Rule 430A information previously omitted from the effective Registration Statement pursuant to Rule 430A shall have been transmitted to the Commission for filing pursuant to Rule 424(b) within the prescribed time period and the Company shall have provided evidence satisfactory to the Underwriters of such timely filing, or a post-effective amendment providing such information shall have been promptly filed and declared effective in accordance with the requirements of Rule 430A.

 

 

 

  

(c)           The representations and warranties of the Company contained in this Agreement and in the certificates delivered pursuant to Section 3(d) shall be true and correct when made and on and as of each Closing Date as if made on such date. The Company shall have performed all covenants and agreements and satisfied all the conditions contained in this Agreement required to be performed or satisfied by them at or before such Closing Date.

 

(d)           The Representative shall have received on each Closing Date a certificate, addressed to the Representative and dated such Closing Date, of the chief executive or chief operating officer and the chief financial officer or chief accounting officer of the Company to the effect that: (i) the representations, warranties and agreements of the Company in this Agreement were true and correct when made and are true and correct as of such Closing Date in all material respects (to the extent not otherwise qualified by materiality); (ii) the Company has performed all covenants and agreements and satisfied all conditions contained herein; (iii) they have carefully examined the Registration Statement, the ADS Registration Statement, the Prospectus, the General Disclosure Package, and any individual Issuer Free Writing Prospectus and, in their opinion (A) as of the Effective Date the Registration Statement and Prospectus did not include, and as of the Applicable Time, neither (i) the General Disclosure Package, nor (ii) any individual Issuer Free Writing Prospectus, when considered together with the General Disclosure Package, nor (iii) as of the date it became effective, the ADS Registration Statement, included any untrue statement of a material fact and did not omit to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading, and (B) since the Effective Date, no event has occurred which should have been set forth in a supplement or otherwise required an amendment to the Registration Statement, the ADS Registration Statement, the Statutory Prospectus or the Prospectus; and (iv) no stop order suspending the effectiveness of the Registration Statement has been issued and, to their knowledge, no proceedings for that purpose have been instituted or are pending under the Securities Act.

 

(e)          The Representative shall have received: (i) simultaneously with the execution of this Agreement, a signed letter from the Auditor addressed to the Representative and dated the date of this Agreement, in form and substance reasonably satisfactory to the Representative, containing statements and information of the type ordinarily included in accountants’ “comfort letters” to underwriters with respect to the financial statements and certain financial information contained in the Registration Statement and the Disclosure Package, and (ii) on each Closing Date, a signed letter from the Auditor addressed to the Representative and dated the date of such Closing Date(s), in form and substance reasonably satisfactory to the Representative containing statements and information of the type ordinarily included in accountants’ “comfort letters” to underwriters with respect to the financial statements and certain financial information contained in the Registration Statement and the Prospectus.

 

(f)          The Representative shall have received on each Closing Date from each of [Mayer Brown LLP and Goldfarb Seligman & Co.], counsel for the Company, an opinion and negative assurance statement, addressed to the Representative and dated such Closing Date, in form and substance reasonably satisfactory to the Representative.

 

 

 

 

(g)          The Representative shall have received on each Closing Date from [Reinhard Cohn & Partners], intellectual property counsel for the Company, an opinion and written negative assurances statement, addressed to the Representative and dated such Closing Date, in form and substance satisfactory to the Representative.

 

(h)           On the Closing Date, the Representative shall have received the opinion of Emmet, Marvin & Martin, LLP, counsel for the Depository, dated the Closing Date, addressed to the Representative in form and substance satisfactory to the Representative .

 

(i)          The Representative shall have received on the Closing Date from each of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. and Zysman, Aharoni, Gayer & Co., counsel for the Representative, a negative assurance statement, addressed to the Representative and dated as of such Closing Date, with respect to such matters as the Representative may reasonably require, and the Company shall have furnished or provided access to such counsel of such documents as they request for enabling them to pass upon such matters.

 

(j)           The Representative shall have received copies of the Lock-Up Agreements executed by each entity or person listed on Schedule II hereto. In the event that Oppenheimer & Co. Inc., in its sole discretion, agrees to release or waive any restriction set forth in a Lock-Up Agreement for an officer or director of the Company, and provides the Company with notice of the impending release or waiver at least three Business Days before the effective date of such release or waiver (which release or waiver shall be substantially in the Form found at Exhibit A-1 attached hereto), the Company agrees to announce the impending release or waiver by a press release substantially in the form of Exhibit A-2 attached hereto through a major news service at least two Business Days before the effective date of the release or waiver .

 

(k)          The Shares shall have been approved for quotation on the Nasdaq Capital Market, subject only to official notice of issuance, and the TASE has approved the registration of the Ordinary Shares.

 

(l)          The Representative shall be reasonably satisfied that since the respective dates as of which information is given in the Registration Statement, the Statutory Prospectus, the General Disclosure Package and the Prospectus, (i) there shall not have been any material change in the capital stock of the Company or any material change in the indebtedness (other than in the ordinary course of business) of the Company, (ii) except as set forth or contemplated by the Registration Statement, the Statutory Prospectus, the General Disclosure Package or the Prospectus, no material oral or written agreement or other transaction shall have been entered into by the Company that is not in the ordinary course of business or that could reasonably be expected to result in a material adverse change in the results of operations of the Company, (iii) no loss or damage (whether or not insured) to the property of the Company shall have been sustained that had or could reasonably be expected to have a Material Adverse Effect, (iv) no legal or governmental action, suit or proceeding affecting the Company or any of its properties that is material to the Company or that affects or could reasonably be expected to affect the transactions contemplated by this Agreement shall have been instituted or threatened and (v) there shall not have been any material adverse change in the assets, properties, condition (financial or otherwise), or in the results of operations, business affairs or business prospects of the Company or its subsidiaries considered as a whole that makes it impractical or inadvisable in the Representative’s judgment to proceed with the purchase or offering of the Shares as contemplated hereby.

 

 

 

  

(m)          FINRA shall have confirmed that it has not raised any objection with respect to the fairness and reasonableness of the underwriting terms and agreements in connection with the offering of the Shares.

 

(n)           The Company and the Depository shall have executed and delivered the Deposit Agreement and the Deposit Agreement shall be in full force and effect and the Company and the Depository shall have taken all action necessary to permit the deposit of the Ordinary Shares and the issuance of the Shares in accordance with the Deposit Agreement. The Company shall, prior to the Closing Date, as the case may be, deposit the Ordinary Shares to be represented by the Shares with the Depository in accordance with the provisions of the Deposit Agreement and otherwise comply with the Deposit Agreement so that the ADSs will be issued by the Depository against receipt of such Ordinary Shares and delivered to the Underwriters at the Closing Dates.

 

(o)          At each Closing Date, the Representative shall have received a certificate from the Depository satisfactory to the Representative with respect to the deposit with the Depository of the underlying Ordinary Shares represented by the Shares against issuance of the ADRs evidencing the Shares, the execution, issuance, countersignature and delivery of the ADRs evidencing the Shares pursuant to the Deposit Agreement and such other matters related thereto as the Representative may reasonably request.

 

(q)          The Company shall have furnished or caused to be furnished to the Representative such further certificates or documents as the Representative shall have reasonably requested.

 

4.            Covenants and Other Agreements of the Company and the Underwriters .

 

(a)          The Company covenants and agrees as follows:

 

(i)          The Company will use its commercially reasonable efforts to cause the Registration Statement and the ADS Registration Statement, if not effective at the time of execution of this Agreement, and any amendments thereto, to become effective as promptly as possible. The Company shall prepare the Prospectus in a form approved by the Representative and file such Prospectus pursuant to Rule 424(b) under the Securities Act not later than the Commission’s close of business on the second business day following the execution and delivery of this Agreement, or, if applicable, such earlier time as may be required by the Rules. The Company will file with the Commission all Issuer Free Writing Prospectuses in the time and manner required under Rules 433(d) or 163(b)(2), as the case may be.

 

 

 

 

(ii)         The Company shall promptly advise the Representative in writing (A) when any post-effective amendment to the Registration Statement shall have become effective or any supplement to the Prospectus shall have been filed, (B) of any request by the Commission for any amendment of the Registration Statement, the ADS Registration Statement or the Prospectus or for any additional information, (C) of the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or of any order preventing or suspending the use of any preliminary prospectus or any “free writing prospectus,” as defined in Rule 405 of the Rules, or the institution or threatening of any proceeding for that purpose and (D) of the receipt by the Company of any notification with respect to the suspension of the qualification of the Shares for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose. Prior to filing any amendment of the Registration Statement or supplement to the Prospectus or any Issuer Free Writing Prospectus, the Company shall furnish a copy thereof to the Representative and obtain the consent of the Representative prior to filing, which consent shall not be unreasonably withheld. The Company shall use its commercially reasonable efforts to prevent the issuance of any such stop order and, if issued, to obtain as soon as possible the withdrawal thereof. The Company has complied and will comply with the requirements of Rule 433 under the Act applicable to any Issuer Free Writing Prospectus, including timely filing with the Commission where required, legending and record keeping.

 

(iii)        If, at any time when a prospectus relating to the Shares (or, in lieu thereof, the notice referred to in Rule 173(a) of the Rules) is required to be delivered under the Securities Act, any event occurs as a result of which the Prospectus as then amended or supplemented would include any untrue statement of a material fact or omit to state any material fact necessary to make the statements therein in the light of the circumstances under which they were made not misleading, or if it shall be necessary to amend or supplement the Prospectus to comply with the Securities Act or the Rules, the Company promptly shall prepare and file with the Commission, subject to the second sentence of paragraph (ii) of this Section 4(a), an amendment or supplement which shall correct such statement or omission or an amendment which shall effect such compliance.

 

(iv)        If at any time following issuance of an Issuer Free Writing Prospectus there occurs an event or development as a result of which such Issuer Free Writing Prospectus would conflict with the information contained in the Registration Statement or would include an untrue statement of a material fact or would omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances prevailing at the subsequent time, not misleading, the Company will promptly notify the Representative and will promptly amend or supplement, at its own expense, such Issuer Free Writing Prospectus to eliminate or correct such conflict, untrue statement or omission.

 

(v)         The Company shall make generally available to its security holders and to the Representative as soon as practicable, but not later than 410 days after the Effective Date (or 545 days if the fourth quarter following the fiscal quarter that includes the Effective Date is the last fiscal quarter of the Company’s fiscal year) an earning statement (which need not be audited) of the Company covering the 12-month period beginning at the end of the fiscal quarter of the Company during which the Effective Date occurs, which shall satisfy the provisions of Section 11(a) of the Securities Act or Rule 158 of the Rules.

 

 

 

  

(vi)        The Company shall furnish upon request to the Representative and counsel for the Underwriters, without charge, signed copies of the Registration Statement (including all exhibits thereto and amendments thereof) and to each other Underwriter a copy of the Registration Statement (without exhibits thereto) and all amendments thereof and, so long as delivery of a prospectus by an Underwriter or dealer may be required by the Securities Act or the Rules, as many copies of any Preliminary Prospectus, any Issuer Free Writing Prospectus and the Prospectus and any amendments thereof and supplements thereto as the Representative may reasonably request. If applicable, the copies of the Registration Statement, preliminary prospectus, any Issuer Free Writing Prospectus and Prospectus and each amendment and supplement thereto furnished to the Underwriters will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.

 

(vii)       The Company shall cooperate with the Representative and its counsel in endeavoring to qualify the Shares for offer and sale in connection with the offering under the laws of such jurisdictions as the Representative may designate and shall maintain such qualifications in effect so long as required for the distribution of the Shares.

 

(viii)      The Company, during the period when the Prospectus (or in lieu thereof, the notice referred to in Rule 173(a) of the Rules) is required to be delivered under the Securities Act and the Rules or the Exchange Act, will file all reports and other documents required to be filed with the Commission pursuant to Section 13, 14 or 15 of the Exchange Act within the time periods required by the Exchange Act and the regulations promulgated thereunder.

 

(ix)         Without the prior written consent of the Representative, for a period of 180 days after the date of this Agreement, the Company and each of its individual directors and executive officers shall not issue, sell or register with the Commission (other than on Form S-8 or on any successor form), or otherwise dispose of, directly or indirectly, any equity securities of the Company (or any securities convertible into, exercisable for or exchangeable for equity securities of the Company), except for (A) the issuance of the Shares pursuant to the Registration Statement, (B) the issuance of securities pursuant to the Company’s existing stock option plan or bonus plan as described in the Registration Statement and the Prospectus, provided that the recipient of any such Ordinary Shares or securities issued pursuant to the Company’s existing stock option plan or bonus plan that are exercisable or that may become exercisable during the 180-day restricted period described above shall enter into an agreement substantially in the form of Exhibit A hereto.

 

 

 

  

(x)          On or before completion of this offering, the Company shall make all filings required under applicable securities laws and by the Nasdaq Capital Market (including any required registration under the Exchange Act). The Company shall use its commercially reasonable efforts to maintain the listing or quotation of the ADSs on the Nasdaq Capital Market. The Company further agrees, if the Company applies to have the ADSs traded on any other trading market, it will then include in such application the Shares and will take such other action as is necessary to cause all of the Shares to be listed or quoted on such other trading market as promptly as possible. The Company will then take all action reasonably necessary to continue the listing and trading of its ADSs on a trading market and will comply in all material respects with the Company’s reporting, filing and other obligations under the bylaws or rules of the trading market.

 

(xi)         The Company will apply the net proceeds from the offering of the Shares in the manner set forth under “Use of Proceeds” in the Prospectus.

 

(xii)        The Company will promptly notify the Representative if the Company ceases to be an Emerging Growth Company at any time prior to the later of (a) completion of the distribution of the Shares within the meaning of the Securities Act and (b) completion of the 180-day restricted period referred to in Section 4(a)(ix) hereof.

 

(xiii)       If at any time following the distribution of any Written Testing-the-Waters Communication there occurred or occurs an event or development as a result of which such Written Testing-the-Waters Communication included or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances existing at that subsequent time, not misleading, the Company will promptly notify the Representative and will promptly amend or supplement, at its own expense, such Written Testing-the-Waters Communication to eliminate or correct such untrue statement or omission.

 

 

 

 

(b)           The Company agrees to pay, or reimburse if paid by the Representative, whether or not the transactions contemplated hereby are consummated or this Agreement is terminated, all costs and expenses incident to the public offering of the Shares and the performance of the obligations of the Company under this Agreement including those relating to: (i) the preparation, printing, reproduction filing and distribution of the Registration Statement, including all exhibits thereto, each Preliminary Prospectus, the Prospectus, any Issuer Free Writing Prospectus, all amendments and supplements thereto, and the printing, filing and distribution of this Agreement; (ii) the preparation and delivery of certificates for the Shares to the Underwriters; (iii) the registration or qualification of the Shares for offer and sale under the securities or Blue Sky laws of the various jurisdictions referred to in Section 4(a)(vii), including the reasonable fees and disbursements of counsel for the Underwriters in connection with such registration and qualification and the preparation, printing, distribution and shipment of preliminary and supplementary Blue Sky memoranda; (iv) the furnishing (including costs of shipping and mailing) to the Representative and to the Underwriters of copies of each Preliminary Prospectus, the Prospectus and all amendments or supplements to the Prospectus, any Issuer Free Writing Prospectus, and of the several documents required by this Section to be so furnished, as may be reasonably requested for use in connection with the offering and sale of the Shares by the Underwriters or by dealers to whom Shares may be sold; (v) the filing fees of FINRA in connection with its review of the terms of the public offering and reasonable fees and disbursements of counsel for the Underwriters in connection with such review; (vi) inclusion of the Shares for quotation on the Nasdaq Capital Market; (vii) all transfer taxes, if any, with respect to the sale and delivery of the Shares by the Company to the Underwriters; and (viii) $75,000 to cover all costs and expenses incident to the offering and the performance of the obligations of the Company under this Agreement, and all reasonable out-of-pocket costs and expenses incident to the performance of the obligations of the Representative under this Agreement (including, without limitation, the fees and expenses of Underwriters’ outside attorneys), provided that such amount may be increased (with the prior written consent of the Company which shall not unreasonably be withheld) to an amount that shall not exceed $200,000.

 

(c)           The Company acknowledges and agrees that each of the Underwriters has acted and is acting solely in the capacity of a principal in an length transaction between the Company, on the one hand, and the Underwriters, on the other hand, with respect to the offering of Shares contemplated hereby (including in connection with determining the terms of the offering) and not as a financial advisor, agent or fiduciary to the Company or any other person. Additionally, the Company acknowledges and agrees that the Underwriters have not and will not advise the Company or any other person as to any legal, tax, investment, accounting or regulatory matters in any jurisdiction. The Company has consulted with its own advisors concerning such matters and shall be responsible for making its own independent investigation and appraisal of the transactions contemplated hereby, and the Underwriters shall have no responsibility or liability to the Company or any other person with respect thereto, whether arising prior to or after the date hereof. Any review by the Underwriters of the Company, the transactions contemplated hereby or other matters relating to such transactions have been and will be performed solely for the benefit of the Underwriters and shall not be on behalf of the Company. The Company agrees that it will not claim that the Underwriters, or any of them, has rendered advisory services of any nature or respect, or owes a fiduciary duty to the company or any other person in connection with any such transaction or the process leading thereto.

 

 

 

  

5.            Indemnification .

 

(a)          The Company agrees to indemnify and hold harmless each Underwriter, its officers and employees and each person, if any, who controls any Underwriter within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act against any and all losses, claims, damages and liabilities, joint or several (including any reasonable investigation, legal and other expenses incurred in connection with, and any amount paid in settlement of, any action, suit or proceeding or any claim asserted), to which they, or any of them, may become subject under the Securities Act, the Exchange Act or other federal or state law or regulation, at common law or otherwise, insofar as such losses, claims, damages or liabilities arise out of or are based upon any untrue statement or alleged untrue statement of a material fact contained in any preliminary prospectus, the Registration Statement, the Statutory Prospectus, the Prospectus, any Issuer Free Writing Prospectus or any “issuer-information” filed or required to be filed pursuant to Rule 433(d) of the Rules, any amendment thereof or supplement thereto, any Written Testing-the-Waters Communication, or in any Blue Sky application or other information or other documents executed by the Company filed in any state or other jurisdiction to qualify any or all of the Shares under the securities laws thereof (any such application, document or information being hereinafter referred to as a “Blue Sky Application”) or arise out of or are based upon any omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading; provided, however, that such indemnity shall not inure to the benefit of any Underwriter (or any person controlling such Underwriter) on account of any losses, claims, damages or liabilities arising from the sale of the Shares to any person by such Underwriter if such untrue statement or omission or alleged untrue statement or omission was made in such preliminary prospectus, the Registration Statement, the Prospectus, the Statutory Prospectus, any Issuer Free Writing Prospectus or such amendment or supplement thereto, any Written Testing-the-Waters Communication, or in any Blue Sky Application in reliance upon and in conformity with the Underwriter Information. This indemnity agreement will be in addition to any liability that the Company may otherwise have.

 

(b)          Each Underwriter, severally and not jointly, agrees to indemnify and hold harmless the Company, its directors and officers, and each person, if any, who controls the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act, against any losses, claims, damages or liabilities to which such party may become subject, under the Securities Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon an untrue statement or alleged untrue statement of a material fact contained in any Preliminary Prospectus, the Registration Statement or the Prospectus, or any amendment or supplement thereto, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, in each case to the extent, but only to the extent, that such untrue statement or alleged untrue statement or omission or alleged omission was made in any Preliminary Prospectus, the Registration Statement, the Statutory Prospectus or the Prospectus or any such amendment or supplement in reliance upon and in conformity with the Underwriter Information; provided, however, that the obligation of each Underwriter to indemnify the Company (including any controlling person, director, officer or employee thereof) shall be limited to the amount of the underwriting discount and commissions applicable to the Shares to be purchased by such Underwriter hereunder. This indemnity agreement will be in addition to any liability that any Underwriter may otherwise have to the Company or any such director, officer, employee or controlling person.

 

 

 

 

(c)          Any party that proposes to assert the right to be indemnified under this Section will, promptly after receipt of notice of commencement of any action, suit or proceeding against such party in respect of which a claim is to be made against an indemnifying party or parties under this Section, notify each such indemnifying party of the commencement of such action, suit or proceeding, enclosing a copy of all papers served. No indemnification provided for in Section 5(a) or 5(b) shall be available to any party who shall fail to give notice as provided in this Section 5(c) if the party to whom notice was not given was unaware of the proceeding to which such notice would have related and was prejudiced by the failure to give such notice but the omission so to notify such indemnifying party of any such action, suit or proceeding shall not relieve it from any liability that it may have to any indemnified party for contribution or otherwise than under this Section. In case any such action, suit or proceeding shall be brought against any indemnified party and it shall notify the indemnifying party of the commencement thereof, the indemnifying party shall be entitled to participate in, and, to the extent that it shall wish, jointly with any other indemnifying party similarly notified, to assume the defense thereof, with counsel reasonably satisfactory to such indemnified party, and after notice from the indemnifying party to such indemnified party of its election so to assume the defense thereof and the approval by the indemnified party of such counsel, the indemnifying party shall not be liable to such indemnified party for any legal or other expenses, except as provided below and except for the reasonable costs of investigation subsequently incurred by such indemnified party in connection with the defense thereof. The indemnified party shall have the right to employ its counsel in any such action, but the fees and expenses of such counsel shall be at the expense of such indemnified party unless (i) the employment of counsel by such indemnified party has been authorized in writing by the indemnifying parties, (ii) the indemnified party shall have been advised by counsel that there may be one or more legal defenses available to it which are different from or in addition to those available to the indemnifying party (in which case the indemnifying parties shall not have the right to direct the defense of such action on behalf of the indemnified party) or (iii) the indemnifying parties shall not have employed counsel to assume the defense of such action within a reasonable time after notice of the commencement thereof, in each of which cases the fees and expenses of counsel shall be at the expense of the indemnifying parties. An indemnifying party shall not be liable for any settlement of any action, suit, and proceeding or claim effected without its written consent, which consent shall not be unreasonably withheld or delayed.

 

6.           Contribution . In order to provide for just and equitable contribution in circumstances in which the indemnification provided for in Section 5(a) or 5(b) is due in accordance with its terms but for any reason is unavailable to or insufficient to hold harmless an indemnified party in respect to any losses, liabilities, claims, damages or expenses referred to therein, then each indemnifying party shall contribute to the aggregate losses, liabilities, claims, damages and expenses (including any investigation, legal and other expenses reasonably incurred in connection with, and any amount paid in settlement of, any action, suit or proceeding or any claims asserted, but after deducting any contribution received by any person entitled hereunder to contribution from any person who may be liable for contribution) incurred by such indemnified party, as incurred, in such proportion as is appropriate to reflect the relative benefits received by the Company on the one hand and the Underwriters on the other hand from the offering of the Shares pursuant to this Agreement or, if such allocation is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to above but also the relative fault of the Company on the one hand and the Underwriters on the other hand in connection with the statements or omissions which resulted in such losses, liabilities, claims, damages or expenses, as well as any other relevant equitable considerations. The Company and the Underwriters agree that it would not be just and equitable if contribution pursuant to this Section 6 were determined by pro rata allocation (even if the Underwriters were treated as one entity for such purpose) or by any other method of allocation which does not take account of the equitable considerations referred to above. The aggregate amount of losses, liabilities, claims, damages and expenses incurred by an indemnified party and referred to above shall be deemed to include any legal or other expenses reasonably incurred by such indemnified party in investigating, preparing or defending against any litigation, or any investigation or proceeding by any governmental agency or body, commenced or threatened, or any claim whatsoever based upon any such untrue or alleged untrue statement or omission or alleged omission. Notwithstanding the provisions of this Section 6, no Underwriter (except as may be provided in the Agreement Among Underwriters) shall be required to contribute any amount in excess of the underwriting discounts and commissions applicable to the Shares purchased by such Underwriter. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. For purposes of this Section 6, each person, if any, who controls an Underwriter within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act shall have the same rights to contribution as such Underwriter, and each director of the Company, including any person who, with his or her consent, is named in the Registration Statement as about to become a director of the Company, each officer of the Company who signed the Registration Statement, and each person, if any, who controls the Company within the meaning of the Section 15 of the Securities Act or Section 20 of the Exchange Act, shall have the same rights to contribution as the Company. Any party entitled to contribution will, promptly after receipt of notice of commencement of any action, suit or proceeding against such party in respect of which a claim for contribution may be made against another party or parties under this Section 6, notify such party or parties from whom contribution may be sought, but the omission so to notify such party or parties from whom contribution may be sought shall not relieve the party or parties from whom contribution may be sought from any other obligation it or they may have hereunder or otherwise than under this Section 6. No party shall be liable for contribution with respect to any action, suit, proceeding or claim settled without its written consent. The Underwriter’s obligations to contribute pursuant to this Section 6 are several in proportion to their respective underwriting commitments and not joint.

 

 

 

  

7.           Termination .

 

(a)          This Agreement may be terminated with respect to the Shares to be purchased on a Closing Date by the Representative by notifying the Company at any time at or before a Closing Date in the absolute discretion of the Representative if: (i) there has occurred any material adverse change in the securities markets or any event, act or occurrence that has materially disrupted, or in the opinion of the Representative, will in the future materially disrupt, the securities markets or there shall be such a material adverse change in general financial, political or economic conditions or the effect of international conditions on the financial markets in the United States is such as to make it, in the judgment of the Representative, inadvisable or impracticable to market the Shares or enforce contracts for the sale of the Shares; (ii) there has occurred any outbreak or material escalation of hostilities or acts of terrorism or other calamity or crisis the effect of which on the financial markets of the United States is such as to make it, in the judgment of the Representative, inadvisable or impracticable to market the Shares or enforce contracts for the sale of the Shares; (iii) trading in the Shares or any securities of the Company has been suspended or materially limited by the Commission or trading generally on the New York Stock Exchange, the NYSE American, the TASE, or the Nasdaq Stock Market has been suspended or materially limited, or minimum or maximum ranges for prices for securities shall have been fixed, or maximum ranges for prices for securities have been required, by any of said exchanges or by such system or by order of the Commission, FINRA, or any other governmental or regulatory authority; (iv) a banking moratorium has been declared by any state or federal authority; or (v) in the judgment of the Representative, there has been, since the time of execution of this Agreement or since the respective dates as of which information is given in the Prospectus, any material adverse change in the assets, properties, condition, financial or otherwise, or in the results of operations, business affairs or business prospects of the Company and its subsidiaries considered as a whole, whether or not arising in the ordinary course of business.

 

 

 

  

(b)          If this Agreement is terminated pursuant to any of its provisions, the Company shall not be under any liability to any Underwriter, and no Underwriter shall be under any liability to the Company, except that (y) if this Agreement is terminated by the Representative or the Underwriters because of any failure, refusal or inability on the part of the Company to comply with the terms or to fulfill any of the conditions of this Agreement, the Company will reimburse the Underwriters for all out-of-pocket expenses (including the reasonable fees and disbursements of their counsel) incurred by them in connection with the proposed purchase and sale of the Shares or in contemplation of performing their obligations hereunder and (z) no Underwriter who shall have failed or refused to purchase the Shares agreed to be purchased by it under this Agreement, without some reason sufficient hereunder to justify cancellation or termination of its obligations under this Agreement, shall be relieved of liability to the Company or to the other Underwriters for damages occasioned by its failure or refusal.

 

8.           Substitution of Underwriters . If any Underwriter shall default in its obligation to purchase on any Closing Date the Shares agreed to be purchased hereunder on such Closing Date, the Representative shall have the right, within 36 hours thereafter, to make arrangements for one or more of the non-defaulting Underwriters, or any other underwriters, to purchase such Shares on the terms contained herein. If, however, the Representative shall not have completed such arrangements within such 36-hour period, then the Company shall be entitled to a further period of thirty-six hours within which to procure another party or other parties satisfactory to the Underwriters to purchase such Shares on such terms. If, after giving effect to any arrangements for the purchase of the Shares of a defaulting Underwriter or Underwriters by the Representative and the Company as provided above, the aggregate number of Shares which remains unpurchased on such Closing Date does not exceed one-eleventh of the aggregate number of all the Shares that all the Underwriters are obligated to purchase on such date, then the Company shall have the right to require each non-defaulting Underwriter to purchase the number of Shares which such Underwriter agreed to purchase hereunder at such date and, in addition, to require each non-defaulting Underwriter to purchase its pro rata share (based on the number of Shares which such Underwriter agreed to purchase hereunder) of the Shares of such defaulting Underwriter or Underwriters for which such arrangements have not been made; but nothing herein shall relieve a defaulting Underwriter from liability for its default. In any such case, either the Representative or the Company shall have the right to postpone the applicable Closing Date for a period of not more than seven business days in order to effect any necessary changes and arrangements (including any necessary amendments or supplements to the Registration Statement or Prospectus or any other documents), and the Company agrees to file promptly any amendments to the Registration Statement or the Prospectus which in the opinion of the Company and the Underwriters and their respective counsels may thereby be made necessary.

 

If, after giving effect to any arrangements for the purchase of the Shares of a defaulting Underwriter or Underwriters by the Representative and the Company as provided above, the aggregate number of such Shares which remains unpurchased exceeds 10% of the aggregate number of all the Shares to be purchased at such date, then this Agreement, or, with respect to a Closing Date which occurs after the First Closing Date, the obligations of the Underwriters to purchase and of the Company to sell the Option Shares to be purchased and sold on such date, shall terminate, without liability on the part of any non-defaulting Underwriter to the Company, and without liability on the part of the Company, except as provided in Sections 4(b), 5, 6 and 7. The provisions of this Section 8 shall not in any way affect the liability of any defaulting Underwriter to the Company or the non-defaulting Underwriters arising out of such default. The term “Underwriter” as used in this Agreement shall include any person substituted under this Section 8 with like effect as if such person had originally been a party to this Agreement with respect to such Shares.

 

 

 

  

Nothing contained herein shall relieve a defaulting Underwriter of any liability it may have to the Company or any non-defaulting Underwriter for damages caused by its default.

 

9.           Persons Entitled to Benefit of Agreement . This Agreement has been and is made for the benefit of and binding upon the Underwriters, the Company, and their respective successors. This Agreement and the terms and provisions hereof are for the sole benefit of only those persons, except that (a) the representations, warranties, indemnities and agreements of the Company contained in this Agreement shall also be deemed to be for the benefit of the directors, officers and employees of the Underwriters and each person or persons, if any, who control any Underwriter within the meaning of Section 15 of the Securities Act, and (b) the indemnity agreement of the Underwriters contained in Section 5 of this Agreement shall be deemed to be for the benefit of the directors of the Company, the officers of the Company who have signed the Registration Statement and any person controlling the Company within the meaning of Section 15 of the Securities Act, but only to the extent specifically described herein. Nothing in this Agreement is intended or shall be construed to give any person, other than the persons referred to in this Section 9, any legal or equitable right, remedy or claim under or in respect of this Agreement or any provision contained herein.

 

10.          Miscellaneous . The respective agreements, representations, warranties, indemnities and other statements of the Company and the several Underwriters, as set forth in this Agreement or made by or on behalf of them pursuant to this Agreement, shall remain in full force and effect, regardless of any investigation (or any statement as to the results thereof) made by or on behalf of any Underwriter or the Company or any of their respective officers, directors or controlling persons referred to in Sections 5 and 6 hereof, and shall survive delivery of and payment for the Shares. In addition, the provisions of Sections 4(b), 5, 6 and 7 shall survive the termination or cancellation of this Agreement.

 

All notices and communications hereunder shall be in writing and mailed or delivered or by telephone or facsimile if subsequently confirmed in writing, (a) if to the Representative, c/o Oppenheimer & Co. Inc., 85 Broad Street, New York, New York 10004 Attention: Equity Capital Markets, with a copy to Oppenheimer & Co. Inc., 85 Broad Street, New York, New York 10004 Attention: General Counsel , with a copy to the Legal Department; and to Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., 666 Third Avenue, New York, New York 10017, Attention: Ivan K. Blumenthal, Esq., Facsimile: 212-983-3115, and (b) if to the Company, to its agent for service as such agent’s address appears on the cover page of the Registration Statement, with a copy to Mayer Brown LLP, 1221 Avenue of the Americas, New York, New York 10020, Attention: Anna T. Pinedo.

 

 

 

 

This Agreement shall be governed by and construed in accordance with the internal laws of the State of New York applicable to agreements made and to be performed in such state. Any legal suit, action or proceeding arising out of or based upon this Agreement or the transactions contemplated hereby (“Related Proceedings”) may be instituted in the federal courts of the United States of America located in the Borough of Manhattan in the City of New York or the courts of the State of New York in each case located in the Borough of Manhattan in the City of New York (collectively, the “Specified Courts”), and each party irrevocably submits to the exclusive jurisdiction (except for proceedings instituted in regard to the enforcement of a judgment of any such court (a “Related Judgment”), as to which such jurisdiction is non-exclusive) of such courts in any such suit, action or proceeding. Service of any process, summons, notice or document by mail to such party’s address set forth above shall be effective service of process for any suit, action or other proceeding brought in any such court. The parties irrevocably and unconditionally waive any objection to the laying of venue of any suit, action or other proceeding in the Specified Courts and irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such suit, action or other proceeding brought in any such court has been brought in an inconvenient forum. The Company has irrevocably appointed Anchiano Therapeutics, Inc., which currently maintains an office at One Kendall Square, Building 600, Suite 6-106, Cambridge, Massachusetts 02139, United States of America, as its agent to receive service of process or other legal summons for purposes of any such suit, action or proceeding that may be instituted in any state or federal court in the Borough of Manhattan in the City of New York, United States of America.

 

With respect to any Related Proceeding, each party irrevocably waives, to the fullest extent permitted by applicable law, all immunity (whether on the basis of sovereignty or otherwise) from jurisdiction, service of process, attachment (both before and after judgment) and execution to which it might otherwise be entitled in the Specified Courts, and with respect to any Related Judgment, each party waives any such immunity in the Specified Courts or any other court of competent jurisdiction, and will not raise or claim or cause to be pleaded any such immunity at or in respect of any such Related Proceeding or Related Judgment, including, without limitation, any immunity pursuant to the United States Foreign Sovereign Immunities Act of 1976, as amended.

 

The obligations of the Company pursuant to this Agreement in respect of any sum due to the Underwriters shall, notwithstanding any judgment in a currency other than United States dollars, not be discharged until the first business day, following receipt by the Underwriters of any sum adjudged to be so due in such other currency, on which the Underwriters may in accordance with normal banking procedures purchase United States dollars with such other currency. If the United States dollars so purchased are less than the sum originally due to the Underwriters in United States dollars hereunder, the Company agrees as a separate obligation and notwithstanding any such judgment, to indemnify the Underwriters against such loss. If the United States dollars so purchased are greater than the sum originally due to the Underwriters hereunder, the Underwriters agree to pay to the Company an amount equal to the excess of the dollars so purchased over the sum originally due to the Underwriters hereunder.

 

All payments made or deemed to be made by the Company under this Agreement, if any, will be made without withholding or deduction for or on account of any present or future taxes, duties, assessments or governmental charges of whatever nature (other than taxes on net income) imposed or levied by or on behalf of the State of Israel, any other jurisdiction from or through which payment is made, or, in each case, any political subdivision or any taxing authority thereof or therein unless the Company is or becomes required by law to withhold or deduct such taxes, duties, assessments or other governmental charges. In such event, the Company will pay such additional amounts as will result, after such withholding or deduction, in the receipt by each Underwriter, its officers and employees, and each person controlling any Underwriter, as the case may be, of the amounts that would otherwise have been receivable in respect thereof.

 

[Remainder of Page Intentionally Left Blank. Signature Page Follows.]

 

 

 

 

This Agreement may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument.

 

Please confirm that the foregoing correctly sets forth the agreement among us.

 

  Very truly yours,
   
  ANCHIANO THERAPEUTICS LTD.
     
  By        
    Title:

 

Confirmed:  
   
Acting severally on behalf of itself and  
as the Representative of the several Underwriters  
named in Schedule I annexed hereto.  
   
OPPENHEIMER & CO. INC.  
     
By                 
Title:    

 

[Signature Page to Underwriting Agreement]

 

 

 

 

 

Exhibit 4.1

 

 

 

ANCHIANO THERAPEUTICS LTD.

 

AND

 

THE BANK OF NEW YORK MELLON

 

As Depositary

 

AND

 

OWNERS AND HOLDERS OF AMERICAN DEPOSITARY SHARES

 

Deposit Agreement

 

Dated as of _______________, 2019

 

 

 

 

 

 

TABLE OF CONTENTS

 

ARTICLE 1. DEFINITIONS 1
SECTION 1.1. American Depositary Shares. 1
SECTION 1.2. Commission. 2
SECTION 1.3. Company. 2
SECTION 1.4. Custodian. 2
SECTION 1.5. Delisting Event. 2
SECTION 1.6. Deliver; Surrender. 2
SECTION 1.7. Deposit Agreement. 3
SECTION 1.8. Depositary; Depositary’s Office. 3
SECTION 1.9. Deposited Securities. 3
SECTION 1.10. Disseminate. 3
SECTION 1.11. Dollars. 4
SECTION 1.12. DTC. 4
SECTION 1.13. Foreign Registrar. 4
SECTION 1.14. Holder. 4
SECTION 1.15. Insolvency Event. 4
SECTION 1.16. Owner. 4
SECTION 1.17. Receipts. 5
SECTION 1.18. Registrar. 5
SECTION 1.19. Replacement. 5
SECTION 1.20. Restricted Securities. 5
SECTION 1.21. Securities Act of 1933. 5
SECTION 1.22. Shares. 5
SECTION 1.23. SWIFT. 6
SECTION 1.24. Termination Option Event. 6
     
ARTICLE 2. FORM OF RECEIPTS, DEPOSIT OF SHARES, DELIVERY, TRANSFER AND SURRENDER OF AMERICAN DEPOSITARY SHARES 6
SECTION 2.1. Form of Receipts; Registration and Transferability of American Depositary Shares. 6
SECTION 2.2. Deposit of Shares. 7
SECTION 2.3. Delivery of American Depositary Shares. 8
SECTION 2.4. Registration of Transfer of American Depositary Shares; Combination and Split-up of Receipts; Interchange of Certificated and Uncertificated American Depositary Shares. 8
SECTION 2.5. Surrender of American Depositary Shares and Withdrawal of Deposited Securities. 9
SECTION 2.6. Limitations on Delivery, Transfer and Surrender of American Depositary Shares. 10

 

- i -

 

 

SECTION 2.7. Lost Receipts, etc. 11
SECTION 2.8. Cancellation and Destruction of Surrendered Receipts. 12
SECTION 2.9. DTC Direct Registration System and Profile Modification System. 12
     
ARTICLE 3. CERTAIN OBLIGATIONS OF OWNERS AND HOLDERS OF AMERICAN DEPOSITARY SHARES 12
SECTION 3.1. Filing Proofs, Certificates and Other Information. 12
SECTION 3.2. Liability of Owner for Taxes. 13
SECTION 3.3. Warranties on Deposit of Shares. 13
SECTION 3.4. Disclosure of Interests. 14
     
ARTICLE 4. THE DEPOSITED SECURITIES 14
SECTION 4.1. Cash Distributions. 14
SECTION 4.2. Distributions Other Than Cash, Shares or Rights. 15
SECTION 4.3. Distributions in Shares. 16
SECTION 4.4. Rights. 17
SECTION 4.5. Conversion of Foreign Currency. 18
SECTION 4.6. Fixing of Record Date. 19
SECTION 4.7. Voting of Deposited Shares. 20
SECTION 4.8. Tender and Exchange Offers; Redemption, Replacement or Cancellation of Deposited Securities. 20
SECTION 4.9. Reports. 22
SECTION 4.10. Lists of Owners. 22
SECTION 4.11. Withholding. 23
     
ARTICLE 5. THE DEPOSITARY, THE CUSTODIANS AND THE COMPANY 23
SECTION 5.1. Maintenance of Office and Transfer Books by the Depositary. 23
SECTION 5.2. Prevention or Delay of Performance by the Company or the Depositary. 24
SECTION 5.3. Obligations of the Depositary and the Company. 25
SECTION 5.4. Resignation and Removal of the Depositary. 26
SECTION 5.5. The Custodians. 27
SECTION 5.6. Notices and Reports. 27
SECTION 5.7. Distribution of Additional Shares, Rights, etc. 28
SECTION 5.8. Indemnification. 29
SECTION 5.9. Charges of Depositary. 30
SECTION 5.10. Retention of Depositary Documents. 30
SECTION 5.11. Exclusivity. 31

 

- ii -

 

 

SECTION 5.12. Information for Regulatory Compliance. 31
     
ARTICLE 6. AMENDMENT AND TERMINATION 31
SECTION 6.1. Amendment. 31
SECTION 6.2. Termination. 32
     
ARTICLE 7. MISCELLANEOUS 33
SECTION 7.1. Counterparts; Signatures. 33
SECTION 7.2. No Third Party Beneficiaries. 33
SECTION 7.3. Severability. 33
SECTION 7.4. Owners and Holders as Parties; Binding Effect. 34
SECTION 7.5. Notices. 34
SECTION 7.6. Appointment of Agent for Service of Process; Submission to Jurisdiction; Jury Trial Waiver. 35
SECTION 7.7. Waiver of Immunities. 36
SECTION 7.8. Governing Law. 36

 

- iii -

 

 

DEPOSIT AGREEMENT

 

DEPOSIT AGREEMENT dated as of _________________, 2019 among ANCHIANO THERAPEUTICS LTD., a company incorporated under the laws of Israel (herein called the Company), THE BANK OF NEW YORK MELLON, a New York banking corporation (herein called the Depositary), and all Owners and Holders (each as hereinafter defined) from time to time of American Depositary Shares issued hereunder.

 

WITNESSETH:

 

WHEREAS, the Company desires to provide, as set forth in this Deposit Agreement, for the deposit of Shares (as hereinafter defined) of the Company from time to time with the Depositary or with the Custodian (as hereinafter defined) under this Deposit Agreement, for the creation of American Depositary Shares representing the Shares so deposited and for the execution and delivery of American Depositary Receipts evidencing the American Depositary Shares; and

 

WHEREAS, the American Depositary Receipts are to be substantially in the form of Exhibit A annexed to this Deposit Agreement, with appropriate insertions, modifications and omissions, as set forth in this Deposit Agreement;

 

NOW, THEREFORE, in consideration of the premises, it is agreed by and between the parties hereto as follows:

 

ARTICLE 1.            DEFINITIONS

 

The following definitions shall for all purposes, unless otherwise clearly indicated, apply to the respective terms used in this Deposit Agreement:

 

SECTION 1.1.         American Depositary Shares.

 

The term “ American Depositary Shares ” shall mean the securities created under this Deposit Agreement representing rights with respect to the Deposited Securities. American Depositary Shares may be certificated securities evidenced by Receipts or uncertificated securities. The form of Receipt annexed as Exhibit A to this Deposit Agreement shall be the prospectus required for an offer under the Securities Act of 1933 of both certificated and uncertificated American Depositary Shares. Except for those provisions of this Deposit Agreement that refer specifically to Receipts, all the provisions of this Deposit Agreement shall apply to both certificated and uncertificated American Depositary Shares.

 

Each American Depositary Share shall represent the number of Shares specified in Exhibit A to this Deposit Agreement, except that , if there is a distribution upon Deposited Securities covered by Section 4.3, a change in Deposited Securities covered by Section 4.8 with respect to which additional American Depositary Shares are not delivered or a sale of Deposited Securities under Section 3.2 or 4.8, each American Depositary Share shall thereafter represent the amount of Shares or other Deposited Securities that are then on deposit per American Depositary Share after giving effect to that distribution, change or sale.

 

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SECTION 1.2.          Commission.

 

The term “ Commission ” shall mean the Securities and Exchange Commission of the United States or any successor governmental agency in the United States.

 

SECTION 1.3.          Company.

 

The term “ Company ” shall mean Anchiano Therapeutics Ltd., a company incorporated under the laws of Israel, and its successors.

 

SECTION 1.4.          Custodian.

 

The term “ Custodian ” shall mean Bank Leumi and Bank Hapoalim, as custodian for the Depositary in Israel for the purposes of this Deposit Agreement, and any other firm or corporation the Depositary appoints under Section 5.5 as a substitute or additional custodian under this Deposit Agreement, and shall also mean all of them collectively.

 

SECTION 1.5.          Delisting Event.

 

A “ Delisting Event ” occurs if the American Depositary Shares are delisted from a securities exchange on which the American Depositary Shares were listed and the American Depositary Shares have not, within a reasonable period thereafter, been accepted for listing on any other securities exchange.

 

SECTION 1.6.          Deliver; Surrender.

 

(a)            The term “ deliver ”, or its noun form, when used with respect to Shares or other Deposited Securities, shall mean (i) book-entry transfer of those Shares or other Deposited Securities to an account maintained by an institution authorized under applicable law to effect transfers of such securities designated by the person entitled to that delivery or (ii) physical transfer of certificates evidencing those Shares or other Deposited Securities registered in the name of, or duly endorsed or accompanied by proper instruments of transfer to, the person entitled to that delivery.

 

(b)            The term “ deliver ”, or its noun form, when used with respect to American Depositary Shares, shall mean (i) registration of those American Depositary Shares in the name of DTC or its nominee and book-entry transfer of those American Depositary Shares to an account at DTC designated by the person entitled to that delivery, (ii) registration of those American Depositary Shares not evidenced by a Receipt on the books of the Depositary in the name requested by the person entitled to that delivery and mailing to that person of a statement confirming that registration or (iii) if requested by the person entitled to that delivery, execution and delivery at the Depositary’s Office to the person entitled to that delivery of one or more Receipts evidencing those American Depositary Shares registered in the name requested by that person.

 

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(c)            The term “ surrender ”, when used with respect to American Depositary Shares, shall mean (i) one or more book-entry transfers of American Depositary Shares to the DTC account of the Depositary, (ii) delivery to the Depositary at its Office of an instruction to surrender American Depositary Shares not evidenced by a Receipt or (iii) surrender to the Depositary at its Office of one or more Receipts evidencing American Depositary Shares.

 

SECTION 1.7.          Deposit Agreement.

 

The term “ Deposit Agreement ” shall mean this Deposit Agreement, as it may be amended from time to time in accordance with the provisions of this Deposit Agreement.

 

SECTION 1.8.          Depositary; Depositary’s Office.

 

The term “ Depositary ” shall mean The Bank of New York Mellon, a New York banking corporation, and any successor as depositary under this Deposit Agreement. The term “ Office ”, when used with respect to the Depositary, shall mean the office at which its depositary receipts business is administered, which, at the date of this Deposit Agreement, is located at 240 Greenwich Street, New York, New York 10286.

 

SECTION 1.9.          Deposited Securities.

 

The term “ Deposited Securities ” as of any time shall mean Shares at such time deposited or deemed to be deposited under this Deposit Agreement, including without limitation, Shares that have not been successfully delivered upon surrender of American Depositary Shares, and any and all other securities, property and cash received by the Depositary or the Custodian in respect of Deposited Securities and at that time held under this Deposit Agreement.

 

SECTION 1.10.        Disseminate.

 

The term “ Disseminate ,” when referring to a notice or other information to be sent by the Depositary to Owners, shall mean (i) sending that information to Owners in paper form by mail or another means or (ii) with the consent of Owners, another procedure that has the effect of making the information available to Owners, which may include (A) sending the information by electronic mail or electronic messaging or (B) sending in paper form or by electronic mail or messaging a statement that the information is available and may be accessed by the Owner on an Internet website and that it will be sent in paper form upon request by the Owner, when that information is so available and is sent in paper form as promptly as practicable upon request.

 

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SECTION 1.11.        Dollars.

 

The term “ Dollars ” shall mean United States dollars.

 

SECTION 1.12.        DTC.

 

The term “ DTC ” shall mean The Depository Trust Company or its successor.

 

SECTION 1.13.        Foreign Registrar.

 

The term “ Foreign Registrar ” shall mean the entity that carries out the duties of registrar for the Shares and any other agent of the Company for the transfer and registration of Shares, including, without limitation, any securities depository for the Shares.

 

SECTION 1.14.        Holder.

 

The term “ Holder ” shall mean any person holding a Receipt or a security entitlement or other interest in American Depositary Shares, whether for its own account or for the account of another person, but that is not the Owner of that Receipt or those American Depositary Shares.

 

SECTION 1.15.        Insolvency Event.

 

An “ Insolvency Event ” occurs if the Company institutes proceedings to be adjudicated as bankrupt or insolvent, consents to the institution of bankruptcy or insolvency proceedings against it, files a petition or answer or consent seeking reorganization or relief under any applicable law in respect of bankruptcy or insolvency, consents to the filing of any petition of that kind or to the appointment of a receiver, liquidator, assignee, trustee, custodian or sequestrator (or other similar official) of it or any substantial part of its property or makes an assignment for the benefit of creditors, or if the Company admits its inability to pay its debts as they become due in the ordinary course of business.

 

SECTION 1.16.        Owner.

 

The term “ Owner ” shall mean the person in whose name American Depositary Shares are registered on the books of the Depositary maintained for that purpose.

 

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SECTION 1.17.        Receipts.

 

The term “ Receipts ” shall mean the American Depositary Receipts issued under this Deposit Agreement evidencing certificated American Depositary Shares, as the same may be amended from time to time in accordance with the provisions of this Deposit Agreement.

 

SECTION 1.18.        Registrar.

 

The term “ Registrar ” shall mean any corporation or other entity that is appointed by the Depositary to register American Depositary Shares and transfers of American Depositary Shares as provided in this Deposit Agreement.

 

SECTION 1.19.        Replacement.

 

The term “ Replacement ” shall have the meaning assigned to it in Section 4.8.

 

SECTION 1.20.        Restricted Securities.

 

The term “ Restricted Securities ” shall mean Shares that (i) are “restricted securities,” as defined in Rule 144 under the Securities Act of 1933, except for Shares that could be resold in reliance on Rule 144 without any conditions, (ii) are control shares, meaning that such shares are beneficially owned by an officer, director (or person performing similar functions) or other affiliate of the Company, (iii) otherwise would require registration under the Securities Act of 1933 in connection with the public offer thereof in the United States or (iv) are subject to other restrictions on sale or deposit under the laws of Israel, a shareholder agreement or the articles of association or similar document of the Company.

 

SECTION 1.21.        Securities Act of 1933.

 

The term “ Securities Act of 1933 ” shall mean the United States Securities Act of 1933, as from time to time amended.

 

SECTION 1.22.        Shares.

 

The term “ Shares ” shall mean ordinary shares of the Company that are validly issued and outstanding, fully paid and nonassessable and that were not issued in violation of any pre-emptive or similar rights of the holders of outstanding securities of the Company; provided , however , that, if there shall occur any change in nominal or par value, a split-up or consolidation or any other reclassification or, upon the occurrence of an event described in Section 4.8, an exchange or conversion in respect of the Shares of the Company, the term “Shares” shall thereafter also mean the successor securities resulting from such change in nominal value, split-up or consolidation or such other reclassification or such exchange or conversion.

 

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SECTION 1.23.        SWIFT.

 

The term “ SWIFT ” shall mean the financial messaging network operated by the Society for Worldwide Interbank Financial Telecommunication, or its successor.

 

SECTION 1.24.        Termination Option Event.

 

The term “ Termination Option Event ” shall mean an event of a kind defined as such in Section 4.1, 4.2 or 4.8.

 

ARTICLE 2.           FORM OF RECEIPTS, DEPOSIT OF SHARES, DELIVERY, TRANSFER AND SURRENDER OF AMERICAN DEPOSITARY SHARES

 

SECTION 2.1.          Form of Receipts; Registration and Transferability of American Depositary Shares.

 

Definitive Receipts shall be substantially in the form set forth in Exhibit A to this Deposit Agreement, with appropriate insertions, modifications and omissions, as permitted under this Deposit Agreement. No Receipt shall be entitled to any benefits under this Deposit Agreement or be valid or obligatory for any purpose, unless that Receipt has been (i) executed by the Depositary by the manual signature of a duly authorized officer of the Depositary or (ii) executed by the facsimile signature of a duly authorized officer of the Depositary and countersigned by the manual signature of a duly authorized signatory of the Depositary or the Registrar or a co-registrar. The Depositary shall maintain books on which (x) each Receipt so executed and delivered as provided in this Deposit Agreement and each transfer of that Receipt and (y) all American Depositary Shares delivered as provided in this Deposit Agreement and all registrations of transfer of American Depositary Shares, shall be registered. A Receipt bearing the facsimile signature of a person that was at any time a proper officer of the Depositary shall, subject to the other provisions of this paragraph, bind the Depositary, even if that person was not a proper officer of the Depositary on the date of issuance of that Receipt.

 

The Receipts and statements confirming registration of American Depositary Shares may have incorporated in or attached to them such legends or recitals or modifications not inconsistent with the provisions of this Deposit Agreement as may reasonably be required by the Company or the Depositary, or required to comply with any applicable law or regulations thereunder or with the rules and regulations of any securities exchange upon which American Depositary Shares may be listed or to conform with any usage with respect thereto, or to indicate any special limitations or restrictions to which any particular Receipts and American Depositary Shares are subject by reason of the date of issuance of the underlying Deposited Securities or otherwise. The Depositary shall notify the Company as promptly as practicable if it imposes any legends, recitals or modifications under this paragraph.

 

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American Depositary Shares evidenced by a Receipt, when the Receipt is properly endorsed or accompanied by proper instruments of transfer, shall be transferable as certificated registered securities under the laws of the State of New York. American Depositary Shares not evidenced by Receipts shall be transferable as uncertificated registered securities under the laws of the State of New York. The Depositary, notwithstanding any notice to the contrary, may treat the Owner of American Depositary Shares as the absolute owner thereof for the purpose of determining the person entitled to distribution of dividends or other distributions or to any notice provided for in this Deposit Agreement and for all other purposes, and neither the Depositary nor the Company shall have any obligation or be subject to any liability under this Deposit Agreement to any Holder of American Depositary Shares (but only to the Owner of those American Depositary Shares).

 

SECTION 2.2.          Deposit of Shares.

 

Subject to the terms and conditions of this Deposit Agreement, Shares or evidence of rights to receive Shares may be deposited under this Deposit Agreement by delivery thereof to any Custodian, accompanied by any appropriate instruments or instructions for transfer, or endorsement, in form satisfactory to the Custodian.

 

As conditions of accepting Shares for deposit, the Depositary may require (i) any certification required by the Depositary or the Custodian in accordance with the provisions of this Deposit Agreement, (ii) a written order directing the Depositary to deliver to, or upon the written order of, the person or persons stated in that order American Depositary Shares representing those deposited Shares, (iii) evidence satisfactory to the Depositary that those Shares have been re-registered in the books of the Company or the Foreign Registrar in the name of the Depositary, a Custodian or a nominee of the Depositary or a Custodian, (iv) evidence satisfactory to the Depositary that any necessary approval for the transfer or deposit has been granted by any governmental body in each applicable jurisdiction and (v) an agreement or assignment, or other instrument satisfactory to the Depositary, that provides for the prompt transfer to the Custodian of any dividend, or right to subscribe for additional Shares or to receive other property, that any person in whose name those Shares are or have been recorded may thereafter receive upon or in respect of those Shares, or, in lieu thereof, such agreement of indemnity or other agreement as shall be satisfactory to the Depositary.

 

At the request and risk and expense of a person proposing to deposit Shares, and for the account of that person, the Depositary may receive certificates for Shares to be deposited, together with the other instruments specified in this Section, for the purpose of forwarding those Share certificates to the Custodian for deposit under this Deposit Agreement.

 

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The Depositary shall refuse, and shall instruct the Custodian to refuse, to accept Shares for deposit if the Depositary has received a notice from the Company that the Company has restricted transfer of those Shares under the Company’s articles of association or any applicable laws or that the deposit would result in any violation of the Company’s articles of association or any applicable laws.

 

The Depositary shall instruct each Custodian that, upon each delivery to a Custodian of a certificate or certificates for Shares to be deposited under this Deposit Agreement, together with the other documents specified in this Section, that Custodian shall, as soon as transfer and recordation can be accomplished, present that certificate or those certificates to the Company or the Foreign Registrar, if applicable, for transfer and recordation of the Shares being deposited in the name of the Depositary or its nominee or that Custodian or its nominee.

 

Deposited Securities shall be held by the Depositary or by a Custodian for the account and to the order of the Depositary or at such other place or places as the Depositary shall determine.

 

SECTION 2.3.          Delivery of American Depositary Shares.

 

The Depositary shall instruct each Custodian that, upon receipt by that Custodian of any deposit pursuant to Section 2.2, together with the other documents or evidence required under that Section, that Custodian shall notify the Depositary of that deposit and the person or persons to whom or upon whose written order American Depositary Shares are deliverable in respect thereof. Upon receiving a notice of a deposit from a Custodian, or upon the receipt of Shares or evidence of the right to receive Shares by the Depositary, the Depositary, subject to the terms and conditions of this Deposit Agreement, shall, without unreasonable delay, deliver, to or upon the order of the person or persons entitled thereto, the number of American Depositary Shares issuable in respect of that deposit, but only upon payment to the Depositary of the fees and expenses of the Depositary for the delivery of those American Depositary Shares as provided in Section 5.9, and of all taxes and governmental charges and fees payable in connection with that deposit and the transfer of the deposited Shares. However , the Depositary shall deliver only whole numbers of American Depositary Shares.

 

SECTION 2.4.          Registration of Transfer of American Depositary Shares; Combination and Split-up of Receipts; Interchange of Certificated and Uncertificated American Depositary Shares.

 

The Depositary, subject to the terms and conditions of this Deposit Agreement, shall register a transfer of American Depositary Shares on its transfer books upon (i) in the case of certificated American Depositary Shares, surrender of the Receipt evidencing those American Depositary Shares, by the Owner or by a duly authorized attorney, properly endorsed or accompanied by proper instruments of transfer or (ii) in the case of uncertificated American Depositary Shares, receipt from the Owner of a proper instruction (including, for the avoidance of doubt, instructions through DRS and Profile as provided in Section 2.9), and, in either case, duly stamped as may be required by the laws of the State of New York and of the United States of America. Upon registration of a transfer, the Depositary shall deliver the transferred American Depositary Shares to or upon the order of the person entitled thereto.

 

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The Depositary, subject to the terms and conditions of this Deposit Agreement, shall upon surrender of a Receipt or Receipts for the purpose of effecting a split-up or combination of such Receipt or Receipts, execute and deliver a new Receipt or Receipts for any authorized number of American Depositary Shares requested, evidencing the same aggregate number of American Depositary Shares as the Receipt or Receipts surrendered.

 

The Depositary, upon surrender of certificated American Depositary Shares for the purpose of exchanging for uncertificated American Depositary Shares, shall cancel the Receipt evidencing those certificated American Depositary Shares and send the Owner a statement confirming that the Owner is the owner of the same number of uncertificated American Depositary Shares. The Depositary, upon receipt of a proper instruction (including, for the avoidance of doubt, instructions through DRS and Profile as provided in Section 2.9) from the Owner of uncertificated American Depositary Shares for the purpose of exchanging for certificated American Depositary Shares, shall cancel those uncertificated American Depositary Shares and register and deliver to the Owner a Receipt evidencing the same number of certificated American Depositary Shares.

 

The Depositary may appoint one or more co-transfer agents for the purpose of effecting registration of transfers of American Depositary Shares and combinations and split-ups of Receipts at designated transfer offices on behalf of the Depositary. In carrying out its functions, a co-transfer agent may require evidence of authority and compliance with applicable laws and other requirements by Owners or persons entitled to American Depositary Shares and will be entitled to protection and indemnity to the same extent as the Depositary. The Depositary shall notify the Company if it appoints a co-transfer agent under this paragraph.

 

SECTION 2.5.          Surrender of American Depositary Shares and Withdrawal of Deposited Securities.

 

Upon surrender of American Depositary Shares for the purpose of withdrawal of the Deposited Securities represented thereby and payment of the fee of the Depositary for the surrender of American Depositary Shares as provided in Section 5.9 and payment of all taxes and governmental charges payable in connection with that surrender and withdrawal of the Deposited Securities, and subject to the terms and conditions of this Deposit Agreement, the Owner of those American Depositary Shares shall be entitled to delivery (to the extent delivery can then be lawfully and practicably made), to or as instructed by that Owner, of the amount of Deposited Securities at the time represented by those American Depositary Shares, but not any money or other property as to which a record date for distribution to Owners has passed (since money or other property of that kind will be delivered or paid on the scheduled payment date to the Owner as of that record date), and except that the Depositary shall not be required to accept surrender of American Depositary Shares for the purpose of withdrawal to the extent it would require delivery of a fraction of a Deposited Security. That delivery shall be made, as provided in this Section, without unreasonable delay.

 

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As a condition of accepting a surrender of American Depositary Shares for the purpose of withdrawal of Deposited Securities, the Depositary may require (i) that each surrendered Receipt be properly endorsed in blank or accompanied by proper instruments of transfer in blank and (ii) that the surrendering Owner execute and deliver to the Depositary a written order directing the Depositary to cause the Deposited Securities being withdrawn to be delivered to or upon the written order of a person or persons designated in that order.

 

Thereupon, the Depositary shall direct the Custodian to deliver, subject to Sections 2.6, 3.1 and 3.2, the other terms and conditions of this Deposit Agreement and local market rules and practices, to the surrendering Owner or to or upon the written order of the person or persons designated in the order delivered to the Depositary as above provided, the amount of Deposited Securities represented by the surrendered American Depositary Shares, and the Depositary may charge the surrendering Owner a fee and its expenses for giving that direction by cable (including SWIFT) or facsimile transmission.

 

If Deposited Securities are delivered physically upon surrender of American Depositary Shares for the purpose of withdrawal, that delivery will be made at the Custodian’s office, except that , at the request, risk and expense of an Owner surrendering American Depositary Shares for withdrawal of Deposited Securities, and for the account of that Owner, the Depositary shall direct the Custodian to forward any cash or other property comprising, and forward a certificate or certificates, if applicable, and other proper documents of title, if any, for, the Deposited Securities represented by the surrendered American Depositary Shares to the Depositary for delivery at the Depositary’s Office or to another address specified in the order received from the surrendering Owner.

 

SECTION 2.6.          Limitations on Delivery, Transfer and Surrender of American Depositary Shares.

 

As a condition precedent to the delivery, registration of transfer or surrender of any American Depositary Shares or split-up or combination of any Receipt or withdrawal of any Deposited Securities, the Depositary, Custodian or Registrar may require payment from the depositor of Shares or the presenter of the Receipt or instruction for registration of transfer or surrender of American Depositary Shares not evidenced by a Receipt of a sum sufficient to reimburse it for any tax or other governmental charge and any stock transfer or registration fee with respect thereto (including any such tax or charge and fee with respect to Shares being deposited or withdrawn) and payment of any applicable fees as provided in this Deposit Agreement, may require the production of proof satisfactory to it as to the identity and genuineness of any signature and may also require compliance with any regulations the Depositary may establish consistent with the provisions of this Deposit Agreement, including, without limitation, this Section 2.6.

 

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The delivery of American Depositary Shares against deposit of Shares generally or against deposit of particular Shares may be suspended, or the registration of transfer of American Depositary Shares in particular instances may be refused, or the registration of transfer of outstanding American Depositary Shares generally may be suspended, during any period when the transfer books of the Depositary are closed, or if any such action is deemed necessary or advisable by the Depositary or the Company at any time or from time to time because of any requirement of law or of any government or governmental body or commission, or under any provision of this Deposit Agreement, or for any other reason. Notwithstanding anything to the contrary in this Deposit Agreement, the surrender of outstanding American Depositary Shares and withdrawal of Deposited Securities may not be suspended, subject only to (i) temporary delays caused by closing of the transfer books of the Depositary or the Company or the Foreign Registrar, if applicable, or the deposit of Shares in connection with voting at a shareholders’ meeting, or the payment of dividends, (ii) the payment of fees, taxes and similar charges, and (iii) compliance with any U.S. or foreign laws or governmental regulations relating to the American Depositary Shares or to the withdrawal of the Deposited Securities.

 

The Depositary shall not knowingly accept for deposit under this Deposit Agreement any Shares that, at the time of deposit, are Restricted Securities or for which the Depositary has received written instructions from the Company that the deposit of those Shares would violate applicable law or regulation.

 

SECTION 2.7.          Lost Receipts, etc.

 

If a Receipt is mutilated, destroyed, lost or stolen, the Depositary shall deliver to the Owner the American Depositary Shares evidenced by that Receipt in uncertificated form or, if requested by the Owner, execute and deliver a new Receipt of like tenor in exchange and substitution for such mutilated Receipt, upon surrender and cancellation of that mutilated Receipt, or in lieu of and in substitution for that destroyed, lost or stolen Receipt. However , before the Depositary will deliver American Depositary Shares in uncertificated form or execute and deliver a new Receipt, in substitution for a destroyed, lost or stolen Receipt, the Owner must (a) file with the Depositary (i) a request for that replacement before the Depositary has notice that the Receipt has been acquired by a bona fide purchaser and (ii) a sufficient indemnity bond and (b) satisfy any other reasonable requirements imposed by the Depositary.

 

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SECTION 2.8.          Cancellation and Destruction of Surrendered Receipts.

 

The Depositary shall cancel all Receipts surrendered to it and is authorized to destroy Receipts so cancelled.

 

SECTION 2.9.          DTC Direct Registration System and Profile Modification System.

 

(a)             Notwithstanding the provisions of Section 2.4, the parties acknowledge that DTC’s Direct Registration System (“ DRS ”) and Profile Modification System (“ Profile ”) apply to the American Depositary Shares upon acceptance thereof to DRS by DTC. DRS is the system administered by DTC that facilitates interchange between registered holding of uncertificated securities and holding of security entitlements in those securities through DTC and a DTC participant. Profile is a required feature of DRS that allows a DTC participant, claiming to act on behalf of an Owner of American Depositary Shares, to direct the Depositary to register a transfer of those American Depositary Shares to DTC or its nominee and to deliver those American Depositary Shares to the DTC account of that DTC participant without receipt by the Depositary of prior authorization from the Owner to register that transfer.

 

(b)            In connection with DRS/Profile, the parties acknowledge that the Depositary will not determine whether the DTC participant that is claiming to be acting on behalf of an Owner in requesting a registration of transfer and delivery as described in paragraph (a) above has the actual authority to act on behalf of that Owner (notwithstanding any requirements under the Uniform Commercial Code). For the avoidance of doubt, the provisions of Sections 5.3 and 5.8 apply to the matters arising from the use of the DRS/Profile. The parties agree that the Depositary’s reliance on and compliance with instructions received by the Depositary through the DRS/Profile system and otherwise in accordance with this Deposit Agreement shall not constitute negligence or bad faith on the part of the Depositary.

 

ARTICLE 3.           CERTAIN OBLIGATIONS OF OWNERS AND HOLDERS OF AMERICAN DEPOSITARY SHARES

 

SECTION 3.1.          Filing Proofs, Certificates and Other Information.

 

Any person presenting Shares for deposit or any Owner or Holder may be required from time to time to file with the Depositary or the Custodian such proof of citizenship or residence, exchange control approval, or such information relating to the registration on the books of the Company or the Foreign Registrar, if applicable, to execute such certificates and to make such representations and warranties, as the Depositary may deem necessary or proper. The Depositary may withhold the delivery or registration of transfer of American Depositary Shares, the distribution of any dividend or other distribution or of the proceeds thereof or the delivery of any Deposited Securities until that proof or other information is filed or those certificates are executed or those representations and warranties are made.

 

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Upon the reasonable written request and at the expense of the Company, the Depositary shall, as promptly as practicable, provide to the Company copies or originals, if necessary or appropriate, of any proofs of citizenship or residence, taxpayer status, exchange control approval, information, certificate or other representations and warranties that the Depositary receives under this Section 3.1 from the Owner or Holder or any person presenting Shares for deposit, to the extent that disclosure is permitted under applicable law. Each Owner and Holder agrees to provide any information reasonably requested by the Company or the Depositary pursuant to this Section 3.1. Neither the Company nor the Depositary is responsible for monitoring the Owners’ or the Holders’ compliance with applicable laws and regulations or their legal right to acquire Shares or American Depositary Shares.

 

SECTION 3.2.          Liability of Owner for Taxes.

 

If any tax or other governmental charge shall become payable by the Custodian or the Depositary with respect to or in connection with any American Depositary Shares or any Deposited Securities represented by any American Depositary Shares or in connection with a transaction to which Section 4.8 applies, that tax or other governmental charge shall be payable by the Owner of those American Depositary Shares to the Depositary. The Depositary may refuse to register any transfer of those American Depositary Shares or any withdrawal of Deposited Securities represented by those American Depositary Shares until that payment is made, and may withhold any dividends or other distributions or the proceeds thereof, or may sell for the account of the Owner any part or all of the Deposited Securities represented by those American Depositary Shares and apply those dividends or other distributions or the net proceeds of any sale of that kind in payment of that tax or other governmental charge but , even after a sale of that kind, the Owner of those American Depositary Shares shall remain liable for any deficiency. The Depositary shall distribute any net proceeds of a sale made under this Section that are not used to pay taxes or governmental charges to the Owners entitled to them in accordance with Section 4.1. If the number of Shares represented by each American Depositary Share decreases as a result of a sale of Deposited Securities under this Section, the Depositary may call for surrender of the American Depositary Shares to be exchanged on a mandatory basis for a lesser number of American Depositary Shares and may sell American Depositary Shares to the extent necessary to avoid distributing fractions of American Depositary Shares in that exchange and distribute the net proceeds of that sale to the Owners entitled to them.

 

SECTION 3.3.          Warranties on Deposit of Shares.

 

Every person depositing Shares under this Deposit Agreement shall be deemed thereby to represent and warrant that those Shares and each certificate therefor, if applicable, are validly issued, fully paid and nonassessable and were not issued in violation of any preemptive or similar rights of the holders of outstanding securities of the Company and that the person making that deposit is duly authorized so to do. Every depositing person shall also be deemed to represent that the Shares, at the time of deposit, are not Restricted Securities. All representations and warranties deemed made under this Section shall survive the deposit of Shares and delivery of American Depositary Shares.

 

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SECTION 3.4.          Disclosure of Interests.

 

When required in order to comply with applicable laws and regulations or the articles of association or similar document of the Company, the Company may from time to time request each Owner and Holder to provide to the Depositary information relating to: (a) the capacity in which it holds American Depositary Shares, (b) the identity of any Holders or other persons or entities then or previously interested in those American Depositary Shares and the nature of those interests and (c) any other matter where disclosure of such matter is, in the Company’s reasonable opinion, required for that compliance.   Each Owner and Holder agrees to provide all information known to it in response to a request made pursuant to this Section.  Each Holder consents to the disclosure by the Depositary and the Owner or any other Holder through which it holds American Depositary Shares, directly or indirectly, of all information responsive to a request made pursuant to this Section relating to that Holder that is known to that Owner or other Holder.  The Depositary agrees to use reasonable efforts to comply with written instructions requesting that the Depositary forward any request authorized under this Section to the Owners and to forward to the Company any responses it receives in response to that request. The Depositary may charge the Company a fee and its expenses for complying with requests under this Section 3.4.

 

As of the date of this Deposit Agreement, each Owner and Holder agrees, if it instructs the Depositary to exercise voting rights with respect to Deposited Shares, that it will comply with any applicable Israeli law requiring it to, inter alia, disclose any personal interest it might have in the matter on the agenda of the general meeting. The Company undertakes no obligations to update this Section to reflect changes in law that occur after the date of this Deposit Agreement.

 

ARTICLE 4.           THE DEPOSITED SECURITIES

 

SECTION 4.1.          Cash Distributions.

 

Whenever the Depositary receives any cash dividend or other cash distribution on Deposited Securities, the Depositary shall, subject to the provisions of Section 4.5, convert that dividend or other distribution into Dollars and distribute the amount thus received (net of the fees and expenses of the Depositary as provided in Section 5.9) to the Owners entitled thereto, in proportion to the number of American Depositary Shares representing those Deposited Securities held by them respectively; provided , however , that if the Custodian or the Depositary shall be required to withhold and does withhold from that cash dividend or other cash distribution an amount on account of taxes or other governmental charges, the amount distributed to the Owners of the American Depositary Shares representing those Deposited Securities shall be reduced accordingly. However , the Depositary will not pay any Owner a fraction of one cent, but will round each Owner’s entitlement to the nearest whole cent.

 

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The Company or its agent will remit to the appropriate governmental agency in each applicable jurisdiction all amounts withheld and owing to such agency. The Depositary will forward to the Company or its agent such information from its records as the Company may reasonably request to enable the Company or its agent to file necessary reports with governmental agencies.

 

If a cash distribution would represent a return of all or substantially all the value of the Deposited Securities underlying American Depositary Shares, the Depositary may, after consultation with the Company to the extent practicable, require surrender of those American Depositary Shares and may require payment of or deduct the fee for surrender of American Depositary Shares (whether or not it is also requiring surrender of American Depositary Shares) as a condition of making that cash distribution. A distribution of that kind shall be a Termination Option Event .

 

SECTION 4.2.          Distributions Other Than Cash, Shares or Rights.

 

Subject to the provisions of Sections 4.11 and 5.9, whenever the Depositary receives any distribution other than a distribution described in Section 4.1, 4.3 or 4.4 on Deposited Securities (but not in exchange for or in conversion or in lieu of Deposited Securities), the Depositary shall cause the securities or property received by it to be distributed to the Owners entitled thereto, after deduction or upon payment of any fees and expenses of the Depositary and any taxes or other governmental charges, in proportion to the number of American Depositary Shares representing such Deposited Securities held by them respectively, in any manner that the Depositary deems equitable and practicable for accomplishing that distribution (which may be a distribution of depositary shares representing the securities received); provided , however , that if in the opinion of the Depositary such distribution cannot be made proportionately among the Owners entitled thereto, or if for any other reason (including, but not limited to, any requirement that the Company or the Depositary withhold an amount on account of taxes or other governmental charges or that securities received must be registered under the Securities Act of 1933 in order to be distributed to Owners or Holders) the Depositary deems such distribution not to be lawful and feasible, the Depositary may, after consultation with the Company to the extent practicable, adopt such other method as it may deem equitable and practicable for the purpose of effecting such distribution, including, but not limited to, the public or private sale of the securities or property thus received, or any part thereof, and distribution of the net proceeds of any such sale (net of the fees and expenses of the Depositary as provided in Section 5.9) to the Owners entitled thereto, all in the manner and subject to the conditions set forth in Section 4.1. The Depositary may withhold any distribution of securities under this Section 4.2 if it has not received satisfactory assurances from the Company that the distribution does not require registration under the Securities Act of 1933. The Depositary may sell, by public or private sale, an amount of securities or other property it would otherwise distribute under this Section 4.2 that is sufficient to pay its fees and expenses in respect of that distribution.

 

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If a distribution under this Section 4.2 would represent a return of all or substantially all the value of the Deposited Securities underlying American Depositary Shares, the Depositary may require surrender of those American Depositary Shares and may require payment of or deduct the fee for surrender of American Depositary Shares (whether or not it is also requiring surrender of American Depositary Shares) as a condition of making that distribution. A distribution of that kind shall be a Termination Option Event .

 

SECTION 4.3.       Distributions in Shares.

 

Whenever the Depositary receives any distribution on Deposited Securities consisting of a dividend in, or free distribution of, Shares, the Depositary may and, if so requested in writing by the Company, shall, deliver to the Owners entitled thereto, in proportion to the number of American Depositary Shares representing those Deposited Securities held by them respectively, an aggregate number of American Depositary Shares representing the amount of Shares received as that dividend or free distribution, subject to the terms and conditions of this Deposit Agreement with respect to the deposit of Shares and issuance of American Depositary Shares, including withholding of any tax or governmental charge as provided in Section 4.11 and payment of the fees and expenses of the Depositary as provided in Section 5.9 (and the Depositary may sell, by public or private sale, an amount of the Shares received (or American Depositary Shares representing those Shares) sufficient to pay its fees and expenses in respect of that distribution). In lieu of delivering fractional American Depositary Shares, the Depositary may sell the amount of Shares represented by the aggregate of those fractions (or American Depositary Shares representing those Shares) and distribute the net proceeds, all in the manner and subject to the conditions described in Section 4.1. If and to the extent that additional American Depositary Shares are not delivered and Shares or American Depositary Shares are not sold, each American Depositary Share shall thenceforth also represent the additional Shares distributed on the Deposited Securities represented thereby.

 

If the Company declares a distribution in which holders of Deposited Securities have a right to elect whether to receive cash, Shares or other securities or a combination of those things, or a right to elect to have a distribution sold on their behalf, the Depositary may, after consultation with the Company, make that right of election available for exercise by Owners in any manner the Depositary considers to be lawful and practical. As a condition of making a distribution election right available to Owners, the Depositary may require satisfactory assurances from the Company that doing so does not require registration of any securities under the Securities Act of 1933.

 

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SECTION 4.4.       Rights.

 

(a)          If rights are granted to the Depositary in respect of deposited Shares to purchase additional Shares or other securities, the Company and the Depositary shall endeavor to consult as to the actions, if any, the Depositary should take in connection with that grant of rights. The Depositary may, to the extent deemed by it to be lawful and practical (i) if requested in writing by the Company, grant to all or certain Owners rights to instruct the Depositary to purchase the securities to which the rights relate and deliver those securities or American Depositary Shares representing those securities to Owners, (ii) if requested in writing by the Company, deliver the rights to or to the order of certain Owners, or (iii) sell the rights to the extent practicable and distribute the net proceeds of that sale to Owners entitled to those proceeds. To the extent rights are not exercised, delivered or disposed of under (i), (ii) or (iii) above, the Depositary shall permit the rights to lapse unexercised.

 

(b)          If the Depositary will act under (a)(i) above, the Company and the Depositary will enter into a separate agreement setting forth the conditions and procedures applicable to the particular offering. Upon instruction from an applicable Owner in the form the Depositary specified and upon payment by that Owner to the Depositary of an amount equal to the purchase price of the securities to be received upon the exercise of the rights, the Depositary shall, on behalf of that Owner, exercise the rights and purchase the securities. The purchased securities shall be delivered to, or as instructed by, the Depositary. The Depositary shall (i) deposit the purchased Shares under this Deposit Agreement and deliver American Depositary Shares representing those Shares to that Owner or (ii) deliver or cause the purchased Shares or other securities to be delivered to or to the order of that Owner. The Depositary will not act under (a)(i) above unless the offer and sale of the securities to which the rights relate are registered under the Securities Act of 1933 or the Depositary has received an opinion of United States counsel that is satisfactory to it to the effect that those securities may be sold and delivered to the applicable Owners without registration under the Securities Act of 1933.

 

(c)          If the Depositary will act under (a)(ii) above, the Company and the Depositary will enter into a separate agreement setting forth the conditions and procedures applicable to the particular offering. Upon (i) the request of an applicable Owner to deliver the rights allocable to the American Depositary Shares of that Owner to an account specified by that Owner to which the rights can be delivered and (ii) receipt of such documents as the Company and the Depositary agreed to require to comply with applicable law, the Depositary will deliver those rights as requested by that Owner.

 

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(d)          If the Depositary will act under (a)(iii) above, the Depositary will use reasonable efforts to sell the rights in proportion to the number of American Depositary Shares held by the applicable Owners and pay the net proceeds to the Owners otherwise entitled to the rights that were sold, upon an averaged or other practical basis without regard to any distinctions among such Owners because of exchange restrictions or the date of delivery of any American Depositary Shares or otherwise.

 

(e)          Payment or deduction of the fees of the Depositary as provided in Section 5.9 and payment or deduction of the expenses of the Depositary and any applicable taxes or other governmental charges shall be conditions of any delivery of securities or payment of cash proceeds under this Section 4.4.

 

(f)          The Depositary shall not be responsible for any failure to determine that it may be lawful or feasible to make rights available to or exercise rights on behalf of Owners in general or any Owner in particular, or to sell rights.

 

SECTION 4.5.       Conversion of Foreign Currency.

 

Whenever the Depositary or the Custodian receives foreign currency, by way of dividends or other distributions or the net proceeds from the sale of securities, property or rights, and if at the time of the receipt thereof the foreign currency so received can in the judgment of the Depositary be converted on a reasonable basis into Dollars and the resulting Dollars transferred to the United States, the Depositary shall convert or cause to be converted by sale or in any other manner that it may determine that foreign currency into Dollars, and those Dollars shall be distributed to the Owners entitled thereto. A cash distribution may be made upon an averaged or other practicable basis without regard to any distinctions among Owners based on exchange restrictions, the date of delivery of any American Depositary Shares or otherwise and shall be net of any expenses of conversion into Dollars incurred by the Depositary as provided in Section 5.9.

 

If a conversion of foreign currency or the repatriation or distribution of Dollars can be effected only with the approval or license of any government or agency thereof, the Depositary may, but will not be required to, file an application for that approval or license.

 

If the Depositary determines that in its judgment any foreign currency received by the Depositary or the Custodian is not convertible on a reasonable basis into Dollars transferable to the United States, or if any approval or license of any government or agency thereof that is required for such conversion is not filed or sought by the Depositary or is not obtained within a reasonable period as determined by the Depositary, the Depositary may distribute the foreign currency received by the Depositary to, or in its discretion may hold such foreign currency uninvested and without liability for interest thereon for the respective accounts of, the Owners entitled to receive the same.

 

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If any conversion of foreign currency, in whole or in part, cannot be effected for distribution to some of the Owners entitled thereto, the Depositary may in its discretion make that conversion and distribution in Dollars to the extent practicable and permissible to the Owners entitled thereto and may distribute the balance of the foreign currency received by the Depositary to, or hold that balance uninvested and without liability for interest thereon for the account of, the Owners entitled thereto.

 

The Depositary may convert currency itself or through any of its affiliates and, in those cases, acts as principal for its own account and not as agent, advisor, broker or fiduciary on behalf of any other person and earns revenue, including, without limitation, transaction spreads, that it will retain for its own account.  The revenue is based on, among other things, the difference between the exchange rate assigned to the currency conversion made under this Deposit Agreement and the rate that the Depositary or its affiliate receives when buying or selling foreign currency for its own account.  The Depositary makes no representation that the exchange rate used or obtained in any currency conversion under this Deposit Agreement will be the most favorable rate that could be obtained at the time or that the method by which that rate will be determined will be the most favorable to Owners, subject to the Depositary’s obligations under Section 5.3. The methodology used to determine exchange rates used in currency conversions is available upon request.

 

SECTION 4.6.       Fixing of Record Date.

 

Whenever a cash dividend, cash distribution or any other distribution is made on Deposited Securities or rights to purchase Shares or other securities are issued with respect to Deposited Securities (which rights will be delivered to or exercised or sold on behalf of Owners in accordance with Section 4.4) or the Depositary receives notice that a distribution or issuance of that kind will be made, or whenever the Depositary receives notice that a meeting of holders of Shares will be held in respect of which the Company has requested the Depositary to send a notice under Section 4.7, or whenever the Depositary will assess a fee or charge against the Owners, or whenever the Depositary causes a change in the number of Shares that are represented by each American Depositary Share, or whenever the Depositary otherwise finds it necessary or convenient, the Depositary shall fix a record date, which shall be the same as, or as near as practicable to, any corresponding record date set by the Company with respect to Shares, (a) for the determination of the Owners (i) who shall be entitled to receive the benefit of that dividend or other distribution or those rights, (ii) who shall be entitled to give instructions for the exercise of voting rights at that meeting or (iii) who shall be responsible for that fee or charge or (iv) for any other purpose for which the record date was set, or (b) on or after which each American Depositary Share will represent the changed number of Shares. Subject to the provisions of Sections 4.1 through 4.5 and to the other terms and conditions of this Deposit Agreement, the Owners on a record date fixed by the Depositary shall be entitled to receive the amount distributable by the Depositary with respect to that dividend or other distribution or those rights or the net proceeds of sale thereof in proportion to the number of American Depositary Shares held by them respectively, to give voting instructions or to act in respect of the other matter for which that record date was fixed, or be responsible for that fee or charge, as the case may be.

 

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SECTION 4.7.       Voting of Deposited Shares.

 

(a)          Upon receipt of notice from the Company of any meeting of holders of Shares at which holders of Shares will be entitled to vote, if requested in writing by the Company, the Depositary shall, as soon as practicable thereafter, Disseminate to the Owners a notice, the form of which shall be prepared by the Depositary and approved by the Company, that shall contain (i) the information contained in the notice of meeting received by the Depositary, (ii) a statement that the Owners as of the close of business on a specified record date will be entitled, subject to any applicable provision of Israeli law and of the articles of association or similar documents of the Company, to instruct the Depositary as to the exercise of the voting rights pertaining to the amount of Shares represented by their respective American Depositary Shares, (iii) a statement as to the manner in which those instructions may be given and (iv) the last date on which the Depositary will accept instructions (the “ Instruction Cutoff Date ”).

 

(b)          Upon the written request of an Owner of American Depositary Shares, as of the date of the request or, if a record date was specified by the Depositary, as of that record date, received on or before any Instruction Cutoff Date established by the Depositary, the Depositary may, and if the Depositary sent a notice under the preceding paragraph shall, endeavor, in so far as practicable, to vote or cause to be voted the amount of deposited Shares represented by those American Depositary Shares in accordance with the instructions set forth in that request. The Depositary shall not vote or attempt to exercise the right to vote that attaches to the deposited Shares other than in accordance with instructions given by Owners and received by the Depositary.

 

(c)          There can be no assurance that Owners generally or any Owner in particular will receive the notice described in paragraph (a) above in time to enable Owners to give instructions to the Depositary prior to the Instruction Cutoff Date.

 

(d)          In order to give Owners a reasonable opportunity to instruct the Depositary as to the exercise of voting rights relating to Shares, if the Company will request the Depositary to Disseminate a notice under paragraph (a) above, the Company shall give the Depositary notice of the meeting, details concerning the matters to be voted upon and copies of materials to be made available to holders of Shares in connection with the meeting not less than 45 days prior to the meeting date.

 

SECTION 4.8.       Tender and Exchange Offers; Redemption, Replacement or Cancellation of Deposited Securities.

 

(a)          The Depositary shall not tender any Deposited Securities in response to any voluntary cash tender offer, exchange offer or similar offer made to holders of Deposited Securities (a “ Voluntary Offer ”), except when instructed in writing to do so by an Owner surrendering American Depositary Shares and subject to any conditions or procedures the Depositary may require.

 

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(b)         If the Depositary receives a written notice that Deposited Securities have been redeemed for cash or otherwise purchased for cash in a transaction that is mandatory and binding on the Depositary as a holder of those Deposited Securities (a “ Redemption ”), the Depositary, at the expense of the Company, shall (i) if required, surrender Deposited Securities that have been redeemed to the issuer of those securities or its agent on the redemption date, (ii) Disseminate a notice to Owners (A) notifying them of that Redemption, (B) calling for surrender of a corresponding number of American Depositary Shares and (C) notifying them that the called American Depositary Shares have been converted into a right only to receive the money received by the Depositary upon that Redemption and those net proceeds shall be the Deposited Securities to which Owners of those converted American Depositary Shares shall be entitled upon surrenders of those American Depositary Shares in accordance with Section 2.5 or 6.2 and (iii) distribute the money received upon that Redemption to the Owners entitled to it upon surrender by them of called American Depositary Shares in accordance with Section 2.5 (and, for the avoidance of doubt, Owners shall not be entitled to receive that money under Section 4.1). If the Redemption affects less than all the Deposited Securities, the Depositary shall call for surrender a corresponding portion of the outstanding American Depositary Shares and only those American Depositary Shares will automatically be converted into a right to receive the net proceeds of the Redemption. The Depositary shall allocate the American Depositary Shares converted under the preceding sentence among the Owners pro-rata to their respective holdings of American Depositary Shares immediately prior to the Redemption, except that the allocations may be adjusted so that no fraction of a converted American Depositary Share is allocated to any Owner. A Redemption of all or substantially all of the Deposited Securities shall be a Termination Option Event .

 

(c)          If the Depositary is notified of or there occurs any change in nominal value or any subdivision, combination or any other reclassification of the Deposited Securities or any recapitalization, reorganization, sale of assets substantially as an entirety, merger or consolidation affecting the issuer of the Deposited Securities or to which it is a party that is mandatory and binding on the Depositary as a holder of Deposited Securities and, as a result, securities or other property have been or will be delivered in exchange, conversion, replacement or in lieu of, Deposited Securities (a “ Replacement ”), the Depositary shall, if required, surrender the old Deposited Securities affected by that Replacement of Shares and hold, as new Deposited Securities under this Deposit Agreement, the new securities or other property delivered to it in that Replacement. However , the Depositary may elect to sell those new Deposited Securities if in the opinion of the Depositary it is not lawful or not practical for it to hold those new Deposited Securities under this Deposit Agreement because those new Deposited Securities may not be distributed to Owners without registration under the Securities Act of 1933 or for any other reason, at public or private sale, at such places and on such terms as it deems proper and proceed as if those new Deposited Securities had been Redeemed under paragraph (b) above. A Replacement shall be a Termination Option Event .

 

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(d)          In the case of a Replacement where the new Deposited Securities will continue to be held under this Deposit Agreement, the Depositary may call for the surrender of outstanding Receipts to be exchanged for new Receipts specifically describing the new Deposited Securities and the number of those new Deposited Securities represented by each American Depositary Share. If the number of Shares represented by each American Depositary Share decreases as a result of a Replacement, the Depositary may call for surrender of the American Depositary Shares to be exchanged on a mandatory basis for a lesser number of American Depositary Shares and may sell American Depositary Shares to the extent necessary to avoid distributing fractions of American Depositary Shares in that exchange and distribute the net proceeds of that sale to the Owners entitled to them.

 

(e)          If there are no Deposited Securities with respect to American Depositary Shares, including if the Deposited Securities are cancelled, or the Deposited Securities with respect to American Depositary Shares have become apparently worthless, the Depositary may call for surrender of those American Depositary Shares or may cancel those American Depositary Shares, upon notice to Owners, and that condition shall be a Termination Option Event .

 

SECTION 4.9.       Reports.

 

The Depositary shall make available for inspection by Owners at its Office any reports and communications, including any proxy solicitation material, received from the Company which are both (a) received by the Depositary as the holder of the Deposited Securities and (b) made generally available to the holders of those Deposited Securities by the Company. The Company shall furnish reports and communications, including any proxy soliciting material to which this Section applies, to the Depositary in English, to the extent those materials are required to be translated into English pursuant to any regulations of the Commission.

 

SECTION 4.10.     Lists of Owners.

 

Upon written request by the Company, the Depositary shall, at the expense of the Company, furnish to it a list, as of a recent date, of the names, addresses and American Depositary Share holdings of all Owners.

 

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SECTION 4.11.     Withholding.

 

If the Depositary determines that any distribution received or to be made by the Depositary (including Shares and rights to subscribe therefor) is subject to any tax or other governmental charge that the Depositary is obligated to withhold, the Depositary may sell, by public or private sale, all or a portion of the distributed property (including Shares and rights to subscribe therefor) in the amounts and manner the Depositary deems necessary and practicable to pay those taxes or charges, and the Depositary shall distribute the net proceeds of that sale, after deduction of those taxes or charges, to the Owners entitled thereto in proportion to the number of American Depositary Shares held by them respectively.

 

Services for Owners and Holders that may permit them to obtain reduced rates of tax withholding at source or reclaim excess tax withheld, and the fees and costs associated with using services of that kind, are not provided under, and are outside the scope of, this Deposit Agreement.

 

Each Owner and Holder agrees to indemnify the Company, the Depositary, the Custodian and their respective directors, employees, agents and affiliates for, and hold each of them harmless against, any claim by any governmental authority with respect to taxes, additions to tax, penalties or interest arising out of any refund of taxes, reduced withholding at source or other tax benefit received by it.

 

The Depositary shall, to the extent required by U.S. law, report to the Owners any taxes or governmental charges withheld from or paid out of a distribution on Deposited Securities by it, the Custodian or, to the extent such information is received from the Company, the Company.

 

ARTICLE 5.          THE DEPOSITARY, THE CUSTODIANS AND THE COMPANY

 

SECTION 5.1.       Maintenance of Office and Transfer Books by the Depositary.

 

Until termination of this Deposit Agreement in accordance with its terms, the Depositary shall maintain facilities for the execution and delivery, registration, registration of transfers and surrender of American Depositary Shares in accordance with the provisions of this Deposit Agreement.

 

The Depositary shall keep books for the registration of American Depositary Shares, which shall be open for inspection by the Owners at the Depositary’s Office during regular business hours, provided that such inspection is not for the purpose of communicating with Owners in the interest of a business or object other than the business of the Company or a matter related to this Deposit Agreement or the American Depositary Shares.

 

The Depositary may close the transfer books, at any time or from time to time, when deemed expedient by it in connection with the performance of its duties under this Deposit Agreement.

 

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If any American Depositary Shares are listed on one or more stock exchanges, the Depositary shall act as Registrar or appoint a Registrar or one or more co-registrars for registry of those American Depositary Shares in accordance with any requirements of that exchange or those exchanges.

 

The Company shall have the right, at all reasonable times, to inspect the transfer and registration records of the Depositary relating to the American Depositary Shares, to make copies thereof and to request the Depositary and the Registrar in writing to supply, at the Company’s expense, copies of such portions of such records as the Company may reasonably request.

 

SECTION 5.2.       Prevention or Delay of Performance by the Company or the Depositary.

 

Neither the Depositary nor the Company nor any of their respective directors, employees, agents or affiliates shall incur any liability to any Owner or Holder:

 

(i) if by reason of (A) any provision of any present or future law or regulation or other act of the government of the United States, any State of the United States or any other state or jurisdiction, or of any governmental or regulatory authority or stock exchange; (B) (in the case of the Depositary only) any provision, present or future, of the articles of association or similar document of the Company, or by reason of any provision of any securities issued or distributed by the Company, or any offering or distribution thereof; or (C) any event or circumstance, whether natural or caused by a person or persons, that is beyond the ability of the Depositary or the Company, as the case may be, to prevent or counteract by reasonable care or effort (including, but not limited to earthquakes, floods, severe storms, fires, explosions, war, terrorism, civil unrest, labor disputes or criminal acts; interruptions or malfunctions of utility services, Internet or other communications lines or systems; unauthorized access to or attacks on computer systems or websites; or other failures or malfunctions of computer hardware or software or other systems or equipment), the Depositary or the Company is, directly or indirectly, prevented from, forbidden to or delayed in, or could be subject to any civil or criminal penalty on account of doing or performing and therefore does not do or perform, any act or thing that, by the terms of this Deposit Agreement or the Deposited Securities, it is provided shall be done or performed;

 

(ii) for any exercise of, or failure to exercise, any discretion provided for in this Deposit Agreement (including any determination by the Depositary to take, or not take, any action that this Deposit Agreement provides the Depositary may take);

 

(iii) for the inability of any Owner or Holder to benefit from any distribution, offering, right or other benefit that is made available to holders of Deposited Securities but is not, under the terms of this Deposit Agreement, made available to Owners or Holders; or

 

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(iv) for any special, consequential or punitive damages for any breach of the terms of this Deposit Agreement.

 

Where, by the terms of a distribution to which Section 4.1, 4.2 or 4.3 applies, or an offering to which Section 4.4 applies, or for any other reason, that distribution or offering may not be made available to Owners, and the Depositary may not dispose of that distribution or offering on behalf of Owners and make the net proceeds available to Owners, then the Depositary shall not make that distribution or offering available to Owners, and shall allow any rights, if applicable, to lapse.

 

SECTION 5.3.       Obligations of the Depositary and the Company.

 

Neither the Company nor any of its directors, officers, employees, agents, controlling persons or affiliates assumes any obligation nor shall any of them be subject to any liability under this Deposit Agreement to any Owner or Holder, except that the Company agrees to perform its obligations specifically set forth in this Deposit Agreement without negligence or bad faith.

 

Neither the Depositary nor any of its directors, officers, employees, agents, controlling persons or affiliates assumes any obligation nor shall any of them be subject to any liability under this Deposit Agreement to any Owner or Holder (including, without limitation, liability with respect to the validity or worth of the Deposited Securities), except that the Depositary agrees to perform its obligations specifically set forth in this Deposit Agreement without negligence or bad faith, and the Depositary shall not be a fiduciary or have any fiduciary duty to Owners or Holders.

 

Neither the Depositary nor the Company nor any of their respective directors, officers, employees, agents, controlling persons or affiliates shall be under any obligation to appear in, prosecute or defend any action, suit or other proceeding in respect of any Deposited Securities or in respect of the American Depositary Shares on behalf of any Owner or Holder or any other person.

 

Each of the Depositary and the Company may rely, and shall be protected in relying upon, any written notice, request, direction or other document believed by it to be genuine and to have been signed or presented by the proper party or parties.

 

Neither the Depositary nor the Company nor any of their respective directors, officers, employees, agents, controlling persons or affiliates shall be liable for any action or non-action by it in reliance upon the advice of or information from legal counsel, accountants, any person presenting Shares for deposit, any Owner or any other person believed by it in good faith to be competent to give such advice or information.

 

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The Depositary shall not be liable for any acts or omissions made by a successor depositary whether in connection with a previous act or omission of the Depositary or in connection with any matter arising wholly after the removal or resignation of the Depositary, provided that in connection with the issue out of which such potential liability arises the Depositary performed its obligations without negligence or bad faith while it acted as Depositary.

 

Neither the Company nor the Depositary shall be liable for the acts or omissions of any securities depository, clearing agency or settlement system in connection with or arising out of book-entry settlement of American Depositary Shares or Deposited Securities or otherwise.

 

In the absence of bad faith on its part, the Depositary shall not be responsible for any failure to carry out any instructions to vote any of the Deposited Securities, or for the manner in which any such vote is cast or the effect of any such vote.

 

The Depositary shall have no duty to make any determination or provide any information as to the tax status of the Company or any liability for any tax consequences that may be incurred by Owners or Holders as a result of owning or holding American Depositary Shares. The Depositary shall not be liable for the inability or failure of an Owner or Holder to obtain the benefit of a foreign tax credit, reduced rate of withholding or refund of amounts withheld in respect of tax or any other tax benefit.

 

No disclaimer of liability under the United States federal securities laws is intended by any provision of this Deposit Agreement.

 

SECTION 5.4.       Resignation and Removal of the Depositary.

 

The Depositary may at any time resign as Depositary hereunder by written notice of its election so to do delivered to the Company, to become effective upon the appointment of a successor depositary and its acceptance of that appointment as provided in this Section. The effect of resignation if a successor depositary is not appointed is provided for in Section 6.2.

 

The Depositary may at any time be removed by the Company by 90 days’ prior written notice of that removal, to become effective upon the later of (i) the 90th day after delivery of the notice to the Depositary and (ii) the appointment of a successor depositary and its acceptance of its appointment as provided in this Section.

 

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If the Depositary resigns or is removed, the Company shall use its best efforts to appoint a successor depositary, which shall be a bank or trust company having an office in the Borough of Manhattan, The City of New York. Every successor depositary shall execute and deliver to the Company an instrument in writing accepting its appointment under this Deposit Agreement. If the Depositary receives notice from the Company that a successor depositary has been appointed following its resignation or removal, the Depositary, upon payment of all sums due it from the Company, shall deliver to its successor a register listing all the Owners and their respective holdings of outstanding American Depositary Shares and shall deliver the Deposited Securities to or to the order of its successor. When the Depositary has taken the actions specified in the preceding sentence (i) the successor shall become the Depositary and shall have all the rights and shall assume all the duties of the Depositary under this Deposit Agreement and (ii) the predecessor depositary shall cease to be the Depositary and shall be discharged and released from all obligations under this Deposit Agreement, except for its duties under Section 5.8 with respect to the time before that discharge. A successor Depositary shall notify the Owners of its appointment as soon as practical after assuming the duties of Depositary.

 

Any corporation or other entity into or with which the Depositary may be merged or consolidated shall be the successor of the Depositary without the execution or filing of any document or any further act.

 

SECTION 5.5.       The Custodian.

 

The Custodian shall be subject at all times and in all respects to the directions of the Depositary and shall be responsible solely to it. The Depositary in its discretion may at any time appoint a substitute or additional custodian or custodians, each of which shall thereafter be one of the Custodians under this Deposit Agreement. If the Depositary receives notice that a Custodian is resigning and, upon the effectiveness of that resignation there would be no Custodian acting under this Deposit Agreement, the Depositary shall, as promptly as practicable after receiving that notice, appoint a substitute custodian or custodians, each of which shall thereafter be a Custodian under this Deposit Agreement. The Depositary shall require any Custodian that resigns or is removed to deliver all Deposited Securities held by it to another Custodian.

 

SECTION 5.6.       Notices and Reports.

 

If the Company takes or decides to take any corporate action of a kind that is addressed in Sections 4.1 to 4.4, or 4.6 to 4.8, or that effects or will effect a change of the name or legal structure of the Company, or that effects or will effect a change to the Shares, the Company shall notify the Depositary and the Custodian of that action or decision as soon as it is lawful and practical to give that notice.  The notice shall be in English and shall include all details that the Company is required to include in any notice to any governmental or regulatory authority or securities exchange or is required to make available generally to holders of Shares by publication or otherwise.

 

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The Company will arrange for the translation into English, if not already in English, to the extent required pursuant to any regulations of the Commission, and the prompt transmittal by the Company to the Depositary and the Custodian of all notices and any other reports and communications which are made generally available by the Company to holders of its Shares. If requested in writing by the Company, the Depositary will Disseminate, at the Company’s expense, those notices, reports and communications to all Owners or otherwise make them available to Owners in a manner that the Company specifies as substantially equivalent to the manner in which those communications are made available to holders of Shares and compliant with the requirements of any securities exchange on which the American Depositary Shares are listed. The Company will timely provide the Depositary with the quantity of such notices, reports, and communications, as requested by the Depositary from time to time, in order for the Depositary to effect that Dissemination.

 

The Company represents that as of the date of this Deposit Agreement, the statements in Article 11 of the Receipt with respect to the Company’s obligation to file periodic reports under the United States Securities Exchange Act of 1934, as amended, are true and correct. The Company agrees to promptly notify the Depositary upon becoming aware of any change in the truth of any of those statements.

 

SECTION 5.7.       Distribution of Additional Shares, Rights, etc.

 

If the Company or any affiliate of the Company determines to make any issuance or distribution of (1) additional Shares, (2) rights to subscribe for Shares, (3) securities convertible into Shares, or (4) rights to subscribe for such securities (each a “ Distribution ”), the Company shall notify the Depositary in writing in English as promptly as practicable and in any event before the Distribution starts and, if requested in writing by the Depositary, the Company shall promptly furnish to the Depositary either (i) evidence reasonably satisfactory to the Depositary that the Distribution is registered under the Securities Act of 1933 or (ii) a written opinion from U.S. counsel for the Company that is reasonably satisfactory to the Depositary, stating that the Distribution does not require, or, if made in the United States, would not require, registration under the Securities Act of 1933.

 

The Company agrees with the Depositary that neither the Company nor any company controlled by, controlling or under common control with the Company will at any time deposit any Shares that, at the time of deposit, are Restricted Securities.

 

Nothing in this Deposit Agreement shall create any obligation on the part of the Company to file a registration statement under the Securities Act of 1933 with respect to any Distribution. To the extent the Company in its sole discretion deems it necessary or advisable in order to avoid any requirement to register securities under the Securities Act of 1933, it may prevent Owners in the United States from purchasing securities and may instruct the Depositary not to accept certain Shares reasonably identified in such instruction for deposit for such period of time following the issuance of such additional securities or to adopt such other specific measures as the Company may reasonably request.

 

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SECTION 5.8.       Indemnification.

 

The Company agrees to indemnify the Depositary, its directors, employees, agents and affiliates and each Custodian against, and hold each of them harmless from, any liability or expense (including, but not limited to any fees and expenses incurred in seeking, enforcing or collecting such indemnity and the reasonable fees and expenses of counsel) that may arise out of or in connection with (a) any registration with the Commission of American Depositary Shares or Deposited Securities or the offer or sale thereof in the United States or (b) acts performed or omitted, pursuant to the provisions of or in connection with this Deposit Agreement and the American Depositary Shares, as the same may be amended, modified or supplemented from time to time, (i) by either the Depositary or a Custodian or their respective directors, employees, agents and affiliates, except for any liability or expense arising out of the negligence or bad faith of either of them, or (ii) by the Company or any of its directors, employees, agents and affiliates.

 

The indemnities contained in the preceding paragraph shall not extend to any Losses arising out of information relating to the Depositary or any Custodian, as the case may be, furnished in writing by the Depositary to the Company expressly for use in any registration statement, proxy statement, prospectus or preliminary prospectus or any other offering documents relating to the American Depositary Share, the Shares or any other Deposited Securities (it being acknowledged that, as of the date of this Deposit Agreement, the Depositary has not furnished any information of that kind). 

 

The Depositary agrees to indemnify the Company, its directors, employees, agents and affiliates and hold them harmless from any liability or expense that may arise out of acts performed or omitted by the Depositary or any Custodian or their respective directors, employees, agents and affiliates due to their negligence or bad faith.

 

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SECTION 5.9.       Charges of Depositary.

 

The following charges shall be incurred by any party depositing or withdrawing Shares or by any party surrendering American Depositary Shares or to whom American Depositary Shares are issued (including, without limitation, issuance pursuant to a stock dividend or stock split declared by the Company or an exchange of stock regarding the American Depositary Shares or Deposited Securities or a delivery of American Depositary Shares pursuant to Section 4.3), or by Owners, as applicable: (1) taxes and other governmental charges, (2) such registration fees as may from time to time be in effect for the registration of transfers of Shares generally on the Share register of the Company or Foreign Registrar and applicable to transfers of Shares to or from the name of the Depositary or its nominee or the Custodian or its nominee on the making of deposits or withdrawals hereunder, (3) such cable (including SWIFT) and facsimile transmission fees and expenses as are expressly provided in this Deposit Agreement, (4) such expenses as are incurred by the Depositary in the conversion of foreign currency pursuant to Section 4.5, (5) a fee of $5.00 or less per 100 American Depositary Shares (or portion thereof) for the delivery of American Depositary Shares pursuant to Section 2.3, 4.3 or 4.4 and the surrender of American Depositary Shares pursuant to Section 2.5 or 6.2, (6) a fee of $.05 or less per American Depositary Share (or portion thereof) for any cash distribution made pursuant to this Deposit Agreement, including, but not limited to Sections 4.1 through 4.4 and Section 4.8, (7) a fee for the distribution of securities pursuant to Section 4.2 or of rights pursuant to Section 4.4 (where the Depositary will not exercise or sell those rights on behalf of Owners), such fee being in an amount equal to the fee for the execution and delivery of American Depositary Shares referred to above which would have been charged as a result of the deposit of such securities under this Deposit Agreement (for purposes of this item 7 treating all such securities as if they were Shares) but which securities are instead distributed by the Depositary to Owners, (8) in addition to any fee charged under item 6 above, a fee of $.05 or less per American Depositary Share (or portion thereof) per annum for depositary services, which will be payable as provided in item 9 below, and (9) any other charges payable by the Depositary or the Custodian, any of the Depositary's or Custodian’s agents or the agents of the Depositary's or Custodian’s agents, in connection with the servicing of Shares or other Deposited Securities (which charges shall be assessed against Owners as of the date or dates set by the Depositary in accordance with Section 4.6 and shall be payable at the sole discretion of the Depositary by billing those Owners for those charges or by deducting those charges from one or more cash dividends or other cash distributions).

 

The Depositary may collect any of its fees by deduction from any cash distribution payable, or by selling a portion of any securities to be distributed, to Owners that are obligated to pay those fees.

 

In performing its duties under this Deposit Agreement, the Depositary may use brokers, dealers, foreign currency dealers or other service providers that are owned by or affiliated with the Depositary and that may earn or share fees, spreads or commissions.

 

The Depositary may own and deal in any class of securities of the Company and its affiliates and in American Depositary Shares.

 

SECTION 5.10.     Retention of Depositary Documents.

 

The Depositary is authorized to destroy those documents, records, bills and other data compiled during the term of this Deposit Agreement at the times permitted by the laws or regulations governing the Depositary, unless the Company requests that such papers be retained for a longer period or turned over to the Company or to a successor depositary.

 

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SECTION 5.11.     Exclusivity.

 

Without prejudice to the Company’s rights under Section 5.4, the Company agrees not to appoint any other depositary for issuance of depositary shares, depositary receipts or any similar securities or instruments so long as The Bank of New York Mellon is acting as Depositary under this Deposit Agreement.

 

SECTION 5.12.     Information for Regulatory Compliance.

 

Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

 

ARTICLE 6.          AMENDMENT AND TERMINATION

 

SECTION 6.1.       Amendment.

 

The form of the Receipts and any provisions of this Deposit Agreement may at any time and from time to time be amended by agreement between the Company and the Depositary without the consent of Owners or Holders in any respect that they may deem necessary or desirable. Any amendment that would impose or increase any fees or charges (other than taxes and other governmental charges, registration fees, cable, telex or facsimile transmission costs, delivery costs or other such expenses), or that would otherwise prejudice any substantial existing right of Owners, shall, however, not become effective as to outstanding American Depositary Shares until the expiration of 30 days after notice of that amendment has been Disseminated to the Owners of outstanding American Depositary Shares. Every Owner and Holder, at the time any amendment so becomes effective, shall be deemed, by continuing to hold American Depositary Shares or any interest therein, to consent and agree to that amendment and to be bound by this Deposit Agreement as amended thereby. Upon the effectiveness of an amendment to the form of Receipt, including a change in the number of Shares represented by each American Depositary Share, the Depositary may call for surrender of Receipts to be replaced with new Receipts in the amended form or call for surrender of American Depositary Shares to effect that change of ratio. In no event shall any amendment impair the right of the Owner to surrender American Depositary Shares and receive delivery of the Deposited Securities represented thereby, except in order to comply with mandatory provisions of applicable law.

 

Notwithstanding the foregoing, if any governmental body should adopt new laws, rules or regulations which would require an amendment of this Deposit Agreement to ensure compliance therewith, the Company and the Depositary may amend this Deposit Agreement at any time in accordance with such changed laws, rules and regulations. Such amendment to this Deposit Agreement in such circumstances may become effective before a notice of such amendment or supplement is given to Owners or within any other period of time as required for compliance with such laws, rules or regulations.

 

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SECTION 6.2.       Termination.

 

(a)          The Company may initiate termination of this Deposit Agreement by notice to the Depositary. The Depositary may initiate termination of this Deposit Agreement if (i) at any time 90 days shall have expired after the Depositary delivered to the Company a written resignation notice and a successor depositary has not been appointed and accepted its appointment as provided in Section 5.4, (ii) an Insolvency Event or Delisting Event occurs with respect to the Company or (iii) a Termination Option Event has occurred or will occur. If termination of this Deposit Agreement is initiated, the Depositary shall Disseminate a notice of termination to the Owners of all American Depositary Shares then outstanding setting a date for termination (the “ Termination Date ”), which shall be at least 90 days after the date of that notice, and this Deposit Agreement shall terminate on that Termination Date.

 

(b)          After the Termination Date, the Company shall be discharged from all obligations under this Deposit Agreement except for its obligations to the Depositary under Sections 5.8 and 5.9.

 

(c)          At any time after the Termination Date, the Depositary may sell the Deposited Securities then held under this Deposit Agreement and may thereafter hold uninvested the net proceeds of any such sale, together with any other cash then held by it hereunder, unsegregated and without liability for interest, for the pro rata benefit of the Owners of American Depositary Shares that remain outstanding, and those Owners will be general creditors of the Depositary with respect to those net proceeds and that other cash. After making that sale, the Depositary shall be discharged from all obligations under this Deposit Agreement, except (i) to account for the net proceeds and other cash (after deducting, in each case, the fee of the Depositary for the surrender of American Depositary Shares, any expenses for the account of the Owner of such American Depositary Shares in accordance with the terms and conditions of this Deposit Agreement and any applicable taxes or governmental charges) and (ii) for its obligations under Section 5.8 and (iii) to act as provided in paragraph (d) below.

 

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(d)          After the Termination Date, if any American Depositary Shares remain outstanding, the Depositary shall continue to receive dividends and other distributions pertaining to Deposited Securities (that have not been sold), may sell rights and other property as provided in this Deposit Agreement and shall deliver Deposited Securities (or sale proceeds) upon surrender of American Depositary Shares (after payment or upon deduction, in each case, of the fee of the Depositary for the surrender of American Depositary Shares, any expenses for the account of the Owner of those American Depositary Shares in accordance with the terms and conditions of this Deposit Agreement and any applicable taxes or governmental charges). After the Termination Date, the Depositary shall not accept deposits of Shares or deliver American Depositary Shares. After the Termination Date, (i) the Depositary may refuse to accept surrenders of American Depositary Shares for the purpose of withdrawal of Deposited Securities (that have not been sold) or reverse previously accepted surrenders of that kind that have not settled if in its judgment the requested withdrawal would interfere with its efforts to sell the Deposited Securities, (ii) the Depositary will not be required to deliver cash proceeds of the sale of Deposited Securities until all Deposited Securities have been sold and (iii) the Depositary may discontinue the registration of transfers of American Depositary Shares and suspend the distribution of dividends and other distributions on Deposited Securities to the Owners and need not give any further notices or perform any further acts under this Deposit Agreement except as provided in this Section.

 

ARTICLE 7.          MISCELLANEOUS

 

SECTION 7.1.       Counterparts; Signatures.

 

This Deposit Agreement may be executed in any number of counterparts, each of which shall be deemed an original and all of those counterparts shall constitute one and the same instrument. Copies of this Deposit Agreement shall be filed with the Depositary and the Custodians and shall be open to inspection by any Owner or Holder during regular business hours.

 

Any manual signature on this Deposit Agreement that is faxed, scanned or photocopied, and any electronic signature valid under the Electronic Signatures in Global and National Commerce Act, 15 U.S.C. § 7001, et. seq ., shall for all purposes have the same validity, legal effect and admissibility in evidence as an original manual signature, and the parties hereby waive any objection to the contrary.

 

SECTION 7.2.       No Third Party Beneficiaries.

 

This Deposit Agreement is for the exclusive benefit of the Company, the Depositary, the Owners and the Holders and their respective successors and shall not be deemed to give any legal or equitable right, remedy or claim whatsoever to any other person.

 

SECTION 7.3.       Severability.

 

In case any one or more of the provisions contained in this Deposit Agreement or in a Receipt should be or become invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained in this Deposit Agreement or that Receipt shall in no way be affected, prejudiced or disturbed thereby.

 

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SECTION 7.4.       Owners and Holders as Parties; Binding Effect.

 

The Owners and Holders from time to time shall be parties to this Deposit Agreement and shall be bound by all of the terms and conditions of this Deposit Agreement and of the Receipts by acceptance of American Depositary Shares or any interest therein.

 

SECTION 7.5.       Notices.

 

Any and all notices to be given to the Company shall be in writing and shall be deemed to have been duly given if personally delivered or sent by domestic first class or international air mail or air courier or sent by facsimile transmission or email attaching a pdf or similar bit-mapped image of a signed writing, provided that receipt of the facsimile transmission or email has been confirmed by the recipient, addressed to Anchiano Therapeutics Ltd., 1/3 High-Tech Village, Givat Ram, Jerusalem, Israel, Attention: Jonathan Burgin, or any other place to which the Company may have transferred its principal office with notice to the Depositary, with a copy to Mayer Brown LLP, 1221 Avenue of the Americas, New York, New York 10020, Attention: Anna T. Pinedo.

 

Any and all notices to be given to the Depositary shall be in writing and shall be deemed to have been duly given if in English and personally delivered or sent by first class domestic or international air mail or air courier or sent by facsimile transmission or email attaching a pdf or similar bit-mapped image of a signed writing, addressed to The Bank of New York Mellon, 240 Greenwich Street, New York, New York 10286, Attention: Depositary Receipt Administration, or any other place to which the Depositary may have transferred its Office with notice to the Company.

 

Delivery of a notice to the Company or Depositary by mail or air courier shall be deemed effected when deposited, postage prepaid, in a post-office letter box or received by an air courier service. Delivery of a notice to the Company or Depositary sent by facsimile transmission or email shall be deemed effected when the recipient acknowledges receipt of that notice.

 

A notice to be given to an Owner shall be deemed to have been duly given when Disseminated to that Owner. Dissemination in paper form will be effective when personally delivered or sent by first class domestic or international air mail or air courier, addressed to that Owner at the address of that Owner as it appears on the transfer books for American Depositary Shares of the Depositary, or, if that Owner has filed with the Depositary a written request that notices intended for that Owner be mailed to some other address, at the address designated in that request. Dissemination in electronic form will be effective when sent in the manner consented to by the Owner to the electronic address most recently provided by the Owner for that purpose.

 

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SECTION 7.6.       Appointment of Agent for Service of Process; Submission to Jurisdiction; Jury Trial Waiver.

 

The Company hereby (i) designates and appoints the person named in Exhibit A to this Deposit Agreement, located in the United States, as the Company's authorized agent upon which process may be served in any suit or proceeding arising out of or relating to the Shares or Deposited Securities, the American Depositary Shares, the Receipts or this Deposit Agreement (a “Proceeding”), (ii) consents and submits to the jurisdiction of any state or federal court in the State of New York in which any Proceeding may be instituted and (iii) agrees that service of process upon said authorized agent shall be deemed in every respect effective service of process upon the Company in any Proceeding. The Company agrees to deliver to the Depositary, upon the execution and delivery of this Deposit Agreement, a written acceptance by the agent named in Exhibit A to this Deposit Agreement of its appointment as process agent. The Company further agrees to take any and all action, including the filing of any and all such documents and instruments, as may be necessary to continue that designation and appointment in full force and effect, or to appoint and maintain the appointment of another process agent located in the United States as required above, and to deliver to the Depositary a written acceptance by that agent of that appointment, for so long as any American Depositary Shares or Receipts remain outstanding or this Deposit Agreement remains in force. In the event the Company fails to maintain the designation and appointment of a process agent in the United States in full force and effect, the Company hereby waives personal service of process upon it and consents that a service of process in connection with a Proceeding may be made by certified or registered mail, return receipt requested, directed to the Company at its address last specified for notices under this Deposit Agreement, and service so made shall be deemed completed five (5) days after the same shall have been so mailed.

 

EACH PARTY TO THIS DEPOSIT AGREEMENT (INCLUDING, FOR AVOIDANCE OF DOUBT, EACH OWNER AND HOLDER) HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY SUIT, ACTION OR PROCEEDING AGAINST THE COMPANY AND/OR THE DEPOSITARY DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THE SHARES OR OTHER DEPOSITED SECURITIES, THE AMERICAN DEPOSITARY SHARES OR THE RECEIPTS, THIS DEPOSIT AGREEMENT OR ANY TRANSACTION CONTEMPLATED HEREIN OR THEREIN, OR THE BREACH HEREOF OR THEREOF, INCLUDING, WITHOUT LIMITATION, ANY QUESTION REGARDING EXISTENCE, VALIDITY OR TERMINATION (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY).

 

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SECTION 7.7.       Waiver of Immunities.

 

To the extent that the Company or any of its properties, assets or revenues may have or may hereafter become entitled to, or have attributed to it, any right of immunity, on the grounds of sovereignty or otherwise, from any legal action, suit or proceeding, from the giving of any relief in any respect thereof, from setoff or counterclaim, from the jurisdiction of any court, from service of process, from attachment upon or prior to judgment, from attachment in aid of execution or judgment, or from execution of judgment, or other legal process or proceeding for the giving of any relief or for the enforcement of any judgment, in any jurisdiction in which proceedings may at any time be commenced, with respect to its obligations, liabilities or any other matter under or arising out of or in connection with the Shares or Deposited Securities, the American Depositary Shares, the Receipts or this Deposit Agreement, the Company, to the fullest extent permitted by law, hereby irrevocably and unconditionally waives, and agrees not to plead or claim, any immunity of that kind and consents to relief and enforcement as provided above.

 

SECTION 7.8.       Governing Law.

 

This Deposit Agreement and the Receipts shall be interpreted in accordance with and all rights hereunder and thereunder and provisions hereof and thereof shall be governed by the laws of the State of New York.

 

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IN WITNESS WHEREOF, ANCHIANO THERAPEUTICS LTD. and THE BANK OF NEW YORK MELLON have duly executed this Deposit Agreement as of the day and year first set forth above and all Owners and Holders shall become parties hereto upon acceptance by them of American Depositary Shares or any interest therein.

 

  ANCHIANO THERAPEUTICS LTD.
                            
  By:  
  Name:
  Title:
   
  THE BANK OF NEW YORK MELLON,
  as Depositary
     
  By:  
  Name:
  Title:

 

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EXHIBIT A

 

  AMERICAN DEPOSITARY SHARES
  (Each American Depositary Share represents
four deposited Shares)

 

THE BANK OF NEW YORK MELLON

AMERICAN DEPOSITARY RECEIPT

FOR ORDINARY SHARES OF

ANCHIANO THERAPEUTICS LTD.

(INCORPORATED UNDER THE LAWS OF ISRAEL)

 

The Bank of New York Mellon, as depositary (hereinafter called the “Depositary”), hereby certifies that _______________________________________, or registered assigns IS THE OWNER OF _____________________________

 

AMERICAN DEPOSITARY SHARES

 

representing deposited ordinary shares (herein called “Shares”) of Anchiano Therapeutics Ltd., incorporated under the laws of Israel (herein called the “ Company ”). At the date hereof, each American Depositary Share represents four Shares deposited or subject to deposit under the Deposit Agreement (as such term is hereinafter defined) with a custodian for the Depositary (herein called the “ Custodian ”) that, as of the date of the Deposit Agreement, was Bank Leumi and Bank Hapoalim located in Israel. The Depositary's Office and its principal executive office are located at 240 Greenwich Street, New York, N.Y. 10286.

 

THE DEPOSITARY'S OFFICE ADDRESS IS

240 GREENWICH STREET, NEW YORK, N.Y. 10286

 

A- 1

 

 

1. THE DEPOSIT AGREEMENT.

 

This American Depositary Receipt is one of an issue (herein called “ Receipts ”), all issued and to be issued upon the terms and conditions set forth in the Deposit Agreement dated as of ______________, 2019 (herein called the “ Deposit Agreement ”) among the Company, the Depositary, and all Owners and Holders from time to time of American Depositary Shares issued thereunder, each of whom by accepting American Depositary Shares agrees to become a party thereto and become bound by all the terms and conditions thereof. The Deposit Agreement sets forth the rights of Owners and Holders and the rights and duties of the Depositary in respect of the Shares deposited thereunder and any and all other securities, property and cash from time to time received in respect of those Shares and held thereunder (those Shares, securities, property, and cash are herein called “ Deposited Securities ”). Copies of the Deposit Agreement are on file at the Depositary's Office in New York City and at the office of the Custodian.

 

The statements made on the face and reverse of this Receipt are summaries of certain provisions of the Deposit Agreement and are qualified by and subject to the detailed provisions of the Deposit Agreement, to which reference is hereby made. Capitalized terms defined in the Deposit Agreement and not defined herein shall have the meanings set forth in the Deposit Agreement.

 

2. SURRENDER OF AMERICAN DEPOSITARY SHARES AND WITHDRAWAL OF SHARES.

 

Upon surrender of American Depositary Shares for the purpose of withdrawal of the Deposited Securities represented thereby and payment of the fee of the Depositary for the surrender of American Depositary Shares as provided in Section 5.9 of the Deposit Agreement and payment of all taxes and governmental charges payable in connection with that surrender and withdrawal of the Deposited Securities, and subject to the terms and conditions of the Deposit Agreement, the Owner of those American Depositary Shares shall be entitled to delivery (to the extent delivery can then be lawfully and practicably made), to or as instructed by that Owner, of the amount of Deposited Securities at the time represented by those American Depositary Shares, but not any money or other property as to which a record date for distribution to Owners has passed (since money or other property of that kind will be delivered or paid on the scheduled payment date to the Owner as of that record date), and except that the Depositary shall not be required to accept surrender of American Depositary Shares for the purpose of withdrawal to the extent it would require delivery of a fraction of a Deposited Security. The Depositary shall direct the Custodian with respect to delivery of Deposited Securities and may charge the surrendering Owner a fee and its expenses for giving that direction by cable (including SWIFT) or facsimile transmission. If Deposited Securities are delivered physically upon surrender of American Depositary Shares for the purpose of withdrawal, that delivery will be made at the Custodian’s office, except that , at the request, risk and expense of the surrendering Owner, and for the account of that Owner, the Depositary shall direct the Custodian to forward any cash or other property comprising, and forward a certificate or certificates, if applicable, and other proper documents of title, if any, for, the Deposited Securities represented by the surrendered American Depositary Shares to the Depositary for delivery at the Depositary’s Office or to another address specified in the order received from the surrendering Owner.

 

A- 2

 

 

3. REGISTRATION OF TRANSFER OF AMERICAN DEPOSITARY SHARES; COMBINATION AND SPLIT-UP OF RECEIPTS; INTERCHANGE OF CERTIFICATED AND UNCERTIFICATED AMERICAN DEPOSITARY SHARES.

 

The Depositary, subject to the terms and conditions of the Deposit Agreement, shall register a transfer of American Depositary Shares on its transfer books upon (i) in the case of certificated American Depositary Shares, surrender of the Receipt evidencing those American Depositary Shares, by the Owner or by a duly authorized attorney, properly endorsed or accompanied by proper instruments of transfer or (ii) in the case of uncertificated American Depositary Shares, receipt from the Owner of a proper instruction (including, for the avoidance of doubt, instructions through DRS and Profile as provided in Section 2.9 of that Agreement), and, in either case, duly stamped as may be required by the laws of the State of New York and of the United States of America. Upon registration of a transfer, the Depositary shall deliver the transferred American Depositary Shares to or upon the order of the person entitled thereto.

 

The Depositary, subject to the terms and conditions of the Deposit Agreement, shall upon surrender of a Receipt or Receipts for the purpose of effecting a split-up or combination of such Receipt or Receipts, execute and deliver a new Receipt or Receipts for any authorized number of American Depositary Shares requested, evidencing the same aggregate number of American Depositary Shares as the Receipt or Receipts surrendered.

 

The Depositary, upon surrender of certificated American Depositary Shares for the purpose of exchanging for uncertificated American Depositary Shares, shall cancel the Receipt evidencing those certificated American Depositary Shares and send the Owner a statement confirming that the Owner is the owner of the same number of uncertificated American Depositary Shares. The Depositary, upon receipt of a proper instruction (including, for the avoidance of doubt, instructions through DRS and Profile as provided in Section 2.9 of the Deposit Agreement) from the Owner of uncertificated American Depositary Shares for the purpose of exchanging for certificated American Depositary Shares, shall cancel those uncertificated American Depositary Shares and register and deliver to the Owner a Receipt evidencing the same number of certificated American Depositary Shares.

 

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As a condition precedent to the delivery, registration of transfer, or surrender of any American Depositary Shares or split-up or combination of any Receipt or withdrawal of any Deposited Securities, the Depositary, the Custodian, or Registrar may require payment from the depositor of the Shares or the presenter of the Receipt or instruction for registration of transfer or surrender of American Depositary Shares not evidenced by a Receipt of a sum sufficient to reimburse it for any tax or other governmental charge and any stock transfer or registration fee with respect thereto (including any such tax or charge and fee with respect to Shares being deposited or withdrawn) and payment of any applicable fees as provided in the Deposit Agreement, may require the production of proof satisfactory to it as to the identity and genuineness of any signature and may also require compliance with any regulations the Depositary may establish consistent with the provisions of the Deposit Agreement.

 

The delivery of American Depositary Shares against deposit of Shares generally or against deposit of particular Shares may be suspended, or the registration of transfer of American Depositary Shares in particular instances may be refused, or the registration of transfer of outstanding American Depositary Shares generally may be suspended, during any period when the transfer books of the Depositary are closed, or if any such action is deemed necessary or advisable by the Depositary or the Company at any time or from time to time because of any requirement of law or of any government or governmental body or commission, or under any provision of the Deposit Agreement, or for any other reason. Notwithstanding anything to the contrary in the Deposit Agreement or this Receipt, the surrender of outstanding American Depositary Shares and withdrawal of Deposited Securities may not be suspended subject only to (i) temporary delays caused by closing the transfer books of the Depositary or the Company or the Foreign Registrar, if applicable, or the deposit of Shares in connection with voting at a shareholders’ meeting, or the payment of dividends, (ii) the payment of fees, taxes and similar charges, and (iii) compliance with any U.S. or foreign laws or governmental regulations relating to the American Depositary Shares or to the withdrawal of the Deposited Securities. The Depositary shall not knowingly accept for deposit under the Deposit Agreement any Shares that, at the time of deposit, are Restricted Securities.

 

4. LIABILITY OF OWNER FOR TAXES.

 

If any tax or other governmental charge shall become payable by the Custodian or the Depositary with respect to or in connection with any American Depositary Shares or any Deposited Securities represented by any American Depositary Shares or in connection with a transaction to which Section 4.8 of the Deposit Agreement applies, that tax or other governmental charge shall be payable by the Owner of those American Depositary Shares to the Depositary. The Depositary may refuse to register any transfer of those American Depositary Shares or any withdrawal of Deposited Securities represented by those American Depositary Shares until that payment is made, and may withhold any dividends or other distributions or the proceeds thereof, or may sell for the account of the Owner any part or all of the Deposited Securities represented by those American Depositary Shares, and may apply those dividends or other distributions or the net proceeds of any sale of that kind in payment of that tax or other governmental charge but, even after a sale of that kind, the Owner shall remain liable for any deficiency. The Depositary shall distribute any net proceeds of a sale made under Section 3.2 of the Deposit Agreement that are not used to pay taxes or governmental charges to the Owners entitled to them in accordance with Section 4.1 of the Deposit Agreement. If the number of Shares represented by each American Depositary Share decreases as a result of a sale of Deposited Securities under Section 3.2 of the Deposit Agreement, the Depositary may call for surrender of the American Depositary Shares to be exchanged on a mandatory basis for a lesser number of American Depositary Shares and may sell American Depositary Shares to the extent necessary to avoid distributing fractions of American Depositary Shares in that exchange and distribute the net proceeds of that sale to the Owners entitled to them.

 

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5. WARRANTIES ON DEPOSIT OF SHARES.

 

Every person depositing Shares under the Deposit Agreement shall be deemed thereby to represent and warrant that those Shares and each certificate therefor, if applicable, are validly issued, fully paid and nonassessable and were not issued in violation of any preemptive or similar rights of the holders of outstanding securities of the Company and that the person making that deposit is duly authorized so to do. Every depositing person shall also be deemed to represent that the Shares, at the time of deposit, are not Restricted Securities. All representations and warranties deemed made under Section 3.3 of the Deposit Agreement shall survive the deposit of Shares and delivery of American Depositary Shares.

 

6. FILING PROOFS, CERTIFICATES, AND OTHER INFORMATION.

 

Any person presenting Shares for deposit or any Owner or Holder may be required from time to time to file with the Depositary or the Custodian such proof of citizenship or residence, exchange control approval, or such information relating to the registration on the books of the Company or the Foreign Registrar, if applicable, to execute such certificates and to make such representations and warranties, as the Depositary may deem necessary or proper. The Depositary may withhold the delivery or registration of transfer of any American Depositary Shares, the distribution of any dividend or other distribution or of the proceeds thereof or the delivery of any Deposited Securities until that proof or other information is filed or those certificates are executed or those representations and warranties are made. As conditions of accepting Shares for deposit, the Depositary may require (i) any certification required by the Depositary or the Custodian in accordance with the provisions of the Deposit Agreement, (ii) a written order directing the Depositary to deliver to, or upon the written order of, the person or persons stated in that order, the number of American Depositary Shares representing those Deposited Shares, (iii) evidence satisfactory to the Depositary that those Shares have been re-registered in the books of the Company or the Foreign Registrar in the name of the Depositary, a Custodian or a nominee of the Depositary or a Custodian, (iv) evidence satisfactory to the Depositary that any necessary approval has been granted by any governmental body in each applicable jurisdiction and (v) an agreement or assignment, or other instrument satisfactory to the Depositary, that provides for the prompt transfer to the Custodian of any dividend, or right to subscribe for additional Shares or to receive other property, that any person in whose name those Shares are or have been recorded may thereafter receive upon or in respect of those Shares, or, in lieu thereof, such agreement of indemnity or other agreement as shall be satisfactory to the Depositary.

 

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7. CHARGES OF DEPOSITARY.

 

The following charges shall be incurred by any party depositing or withdrawing Shares or by any party surrendering American Depositary Shares or to whom American Depositary Shares are issued (including, without limitation, issuance pursuant to a stock dividend or stock split declared by the Company or an exchange of stock regarding the American Depositary Shares or Deposited Securities or a delivery of American Depositary Shares pursuant to Section 4.3 of the Deposit Agreement), or by Owners, as applicable: (1) taxes and other governmental charges, (2) such registration fees as may from time to time be in effect for the registration of transfers of Shares generally on the Share register of the Company or Foreign Registrar and applicable to transfers of Shares to or from the name of the Depositary or its nominee or the Custodian or its nominee on the making of deposits or withdrawals hereunder, (3) such cable (including SWIFT) and facsimile transmission fees and expenses as are expressly provided in the Deposit Agreement, (4) such expenses as are incurred by the Depositary in the conversion of foreign currency pursuant to Section 4.5 of the Deposit Agreement, (5) a fee of $5.00 or less per 100 American Depositary Shares (or portion thereof) for the delivery of American Depositary Shares pursuant to Section 2.3, 4.3 or 4.4 of the Deposit Agreement and the surrender of American Depositary Shares pursuant to Section 2.5 or 6.2 of the Deposit Agreement, (6) a fee of $.05 or less per American Depositary Share (or portion thereof) for any cash distribution made pursuant to the Deposit Agreement, including, but not limited to Sections 4.1 through 4.4 and 4.8 of the Deposit Agreement, (7) a fee for the distribution of securities pursuant to Section 4.2 of the Deposit Agreement or of rights pursuant to Section 4.4 of that Agreement (where the Depositary will not exercise or sell those rights on behalf of Owners), such fee being in an amount equal to the fee for the execution and delivery of American Depositary Shares referred to above which would have been charged as a result of the deposit of such securities under the Deposit Agreement (for purposes of this item 7 treating all such securities as if they were Shares) but which securities are instead distributed by the Depositary to Owners, (8) in addition to any fee charged under item 6, a fee of $.05 or less per American Depositary Share (or portion thereof) per annum for depositary services, which will be payable as provided in item 9 below, and (9) any other charges payable by the Depositary or the Custodian, any of the Depositary's or Custodian’s agents or the agents of the Depositary's or Custodian’s agents, in connection with the servicing of Shares or other Deposited Securities (which charges shall be assessed against Owners as of the date or dates set by the Depositary in accordance with Section 4.6 of the Deposit Agreement and shall be payable at the sole discretion of the Depositary by billing those Owners for those charges or by deducting those charges from one or more cash dividends or other cash distributions).

 

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The Depositary may collect any of its fees by deduction from any cash distribution payable, or by selling a portion of any securities to be distributed, to Owners that are obligated to pay those fees.

 

The Depositary may own and deal in any class of securities of the Company and its affiliates and in American Depositary Shares.

 

From time to time, the Depositary may make payments to the Company to reimburse the Company for costs and expenses generally arising out of establishment and maintenance of the American Depositary Shares program, waive fees and expenses for services provided by the Depositary or share revenue from the fees collected from Owners or Holders. In performing its duties under the Deposit Agreement, the Depositary may use brokers, dealers, foreign currency dealers or other service providers that are owned by or affiliated with the Depositary and that may earn or share fees, spreads or commissions.

 

8. DISCLOSURE OF INTERESTS.

 

When required in order to comply with applicable laws and regulations or the articles of association or similar document of the Company, the Company may from time to time request each Owner and Holder to provide to the Depositary information relating to: (a) the capacity in which it holds American Depositary Shares, (b) the identity of any Holders or other persons or entities then or previously interested in those American Depositary Shares and the nature of those interests and (c) any other matter where disclosure of such matter is required for that compliance. Each Owner and Holder agrees to provide all information known to it in response to a request made pursuant to Section 3.4 of the Deposit Agreement. Each Holder consents to the disclosure by the Depositary and the Owner or other Holder through which it holds American Depositary Shares, directly or indirectly, of all information responsive to a request made pursuant to that Section relating to that Holder that is known to that Owner or other Holder.

 

As of the date of the Deposit Agreement, each Owner and Holder agrees, if it instructs the Depositary to exercise voting rights with respect to Deposited Shares, that it will comply with any applicable Israeli law requiring it to, inter alia, disclose any personal interest it might have in the matter on the agenda of the general meeting. The Company undertakes no obligations to update this Section to reflect changes in law that occur after the date of the Deposit Agreement.

 

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9. TITLE TO AMERICAN DEPOSITARY SHARES.

 

It is a condition of the American Depositary Shares, and every successive Owner and Holder of American Depositary Shares, by accepting or holding the same, consents and agrees that American Depositary Shares evidenced by a Receipt, when the Receipt is properly endorsed or accompanied by proper instruments of transfer, shall be transferable as certificated registered securities under the laws of the State of New York, and that American Depositary Shares not evidenced by Receipts shall be transferable as uncertificated registered securities under the laws of the State of New York. The Depositary, notwithstanding any notice to the contrary, may treat the Owner of American Depositary Shares as the absolute owner thereof for the purpose of determining the person entitled to distribution of dividends or other distributions or to any notice provided for in the Deposit Agreement and for all other purposes, and neither the Depositary nor the Company shall have any obligation or be subject to any liability under the Deposit Agreement to any Holder of American Depositary Shares, but only to the Owner.

 

10. VALIDITY OF RECEIPT.

 

This Receipt shall not be entitled to any benefits under the Deposit Agreement or be valid or obligatory for any purpose, unless this Receipt shall have been (i) executed by the Depositary by the manual signature of a duly authorized officer of the Depositary or (ii) executed by the facsimile signature of a duly authorized officer of the Depositary and countersigned by the manual signature of a duly authorized signatory of the Depositary or the Registrar or a co-registrar.

 

11. REPORTS; INSPECTION OF TRANSFER BOOKS.

 

The Company is subject to the periodic reporting requirements of the Securities Exchange Act of 1934 and, accordingly, files certain reports with the Securities and Exchange Commission. Those reports will be available for inspection and copying through the Commission's EDGAR system or at public reference facilities maintained by the Commission in Washington, D.C.

 

The Depositary will make available for inspection by Owners at its Office any reports, notices and other communications, including any proxy soliciting material, received from the Company which are both (a) received by the Depositary as the holder of the Deposited Securities and (b) made generally available to the holders of those Deposited Securities by the Company. The Company shall furnish reports and communications, including any proxy soliciting material to which Section 4.9 of the Deposit Agreement applies, to the Depositary in English, to the extent such materials are required to be translated into English pursuant to any regulations of the Commission.

 

The Depositary will keep books for the registration of American Depositary Shares and transfers of American Depositary Shares, which shall be open for inspection by the Owners at the Depositary’s Office during regular business hours, provided that such inspection shall not be for the purpose of communicating with Owners in the interest of a business or object other than the business of the Company or a matter related to the Deposit Agreement or the American Depositary Shares.

 

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12. DIVIDENDS AND DISTRIBUTIONS.

 

Whenever the Depositary receives any cash dividend or other cash distribution on Deposited Securities, the Depositary will, if at the time of receipt thereof any amounts received in a foreign currency can in the judgment of the Depositary be converted on a reasonable basis into Dollars transferable to the United States, and subject to the Deposit Agreement, convert that dividend or other cash distribution into Dollars and distribute the amount thus received (net of the fees and expenses of the Depositary as provided in Article 7 hereof and Section 5.9 of the Deposit Agreement) to the Owners entitled thereto; provided , however , that if the Custodian or the Depositary is required to withhold and does withhold from that cash dividend or other cash distribution an amount on account of taxes or other governmental charges, the amount distributed to the Owners of the American Depositary Shares representing those Deposited Securities shall be reduced accordingly. If a cash distribution would represent a return of all or substantially all the value of the Deposited Securities underlying American Depositary Shares, the Depositary may require surrender of those American Depositary Shares and may require payment of or deduct the fee for surrender of American Depositary Shares (whether or not it is also requiring surrender of American Depositary Shares) as a condition of making that cash distribution. A distribution of that kind shall be a Termination Option Event .

 

Subject to the provisions of Section 4.11 and 5.9 of the Deposit Agreement, whenever the Depositary receives any distribution other than a distribution described in Section 4.1, 4.3 or 4.4 of the Deposit Agreement on Deposited Securities (but not in exchange for or in conversion or in lieu of Deposited Securities), the Depositary will cause the securities or property received by it to be distributed to the Owners entitled thereto, after deduction or upon payment of any fees and expenses of the Depositary and any taxes or other governmental charges, in any manner that the Depositary deems equitable and practicable for accomplishing that distribution (which may be a distribution of depositary shares representing the securities received); provided , however , that if in the opinion of the Depositary such distribution cannot be made proportionately among the Owners of Receipts entitled thereto, or if for any other reason the Depositary deems such distribution not to be lawful and feasible, the Depositary may adopt such other method as it may deem equitable and practicable for the purpose of effecting such distribution, including, but not limited to, the public or private sale of the securities or property thus received, or any part thereof, and distribution of the net proceeds of any such sale (net of the fees and expenses of the Depositary as provided in Article 7 hereof and Section 5.9 of the Deposit Agreement) to the Owners entitled thereto all in the manner and subject to the conditions set forth in Section 4.1 of the Deposit Agreement. The Depositary may withhold any distribution of securities under Section 4.2 of the Deposit Agreement if it has not received satisfactory assurances from the Company that the distribution does not require registration under the Securities Act of 1933. The Depositary may sell, by public or private sale, an amount of securities or other property it would otherwise distribute under this Article that is sufficient to pay its fees and expenses in respect of that distribution. If a distribution under Section 4.2 of the Deposit Agreement would represent a return of all of substantially all the value of the Deposited Securities underlying American Depositary Shares, the Depositary may require surrender of those American Depositary Shares and may require payment of or deduct the fee for surrender of American Depositary Shares (whether or not it is also requiring surrender of American Depositary Shares) as a condition of making that distribution. A distribution of that kind shall be a Termination Option Event .

 

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Whenever the Depositary receives any distribution consisting of a dividend in, or free distribution of, Shares, the Depositary may deliver to the Owners entitled thereto, an aggregate number of American Depositary Shares representing the amount of Shares received as that dividend or free distribution, subject to the terms and conditions of the Deposit Agreement with respect to the deposit of Shares and issuance of American Depositary Shares, including the withholding of any tax or other governmental charge as provided in Section 4.11 of the Deposit Agreement and the payment of the fees and expenses of the Depositary as provided in Article 7 hereof and Section 5.9 of the Deposit Agreement (and the Depositary may sell, by public or private sale, an amount of Shares received (or American Depositary Shares representing those Shares) sufficient to pay its fees and expenses in respect of that distribution). In lieu of delivering fractional American Depositary Shares, the Depositary may sell the amount of Shares represented by the aggregate of those fractions (or American Depositary Shares representing those Shares) and distribute the net proceeds, all in the manner and subject to the conditions described in Section 4.1of the Deposit Agreement. If and to the extent that additional American Depositary Shares are not delivered and Shares or American Depositary Shares are not sold, each American Depositary Share shall thenceforth also represent the additional Shares distributed on the Deposited Securities represented thereby.

 

If the Company declares a distribution in which holders of Deposited Securities have a right to elect whether to receive cash, Shares or other securities or a combination of those things, or a right to elect to have a distribution sold on their behalf, the Depositary may, after consultation with the Company, make that right of election available for exercise by Owners any manner the Depositary considers to be lawful and practical. As a condition of making a distribution election right available to Owners, the Depositary may require satisfactory assurances from the Company that doing so does not require registration of any securities under the Securities Act of 1933.

 

If the Depositary determines that any distribution received or to be made by the Depositary (including Shares and rights to subscribe therefor) is subject to any tax or other governmental charge that the Depositary is obligated to withhold, the Depositary may sell, by public or private sale, all or a portion of the distributed property (including Shares and rights to subscribe therefor) in the amounts and manner the Depositary deems necessary and practicable to pay any those taxes or charges, and the Depositary shall distribute the net proceeds of that sale, after deduction of those taxes or charges, to the Owners entitled thereto in proportion to the number of American Depositary Shares held by them respectively.

 

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Each Owner and Holder agrees to indemnify the Company, the Depositary, the Custodian and their respective directors, employees, agents and affiliates for, and hold each of them harmless against, any claim by any governmental authority with respect to taxes, additions to tax, penalties or interest arising out of any refund of taxes, reduced withholding at source or other tax benefit received by it. Services for Owners and Holders that may permit them to obtain reduced rates of tax withholding at source or reclaim excess tax withheld, and the fees and costs associated with using services of that kind, are not provided under, and are outside the scope of, the Deposit Agreement.

 

13. RIGHTS.

 

(a)          If rights are granted to the Depositary in respect of deposited Shares to purchase additional Shares or other securities, the Company and the Depositary shall endeavor to consult as to the actions, if any, the Depositary should take in connection with that grant of rights. The Depositary may, to the extent deemed by it to be lawful and practical (i) if requested in writing by the Company, grant to all or certain Owners rights to instruct the Depositary to purchase the securities to which the rights relate and deliver those securities or American Depositary Shares representing those securities to Owners, (ii) if requested in writing by the Company, deliver the rights to or to the order of certain Owners, or (iii) sell the rights to the extent practicable and distribute the net proceeds of that sale to Owners entitled to those proceeds. To the extent rights are not exercised, delivered or disposed of under (i), (ii) or (iii) above, the Depositary shall permit the rights to lapse unexercised.

 

(b)          If the Depositary will act under (a)(i) above, the Company and the Depositary will enter into a separate agreement setting forth the conditions and procedures applicable to the particular offering. Upon instruction from an applicable Owner in the form the Depositary specified and upon payment by that Owner to the Depositary of an amount equal to the purchase price of the securities to be received upon the exercise of the rights, the Depositary shall, on behalf of that Owner, exercise the rights and purchase the securities. The purchased securities shall be delivered to, or as instructed by, the Depositary. The Depositary shall (i) deposit the purchased Shares under the Deposit Agreement and deliver American Depositary Shares representing those Shares to that Owner or (ii) deliver or cause the purchased Shares or other securities to be delivered to or to the order of that Owner. The Depositary will not act under (a)(i) above unless the offer and sale of the securities to which the rights relate are registered under the Securities Act of 1933 or the Depositary has received an opinion of United States counsel that is satisfactory to it to the effect that those securities may be sold and delivered to the applicable Owners without registration under the Securities Act of 1933.

 

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(c)          If the Depositary will act under (a)(ii) above, the Company and the Depositary will enter into a separate agreement setting forth the conditions and procedures applicable to the particular offering. Upon (i) the request of an applicable Owner to deliver the rights allocable to the American Depositary Shares of that Owner to an account specified by that Owner to which the rights can be delivered and (ii) receipt of such documents as the Company and the Depositary agreed to require to comply with applicable law, the Depositary will deliver those rights as requested by that Owner.

 

(d)          If the Depositary will act under (a)(iii) above, the Depositary will use reasonable efforts to sell the rights in proportion to the number of American Depositary Shares held by the applicable Owners and pay the net proceeds to the Owners otherwise entitled to the rights that were sold, upon an averaged or other practical basis without regard to any distinctions among such Owners because of exchange restrictions or the date of delivery of any American Depositary Shares or otherwise.

 

(e)          Payment or deduction of the fees of the Depositary as provided in Section 5.9 of the Deposit Agreement and payment or deduction of the expenses of the Depositary and any applicable taxes or other governmental charges shall be conditions of any delivery of securities or payment of cash proceeds under Section 4.4 of that Agreement.

 

(f)          The Depositary shall not be responsible for any failure to determine that it may be lawful or feasible to make rights available to or exercise rights on behalf of Owners in general or any Owner in particular, or to sell rights.

 

14. CONVERSION OF FOREIGN CURRENCY.

 

Whenever the Depositary or the Custodian receives foreign currency, by way of dividends or other distributions or the net proceeds from the sale of securities, property or rights, and if at the time of the receipt thereof the foreign currency so received can in the judgment of the Depositary be converted on a reasonable basis into Dollars and the resulting Dollars transferred to the United States, the Depositary shall convert or cause to be converted by sale or in any other manner that it may determine that foreign currency into Dollars, and those Dollars shall be distributed to the Owners entitled thereto. A cash distribution may be made upon an averaged or other practicable basis without regard to any distinctions among Owners based on exchange restrictions, the date of delivery of any American Depositary Shares or otherwise and shall be net of any expenses of conversion into Dollars incurred by the Depositary as provided in Section 5.9 of the Deposit Agreement.

 

If a conversion of foreign currency or the repatriation or distribution of Dollars can be effected only with the approval or license of any government or agency thereof, the Depositary may, but will not be required to, file an application for that approval or license.

 

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If the Depositary determines that in its judgment any foreign currency received by the Depositary or the Custodian is not convertible on a reasonable basis into Dollars transferable to the United States, or if any approval or license of any government or agency thereof that is required for such conversion is not filed or sought by the Depositary or is not obtained within a reasonable period as determined by the Depositary, the Depositary may distribute the foreign currency received by the Depositary to, or in its discretion may hold such foreign currency uninvested and without liability for interest thereon for the respective accounts of, the Owners entitled to receive the same.

 

If any conversion of foreign currency, in whole or in part, cannot be effected for distribution to some of the Owners entitled thereto, the Depositary may in its discretion make that conversion and distribution in Dollars to the extent practicable and permissible to the Owners entitled thereto and may distribute the balance of the foreign currency received by the Depositary to, or hold that balance uninvested and without liability for interest thereon for the account of, the Owners entitled thereto.

 

The Depositary may convert currency itself or through any of its affiliates and, in those cases, acts as principal for its own account and not as agent, advisor, broker or fiduciary on behalf of any other person and earns revenue, including, without limitation, transaction spreads, that it will retain for its own account.  The revenue is based on, among other things, the difference between the exchange rate assigned to the currency conversion made under the Deposit Agreement and the rate that the Depositary or its affiliate receives when buying or selling foreign currency for its own account.  The Depositary makes no representation that the exchange rate used or obtained in any currency conversion under the Deposit Agreement will be the most favorable rate that could be obtained at the time or that the method by which that rate will be determined will be the most favorable to Owners, subject to the Depositary’s obligations under Section 5.3 of that Agreement. The methodology used to determine exchange rates used in currency conversions is available upon request.

 

15. RECORD DATES.

 

Whenever a cash dividend, cash distribution or any other distribution is made on Deposited Securities or rights to purchase Shares or other securities are issued with respect to Deposited Securities (which rights will be delivered to or exercised or sold on behalf of Owners in accordance with Section 4.4 of the Deposit Agreement) or the Depositary receives notice that a distribution or issuance of that kind will be made, or whenever the Depositary receives notice that a meeting of holders of Shares will be held in respect of which the Company has requested the Depositary to send a notice under Section 4.7 of the Deposit Agreement, or whenever the Depositary will assess a fee or charge against the Owners, or whenever the Depositary causes a change in the number of Shares that are represented by each American Depositary Share, or whenever the Depositary otherwise finds it necessary or convenient, the Depositary shall fix a record date, which shall be the same as, or as near as practicable to, any corresponding record date set by the Company with respect to Shares, (a) for the determination of the Owners (i) who shall be entitled to receive the benefit of that dividend or other distribution or those rights, (ii) who shall be entitled to give instructions for the exercise of voting rights at that meeting, (iii) who shall be responsible for that fee or charge or (iv) for any other purpose for which the record date was set, or (b) on or after which each American Depositary Share will represent the changed number of Shares. Subject to the provisions of Sections 4.1 through 4.5 of the Deposit Agreement and to the other terms and conditions of the Deposit Agreement, the Owners on a record date fixed by the Depositary shall be entitled to receive the amount distributable by the Depositary with respect to that dividend or other distribution or those rights or the net proceeds of sale thereof in proportion to the number of American Depositary Shares held by them respectively, to give voting instructions or to act in respect of the other matter for which that record date was fixed, or be responsible for that fee or charge, as the case may be.

 

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16. VOTING OF DEPOSITED SHARES.

 

(a)          Upon receipt of notice from the Company of any meeting of holders of Shares at which holders of Shares will be entitled to vote, if requested in writing by the Company, the Depositary shall, as soon as practicable thereafter, Disseminate to the Owners a notice, the form of which shall be prepared by the Depositary and approved by the Company, that shall contain (i) the information contained in the notice of meeting received by the Depositary, (ii) a statement that the Owners as of the close of business on a specified record date will be entitled, subject to any applicable provision of Israeli law and of the articles of association or similar documents of the Company, to instruct the Depositary as to the exercise of the voting rights pertaining to the amount of Shares represented by their respective American Depositary Shares, (iii) a statement as to the manner in which those instructions may be given and (iv) the last date on which the Depositary will accept instructions (the “Instruction Cutoff Date”).

 

(b)          Upon the written request of an Owner of American Depositary Shares, as of the date of the request or, if a record date was specified by the Depositary, as of that record date, received on or before any Instruction Cutoff Date established by the Depositary, the Depositary may, and if the Depositary sent a notice under the preceding paragraph shall, endeavor, in so far as practicable, to vote or cause to be voted the amount of deposited Shares represented by those American Depositary Shares in accordance with the instructions set forth in that request. The Depositary shall not vote or attempt to exercise the right to vote that attaches to the deposited Shares other than in accordance with instructions given by Owners and received by the Depositary.

 

(c)          There can be no assurance that Owners generally or any Owner in particular will receive the notice described in paragraph (a) above in time to enable Owners to give instructions to the Depositary prior to the Instruction Cutoff Date.

 

(d)          In order to give Owners a reasonable opportunity to instruct the Depositary as to the exercise of voting rights relating to Shares, if the Company will request the Depositary to Disseminate a notice under paragraph (a) above, the Company shall give the Depositary notice of the meeting, details concerning the matters to be voted upon and copies of materials to be made available to holders of Shares in connection with the meeting not less than 45 days prior to the meeting date.

 

A- 14

 

 

17. TENDER AND EXCHANGE OFFERS; REDEMPTION, REPLACEMENT OR CANCELLATION OF DEPOSITED SECURITIES.

 

(a)          The Depositary shall not tender any Deposited Securities in response to any voluntary cash tender offer, exchange offer or similar offer made to holders of Deposited Securities (a “ Voluntary Offer ”), except when instructed in writing to do so by an Owner surrendering American Depositary Shares and subject to any conditions or procedures the Depositary may require.

 

(b)          If the Depositary receives a written notice that Deposited Securities have been redeemed for cash or otherwise purchased for cash in a transaction that is mandatory and binding on the Depositary as a holder of those Deposited Securities (a “ Redemption ”), the Depositary, at the expense of the Company, shall (i) if required, surrender Deposited Securities that have been redeemed to the issuer of those securities or its agent on the redemption date, (ii) Disseminate a notice to Owners (A) notifying them of that Redemption, (B) calling for surrender of a corresponding number of American Depositary Shares and (C) notifying them that the called American Depositary Shares have been converted into a right only to receive the money received by the Depositary upon that Redemption and those net proceeds shall be the Deposited Securities to which Owners of those converted American Depositary Shares shall be entitled upon surrenders of those American Depositary Shares in accordance with Section 2.5 or 6.2 of the Deposit Agreement and (iii) distribute the money received upon that Redemption to the Owners entitled to it upon surrender by them of called American Depositary Shares in accordance with Section 2.5 of that Agreement (and, for the avoidance of doubt, Owners shall not be entitled to receive that money under Section 4.1 of that Agreement). If the Redemption affects less than all the Deposited Securities, the Depositary shall call for surrender a corresponding portion of the outstanding American Depositary Shares and only those American Depositary Shares will automatically be converted into a right to receive the net proceeds of the Redemption. The Depositary shall allocate the American Depositary Shares converted under the preceding sentence among the Owners pro-rata to their respective holdings of American Depositary Shares immediately prior to the Redemption, except that the allocations may be adjusted so that no fraction of a converted American Depositary Share is allocated to any Owner. A Redemption of all or substantially all of the Deposited Securities shall be a Termination Option Event .

 

A- 15

 

 

(c)          If the Depositary is notified of or there occurs any change in nominal value or any subdivision, combination or any other reclassification of the Deposited Securities or any recapitalization, reorganization, sale of assets substantially as an entirety, merger or consolidation affecting the issuer of the Deposited Securities or to which it is a party that is mandatory and binding on the Depositary as a holder of Deposited Securities and, as a result, securities or other property have been or will be delivered in exchange, conversion, replacement or in lieu of, Deposited Securities (a “ Replacement ”), the Depositary shall, if required, surrender the old Deposited Securities affected by that Replacement of Shares and hold, as new Deposited Securities under the Deposit Agreement, the new securities or other property delivered to it in that Replacement. However , the Depositary may elect to sell those new Deposited Securities if in the opinion of the Depositary it is not lawful or not practical for it to hold those new Deposited Securities under the Deposit Agreement because those new Deposited Securities may not be distributed to Owners without registration under the Securities Act of 1933 or for any other reason, at public or private sale, at such places and on such terms as it deems proper and proceed as if those new Deposited Securities had been Redeemed under paragraph (b) above. A Replacement shall be a Termination Option Event .

 

(d)          In the case of a Replacement where the new Deposited Securities will continue to be held under the Deposit Agreement, the Depositary may call for the surrender of outstanding Receipts to be exchanged for new Receipts specifically describing the new Deposited Securities and the number of those new Deposited Securities represented by each American Depositary Share. If the number of Shares represented by each American Depositary Share decreases as a result of a Replacement, the Depositary may call for surrender of the American Depositary Shares to be exchanged on a mandatory basis for a lesser number of American Depositary Shares and may sell American Depositary Shares to the extent necessary to avoid distributing fractions of American Depositary Shares in that exchange and distribute the net proceeds of that sale to the Owners entitled to them.

 

(e)          If there are no Deposited Securities with respect to American Depositary Shares, including if the Deposited Securities are cancelled, or the Deposited Securities with respect to American Depositary Shares become apparently worthless, the Depositary may call for surrender of those American Depositary Shares or may cancel those American Depositary Shares, upon notice to Owners, and that condition shall be a Termination Option Event .

 

18. LIABILITY OF THE COMPANY AND DEPOSITARY.

 

Neither the Depositary nor the Company nor any of their respective directors, employees, agents or affiliates shall incur any liability to any Owner or Holder:

 

A- 16

 

 

(i) if by reason of (A) any provision of any present or future law or regulation or other act of the government of the United States, any State of the United States or any other state or jurisdiction, or of any governmental or regulatory authority or stock exchange; (B) (in the case of the Depositary only) any provision, present or future, of the articles of association or similar document of the Company, or by reason of any provision of any securities issued or distributed by the Company, or any offering or distribution thereof; or (C) any event or circumstance, whether natural or caused by a person or persons, that is beyond the ability of the Depositary or the Company, as the case may be, to prevent or counteract by reasonable care or effort (including, but not limited to earthquakes, floods, severe storms, fires, explosions, war, terrorism, civil unrest, labor disputes or criminal acts; interruptions or malfunctions of utility services, Internet or other communications lines or systems; unauthorized access to or attacks on computer systems or websites; or other failures or malfunctions of computer hardware or software or other systems or equipment), the Depositary or the Company is, directly or indirectly, prevented from, forbidden to or delayed in, or could be subject to any civil or criminal penalty on account of doing or performing and therefore does not do or perform, any act or thing that, by the terms of the Deposit Agreement or the Deposited Securities, it is provided shall be done or performed;

 

(ii) for any exercise of, or failure to exercise, any discretion provided for in the Deposit Agreement (including any determination by the Depositary to take, or not take, any action that the Deposit Agreement provides the Depositary may take);

 

(iii) for the inability of any Owner or Holder to benefit from any distribution, offering, right or other benefit that is made available to holders of Deposited Securities but is not, under the terms of the Deposit Agreement, made available to Owners or Holders; or

 

(iv) for any special, consequential or punitive damages for any breach of the terms of the Deposit Agreement.

 

Where, by the terms of a distribution to which Section 4.1, 4.2 or 4.3 of the Deposit Agreement applies, or an offering to which Section 4.4 of that Agreement applies, or for any other reason, that distribution or offering may not be made available to Owners, and the Depositary may not dispose of that distribution or offering on behalf of Owners and make the net proceeds available to Owners, then the Depositary shall not make that distribution or offering available to Owners, and shall allow any rights, if applicable, to lapse.

 

A- 17

 

 

Neither the Company nor the Depositary assumes any obligation or shall be subject to any liability under the Deposit Agreement to Owners or Holders, except that they agree to perform their obligations specifically set forth in the Deposit Agreement without negligence or bad faith. The Depositary shall not be a fiduciary or have any fiduciary duty to Owners or Holders. The Depositary shall not be subject to any liability with respect to the validity or worth of the Deposited Securities. Neither the Depositary nor the Company shall be under any obligation to appear in, prosecute or defend any action, suit, or other proceeding in respect of any Deposited Securities or in respect of the American Depositary Shares, on behalf of any Owner or Holder or other person. Neither the Depositary nor the Company shall be liable for any action or non-action by it in reliance upon the advice of or information from legal counsel, accountants, any person presenting Shares for deposit, any Owner or Holder, or any other person believed by it in good faith to be competent to give such advice or information. Each of the Depositary and the Company may rely, and shall be protected in relying upon, any written notice, request, direction or other document believed by it to be genuine and to have been signed or presented by the proper party or parties. The Depositary shall not be liable for any acts or omissions made by a successor depositary whether in connection with a previous act or omission of the Depositary or in connection with a matter arising wholly after the removal or resignation of the Depositary, provided that in connection with the issue out of which such potential liability arises, the Depositary performed its obligations without negligence or bad faith while it acted as Depositary. The Depositary shall not be liable for the acts or omissions of any securities depository, clearing agency or settlement system in connection with or arising out of book-entry settlement of American Depositary Shares or Deposited Securities or otherwise. In the absence of bad faith on its part, the Depositary shall not be responsible for any failure to carry out any instructions to vote any of the Deposited Securities or for the manner in which any such vote is cast or the effect of any such vote. The Depositary shall have no duty to make any determination or provide any information as to the tax status of the Company or any liability for any tax consequences that may be incurred by Owners or Holders as a result of owning or holding American Depositary Shares. The Depositary shall not be liable for the inability or failure of an Owner or Holder to obtain the benefit of a foreign tax credit, reduced rate of withholding or refund of amounts withheld in respect of tax or any other tax benefit. No disclaimer of liability under the United States federal securities laws is intended by any provision of the Deposit Agreement.

 

19. RESIGNATION AND REMOVAL OF THE DEPOSITARY; APPOINTMENT OF SUCCESSOR CUSTODIAN.

 

The Depositary may at any time resign as Depositary under the Deposit Agreement by written notice of its election so to do delivered to the Company, to become effective upon the appointment of a successor depositary and its acceptance of such appointment as provided in the Deposit Agreement. The Depositary may at any time be removed by the Company by 120 days’ prior written notice of that removal, to become effective upon the later of (i) the 120th day after delivery of the notice to the Depositary and (ii) the appointment of a successor depositary and its acceptance of its appointment as provided in the Deposit Agreement. The Depositary in its discretion may at any time appoint a substitute or additional custodian or custodians.

 

20. AMENDMENT.

 

The form of the Receipts and any provisions of the Deposit Agreement may at any time and from time to time be amended by agreement between the Company and the Depositary without the consent of Owners or Holders in any respect which they may deem necessary or desirable. Any amendment that would impose or increase any fees or charges (other than taxes and other governmental charges, registration fees, cable, telex or facsimile transmission costs, delivery costs or other such expenses), or that would otherwise prejudice any substantial existing right of Owners, shall, however, not become effective as to outstanding American Depositary Shares until the expiration of 30 days after notice of that amendment has been Disseminated to the Owners of outstanding American Depositary Shares. Every Owner and Holder, at the time any amendment so becomes effective, shall be deemed, by continuing to hold American Depositary Shares or any interest therein, to consent and agree to that amendment and to be bound by the Deposit Agreement as amended thereby. Upon the effectiveness of an amendment to the form of Receipt, including a change in the number of Shares represented by each American Depositary Share, the Depositary may call for surrender of Receipts to be replaced with new Receipts in the amended form or call for surrender of American Depositary Shares to effect that change of ratio. In no event shall any amendment impair the right of the Owner to surrender American Depositary Shares and receive delivery of the Deposited Securities represented thereby, except in order to comply with mandatory provisions of applicable law.

 

A- 18

 

 

21. TERMINATION OF DEPOSIT AGREEMENT.

 

(a)          The Company may initiate termination of the Deposit Agreement by notice to the Depositary. The Depositary may initiate termination of the Deposit Agreement if (i) at any time 60 days shall have expired after the Depositary delivered to the Company a written resignation notice and a successor depositary has not been appointed and accepted its appointment as provided in Section 5.4 of that Agreement, (ii) an Insolvency Event or Delisting Event occurs with respect to the Company or (iii) a Termination Option Event has occurred or will occur. If termination of the Deposit Agreement is initiated, the Depositary shall Disseminate a notice of termination to the Owners of all American Depositary Shares then outstanding setting a date for termination (the “ Termination Date ”), which shall be at least 90 days after the date of that notice, and the Deposit Agreement shall terminate on that Termination Date.

 

(b)          After the Termination Date, the Company shall be discharged from all obligations under the Deposit Agreement except for its obligations to the Depositary under Sections 5.8 and 5.9 of that Agreement.

 

(c)          At any time after the Termination Date, the Depositary may sell the Deposited Securities then held under the Deposit Agreement and may thereafter hold uninvested the net proceeds of any such sale, together with any other cash then held by it hereunder, unsegregated and without liability for interest, for the pro rata benefit of the Owners of American Depositary Shares that remain outstanding, and those Owners will be general creditors of the Depositary with respect to those net proceeds and that other cash. After making that sale, the Depositary shall be discharged from all obligations under the Deposit Agreement, except (i) to account for the net proceeds and other cash (after deducting, in each case, the fee of the Depositary for the surrender of American Depositary Shares, any expenses for the account of the Owner of such American Depositary Shares in accordance with the terms and conditions of the Deposit Agreement and any applicable taxes or governmental charges) and (ii) for its obligations under Section 5.8 of that Agreement and (iii) to act as provided in paragraph (d) below.

 

A- 19

 

 

(d)          After the Termination Date, the Depositary shall continue to receive dividends and other distributions pertaining to Deposited Securities (that have not been sold), may sell rights and other property as provided in the Deposit Agreement and shall deliver Deposited Securities (or sale proceeds) upon surrender of American Depositary Shares (after payment or upon deduction, in each case, of the fee of the Depositary for the surrender of American Depositary Shares, any expenses for the account of the Owner of those American Depositary Shares in accordance with the terms and conditions of the Deposit Agreement and any applicable taxes or governmental charges). After the Termination Date, the Depositary shall not accept deposits of Shares or deliver American Depositary Shares. After the Termination Date, (i) the Depositary may refuse to accept surrenders of American Depositary Shares for the purpose of withdrawal of Deposited Securities (that have not been sold) or reverse previously accepted surrenders of that kind that have not settled if in its judgment the requested withdrawal would interfere with its efforts to sell the Deposited Securities, (ii) the Depositary will not be required to deliver cash proceeds of the sale of Deposited Securities until all Deposited Securities have been sold and (iii) the Depositary may discontinue the registration of transfers of American Depositary Shares and suspend the distribution of dividends and other distributions on Deposited Securities to the Owners and need not give any further notices or perform any further acts under the Deposit Agreement except as provided in Section 6.2 of that Agreement.

 

22. DTC DIRECT REGISTRATION SYSTEM AND PROFILE MODIFICATION SYSTEM.

 

(a)          Notwithstanding the provisions of Section 2.4 of the Deposit Agreement, the parties acknowledge that DTC’s Direct Registration System (“ DRS ”) and Profile Modification System (“ Profile ”) apply to the American Depositary Shares upon acceptance thereof to DRS by DTC. DRS is the system administered by DTC that facilitates interchange between registered holding of uncertificated securities and holding of security entitlements in those securities through DTC and a DTC participant. Profile is a required feature of DRS that allows a DTC participant, claiming to act on behalf of an Owner of American Depositary Shares, to direct the Depositary to register a transfer of those American Depositary Shares to DTC or its nominee and to deliver those American Depositary Shares to the DTC account of that DTC participant without receipt by the Depositary of prior authorization from the Owner to register that transfer.

 

(b)          In connection with DRS/Profile, the parties acknowledge that the Depositary will not determine whether the DTC participant that is claiming to be acting on behalf of an Owner in requesting registration of transfer and delivery described in paragraph (a) above has the actual authority to act on behalf of that Owner (notwithstanding any requirements under the Uniform Commercial Code). For the avoidance of doubt, the provisions of Sections 5.3 and 5.8 of the Deposit Agreement apply to the matters arising from the use of the DRS/Profile. The parties agree that the Depositary’s reliance on and compliance with instructions received by the Depositary through the DRS/Profile system and otherwise in accordance with the Deposit Agreement, shall not constitute negligence or bad faith on the part of the Depositary.

 

A- 20

 

 

23. APPOINTMENT OF AGENT FOR SERVICE OF PROCESS; SUBMISSION TO JURISDICTION; JURY TRIAL WAIVER; WAIVER OF IMMUNITIES.

 

The Company has (i) appointed Anchiano Therapeutics, Inc., which currently maintains an office at One Kendall Square, Building 600, Suite 6-106, Cambridge, Massachusetts 02139, United States of America, as the Company's authorized agent upon which process may be served in any suit or proceeding arising out of or relating to the Shares or Deposited Securities, the American Depositary Shares, the Receipts or this Agreement, (ii) consented and submitted to the jurisdiction of any state or federal court in the State of New York in which any such suit or proceeding may be instituted, and (iii) agreed that service of process upon said authorized agent shall be deemed in every respect effective service of process upon the Company in any such suit or proceeding.

 

EACH PARTY TO THE DEPOSIT AGREEMENT (INCLUDING, FOR AVOIDANCE OF DOUBT, EACH OWNER AND HOLDER) THEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY SUIT, ACTION OR PROCEEDING AGAINST THE COMPANY AND/OR THE DEPOSITARY DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THE SHARES OR OTHER DEPOSITED SECURITIES, THE AMERICAN DEPOSITARY SHARES OR THE RECEIPTS, THE DEPOSIT AGREEMENT OR ANY TRANSACTION CONTEMPLATED HEREIN OR THEREIN, OR THE BREACH HEREOF OR THEREOF, INCLUDING WITHOUT LIMITATION ANY QUESTION REGARDING EXISTENCE, VALIDITY OR TERMINATION (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY).

 

To the extent that the Company or any of its properties, assets or revenues may have or hereafter become entitled to, or have attributed to it, any right of immunity, on the grounds of sovereignty or otherwise, from any legal action, suit or proceeding, from the giving of any relief in any respect thereof, from setoff or counterclaim, from the jurisdiction of any court, from service of process, from attachment upon or prior to judgment, from attachment in aid of execution or judgment, or other legal process or proceeding for the giving of any relief or for the enforcement of any judgment, in any jurisdiction in which proceedings may at any time be commenced, with respect to its obligations, liabilities or any other matter under or arising out of or in connection with the Shares or Deposited Securities, the American Depositary Shares, the Receipts or the Deposit Agreement, the Company, to the fullest extent permitted by law, hereby irrevocably and unconditionally waives, and agrees not to plead or claim, any such immunity and consents to such relief and enforcement.

 

A- 21

 

 

Exhibit 5.1

 

 

Ampa Tower

98 Yigal Alon Street

Tel Aviv 6789141, Israel

Tel +972 (3) 608-9999

Fax +972 (3) 608-9909


info@goldfarb.com

www.goldfarb.com

 

 

 

  February ___, 2019

Anchiano Therapeutics Ltd.

1/3 High-Tech Village

Givat Ram, P.O. Box 39264 
Jerusalem 9139102

Israel  

 

 

 

Ladies and Gentlemen,

 

Re: Registration Statement on Form F-1

 

 

We refer to the Registration Statement on Form F-1 (the “Registration Statement”) filed with the Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended (the “Act”), by Anchiano Therapeutics Ltd., a company organized under the laws of the State of Israel (the “Company”), relating to the offering by the Company of up to 2,760,000 American Depositary Shares (“ADSs”), each representing five ordinary shares, no par value, of the Company (“Ordinary Shares”) (the ADSs being registered under the Registration Statement are referred to herein as the “Offering ADSs”).

 

The Offering ADSs will be issued under the Deposit Agreement, dated as of February ___, 2019, among the Company, the Bank of New York Mellon, as Depositary (the “Depositary”), and the owners and holders from time to time of ADSs issued thereunder (the “Deposit Agreement”).

 

In connection with this opinion, we have examined such corporate records, other documents and such questions of Israeli law as we have considered necessary or appropriate for the purposes of this opinion and, upon the basis of such examination, advise you that we are of the opinion that:

 

1. The Deposit Agreement has been duly authorized, executed and delivered by the Company.

 

2. Upon the issuance and deposit with the Depositary (or its custodian) of the Ordinary Shares to be represented by the Offering ADSs in the manner described in the Deposit Agreement, the Ordinary Shares to be represented by the Offering ADSs will be duly authorized, validly issued, fully paid and non-assessable.

 

We are members of the Israel Bar and we express no opinion as to any matter relating to the laws of any jurisdiction other than the laws of Israel.

 

We hereby consent to the filing of this opinion as an exhibit to the Registration Statement and to the references to this firm in the sections of the Registration Statement entitled “Legal Matters” and “Enforceability of Civil Liabilities.” In giving such consent, we do not believe that we are “experts” within the meaning of such term as used in the Act, or the rules and regulations of the SEC issued thereunder with respect to any part of the Registration Statement, including this opinion as an exhibit or otherwise. This consent is not to be construed as an admission that we are a party whose consent is required to be filed as part of the Registration Statement under the provisions of the Act.

 

Mayer Brown LLP, U.S. counsel to the Company, may rely on the opinions given herein in rendering their opinion of even date herewith in connection with the Registration Statement.

 

Very truly yours,

 

Goldfarb Seligman & Co.

 

 

 

 

Exhibit 5.2

 

 

     

Mayer Brown LLP

1221 Avenue of the Americas
New York, New York 10020-1001

 

Main Tel +1 212 506 2500
Main Fax +1 212 262 1910

www.mayerbrown.com

 

 

 
   

 

 

 

 

February ___, 2019

 
   

 

Anchiano Therapeutics Ltd.

1/3 High-Tech Village,

Givat Ram, P.O. Box 39264

Jerusalem, 9139102 Israel

 

Re: Registration Statement on Form F-1

 

Ladies and Gentlemen:

 

This opinion is furnished to you in connection with a Registration Statement on Form F-1 (File No. 333-229155) (as amended to date, the “Registration Statement”) filed by Anchiano Therapeutics Ltd., an Israeli company (the “Company”), with the Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended (the “Securities Act”), for the registration and proposed offering of up to 2,760,000 American Depositary Shares (“ADSs”), each representing five ordinary shares of the Company, no par value per ordinary share (the “Ordinary Shares”). The ADSs will be issued pursuant to a Deposit Agreement, dated February ___, 2019 (the “Deposit Agreement”) among the Company, The Bank of New York Mellon, as depositary (the “Depositary”), and all owners and holders of the ADSs issued thereunder.

 

We are acting as U.S. securities counsel for the Company in connection with the Registration Statement. In connection with this opinion, we have examined such corporate records, documents, instruments, certificates of public officials and of the Company and such questions of law as we have deemed necessary for the purpose of rendering the opinions set forth herein.

 

In our examination of the foregoing documents, we have assumed the genuineness of all signatures, the authenticity of all documents submitted to us as originals, the conformity to original documents of all documents submitted to us as copies and the authenticity of the originals of such latter documents.

 

Based on the foregoing, and subject to the further assumptions and qualifications set forth below, it is our opinion that, when the ADSs are issued in accordance with the Deposit Agreement against the deposit of duly authorized, validly issued, fully paid and non-assessable Ordinary Shares, such ADSs will be duly and validly issued under the Deposit Agreement and will entitle the holders thereof to the rights specified therein.

 

 

 

Mayer Brown is a global services provider comprising an association of legal practices that are separate entities including
Mayer Brown LLP (Illinois, USA), Mayer Brown International LLP (England), Mayer Brown (a Hong Kong partnership)
and Tauil & Chequer Advogados (a Brazilian partnership).

 

 

 

2  

 

 

 

Please note that we are opining only as to the matters expressly set forth herein, that no opinion should be inferred as to any other matter. We are opining herein as to the laws of the State of New York as in effect on the date hereof, and we express no opinion with respect to any other laws, rules or regulations. This opinion is based upon currently existing laws, rules, regulations and judicial decisions, and we disclaim any obligation to advise you of any change in any of these sources of law or subsequent legal or factual developments which might affect any matters or opinions set forth herein. In rendering the foregoing opinions, we have relied, for matters involving Israeli law, on the opinion of Goldfarb Seligman & Co., Israeli counsel to the Company.

 

This opinion is being rendered solely in connection with the registration of the offering and sale of the ADSs, pursuant to the registration requirements of the Securities Act.

 

We hereby consent to the filing of this opinion as Exhibit 5.2 to the Registration Statement and to the reference to this firm under the caption “Legal Matters” in the Registration Statement and in any Registration Statement pursuant to Rule 462(b) under the Securities Act. In giving such consent, we do not admit that we are in the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations of the Commission.

 

 

 

Very truly yours,

 

 

 

Mayer Brown LLP

 

 

 

[AP]

 

 

 

 

Exhibit 10.3

 

[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS EXHIBIT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED

 

BI Contract No. 100704

 

CLINICAL SUPPLY AGREEMENT

 

This Clinical Supply Agreement ("Agreement") is made by and among

 

BioCancell Therapeutics Israel Ltd.

1/3 High-Tech VillageGivat Ram

P.O. Box 39264

Jerusalem

9139102 Israel

(hereinafter called "BioCancell"), on one hand

 

and

 

Boehringer Ingelheim Biopharmaceuticals GmbH

Binger Straße 173,

55216 Ingelheim/Rhein

Germany

 

(hereinafter called "BI"),

and

 

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringer-Gasse 5-11

1121 Vienna

Austria

 

(hereinafter called “BI RCV”), on the other hand

 

(hereinafter BI, BI RCV and BioCancell each shall also be called “Party” and collectively “Parties” as the case may be).

 

EFFECTIVE DATE: 3 April 2013

 

  Page 1 of 57

 

 

[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS EXHIBIT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED

 

Preamble

 

WHEREAS , BioCancell’s Affiliated Company BioCancell Ltd. and BI RCV entered into a secrecy agreement (“CDA”) dated as of November 16, 2006, a material transfer agreement (“MTA”) dated as of April 3, 2013 and a Quality Agreement ("QA") dated as of September 12, 2013; and

 

WHEREAS , BioCancell is a biotechnology company engaged in, among other things, the research and development of cancer treatments and has all rights (whether by ownership or in-licensed) to the Product (as defined below) and is the owner of a cell line for a manufacturing process for manufacturing the Product; and

 

WHEREAS , BI RCV performed certain services between April 3, 2013 and December 31, 2013 for BioCancell Ltd., and effective January 1, 2014 BI RCV performs contract development and manufacturing services for biopharmaceuticals, owns a proprietary pDNA Technology platform and maintains a staff of trained professionals who are knowledgeable, experienced and skilled in biopharmaceuticals manufacturing including pDNA on behalf of BI; and

 

WHEREAS , BioCancell now wishes and BI has agreed to (i) BI’s performance (by itself and/or its Affiliated Companies) of certain development work relating to the industrial manufacturing of the Product, including (A) the development of a new Cell Line for the Product, and comparison of the BioCancell Cell Line and the new Cell Line for cGMP production of the Product using BI’s proprietary pDNA Technology platform, and including (B) the adaptation of BI’s generic pDNA Technology platform to the Cell Line finally selected by BioCancell during the performance of the services; and (ii) BI’s manufacturing of the Product for clinical testing (by BI itself and/or its Affiliated Companies) with the finally selected Cell Line. The services listed in this WHEREAS clause have partially already been started and/or performed under the MTA.

 

NOW, THEREFORE, and in consideration of the mutual covenants set forth in this Agreement, BI and BioCancell, and solely regarding the Services provided until December 31, 2013 also BI RCV, hereby agree as follows:

 

1 Definitions

 

1.1 “Affiliated Companies”

 

means any company or business entity which controls, is controlled by, or is under common control with, either BioCancell or BI. For purposes of this definition, "control" shall mean the possession, directly or indirectly of the power to direct or cause the direction of the management and policies of an entity (other than a natural person), whether through the majority ownership of voting capital stock, by contract or otherwise.

 

1.2 “Background IP”

 

means Intellectual Property Rights (i) owned, licensed to or controlled by a Party prior to the effective date of the MTA, or (ii) developed by a Party outside of the scope of this Agreement without use of the other Party’s Confidential Information.

 

1.3 “Batch”

 

shall have the meaning as set forth in the QA.

 

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1.4 “Batch Records”

 

shall have the meaning as set forth in the QA.

 

1.5 “BI Deliverables”

 

any material and documents or results other than the Product to be provided by BI to BioCancell as provided for herein in Section 2.6 and listed in detail in the Project Plan.

 

1.6 “BI Improvements”

 

shall have the meaning as set forth in Section 8.2.2.

 

1.7 “BioCancell Deliverables”

 

means any material and documents to be provided by BioCancell to BI as provided for herein in Section 2.5 and listed in detail in Appendix 1 .

 

1.8 “BioCancell Improvements”

 

shall have the meaning as set forth in Section 8.2.1.

 

1.9 ”BIP”

 

means BI's Affiliated Company, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach, Germany.

 

1.10 “BI RCV”

 

means BI's Affiliated Company, Boehringer Ingelheim Pharma RCV GmbH & Co KG, Dr. Boehringer-Gasse 5-11, 1121 Vienna, Austria.

 

1.11 “Cell Line”

 

shall mean the cell line used for the manufacture of clinical trial material which includes the BioCancell proprietary plasmid as further described in Appendix 1 .

 

1.12 “Certificate of Analysis” (CoA)

 

shall have the meaning as set forth in the QA.

 

1.13 “Certificate of Compliance” (CoC)

 

shall have the meaning as set forth in the QA.

 

1.14 “cGMP”

 

means current Good Manufacturing Practice regulations as set forth in more detail in the QA.

 

1.15 “Change of Control”

 

means the merger with, transfer to or acquisition of beneficial ownership of more than fifty percent (50%) of the outstanding voting shares of BI or BioCancell respectively and/or its respective Affiliated Companies in a transaction in which the shareholders of BI or BioCancell do not retain a majority of the voting power in the surviving or acquiring corporation.

 

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1.16 “Confidential Information”

 

means any information and materials disclosed by a Party or an Affiliated Company of such Party to the other Party or its Affiliated Company(ies), which information includes, but is not limited to: all know-how, trade secrets, inventions, non-public patent applications, processes, concepts, technology regarding the manufacture of biopharmaceuticals, and experimental methods as well as information concerning the Disclosing Party's and/or its Affiliated Companies’ financial situation, customers, business plans, and its or its Affiliated Companies’ research and product designs and other data and information disclosed or exchanged under the CDA, the MTA and/or this Agreement; as well as the terms of the CDA, the MTA and of this Agreement.

 

1.17 “Direct Competitor”

 

means [***] for BioCancell a third party (other than any of BI’s Affiliated Companies) developing, manufacturing or selling pharmaceutical products for the same indication as the Product.

 

1.18 “Disclosing Party”

 

in the capacity of disclosing Confidential Information and know-how, each Party is referred to as the Disclosing Party.

 

1.19 “Effective Date”

 

means the date of commencement of this Agreement as mentioned on the cover page above.

 

1.20 “Facility”

 

means either the biotech buildings and all other buildings located at Dr. Boehringer-Gasse 5-11, 1121 Vienna, Austria used by BI or located at Biberach/Riss, Germany used by BI’s Affiliated Company BI RCV and/or BIP in performance of the Project.

 

1.21 "Health Authorities"

 

shall have the meaning as set forth in the QA, and shall also include the FDA and the EMA, as set forth in the QA.

 

1.22 “Improvements”

 

means all discoveries and inventions, and all modifications, derivatives and improvements of Background IP or new uses thereof (whether or not protectable under patent, trademark, copyright or similar laws) that are discovered, developed or reduced to practice in the performance of this Agreement.

 

1.23 “IND (or “IMPD”)

 

means an Investigational New Drug application or an Investigational Medicinal Product Dossier application for the Product, and all associated documents to support such applications, as submitted or to be submitted to the applicable Health Authorities.

 

1.24 “Indemnitee”

 

shall have the meaning as set forth in Section 7.4.

 

1.25 “Indemnitor”

 

shall have the meaning as set forth in Section 7.4.

 

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1.26 “Intellectual Property Rights”

 

means any and all now known or hereafter existing: (i) rights associated with works of authorship, including copyrights and moral rights; (ii) trade secret rights; (iii) patent rights, and industrial property rights; (iv) other proprietary rights in all inventions (whether or not patentable), discoveries, methods, processes, techniques, specifications, protocols, schematics, diagrams, reagents, compounds, samples, formulation, data, circuit designs, design layout, databases, data, and other forms of technology; and (v) all registrations, applications, renewals, and extensions of the foregoing, in each case in any jurisdiction throughout the world, including, but not limited to, inventor’s certificates, utility models, substitutions, confirmations, reissues, re-examinations, renewals or any like governmental grants for protection of inventions; and any pending application for any of the foregoing, including any continuation, divisional, substitution, additions, continuations-in-part, provisional and converted provisional applications, as well as extensions and supplementary protection certificates based thereon.

 

1.27 “Latent Defects”

 

means non-conformance of the Batches or the Product with the Specifications proven or reasonably determined by a testing laboratory according to Section 4.1.3, other than Obvious Defects.

 

1.28 “Losses”

 

shall have the meaning set forth in Section 7.3a.

 

1.29 “Manufacturing Process”

 

means BI’s platform process based on the pDNA Technology, as detailed in Appendix 4 , to be adapted to the manufacturing of Product and/or optimized or further developed by BI during the performance of the Project as provided for in this Agreement.

 

1.30 “Manufacturer’s Release”

 

shall mean BI’s release of a cGMP conforming Batch of Product (either as drug substance or in the final dosage form as drug product- whichever is the case) in accordance with the QA.

 

1.31 “Master Batch Record”

 

shall have the meaning as set forth in the QA.

 

1.32 “NDA (or “CTD”)

 

means the New Drug Application or Common Technical Document for the Product, and all associated documents to support such applications, as submitted or to be submitted to the applicable Health Authorities.

 

1.33 “Obvious Defects”

 

means any non-conformance of the Batches or the Product with the Specifications which is visible or easily detectable without any analysis in a laboratory.

 

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1.34 “pDNA Technology”

 

means the host cell line, vectors, genetic elements, medium and other materials, as well as the fermentation, harvesting, purification, bulk formulation, and other biopharmaceutical manufacturing and analytical methods used by BI for generating the Product as detailed in Appendix 4 . The pDNA Technology shall be considered a part of the BI Background IP.

 

1.35 “Product”

 

means the biopharmaceutical product owned by BioCancell as detailed in Appendix 1 , and formulated either as bulk drug substance or in final dosage form as drug product.

 

1.36 “Product-Dedicated Equipment”

 

shall have the meaning specified in Section 3.2 hereof. Estimates of the Product Dedicated Equipment are included in Appendix 5 .

 

1.37 “Project”

 

means the performance of the Services, including without limitation the development of the Manufacturing Process, if any, for the Product, and the manufacture and supply of Batches, as provided for under this Agreement.

 

1.38 “Project Fees”

 

shall have the meaning specified in Section 3.1 hereof.

 

1.39 “Project Manager“

 

shall have the meaning specified in Section 2.2.1 hereof.

 

1.40 “Project Plan”

 

means the plan describing the Services to be performed by BI (by itself or its Affiliated Companies) under the Project, including the Project timeline, attached to this Agreement as Appendix 2 .

 

1.41 “Project Team“

 

shall have the meaning specified in Section 2.2.2 hereof.

 

1.42 “Raw Materials”

 

means raw materials, filters, membranes, consumables and resins applied in the performance of the Services. Estimates of the Raw Materials are included in Appendix 5 .

 

1.43 “Receiving Party”

 

in the capacity of receiving Confidential Information and know-how, each Party is referred to as the Receiving Party.

 

1.44 “Representatives”

 

means a Party’s Affiliated Companies and its and its Affiliated Companies’ directors, officers, employees and agents.

 

1.45 “Service(s)“

 

shall mean those certain services performed by BI under this Agreement as outlined in the Project Plan or otherwise agreed by the Parties in writing (e.g. by a change of the Project Plan).

 

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1.46 “Specification(s)”

 

means all the specifications and tests, analytical methods and/or limits, and the results thereof, as applicable, within which the Product has to conform to be considered acceptable by BioCancell for clinical use. The Parties are in agreement, that pursuant to Section 2.7 the preliminary specifications shall be updated into revised specifications for the release of the Product.

 

1.47 “Steering Committee”

 

shall have the meaning specified in Section 2.2.3 hereof.

 

1.48 “Territory”

 

shall mean the following countries or regions where BioCancell intends to perform clinical trials with the Product: Israel, USA, and the EU member states.

 

2 Cooperation between the Parties in the Course of the Project

 

2.1 General

 

This Agreement sets forth the terms and conditions under which BI (by itself or its Affiliated Companies) will provide the Services to BioCancell.

 

2.2 Governance
   
2.2.1 Designation of Project Manager
   

Upon commencement of the Project, BI and BioCancell will each appoint a project manager (“Project Manager”), who will coordinate and supervise the Project on its behalf including communication of all instructions and information concerning the Project to the other Party. The Project Manager will serve as a contact person for the other Party. Each Project Manager will be available on an agreed (monthly) basis for consultation at prearranged times during the course of the Project. Project Managers shall also be available for necessary consultations without undue delay. The Project Managers shall be copied on all correspondence by other Project Team members and all correspondence between the Parties. In the absence of the Project Manager, a substitute shall be appointed. Additional modes or methods of communication and decision making may be implemented with the mutual written consent of each Party. Each Party will use reasonable efforts to provide the other Party with ten (10) calendar days prior written notice of any change in such Party’s Project Manager.

 

2.2.2 Project Team
   
a. The Parties shall establish a Project Team consisting of members of its professional staff and their respective Project Manager to (i) ensure the progress of the Project, (ii) coordinate the performance of the Project, (iii) monitor and review BI’s performance of the Services and BioCancell’s fulfilment of its obligations, and (iv) facilitate communication among the Parties. Each Project Team member shall have knowledge and ongoing familiarity with the Project and will possess the authority to make decisions on matters likely to be raised in the Project Team. Each Party shall have the right to substitute its members of the Project Team as needed from time to time by giving written notice to the other Party due time in advance.
     
b. The Project Team shall meet in person or by means of a video conference or teleconference on a periodic basis (i) as agreed by the Project Managers after written request for such meeting by either Party, (ii) as specified in the Project Plan, as may be amended from time to time, or (iii) within seven (7) calendar days after receipt of a written request by one Party to the other Party.

 

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c. The Project Team shall oversee the Project. Prior to each meeting of the Project Team the Parties will distribute to each other written copies of all reasonably necessary materials, data and information arising out of the conduct of their activities hereunder.
     
d. Each Party shall bear its own costs associated with such meetings and communications.
     
2.2.3 Steering Committee
   
a. The Parties shall form a Steering Committee, to which each Party will appoint three (3) executive employees, all of whom shall be familiar with the Project. Each Party shall have the right to substitute its members of the Steering Committee as needed from time to time by giving written notice to the other Party due time in advance. The Steering Committee may invite the Project Managers, members of the Project Team or other experts of either Party to present the issues. The initial members of the Steering Committee are listed in Appendix 6 .
     
b. The Steering Committee is responsible (i) for strategic oversight and management of the Services and the manufacture of the Product; (ii) to settle disputes or disagreements not resolved by the Project Team unless otherwise indicated in this Agreement; (iii) to discuss major issues regarding the performance of the Manufacturing Process which cannot timely be resolved despite efforts of both Parties, and (iv) for approving by written documentation any major changes to the Services, Project Plan, or budget.
     
c. The Steering Committee shall meet in person or by means of a video conference or teleconference within fourteen (14) calendar days after receipt of a written request by one Party to the other Party. Each Party shall bear its own costs associated with such meetings and communications.
     
d. The Steering Committee will take action by unanimous consent of the Parties, with the Representatives of each Party collectively having a single vote, or by a written resolution signed by all of the Representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to senior management of the Parties, who will use good faith efforts to resolve such matter.
     
2.2.4 Documentation

 

The Parties shall prepare minutes (alternating responsibility) of the Project Team and Steering Committee meetings as appropriate (in particular to document important decisions) which shall be circulated promptly following the meeting. If meeting minutes are prepared by one Party they shall be reviewed by the other Party within fourteen (14) calendar days as of receipt and are deemed accepted unless the other Party raises objections in writing within such fourteen (14) calendar days’ period.

 

2.2.5 No Power to amend, modify or waive compliance with Agreement

 

For the avoidance of doubt, the Project Team and the Steering Committee shall not have any power to amend or modify this Agreement or waive compliance therewith. Any amendments, modifications or waivers shall be undertaken in accordance with Section 11.2.

 

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2.3 Performance of the Services by BI; Conduct of the Project

 

Pursuant to the terms and conditions of this Agreement, BI shall provide the Services (as detailed in Appendix 2 ) to BioCancell, including, (i) BI’s performance (by itself and/or its Affiliated Companies) of certain development work relating to the manufacturing of the Product, including (A) the development of a new Cell Line for the Product, and comparison of the BioCancell cell line and the new Cell Line for cGMP production of the Product using BI’s proprietary pDNA Technology platform, and (B) the adaptation of BI’s generic pDNA Technology platform to the Cell Line finally selected by BioCancell during the performance of the services; and (ii) BI’s manufacturing and supply of the Product for clinical testing (by BI itself and/or its Affiliated Companies) with the finally selected Cell Line.

 

BioCancell acknowledges that the firm period for reservation of Batches in the BI cGMP Facility is [***] months and that BI firmly reserves the respective Services in accordance with the Project Plan.

 

BI (as well as BI’s subcontractors) shall use the Project-Dedicated Equipment solely in connection with the Project and in accordance with the terms and conditions of this Agreement.

 

Each Party shall fully and reasonably cooperate with the other Party to provide appropriate information and assistance to the other Party in connection with the Project and its performance under this Agreement, responding in a reasonable and timely manner with respect to all reasonable requests for information and approval. Neither Party shall be responsible for any delays in its performance of the Project to the extent caused by the other Party’s failure to provide in a reasonably timely manner any required or necessary information (in particular, but not limited any BI Deliverables or BioCancell Deliverables) or any approval reasonably requested by the other Party and/or as set forth in the Project Plan.

 

Each Party shall assign a sufficient number of professionally qualified personnel to perform the Project and shall perform its tasks under this Agreement according to the generally acceptable professional and then current industry standards and subject to terms and conditions as set forth in this Agreement, at all times in compliance with the requirements of applicable laws and regulations of the country/ State where the Services are performed and in accordance with its obligations under Section 6.3. Each Party will use commercially reasonable efforts to achieve the estimated timelines as laid down in the Project Plan, subject to Section 2.4.

 

2.4 Changes to the Project Plan (including Additional Services)

 

Services which are agreed to are regarded as firmly ordered under this Agreement. Changes to the Project Plan (such as, but not limited to, the Services), if any, shall require the written consent of both Parties.

 

In case that the Parties mutually agree on additional Services for the benefit of the Project by changing the Project Plan, BI shall perform such additional Services to sustain the progress of the Project pursuant to conditions and terms related to compensation, time and scope to be mutually agreed upon in writing by the Parties hereto.

 

In case that the Parties mutually agree to reduce the scope of the Services, BioCancell shall only be required to pay the relevant fees for such reduced Services.

 

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If changes to the Project Plan (including, but not limited, changes to the Manufacturing Process or the Specifications), become necessary because of Health Authority investigations, changes to applicable laws or regulations or otherwise or supply issues regarding Raw Materials and other equipment required for the performance of the Services, the Parties shall negotiate in good faith on how to proceed. The Parties acknowledge that if such changes are due to the Facility, BI will typically bear the costs of such changes, and if such changes are due to the Raw Materials and/or Product-Dedicated Equipment used in the Manufacturing Process, BioCancell will typically bear them.

 

BioCancell acknowledges that BI has pre-existing commitments to other customers. Accordingly, in case BioCancell intends to change the Project Plan, BI may not be able to offer BioCancell additional/different manufacturing slots at the times desired by BioCancell.

 

If any Raw Materials and Project-Dedicated Equipment is required beyond that provided in Appendix 5 , such additional Raw Materials and Project-Dedicated Equipment shall be subject to the prior approval of BioCancell.

 

2.5 BioCancell Deliverables

 

To the extent not already transferred by BioCancell, BioCancell shall transfer the BioCancell Deliverables for the Project to BI (or to the Affiliated Company indicated by BI on behalf of BI) within the timelines laid down in the Project Plan and subject to the terms of this Section 2.5. Delivery of BioCancell Deliverables shall be made "Delivery Duty Paid" (DDP) Facility as that term is defined in Incoterms 2010, ICC Rules for the Use of Domestic and International Trade Terms, ICC Publication No. 715EF), and BI shall use such BioCancell Deliverables solely to conduct the Project in accordance with the Project Plan, this Agreement, or as otherwise may be agreed to by the Parties in writing. In particular, the BioCancell Deliverables will not be used by BI in connection with any diagnosis, treatment or any activity in humans. BI’s use of the BioCancell Deliverables will be in compliance with all applicable laws in the country/ State where the Services are performed and in accordance with its obligations under Section 6.3. BI accepts the BioCancell Deliverables with the knowledge that BioCancell Deliverables are experimental. The BioCancell Deliverables may not be transferred or otherwise made available, in whole or in part, by BI to any other individual, entity or institution, except to its Affiliated Companies, without the prior written consent of BioCancell, which may be withheld by BioCancell for any reason. Notwithstanding the foregoing, such consent is hereby given for quality control testing performed by a third party on a blinded basis.

 

The BioCancell Deliverables are the property of BioCancell. It is agreed that the transfer of the BioCancell Deliverables hereunder shall not constitute a sale of BioCancell Deliverables or a grant, option or license of any patent or other rights except to allow BI to perform the Project. BioCancell shall retain and have all right, title and interest in and to the BioCancell Deliverables.

 

BioCancell will inform BI immediately about any safety issues of which BioCancell becomes aware relating to the handling of the BioCancell Deliverables and the Product, after the date of the execution of this Agreement.

 

BI shall store the BioCancell Deliverables according to BioCancell’s instructions. BI shall at all times take commercially reasonable measures to protect the BioCancell Deliverables from loss or damage and in no event measures less stringent than employed by BI in the protection of its own proprietary materials, and shall promptly notify BioCancell, if at any time it believes the BioCancell Deliverables have been damaged, lost or stolen. BI shall not be liable for any loss of the BioCancell Deliverables occurring due to BioCancell’s instructions or other reasons outside of BI’s sphere of influence (including, but not limited to, events of Force Majeure or lack of stability of the BioCancell Deliverables.

 

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2.6 BI Deliverables

 

BI will deliver the BI Deliverables expressly laid down in detail in the Project Plan within the timelines laid down in the Project Plan and the QA. Delivery of BI Deliverables by BI shall be made "ex works" (EXW) Facility, as that term is defined in Incoterms 2010, ICC Rules for the Use of Domestic and International Trade Terms, ICC Publication No. 715EF).

 

2.7 Nature of the Project; Specifications

 

As the Product has never been produced by BI at the Facility, BioCancell acknowledges that the Project is experimental in nature and that no favorable or useful results can be assured by BI.

 

Preliminary specifications of the Product shall be set by the Parties after completion of the consolidation runs.

 

No later than two (2) months after the Manufacturer’s Release of three (3) initial manufacturing runs under cGMP conditions, the Parties shall in good faith agree on a revision (if necessary) of the preliminary specifications that shall then be the Specifications for Product manufactured in subsequent manufacturing runs at such scale, and, provided that the Manufacturing Process has not been materially changed by mutual consent of the Parties, the Project shall no longer be considered experimental in nature and the obligation of BI to meet the respective Specification shall apply to all future manufacturing runs at such scale.

 

2.8 Clinical Manufacturing Forecasts

 

BioCancell shall provide a quarterly demand forecast for clinical Product covering the subsequent eighteen (18) months (i.e. update every quarter regarding all demands for the following six quarters).

 

3 Project Fee and Payments

 

3.1 Project Fee

 

As consideration for BI’s performance of the Services, BioCancell shall pay BI the fixed fees set forth in the Billing Plan attached hereto as Appendix 3 or as otherwise agreed in writing, including the price basis of a certain year (the “Project Fees”), subject to the inflation provisions of Section 3.3. It is hereby agreed that no payments of Project Fees, or any other payments or consideration will be made or due from BioCancell to BI RCV, BIP or any other permitted sub-contractors of BI and BI shall be responsible for any payments or consideration due to such third parties for their performance under this Agreement. Other than the Project Fees, payment of the Product Dedicated Equipment and Raw Materials, which shall be charged at cost to BioCancell, and BioCancell’s indemnification and/or compensation obligations as provided for under this Agreement, BioCancell shall not be required to make any additional payments for BI's performance and provision of the Services hereunder without BioCancell’s prior written consent.

 

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3.2 Product- Dedicated Equipment

 

If agreed upon by the Parties in the Project Plan in Appendix 5 or otherwise in writing, BI may purchase certain Product-dedicated equipment ("Product Dedicated Equipment") on the account and instructions of BioCancell and at BioCancell's cost and expense for the manufacture of Product. For book keeping, maintenance and insurance purposes, such equipment shall be the property of BI. Notwithstanding the aforesaid, the risk of loss in such Product Dedicated Equipment shall be borne by BI. At the termination or expiration time of this Agreement Sections 10.3.3. and 10.3.6 shall apply with regards to such Product-Dedicated Equipment.

 

3.3 Invoicing and Payment

 

BI shall invoice BioCancell for Project Fees according to the Payment Schedule in the Project Plan.

 

BioCancell shall make payment of all invoiced amounts net forty-five (45) calendar days from the date of receipt of BI’s invoice. If BioCancell fails to make timely payment when due under this Agreement, interest shall accrue at a fixed annual rate equal to the highest rate of interest quoted as the “prime rate” in "The Wall Street Journal" on the day that payment was due. All payments due under this Agreement shall be paid in Euros by wire transfer or by such other means agreed to in writing by the Parties. BioCancell will provide at least twenty-four (24) hours advance notice to BI of each wire transfer to the bank account identified below or such other bank accounts as BI shall designate in writing.

 

Account Name: Boehringer Ingelheim Biopharmaceuticals GmbH
Account Number: [***]
Bank: [***]
IBAN  Number: [***]
BIC Number: [***]

 

BI shall pay any and all taxes, duties, fees and/or other impositions that may be levied upon BI with regard to the provision of the Services. BioCancell shall be entitled to withhold from any payment due to BI under this Agreement any withholding tax amount that BioCancell is required to pay, and such withholding shall decrease by an equivalent amount the payment due to BI. In the event of any withholding under this Section, BioCancell shall provide receipts of payment of any withheld amounts, or other documents reasonably available, to BI.

 

All payments under this Agreement should be understood as net payments without value added tax (“VAT”). VAT, if any, should be added to the respective payment. Each invoice will show any applicable VAT separately.

 

The Project Fees will be adjusted (increased or decreased) year by year in accordance with the average of (a) the change in a respective consumer index [***] and (b) the average change in the respective wages index [***] shown in the respective statistic monthly report [***].

 

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Additionally, BI shall be entitled to adjust the prices for Raw Materials and services, which are provided for in the Project Plan or agreed to by BioCancell, supplied to BI by third parties which are utilized in the performance of the Services at any time in the event that a significant increase in such costs of more than ten percent (10 %) has occurred over a period of twelve (12) months preceding such adjustment.

 

4 Delivery Terms of Product for Clinical Use and Cancellation of Orders

 

4.1 Delivery Terms
   
4.1.1 Delivery Terms

 

BI shall (a) deliver to BioCancell or, (b) as requested by BioCancell reasonably in advance, store the Product in accordance with the agreed upon schedule, at the agreed Project Fee price (e.g. price set forth in the Project Plan). Delivery of Product by BI shall be made "ex works" (EXW) Facility, as that term is defined in Incoterms 2010 ICC Rules for the Use of Domestic and International Trade Terms, ICC Publication No. 715EF). BI shall package and arrange for shipment of Product to the delivery address specified by BioCancell, all in accordance with the (i) QA; and (ii) any additional instructions of BioCancell according to Appendix 7 , provided that BioCancell shall hold harmless and indemnify BI from any damages or third party claims arising out of such arrangements for shipment of Product in accordance with any additional instructions provided by BioCancell. Each shipment of cGMP Product will include a Certificate of Analysis, a Confirmation of Compliance and such other documentation as provided for under the QA and as reasonably required to meet all applicable statutory and regulatory requirements for EXW delivery. Delivery of the Product shall be subject to quality and other provisions set forth in the QA. The Parties shall cooperate reasonably to obtain all customs licenses or permits necessary to have the Product transported to BioCancell (the evaluation of which customs licenses or permits required shall be performed by BioCancell). BioCancell is responsible for export control compliance.

 

4.1.2 Examination for Defects

 

BioCancell shall diligently examine all Product delivered under this Agreement as soon as practicable after receipt. Notice of all claims arising out of or relating to Obvious Defects shall be given in writing to BI within fifteen (15) calendar days after the date of delivery, otherwise, such Product shall be considered free of any Obvious Defects as between BI and BioCancell. Notwithstanding the foregoing, BioCancell shall make a defective Product available for inspection and shall comply with the requirements of any insurance policy covering the Product and BI shall offer BioCancell commercially reasonable assistance, at the cost and expense of BioCancell, in pursuing any claims arising out of the transportation of the Product.

 

BioCancell shall have six (6) months from the date of delivery of the Product in order to evaluate the Product and accept or reject such delivery for Latent Defects.

 

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If BioCancell determines within such period after reviewing the relevant documentation and performing reasonable testing that any Batch/ Product does not meet the Specifications and BI or the testing laboratory according to Section 4.1.3 agrees with BioCancell’s assessment, or if a Batch/ Product is determined by BI to be unsuitable for release (hereinafter a “Non-Conforming Batch/Product”), BI shall replace such Non-Conforming Batch/ Product with a conforming Batch/ Product, and BioCancell is required to accept such conforming Batch/ Product. BioCancell may, at its sole discretion, either (a) request that such replacement be done at BI’s cost and expense, including the costs of materials used in the manufacture of such Batch, or (b) withhold payment for the relevant Non-Conforming Batch/ Product, in which case BI shall first issue a credit note for the invoice corresponding to such Non-Conforming Batch/ Product, including the costs of materials used in the manufacture of such Batch/ Product, and later issue a new invoice at the time of delivery of the replacement Batch/ Product, or (c) provided that BioCancell has already pre-paid a certain amount for the Non-Conforming Batch/ Product to BI and BI’s replacement of such Batch/ Product as set forth in this Section 4.1.2 takes longer than [***] months from confirmation of a Non-Conforming Batch/ Product BioCancell may request from BI to refund the respective amount of BioCancell’s pre-payment. BI shall start the applicable replacement work as soon as reasonably practicable, such that the next available manufacturing slot shall be used by BI to produce the replacement Batch/ Product. In any event the production of the replacement Batch/ Product shall start within [***] months after BioCancell’s notification of the defect. After receipt of the replacement Batch/ Product, BioCancell shall destroy all defective Batch/ Product and provide BI with written confirmation of such destruction.

 

4.1.3 Retesting of Samples; Dispute related to (alleged) defects

 

In the event BioCancell rejects the Batch/ Product for Obvious or Latent Defects, BI shall have the right to sample and retest the Product, which shall be done as soon as practicable. In the event of a discrepancy between BioCancell’s and BI’s test results such that one Party’s results fall within the Specifications and the other Party’s test results fall outside the Specifications, or there exists a dispute over whether such failure is due (in whole or in part) to acts or omissions of BioCancell or any third party after delivery, the Parties shall cause a testing laboratory agreeable to both Parties (original cost split 50:50) to perform comparative tests and/or analyses on samples of the alleged defective Product. The testing laboratory’s results shall be in writing and shall be final and binding save for manifest error on the face of its report. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the testing laboratory result finally rules and such Party shall reimburse to the other Party the costs advanced to the laboratory pursuant to the foregoing cost split. The testing laboratory shall be required to enter into written undertakings of confidentiality no less burdensome than set forth or referred to by this Agreement.

 

The Parties agree that during the resolution of any dispute related to an alleged defect of a Batch/ Product, BI shall, irrespective of the final allocation of the cost for the replacement of such alleged defective Batch/ Product, supply any replacement of such alleged defective Batch/ Product requested by BioCancell or credit BioCancell for such replacement Batch/ Product as appropriate in accordance with the provisions of 4.1.2.

 

4.2 Cancellation / Postponement of Order

 

If BioCancell at any time and for any reason cancels or postpones the manufacture of any Batches set forth in the Project Plan for the manufacture of Product at the 200 L fermentation scale less than [***] months prior to the start of the fermentation (breaking of cell bank vial), BioCancell shall pay the following percentages of the Project Fees for such specific Batches, as further stipulated in the table below, unless, (i) such cancellation or postponement is due to BI’s material breach of this Agreement, or (ii) a case of Force Majeure, or (iii) the Steering Committee unanimously agrees that the cancellation or postponement is due to a technical or scientific reason. BioCancell acknowledges that the partial postponement or cancellation of Batches in a campaign may affect the Project Fees for the remaining Batches.

 

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Payment in case of cancellation or postponement of the manufacture of any Batches by BioCancell:

 

Time from
notification of
BioCancell until
beginning of
scheduled
manufacture of a
Batch (start of the
fermentation)
  Cancellation by
BioCancell for
reasons set forth
in Section 10.2.2
(i) (scientific (i.e.
clinical failure)
reasons)
  Cancellation by
BioCancell  for
reasons other than as
set forth in  Section
10.2.2
  Postponement
by BioCancell
             
[***]   [***]   [***]   [***]
             
[***]   [***]   [***]   [***]
             
[***]   [***]   [***]   [***]
             
[***]   [***]   [***]   [***]

 

In any event, BI shall use its commercially reasonable efforts to use the capacity resulting from the cancellation or postponement of the manufacture of any Batches and to mitigate any losses that may incur from such cancellation or postponement, including for the avoidance of doubt, the reapplication of Raw Materials and equipment, if possible.

 

In the event BI is able to sell to any third-party customer the capacity formerly reserved for BioCancell, BI shall provide financial information of such mitigation efforts to BioCancell. The amounts paid to BI for such capacity sold to such third-party shall be deducted from the amounts due to BI pursuant to this Section 4.2.

 

5 Use of Project Data; Record Keeping

 

5.1 Project Data
   
a. BI shall supply BioCancell with all documents, data, results, files and information as required under the QA and as may be reasonably requested by BioCancell to comply with any request of any applicable regulatory body or to comply with such regulatory body’s requirement, including, but not limited to, those related to a IND, IMPD, NDA or CTD; and
     
b. BI shall prepare the draft chemistry, manufacturing and controls section of any regulatory filing supporting the clinical development of the Product for the Health Authorities in the United States and the European Union according to the QA. BioCancell shall review, finalize and approve the chemistry, manufacturing and controls section of any regulatory filing drafted by BI. BI shall timely perform reviews of the chemistry, manufacturing and controls section of any such regulatory filing for accuracy of content of such section prior to filing by BioCancell with the relevant Health Authorities and other regulatory authorities.

 

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c. Without derogating from the aforesaid, BI shall provide BioCancell with physical access to any and all Product-related documents on-site at BI at mutually agreed times and with copies of the following Product-specific documents for each Batch of MCB/WCB and Product:

 

· COA
· COC
· Executed Batch Production Records
· Batch genealogy (if applicable)
· Summary report of all Product-related deviations (Minor Deviations, Major Deviations, Planned Deviations, Unplanned Deviations) including confirmed OOS investigations, as applicable, and all other reports required under the QA.

 

BI shall provide BioCancell and its designee with a letter of authorization, in a form acceptable to BioCancell, permitting BioCancell, its designees, the FDA and other regulatory authorities to review and make reference to the Site Master File and/or Drug Master File (Type V) of BI.

 

BI shall maintain all original documents and data related to this Agreement and the Project for at least ten (10) years after Manufacturer´s Release of a Batch. After such ten (10) year period BioCancell shall decide and notify BI in writing whether BI shall (a) provide documentation to BioCancell for further storage or (b) destroy such documentation.

 

d. The provisions of this Section 5 shall survive the termination or expiration of this Agreement for a period of three (3) years or such longer period required pursuant to applicable law.

 

5.2 Record Keeping and Reporting Requirements of BI
   
a. BI shall prepare and keep comprehensive and complete documents, data, results, files and information regarding the Services it provides to BioCancell, including, but not limited to, those related to a IND, IMPD, NDA or CTD, and the manufacture and supply of the Product and the performance of its other obligations hereunder. Such documentation shall be prepared and kept in accordance with the cGMP and the requirements of the relevant Health Authorities, including the FDA and the EMA. The documentation and records shall include, but shall not be limited to the data required by BioCancell for the submission of drug registration applications, those required in order to assure compliance with all applicable national and local environmental laws, as well as all other documentation and records that may be reasonably required.
     
b. Upon the request of BioCancell, BI shall provide it with copies of the documents, data, results, files and information specified in the QA or prepared or kept in accordance with this Agreement regarding the Product.

 

6 Representations, Warranties and Indemnification

 

6.1 Mutual Representations, Warranties and Covenants

 

Each Party hereby represents and warrants to the other Party as follows:

 

a. it is a corporation duly organized and validly existing under the laws of the state or other jurisdiction of incorporation or formation; and
     
b. the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action; and

 

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c. it has full corporate authority to enter into this Agreement and the Agreement is binding upon it in accordance with its terms.

 

6.2 BioCancell Warranties

 

BioCancell hereby represents and warrants that:

 

a. BioCancell is the owner or has the right to provide the BioCancell Deliverables, the BioCancell Background IP and all BioCancell Confidential Information under this Agreement and that to the best of its knowledge, at the Effective Date, there are no third party rights that will affect supply thereof to BI and/or its Affiliated Companies; and
     
b. to the best of its knowledge, at the Effective Date, the BioCancell Deliverables, the BioCancell Background IP, and the BioCancell Confidential Information and their use by BI and/or its Affiliated Companies do not infringe the Intellectual Property Rights of any third party and BioCancell will promptly notify BI in writing should BioCancell become aware of any claims asserting such infringement; and
     
c. BioCancell is not aware of any special or unusual hazards involved in handling the BioCancell Deliverables and/or Product of which BioCancell has failed to inform BI and that it will inform BI immediately of any changes related thereto after the date of execution of this Agreement; and
     
d. BioCancell has the right to grant BI the licenses stipulated under this Agreement; and
     
e. all BioCancell Deliverables are fit for use in a multi-purpose manufacturing facility, i.e. are free of adventitious agents (such as bacteriophage); and
     
f. it shall use the Product or documents provided by BI under this Agreement in clinical studies and for regulatory purposes, only.

 

6.3 BI Warranties

 

BI hereby represents and warrants that:

 

a. BI is entitled to use the Facility for the purposes set forth in this Agreement; and
     
b. BI at the Effective Date is not aware of any special or unusual hazards that would arise as a result of its carrying out of the Project as planned and BI will promptly notify BioCancell in writing should BI become aware of any such hazards; and
     
c. BI has not been debarred, nor is it subject to a pending debarment, and to the best of its knowledge, that it will not use in any capacity in connection with the services under this Agreement any person, who has been debarred pursuant to section 306 of the FDCA, 21 U.S.C. § 335a, or who is the subject of a conviction described in such section. BI agrees to notify BioCancell in writing immediately if it comes to its knowledge that BI or any person who is performing Services is debarred or is the subject of a conviction described in section 306, or if any action, suit, claim, investigation, or proceeding is pending, or to BI’s knowledge, is threatened, relating to the debarment or conviction of BI or any person performing services under this Agreement; and
     
d. BI is the owner or has the right to provide and/or disclose, as applicable, the BI Background IP, including the pDNA Technology, the Site Master File and/or Drug Master File (Type V) and all BI Confidential Information under this Agreement and that to the best of its knowledge, at the Effective Date, the BI Background IP, including the pDNA Technology, and the Site Master File and/or Drug Master File (Type V) do not infringe the Intellectual Property Rights of any third party and BI will promptly notify BioCancell in writing should it become aware of any claims asserting such infringement; and

 

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e. To the best of its knowledge, (i) as of the Effective Date and (ii) as of the commencement of each clinical trial being undertaken by BioCancell (subject to BioCancell providing BI with at least thirty (30) days prior written notice of such commencement), the use of Product supplied by BI for use in clinical trials in the Territory will not infringe the Intellectual Property Rights of any third party, provided that the BioCancell Confidential Information and/or all BioCancell Deliverables provided to BI do not infringe any third party Intellectual Property Rights and the use of Product is not subject to third party rights which are unrelated to the manufacture of Product or to the pDNA Technology. The aforesaid shall not be considered a representation by BI that the application or combination of any BI Background IP with the BioCancell Deliverables will not infringe any third party rights where the Background IP, standing alone, would not have infringed such third party rights; and
     
f. BI will not introduce into the Manufacturing Process any technology that would infringe, during BI’s performance of the Services or during the license period of a license granted to BioCancell pursuant to Section 10.3.8, any third party rights in the European Union or the United States; and
     
g. BI will not make any use of the BioCancell Deliverables, the BioCancell Background IP, and the BioCancell Confidential Information except as specifically provided for in this Agreement; and
     
h. the Product: (i) will conform to the Specifications on the date of Manufacturer’s Release, (ii) will be manufactured in accordance with and in compliance with the QA, including cGMP, and (iii) will be transferred to BioCancell free and clear of any security interests, liens or encumbrances; and
     
i. it will perform its obligations hereunder in a professional and workmanlike manner and in compliance with cGMP (if applicable) and it will obtain, maintain and comply with all licenses and permits of the Health Authorities and other relevant regulatory authorities required in connection with the provision of Services hereunder and the manufacture of the Product; and
     
j. it will be responsible to ensure the compliance with this Agreement by BI RCV, BIP and other permitted sub-contractors, will be responsible and liable to BioCancell for the acts and omissions of BI RCV, BIP and its other permitted sub-contractors and these representations and warranties apply to BI RCV, BIP and BI's other permitted sub-contractors.

 

For avoidance of doubt, all BI liability or indemnification obligations that might result from the representations and warranties under this Section 6.3 are always subject to the limitations set forth in Section 7 of this Agreement.

 

6.4 Disclaimer of Warranties

 

EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WITH RESPECT TO ANY INTELLECTUAL PROPERTY, TECHNOLOGY, RIGHTS, RESULTS OF THE PROJECT, THE BIOCANCELL DELIVERABLES OR BI DELIVERABLES OR OTHER SUBJECT MATTER OF THIS AGREEMENT OR THAT THE PROJECT WILL RESULT IN A COMMERCIALLY VIABLE PROCESS, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

 

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7 Liability, Indemnification, Limitations and Insurance

 

7.1 General

 

BI does not know or control how BioCancell intends to use the Product or other results derived under this Agreement in clinical studies. BI understands and accepts that the Products manufactured under this Agreement will be used by BioCancell in connection with clinical studies and for regulatory purposes.

 

7.2 Disclaimer of Consequential Damages

 

EXCEPT FOR CASES OF WILFUL MISCONDUCT OF EITHER PARTYAND SUCH CASES WHERE A LIMITATION OF LIABILITY AND/OR A LIMITATION OF INDEMNIFICATION OBLIGATIONS IS NOT POSSIBLE UNDER APPLICABLE LAW FOR WHICH CASES THERE SHALL BE NO LIMITATION OF LIABILITY AS WELL AS NO LIMITATION OF ANY INDEMNIFICATION OBLIGATION, IN NO EVENT, EITHER DIRECTLY OR BY WAY OF INDEMNIFICATION, SHALL A PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INCIDENTAL, INDIRECT, EXEMPLARY, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, IRRESPECTIVE OF THE THEORY OF LIABILITY, ARISING FROM OR RELATED TO BREACH OF THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY CLAIMS FOR DAMAGES BY THIRD PARTIES, CLAIMS FOR DAMAGES BASED UPON LOST PROFITS FOR SALES TO THIRD PARTIES, LOSS OF REPUTATION OR LOSS OF GOOD WILL, EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBLITY OF SUCH DAMAGES.

 

7.3 Liability between the Parties and Indemnification obligations of the Parties

 

a. Of BI

 

Subject to the limitations set forth in Section 7.2 and Section 7.5, BI shall be liable for and indemnify and hold BioCancell and its Representatives harmless

 

- for any losses, damages, costs or expenses including without limitation, reasonable attorney’s fees of any nature (“Losses”) incurred or suffered directly by BioCancell or its Representatives; and
   
- from and against any third party claims

 

to the extent such Losses and third party claims arise from

 

(i) BioCancell's or its Affiliated Companies’ use of the BI Background IP and/or BI Confidential Information, and/or reference to the Site Master File and/or Drug Master File (Type V) in BioCancell’s regulatory submissions in accordance with this Agreement; and/or

 

(ii) BI's breach of its representations and warranties given under this Agreement, and/or

 

(iii) BI’s negligence in the performance of its obligations under this Agreement and/or BI’s material breach with its obligations under this Agreement, and/or

 

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(iv) BI's breach or non-compliance with the requirements of any laws and regulations applicable to a biopharmaceutical company operating in Austria and Germany.

 

Notwithstanding the foregoing, BI shall not be liable or have an indemnification obligation hereunder to the extent such third party claims and Losses result from

 

aa. BioCancell's breach of its representations and warranties given under this Agreement; and/or
     
bb. BioCancell’s negligence in the performance of its obligations under this Agreement and/or BioCancell’s material breach of its obligations under this Agreement; and/or
     
cc. BioCancell's or its Affiliated Companies’ use of the BI Background IP and/or BI Confidential Information and/or reference to the Site Master File and/or Drug Master File (Type V) in BioCancell’s regulatory submissions not in accordance with this Agreement.

 

b. Of BioCancell

 

Subject to the limitations set forth in Section 7.2, BioCancell shall be liable for and indemnify and hold BI and its Representatives harmless

 

- for any Losses incurred or suffered directly by BI or its Representatives; and
   
- from and against any third party claims

 

to the extent such Losses and third party claims are arising from

 

(i) BI’s and/or its Affiliated Companies’ use of BioCancell Deliverables and/or the BioCancell Background IP and/or BioCancell Confidential Information, in accordance with this Agreement; and/or

 

(ii) BioCancell's breach of its representations and warranties given under this Agreement; and/or

 

(iii) BioCancell’s negligence in the performance of its obligations under this Agreement and/or BioCancell’s material breach of its obligations under this Agreement; and/or

 

(iv) BioCancell’s use of the BI Deliverables and/or the Product in humans; and/or

 

(v) BioCancell's or its Affiliated Companies’ use of the BI Background IP and/or BI Confidential Information and/or reference to the Site Master File and/or Drug Master File (Type V) in breach of this Agreement; and/or

 

(vi) BioCancell's breach or non-compliance with the requirements of any laws and regulations applicable to a marketing authorization holder of the Product.

 

Notwithstanding the foregoing, BioCancell shall not be liable or have an indemnification obligation hereunder if and to the extent such third party claims and Losses result from

 

aa. BI's breach of its representations and warranties given under this Agreement, and/or
     
bb. BI’s negligence in the performance of its obligations under this Agreement and/or BI’s material breach with its obligations under this Agreement; and/or.
     
cc. BI's breach or non-compliance with the requirements of any applicable laws and regulations.

 

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7.4 Indemnification Procedure

 

To be eligible to be indemnified under Section 7.3 , the Party having a right to be indemnified (“Indemnitee”) shall provide the indemnifying Party (“Indemnitor”) with prompt notice of the third party claim giving rise to the indemnification obligation pursuant to Section 7.3. and the exclusive ability to defend (with the reasonable cooperation of the Indemnitee) or settle any such claim; provided, however, that the Indemnitor shall not enter into any settlement that admits fault, wrongdoing or damages without the Intemnitee’s written consent, such consent not to be unreasonably withheld or delayed. The Indemnitee shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the Indemnitor. The Indemnitee shall (i) fully cooperate with the Indemnitor in connection with the defense or settlement of the relevant claim; and (ii) not make any admission or settlement in connection with the relevant claim without the prior approval of the Indemitor.

 

7.5 Limitation of BI’s Liability and Indemnification Obligations

 

WITH THE EXCEPTION OF WILFUL MISCONDUCT OF BI AND SUCH CASES WHERE A LIMITATION OF LIABILITY AND/OR A LIMITATION OF INDEMNIFICATION OBLIGATIONS IS NOT POSSIBLE UNDER APPLICABLE LAW, FOR WHICH CASES THERE SHALL BE NO LIMITATION OF LIABILITY OR INDEMNIFICATON OBLIGATIONS, ANY AND ALL LIABILITY AND/OR INDEMNIFICATION OBLIGATIONS OF BI UNDER THIS AGREEMENT SHALL BE SUBJECT TO THE FOLLOWING:

 

- IN CASES OF NEGLIGENCE OR BREACH OF CONTRACT, EXCEPT BREACH OF SECTIONS 6.3 (d) or (e) , BI'S LIABILITY AND/OR INDEMNIFICATION OBLIGATIONS SHALL BE LIMITED TO THE GREATER OF [***].
   
- IN CASES OF PERSONAL INJURY, BI'S LIABILITY AND/OR INDEMNIFICATION OBLIGATIONS SHALL BE LIMITED TO THE GREATER OF [***].
   
- IN CASES OF BREACH OF SECTION 6.3 (d) or (e), BI'S LIABILITY AND/OR INDEMNIFICATION OBLIGATIONS SHALL BE LIMITED TO THE GREATER OF [***].

 

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For purposes of this Section 7.5, the [***] shall mean:

 

[***] during the applicable Contract Year, the previous Contract Year and the subsequent Contract Year [***].

 

Notwithstanding the aforesaid:

 

During the first Calendar Year, [***] shall mean the [***] during the first and second Contract Years [***]; and

 

During the final Calendar Year, [***] shall mean the [***] during each of the final Contract Year, and the previous two (2) Contracts Years [***].

 

For purposes of this Section 7.5, "Contract Year" shall mean the calendar year from January to December”.

 

7.6 Insurance

 

BioCancell and BI shall each obtain and/or maintain during the term of this Agreement and for a period of five (5) years thereafter, liability insurance in amounts which are reasonable and customary in the biopharmaceutical industry for the respective activities (i.e. BI as contract manufacturing organisation and BioCancell as sponsor/pharmaceutical company), but no less than US $ 10 Million in the aggregate, and such liability insurance shall insure against all mandatory liability, including liability for personal injury, physical injury and property damage. BI shall have the right to self-insure at any time if (i) BI self-insures similar agreements with third party which provide for the similar extent of services; and (ii) BI's financial stability will allow for such self-insurance. Upon written request, each Party shall provide the other Party with copies of all relevant insurance policies and any changes made thereto.

 

8 Intellectual Property

 

8.1 Existing Intellectual Property Rights

 

BI shall acquire no rights, title or interest whatsoever in or to any of the BioCancell Background IP, including, but not limited to, the BioCancell Deliverables, and the Product, except as specifically provided for in this Agreement, and BioCancell shall remain at all times the exclusive owner of such Background IP.

 

BioCancell shall acquire no rights, title or interest whatsoever in or to any of BI Background IP, including, but not limited to the pDNA Technology, except as specifically provided for in this Agreement, and BI shall remain at all times the exclusive owner of such BI Background IP .

 

8.2 New Intellectual Property, Project Results and Licenses
   
8.2.1 BioCancell

 

BioCancell shall have the exclusive ownership of all Intellectual Property Rights and other proprietary rights in any Improvements that are solely and directly related to the BioCancell Background IP, including the BioCancell Deliverables (unless such BioCancell Deliverables, other than copyrights, are in the public domain), and/or the Product, (collectively, “BioCancell Improvements”) deriving from this Agreement. BioCancell shall control patent prosecution and maintenance thereof. BI agrees, for no additional consideration, to assign and hereby assigns to BioCancell all right title and interest it may have in any BioCancell Improvements. BI shall provide reasonable assistance to BioCancell for any action which may be necessary to assign or otherwise transfer any such rights to BioCancell Improvements contemplated by this Section 8.2.1. BI shall notify BioCancell within thirty (30) calendar days of becoming aware of such BioCancell Improvements.

 

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In addition, any compensation that may be due to an inventor of any BioCancell Improvements who is an employee, consultant or agent of BI under the provisions of applicable labor or other applicable laws shall be paid by BI and BI shall not be entitled to any additional compensation from BioCancell in this regard.

 

BI shall provide BioCancell with access to all relevant research documents, data and lab notebooks related to the BioCancell Improvements in order to enable BioCancell to prepare and defend patent applications related to the BioCancell Improvements. BI shall provide BioCancell reasonable access to its employees, consultants and agents who were involved in the provision of Services hereunder and shall cause such employees, consultants and agents to assist BioCancell with the preparation and defense of patent applications related to the BioCancell Improvements. BioCancell shall reimburse BI for its direct costs associated with such support (work time, travel costs, etc.).

 

8.2.2 BI

 

BI shall have the exclusive ownership of all Intellectual Property Rights and other proprietary rights in any Improvements that are solely and directly related to the BI Background IP, including the pDNA Technology (unless the aforesaid, other than copyrights, are in the public domain) (collectively, “BI Improvements”) deriving from this Agreement. BI shall control patent prosecution and maintenance thereof. BioCancell agrees to assign and hereby assigns to BI all right, title and interest it may have in any BI Improvements. BioCancell shall provide reasonable assistance to BI for any action which may be necessary to assign or otherwise transfer such rights to BI Improvements contemplated by this Section 8.2.2.

 

8.2.3 Other IP generated under the Agreement

 

Any other Intellectual Property Rights generated under the terms of this Agreement, including, but not limited to the Manufacturing Process, shall belong to BI and Section 8.2.2 shall apply accordingly, unless such Intellectual Property Rights are not applicable to any other biopharmaceutical product than the Product. The latter shall belong to BioCancell, and Section 8.2.1 shall apply accordingly.

 

8.2.4 License

 

BioCancell hereby grants to BI during the term of this Agreement and BI hereby accepts for the purpose of pursuing the Project a non-exclusive, non-sublicensable (except to BI’s Affiliated Companies and subcontractors of BI pursuant to Section 11.8), royalty-free, license to use the BioCancell Background IP and the BioCancell Improvements for the sole purpose to develop the Manufacturing Process, and for the manufacturing of the Product for clinical purposes in accordance with this Agreement.

 

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9 Confidentiality

 

9.1 During the term hereof and for a period of ten (10) years after termination or expiration of this Agreement, Receiving Party agrees to hold all Confidential Information disclosed to it or its Affiliated Companies by the Disclosing Party or its Affiliated Companies in strict confidence and to use such Confidential Information only in connection with the performance of its obligations under this Agreement, as contemplated by or as permitted under this Agreement. Receiving Party shall not use the Disclosing Party’s Confidential Information for any purpose other than as permitted in the preceding sentence, reproduce such Confidential Information, or disclose such Confidential Information to any third party, without prior approval of Disclosing Party. Receiving Party agrees to protect Disclosing Party’s Confidential Information with at least the same degree of care as it normally exercises to protect its own proprietary information of a similar nature, but in any case using no less than a reasonable degree of care. Receiving Party shall take all appropriate steps to ensure that all of its or its Affiliated Companies’ employees and consultants receive Disclosing Party’s Confidential Information only on a need to know basis, within the scope of this Agreement, and then, only if such persons are bound by obligations of confidentiality and non-use substantially similar to those under this Agreement. For purposes of clarity, the Specifications shall be deemed BioCancell’s Confidential Information and proprietary to BioCancell.

 

9.2 The restrictions of this Agreement regarding Confidential Information of the other Party shall not apply to such Confidential Information which: (a) was known to Receiving Party or its Affiliated Companies prior to receipt hereunder as evidenced by written records; (b) at the time of disclosure by Disclosing Party was generally available to the public, or which after disclosure hereunder becomes generally available to the public through no fault attributable to Receiving Party or its Affiliated Companies; (c) is hereafter made available to Receiving Party or its Affiliated Companies for use or disclosure by Receiving Party or its Affiliated Companies from any third party having a right do so; or (d) is independently developed by Receiving Party or its Affiliated Companies without the use of the Disclosing Party’s Confidential Information as evidenced by written records. Further, subject to Receiving Party providing Disclosing Party with reasonable advance notice (to the extent possible and permitted by law) and the opportunity to challenge, limit or seek a protective order for such disclosure, Receiving Party and/or its Affiliated Companies may make such limited disclosure as is required by mandatory law. Receiving Party shall provide Disclosing Party with reasonable assistance in any challenge undertaken by Disclosing Party.
   
9.3 Subject to any right to continued use as provided herein (such as, but not limited to, license rights), upon Disclosing Party’s written request, Receiving Party agrees to, at Receiving Party’s discretion, either deliver to Disclosing Party or destroy all written materials embodying the Confidential Information of the Disclosing Party and/or its Affiliated Companies and all materials that constitute such Confidential Information, which are in the possession or under the control of Receiving Party or its Affiliated Companies, in each case subject to the last sentence of this Section. In the event that Receiving Party elects to destroy the materials, upon destruction of such materials, Receiving Party will issue to Disclosing Party a certificate of destruction as proof of compliance with Disclosing Party’s request. Receiving Party further agrees not to retain any copies, notes or compilations of any written materials pertaining to the Confidential Information received from Disclosing Party or its Affiliated Companies, save that Receiving Party may retain one (1) copy of documentary Confidential Information for the sole purpose of monitoring its compliance with this Agreement.

 

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9.4 In the event that either Party is required to file this Agreement with Health Authorities or other government agencies (e.g. under Israeli Securities Authority rules), that Party shall seek confidential treatment of sensitive information of the Disclosing Party (in particular, but not limited to trade secrets, confidential commercial or financial information). The Party required to make the submission will give reasonable advance notice to the Disclosing Party of such disclosure requirement in order to enable the Disclosing Party to comment on such submission, and shall use reasonable efforts to incorporate the Disclosing Party’s comments in order to secure a protective order or confidential treatment of any Confidential Information required to be disclosed.

 

9.5 BI acknowledges that BioCancell is a public company and that BioCancell may be required to issue press releases or public announcements with respect to this Agreement and the transactions contemplated hereunder. Unless mandatory applicable laws require an immediate public announcement, neither Party shall issue any press release or other public announcement with respect to such transactions without the other Party's written consent, such consent not to be unreasonably withheld.

 

10 Term and Termination

 

10.1 Term

 

This Agreement shall take effect as of the Effective Date and shall expire upon completion of the Services, unless terminated earlier in accordance with this Agreement.

 

10.2 Termination of this Agreement
   
10.2.1 Termination for convenience

 

This Agreement may be terminated by BioCancell upon the provision of six (6) months prior written notice to BI and by BI upon provision of twenty-four (24) months prior written notice to BioCancell. BI's provision of a termination notice in accordance with the provisions of this Section 10.2.1, shall not derogate from the rights of BioCancell to subsequently terminate this Agreement in accordance with the provisions of this Section 10.2.1.

 

10.2.2 Termination for scientific or technical reasons

 

If it is apparent at any stage of the Project that it will not be possible to carry out the Project for (i) scientific (i.e. clinical failure) or (ii) process related technical reasons (e.g. scale-up of the Manufacturing Process), and the Parties cannot agree in a timely fashion on a change to the Project Plan to overcome this issue, BioCancell or in case (ii) above also BI may terminate this Agreement upon thirty (30) calendar days prior written notice to the other Party.

 

10.2.3 Termination for business reasons

 

If it is apparent to BioCancell at any stage of the Project that it will not be possible to carry out the Project for business reasons, BioCancell may terminate this Agreement upon the provision of ninety (90) calendar days prior written notice.

 

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10.2.4 Termination of this Agreement for material breach

This Agreement may be terminated with immediate effect by written notice by either Party, if the other Party breaches this Agreement in any material manner and shall have failed to remedy such default within one-hundred and eighty (180) calendar days (in case of a failed Batch, the timelines are subject to Section 4.1.2) after written notice thereof from the terminating Party. For the purpose of clarity, the manufacture of three (3) Non-Conforming Batches of Product in a year by BI under this Agreement shall also be considered a material breach of this Agreement by BI.

 

10.2.5 Termination for bankruptcy

This Agreement may be terminated with immediate effect by written notice by either Party, if the other Party is not able to repeatedly fulfill its payment obligations towards its debtors, declares bankruptcy, is declared or adjudicated bankrupt, by voluntary or involuntary action goes into liquidation, or dissolves or files a petition for bankruptcy or suspension of payments, or enters into a procedure of winding up or dissolution that is not dismissed within forty-five (45) calendar days, or a trustee in bankruptcy or receiver or other equivalent entity is appointed for the other Party’s property or estate.

 

10.2.6 Termination due to Change of Control

This Agreement may be terminated with immediate effect by either Party upon written notice to the other Party, if either Party undergoes a Change of Control by being taken over by a Direct Competitor of the other Party. Pursuant to the aforesaid, either Party may exercise such right to terminate the Agreement under this Section 10.2.5 no later than two (2) months after the notification of the applicable Change of Control. A party undergoing a Change of Control shall notify the other Party of the same.

 

10.2.7 Termination due to Force Majeure

This Agreement may be terminated by BioCancell upon the provision of written notice to BI in accordance with the provisions of Section 11.

 

10.3 Effect of Termination

 

Upon termination or expiration of this Agreement:

 

10.3.1 Each party shall promptly return to the other all Confidential Information of the Disclosing Party then in its possession or under the Receiving Party’s control, or, at the Disclosing Party’s request, destroy and thereafter confirm the destruction of such Confidential Information.
   
10.3.2 If requested by BioCancell, and BI is able to do so, BI shall complete the production of all in-process Batches which shall be completed and delivered in accordance with the provisions of this Agreement and the QA.
   
10.3.3 Subject to the provision of Section 10.3.2 and BioCancell´s full payment of all outstanding Project Fees for Services performed by BI up to and until the effect of termination, all other Raw Materials and work-in-process shall be delivered to BioCancell by BI "ex works" (EXW) Facility, as that term is defined in Incoterms 2010, ICC Rules for the Use of Domestic and International Trade Terms, ICC Publication No. 715EF).
   
10.3.4 BI shall, at BioCancell’s expense, transfer to BioCancell or its nominees, all relevant Product-related cGMP documents, data, results, files and information related to this Agreement, in accordance with the QA, including, but not limited to those related to a IND, IMPD, NDA or CTD, within ninety (90) days after settlement of all material outstanding payments. Notwithstanding the foregoing, in the event of a material breach by BioCancell of its Intellectual Property Rights related obligations including but not limited to Sections 6.2, 8 and 9, BI shall provide to BioCancell only such documentation and data required for regulatory purposes.

 

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10.3.5 (A) Subject to Sections 10.3.5 (B), 10.3.8, 10.3.9, 10.3.10, and 10.3.11, the amounts due to BI from BioCancell shall be limited to:
   
(i) all Project Fees outstanding for Services performed by BI up to and until the effect of termination calculated on a pro-rata basis, and

 

(ii) all non-cancellable expenses reasonably incurred by BI in accordance with the terms and conditions of this Agreement prior to receipt of such termination notice in respect of the purchase of supplies including but not limited to Raw Materials and/or Product-dedicated equipment for use in manufacturing of the Product; and

 

(iii) all cancellation costs for scheduled Batches pursuant to and subject to Section 4.2; and (iv) wind-down costs for [***] months, not to exceed a total of [***].

 

BI shall use its commercially reasonable efforts to mitigate all fees due under this Section and provide financial information of such mitigation efforts to BioCancell. The amounts paid to BI for such capacity sold to such third-party shall be deducted from the amounts due to BI pursuant to this Section.

 

(B)       For the avoidance of doubt, in the event of termination by BI pursuant to Section 10.2.1 (BI termination for convenience) the Parties shall continue to perform the Services in accordance with the Project Plan, and BioCancell has not provided a subsequent notice of termination as provided for in Section 10.2.1, BioCancell shall pay to BI only the respective fees for such Services, i.e. for the period of [***] months after BioCancell’s receipt of written notice.

 

10.3.6 For a period of one hundred eighty (180) calendar days following termination for any reason and upon the provision of at least sixty (60) calendar days prior written notice, BioCancell shall have the right to purchase for one (1) Euro, take possession of, and remove from the Facility the Product Dedicated Equipment, to the extent such Product Dedicated Equipment, all Project Fees outstanding and due up to and until the effect of termination and cancellation cost pursuant to Section 4.2 or Section 10.3.11, as applicable, have been paid for by BioCancell, as applicable, and in accordance with the terms and conditions of this Section 10.
   
10.3.7 Storage of Product/ Materials

 

BI’s responsibility to keep and store the Product (if any) and/or any materials received or generated under this Agreement shall terminate six (6) months after expiration or termination of this Agreement.

 

10.3.8 Unless this Agreement was terminated by BI pursuant to Sections 10.2.4, 10.2.5 or 10.2.6 due to a material breach by BioCancell, the bankruptcy of BioCancell or a Change of Control of BioCancell, or pursuant to Section 10.2.2 for scientific or technical reasons, BI shall provide BioCancell with a license to the BI Background IP and the BI Improvements in accordance with the provisions of the pDNA License Agreement to be attached hereto as Appendix 4 . Additionally, BioCancell may request for a period of twelve (12) month after termination, that BI assist BioCancell at BioCancell’s cost and expense with the transfer of the then current Manufacturing Process with a total capacity of [***].

 

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10.3.9 In the event of termination by either Party according to Section 10.2.2 (ii) (process related technical reasons) the amounts due to BI from BioCancell shall be limited to:
   
(i) all Project Fees outstanding for Services performed by BI up to and until the effect of termination calculated on a pro-rata basis; and

 

(ii) wind-down costs for up to [***] months, not to exceed a total [***].

 

BI shall not be entitled to charge any additional non-cancellable expenses.

 

10.3.10 In the event of termination by BI according to Section 10.2.6 (Change of Control of BioCancell) or termination by BioCancell according to 10.2.4 (material breach by BI) or according to 10.2.5 (BI bankruptcy), the amount due to BI from BioCancell shall be limited to: all Project Fees outstanding for Services performed by BI up to and until the effect of termination calculated on a pro-rata basis.

 

In the event of termination by BioCancell according to 10.2.4 (material breach by BI) or according to 10.2.5 (BI bankruptcy), BI shall not be entitled to charge

 

(a) any additional non-cancellable expenses or (b) any wind-down costs. Further, in the event of termination by BioCancell according to Section 10.2.4 (material breach by BI), transfer of the then current Manufacturing Process pursuant to Section 10.3.8 up to a total [***] shall be rendered by BI to BioCancell free of charge.

 

10.3.11 In case of a termination by BI according to Section 10.2.4 (material breach by BioCancell), the amounts due to BI from BioCancell shall be limited to:

 

(i) all Project Fees outstanding for Services performed by BI through the termination calculated on a pro-rata basis; and

 

(ii) all non-cancellable expenses reasonably incurred by BI in accordance with the terms and conditions of this Agreement prior to receipt of such termination in respect of the purchase of supplies including but not limited to Raw Materials and/or Product-specific equipment for use in manufacturing of the Product; and

 

(iii) [***] Project Fees for ordered Batches scheduled for manufacture (according to the date of the start of fermentation) within a twelve (12) month period from notice of termination; and

 

(iv) wind-down costs for up to [***] months, not to exceed a [***].

 

In addition, BI shall be free to claim damages and indemnification in accordance with the terms of this Agreement.

 

10.3.12 Following payment to BI in accordance with the terms and conditions of this Section 10.3 upon the termination of this Agreement, BI shall refund to BioCancell the excess amount, if any, of Project Fees pre-paid by BioCancell to BI in accordance with the Billing Plan calculated against the fees owed by BioCancell to BI under Section 10.3.
   
10.3.13 Surviving Provisions

 

As far as not expressly set forth in this Agreement all provisions designed to have effect even after the termination or expiration of this Agreement shall survive the termination or expiration of this Agreement, in particular Sections 1, 5, 6, 7, 8 (other than sub-section 8.2.4), 9, 10 and 11.

 

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11 Miscellaneous

 

11.1 Force Majeure

 

Neither Party shall be in breach of this Agreement if there is any failure of performance under this Agreement (except for payment of any amounts due hereunder) occasioned by any act of God, fire, act of government or state, war, civil commotion, insurrection, embargo, prevention from or hindrance in obtaining energy or other utilities, labor disputes of whatever nature or any other reason beyond the control of either Party; provided, however, that the Party affected shall: (i) give prompt written notice to the other Party of the date of commencement of the force majeure, the nature thereof, and expected duration; and (ii) use commercially reasonable efforts to avoid or remove the force majeure to the extent it is able to do so; and (iii) make up, continue on and complete performance when such cause is removed to the extent it is able to do so. In the event BI’s performance of the Services, due to reasons of force majeure ceases to be provided under this Agreement for more than three (3) months, or more than twelve (12) months in case of an unforeseen supply issue with any Raw Materials, BioCancell shall have the right to terminate this Agreement pursuant to Section 10.2.7., and Sections 10.3.1. through 10.3.8 shall apply.

 

11.2 Prior Agreements

 

This Agreement constitutes the entire understanding of the Parties with respect to the subject matters contained herein, superseding all prior oral or written understandings or communications between the Parties, and it may be modified only by a written agreement signed by the Parties. This Agreement supersedes all prior agreements, whether written or oral, with respect to the subject matters contained herein, including the CDA and/or MTA. Exchange of any information, including but not limited to the exchange of Confidential Information (as defined herein) and the performance of any services (including but not limited to the Services) initiated under the MTA shall be performed under the terms of this Agreement only, as of the Effective Date. This Agreement may only be modified or amended in a writing duly executed by both Parties.

 

11.3 No application of the Parties’ General Terms and Conditions

 

The Parties acknowledge that due to the internal guidelines, procedures or systems of a Party it might not be avoidable that communication or documents and the like are issued containing a reference to the general terms and conditions of such Party. Moreover, BI acknowledges that BioCancell for such reasons as outlined in the previous sentence might not be able to avoid the issuance of one or more purchase orders (or the like) replicating what was already agreed upon in this Agreement and which due to technical reasons of the system might contain a reference to BioCancell’s general terms and conditions. Therefore, the Parties agree that the general terms and conditions of the Parties shall not apply, even if reference is made thereto in such purchase order (or the like) or any other communication or documents related to this Agreement.

 

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11.4 Notices

 

Any notice required or permitted to be given hereunder by either Party shall be in writing and shall be (i) delivered personally, (ii) sent by registered mail, return receipt requested, postage prepaid (iii) delivered by facsimile with immediate confirmation of receipt, or (iv) sent by email (which shall only be deemed received upon confirmation or acknowledgement by the recipient) to the addresses, e-mail recipients or facsimile numbers set forth below:

 

If to BI :

[***]

[***]

[***]

[***]

Attn: [***]

Fax: [***]

E-Mail: [***]

 

Copy to :

[***]

[***]

[***]

[***]

Attn.: [***]

Fax: [***]

E-Mail: [***]

 

If to BioCancell :

1/3 High-Tech VillageGivat Ram

P.O. Box 39264

Jerusalem

9139102 Israel

Attn: Jonathan Burgin

Fax: +972-722-740-864

E-Mail: jonthan.burgin@biocancell.com

Phone: +972-2-548-6555

Mobile: +972-54-774-5445

 

Copy to:

Rivka Zaibel

CEO

ADRES, Advanced Regulatory Services Ltd.

Golda Meir 3

Ness Ziona

E-Mail: rivkaz@adres.co.il

Phone: +97289319585

Mobile: +972542274003

Fax: +97288539587

 

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11.5 Dispute Resolution, Applicable Law and Arbitration
   
11.5.1 Dispute Resolution

 

Any dispute relating to the validity, performance, construction or interpretation of this Agreement shall first be submitted for resolution to the Steering Committee.

 

11.5.2 Applicable Law

 

This Agreement shall be exclusively governed by and construed in accordance with the laws of the State of New York without regard to its conflict of laws provisions. The application of the UN Convention on Contracts for the International Sale of Goods is excluded.

 

11.5.3 Arbitration

 

The Parties agree that all disputes, claims or controversies arising out of, relating to, or in connection with this Agreement, including any question regarding its formation, existence, validity, enforceability, performance, interpretation, breach or termination, shall be exclusively and finally settled under the Rules of Arbitration of the International Chamber of Commerce (“ICC”) by one arbitrator appointed in accordance with said rules.

 

The exclusive place of arbitration shall be Frankfurt am Main, Germany and the proceedings shall be conducted in English language.

 

The award for arbitration shall be final and binding and may be enforced in any court of competent jurisdiction against BI or BioCancell. Nothing in this Section 11.5.3 shall prevent any Party, before an arbitration has commenced hereunder or any time thereafter during such arbitration proceedings, from seeking conservatory measures and interim measures, including, but not limited to temporary restraining orders or preliminary injunctions, or their equivalent, from any court of competent jurisdiction.

 

The Parties further agree that

 

a. except as may be otherwise required by law, neither Party, its witnesses, or the arbitrator may disclose the existence, content, results of the arbitration hereunder without prior written consent of both Parties; and

 

b. neither Party shall be required to give general discovery of documents, but may be required only to produce specific, identified documents, or narrow and specific categories of documents, which are relevant to the case and material to its outcome and reasonably believed to be in the custody, possession or control of the other Party; and

 

c. decisions ex aequo et bono or in equity are not permissible.

 

The costs of the arbitration (including reasonable attorney’s fees and associated costs and expenses) shall be borne by the Parties in proportion to the outcome of the arbitration (taking into account the relative success of the claims and defenses of the Parties), as ordered by the arbitrator(s).

 

11.6 Waiver

 

No waiver of any term, provision or condition of this Agreement whether by conduct or otherwise in any one or more instances shall be deemed to be or construed as a further or continuing waiver of any such term, provision or condition or of any other term, provision or condition of this Agreement.

 

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11.7 Severability

 

If any provision of this Agreement is held to be invalid or unenforceable by a court of competent jurisdiction or an arbitrator all other provisions shall continue in full force and effect. The Parties hereby agree to attempt to substitute for any invalid or unenforceable provision a valid and enforceable provision which achieves to the greatest extent possible the economic legal and commercial objectives of the invalid or unenforceable provision.

 

11.8 Assignment / Subcontracting
   
11.8.1 Assignment

 

This Agreement shall be binding upon the successors and permitted assigns of the Parties and the name of a Party appearing herein shall be deemed to include the names of its successors and assigns, provided always that, except as provided for herein, neither Party shall assign this Agreement in whole or in part. Notwithstanding the aforesaid, (i) either Party may, without the other Party’s consent but upon the provision of written notice, assign its rights and obligations under this Agreement to any of its Affiliated Companies, or (ii) either Party may, without the other Party’s consent but upon the provision of written notice, assign this Agreement in its entirety to its successor to all or substantially all of its business or assets to which this Agreement relates, unless such successor is either (a) a Direct Competitor or (b) does not have the financial resources to perform such Party’s obligations under this Agreement. In case of an assignment, the assigning Party shall immediately notify the other Party about the intended or executed assignment, as applicable, and the assignee. Any assignment of this Agreement that is not in conformance with this Section 11.8 shall be null, void and of no legal effect.

 

11.9 Subcontracting

 

BI shall be permitted to subcontract portions of the Services to third parties subject to the prior written approval of BioCancell, not to be unreasonably withheld or delayed; provided that BI shall ensure compliance by and remain liable towards BioCancell for such subcontractors’ performance or non-performance of the Services under this Agreement or breach hereof. BioCancell acknowledges and agrees that BI may subcontract all Services and/or parts thereof to BI RCV and/or BIP, as well as specific Services to third parties performing quality control services in accordance with Section 2.5. BI will be responsible and liable to BioCancell for the acts and omissions of BI RCV, BIP and its other permitted sub-contractors.

 

11.10 Appendices; Priority of Documents

 

The Appendices attached to this Agreement shall be considered an integral part hereof. In the event of a conflict or ambiguity between any term of this Agreement and an Appendix, the terms of this Agreement shall prevail. Notwithstanding the foregoing, the QA shall supersede this Agreement.

 

11.11 Licensing Terms; Amendment to QA

 

The parties agree that they will use their best commercial efforts to (i) amend the QA in order to ensure its compliance with applicable Israeli laws and regulations; and (ii) agree upon the terms of the pDNA License Agreement referred to in Section 10.3.8 (which agreement will be attached to this Agreement as Appendix 4 ), within one hundred and twenty (120) days of the date of last signature of this Agreement.

 

--- SIGNATURE PAGE FOLLOWS ---

 

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the dates appearing below.

 

Jerusalem ,                     ,           2014   Ingelheim,                                      2014

BioCancell Therapeutics

Israel Ltd.

 

Boehringer Ingelheim Biopharmaceuticals

GmbH

By:   ppa.                                             ppa.

 

     
Name: Jonathan Burgin   [***]                                  [***]
Title:   CEO   [***]                                  [***]

 

 

  Vienna,                                          2014
  Boehringer Ingelheim RCV GmbH & Co KG
  ppa.                                                     i.V.

 

 

   
  [***]                                      [***]
  [***]                                      [***]

 

List of Appendices:

 

Appendix 1 : Product description; Cell Line, Product and BioCancell Deliverables;  (incl. Requirements for BioCancell Deliverables) and BI Assumptions.  
   
Appendix 2 : Services, Prices and Project Timeline (including the tasks of the Services covered under the MTA, dd April 3, 2013)
   
Appendix 3 : Billing Plan
   
Appendix 4 : Licensing Agreement (to be added)
   
Appendix 5 : Estimates for Raw Materials and Product-Dedicated Equipment
   
Appendix 6 : Project and Steering Committee Members
   
Appendix 7 : Shipping and packing instructions agreed by the Parties (to be attached upon agreement of the Parties)

 

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Appendix 1 :

 

Product description, Cell Line, Product and BioCancell Deliverables (incl. Requirements for BioCancell Deliverables) and BI Assumptions

 

1) Product description

 

The product BC-819 [***] is a [***] (DNA) plasmid [***]. The selective initiation of toxin expression results in selective tumor cell destruction via inhibition of protein synthesis in the tumor cell, enabling highly targeted cancer treatment.

 

[***]

 

[***]

 

 

 

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2) Deliverables from BioCancell

 

BI RCV assumes that all deliverables will be provided by BioCancell prior to project start.

 

a) Documents
· Product description of BC-819 (e.g. sequence of pDNA, MSDS, etc.)
· Plasmid map (in paper format and in electronic version)
· IPC and release specifications for drug substance and drug product
· SOPs of product-specific analytical methods, if applicable
· Reports on stability studies performed for drug substance and drug product including hold times
· Provision of the packaging material for drug substance (type of containers and size incl. vendors, part number)
· Provision of the container closure systems for drug product (type of vials and stoppers, size incl. vendors, part number)
· Composition of the formulation buffer and bulk concentration
· Specifications for excipients for drug substance (incl. vendors, part number and quality)
· Detailed description, technical reports and batch records for the formulation and fill & finish process
· Maximum daily dose information
· OEL Report (Occupational Exposure Level) for BC-819

 

b) Materials
· Master (MCB) and/or Working Cell Bank (WCB) for the current E. coli DH5alpha host, including all required certificates and tested for absence of bacteriophage
· Purified plasmid (including DNA sequence)
· Samples of intermediates (e.g. loads, pools) for establishing analytical methods
· Product specific reagents (e.g. antibodies for ELISA), if applicable
· Drug substance reference material, reference standard & working standard including CoA from a GMP batch
· 3 g pDNA for the establishment of the fill & finish process if available

 

In case deliverables by BioCancell cannot be supplied as assumed or assumptions made cannot be verified, the timeline, scope and prices (e.g. activities under a certain task) may be impacted and may require adjustment.

 

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BI Method  

Method from

former CMO used

for phase 2 testing

  Comments
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Activities / Services included   Price [in €]   BI RCV deliverables
         
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BioCancell / Boehringer Ingelheim Biopharmaceuticals Clin. Suppl. Agr.

 

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Appendix 4: Licensing Agreement

 

(to be attached)

 

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Appendix 5: Estimates for Raw Materials and Product-Dedicated Equipment

 

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Appendix 6: Project and Steering Committee Members

 

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Appendix 7 : Shipping and packing instructions agreed by the Parties (to be attached upon agreement of the Parties)

 

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