Document:

Exhibit 10.7

 

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT

 

THIS AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT is made as of July 3, 2017, by and among Gamida Cell Ltd., an Israeli company (the “Company”), and the Investors listed on Schedule A hereto (including any additional Investor that becomes a party to this Agreement following the date hereof in accordance with Section 5.9 hereof), each of which is referred to in this Agreement as an “Investor”.

 

RECITALS

 

WHEREAS, the Company and certain of the Investors are parties to that certain Series F Preferred Share Purchase Agreement dated June 18, 2017 (the “Investment Agreement”); and

 

WHEREAS, in order to induce the Company to enter into the Investment Agreement and to induce the aforesaid Investors to invest funds in the Company pursuant to the Investment Agreement, the Investors and the Company hereby agree that this Agreement shall govern the rights of all Investors to cause the Company to register Ordinary Shares issuable to the Investors, and to receive certain information from the Company, and shall govern certain other matters as set forth in this Agreement; and

 

WHEREAS, the Company and certain of the Investors (the “Existing Investors”) are parties to that certain Second Amended and Restated Investors’ Rights Agreement dated as of September 1, 2014 (the “Prior Agreement”), and desire to amend, restate and terminate the Prior Agreement in its entirety and to accept the rights and obligations created pursuant to this Agreement, in lieu of the rights and obligations granted to them under the Prior Agreement; and

 

WHEREAS, (i) Section 5.6 of the Prior Agreement provides that the Prior Agreement may be amended by a written instrument signed by the Company and holders of at least a majority of the Registrable Securities then outstanding, except for the provisions set forth in Section 3 (Information Rights) which may be amended by the holders of at least 70% of the outstanding Registrable Securities (as defined under the Prior Agreement), and (ii) the Existing Investors who have executed and delivered this Agreement currently (as of immediately prior to the Closing under the Investment Agreement) hold such applicable simple and 70% majorities of such Registrable Securities.

 

NOW, THEREFORE, the parties hereby agree as follows:

 

	1.	
Definitions.  For purposes of this Agreement:

 

1.1.          “Affiliate” means, with respect to any specified Person, any other Person who, directly or indirectly, controls, is controlled by, or is under common control with such Person, including without limitation any general partner, managing member, officer or director of such Person or any venture capital fund now or hereafter existing that is controlled by one or more general partners or managing members of, or shares the same management company with, such Person.

 

1.2.          “Damages” means any loss, damage, claim, cost, expense, or liability (joint or several) to which a party hereto may become subject under the Securities Act, the Exchange Act, or other federal or state law, insofar as such loss, damage, claim or liability (or any action in respect thereof) arises out of or is based upon (i) any untrue statement or alleged untrue statement of a material fact contained in any registration statement of the Company, including any preliminary prospectus or final prospectus contained therein or any amendments or supplements thereto; (ii) an omission or alleged omission to state therein a material fact required to be stated therein, or necessary to make the statements therein not misleading; or (iii) any violation or alleged violation by the indemnifying party (or any of its agents or Affiliates) of the Securities Act, the Exchange Act, any state securities law, or any rule or regulation promulgated under the Securities Act, the Exchange Act, or any state securities law.

 

1.3.          “Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

 

1.4.          “Excluded Registration” means (i) a registration relating to the sale of securities to employees of the Company or a subsidiary pursuant to a share option, share purchase, or similar plan; (ii) a registration relating to an SEC Rule 145 transaction; (iii) a registration on any form that does not include substantially the same information as would be required to be included in a registration statement covering the sale of the Registrable Securities; or (iv) a registration in which the only Ordinary Shares being registered are Ordinary Shares issuable upon conversion of debt securities that are also being registered.

 

1.5.          “Form F‐1” means such form under the Securities Act as in effect on the date hereof or any successor registration form under the Securities Act subsequently adopted by the SEC.

 

1.6.          “Form F‐3” means such form under the Securities Act as in effect on the date hereof or any registration form under the Securities Act subsequently adopted by the SEC that permits incorporation of substantial information by reference to other documents filed by the Company with the SEC.

 

1.7.          “Holder” means any holder of Registrable Securities who is a party to this Agreement.

 

1.8.          “Initiating Holders” means, collectively, Holders who properly initiate a registration request under this Agreement.

 

1.9.          “IPO” shall have the meaning ascribed to it in the Company’s Articles of Association, as may be amended from time to time ("Articles").

 

1.10.        “Major Investor” means any Investor that, individually or together with such Investor’s Affiliates and other Permitted Transferees, holds at least 0.5% of the voting power represented by the then issued and outstanding shares of the Company, on a Fully-Diluted Basis (as defined in the Articles).

 

1.11.        “Ordinary Shares” means Ordinary Shares of the Company, nominal value NIS 0.01 each.

 

1.12.        “Permitted Transferee” shall have the meaning set forth in the Articles.

 

1.13.        “Person” means any individual, corporation, partnership, trust, limited liability company, association or other entity.

 

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1.14.        “Preferred Shares” means, collectively, Series A Preferred Shares of the Company, Series B Preferred Shares of the Company, Series C Preferred Shares of the Company, in each case, of nominal value NIS 0.01 each, and , Series D Preferred Shares, Series E Preferred Shares and Series F Preferred Shares.

 

1.15.        “Registrable Securities” means (i) the Ordinary Shares issued or issuable upon conversion of the Preferred Shares or upon the exercise of any warrants to purchase Ordinary Shares held by Novartis Pharma AG (hereinafter, "Novartis") on the date hereof; (ii) any Ordinary Shares issued or issuable (directly or indirectly) upon conversion and/or exercise of any other preferred shares or securities for preferred shares of the Company, held by the Investors on the date hereof or acquired by the Investors after the date hereof; and (iii) any Ordinary Shares issued as (or issuable upon the conversion or exercise of any warrant, right, or other security that is issued as) a dividend or other distribution with respect to, or in exchange for or in replacement of, the shares referenced in clauses (i) and (ii) above; excluding in all cases, however, any Registrable Securities sold by a Person in a transaction in which the applicable rights under this Agreement are not assigned pursuant to Section 5.1, and excluding for purposes of Section 2 any shares for which registration rights have terminated pursuant to Section 2.13 of this Agreement.

 

1.16.        “Registrable Securities then outstanding” means the number of shares determined by adding the number of outstanding Ordinary Shares that are Registrable Securities and the number of Ordinary Shares issuable (directly or indirectly) pursuant to then exercisable and/or convertible securities that are Registrable Securities.

 

1.17.        “SEC” means the Securities and Exchange Commission.

 

1.18.        “SEC Rule 144” means Rule 144 promulgated by the SEC under the Securities Act.

 

1.19.         “SEC Rule 145” means Rule 145 promulgated by the SEC under the Securities Act.

 

1.20.        “Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

1.21.        “Selling Expenses” means all underwriting discounts, selling commissions, and share transfer taxes applicable to the sale of Registrable Securities, and fees and disbursements of counsel for any Holder.

 

1.22.        "Series D Preferred Shares" - Series D Preferred Shares of the Company, nominal value NIS 0.01 each.

 

1.23.        "Series E Preferred Shares" - Series E-1 Preferred Shares and Series E-2 Preferred Shares of the Company, nominal value NIS 0.01 each.

 

1.24.        "Series F Preferred Shares" - Series F-1 Preferred Shares and Series F-2 Preferred Shares of the Company, nominal value NIS 0.01 each.

 

	2.	
Registration Rights.  The Company covenants and agrees as follows:

 

2.1.          Demand Registration.

 

(a)          Form F-1 Demand.  If at any time after one hundred eighty (180) days after the effective date of the registration statement for the IPO, the Company receives a request from (1) Holders of a majority of the Registrable Securities (ignoring, for such purpose, but only (A) prior to the exercise of the demand right under clause (2) below, or (B) after an exercise of the demand right under clause (2) below in which none of the Registrable Securities underlying Series F Preferred Shares and requested to be included therein were not excluded from registration (‘cutback’) in accordance with Section 2.3(a)(i) below), any Registrable Securities then outstanding that were issued or are issuable upon conversion or in respect of any Series F Preferred Shares) then outstanding or (2) Holders of Registrable Securities then outstanding and constituting the Special F Majority (as defined in the Articles) that the Company file a Form F-1 registration statement with respect to (x) at least a majority of the Registrable Securities then outstanding or (y) Registrable Securities of such Holders having an anticipated aggregate offering price, net of Selling Expenses, of at least $10 million, then the Company shall (i) within ten (10) days after the date such request is given, give notice thereof (the “Demand Notice”) to all Holders other than the Initiating Holders; and (ii) as soon as practicable, and in any event within sixty (60) days after the date such request is given by the Initiating Holders, use commercially reasonable efforts to file a Form F-1 registration statement under the Securities Act covering all Registrable Securities that the Initiating Holders requested to be registered and any additional Registrable Securities requested to be included in such registration by any other Holders, as specified by notice given by each such Holder to the Company within twenty (20) days of the date the Demand Notice is given, and in each case, subject to the limitations of Section 2.1(c) and Section 2.3.

 

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(b)          Form F-3 Demand.  If at any time when it is eligible to use a Form F-3 registration statement, the Company receives a request from (1) Holders of at least 25 percent (25%) of the Registrable Securities (ignoring, for such purpose, but only (A) prior to the exercise of the demand right under clause (2) below, or (B) after an exercise of the demand right under clause (2) below in which none of the Registrable Securities underlying Series F Preferred Shares and requested to be included therein were not excluded from registration (‘cutback’) in accordance with Section 2.3(b)(i) below), any Registrable Securities then outstanding that were issued or are issuable upon conversion or in respect of any Series F Preferred Shares) then outstanding or (2) Holders of Registrable Securities then outstanding and constituting the Special F Majority, that the Company file a Form F-3 registration statement with respect to outstanding Registrable Securities of such Holders having an anticipated aggregate offering price, net of Selling Expenses, of at least $2 million, then the Company shall (i) within ten (10) days after the date such request is given, give a Demand Notice to all Holders other than the Initiating Holders; and (ii) as soon as practicable, and in any event within forty-five (45) days after the date such request is given by the Initiating Holders, use commercially reasonable efforts to file a Form F-3 registration statement under the Securities Act covering all Registrable Securities that the Initiating Holders requested to be registered and any additional Registrable Securities requested to be included in such registration by any other Holders, as specified by notice given by each such Holder to the Company within twenty (20) days of the date the Demand Notice is given, and in each case, subject to the limitations of Section 2.1 and Section 2.3.

 

(c)          Notwithstanding the foregoing obligations, if the Company furnishes to Holders requesting a registration pursuant to this Section 2.1, a certificate signed by the Company’s chief executive officer stating that in the good faith judgment of the Company’s Board of Directors (the “Board”), it would be materially detrimental to the Company and its shareholders for such registration statement to either become effective or remain effective for as long as such registration statement otherwise would be required to remain effective, because such action would (i) materially interfere with a significant acquisition, corporate reorganization, or other similar transaction involving the Company; (ii) require premature disclosure of material information that the Company has a bona fide business purpose for preserving as confidential; or (iii) render the Company unable to comply with requirements under the Securities Act or Exchange Act, then the Company shall have the right to defer taking action with respect to such filing, and any time periods with respect to filing or effectiveness thereof shall be tolled correspondingly, for a period of not more than one hundred twenty (120) days after the request of the Initiating Holders is given; provided, however, that the Company may not invoke this right more than once in any twelve (12) month period; and provided further that the Company shall not register any securities for its own account or that of any other shareholder during such one hundred twenty (120) day period other than an Excluded Registration.

 

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(d)          The Company shall not be obligated to effect, or to take any action to effect, (i) any registration pursuant to Section 2.1(a) - during the period that is sixty (60) days before the Company’s good faith estimate of the date of filing of, and ending on a date that is one hundred eighty (180) days after the effective date of, a Company-initiated registration, provided, that the Company is actively employing in good faith commercially reasonable efforts to cause such registration statement to become effective; (ii) any registration pursuant to Section 2.1(a)(1) - after the Company has effected three registrations pursuant to Section 2.1(a)(1); (iii) any registration pursuant to Section 2.1(a)(2) - after the Company has effected one registration pursuant to Section 2.1(a)(2); or (iv) any registration pursuant to Section 2.1(a) - if the Initiating Holders propose to dispose of shares of Registrable Securities that all of which may be immediately registered on Form F-3 pursuant to a request made pursuant to Section 2.1(b).

 

(e)          The Company shall not be obligated to effect, or to take any action to effect, (i) any registration pursuant to Section 2.1(b) - during the period that is thirty (30) days before the Company’s good faith estimate of the date of filing of, and ending on a date that is ninety (90) days after the effective date of, a Company-initiated registration, provided, that the Company is actively employing in good faith commercially reasonable efforts to cause such registration statement to become effective; or (ii) any registration pursuant to Section 2.1(b)(1) - if the Company has effected three registrations pursuant to Section 2.1(b)(1) within the twelve (12) month period immediately preceding the date of such request; or (iii) any registration pursuant to Section 2.1(b)(2) - if the Company has effected one registration pursuant to Section 2.1(b)(2) within the twelve (12) month period immediately preceding the date of such request.  A registration shall not be counted as “effected” for purposes of this Section 2.1(b) until such time as the applicable registration statement has been declared effective by the SEC, unless the Initiating Holders withdraw their request for such registration, elect not to pay the registration expenses therefor, and forfeit their right to one demand registration statement pursuant to Section 2.6, in which case such withdrawn registration statement shall be counted as “effected” for purposes of this Section 2.1(d).

 

2.2.          Company Registration.  If the Company proposes to register (including, for this purpose, a registration effected by the Company for shareholders other than the Holders) any of its securities under the Securities Act in connection with the public offering of such securities (other than in an Excluded Registration), the Company shall, at such time, promptly give each Holder notice of such registration.  Upon the request of each Holder given within twenty (20) days after such notice is given by the Company, the Company shall, subject to the provisions of Section 2.3, cause to be registered all of the Registrable Securities that each such Holder has requested to be included in such registration.  The Company shall have the right to terminate or withdraw any registration initiated by it under this Section 2.2 before the effective date of such registration, whether or not any Holder has elected to include Registrable Securities in such registration.  The expenses of such withdrawn registration shall be borne by the Company in accordance with Section 2.6 (ignoring, for such purpose, any reference to Selling Expenses thereunder).

 

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2.3.          Underwriting Requirements.

(a)          If, pursuant to Section 2.1, the Initiating Holders intend to distribute the Registrable Securities covered by their request by means of an underwriting, they shall so advise the Company as a part of their request made pursuant to Section 2.1, and the Company shall include such information in the Demand Notice.  The underwriter(s) will be selected by the Company and shall be reasonably acceptable to a majority in interest of the Initiating Holders.  In such event, the right of any Holder to include such Holder’s Registrable Securities in such registration shall be conditioned upon such Holder’s participation in such underwriting and the inclusion of such Holder’s Registrable Securities in the underwriting to the extent provided herein.  All Holders proposing to distribute their securities through such underwriting shall (together with the Company as provided in Section 2.4(e)) enter into an underwriting agreement in customary form with the underwriter(s) selected for such underwriting.  Notwithstanding any other provision of this Section 2.3, if the managing underwriter(s) advise(s) the Initiating Holders in writing that marketing factors require a limitation on the number of shares to be underwritten, then the Initiating Holders shall so advise all Holders of Registrable Securities that otherwise would be underwritten pursuant hereto, and the number of Registrable Securities that may be included in the underwriting shall be allocated among such Holders of Registrable Securities, including the Initiating Holders, as follows: (i) first, that number of the Registrable Securities, which were requested to be included in such registration and are underlying Series F Preferred Shares, allocated among the requesting Holders in proportion (as nearly as practicable) to the number of Registrable Securities, which are underlying Series F Preferred Shares, then owned by each Holder or in such other proportion as shall mutually be agreed to by all such requesting applicable Holders, provided however that such total number of Registrable Securities does not exceed 40% of the maximum total Registrable Securities to be included in such registration (in the opinion of the underwriters); (ii) second, that number of the Registrable Securities, which were requested to be included in such registration and are underlying Series E Preferred Shares, allocated among the requesting Holders in proportion (as nearly as practicable) to the number of Registrable Securities, which are underlying Series E Preferred Shares, then owned by each Holder or in such other proportion as shall mutually be agreed to by all such requesting applicable Holders, provided however such total number of Registrable Securities does not exceed 30% of the maximum total Registrable Securities to be included in such registration (in the opinion of the underwriters); (iii) third, that number of the Registrable Securities, which were requested to be included in such registration and are underlying Series D Preferred Shares, allocated among the requesting Holders in proportion (as nearly as practicable) to the number of Registrable Securities, which are underlying Series D Preferred Shares, then owned by each Holder or in such other proportion as shall mutually be agreed to by all such requesting applicable Holders, provided however such total number of Registrable Securities does not exceed 30% of the maximum total Registrable Securities to be included in such registration (in the opinion of the underwriters); and thereafter (iv) if applicable, that number of the remaining Registrable Securities, which were requested to be included in such registration, allocated among the requesting Holders in proportion (as nearly as practicable) to the number of Registrable Securities owned by each Holder or in such other proportion as shall mutually be agreed to by all such selling Holders; provided, however, that the number of Registrable Securities held by the Holders to be included in such underwriting shall not be reduced unless all other securities are first entirely excluded from the underwriting.

 

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(b)          In connection with any offering involving an underwriting of shares of the Company’s share capital pursuant to Section 2.2, the Company shall not be required to include any of the Holders’ Registrable Securities in such underwriting unless the Holders accept the terms of the underwriting as agreed upon between the Company and its underwriters, and then only in such quantity as the underwriters in their sole discretion determine will not jeopardize the success of the offering by the Company.  If the total number of securities, including Registrable Securities, requested by shareholders to be included in such offering exceeds the number of securities to be sold (other than by the Company) that the underwriters in their reasonable discretion determine is compatible with the success of the offering, then the Company shall be required to include in the offering only that number of such securities, including Registrable Securities, which the underwriters and the Company in their sole discretion determine will not jeopardize the success of the offering.  If the underwriters determine that less than all of the Registrable Securities requested to be registered can be included in such offering, then the Registrable Securities that are included in such offering (after inclusion in such registration of all of the Company’s securities requested to be included therein) shall be allocated among the selling Holders as follows: (i) first, that number of the Registrable Securities, which were requested to be included in such registration and are underlying Series F Preferred Shares, allocated among the requesting Holders in proportion (as nearly as practicable) to the number of Registrable Securities, which are underlying Series F Preferred Shares, then owned by each Holder or in such other proportion as shall mutually be agreed to by all such requesting applicable Holders, provided however that such total number of Registrable Securities does not exceed 40% of the maximum total Registrable Securities to be included in such registration (in the opinion of the underwriters); (ii) second, that number of the Registrable Securities, which were requested to be included in such registration and are underlying Series E Preferred Shares, allocated among the requesting Holders in proportion (as nearly as practicable) to the number of Registrable Securities, which are underlying Series E Preferred Shares, then owned by each Holder or in such other proportion as shall mutually be agreed to by all such requesting applicable Holders, provided however such total number of Registrable Securities does not exceed 30% of the maximum total Registrable Securities to be included in such registration (in the opinion of the underwriters); (iii) third, that number of the Registrable Securities, which were requested to be included in such registration and are underlying Series D Preferred Shares, allocated among the requesting Holders in proportion (as nearly as practicable) to the number of Registrable Securities, which are underlying Series D Preferred Shares, then owned by each Holder or in such other proportion as shall mutually be agreed to by all such requesting applicable Holders, provided however such total number of Registrable Securities does not exceed 30% of the maximum total Registrable Securities to be included in such registration (in the opinion of the underwriters); and thereafter (iv) if applicable, that number of the remaining Registrable Securities, which were requested to be included in such registration, allocated among the requesting Holders in proportion (as nearly as practicable to) the number of Registrable Securities owned by each selling Holder or in such other proportions as shall mutually be agreed to by all such selling Holders.  Notwithstanding the foregoing, in no event shall the number of Registrable Securities included in the offering be reduced unless all other securities (other than securities to be sold by the Company) are first entirely excluded from the offering. For purposes of the provision in thisSection 2.3(b)concerning apportionment, for any selling Holder, such Holder and the Permitted Transferees of such Holder shall be deemed to be a single “selling Holder,” and any pro rata reduction with respect to such “selling Holder” shall be based upon the aggregate number of Registrable Securities owned by all Persons included in such “selling Holder,” as defined in this sentence.

 

(c)          For purposes of Section 2.1, a registration shall not be counted as “effected” if, as a result of an exercise of the underwriter’s cutback provisions in Section 2.3(a), fewer than fifty percent (50%) of the total number of Registrable Securities that Holders have requested to be included in such registration statement are actually included.

 

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2.4.          Obligations of the Company.  Whenever required under this Section 2 to effect the registration of any Registrable Securities, the Company shall, as expeditiously as reasonably possible:

 

(a)          prepare and file with the SEC a registration statement with respect to such Registrable Securities and use its commercially reasonable efforts to cause such registration statement to become effective and, upon the request of the Holders of a majority of the Registrable Securities registered thereunder, keep such registration statement effective for a period of up to one hundred twenty (120) days or, if earlier, until the distribution contemplated in the registration statement has been completed; provided, however, that (i) such one hundred twenty (120) day period shall be extended for a period of time equal to the period the Holder refrains, at the request of an underwriter of Ordinary Shares (or other securities) of the Company, from selling any securities included in such registration, and (ii) in the case of any registration of Registrable Securities on Form F-3 that are intended to be offered on a continuous or delayed basis, subject to compliance with applicable SEC rules, such one hundred twenty (120) day period shall be extended for up to thirty (30) days, if necessary, to keep the registration statement effective until all such Registrable Securities are either sold or may be sold;

 

(b)          prepare and file with the SEC such amendments and supplements to such registration statement, and the prospectus used in connection with such registration statement, as may be necessary to comply with the Securities Act in order to enable the disposition of all securities covered by such registration statement;

 

(c)          furnish to the selling Holders such numbers of copies of a prospectus, including a preliminary prospectus, as required by the Securities Act, and such other documents as the Holders may reasonably request in order to facilitate their disposition of their Registrable Securities;

 

(d)          use its commercially reasonable efforts to register and qualify the securities covered by such registration statement under such other securities and/or blue-sky laws of such jurisdictions as shall be reasonably requested by the selling Holders; provided that the Company shall not be required to qualify to do business or to file a general consent to service of process in any such states or jurisdictions, unless the Company is already subject to service in such jurisdiction and except as may be required by the Securities Act;

 

(e)          in the event of any underwritten public offering, enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the underwriter(s) of such offering;

 

(f)           use its commercially reasonable efforts to cause all such Registrable Securities covered by such registration statement to be listed on a national securities exchange or trading system and each securities exchange and trading system (if any) on which similar securities issued by the Company are then listed;

 

(g)          provide a transfer agent and registrar for all Registrable Securities registered pursuant to this Agreement and provide a CUSIP number for all such Registrable Securities, in each case not later than the effective date of such registration;

 

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(h)          use its commercially reasonable efforts to obtain and furnish, at the request of any Holder requesting registration of Registrable Securities pursuant to Section 2, on the date that such Registrable Securities are delivered to the underwriters for sale in connection with a registration pursuant to Section 2, (i) an opinion, dated such date, of the counsel representing the Company for the purposes of such registration, in form and substance as is customarily given to underwriters in an underwritten public offering, addressed to the underwriters and to the Holders requesting registration of Registrable Securities, provided that the delivery of any “10b-5 statement” and opinion may be conditioned on the prior or concurrent delivery of a comfort letter pursuant to subsection (ii) below, and (ii) a letter dated such date, from the independent certified public accountants of the Company (to the extent deliverable in accordance with their professional standards), in form and substance as is customarily given by independent certified public accountants to underwriters in an underwritten public offering, addressed to the underwriters, if any, and to the Holders requesting registration of Registrable Securities; provided, that the Company shall only be required to comply with this clause (h) in connection with an underwritten offering and subject to each selling Holder to whom the comfort letter is addressed providing a customary representation letter to the independent registered public accounting firm of the Company in form and substance reasonably satisfactory to such accountants; 

 

(i)           promptly make available for inspection by the selling Holders, any managing underwriter(s) participating in any disposition pursuant to such registration statement, and any attorney or accountant or other agent retained by any such underwriter or selected by the selling Holders, all financial and other records, pertinent corporate documents, and properties of the Company, and cause the Company’s officers, directors, employees, and independent accountants to supply all information reasonably requested by any such seller, underwriter, attorney, accountant, or agent, in each case, as necessary or advisable to verify the accuracy of the information in such registration statement and to conduct appropriate due diligence in connection therewith;

 

(j)           notify each selling Holder, promptly after the Company receives notice thereof, of the time when such registration statement has been declared effective or a supplement to any prospectus forming a part of such registration statement has been filed; and

 

(k)          after such registration statement becomes effective, notify each selling Holder of any request by the SEC that the Company amend or supplement such registration statement or prospectus.

 

In addition, the Company shall ensure that, at all times after any registration statement covering a public offering of securities of the Company under the Securities Act shall have become effective, its insider trading policy shall provide that the Company’s directors may implement a trading program under Rule 10b5-1 of the Exchange Act.

 

2.5.          Furnish Information.  It shall be a condition precedent to the obligations of the Company to take any action pursuant to this Section 2 with respect to the Registrable Securities of any selling Holder that such Holder shall furnish to the Company such information regarding itself, the Registrable Securities held by it, and the intended method of disposition of such securities as is reasonably required to effect the registration of such Holder’s Registrable Securities.

 

2.6.          Expenses of Registration.  All expenses (other than Selling Expenses) incurred in connection with registrations, filings, or qualifications pursuant to Section 2, including all registration, filing, and qualification fees; printers’ and accounting fees; fees and disbursements of counsel for the Company; and the reasonable fees and disbursements of one counsel for all the selling Holders(“Selling Holders Counsel”), shall be borne and paid by the Company; provided, however, that the Company shall not be required to pay for any expenses of any registration proceeding begun pursuant to Section 2.1 if the registration request is subsequently withdrawn at the request of the Initiating Holders (in which case all selling Holders shall bear such expenses pro rata based upon the number of Registrable Securities that were to be included in the withdrawn registration), unless the applicable Initiating Holders agree to forfeit their right to one registration pursuant to Section 2.1(a) or Section 2.1(b), as the case may be; provided further that if, at the time of such withdrawal, the Holders shall have learned of a material adverse change in the condition, business, or prospects of the Company from that known to the Holders at the time of their request and have withdrawn the request with reasonable promptness after learning of such information then the Holders shall not be required to pay any of such expenses and shall not forfeit their right to one registration pursuant to Section 2.1(a) or Section 2.1(b).  All Selling Expenses other than reasonable fees and disbursements of Selling Holders Counsel relating to Registrable Securities registered pursuant to this Section 2 shall be borne and paid by the Holders pro rata on the basis of the number of Registrable Securities registered on their behalf. 

 

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2.7.          Delay of Registration.  No Holder shall have any right to obtain or seek an injunction restraining or otherwise delaying any registration pursuant to this Agreement as the result of any controversy that might arise with respect to the interpretation or implementation of this Section 2.

 

2.8.          Indemnification.  If any Registrable Securities are included in a registration statement under this Section 2:

 

(a)          To the extent permitted by law, the Company will indemnify and hold harmless each selling Holder, and the partners, members, officers, directors, and shareholders of each such Holder; legal counsel and accountants for each such Holder; any underwriter (as defined in the Securities Act) for each such Holder; and each Person, if any, who controls such Holder or underwriter within the meaning of the Securities Act or the Exchange Act, against any Damages, and the Company will pay to each such Holder, underwriter, controlling Person, or other aforementioned Person any legal or other expenses reasonably incurred thereby in connection with investigating or defending any claim or proceeding from which Damages may result, as such expenses are incurred; provided, however, that the indemnity agreement contained in this Section 2.8(a) shall not apply to amounts paid in settlement of any such claim or proceeding if such settlement is effected without the consent of the Company, which consent shall not be unreasonably withheld, nor shall the Company be liable for any Damages to the extent that they arise out of or are based upon actions or omissions made in reliance upon and in conformity with written information furnished by or on behalf of any such Holder, underwriter, controlling Person, or other aforementioned Person expressly for use in connection with such registration.

 

(b)          To the extent permitted by law, each selling Holder, severally and not jointly, will indemnify and hold harmless the Company, and each of its directors, each of its officers who has signed the registration statement, each Person (if any), who controls the Company within the meaning of the Securities Act, legal counsel and accountants for the Company, any underwriter (as defined in the Securities Act), any other Holder selling securities in such registration statement, and any controlling Person of any such underwriter or other Holder, against any Damages, in each case only to the extent that such Damages arise out of or are based upon actions or omissions made in reliance upon and in conformity with written information furnished by or on behalf of such selling Holder expressly for use in connection with such registration; and each such selling Holder will pay to the Company and each other aforementioned Person any legal or other expenses reasonably incurred thereby in connection with investigating or defending any claim or proceeding from which Damages may result, as such expenses are incurred; provided, however, that the indemnity agreement contained in this Section 2.8(b) shall not apply to amounts paid in settlement of any such claim or proceeding if such settlement is effected without the consent of the Holder, which consent shall not be unreasonably withheld; and provided further that in no event shall the aggregate amounts payable by any Holder by way of indemnity or contribution under Sections 2.8(b) and 2.8(d) exceed the proceeds from the offering received by such Holder (net of any Selling Expenses paid by such Holder), except in the case of fraud or willful misconduct by such Holder.

 

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(c)          Promptly after receipt by an indemnified party under this Section 2.8 of notice of the commencement of any action (including any governmental action) for which a party may be entitled to indemnification hereunder, such indemnified party will, if a claim in respect thereof is to be made against any indemnifying party under this Section 2.8, give the indemnifying party notice of the commencement thereof.  The indemnifying party shall have the right to participate in such action and, to the extent the indemnifying party so desires, participate jointly with any other indemnifying party to which notice has been given, and to assume the defense thereof with counsel mutually satisfactory to the parties; provided, however, that an indemnified party (together with all other indemnified parties that may be represented without conflict by one counsel) shall have the right to retain one separate counsel, with the fees and expenses to be paid by the indemnifying party, if representation of such indemnified party by the counsel retained by the indemnifying party would be inappropriate due to actual or potential differing interests between such indemnified party and any other party represented by such counsel in such action.  The failure to give notice to the indemnifying party within a reasonable time of the commencement of any such action shall relieve such indemnifying party of any liability to the indemnified party under this Section 2.8, to the extent that such failure materially prejudices the indemnifying party’s ability to defend such action.  The failure to give notice to the indemnifying party will not relieve it of any liability that it may have to any indemnified party otherwise than under this Section 2.8.

 

(d)          To provide for just and equitable contribution to joint liability under the Securities Act in any case in which either (i) any party otherwise entitled to indemnification hereunder makes a claim for indemnification pursuant to this Section 2.8 but it is judicially determined (by the entry of a final judgment or decree by a court of competent jurisdiction and the expiration of time to appeal or the denial of the last right of appeal) that such indemnification may not be enforced in such case, notwithstanding the fact that this Section 2.8 provides for indemnification in such case, or (ii) contribution under the Securities Act may be required on the part of any party hereto for which indemnification is provided under this Section 2.8, then, and in each such case, such parties will contribute to the aggregate losses, claims, damages, liabilities, or expenses to which they may be subject (after contribution from others) in such proportion as is appropriate to reflect the relative fault of each of the indemnifying party and the indemnified party in connection with the statements, omissions, or other actions that resulted in such loss, claim, damage, liability, or expense, as well as to reflect any other relevant equitable considerations.  The relative fault of the indemnifying party and of the indemnified party shall be determined by reference to, among other things, whether the untrue or allegedly untrue statement of a material fact, or the omission or alleged omission of a material fact, relates to information supplied by the indemnifying party or by the indemnified party and the parties’ relative intent, knowledge, access to information, and opportunity to correct or prevent such statement or omission; provided, however, that, in any such case, (x) no Holder will be required to contribute any amount in excess of the public offering price of all such Registrable Securities offered and sold by such Holder pursuant to such registration statement, and (y) no Person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) will be entitled to contribution from any Person who was not guilty of such fraudulent misrepresentation; and provided further that in no event shall a Holder’s liability pursuant to this Section 2.8(d), when combined with the amounts paid or payable by such Holder pursuant to Section 2.8(b), exceed the proceeds from the offering received by such Holder (net of any Selling Expenses paid by such Holder), except in the case of willful misconduct or fraud by such Holder.

 

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(e)          Notwithstanding the foregoing, to the extent that the provisions on indemnification and contribution contained in the underwriting agreement entered into in connection with the underwritten public offering are in conflict with the foregoing provisions, the provisions in the underwriting agreement shall control.

 

(f)           Unless otherwise superseded by an underwriting agreement entered into in connection with the underwritten public offering, the obligations of the Company and Holders under this Section 2.8 shall survive the completion of any offering of Registrable Securities in a registration under this Section 2, and otherwise shall survive the termination of this Agreement.

 

2.9.          Reports Under Exchange Act.  With a view to making available to the Holders the benefits of SEC Rule 144 and any other rule or regulation of the SEC that may at any time permit a Holder to sell securities of the Company to the public without registration or pursuant to a registration on Form F‐3, the Company shall:

 

(a)          make and keep available adequate current public information, as those terms are understood and defined in SEC Rule 144, at all times after the effective date of the registration statement filed by the Company for the IPO;

 

(b)          file with the SEC in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act (at any time after the Company has become subject to such reporting requirements); and

 

(c)          furnish to any Holder, so long as the Holder owns any Registrable Securities, forthwith upon request (i) to the extent accurate, a written statement by the Company that it has complied with the reporting requirements of SEC Rule 144 (at any time after ninety (90) days after the effective date of the registration statement filed by the Company for the IPO), the Securities Act, and the Exchange Act (at any time after the Company has become subject to such reporting requirements), or that it qualifies as a registrant whose securities may be resold pursuant to Form F‐3 (at any time after the Company so qualifies); (ii) a copy of the most recent annual or quarterly report of the Company and such other reports and documents so filed by the Company; and (iii) such other information as may be reasonably requested in availing any Holder of any rule or regulation of the SEC that permits the selling of any such securities without registration (at any time after the Company has become subject to the reporting requirements under the Exchange Act) or pursuant to Form F‐3 (at any time after the Company so qualifies to use such form).

 

2.10.        Limitations on Subsequent Registration Rights.  From and after the date of this Agreement, the Company shall not, without the prior written consent of the Holders of at least a majority of the Registrable Securities then outstanding, enter into any agreement with any holder or prospective holder of any securities of the Company that would provide to such holder the right to include securities in any registration other than on a subordinate basis after all Holders have had the opportunity to include in the registration and offering all shares of Registrable Securities that they wish to so include.

 

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2.11.        “Market Stand‐off” Agreement.  In connection with the IPO, each Holder hereby agrees that it will not, without the prior written consent of the managing underwriter, during the period commencing on the date of the final prospectus relating to the registration by the Company for its own behalf of Ordinary Shares or any other equity securities under the Securities Act on a registration statement on Form F-1, or Form F-3, and ending on the date specified by the Company and the managing underwriter (such period not to exceed  one hundred eighty (180) days in the case of the IPO), (i) lend; offer; pledge; sell; contract to sell; sell any option or contract to purchase; purchase any option or contract to sell; grant any option, right, or warrant to purchase; or otherwise transfer or dispose of, directly or indirectly, any Ordinary Shares or any securities convertible into or exercisable or exchangeable (directly or indirectly) for Ordinary Shares (held immediately before the effective date of the registration statement for such offering) or (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of such securities, whether any such transaction described in clause (i) or (ii) above is to be settled by delivery of Ordinary Shares or other securities, in cash, or otherwise.  The foregoing provisions of this Section 2.11 (1) shall not apply to the sale of any shares to an underwriter pursuant to an underwriting agreement, or the transfer of any shares to any trust for the direct or indirect benefit of the Holder or the immediate family or to Permitted Transferees of the Holder, provided that the trustee of the trust agrees to be bound in writing by the restrictions set forth herein, and provided further that any such transfer shall not involve a disposition for value, (2) shall not be construed as to prohibit or limit the exercise during such period of warrants or options to purchase shares of the Company, and (3) shall be applicable to the Holders only if all officers, directors and shareholders individually owning more than one percent (1%) of the Company’s outstanding Ordinary Shares (after giving effect to conversion into Ordinary Shares of all outstanding Preferred Shares) are subject to the same restrictions. The underwriters in connection with such registration are intended third‐party beneficiaries of this Section 2.11 and shall have the right, power, and authority to enforce the provisions hereof as though they were parties hereto.  Each Holder further agrees to execute such agreements as may be reasonably requested by the underwriters in connection with such registration that are consistent with this Section 2.11 or that are necessary to give further effect thereto.  Any discretionary waiver or termination of the restrictions of any or all of such agreements by the Company or the underwriters shall apply pro rata to all Holders subject to such agreements, based on the number of shares subject to such agreements.

 

2.12.        Registration Outside the U.S.          The provisions of Section 2 hereof shall apply also, mutatis mutandis, to any registration of shares of the Company in any jurisdiction other than the U.S. and all references to U.S. laws and regulations shall be deemed as made to the applicable relevant laws.

2.13.        Termination of Registration Rights.  The right of any Holder to request registration or inclusion of Registrable Securities in any registration pursuant to Section 2.1 or Section 2.2 shall terminate upon the earliest to occur of:

(a)          the closing of a Deemed Liquidation (other than a Non-Liquidity Event, as defined in the Articles); and

 

(b)          such time as Rule 144 or another similar exemption under the Securities Act is available for the sale of all of such Holder’s shares without limitation during a three-month period without registration; and 

 

(c)          the 7th anniversary of the IPO.

	
3.

	
Information Rights.

 

3.1.          Delivery of Financial Statements.  The Company shall deliver to each Major Investor:

 

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(a)          as soon as practicable, but in any event within 50 days after the end of each fiscal year of the Company, financial statement for such fiscal year, prepared in accordance with International Financial Reporting Standards (“IFRS”), audited by an accounting firm associated with one of the “Big 4” international accounting firms;

 

(b)          as soon as practicable, but in any event within 35 days after the end of each of the first three (3) quarters of each fiscal year of the Company, unaudited financial statements for such fiscal quarter, prepared in accordance with IFRS, consistently applied with prior practices for earlier periods, reviewed by such “Big 4” international accounting firm;

 

(c)          as soon as practicable, but in any event thirty (30) days before the end of each fiscal year, a budget and business plan for the next fiscal year (collectively, the “Budget”), approved by the Board and prepared on a quarterly basis;

 

(d)          as soon as practicable following such Major Investor's request, but in any event within 7 days (or, if such requested information is not readily available for delivery or requires certain preparation or compilation by or on behalf the Company, then as soon as practicably thereafter), such other information relating to the financial condition, business, prospects, or corporate affairs of the Company and its subsidiaries as any Major Investor may from time to time reasonably request for purposes of good faith compliance with any disclosure obligation or requirement of such Major Investor under any applicable law or regulations; provided, however, that such Major Investor’s request will be made in the most limited scope as required for the purposes of compliance with such applicable law;

 

(e)          as soon as practicable following such Major Investor's request, but in any event within sixty (60) days after the end of each quarter of each fiscal year of the Company, a statement showing the number of shares of each class and series of share capital and securities convertible into or exercisable for share capital outstanding at the end of the period, the Ordinary Shares issuable upon conversion or exercise of any outstanding securities convertible or exercisable for Ordinary Shares and the exchange ratio or exercise price applicable thereto, and the number of options (issued and not yet issued but reserved for issuance, if any), all in sufficient detail as to permit the Major Investors to calculate their respective percentage equity ownership in the Company on both issued and fully-diluted bases, and certified by the chief financial officer or chief executive officer of the Company as being true, complete, and correct.

 

If, for any period, the Company has any subsidiary whose accounts are consolidated with those of the Company, then in respect of such period the financial statements delivered pursuant to the foregoing sections shall be the consolidated and consolidating financial statements of the Company and all such consolidated subsidiaries.

 

Without derogating from the foregoing, the Company shall deliver to any Investor which is either a public company, a regulated body or a provident fund (“Regulated Body”), as soon as practicable following such Investor's reasonable request, any information or report relating to the financial condition, business, prospects, or corporate affairs of the Company and its subsidiaries as may reasonably be requested by such Investor in order to comply with any obligation of such Investor under applicable law, including without limitation, Securities Laws, Stock Exchange rules and regulations and/or any request of the Stock Exchange, Securities Authority, Ministry of Finance or any other authority. Without derogating from the generality of the above, the Company was informed that such Regulated Bodies may be subject to the Securities Law, 5728-1968 and the regulations promulgated thereunder (together the “Securities Law”), as well as to the instructions of the professional staff of the Israel Securities Authority (the “Securities Authority”), and that the obligation of the Company under this paragraph is necessary in order to assist the Regulated Body to fulfill the aforementioned legal obligations.

 

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Notwithstanding anything else in this Section 3.1 to the contrary, the Company may cease providing the information set forth in this Section 3.1 during the period starting with the date thirty (30) days before the Company’s good-faith estimate of the date of filing of a registration statement if it reasonably concludes, based upon opinion of its counsel, it must do so to comply with the SEC rules applicable to such registration statement and related offering, except as required for a Regulated Body or any other Major Investor which is (or its controlling parent company is) a publicly traded company for purposes of compliance with its obligations under applicable law or regulations to issue annual, quarterly or other periodic reports; provided that the Company’s covenants under this Section 3.1 shall be reinstated at such time as the Company is no longer actively employing its commercially reasonable efforts to cause such registration statement to become effective.

 

3.2.          Inspection.  The Company shall permit each Major Investor and its representative (provided that the Board has not reasonably determined that such Major Investor is a competitor of the Company), at such Major Investor’s expense, to visit and inspect the Company’s properties; examine its books of account and records; and discuss the Company’s affairs, finances, and accounts with its representatives, during normal business hours of the Company as may be reasonably requested by the Major Investor; provided, however, that the Company shall not be obligated pursuant to this Section 3.2 to provide access to any information that it reasonably and in good faith considers to be a trade secret or confidential information (unless covered by an enforceable confidentiality agreement, in a customary form acceptable to the Company) or the disclosure of which would adversely affect the attorney-client privilege between the Company and its counsel.

 

3.3.          Accounting. The Company will maintain and cause each of its subsidiaries to maintain a system of accounting established and administered in accordance with IFRS consistently applied, and will set aside on its books and cause each of its operating subsidiaries to set aside on its respective books all such proper reserves as shall be required by IFRS.

 

3.4.          Termination of Information Rights.  The covenants set forth in Section 3.1 and Section 3.2 shall terminate and be of no further force or effect upon the earlier of the consummation of a Qualified IPO or a Deemed Liquidation under Article 6.5 thereof (as such terms are defined in the Articles), whichever event occurs first, subject to and immediately prior to the closing thereof. 

 

3.5.          Confidentiality.  Each Investor agrees that such Investor will keep confidential and will not disclose, divulge, or use for any purpose (other than to monitor its investment in the Company) any confidential information obtained from the Company (whether pursuant to the terms of this Agreement or otherwise) (including notice of the Company’s intention to file a registration statement), unless such confidential information (a) is known or becomes known to the public in general (other than as a result of a breach by such Investor of any confidentiality obligation), (b) is or has been independently developed or conceived by the Investor without use of the Company’s confidential information, or (c) is or has been made known or disclosed to the Investor by a third party without a breach of any obligation of confidentiality such third party may have to the Company; provided, however, that an Investor may disclose confidential information (i) to its attorneys, accountants, consultants, and other professionals to the extent necessary to obtain their services in connection with monitoring its investment in the Company; (ii) to any prospective purchaser of any Registrable Securities from such Investor, if such prospective purchaser agrees to be bound by the provisions of this Section 3.5; (iii) to any existing or prospective Affiliate, partner, member, shareholder, or wholly-owned subsidiary of such Investor in the ordinary course of business, provided that such Investor informs such Person that such information is confidential and directs such Person to maintain the confidentiality of such information; or (iv) as may otherwise be required for purposes of compliance by such Investor with any disclosure obligation or requirement of such Investor (or its controlling parent company) under applicable law or regulations, provided that the Investor promptly notifies the Company of such disclosure and takes reasonable steps to minimize the extent of any such required disclosure. The members of the Board (including for such purpose, any observer to the Board) may share information regarding the Company’s operating plans and budgets with the shareholders who appointed them, subject to enforceable confidentiality agreement, in a customary form acceptable to the Company.

 

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3.6.          Dividend Policy. As soon as is reasonably practicable after the end of each fiscal year and at such other time(s) as the Board shall specify, the Board shall consider the distribution of some or all of the profits of the Company available for distribution to the shareholders. The Board may, in making that determination, take into account the provisions of applicable law and the reasonable financial requirements of the Company. Notwithstanding the foregoing, until the payment in full to the holders of Series F Preferred Shares of their entire Preference F Amounts (as defined in the Articles), if, at any time, the Company grants an exclusive license of its intellectual property or assets and pursuant to such transaction, the Company has actually received non-refundable and non-contingent cash (revenues and/or receipts) in an amount which shall exceed US$ 50 Million (after deduction of VAT and any amounts paid in consideration for manufacturing, research and/or development and other third party expenses and royalties), then to the extent permitted under applicable law, and unless the Special F Majority otherwise agree, the shareholders will recommend to the Board to distribute, in accordance with the Dividend Provisions in the Articles (Article 5.3.1), the balance of all of its distributable profits accumulated and undistributed in respect of prior periods to that date BUT after allowing for and/or deducting the Company’s budgeted expenditure for the next ensuing twenty-four (24) months. This section will expire upon the consummation of a Qualified IPO.  

	4.	
Bring Along; Stand-still.

 

4.1.          Bring Along. Each Investor hereby agrees to be bound by, and further undertakes to comply in a timely manner and in all respects with, the terms and conditions of the Bring Along provisions set forth in Article 18.4 of the Articles.

 

4.2.          Stand-still. Notwithstanding anything to the contrary contained in the Articles, Novartis’ and its Affiliates’ (collectively, the “Stand-Still Shareholders Group”) holding percentage in Company’s issued and outstanding share capital on an as-converted basis, at any time, shall be limited such that, unless approved by the holders of at least a majority of the voting power represented by the then issued and outstanding Preferred Shares (treated together as a single class, on an as-converted basis, without taking into account any Preferred Shares held by Novartis or any of its Affiliates), (i) in no event (whether pursuant to the purchase of shares or rights thereto from the Company, directly or by exercising preemptive rights pursuant to the Articles or similar participation rights, or from any shareholder of the Company (whether directly, by exercising first refusal rights pursuant to the Articles or otherwise), or by the conversion of any Convertible Securities or Options (as such terms are defined in the Articles) or the application of any anti-dilution protection, or by entering into any voting or similar agreement with any holder of an equity interest in the Company (other than voting undertakings actually taken by the holders of substantially all of the shares of the Company on a Fully Diluted Basis), or otherwise) shall Novartis and/or its Affiliates hold Ordinary Shares, Options or Convertible Securities (as such terms are defined in the Articles) constituting more than the Novartis Permitted Percentage of the issued and outstanding share capital of the Company (as defined below), and (ii) any issuance by the Company or Transfer (as defined in the Articles) by any party to Novartis or its Affiliates of any Ordinary Shares, Options or Convertible Securities, in a number that will result in Novartis and its Affiliates holding, in the aggregate, more than Novartis Permitted Percentage of the Company’s issued and outstanding share capital, shall be null and void and shall not be recorded by the Company in its corporate records; provided, however, that nothing herein shall require Novartis or its Affiliates to sell or Transfer (a) any of the shares that have been issued to Novartis pursuant to those certain Investment Agreements by and between the Company and Novartis dated August 18, 2014 and October 9, 2015 and by and between the Company, Novartis and other investors dated June 18, 2017,  nor any of the Ordinary Shares that are issuable to Novartis upon an exercise of the Ordinary Shares Warrant Agreement by and between the Company and Novartis dated September 1, 2014 or the Series F-2 Preferred Shares issuable upon exercise of the Warrant Agreement by and between the Company and Novartis dated July 3, 2017 in order to keep the Permitted Percentage. The "Novartis Permitted Percentage" shall mean the lesser of (i) 19.90% of the issued and outstanding share capital of the Company, or (ii) 19.90% of the voting power represented by the issued and outstanding share capital of the Company on an as-converted basis.

 

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	5.	
Miscellaneous.

 

5.1.          Successors and Assigns. The rights under this Agreement may be assigned (but only with all related obligations) by a Holder to a transferee or assignee of Registrable Securities that (i) is a Permitted Transferee of a Holder or (ii) is a Major Investor or becomes a Major Investor as a result of such transfer or assignment; provided, however, that (x) the Company is, as a condition to such transfer or assignment, furnished with written notice of the name and address of such transferee or assignee and the Registrable Securities with respect to which such rights are being transferred or assigned; and (y) such transferee or assignee agrees in a written instrument delivered to the Company, to be bound by and subject to the terms and conditions of this Agreement, including without limitation the provisions of Section 2.11 above.  For the purposes of determining the percentage of voting power held by a transferee, the holdings of a transferee that is a Permitted Transferee of a Holder shall be aggregated together and with those of the transferring Holder; provided further that all transferees who would not qualify individually for assignment of rights shall have a single attorney-in-fact for the purpose of exercising any rights, receiving notices, or taking any action under this Agreement. The terms and conditions of this Agreement inure to the benefit of and are binding upon the respective successors and permitted assignees of the parties.  Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and permitted assignees any rights, remedies, obligations or liabilities under or by reason of this Agreement, except as expressly provided herein.

 

5.2.          Governing Law; Jurisdiction.  This Agreement and any controversy arising out of or relating to this Agreement shall be governed by and construed in accordance with the internal laws of the State of Israel, without regard to conflict of law principles that would result in the application of any law other than the law of the State of Israel.  Any dispute arising under or in relation to this Agreement shall be resolved exclusively in the competent court located in Tel Aviv-Jaffa, Israel, and each of the parties hereby irrevocably submits to the exclusive jurisdiction of such court.

 

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5.3.          Counterparts.  This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.  Counterparts may be delivered via facsimile, electronic mail (including pdf) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

 

5.4.          Titles and Subtitles. The titles and subtitles used in this Agreement are for convenience only and are not to be considered in construing or interpreting this Agreement.

 

5.5.          Notices. Any notice and other communication required or permitted to be given to a party pursuant to the provisions of this Agreement will be in writing,  mailed by registered or certified mail, postage prepaid, or prepaid express courier service, transmitted by facsimile or email, or otherwise delivered by hand or by messenger, addressed to such party's address as set forth below, and will be effective and deemed given to such party on the earliest of the following: (a) the date of personal delivery (or refusal to receive); (b) one (1) Business Day (as defined in the Investment Agreement) after transmission via email, except where a notice is received stating that such email has not been successfully delivered); (c) one (1) Business Day after deposit with a return receipt express courier service; or (d) three (3) Business Days after deposit in local mail for registered or certified mail. All notices not delivered personally or by facsimile or email will be sent with postage and/or other charges prepaid and properly addressed to the party to be notified. All communications shall be sent to the respective parties at their addresses as set forth on Schedule A hereto, or to the principal office of the Company and to the attention of the Chief Executive Officer, in the case of the Company, or to such email address, facsimile number, or address as subsequently modified by written notice given in accordance with this Section 5.5.

 

5.6.          Amendments and Waivers.  Notwithstanding anything to the contrary contained in this Section 5.6 or elsewhere in this Agreement, this Agreement shall terminate automatically upon a Deemed Liquidation event. Any term of this Agreement may be amended or terminated, only with the written consent of the Company and the holders of at least a majority of the Registrable Securities then outstanding, (i) except for the provisions set forth in Section 3 above (Information Rights) which may be amended or terminated only with the written consent of the Company and the holders of at least 70% of the Registrable Securities then outstanding (which 70% majority shall include the Special F Majority (as defined in the Articles)), and (ii) except for any rights that are specifically granted in this Agreement to the Series F Preferred Shares (and not merely by virtue of the inclusion of such shares within a group that also includes other shares, such as being included within the definition of Preferred Shares) (the “Series F Rights”), which may be amended or terminated only with the written consent of the Company and the Special F Majority, provided that no consent under this clause (ii) shall be required if such amendment or termination is made in connection with External Financing(s) (as defined in the Articles) in which (A) the rights of the Series F Preferred Shares are adversely affected in a manner that is proportionate to any adverse effect such amendment or termination would have on the rights hereunder of the other Preferred Shares then outstanding and (B) the percentage of participation of the Series F Preferred Shares in case of a ‘cutback’ under Section 2.3(a)(i) and 2.3(b)(i) above are reduced by not more than 50%. The observance of any term of this Agreement may be waived (either generally or in a particular instance, and either retroactively or prospectively) only with the written consent of the Company (if such term inures to the benefit of the Company) and/or the holders of at least a majority of the Registrable Securities then outstanding (if such term inures to the benefit of the Investors), (i) except that the observance of the provisions set forth in Section 3 above (‘Information Rights’) may be waived (either generally or in a particular instance, and either retroactively or prospectively) only with the written consent of the Company (if such term inures to the benefit of the Company) and/or (if such term inures to the benefit of the Investors) the holders of at least 70% of the Registrable Securities then outstanding (which 70% majority shall include the Special F Majority), and (ii) except that the observance of the provisions setting forth the Series F Rights may be waived (either generally or in a particular instance, and either retroactively or prospectively) only with the written consent of the holders of the Special F Majority if such waiver is made in connection with External Financing(s) (as defined in the Articles) in which (A) the rights of the Series F Preferred Shares are adversely affected in a manner that is proportionate to any adverse effect such waiver would have on the rights of the other Preferred Shares then outstanding under this Agreement and (B) the percentage of participation of the Series F Preferred Shares in case of a ‘cutback’ under Section 2.3(a)(i) or 2.3(b)(i) above are reduced by not more than 50%; provided further that any provision hereof may be waived by any waiving party on such party’s own behalf, without the consent of any other party.  Notwithstanding the foregoing, this Agreement may not be amended or terminated and the observance of any term hereof may not be waived with respect to any Investor without the written consent of such Investor, unless such amendment, termination, or waiver applies to all Investors in the same fashion.  The Company shall give prompt notice of any amendment or termination hereof or waiver hereunder to any party hereto that did not consent in writing to such amendment, termination, or waiver.  Any amendment, termination, or waiver effected in accordance with this Section 5.6 shall be binding on all parties hereto, regardless of whether any such party has consented thereto.  No waivers of or exceptions to any term, condition, or provision of this Agreement, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver of any such term, condition, or provision.

 

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5.7.          Severability.  In case any one or more of the provisions contained in this Agreement is for any reason held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality, or unenforceability shall not affect any other provision of this Agreement, and such invalid, illegal, or unenforceable provision shall be reformed and construed so that it will be valid, legal, and enforceable to the maximum extent permitted by law.

 

5.8.          Aggregation of Shares.  All Registrable Securities held or acquired by Permitted Transferees shall be aggregated together for the purpose of determining the availability of any rights under this Agreement and such Permitted Transferees may apportion such rights as among themselves in any manner they deem appropriate.

 

5.9.          Additional Investors.  Notwithstanding anything to the contrary contained herein, if the Company issues additional Preferred Shares after the date hereof, whether pursuant to the Investment Agreement or otherwise, to a purchaser approved in advance and in writing by the Company and the holders of at least a majority of the Registrable Securities then outstanding, then such preapproved purchaser of Preferred Shares may become a party to this Agreement by executing and delivering an additional counterpart signature page to this Agreement with the Company, and agreeing in writing to be bound by all of the obligations as an “Investor” hereunder, whereupon Schedule A attached hereto shall be updated to include such additional Investor, and thereafter such preapproved purchaser shall be deemed an “Investor” for all purposes hereunder.

 

5.10.        Entire Agreement.  This Agreement (including any Schedules hereto) constitutes the full and entire understanding and agreement among the parties with respect to the subject matter hereof, and any other written or oral agreement relating to the subject matter hereof existing between the parties (including without limitation the Prior Agreement (excluding those provisions thereof that terminate any prior agreements or rights) is expressly terminated and no further force and effect.

 

19

5.11.        Delays or Omissions.  No delay or omission to exercise any right, power, or remedy accruing to any party under this Agreement, upon any breach or default of any other party under this Agreement, shall impair any such right, power, or remedy of such non-breaching or non-defaulting party, nor shall it be construed to be a waiver of or acquiescence to any such breach or default, or to any similar breach or default thereafter occurring, nor shall any waiver of any single breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring.  All remedies, whether under this Agreement or by law or otherwise afforded to any party, shall be cumulative and not alternative.

 

5.12.        Further Action.  Each of the parties shall take such actions, including the execution and delivery of further instruments and voting its shares in the Company, as may be necessary to give full effect to the provisions hereof and to the intent of the parties hereto.

 

5.13.        Acknowledgment.  The Company acknowledges that the Investors are in the business of venture capital investing and therefore review the business plans and related proprietary information of many enterprises, including enterprises which may have products or services which compete directly or indirectly with those of the Company.  Nothing in this Agreement shall preclude or in any way restrict the Investors from investing or participating in any particular enterprise whether or not such enterprise has products or services which compete with those of the Company.

 

[Remainder of Page Intentionally Left Blank]

 

20

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

	
The Company:

	 
	 	 
	
Gamida Cell Ltd.

	 
	
By:

	/s/ Yael Margolin	 
	
Chief Executive Officer

	 

 

[Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

21

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

 

The Investors:

 

	
Shavit Capital Fund III (US), L.P.

	
Shavit Capital Fund IV (US), L.P.

	 	 
	
By: Shavit Capital Fund 3 GP, LP

	
By: Shavit Capital Fund 4 GP, LP

	
By: Shavit Capital Management 3 (GP) Ltd., its general partner:

	
By: Shavit Capital Management 4 (GP) Ltd., its general partner:

	 	 
	
By (sign name):

	/s/ Gary Leibler	 	
By (sign name):

	/s/ Gary Leibler	 

	
Print Name: Gary Leibler

	
Print Name: Gary Leibler

	
Title: Director

	
Title: Director

 

	
Shavit Capital Fund 3 (Israel), L.P.

	
Shavit Capital Fund 4 (Israel), L.P.

	 	 
	
By: Shavit Capital Fund 3 GP, LP

	
By: Shavit Capital Fund 4 GP, LP

	
By: Shavit Capital Management 3 (GP) Ltd., its general partner:

	
By: Shavit Capital Management 4 (GP) Ltd., its general partner:

	 	 
	
By (sign name):

	/s/ Gary Leibler	 	
By (sign name):

	/s/ Gary Leibler	 
	
Print Name: Gary Leibler

	
Print Name: Gary Leibler

	
Title: Director

	
Title: Director

 

	
Gabriel Capital Management Ltd.

	 
	 	 
	
By (sign name):

	/s/ Gary Leibler	 	 
	
Print Name: Gary Leibler

	 
	
Title: Director

	 

 

[Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

22

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

 

The Investors (continued):

 

	
SMARTMIX LIMITED

	 
	 	 
	
By:

	/s/ Benny Chong	 
	
(Name & Title of Signatory)

	 
	
Name: Benny Chong

	 
	
Title: Director

	 

[Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

23

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

 

The Investors (continued):

 

	
ISRAEL BIOTECH FUND I, L.P. 

	 	 
	
By its general partner: 

	 	 
	
ISRAEL BIOTECH FUND GP PARTNERS, L.P.

	 	 
	
By its general partner: 

	 	 
	
I.B.F. Management, Ltd. 

	 	 
	
By:

	/s/ Yuval Cabiily	 
	  
	
Name:  Yuval Cabiily 

	
Title:    Director 

 

[Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

24

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

 

	
YELIN-LAPIDOT PROVIDENT

FUNDS MANAGEMENT LTD.

	 
	
(as fiduciary manager solely on behalf of certain managed provident funds)

	 
	 	 
	
By:

	/s/ Orit Oren	 
	
(Name & Title of Signatory)

	 
	
Orit Oren

	 
	
Portfolio Manager

	 
	 	 
	
/s/ Sany Zelka

	 
	
Sany Zelka

	 
	
Co-CEO

	 

 

[Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

25

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

	
C.C.R Trustees in Investments

(as trustee for certain investors)

	 
	 	 
	
By:

	[Illegible Signature]	 
	
(Name & Title of Signatory)

	 

 

 [Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

26

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

 

	
NOVARTIS PHARMA AG

	 
	 	 
	
By:

	[Illegible Signature]	 
	
Head Strategic Venture Capital Fund & Pharma Equities

	 
	
(Name & Title of Signatory)

	 
	 	 
	
By:

	/s/Klupp Jochen	 
	
(Name & Title of Signatory)

	 

 

[Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

27

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

 

	
Clal Biotechnology Industries

	
Bio Medical Investment (1997) Ltd.

	 	 
	
/s/Assaf Segal

	
/s/Assaf Segal

	
By:

	Assaf Segal, CFO	 	
By:

	Assaf Segal, CFO	 
	
(Name & Title of Signatory)

	
(Name & Title of Signatory)

	 	 
	
/s/ Ofer Goldberg

	
/s/ Ofer Goldberg

	
By:

	Ofer Goldberg, VP	 	
By:

	Ofer Goldberg, VP	 
	
(Name & Title of Signatory)

	
(Name & Title of Signatory)

 

[Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

28

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

	
Israel HealthCare Ventures 2 LP

Incorporated (IHCV II)

	 
	 	 
	
By:

	/s/ P.M. Whitford	 
	
(Name & Title of Signatory)

	 
	 	 
	
P.M. Whitford – Director

	 
	
IHCV2 General

	 
	
Partner Limited

	 

 

[Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

29

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

	
Joseph Investment LLC

	 
	 	 
	
By:

	[Illegible Signature]	 
	
(Name & Title of Signatory)

	 

 

 [Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

30

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

	
Your Niece Ltd. (on its own behalf and in trust)

	 	 
	
By:

	/s/ Alan Glasenberg	 
	
(Name & Title of Signatory)

	 
	 	 
	
Alan Glasenberg

	 
	
President

	 

 

 [Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

31

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

	
GC-SC Holdings LLC

	 
	 	 
	
By:

	/s/ Irene Susmano	 
	
(Name & Title of Signatory)

	 
	 	 
	
Irene Susmano

	 
	
VP

	 

 

 [Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

32

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

	
Ligon 205 Pty Ltd ATF The Summit Road Investment Trust

	 
	
/s/ Bruce Fink

	 

 

	
By:

	Mr. Bruce Fink, Director of Trustee	 
	
(Name & Title of Signatory)

	 

 

 [Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

33

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

	
/s/ Harry Grynberg

	 
	
Harry Grynberg

	 

 

 [Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

34

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

	
Do-Tsach Ltd.

	 
	 	 
	
By:

	[Illegible Signature]	 
	
(Name & Title of Signatory)

	 

 

 [Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

35

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

	
/s/ Gary Leibler

	 
	
Gary Leibler

	 

 

 [Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

36

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

 

	
Nordea Bank  SA

	
Federman Enterprises Ltd

 

	
By:

	 	 	
By:

	 	 

	
(Name & Title of Signatory)

	
(Name & Title of Signatory)

	 	 
	
Lerosh Investments Ltd.

	
Indufin SA

 

	
By:

	 	 	
By:

	 	 

	
(Name & Title of Signatory)

	
(Name & Title of Signatory)

	 	 
	
Vintage Venture Partners, L.P.

	
Vintage Venture Partners (Parallel), L.P.

 

	
By:

	 	 	
By:

	 	 

	
(Name & Title of Signatory)

	
(Name & Title of Signatory)

	 	 
	
Vintage Venture Partners (Israel), L.P.

	
Vintage Venture Partners III (Cayman), L.P.

 

	
By:

	 	 	
By:

	 	 

	
(Name & Title of Signatory)

	
(Name & Title of Signatory)

	 	 
	
Vintage Venture Partners III (Israel), L.P.

	 

 

	
By:

	 	 	 

	
(Name & Title of Signatory)

	 

[Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

37

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

 

	
Atara Technology Ventures Ltd.

	
Caremi Partners Ltd.

 

	
By:

	 	 	
By:

	 	 

	
(Name & Title of Signatory)

	
(Name & Title of Signatory)

	 	
 

	
Rose Nominees Ltd.

	
Byrthen Holdings Limited

 

	
By:

	 	 	
By:

	 	 

	
(Name & Title of Signatory)

	
(Name & Title of Signatory)

	 	 
	
Sheipaula Ltd.

	
Dagon Batey Mamgurot LeIsrael Ltd.

 

	
By:

	 	 	
By:

	 	 

	
(Name & Title of Signatory)

	
(Name & Title of Signatory)

	 	 
	
Paramar Limited

	
Whitehall Financial Group Inc.

 

	
By:

	 	 	
By:

	 	 

	
(Name & Title of Signatory)

	
(Name & Title of Signatory)

	 	 
	
/s/Elie Zilkha

	 	 	 

	
Elie Zilkha

	
Meir Riba

[Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

38

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

 

	
Sage Holding Inc.

	
Socingestao Sociedade Independente de Gestao Limited

 

	
By:

	 	 	
By:

	 	 

	
(Name & Title of Signatory)

	
(Name & Title of Signatory)

	 	 
	
Denali Ventures LLC

	
Atlas Capital SA.

 

	
By:

	 	 	
By:

	 	 

	
(Name & Title of Signatory)

	
(Name & Title of Signatory)

	 	 
	
Auriga Ventures

	
B.J.Gottstein, LLC

 

	
By:

	 /s/ S. Descarpentries	 	
By:

	 	 

	
(Name & Title of Signatory)

	
(Name & Title of Signatory)

 

	
S. Descarpentries

	 
	
Managing Partner

	
	 	
/s/ Meir Shani

	 
	 	
Meir Shani

[Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

39

IN WITNESS WHEREOF, the parties have executed this Amended and Restated Investors' Rights Agreement as of the date first written above.

The Investors (continued):

 

	 	 	 	 
	
Ariel Landau

	
Amir Beker

	 	 
	
Elbit Cord Blood Limited Partnership

	
Goldwaser Investment and Management Ltd.

	 	 
	
By:

	/s/ Doron Moshe	 	 
	
Doron Moshe

	
By:

	/s/ Benad Goldwasser	 
	 	
(Name & Title of Signatory)

	 	 
	
By:

	/s/ Yael Naftali	 	 
	
Yael Naftali

	 
	 	 
	
/s/ Benad Goldwasser

	 	 	 
	
Benad Goldwasser

	
Ehud Gilboa

	 	 
	 	 	
Amgen Inc.

	
Yoseph Shimony

	 
	
(in trust for Alejandro and Lida Zaffaroni)

	 
	 	
By:

	 	 
	 	
(Name & Title of Signatory)

[Gamida Cell Ltd./ Signature Page to

Amended & Restated Investors' Rights Agreement / 2017]

 

40

Schedule A - Investors Information

 

	 	
Investor

	 	
Address

	 	
Shavit Capital Fund III (US), L.P.

	 	
c/o Shavit Capital

Jerusalem Technology Park – Malha

Building 1B, Box 70

Jerusalem, Israel 96951

Fax: 972-2-649-0401

 

	 	
Shavit Capital Fund 3 (Israel), L.P.

	 
	 	
Shavit Capital Fund IV (US), L.P.

	 
	 	
Shavit Capital Fund 4 (Israel), L.P.

	 
	 	
Gabriel Capital Management Ltd.

	 
	 	
YELIN-LAPIDOT PROVIDENT FUNDS MANAGEMENT LTD.  in its capacity as fiduciary manager solely on behalf of certain managed provident funds

	 	
Migdal Al, 50 Dizengoff St.

Tel Aviv, 6433222 Israel

Fax – 972-37132322

Attn.: Itay Danieli

e-mail:  itayd@yl-invest.co.il

	 	 	 	 
	 	
C.C.R Trust in Investments Ltd.

(as trustee)

	 	
c/o Chaikin Cohen Rubin & Co.

Kiryat Atidim, Bldg. 4, PO 58143

Tel-Aviv, 6158002, Israel

Fax: 03-6489946

Attn.: Dov Gutmman, CPA

dov@ccrcpa.co.il

	 	 	 	 
	 	
SMARTMIX LIMITED

	 	
c/o VMS Investment Group

49/F, One Exchange Square

8 Connaught Place,

Central, Hong Kong

Fax: +852 2996 2101

Attn.: Andrew Ng; Jason Ho

email: andrewng@vmsig.com; jasonh@vmsig.com

	 	 	 	 
	 	
Israel Biotech Fund I, L.P.

	 	
Ruhrberg Science Center

Pekeris 3, Rehovot

Israel 7670203

Fax: + 97237617730

Attn.: Sarit Steinberg, Adv., General Counsel

email: Sarit@IsraelBiotechFund.com

	 	 	 	 
	 	
Novartis Pharma AG

	 	
Lichstrasse 35

Postfach

Legal Department Forum 2.6.16A

Ch-4002 Basel Switzerland

Attn.: General Counsel

email: harshad.vaidya@novartis.com

	 	 	 	 

 

41

	 	
Investor

	 	
Address

	 	
Clal Biotechnology Industries Ltd.

 

 

	 	
3 Azrieli Center, Triangle Tower

132 Menachem Begin St.

Tel Aviv 6702301, Israel

Fax. +972 3 6124545

Attn.: Shiran Manor, Adv. or Assaf Segal, CFO

email: Shiran@cbi.co.il; Assaf@cbi.co.il

	 	
Bio Medical Investment (1997) Ltd.

	 
	 	 	 	 
	 	
Israel HealthCare Ventures 2 LP Incorporated (IHCV II)

	 	
c/o Israel Health Care Ventures Ltd.

32 Habarzel St., Tel Aviv, 69710, Israel

Fax: +972-3-6488474

Attn. : Dr. Hadar Ron, Managing Partner

email: hron@ihcv.co.il

	 	 	 	 
	 	
Joseph Investment LLC

	 	
c/o Tag Associates

810 Seventh Avenue, 7th Floor

New York, NY  10019-5890  USA

Attn: Clara Wong,

cwong@tagassoc.com

	 	 	 	 
	 	
Your Niece Ltd. (on its own behalf and in trust)

	 	
150 Signet Drive

Toronto, ON  M9L 1T9, Canada

Attn: Jonathan Grauman, jgrauman@sherfam.com

	 	 	 	 
	 	
GC-SC Holdings LLC

	 	
655 Third Avenue, 28th Floor

New York, NY  10017

Attn: Irene Susmano,

isusmano@arcny.com

	 	 	 	 
	 	
Ligon 205 Pty Ltd ATF The Summit Road Investment Trust

	 	
Level 6, 77 Castlereagh Street

Sydney, NSW 2000 Australia

Attn: Bruce Fink, bfink@bickhamcourt.com.au

	 	 	 	 
	 	
Harry Grynberg

	 	
Ephraim Abramson & Co.

Beit Hatayelet

2 Beitar Street, 3rd Floor

Jerusalem 93386 Israel

Fax: (+972) 2 565 4001

Attn.: Harry Grynberg, Adv. and Ami Hordes, Adv.

E-mail: hgrynberg@abramson-law.co.il and ahordes@abramson-law.co.il

	 	 	 	 
	 	
Do-Tsach Ltd.

	 	
19 Kehilat Odesa

Tel-Aviv 6951911

Israel

	 	 	 	 

 

42

	 	
Investor

	 	
Address

	 	
Gary Leibler

	 	
c/o Shavit Capital Fund 4 (Israel), L.P.

(at the address above)

	 	 	 	 
	 	
Yoseph Shimony (in trust for Alejandro and Lida Zaffaroni)

	 	
5 Bedner, Ramat Gan, Israel

Fax: 972-3-6116610

e-mail: yossi@shimony.com

	 	 	 	 
	 	
Nordea Bank SA

	 	
Nordea Bank SA

532 Postfach St.,

Zuerich 8039, Suisse

e-mail: Oscar.lewisonn@soditic.co.uk

Attntion: Oscar Lewisonn

	 	 	 	 
	 	
Lerosh Investments Ltd.

	 	
9 Ehad Ha’am St., Tel-Aviv 61291, Israel

Fax: 972-3-5168188

e-mail: leroshinvest@lerosh.co.il

Attention: Ms. Ruthi Gorenshtein

	 	 	 	 
	 	
Indufin SA

	 	
Interleuvenlaan 15/D1, Heverlee 3001, Belgium

Fax: +32-(0)16-39 30 49

e-mail: evelyne.ackermans@indufin.be

Attention: Evelyn Ackerman

	 	 	 	 
	 	
Vintage Venture Partners, L.P.

	 	
Aba Even 12, Hertzelia, Israel

Fax: +972-9 9541012

e-mail:alanf@vintage-ip.com

Attention: Alan Feld

 

	 	
Vintage Venture Partners (Parallel), L.P.

	 
	 	
Vintage Venture Partners (Israel), L.P.

	 
	 	
Vintage Venture Partners III (Cayman), L.P.

	 
	 	
Vintage Venture Partners III (Israel), L.P.

	 
	 	
Federman Enterprises Ltd

	 	
Hayarkon 99, Tel Aviv Israel

e-mail: tzvika@federmann-ent.com

Attention: Tsvika Federman

	 	 	 	 
	 	
Atara Technology Ventures Ltd.

	 	
Hashalom 53, Givataaim, Israel

e-mail: Sharonf3@fnx.co.il / yanivc2@fnx.co.il

Attention: David Federman

	 	 	 	 
	 	
Caremi Partners Ltd.

	 	
American Lane 2, GreenWich, Connecticut, U.S.A

e-mail: sruchefsky@paloma.com

Attention: Steven Ruchefsky

	 	 	 	 
	 	
Rose Nominees Ltd.

	 	
The Grange, Rosenheath, P.O. Box 25, St. Peter Port, Guernsey, Channel Islands

Fax: +44 1 481 714 796

e-mail: subs@gg.butterfieldgroup.com

Attention: Maxine Vaudin

	 	 	 	 

 

43

	 	
Investor

	 	
Address

	 	
Meir Riba

	 	
Mishael 4, Holon Israel 5883815

e-mail: eldadhadani@gmail.com / meirriba@orange.net.il

Attention: Meir Riba

	 	 	 	 
	 	
Sheipaula Ltd.

	 	
18 Luard Road, 1 Capital Place, Unit A, 19/F 

Wanchai, Hong Kong

e-mail: jmd@floridienne.be

Attention: Jean Marie Delwart

	 	 	 	 
	 	
Dagon Batey Mamgurot LeIsrael Ltd.

	 	
P.O.Box 407, Haifa 3100301, Israel

e-mail: aamit@dagon.co.il

Attention: Amnon Amit

	 	 	 	 
	 	
Paramar Limited

	 	
c/o Sodipra SA, 114 Rue du Rhone, Geneve 1204, Suisse

e-mail: karin.meier@sodipra.com

Attention: Karin Meier

	 	 	 	 
	 	
Whitehall Financial Group Inc.

	 	
711 Fifth Avenue, 16th fl., New York, NY 10022, USA

Fax: 212-634-3312

e-mail: lgould@whitehallcap.com

Attention: Mr. Leon Gould

	 	 	 	 
	 	
Elie Zilkha

	 	
c/o Sodipra SA, 114 Rue du Rhone, Geneve 1204, Suisse

e-mail: elie.zilkha@gmail.com

Attention: Elie Zilkha

	 	 	 	 
	 	
Byrthen Holdings Limited

	 	
c/o Edoardo Bugnone

chemin des Sansonnets 11

1222 Vésena

Switzerland

Fax: +41792002511

e-mail: edbugnone@bluewin.ch

	 	 	 	 
	 	
Ariel Landau

	 	
30 Yehiam St., Ramat Hasharon, Israel 4730128

Fax: +972-3-5409347

e-mail: meir@dardar.co.il / mspigelman@skzlaw.co.il/nforer@skzlaw.co.il

Attention: Meir Burstin / Noam Forer / Michael Spigelman

	 	 	 	 

 

44

	 	
Investor

	 	
Address

	 	
Socingestao Sociedade Independente de Gestao Limited

	 	
c/o Edoardo Bugnone

chemin des Sansonnets 11

1222 Vésena

Switzerland

Fax: +41792002511

e-mail: edbugnone@bluewin.ch

	 	
Sage Holding Inc.

	 	
c/o Atlanticominium SA. 24 Route de Malagnou, 

Geneve 1211, Suisse

e-mail: Jeremy.Smouha@gam.com

Attention: Jeremy Smouha

	 	 	 	 
	 	
Atlas Capital SA.

	 	
116 Rue du Rhone, Geneve 1204, Suisse

e-mail: avy.lugassy@gva.hyposwiss.ch

robert.dwek@gva.hyposwiss.ch

Attention: Avy Luassy/ Robert Dwek

	 	 	 	 
	 	
Meir Shani

	 	
1st Altalef stree, Yahud, Israel 5621601

Fax: +972 -35360332

e-mail: meir@saholdings.com

Attention: Meir Shani

	 	 	 	 
	 	
Amir Beker

	 	
9 Mivsa Uvda, street, Rosh Haayin, Israel

e-mail: amirbeker@gmail.com

Attention: Amir Beker

	 	 	 	 
	 	
Denali Ventures LLC

	 	
City Gate 2, 22 Ben-Gurion St. Herzelia, Israel

e-mail: kate@carrgottstein.com/

dave@carrgottstein.com

Attention: Dave Le Clair

	 	 	 	 
	 	
B.J.Gottstein, LLC

	 	
c/o Denali Ventures LLC, City Gate 2, 22 Ben-Gurion St., Herzelia, Israel

e-mail: kate@carrgottstein.com /

dave@carrgottstein.com

Attention: Dave Le Clair

	 	 	 	 
	 	
Auriga Ventures

	 	
18 Avenue Matignon 75008 Paris, France

e-mail: elbez@aurigapartners.com /

descarpentries@aurigapartner.com

Attention: Franck Elbez / Sebastien Descarpentries

	 	 	 	 
	 	
Elbit Cord Blood Limited Partnership

	 	
7 Motah Gur st. Petach Tikva , Isarel

Fax: +972 -3-6086050

e-mail: doron@elbitimaging.com

Attention: Doron Moshe

	 	 	 	 

 

45

	 	
Investor

	 	
Address

	 	
Benad Goldwasser

 

	 	
6 Herzl Rosenbaum St. Apt. 6114, Tel Aviv, Israel

Fax: +972 -3-5100868

e-mail: benadgold@gmail.com

Attention: Benad Goldwasser

	 	
Goldwaser Investment and Management Ltd.

	 
	 	 	 	 
	 	
Ehud Gilboa

	 	
53 Hashsom street, Givaateim

e-mail: gilboa@topnotchcapital.com

	 	 	 	 
	 	
Amgen Inc.

	 	
One Amgen Center Drive, Thousand Oaks, CA  91320-1799, USA

e-mail: munshi@amgen.com

Attention: Abdul Safik Munshi

	 	 	 	 

 

 

46Exhibit 10.8

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

  

MANUFACTURING SERVICES AGREEMENT

This Manufacturing Services Agreement (the “Agreement”) is made as of February 8, 2016, (the “Effective Date”) between Lonza Walkersville, Inc., a Delaware corporation having its principal place of business at 8830 Biggs Ford Road, Walkersville, Maryland 21793 (“LWI”), and Gamida Cell Ltd., an Israeli corporation (“CLIENT”) (each of LWI and CLIENT, a “Party” and, collectively, the “Parties”).

RECITALS

A.          CLIENT desires to have LWI produce a product containing human cells and intended for therapeutic use in humans, and LWI desires to produce such product.

B.          CLIENT desires to have LWI conduct work according to individual Statement of Work, as further defined in Section 1.33 below.

NOW, THEREFORE, in consideration of the foregoing and the mutual promises and covenants hereinafter set forth, LWI and CLIENT, intending to be legally bound, hereby agree as follows:

AGREEMENT

	1.	
Definitions

When used in this Agreement, capitalized terms will have the meanings as defined below and throughout this Agreement.  Unless the context indicates otherwise, the singular will include the plural and the plural will include the singular.

		1.1.	
“Acceptance Period” shall have the meaning set forth in Section 5.2.2.

		1.2.	
“Affiliate” means, with respect to either Party, any other corporation or business entity that directly, or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Party.  For purposes of this definition, the term “control” and, with correlative meanings, the terms “controlled by” and “under common control with” means direct or indirect ownership of more than fifty percent (50%) of the securities or other ownership interests representing the equity voting stock or general partnership or membership interest of such entity or the power to direct or cause the direction of the management or policies of such entity, whether through the ownership of voting securities, by contract, or otherwise.

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		1.3.	
“Background Intellectual Property” means any Intellectual Property either (i) owned or controlled by a Party prior to the Effective Date or (ii) developed or acquired by a Party independently from performance under this Agreement during the term of the Agreement.

		1.4.	
“Batch” means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

		1.5.	
“Batch Record” means the production record pertaining to a Batch.

		1.6.	
“cGMP” means the regulatory requirements for current good manufacturing practices promulgated by the FDA and the European Medicines Agency as may be amended from time to time.

		1.7.	
“Change Order” has the meaning set forth in Section 2.2.

		1.8.	
“CLIENT Development Materials” has the meaning set forth in Section 2.3.

		1.9.	
“CLIENT Inventions” means any know-how or inventions, whether or not patentable, conceived, developed or reduced to practice by, or on the behalf of, CLIENT on or before the Effective Date.

		1.10.	
“CLIENT Materials” means the CLIENT Development Materials and the CLIENT Production Materials.

		1.11.	
“CLIENT Personnel” has the meaning set forth in Section 4.7.1.

		1.12.	
“CLIENT Production Materials” has the meaning set forth in Section 4.1.

		1.13.	
“Commencement Date” means the date set forth in the Statement of Work for the commencement of the production of the Product.

		1.14.	
“Confidential Information” has the meaning set forth in Section 10.1.

		1.15.	
“Disapproval Notice” shall have the meaning set forth in Section 5.2.2.

		1.16.	
“Facility” means a multi-client cell-therapy facility operated by LWI located in Maryland.

		1.17.	
“FDA” means the U.S. Food and Drug Administration, and any successor agency thereof.

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

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		1.18.	
“First Statement of Work” has the meaning set forth in the definition of Statement of Work.

		1.19.	
“Intellectual Property” means all worldwide patents, copyrights, trade secrets, know-how and all other intellectual property rights, including all applications and registrations with respect thereto, but excluding all trademarks, trade names, service marks, logos and other corporate identifiers.

		1.20.	
“LWI Inventions” means any know-how, media, assays, methods or other inventions, whether or not patentable, conceived, developed or reduced to practice by LWI: (a) on or before the Effective Date; or (b) in connection with the performance of the Statement of Work.

		1.21.	
“LWI Operating Documents” means the standard operating procedures, standard manufacturing procedures, raw material specifications, protocols, validation documentation, and supporting documentation used by LWI, such as environmental monitoring, for operation and maintenance of the Facility and LWI equipment used in the process of producing the Product, excluding any of the foregoing that are unique to the manufacture of Product.

		1.22.	
“LWI Parties” has the meaning set forth in Section 15.2.

		1.23.	
“Master Production Record” means the documentation developed by LWI that contains a detailed description of a Process and any other instructions to be followed by LWI in the production of a Product.

		1.24.	
“Materials” means all raw materials and supplies to be used in the production of a Product.

		1.25.	
“Process” means the manufacturing process for a Product developed by LWI pursuant to the terms of this Agreement.

		1.26.	
“Product” has the meaning set forth in a Statement of Work.

		1.27.	
“Product Warranties” means those warranties as specifically stated in Section 5.2.2.

		1.28.	
“Production Term” shall have the meaning set forth in Section 4.3.

		1.29.	
“Quality Agreement” means the Quality Agreement entered into by the Parties before March 31, 2016 (or such other date to be agreed by the Parties) relating to a Product.

		1.30.	
“Regulatory Approval” means the approval by the FDA to market and sell the Product in the United States.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

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		1.31.	
“SOP” means a standard operating procedure.

		1.32.	
“Specifications” means the Product specifications set forth in the Statement of Work or as modified by the Parties in connection with the production of a particular Batch of Product hereunder.

		1.33.	
“Statement of Work” or “SOW” means a plan to develop a Process or Product that is attached hereto as Appendix A or later becomes attached through an amendment by the Parties.  The first Statement of Work, which is attached hereto, is numbered Appendix A-1 and is hereby incorporated and made a part of this Agreement (the “First Statement of Work”).  It is contemplated that each separate project shall have its own Statement of Work.  As each subsequent Statement of Work is agreed to by the Parties, each shall state that it is to be incorporated and made a part of this Agreement and shall be consecutively numbered as A-2, A-3, etc.

		1.34.	
“Technology Transfer” means the transfer of documentation, specifications, and production process by CLIENT to LWI for the development of the Master Production Record for the manufacturing of the Product specifically for the CLIENT as further detailed in the SOW.

		1.35.	
“Third Party” means any party other than LWI, CLIENT or their respective Affiliates.

	2.	
Statements of Work - Process and Product Development; Technology Transfer; Process or Product Manufacture

2.1          Statement of Work.  Prior to performing any Process or Product development, Technology Transfer, or Process or Product manufacture, the Parties will collaborate to develop a Statement of Work, describing the activities to be performed by the Parties, or, if specifically approved by CLIENT, to be subcontracted by LWI to Third Parties.  Once agreed to by the Parties, the Statement of Work shall be executed by each of the Parties and appended hereto as part of Appendix A.  In the event of a conflict between the terms and conditions of this Agreement and any Statement of Work, the terms and conditions of this Agreement shall control unless specified otherwise in the SOW.

2.2          Modification of Statement of Work.  Should CLIENT want to change a Statement of Work or to include additional services to be provided by LWI, CLIENT may propose to LWI an amendment to the Statement of Work with the desired changes or additional services (“Change Order”).  If LWI determines, in good faith, that it has the resources and capabilities to accommodate such Change Order, LWI will prepare a modified version of the Statement of Work reflecting such Change Order (including, without limitation, any changes to the estimated timing, estimated charges or scope of a project) and will submit such modified version of the Statement of Work to CLIENT for review and comment. The modified Statement of Work shall be binding on the Parties only if it refers to this Agreement, states that it is to be made a part thereof, and is signed by both Parties.  Whereafter, such modified version of the Statement of Work will be deemed to have replaced the prior version of the Statement of Work.  Notwithstanding the foregoing, if a modified version of the Statement of Work is not agreed to by both Parties, the existing Statement of Work shall remain in effect.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

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2.3          CLIENT Deliverables.  Within the time period specified in a Statement of Work, CLIENT will provide LWI with (a) the materials listed in the Statement of Work for which CLIENT is responsible for delivering to LWI, and any handling instructions, protocols, SOPs and other documentation necessary to maintain the properties of such materials for the performance of the Statement of Work, and (b) any protocols, SOPs and other information and documentation in possession or control of CLIENT and necessary for the performance of the Statement of Work, and for the preparation of the Master Production Record in conformance with cGMP, including, without limitation, process information, SOPs, development data and reports, quality control assays, raw material specifications (including vendor, grade and sampling/testing requirements), product and sample packing and shipping instructions, and product specific cleaning and decontamination information (collectively, the “CLIENT Development Materials”).  If CLIENT does not provide the CLIENT Development Materials within the time period specified in a Statement of Work, then CLIENT shall be responsible for any costs reasonably incurred by LWI arising from such failure, if any.

2.4          Performance by LWI.  Subject to the provision by CLIENT of the CLIENT Development Materials pursuant to Section 2.3, LWI [*], subject to the terms of the Statement of Work or approval by CLIENT (such approval not to be unreasonably withheld), through a Third Party contractor, the work described in a Statement of Work [*] manner in accordance with the terms of this Agreement.  LWI will use commercially reasonable efforts promptly to notify CLIENT of any material delays that arise during the performance of the Statement of Work.

	3.	
Technology Transfer

3.1          Based on the information provided by CLIENT and including process changes developed by LWI pursuant to any applicable Statement of Work, LWI will prepare the Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work.  CLIENT will inform LWI of any specific requirements CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein.  If LWI intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LWI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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3.2          CLIENT will cooperate with LWI to assist LWI to develop the Master Production Record and Process, including, without limitation, by providing LWI with additional information and procedures as may be required to create the Master Production Record, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.

3.3          LWI will deliver a draft version of the Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LWI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LWI and CLIENT will meet promptly (whether in person or by teleconference) to resolve such objections.  Upon CLIENT’s written acceptance of the draft Master Production Record, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft Master Production Record within [*] days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.

3.4          The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LWI Operating Documents, LWI Inventions or LWI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. [*].

3.5          Any subsequent transfer of documentation, specifications, and production process [*] from LWI’s facility in Walkersville, Maryland to another Facility for the manufacturing of the Product [*] shall be [*]; provided, however, that any such transfer [*], shall be [*].  For the avoidance of doubt, in the event a subsequent transfer is [required for commercial manufacturing purposes], the Parties will [*].

	4.	
Manufacture Of Product; Order Process; Deliveries

4.1          CLIENT Deliverables.  Within any time period specified in and agreed to in any applicable Statement of Work, CLIENT will provide LWI with the materials listed in the Statement of Work required to be supplied by CLIENT for the production of the Product, and any handling instructions, protocols, SOPs and other documentation necessary to maintain the properties of such materials for the performance of the Statement of Work (collectively, the “CLIENT Production Materials”).

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

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4.2          Commencement Date.  The Statement of Work will include a Commencement Date agreed upon by the Parties.

4.3          Manufacture by LWI.  During the time period specified in any Statement of Work during which Product will be manufactured (the “Production Term”), LWI [*] package, ship, handle quality assurance and quality control for the Product, all as set forth in the Statement of Work, and [*] to manufacture and deliver to CLIENT the quantities of Product requested by CLIENT in the Statement of Work, all in accordance with the terms set forth in Section 4.4 below.

4.4          Packaging and Shipping.  LWI [*] package and label the Product for shipment in accordance with the Master Production Record and LWI’s standard practices in effect at the time of performance by LWI.  LWI will ship the Product FCA Facility to a common carrier designated by CLIENT to LWI in writing not less than ten days prior to the applicable delivery date unless otherwise agreed to in the Statement of Work.  CLIENT will provide to LWI its account number with the selected carrier and will pay for all shipping costs in connection with each shipment of Product.  Each shipment will be accompanied by the documentation listed in the Statement of Work.  Risk and title in the Product will pass upon delivery to the carrier.  LWI will use best efforts to deliver each shipment of Product to CLIENT on the requested delivery date for such shipment.  Notwithstanding the foregoing, in the event CLIENT changes the originally proposed delivery date or time within 5 days from the delivery time, LWI will use [*] to comply with the new date/time of delivery (“Expedited Delivery”); provided, however, that LWI shall have no liability in the event it does not or cannot comply with the new date and/or time to the extent LWI used its [*]; provided, further, however, that LWI shall be entitled to increase any and all fees associated with Expedited Delivery.  LWI will promptly notify CLIENT if LWI reasonably believes that it will be unable to meet a delivery date.  CLIENT shall be required to take delivery of a Batch of Product within [*] after completion of such Batch in accordance with Section 5.2 (the “Delivery Period”) and no fees will charged for storage of the Batch during the Delivery Period.

4.5          Quality Agreement.  Upon the decision to manufacture a Product according to a Statement of Work, the Parties shall enter into a separate Quality Agreement which will be based upon the quality agreement previously executed between the Parties, in a form to be agreed upon by the Parties as soon as practicable following the Effective Date (acting expeditiously and in good faith), setting forth the terms for Product quality, quantity, price, and any other terms necessary for such agreements.  Such Quality Agreement when executed shall be separately appended to this Agreement.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

7

4.6          Records.  LWI will maintain accurate records for the production of the Product, as required by applicable laws and regulations. LWI will retain possession of the Master Production Record, all Batch Records and LWI Operating Documents, and will make copies thereof available to CLIENT in a joint database.  LWI Operating Documents will remain LWI Confidential Information.  CLIENT will have the right to use and reference any of the foregoing in connection with a filing for Regulatory Approval of the Product or as otherwise authorized by the Agreement.

4.7          CLIENT Access.

4.7.1          CLIENT’s employees and agents (including its independent contractors) (collectively, “CLIENT Personnel”) may participate in the production of the Product only in such capacities as agreed in the Quality Agreement and as may be approved in writing in advance by LWI. Such approval not to be unreasonably withheld or delayed.  CLIENT Personnel working at the Facility are required to comply with LWI’s Operating Documents and any other applicable LWI facility and/or safety policies.  For the avoidance of doubt, CLIENT Personnel may not physically participate in the production or manufacture of any Product that may be used in or on humans.

4.7.2          CLIENT Personnel working at the Facility will be and remain employees of CLIENT, and CLIENT will be solely responsible for the payment of compensation for such CLIENT Personnel (including applicable Federal, state and local withholding, FICA and other payroll taxes, workers’ compensation insurance, health insurance, and other similar statutory and fringe benefits).  CLIENT covenants and agrees to maintain workers’ compensation benefits and employers’ liability insurance as required by applicable law with respect to all CLIENT Personnel working at the Facility.

4.7.3          CLIENT will pay for the actual cost of repairing or replacing to its previous status (to the extent that LWI determines, in its reasonable judgment, that repairs cannot be adequately effected) any property of LWI damaged or destroyed by CLIENT Personnel (as shall be reasonably proven by LWI), provided CLIENT shall not be liable for repair or replacement costs resulting from ordinary wear and tear.

4.7.4          CLIENT Personnel visiting or having access to the Facility will abide by LWI standard policies, operating procedures and the security procedures established by LWI.  CLIENT will be liable for any breaches of security by CLIENT Personnel.  In addition, CLIENT will reimburse LWI for the cost of any lost security cards issued to CLIENT Personnel, at the rate of $50 per security card.  All CLIENT Personnel will agree to abide by LWI policies and SOPs established by LWI and conveyed in writing to CLIENT, and will sign an appropriate confidentiality agreement.

4.7.5          CLIENT will indemnify and hold harmless LWI from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) arising out of any injuries suffered by CLIENT Personnel while at the Facility or elsewhere, except to the extent caused by the gross negligence or willful misconduct on the part of any LWI Party.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

8

 

4.8          Disclaimers.  CLIENT acknowledges and agrees that LWI Parties will not engage in any Product refinement or development of the Product, other than as expressly set forth in this Agreement and the Statement of Work.  CLIENT acknowledges and agrees that LWI Parties have not participated in the invention or testing of any Product, and have not evaluated its safety or suitability for use in humans or otherwise.

	5.	
Product Warranties; Acceptance And Rejection Of Products

5.1          Product Warranties.  LWI warrants that any Product manufactured by LWI pursuant to this Agreement, at the time of delivery pursuant to Section 4.4: (a) conforms to the Specifications; (b) was manufactured in accordance with the Master Production Record; and (c) was manufactured in accordance with cGMP.

5.2          Approval of Shipment.

5.2.1          When the Product ordered by CLIENT is ready for delivery, LWI will notify CLIENT and supply CLIENT with the required documentation set forth in the Statement of Work.

5.2.2          Within [*] after CLIENT’s receipt of such documentation regarding such Product (the “Acceptance Period”), Client shall determine by review of such documentation whether or not the given Batch conforms to the product warranties set forth in Section 5.1 above (“Product Warranties”).  If CLIENT asserts that the Product does not comply with the Product Warranties set forth in Section 5.1 above, CLIENT will deliver to LWI, in accordance with the notice provisions set forth in Section 17.4 hereof, written notice of disapproval (the “Disapproval Notice”) of such Product, stating in reasonable detail the basis for such assertion of non-compliance with the Product Warranties.  If a valid Disapproval Notice is received by LWI during the Acceptance Period, then LWI and CLIENT will provide one another with all related paperwork and records (including, but not limited to, quality control tests) relating to both the production of the Product and the Disapproval Notice.  If a valid Disapproval Notice is not received during the Acceptance Period, the Product will be deemed accepted and ready for shipment.  Upon acceptance, the Product shall be delivered to CLIENT, and CLIENT shall accept delivery thereof, within the Delivery Period.  Title and risk of loss to such Product shall pass to CLIENT at the time of acceptance, provided that LWI shall use commercially reasonable efforts to continue to comply with the Quality Agreement. 

5.3          Dispute Resolution.  LWI and CLIENT will attempt to resolve any dispute regarding the conformity of a shipment of Product with the Product Warranties.  If such dispute cannot be settled within [*] of the submission by each Party of such related paperwork and records to the other Party, and if the Product is alleged not to conform with the Product Warranties set forth in Section 5.1(a), then CLIENT will submit a sample of the Batch of the disputed shipment to an independent testing laboratory of recognized repute selected by CLIENT and approved by LWI (such approval not to be unreasonably withheld, delayed or conditioned) for analysis, under quality assurance approved procedures, of the conformity of such shipment of Product with the Specifications.  The costs associated with such analysis by such independent testing laboratory will be paid by the Party whose assessment of the conformity of the shipment of Product with the Specifications was mistaken. Without derogating the foregoing, it is agreed that to the extent such independent testing laboratory is unable determine whether the shipment of Product conforms with the Product Warranties, then the dispute will be submitted to an arbitrator, with the requisite scientific background and training selected jointly by LWI and CLIENT.  Such arbitrator, employing the Commercial Arbitration Rules of the American Arbitration Association, will determine whether the Product shipped by LWI conforms with the Product Warranties and either Party’s responsibility to any nonconformity discovered (if any), and such arbitrator’s findings will be final and binding.  The arbitration shall take place in New York.  The costs and expenses of such arbitrator will be borne by the party that does not prevail in the arbitration proceeding.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

9

5.4          Remedies for Non-Conforming Product.

5.4.1          In the event that the Parties agree, or an independent testing laboratory or arbitrator, as applicable, determines, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties (for clarity, CLIENT’s inability to use such Batch caused by non-conformance with the Product Warranties as determined by an independent testing laboratory or an arbitrator, as applicable, of Product shall be deemed, inter alia, a material failure)  due to the failure of: (a) LWI personnel properly to execute the Master Production Record, (b) LWI personnel to comply with cGMP, or (c) the Facility utilities, then, at CLIENT’s request, LWI will produce for CLIENT sufficient quantities of Product to replace the non-conforming portion of such Batch of Product or provide another Batch of Product in accordance with CLIENT’s reasonable request (the “Production Rerun”), in accordance with the provisions of this Agreement and at no additional cost to CLIENT; provided, however, CLIENT shall have first paid for the original Batch of Product.

5.4.2          In the event that the Parties agree, or an independent testing laboratory determines, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties for any reason other than as set forth in Section 5.4.1, then LWI shall have no liability to CLIENT with respect to such Batch and LWI will, at CLIENT’s request, produce for CLIENT a Production Rerun at CLIENT’s expense.

5.4.3          CLIENT acknowledges and agrees that its sole remedy with respect to the failure of Product to conform with any of the Product Warranties (except to the extent such failure is caused due to LWI’s gross negligence or willful misconduct) are (i) as set forth in this Section 5.4, and (ii) when [*] Production Reruns are produced (pursuant to Section 5.4.1), and the [*] Production Rerun materially fails to conform to the Product Warranties due to: (a) LWI personnel to properly execute the Master Production Record, (b) LWI personnel to comply with cGMP, or (c) the Facility utilities, then CLIENT may terminate this Agreement [*], and in furtherance thereof, CLIENT hereby waives all other remedies at law or in equity regarding the foregoing claims.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

10

	6.	
Damage or Destruction of Materials and/or Product

6.1          Remedies.  If during the manufacture of Product pursuant to this Agreement, including without limitation during the Technology Transfer procedures, Product and/or Materials are destroyed or damaged by LWI Personnel, and such damage or destruction resulted from LWI’s failure to execute the Process in conformity with the Master Production Record, then, except as provided in Section 6.2 below, LWI, as soon as it is commercially practicable to do so, will provide CLIENT with additional Product production time equal to the actual time lost because of the destruction or damage of the Product and/or Materials and will replace such Product and/or Materials at no additional cost to CLIENT.  CLIENT acknowledges and agrees that its sole remedy with respect to damaged or destroyed Materials and/or Product (except for the non-conformity of shipped Product described in Section 5) is as set forth in this Section 6.1, and in furtherance thereof, CLIENT hereby waives all other remedies at law or in equity regarding the foregoing claims.

6.2          Limitations.  Notwithstanding anything to the contrary set forth in the preceding Section 6.1, if during the manufacture of Product pursuant to this Agreement, Product or Materials are destroyed or damaged by LWI Personnel while LWI Personnel were acting at the direction of CLIENT Personnel and such damage or destruction of the Materials resulted directly from the directions by CLIENT Personnel, then LWI will have no liability to CLIENT as the result of such destruction or damage.

	7.	
Storage Of Materials

7.1          Pre-Production.  LWI will store at the expense of CLIENT any CLIENT Materials, equipment or other property delivered pursuant to the Statement of Work to the Facility by CLIENT more than [*] prior to the Commencement Date.  The storage rates will be set forth in the Statement of Work and may be amended from time to time by LWI.  No storage fees will be charged during the period starting [*] prior to the Commencement Date and ending upon the expiration or termination of the Production Term.

7.2          Post-Production.  LWI will store at the Facility free of charge any in–process materials, CLIENT Materials, equipment and other CLIENT property (other than Product manufactured hereunder) that remains at the Facility on the date of expiration or termination of the Production Term (collectively “Remaining CLIENT Property”), for up to [*] calendar days.  If CLIENT has not provided any instructions as to the shipment or other disposition of Remaining CLIENT Property prior to the expiration of such [*]-day period, LWI may, in its sole discretion, and after notifying the same to the Client in writing (and confirming the receipt of such notice), destroy such Remaining CLIENT Property, or continue to store such Remaining CLIENT Property at the Facility or elsewhere.  In the event that LWI continues to store such Remaining CLIENT Property, CLIENT will pay to LWI a storage charge at LWI’s then-standard storage rates for the period beginning on the [*] day after the expiration or termination of the Production Term through the date that the storage terminates.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

11

7.3          Product.  Notwithstanding the foregoing, if CLIENT fails to take delivery of a Product within the applicable Delivery Period as required by Section 4.4, LWI shall have the right to immediately dispose of the Product without Client’s approval.

	8.	
Regulatory Matters

8.1          Permits and Approvals.  During the Production Term, LWI will  maintain any currently known licenses, permits and approvals necessary for the manufacture of the Product in the Facility and use its best efforts to obtain new licenses, permits and approvals necessary for the manufacture of the Product in the Facility.  LWI will promptly notify CLIENT if LWI receives notice that any such license, permit, or approval is or may be refused, revoked or suspended.

8.2          Inspections/Quality Audit by CLIENT.  Up to [*] during the Production Term and upon not less than [*] prior written notice, LWI will permit CLIENT to inspect and audit the parts of the Facility where the manufacture of the Product is carried out in order to assess LWI’s compliance with cGMP. In the event that, in the reasonable opinion of CLIENT, corrective action is necessary so as to cause LWI to comply with the requirements of cGMP, then LWI and CLIENT will meet to discuss in good faith (i) a potential action plan with respect to same and (ii) any costs associated with such action plan, provided that [*] shall bear all costs in connection with [*] and [*] shall bear all costs in connection with [*].  CLIENT shall have the right to additional audit if LWI receives notice that any necessary license, permit, or approval is or may be refused, revoked or suspended, following any Product found to have failed to confirm with Specifications or performance of an action plan or following any correction of any finding during CLIENT’s audit. CLIENT Personnel engaged in such inspection will abide by the terms and conditions set forth in Sections 4.9.4 and 10.

8.3          Inspections by Regulatory Agencies.  LWI will allow representatives of any regulatory agency to inspect the relevant parts of the Facility where the manufacture of the Product is carried out and to inspect the Master Production Record and Batch Records to verify compliance with cGMP and other practices or regulations and will promptly notify CLIENT of the scheduling of any such inspection relating to the manufacture of Product.  LWI will promptly send to CLIENT a copy of any reports, citations, or warning letters received by LWI in connection with an inspection of a regulatory agency to the extent such documents relate to or affect the manufacture of the Product. If a regulatory agency notifies LWI and/or Client that certain actions are required by LWI in order to comply with the regulations applicable to the manufacture of Product (“Compliance Actions”), then LWI shall, at no additional charge to CLIENT, perform such Compliance Actions as soon as practicable.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

12

	9.	
Financial Terms

9.1          Payments.  CLIENT will make payments to LWI in the amounts and on the dates set forth in the Statement of Work upon receipt of an invoice from LWI.  In the event that CLIENT has not paid an invoice within [*] business days of the applicable due date (as established by Section 9.3), CLIENT’s failure shall be considered a material breach under Section 14.2, subject to the cure provisions set forth therein.  Further, in addition to all other remedies available to LWI, in the event that CLIENT has not paid an invoice with respect to undisputed charges within [*] business days of the applicable due date (as established by Section 9.3), LWI may elect to suspend the provision of all or a portion of the services under this Agreement, provided that CLIENT shall remain liable for all fees owed pursuant to the Statement of Work during any such suspension.  In the event that CLIENT has a reasonable dispute with regard to any amounts invoice, CLIENT shall provide written notice of such dispute, in reasonable detail, within [*] business days of receipt of invoice.  The Parties shall meet to discuss such dispute and shall use commercially reasonable efforts to resolve any such dispute within [*] business days after the date of such written notice.  Upon the determination that the amount is no longer in dispute and is and was properly payable, such amount shall be payable immediately, together with interest (at the rate set forth in Section 9.5 below) accrued as of the date such dispute was resolved.  In the event that CLIENT has not paid an undisputed invoice within [*] business days of the applicable due date (as established by the preceding sentences), CLIENT’s failure shall be considered a material breach under this Agreement.

9.2          Security Deposit.  The Security Deposit, as defined in the Statement of Work, will be returned to CLIENT within [*] days after the date of expiration or termination of this Agreement, if CLIENT has paid all fees, charges, or other payments due in connection with charges incurred prior to the expiration or termination of this Agreement, including, but not limited to, charges for lost, destroyed, stolen or damaged property of LWI (all such fees, charges, or other payments being called “Obligations”).  If any Obligations remain outstanding after the date of expiration or termination of this Agreement, then LWI, after notifying CLIENT in writing in advance, shall be entitled to apply the Security Deposit against the payment of such Obligations.  The amount of the Security Deposit remaining, if any, after such application will be returned to CLIENT.  CLIENT shall remain liable to LWI for any deficiencies remaining after the application of the Security Deposit against the Obligations.

9.3          Invoices and Pricing.  Within [*] days of the end of each month during which charges were incurred, LWI will provide CLIENT with an invoice setting forth a detailed account of any fees, expenses, or other payments payable by CLIENT under this Agreement for the preceding month.  The amounts set forth in each such invoice which has been received by CLIENT prior to the [*] day of each month will be due and payable by the end of such month. However, any invoice which will be received by CLIENT after the [*] day of the each month will be due and payable by the end of the next month.  All pricing excludes costs relating to shipping, validation and regulatory filings, all taxes shall be paid in accordance with the provisions of Section 9.4 below.  The price of Product manufactured outside of the United States shall be invoiced to CLIENT in either the local currency of the location of the Facility in which the Product is manufactured or such other currency mutually agreed by the Parties.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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9.4          Taxes.  All amounts due under this Agreement are exclusive of any Value Added Tax or of any other applicable taxes, levies, imposts, duties and fees of whatever nature imposed by or under the authority of any government or public authority which shall be paid by CLIENT. CLIENT shall be entitled to deduct and withhold from the amount payable the tax which CLIENT is liable under any provisions of tax law. If the withholding tax rate is reduced according to the regulations in the Double Tax Treaty, no deduction shall be made or a reduced amount shall be deducted only if CLIENT is timely furnished with necessary documents by LWI.  Any withheld tax shall be treated as having been paid by CLIENT to LWI  for all purposes of this Agreement. CLIENT shall timely forward the tax receipts certifying the payments of withholding tax on behalf of LWI.

9.5          Interest.  Any fee, charge or other payment due to LWI by CLIENT under this Agreement that is not paid within 30 days after it is due will accrue interest on a daily basis at a rate of [*] (or the maximum legal interest rate allowed by applicable law, if less) from and after such date.

9.6          Method of Payment.  Except as otherwise set forth in Section 9.3, all payments to LWI hereunder by CLIENT will be in United States currency and will be by check, wire transfer, money order, or other method of payment approved by LWI.  Bank information for wire transfers is as follows:

Mailing address for wire transfer payments:

[*]

ABA# for wires and ACH for our account = [*]

[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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9.7          Cost Adjustments.  In the event of mutually agreed upon changes to a Statement of Work, LWI may annually adjust the costs and rates directly and solely attributable to such changes to the applicable Statement of Work; provided, however, that any increase in labor rates shall not exceed any percentage increase in the [*] for the most recently published percentage change for the 12-month period preceding the applicable contract anniversary date.  LWI agrees to provide CLIENT with written notice and reasonable documentation of any such cost adjustment at least [*] days prior.

	10.	
Confidential Information

10.1          Definition.  “Confidential Information” means all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, specifications, data, results and other material, pre-clinical and clinical trial results, manufacturing procedures, test procedures and purification and isolation techniques, and any tangible embodiments of any of the foregoing, and any scientific, manufacturing, marketing and business plans, any financial and personnel matters relating to a Party or its present or future products, sales, suppliers, customers, employees, investors or business, that has been disclosed by or on behalf of such Party or such Party’s Affiliates to the other Party or the other Party’s Affiliates either in connection with the discussions and negotiations pertaining to this Agreement or in the course of performing this Agreement.  Without limiting the foregoing, the terms of this Agreement will be deemed “Confidential Information” and will be subject to the terms and conditions set forth in this Article 10.

10.2          Exclusions.  Notwithstanding the foregoing Section 10.1, any information disclosed by a Party to the other Party will not be deemed “Confidential Information” to the extent that such information:

(a)          at the time of disclosure is in the public domain;

(b)          becomes part of the public domain, by publication or otherwise, through no fault of the Party receiving such information;

(c)          at the time of disclosure is already in possession of the Party who received such information, as established by contemporaneous written records;

(d)          is lawfully provided to a Party, without restriction as to confidentiality or use, by a Third Party lawfully entitled to possession of such Confidential Information; or

(e)          is independently developed by a Party without use of or reference to the other Party’s Confidential Information, as established by contemporaneous written records.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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To remove doubt, it is expressly stated that the fact that a specific part of the Confidential Information is encompassed by more general Confidential Information which falls within one of the exemptions stated in this Section 10.2, or the fact that any Confidential Information is a combination of individual items of Confidential Information which, individually, fall within the above-mentioned exemptions, shall not itself result in such Confidential Information itself falling within the above-mentioned exemptions.

10.3          Disclosure and Use Restriction.  Except as expressly provided herein, the Parties agree that for the longer of (i) [*] years from the Effective Date, and (ii) the term of this Agreement and the [*]-year period following any termination of this Agreement, each Party and its Affiliates will keep completely confidential and will not publish or otherwise disclose any Confidential Information of the other Party, its Affiliates or sublicensees, except in accordance with Section 10.4.  Neither Party will use Confidential Information of the other Party except as necessary to perform its obligations or to exercise its rights under this Agreement.

10.4          Permitted Disclosures.  Each receiving Party agrees to (i) institute and maintain security procedures to identify and account for all copies of Confidential Information of the disclosing Party and (ii) limit disclosure of the disclosing Party’s Confidential Information to its Affiliates and each of its and their respective officers, directors, employees, agents, consultants and independent contractors having a need to know such Confidential Information for purposes of this Agreement; provided that such Affiliates and each of its and their respective officers, directors, employees, agents, consultants and independent contractors are informed of the terms of this Agreement and are subject to obligations of confidentiality, non-disclosure and non-use similar to those set forth herein. Provided further that the receiving Party shall remain liable for any breach of the obligations hereunder by the entities and individuals described in this Section 10.4.

10.5          Government-Required Disclosure.  If a duly constituted government authority, court or regulatory agency orders that a Party hereto disclose information subject to an obligation of confidentiality under this Agreement, such Party shall comply with the order, but shall notify the other Party as soon as possible, so as to provide the said Party an opportunity to apply to a court of record for relief from the order.

10.6          Publicity.  Neither Party will refer to, display or use the other’s name, trademarks or trade names confusingly similar thereto, alone or in conjunction with any other words or names, in any manner or connection whatsoever, including any publication, article, or any form of advertising or publicity, except with the prior written consent of the other Party.

	11.	
Intellectual Property

11.1          Ownership.

11.1.1          Except as expressly otherwise provided herein, neither Party will, as a result of this Agreement, acquire any right, title, or interest in any Background Intellectual Property of the other Party. Except as expressly otherwise provided herein, ownership of any Intellectual Property that is developed, conceived, invented, first reduced to practice or made in connection with the performance under this Agreement shall follow inventorship all as determined under applicable laws.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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11.1.2          CLIENT shall own all right, title, and interest in and to any and all Intellectual Property that LWI and/or its Affiliates develops, conceives, invents, first reduces to practice or makes, solely or jointly with CLIENT or others, that is [*] and/or [*] (collectively, “CLIENT New IP”).  LWI hereby assigns to CLIENT all of LWI’s right, title and interest in and to such CLIENT New IP. LWI shall promptly disclose to CLIENT in writing all CLIENT New IP.  LWI shall execute, and shall require its personnel as well as its Affiliates, or other contractors or agents and their personnel involved in the performance of this Agreement to execute, any documents reasonably required to confirm CLIENT’s ownership of CLIENT New IP, and any documents required to apply for, maintain and enforce any patent or other right in the CLIENT New IP.

11.1.3          [*], LWI shall own all right, title and interest in “LWI New IP”, which as used in this Agreement means Intellectual Property that LWI and/or its Affiliates, or other contractors or agents of LWI develops, conceives, invents, or first reduces to practice or makes in the course of performance under this Agreement that (i) is [*] or (ii) is [*].  For avoidance of doubt, “LWI New IP” shall include any material, processes or other items that embody, or that are claimed or covered by, any of the foregoing Intellectual Property. For the removal of doubt, LWI New IP shall not include CLIENT New IP, as defined above.   CLIENT hereby assigns to LWI all of CLIENT’s right, title and interest in and to such LWI New IP.  CLIENT shall promptly disclose to LWI in writing all LWI New IP.  CLIENT shall execute, and shall require its personnel as well as its Affiliates, or other contractors or agents and their personnel involved in the performance of this Agreement to execute, any documents reasonably required to confirm LWI’s ownership of the LWI New IP, and any documents required to apply for, maintain and enforce any patent or other right in the LWI New IP.

11.2          License Grants.

11.2.1          During the term of this Agreement, CLIENT hereby grants to LWI a fully paid, revocable, non-exclusive license under any and all CLIENT Intellectual Property that is necessary for LWI to perform its obligations under this Agreement for the sole and limited purpose of LWI’s performance of its obligations under this Agreement, including, without limitation, the development of the Process and the development of the Process and the manufacture of Product for CLIENT.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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11.2.2          Subject to the terms and conditions set forth herein (including the payment required under this Agreement), LWI hereby grants to CLIENT a non-exclusive, world-wide, fully paid-up, irrevocable, transferable license, including the right to grant sublicenses, under the LWI New IP, [*].

11.3          Further Assurances.  Each Party agrees to take all necessary and proper acts, and will cause its employees, Affiliates, contractors, and consultants to take such necessary and proper acts, to effectuate the ownership provisions set forth in this Article 11.

11.4          Prosecution of Patents.

11.4.1          LWI will have the sole right and discretion to file, prosecute and maintain patent applications and patents claiming LWI Inventions at LWI’s expense.  CLIENT will reasonably cooperate with LWI to file, prosecute and maintain patent applications and patents claiming LWI Inventions, and will have the right to review and provide comments to LWI relating to such patent applications and patents.

11.4.2        CLIENT will have the sole right and discretion to file, prosecute and maintain patent applications and patents claiming CLIENT Inventions at CLIENT’s expense.  LWI will reasonably cooperate with CLIENT to file, prosecute and maintain patent applications and patents claiming CLIENT Inventions, and will have the right to review and provide comments to CLIENT relating to such patent applications and patents.

	12.	
Representations and Warranties

12.1          By CLIENT.  CLIENT hereby represents and warrants to LWI that it has the full corporate right, power, and authority to enter into this Agreement and perform its obligations hereunder. CLIENT further represents and warrants to LWI that, to the best of its knowledge, (i) it has the requisite intellectual property and legal rights related to the CLIENT Materials and the Product to authorize the performance of LWI’s obligations under this Agreement, and (ii) the performance of the Statement of Work and the production by LWI of the Product as contemplated in this Agreement will not give rise to a potential cause of action by a Third Party against LWI for infringement or another violation of intellectual property rights.  Such representation and warranty will not apply to any production equipment supplied by LWI, or any performance under LWI’s SOPs or in connection with LWI Intellectual Property or Confidential Information of LWI to the extent that such infringement or another violation of intellectual property rights is solely due to LWI’s SOPs, LWI Intellectual Property or Confidential Information of LWI.

12.2          By LWI.  LWI hereby represents and warrants to CLIENT that it has the full corporate right, power, and authority to enter into this Agreement and perform its obligations hereunder. LWI further represents and warrants to Client that, to the best of its knowledge, (i) it or its Affiliates have the requisite intellectual property rights in its equipment and Facility to be able to perform its obligations under this Agreement, (ii) [*] and (iii) neither LWI, nor any of its or its Affiliates’ respective directors, officers, employees and agents, is known to have been, debarred, suspended, proposed for debarment, declared ineligible or voluntarily excluded from participation in any health care program by any federal or state law or regulation. LWI undertakes to promptly notice the CLIENT should the situations described in the precedent sentence changes. \

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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	13.	
Disclaimer; Limitation of Liability

13.1          DISCLAIMER.  EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT, LWI MAKES NO REPRESENTATIONS AND GRANTS NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, WITH RESPECT TO THE PRODUCTS, MATERIALS, AND SERVICES PROVIDED UNDER THIS AGREEMENT, AND LWI SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE WITH RESPECT TO SUCH PRODUCTS, MATERIALS, OR SERVICES.

13.2          Disclaimer of Consequential Damages.  IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES IN CONNECTION WITH THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

13.3          Limitation of Liability. BOTH PARTIES HEREBY AGREE THAT TO THE FULLEST EXTENT PERMITTED BY LAW, LWI’S LIABILITY TO CLIENT, FOR ANY AND ALL INJURIES, CLAIMS, LOSSES, EXPENSES, OR DAMAGES, WHATSOEVER, ARISING OUT OF OR IN ANY WAY RELATED TO THIS AGREEMENT FROM ANY CAUSE OR CAUSES, INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE, ERRORS, OMISSIONS OR STRICT LIABILITY (“TOTAL LIABILITY”), SHALL NOT EXCEED THE TOTAL CHARGES PAID BY CLIENT TO LWI UNDER THE APPLICABLE STATEMENT OF WORK DURING THE [*] PRECEDING THE EVENT GIVING RISE TO LIABILITY, PROVIDED THAT TO THE EXTENT THE EVENT GIVING RISE TO LIABILITY HAS OCCURRED BEFORE THE LAPSE OF THE FIRST [*] FOLLOWING THE COMMENCENET OF THE APPLICABLE STATEMENT OF WORK, THEN THE TOTAL LIABILITY SHALL BE [*] BY CLIENT TO LWI UNDER [*] DURING THE FIRST [*] FOLLOWING THE COMMENCENET OF THE APPLICABLE STATEMENT OF WORK.  TO THE EXTENT THAT THIS CLAUSE 13 CONFLICTS WITH ANY OTHER CLAUSE, THIS CLAUSE 13 SHALL TAKE PRECEDENCE OVER SUCH CONFLICTING CLAUSE.  IF APPLICABLE LAW PREVENTS ENFORCEMENT OF THIS CLAUSE, THEN THIS CLAUSE 13 SHALL BE DEEMED MODIFIED TO PROVIDE THE MAXIMUM PROTECTION FOR LWI AS IS ALLOWABLE UNDER APPLICABLE LAW.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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13.4          Carve-Outs. The limitations set forth in this Clause 13 shall not apply to damages caused due to, or in connection with, either Party’s (i) gross negligence or willful misconduct; (ii) breach of the confidentiality obligations hereunder; (iii) intentional misappropriation of other Party’s Intellectual Property rights; and (iv) breach by CLIENT of its warranty under Section 12.1(ii) and by [*].

	14.	
Term and Termination

14.1          Term.  The term of this Agreement will commence on the Effective Date and will continue until the fifth anniversary of the Effective Date unless terminated prior to that time or extended by the Parties.

14.2          Termination for Material Breach.  Either Party may terminate this Agreement, or any applicable Statement of Work by written notice to the other Party, for any material breach of this Agreement by the other Party, if such breach is not cured within [*] after the breaching Party receives written notice of such breach from the non-breaching Party; provided, however, that if such breach is not capable of being cured within such thirty-day period and the breaching Party has commenced and diligently continued actions to cure such breach within such thirty-day period, except in the case of a payment default, the cure period shall be extended to [*], so long as the breaching Party is making diligent efforts to do so.  Such termination shall be effective upon expiration of such cure period.  For the avoidance of doubt, in the event of any termination under this Section 14.2, CLIENT shall remain liable for all fees owed pursuant to any applicable Statement of Work during such cure period if Services were being provided during such notice period in accordance with this Agreement and no further fees shall be owed to LWI with respect to such termination.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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14.3          Termination by Notice.

14.3.1          Without Cause.

(a)          CLIENT may terminate this Agreement or any applicable Statement of Work by providing written notice of termination not less than [*] in advance of the date of termination. For the avoidance of doubt, in the event of termination by CLIENT under this Section 14.3.1, CLIENT shall remain liable for all fees (including monthly fees) owed pursuant to each outstanding Statement of Work during such six-month period, provided that services are being provided by LWI during such six-month period in accordance with the terms of the Agreement.

(b)          After December 31, 2017, LWI may terminate this Agreement or any applicable Statement of Work by providing written notice of termination not less than [*] in advance of the date of termination.

14.3.2      Termination of Clinical Trials.  Either Party may terminate this Agreement or any applicable Statement of Work if such Party receives notice that the production of Product hereunder or the clinical trials for which Product is being produced hereunder have been or will be suspended or terminated by the FDA (or other regulatory authority) due to failure of the Product by providing written notice of termination not less than [*] in advance of the date of termination.  For the avoidance of doubt, in the event of termination under this Section 14.3.2, CLIENT shall remain liable for all fees (including monthly fees) owed pursuant to each outstanding Statement of Work during such two-month period.

14.4          Termination by Insolvency.  Either Party may terminate this Agreement upon notice to the other Party, upon (a) the dissolution, termination of existence, liquidation or business failure of the other Party; (b) the appointment of a custodian or receiver for the other Party who has not been terminated or dismissed within [*] of such appointment; (c) the institution by the other Party of any proceeding under national, federal or state bankruptcy, reorganization, receivership or other similar laws affecting the rights of creditors generally or the making by such Party of a composition or any assignment for the benefit of creditors under any national, federal or state bankruptcy, reorganization, receivership or other similar law affecting the rights of creditors generally, which proceeding is not dismissed within [*] of filing.  All rights and licenses granted pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the United States Code, licenses of rights of “intellectual property” as defined therein.

14.5          Effects of Termination.

14.5.1          Accrued Rights.  Termination of this Agreement for any reason will be without prejudice to any rights that will have accrued to the benefit of a Party prior to such termination.  Such termination will not relieve a Party of obligations that are expressly indicated to survive the termination of this Agreement.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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14.5.2          Disposition of Remaining CLIENT Property and Confidential Information.  Upon termination or expiration of this Agreement, LWI will store any Remaining CLIENT Property as set forth in Section 7.2 and, at CLIENT’s option, return or destroy any CLIENT Confidential Information in the possession or control of LWI.  Likewise, CLIENT will, at LWI’s option, return or destroy any LWI Confidential Information in the possession or control of CLIENT.  Notwithstanding the foregoing provisions: (i) LWI may retain and preserve, at its sole cost and expense, samples and standards of each Product following termination or expiration of this Agreement solely for use in determining LWI’s rights and obligations hereunder; and (ii) each Party may retain a single copy of the other Party’s Confidential Information for documentation purposes only and which shall remain subject to the obligations of nonuse and confidentiality set forth in this Agreement.

14.5.3          Survival.  Sections 1, 3.4, 4.8, 7.2, 8.3, 10, 11, 13, 14.5, 15, 16 and 17 of this Agreement, together with any appendices referenced therein, will survive any expiration or termination of this Agreement.

	15.	
Indemnification

15.1          Indemnification of Client.  LWI will indemnify CLIENT, its Affiliates, and their respective directors, officers, employees and agents, and defend and hold each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) in connection with any and all liability suits, investigations, claims or demands finally awarded against or settled with such indemnitees (collectively, “Losses”) to the extent such Losses arise out of or result from any claim, lawsuit or other action or threat by a Third Party arising out of:  (a) any material breach by LWI of this Agreement, (b) the gross negligence or willful misconduct on the part of one or more of the LWI Parties in performing any activity contemplated by this Agreement, or (c) [*], except for those Losses for which CLIENT has an obligation to indemnify the LWI Parties pursuant to Section 15.2, as to which Losses each Party will indemnify the other to the extent of their respective liability for the Losses.

15.2          Indemnification of LWI.  CLIENT will indemnify LWI and its Affiliates, and their respective directors, officers, employees and agents (the “LWI Parties”), and defend and hold each of them harmless, from and against any and all Losses to the extent such Losses arise out of or result from any claim, lawsuit or other action or threat by a Third Party arising out of: (a) any material breach by CLIENT of this Agreement, (b) the use or sale of Products, except to the extent such Losses arise out of or result from a breach by LWI of the Product Warranties, (c) the gross negligence or willful misconduct on the part of CLIENT or its Affiliates in performing any activity contemplated by this Agreement, or (d) the use or practice by LWI in accordance with this Agreement of any process, invention or other intellectual property supplied by CLIENT to LWI under this Agreement, except for those Losses for which LWI has an obligation to indemnify CLIENT pursuant to Section 15.1, as to which Losses each Party will indemnify the other to the extent of their respective liability for the Losses.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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15.3          Indemnification Procedure.

15.3.1          An “Indemnitor” means the indemnifying Party.  An “Indemnitee” means the indemnified Party, its Affiliates, and their respective directors, officers, employees and agents.  

15.3.2          An Indemnitee which intends to claim indemnification under Section 15.1 or Section 15.2 hereof shall promptly notify the Indemnitor in writing of any claim, lawsuit or other action in respect of which the Indemnitee, its Affiliates, or any of their respective directors, officers, employees and agents intend to claim such indemnification.  The Indemnitee shall permit, and shall cause its Affiliates and their respective directors, officers, employees and agents to permit, the Indemnitor, at its discretion, to settle any such claim, lawsuit or other action and agrees to the complete control of such defense or settlement by the Indemnitor; provided, however, that in order for the Indemnitor to exercise such rights, such settlement shall not adversely affect the Indemnitee’s rights under this Agreement or impose any obligations on the Indemnitee in addition to those set forth herein.  No such claim, lawsuit or other action shall be settled without the prior written consent of the Indemnitor and the Indemnitor shall not be responsible for any legal fees or other costs incurred other than as provided herein.  The Indemnitee, its Affiliates and their respective directors, officers, employees and agents shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of any claim, lawsuit or other action covered by this indemnification, all at the reasonable expense of the Indemnitor.  The Indemnitee shall have the right, but not the obligation, to be represented by counsel of its own selection and expense.

15.4          Insurance.  CLIENT will maintain, at all times during the term of this Agreement a Clinical Trial insurance policy (the “Insurance Policy”), including extended reporting period and limits of liability as per local standard in the territory of which the study takes place. The CLIENT will provide a Certificate of Insurance to LWI that the Insurance Policy has been endorsed to designate LWI as an additional insured only in territories for which it is accordance with the local regulation.  CLIENT will maintain the Insurance Policy with an insurance company having a minimum AM Best rating of A. CLIENT will provide LWI with at least 30 days’ written notice prior to termination of such Insurance Policy.

LWI will maintain, at all times during the term of this Agreement and for five years thereafter, a products liability insurance policy (the “Insurance Policy”), with a per occurrence limit of at least [*] and an aggregate limit of at least [*], and will provide a Certificate of Insurance to the CLIENT that the Insurance Policy has been endorsed to designate the CLIENT as an additional insured.  LWI will maintain the Insurance Policy with an insurance company having a minimum AM Best rating of A.  LWI will provide the CLIENT with at least [*] written notice prior to termination of such Insurance Policy.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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	16.	
Additional Covenants

16.1          Non-Solicitation.  During the term of this Agreement and for [two (2) years] thereafter, each of the Parties agrees not to seek to induce or solicit any employee of the other Party or its Affiliates to discontinue his or her employment with the other Party or its Affiliate in order to become an employee or an independent contractor of the soliciting Party or its Affiliate; provided, however, that neither Party shall be in violation of this Section 16.1 as a result of making a general solicitation for employees or independent contractors.  For the avoidance of doubt, the publication of an advertisement shall not constitute solicitation or inducement.

16.2          Commercial Scale Manufacture and Other Products.  In the event that CLIENT desires to commence commercial scale manufacture of Product and any clinical scale manufacturing of other products, the Parties agree to negotiate for the provision of such manufacturing services to CLIENT by LWI, provided that CLIENT will be free, at its discretion, to engage with any third party for the provision of such manufacturing services.

	17.	
Miscellaneous

17.1          Independent Contractors.  Each of the Parties is an independent contractor and nothing herein contained shall be deemed to constitute the relationship of partners, joint venturers, nor of principal and agent between the Parties.  Neither Party shall at any time enter into, incur, or hold itself out to Third Parties as having authority to enter into or incur, on behalf of the other Party, any commitment, expense, or liability whatsoever.

17.2          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 under this Agreement) occasioned by any reason beyond the control and without the fault or negligence of the Party affected thereby, including, without limitation, an act of God, fire, flood, act of government or state, war, civil commotion, insurrection, acts of terrorism, embargo, sabotage, prevention from or hindrance in obtaining energy or other utilities, labor disputes of whatever nature, or any other reason beyond the control and without the fault or negligence of the Party affected thereby (a “Force Majeure Event”).  Such excuse shall continue as long as the Force Majeure Event continues.  Upon cessation of such Force Majeure Event, the affected Party shall promptly resume performance under this Agreement as soon as it is commercially reasonable for the Party to do so.  Each Party agrees to give the other Party prompt written notice of the occurrence of any Force Majeure Event, the nature thereof, and the extent to which the affected Party will be unable to fully perform its obligations under this Agreement.  Each Party further agrees to use commercially reasonable efforts to correct the Force Majeure Event as quickly as practicable (provided that in no event shall a Party be required to settle any labor dispute) and to give the other Party prompt written notice when it is again fully able to perform such obligations. It is hereby clarified that LWI shall not be entitled to any payments or fees related to any services not completed and which cannot be completed appropriately after the correction the Force Majeure Event or if there is no more need for such services after the correction the Force Majeure Event.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

24

17.3          Condemnation.  LWI shall use commercially reasonable efforts to oppose any Condemnation (as defined below) efforts, provided, however, that if the Facility is condemned or taken as a result of the exercise of the power of eminent domain or will be conveyed to a governmental agency having power of eminent domain under the threat of the exercise of such power (any of the foregoing, a “Condemnation”), then this Agreement will terminate as of the date on which title to the Facility vests in the authority so exercising or threatening to exercise such power and CLIENT will not have any right to the Condemnation proceeds.

17.4          Notices.  Any notice required or permitted to be given under this Agreement by any Party shall be in writing and shall be (a) delivered personally, (b) sent by registered mail, return receipt requested, postage prepaid, (c) sent by a nationally-recognized courier service guaranteeing next-day or second day delivery, charges prepaid, or (d) delivered by facsimile (with documented evidence of transmission), to the addresses or facsimile numbers of the other Party set forth below, or at such other addresses as may from time to time be furnished by similar notice by any Party.  The effective date of any notice under this Agreement shall be the date of receipt by the receiving Party.

If to LWI:

Lonza Walkersville, Inc.

Attn: Vice President, Cell Therapy Bioservice

8830 Biggs Ford Road

Walkersville, Maryland 21793

Fax:  (301) 845-6099

With a copy to:

Assistant General Counsel

Lonza America, Inc.

90 Boroline Road

Allendale, NJ  07401

Fax: (201) 696-3589

If to Client:

Gamida Cell Ltd.,

5 Nachum Hafzadi St.,

Jerusalem, Israel

Fax: 972-2-6595616

Attn: Company Executive Officer

with a copy to:

Meitar Liquornik Geva Leshem Tal, Law Offices

16 Abba Hillel Silver Rd., Ramat Gan, Israel

Fax: 972-3-6103732

Attn: Boaz Mizrahi, Adv.

e-mail: mizrahib@meitar.com

Either Party may change its address for notice by giving notice thereof in the manner set forth in this Section 17.3.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

25

17.5        Entire Agreement; Amendments.  This Agreement, including the Appendices attached hereto and referenced herein, constitutes the full understanding of the Parties and a complete and exclusive statement of the terms of their agreement with respect to the specific subject matter hereof and supersedes all prior agreements and understandings, oral and written, among the Parties with respect to the subject matter hereof.  No terms, conditions, understandings or agreements purporting to amend, modify or vary the terms of this Agreement (including any Appendix hereto) shall be binding unless hereafter made in a written instrument referencing this Agreement and signed by each of the Parties.

17.6          Governing Law.  The construction, validity and performance of the Agreement shall be governed by and construed in accordance with the internal laws of the State of New York, without giving effect to its conflicts of laws provisions.

17.7          Counterparts.  This Agreement and any amendment hereto may be executed in any number of counterparts, each of which shall for all purposes be deemed an original and all of which shall constitute the same instrument.  This Agreement shall be effective upon full execution by facsimile or original, and a facsimile signature shall be deemed to be and shall be as effective as an original signature.

17.8          Severability.  If any part of this Agreement shall be found to be invalid or unenforceable under applicable law in any jurisdiction, such part shall be ineffective only to the extent of such invalidity or unenforceability in such jurisdiction, without in any way affecting the remaining parts of this Agreement in that jurisdiction or the validity or enforceability of the Agreement as a whole in any other jurisdiction.  In addition, the part that is ineffective shall be reformed in a mutually agreeable manner so as to as nearly approximate the intent of the Parties as possible.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

26

17.9          Titles and Subtitles.  All headings, titles and subtitles used in this Agreement (including any Appendix hereto) are for convenience only and are not to be considered in construing or interpreting any term or provision of this Agreement (or any Appendix hereto).

17.10         Exhibits.  All “RECITALS”, “DEFINITIONS”, exhibits and appendices referred to herein form an integral part of this Agreement and are incorporated into this Agreement by such reference.

17.11          Pronouns.  Where the context requires, (i) all pronouns used herein will be deemed to refer to the masculine, feminine or neuter gender as the context requires, and (ii) the singular context will include the plural and vice versa.

17.12          Assignment.  This Agreement shall be binding upon the successors and assigns of the Parties and the name of a Party appearing herein shall be deemed to include the names of its successors and assigns.  Neither Party may assign its interest under this Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld; provided, however, either Party shall be entitled without the prior written consent of the other Party to assign this Agreement to an Affiliate or to any company to which such Party may transfer all or substantially all of its assets or capital stock relating to the activities contemplated under this Agreement, whether through purchase, merger, consolidation or otherwise; provided, however, that notwithstanding the forgoing, neither Party shall assign or transfer (whether through purchase, merger, consolidation or otherwise) its interest under this Agreement to a competitor of the other Party.  Any permitted assignment of this Agreement by either Party will be conditioned upon that Party’s permitted assignee agreeing in writing to comply with all the terms and conditions contained in this Agreement.  Any purported assignment without a required consent shall be void.  No assignment shall relieve any Party of responsibility for the performance of any obligation that accrued prior to the effective date of such assignment.

17.13          Waiver.  The failure of any Party at any time or times to require performance of any provision of this Agreement (including any Appendix hereto) will in no manner affect its rights at a later time to enforce the same.  No waiver by any Party of any term, provision or condition contained in this Agreement (including any Appendix hereto), 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 (including any Appendix hereto). For the avoidance of doubt, it is hereby clarified that unless specifically stated otherwise, the contents of any inspection report provided by CLIENT in accordance with this Agreement and anything omitted from it, shall not constitute a waiver of any term, provision or condition of this Agreement or of any of CLIENT’s rights.

17.14          Dispute Resolution.  If the Parties are unable to resolve a dispute, despite its good faith efforts, either Party may refer the dispute to the President of each Party’s respective business unit (or other designee).  In the event that no agreement is reached by the Presidents (or other designees) with respect to such dispute within thirty (30) days after its referral to them, either Party may pursue any and all remedies available at law or in equity; provided that any and all such disputes hereunder shall be resolved exclusively by the courts of New York, New York.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

27

17.15          No Presumption Against Drafter.  For purposes of this Agreement, CLIENT hereby waives any rule of construction that requires that ambiguities in this Agreement (including any Appendix hereto) be construed against the drafter.

{REMAINDER OF PAGE INTENTIONALLY LEFT BLANK}

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

28

IN WITNESS WHEREOF, the parties have executed this Agreement as of the date last signed by the parties hereto.

	 	
GAMIDA CELL LTD.

	 	 	 
	
Feb. 10, 2016

	
By:

	
/s/ Yael Margolin

	
Date

	
 

	
Name: Yael Margolin

	 		Title:

 

	 	
LONZA WALKERSVILLE, INC.

	 	 	 
	
Feb. 11, 2016

	
By:

	 
	
Date

	
 

	
Name: 

	 	
 

	Title:

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406

 

APPENDIX A

TECHNOLOGY TRANSFER AND STATEMENT OF WORK

TO BE ATTACHED

APPENDIX B

QUALITY AGREEMENT

TO BE ATTACHED

APPENDIX A:

 

 

PROTOCOL

 

TECHNOLOGY TRANSFER OF NICORD TO LONZA WALKERSVILLE, US

 

	
Protocol #VP30

	
Page 1 of 4 Pages

 

[*]

 

Strictly Confidential

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

	
APPENDIX B: QUALITY AGREEMENT

	
Page 1 of 34 pages

 

	
1.

	
SCOPE

 

This QUALITY AGREEMENT (“AGREEMENT”) outlines the co-operation and Good Manufacturing Practices (“GMP”), Quality Assurance (“QA”) responsibilities (“QUALITY RESPONSIBILITIES) between Client, Lonza, Walkersville, Inc. (LWI) and Lonza, Verviers Sprl (LVS) with respect to CLIENT’s products (“PRODUCT”).

 

	
2.

	
OBJECT OF THE AGREEMENT

 

The aim of this AGREEMENT is to define and agree upon the GMP and QUALITY RESPONSIBILITIES associated with the manufacture, testing and release of the PRODUCT by Qualified Project Team Members, whilst utilizing CLIENT’S process for ex vivo expansion of hematopoietic stem/progenitor cells (“Process”), testing and releasing of the PRODUCT and Materials to be used at the clinical trials (“Clinical Trials”) under the MANUFACTURING SERVICES AGREEMENT.

 

[The QUALITY RESPONSIBILITIES associated with the manufacture of the PRODUCT must meet all applicable requirements of the “Code of Federal Regulations of the U.S. Food and Drug Administration”, 21 CFR Parts 210, 211, 610, 820, and 1271, FDA guidelines as well as EU Commission Directive 2003/94/EC and any additional regulatory agency requirements that Client communicates to LWI from time-to-time in order to seek registration ex-US. Client may not require LWI to perform activities that do not meet the current requirements of 21 CFR Parts 210, 211, 610, 820, and 1271 and FDA guidelines unless discussed and agreed with the FDA in writing, with pertinent copies provided to Lonza]

 

	
3.

	
MANUFACTURER DESCRIPTION

 

LWI will manufacture, test, disposition and store the Client PRODUCT, identified as NiCord and CordIn, at the LWI Facility, 8830 Biggs Ford Road, Walkersville, MD in accordance with Food and Drug Administration, 21 CFR Parts 210 and 211, 610, 820, and 1271 and any relevant FDA guideline as well as with EU Commission Directive 2003/94/EC

 

1.

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

	
MSA APPENDIX B: QUALITY AGREEMENT

	
Page 2 of 34 pages

	
4.

	
DESCRIPTION OF PRODUCTION PROCESS

 

		4.1.	
[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

	
MSA APPENDIX B: QUALITY AGREEMENT

	
Page 3 of 34 pages

	
5.

	
ANALYTICAL METHODS

 

[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

	
MSA APPENDIX B: QUALITY AGREEMENT

	
Page 4 of 34 pages

	
6.

	
QUALITY RESPONSIBILITIES ASSOCIATED WITH THE MANUFACTURING OF THE PRODUCT

 

[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

	
MSA APPENDIX B: QUALITY AGREEMENT

	
Page 5 of 34 pages

	
7.

	
TESTING OF PRODUCT

 

[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

	
MSA APPENDIX B: QUALITY AGREEMENT

	
Page 6 of 34 pages

	
8.

	
QUALIFIED PRODUCTION AND QUALITY CONTROL EMPLOYEES

 

[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

	
MSA APPENDIX B: QUALITY AGREEMENT

	
Page 7 of 34 pages

	
9.

	
QUALIFIED PERSON

 

		9.1.	
[*]

 

	
10.

	
INTERACTIONS BETWEEN THE SLM, LWI AND QUALIFIED PERSON DURING AND AT THE END OF THE PRODUCTION PROCESS

 

		10.1.	
[*]

 

	
11.

	
PROJECT CLOSEOUT AND RESTART

 

[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

	
MSA APPENDIX B: QUALITY AGREEMENT

	
Page 8 of 34 pages

	
12.

	
REGULATORY

 

[*]

 

	
13.

	
REGULATORY AND QUALITY AUDITS

 

[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

	
MSA APPENDIX B: QUALITY AGREEMENT

	
Page 9 of 34 pages

	
14.

	
RESPONSIBILITIES

 

[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

	
MSA APPENDIX B: QUALITY AGREEMENT

	
Page 10 of 34 pages

	
15.

	
VALIDITY AND DISCLOSURE

 

In case of any conflict between this AGREEMENT and the Manufacturing Services Agreement, the Manufacturing Services Agreement shall govern.

 

This AGREEMENT may be disclosed to the Regulatory Authorities during the course of either routine GMP or Pre-Approval inspections.

 

This AGREEMENT may only be amended by the procedures described herein and signed by the duly authorised representatives of the Client and LWI.

 

	LWI:	
Gamida Cell:

	Print Name:  Michele Jones	Print Name:  Dorit Harati
	Position:  Director of Quality	Position:  VP, Quality Assurance
	Signature: /s/ Michele Jones	Signature: /s/ Dorit Harati
	Date:  15 Aug 2016          	Date:  29-Aug-2016
	Print Name:  Laura LeClair	
 

	Position:  Manager, QA CT Operations	
      

	Signature: /s/ Laura LeClair	
     

	Date: 15 Aug 2016          	
      

	Qualified Person:	
   

	Print Name:  Veronique Dengis	
      

	Position:  Principal Qualified Person	
    

	Signature: /s/ Veronique Dengis	
   

	Date:  09 Aug 2016	
      

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

	
MSA APPENDIX B: QUALITY AGREEMENT

	
Page 11 of 34 pages

Attachment 1: Quality Control Testing of the PRODUCT

 

	 Testing Facility	Client SOP#	LWI SOP#	LWI Test Code	Test
	[*]	[*]	[*]	[*]	[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

	
MSA APPENDIX B: QUALITY AGREEMENT

	
Page 12 of 34 pages

APPENDIX A

 

STANDARD OPERATING PROCEDURE

 

[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

APPENDIX B: QUALITY AGREEMENT

 

Page 31 of 34

 

Attachment 2: Qualified Project Team Members

 

	Name	
Department

	
[*]

	
[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

APPENDIX B: QUALITY AGREEMENT

 

Page 33 of 34 pages

 

Attachment 4: Information, Timelines and Certificates Required for Release of Products

 

[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

MSA APPENDIX B: QUALITY AGREEMENT

 

Page 32 of 34 pages

 

Attachment 3: Responsible Personnel

 

[*]

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

APPENDIX B: QUALITY AGREEMENT

 

Page 34 of 34 pages

 

Attachment 5: Raw Materials Provided to LWI by the Client

 

	
LWI PN

	
Material Dacriptioa

	
Mannfacturer

	
Manufacturer’s Number

	
Source Manufacturer Address

	
[*]

	
[*]

	
[*]

	
[*]

	
[*]

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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