UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
 
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): September 25, 2018
 
CELLULAR BIOMEDICINE GROUP, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-36498
 
86-1032927
(State or other Jurisdiction of Incorporation)
 
(Commission File Number)
 
(IRS Employer Identification No.)
 
19925 Stevens Creek Blvd., Suite 100
Cupertino, California
 
95014
(Address of Principal Executive Offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code:      (408) 973-7884
 
(Former name or former address, if changed since last report.)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Emerging growth company 
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 
 

 
 
 
Item 1.01 Entry into a Material Definitive Agreement
 
License and Collaboration Agreement
 
On September 25, 2018, Cellular Biomedicine Group, Inc. (the “Company”) together with certain of its subsidiaries and controlled entities entered into a License and Collaboration Agreement (the “Collaboration Agreement”) with Novartis Pharma AG (“Novartis”) pursuant to which the Company will manufacture and supply Novartis the Chimeric Antigen Receptor T (“CAR-T”) cell therapy Kymriah® (tisagenlecleucel) (the “Product”). The Company also granted Novartis a world-wide license certain of its intellectual property and technology, including those related to the Product. Such license is exclusive with respect to the development, manufacture and commercialization of the Product and non-exclusive with respect to the development, manufacture and commercialization of other products.
 
Under the Collaboration Agreement, the Company will receive collaboration payments equal to a single-digit escalating percentage of net sales of the Product in China, subject to certain caps set forth thereunder, for sales in diffuse large B-cell lymphoma and pediatric acute lymphoblastic leukemia indications and up to a maximum amount to be agreed upon for sales in other indications.
 
The Company is also obligated to assist Novartis with the development of the Product in China as Novartis may request and is responsible for a certain percentage of the total development costs for development of the Product in China for indications other than diffuse large B-cell lymphoma and pediatric acute lymphoblastic leukemia indications. Additionally, the Company is obligated to conduct a technology transfer to Novartis of the technology to be licensed to Novartis and perform activities to receive a transfer of the manufacturing process for the Product from Novartis, each in accordance with mutually agreed transfer plans. The Company will bear all costs incurred by the parties in connection with or arising out of the transfer plans.
 
Pursuant to the Collaboration Agreement, within 90 days of the date of the Collaboration Agreement, the Company will enter into a manufacturing and supply agreement (“Manufacture and Supply Agreement”) with Novartis that will govern the terms of manufacture and supply of the Product. Under the Manufacture and Supply Agreement, it is contemplated that the Company will be entitled to a transfer payment for supply of the Product to Novartis equal to certain direct costs plus a mark-up, subject to a maximum transfer price. Additionally, the Company will be obligated at its cost to establish manufacturing capacity as requested by Novartis and will be obligated during the first two years of the term of the Manufacture and Supply Agreement to offer any additional manufacturing capacity to Novartis before entering into any agreement relating to such additional capacity.
 
The Collaboration Agreement provides that, during its term and for certain period thereafter, the Company will not, and will cause its affiliates, licensees and sublicensees not to, develop, manufacture or commercialize any CAR-T therapy targeting CD-19 other than the Product. Additionally, the Company has granted Novartis certain first rights with respect to its CAR-T therapies and for a change of control.
 
The Collaboration Agreement will continue for 10 years and then automatically renew for additional two years unless Novartis provides notice of non-renewal. It also contains standard and customary termination rights and provides for termination by Novartis in other circumstances. Novartis’s non-exclusive license under the Company’s intellectual property and technology with respect to the development, manufacture, commercialization of any product will survive any expiration or termination of the Collaboration Agreement.
 
Securities Purchase Agreement
 
On September 25, 2018, the Company entered into a Share Purchase Agreement (the “Purchase Agreement”) with Novartis pursuant to which the Company agreed to sell, and Novartis agreed to purchase from the Company, an aggregate of 1,458,257 shares (the “Shares”) of the Company’s common stock, par value $0.001 per share (“Common Stock”), at a purchase price of $27.43 per share, which was the equivalent of 130% of the volume-weighted average price of the Common Stock for the prior 20 consecutive trading days (the “Purchase Price”), for total gross proceeds of approximately $40 million (the “Private Placement”). 
 
 
 
 
The Purchase Agreement sets forth certain conditions under which the Company and/or Novartis can terminate the agreement. Among other conditions, if the Company breaches any of its obligation under the Registration Rights Agreement (as defined below), Novartis may terminate the Purchase Agreement and exercise any other remedies available to it. Within 10 business days of receipt of notice of such termination, the Company has the obligation to repurchase the Shares from Novartis at the Purchase Price and the Registration Rights Agreement will be deemed terminated.
 
The Purchase Agreement also contains mutual indemnification provisions pursuant to which each of the Company and Novartis agreed to indemnify the other party for its any breaches of its representations and warranties under the Purchase Agreement, any failure to comply with covenants, agreements and other obligations therein and enforcement of indemnification rights provided thereunder. In addition, subject to certain exceptions, the indemnification obligations of each party under the Purchase Agreement are subject to an indemnification cap of the aggregate purchase price (approximately $40 million) and a $200,000 deductible.
  
Registration Rights Agreement
 
In connection with the Private Placement, the Company and Novartis entered into a Registration Rights Agreement (the “Registration Rights Agreement”) pursuant to which the Company has agreed, subject to certain conditions set forth therein, to file a registration statement (the “Registration Statement”) on Form S-3 or other appropriate form if the Company is then ineligible for using Form S-3 with the Securities and Exchange Commission (the “SEC”) within 15 calendar days following the Closing (as defined below) to register resale of the Shares and any securities issued or then issuable upon stock split and other events set forth under the Registration Rights Agreement (the “Registrable Securities”). The Company has also agreed to use commercially reasonable efforts to cause such registration statement to be declared effective under the Securities Act of 1933, as amended (the “Securities Act”) as promptly as reasonably practicable after the filing date thereof but no later than the applicable outside date set forth under the Registration Rights Agreement. The Company has also agreed to use commercially reasonable efforts to keep such registration statement continuously effective until all Registrable Securities covered thereby have been sold or are eligible for resale pursuant to Rule 144 under the Securities Act. If the Company fails to perform any of the foregoing obligations, it has the obligation to pay certain liquidated damages set forth under the Registration Rights Agreement, subject to a cap in the amount of 9% of the aggregate purchase price of the Shares.
 
Subject to certain exceptions under the Registration Rights Agreement, the Company has agreed not to include any securities other than the Registrable Securities in the Registration Statement and not to file any other registration statements until the Registration Statement is declared effective by the SEC.
 
The Company has also agreed, among other things, to provide Novartis with piggyback registration rights (subject to certain conditions), to indemnify the selling holders under the Registration Statement from certain liabilities and to pay all fees and expenses (excluding underwriting discounts and selling commissions and expenses of selling stockholders) incident to the Company’s obligations under the Registration Rights Agreement.
 
The closing of the Private Placement (the “Closing”) occurred on September 26, 2018. The sale and issuance of the Shares were made in reliance on the exemption from registration provided by Regulation S and/or Section 4(a)(2) under the Securities Act. The securities sold and issued in connection with the Purchase Agreement are not registered under the Securities Act or any state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from the registration requirements.
 
The foregoing descriptions of the Collaboration Agreement, the Purchase Agreement and the Registration Rights Agreement are only a summary and are qualified in their entirety by reference to each of these agreements, a copy of which is filed herewith as Exhibits 10.1, 10.2 and 4.1, respectively.
 
Item 3.02 Unregistered Sales of Equity Securities.
 
The information called for by this item is contained in Item 1.01, which is incorporated herein by reference.
 
Item 8.01.    Other Events.
  
On September 26, 2018, the Company issued a press release announcing entry into of the Collaboration Agreement and the Closing, a copy of which is attached as Exhibit 99.1 to this Current Report on Form 8-K.
 
 
 
 
Item 9.01 Financial Statements and Exhibits.
 
(d)          Exhibits
 
Registration Rights Agreement, dated September 26, 2018, by and between the Company and Novartis Pharma AG.
 
 
License and Collaboration Agreement, dated September 25, 2018, by and among the Company, Novartis Pharma AG and other parties thereto.*
 
 
Securities Purchase Agreement, dated September 25, 2018, by and among the Company, Novartis Pharma AG and Shanghai Cellular Biopharmaceutical Group Ltd.
 
 
Press Release, dated September 26, 2018
 
*Confidential treatment is requested for portions of this exhibit pursuant to 17 CFR Section 240.246-2
 
 
 
 
 
 
 

 
 
SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
Cellular Biomedicine Group, Inc.
 
 
 
 
 
Date: September 27, 2018
By:
/s/ Bizuo (Tony) Liu
 
 
 
Bizuo (Tony) Liu
 
 
 
Chief Executive Officer
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  EXHIBIT 4.1
REGISTRATION RIGHTS AGREEMENT
 
This Registration Rights Agreement (this “ Agreement ”) is made and entered into as of September 26, 2018, by and among Cellular Biomedicine Group, Inc., a Delaware corporation (the “ Company ”), and Novartis Pharma AG, a company organized under the laws of Switzerland (the “ Purchaser ”).
 
               This Agreement is made pursuant to the Securities Purchase Agreement, dated as of the date hereof, among the Company, Shanghai Cellular Biopharmaceutical Group Ltd. and the Purchaser (the “ Purchase Agreement ”).
 
               The Company and the Purchaser hereby agree as follows:
 
        1.                       
Definitions .
 
                Capitalized terms used and not otherwise defined herein that are defined in the Purchase Agreement shall have the meanings given such terms in the Purchase Agreement. As used in this Agreement, the following terms shall have the following meanings:
 
            “ Advice ” shall have the meaning set forth in Section 6(c).
 
Effectiveness Date ” means, with respect to the Registration Statement required to be filed hereunder, the 75 th calendar day following the date hereof (or, in the event of a substantive review by the Commission, the 105 th calendar day following the date hereof) (the “Outside Date”); provided , however , that in the event the Company is notified by the Commission that the Registration Statement will not be reviewed or is no longer subject to further review and comments, the Effectiveness Date as to the Registration Statement shall be the fifth Trading Day following the date on which the Company is so notified if such date precedes the dates otherwise required above, provided , further , that if the Commission notifies the Company that it will not review the Registration Statement or declare the Registration Statement effective until the Company files its Quarterly Report on Form 10-Q for the quarter ended September 30, 2018 (the “ 10-Q ”), the number of days from which the Company is so notified through the date the Company files its 10-Q shall be added to the Outside Date, and provided , further , that if such Effectiveness Date falls on a day that is not a Trading Day, then the Effectiveness Date shall be the next succeeding Trading Day.
 
Effectiveness Period ” shall have the meaning set forth in Section 2(a).
 
Event ” shall have the meaning set forth in Section 2(b).
 
Event Date ” shall have the meaning set forth in Section 2(b).
 
Filing Date ” means, with respect to the Registration Statement required hereunder, the 15 th calendar day following the date hereof.
 
Holder ” or “ Holders ” means the holder or holders, as the case may be, from time to time of Registrable Securities.
 
Indemnified Party ” shall have the meaning set forth in Section 5(c).
 
Indemnifying Party ” shall have the meaning set forth in Section 5(c).
 
 
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Losses ” shall have the meaning set forth in Section 5(a).
 
Plan of Distribution ” shall have the meaning set forth in Section 2(a).
 
Prospectus ” means the prospectus included in the Registration Statement (including a prospectus that includes any information previously omitted from a prospectus filed as part of an effective registration statement in reliance upon Rule 430A promulgated by the Commission pursuant to the Securities Act), as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Registrable Securities covered by the Registration Statement, and all other amendments and supplements to the Prospectus, including post-effective amendments, and all material incorporated by reference or deemed to be incorporated by reference in such Prospectus.
 
Registrable Securities ” means, as of any date of determination, (a) all of the Shares, and (b) any securities issued or then issuable upon any stock split, dividend or other distribution, recapitalization or similar event with respect to the foregoing; provided, however , that any such Registrable Securities shall cease to be Registrable Securities (and the Company shall not be required to maintain the effectiveness of any, or file another, Registration Statement hereunder with respect thereto) for so long as (x)   the Registration Statement with respect to the sale of such Registrable Securities is declared effective by the SEC under the Securities Act and such Registrable Securities have been disposed of by the Holder in accordance with such effective Registration Statement, (y)   such Registrable Securities have been previously sold in accordance with Rule 144, or (z)   after such time as the Registrable Securities constitute 4.9% or less of the outstanding shares of Common Stock of the Company, such securities become eligible for resale without volume or manner-of-sale restrictions and without current public information pursuant to Rule 144 as set forth in a written opinion letter to such effect, addressed, delivered and acceptable to the Transfer Agent and the affected Holders, as reasonably determined by the Company, upon the advice of counsel to the Company.
 
Registration Statement ” means the registration statement required to be filed hereunder pursuant to Section 2(a), including the Prospectus, amendments and supplements to any such registration statement or Prospectus, including pre- and post-effective amendments, all exhibits thereto, and all material incorporated by reference or deemed to be incorporated by reference in such registration statement.
 
 “ Rule 415 ” means Rule 415 promulgated by the SEC pursuant to the Securities Act, as such Rule may be amended or interpreted from time to time, or any similar rule or regulation hereafter adopted by the SEC having substantially the same purpose and effect as such Rule.
 
Rule 424 ” means Rule 424 promulgated by the SEC pursuant to the Securities Act, as such Rule may be amended or interpreted from time to time, or any similar rule or regulation hereafter adopted by the SEC having substantially the same purpose and effect as such Rule.
 
Selling Stockholder Questionnaire ” shall have the meaning set forth in Section 3(a).
 
 
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SEC Guidance ” means (i) any publicly-available written or oral guidance of the SEC staff, or any comments, requirements or requests of the SEC staff and (ii) the Securities Act.
 
Trading Day ” means any day on which the Common Stock is traded on the Trading Market on which the Common Stock is then traded; provided , that “Trading Day” shall not include any day on which the Common Stock is scheduled to trade on such Trading Market for less than 4.5 hours or any day that the Common Stock is suspended from trading during the final hours of trading on such Trading Market (or, if such Trading Market does not designate in advance the closing time of trading on such Trading Market, then during the hour ending at 4:00:00 p.m., New York time).
 
Trading Market ” means any of the following markets or exchanges on which the Common Stock may be listed or quoted for trading: the NYSE MKT, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market, the New York Stock Exchange, or any successor to any of the foregoing.
 
        2.                       
Shelf Registration .
 
(a)   On or prior to the Filing Date, the Company shall prepare and file with the SEC the Registration Statement covering the resale of all of the Registrable Securities that are not then registered on an effective Registration Statement for an offering to be made on a continuous basis pursuant to Rule 415. Each Registration Statement filed hereunder shall be on Form S-3 (except if the Company is not then eligible to register for resale the Registrable Securities on Form S-3, in which case such registration shall be on another appropriate form in accordance herewith, subject to the provisions of Section 2(c)) and shall contain (unless otherwise directed by at least 85% in interest of the Holders) substantially the “ Plan of Distribution ” attached hereto as Annex A and substantially the “ Selling Stockholders ” section attached hereto as Annex B ; provided , however , that no Holder shall be required to be named as an “underwriter” without such Holder’s express prior written consent, except that a Holder may be named as a “statutory underwriter” if such Holder is, or is affiliated with, a broker-dealer and states such fact in its Selling Stockholder Questionnaire. Subject to the terms of this Agreement, the Company shall use commercially reasonable efforts to cause the Registration Statement filed under this Agreement (including under Section 3(c)) to be declared effective under the Securities Act as promptly as reasonably practicable after the filing thereof, but in any event no later than the applicable Effectiveness Date, and shall use commercially reasonable efforts to keep such Registration Statement continuously effective under the Securities Act until the date that all Registrable Securities covered by such Registration Statement (i) have been sold, thereunder or pursuant to Rule 144, or (ii) may be sold without volume or manner-of-sale restrictions pursuant to Rule 144 and without the requirement for the Company to be in compliance with the current public information requirement under Rule 144, as determined by the counsel to the Company pursuant to a written opinion letter to such effect, addressed and acceptable to the Transfer Agent and the affected Holders (the “ Effectiveness Period ”).   The Company shall telephonically request effectiveness of the Registration Statement as of 5:00 p.m. Eastern Time on a Trading Day. The Company shall immediately notify the Holders via e-mail of the effectiveness of the Registration Statement on the same Trading Day that the Company telephonically confirms effectiveness with the SEC, which shall be the date requested for effectiveness of such Registration Statement. The Company shall, by 9:30 a.m. Eastern Time on the Trading Day after the effective date of such Registration Statement, file a final Prospectus with the SEC as required by Rule 424. Failure to so notify the Holder within one (1) Trading Day of such notification of effectiveness or failure to file a final Prospectus as foresaid shall be deemed an Event under Section 2(b).
 
 
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(b)     If:
 
(i)
the Registration Statement is not filed on or prior to its Filing Date (if the Company files the Registration Statement without affording the Holders the opportunity to review and comment on the same as required by Section 3(a) herein, the Company shall be deemed to have not satisfied this clause (i)), or
 
(ii)
the Company fails to file with the SEC a request for acceleration of the Registration Statement in accordance with Rule 461 promulgated by the SEC pursuant to the Securities Act, within five Trading Days of the date that the Company is notified (orally or in writing, whichever is earlier) by the SEC that such Registration Statement will not be “reviewed” or will not be subject to further review, or
 
(iii)
prior to the effective date of the Registration Statement, the Company fails to file a pre-effective amendment and otherwise respond in writing to comments made by the SEC in respect of such Registration Statement within ten (10) calendar days after the receipt of comments by or notice from the SEC that such amendment is required in order for such Registration Statement to be declared effective, provided, however, that if the SEC issues a comment that requires the Company to file its 10-Q on a pre-effective amendment, the deadline to file such pre-effective amendment or response relating to such comment shall be no later than November 13, 2018, or
 
(iv)
the Registration Statement registering for resale all of the Registrable Securities is not declared effective by the SEC by the Effectiveness Date, or
 
(v)
after the effective date of the Registration Statement, the Registration Statement ceases for any reason to remain continuously effective as to all Registrable Securities included in such Registration Statement, or the Holders are otherwise not permitted to utilize the Prospectus therein to resell such Registrable Securities, for more than 15 consecutive calendar days or more than an aggregate of 30 calendar days (which need not be consecutive calendar days) during any 12-month period,
 
(any such failure or breach being referred to as an “ Event ”) then, in addition to any other rights the Holders may have hereunder or under applicable Law, on each Event Date and on each monthly anniversary of each such Event Date (if the applicable Event shall not have been cured by such date) until the applicable Event is cured, the Company shall pay to each Holder an amount in cash, as partial liquidated damages and not as a penalty, equal to the product of 1.5% multiplied by the aggregate Purchase Price multiplied by the proportion of (A) the Shares held by such Holder for which the Registration Statement had not been declared effective to (B) the total number of Shares purchased pursuant to the Purchase Agreement. The parties agree that the maximum aggregate liquidated damages payable to a Holder under this Agreement shall be 9.0% of the aggregate Purchase Price. If the Company fails to pay any partial liquidated damages pursuant to this Section in full within seven days after the date payable, the Company will pay interest thereon at a rate of 18% per annum (or such lesser maximum amount that is permitted to be paid by applicable Law) to the Holder, accruing daily from the date such partial liquidated damages are due until such amounts, plus all such interest thereon, are paid in full. The partial liquidated damages pursuant to the terms hereof shall apply on a daily pro rata basis for any portion of a month prior to the cure of an Event. For purposes of this Agreement, the “ Event Date ” shall be (A) for purposes of clauses (i) and (iv), the date on which such Event occurs, (B) for purpose of clause (ii), the date on which such five Trading Day period is exceeded, (C) for purpose of clause (iii), the date which such ten calendar day period is exceeded , and (D) for purpose of clause (v), the date on which such 15 or 30 calendar day period, as applicable, is exceeded.
 
 
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(c)   If Form S-3 is not available for the registration of the resale of Registrable Securities hereunder, the Company shall (i) register the resale of the Registrable Securities on another appropriate form and (ii) undertake to register the Registrable Securities on Form S-3 as soon as such form is available, provided that the Company shall maintain the effectiveness of the Registration Statement then in effect until such time as the Registration Statement on Form S-3 covering the Registrable Securities has been declared effective by the SEC.
 
(d)   Notwithstanding anything to the contrary contained herein, in no event shall the Company be permitted to name any Holder or affiliate of a Holder as any Underwriter without the prior written consent of such Holder, except that a Holder may be named as a “statutory underwriter” if such Holder is, or is affiliated with, a broker-dealer and states such fact in its Selling Stockholder Questionnaire.
 
3.            
Registration Procedures .
 
               In connection with the Company’s registration obligations hereunder, the Company shall:
 
(a)   Not less than five Trading Days prior to the filing of the Registration Statement and not less than three Trading Day prior to the filing of any related Prospectus or any amendment or supplement thereto (including any document that would be incorporated or deemed to be incorporated therein by reference, but not including (A) any Exchange Act filing or (B) any supplement or post-effective amendment to a registration statement that is not related to such Holder’s Registrable Securities), (i) furnish to each Holder copies of all such documents proposed to be filed, which documents (other than those incorporated or deemed to be incorporated by reference) will be subject to the review of such Holders, and (ii) cause Representatives to respond to such inquiries as shall be necessary, in the reasonable opinion of respective counsel to each Holder, to conduct a reasonable investigation within the meaning of the Securities Act. The Company shall not file the Registration Statement or any such Prospectus or any amendments or supplements thereto to which the Holders of a majority of the Registrable Securities shall reasonably object in good faith, provided that the Company is notified of such objection in writing no later than four Trading Days after the Holders have been so furnished copies of the Registration Statement or two Trading Days after the Holders have been so furnished copies of any related Prospectus or amendments or supplements thereto. As a condition for inclusion in any Registration Statement, each Holder agrees to furnish to the Company a completed questionnaire in the form attached to this Agreement as Annex B (a “ Selling Stockholder Questionnaire ”) on a date that is not less than two Trading Days prior to the Filing Date or by the end of the third Trading Day following the date on which such Holder receives draft materials in accordance with this Section.
 
 
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(b)   (i) Prepare and file with the SEC such amendments, including post-effective amendments, to the Registration Statement and the Prospectus used in connection therewith (subject to any requirement that a post-effective amendment be declared effective by the SEC) as may be necessary to keep the Registration Statement continuously effective as to the applicable Registrable Securities for the Effectiveness Period, (ii) cause the related Prospectus to be amended or supplemented by any required Prospectus supplement (subject to the terms of this Agreement), and, as so supplemented or amended, to be filed pursuant to Rule 424, (iii) respond as promptly as reasonably practicable to any comments received from the SEC with respect to the Registration Statement or any amendment thereto and provide as promptly as reasonably practicable to the Holders true and complete copies of all correspondence from and to the SEC relating to the Registration Statement (provided that, the Company shall excise any information contained therein which would constitute material non-public information regarding the Company or any of its Subsidiaries), and (iv) comply in all material respects with the applicable provisions of the Securities Act and the Exchange Act with respect to the disposition of all Registrable Securities covered by the Registration Statement during the applicable period in accordance (subject to the terms of this Agreement) with the intended methods of disposition by the Holders thereof set forth in such Registration Statement as so amended or in such Prospectus as so supplemented.
 
(c)   If, during the Effectiveness Period, the number of Registrable Securities at any time exceeds 100% of the number of shares of Common Stock then registered in the Registration Statement, file as soon as reasonably practicable, but in any case prior to the applicable Filing Date, an additional Registration Statement covering the resale by the Holders of not less than the number of such Registrable Securities.
 
(d)   Notify the Holders of Registrable Securities to be sold (which notice shall, pursuant to clauses (iii) through (vi) hereof, be accompanied by an instruction to suspend the use of the Prospectus until the requisite changes have been made) as promptly as reasonably practicable (and, in the case of (i)(A) below, not less than one Trading Day prior to such filing) and, if requested by any such Person, confirm such notice in writing no later than one Trading Day following the day:
 
(i)
(A) when a Prospectus or any Prospectus supplement or post-effective amendment to the Registration Statement is proposed to be filed (other than (I) any Exchange Act filing or (II) any supplement or post-effective amendment to the Registration Statement that is not related to such Holder’s Registrable Securities), (B) when the SEC notifies the Company whether there will be a “review” of such Registration Statement and whenever the SEC comments in writing on such Registration Statement, and (C) with respect to the Registration Statement or any post-effective amendment, when the same has become effective,
 
 
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(ii)
of any request by the SEC or any other federal or state Governmental Authority for amendments or supplements to the Registration Statement or Prospectus or for additional information,
 
(iii)
of the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of the Registration Statement covering any or all of the Registrable Securities or the initiation of any Proceedings for that purpose,
 
(iv)
of the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Registrable Securities for sale in any jurisdiction, or the initiation or threatening of any Proceeding for such purpose,
 
(v)
of the occurrence of any event or passage of time that makes the financial statements included in the Registration Statement ineligible for inclusion therein or any statement made in the Registration Statement or Prospectus or any document incorporated or deemed to be incorporated therein by reference untrue in any material respect or that requires any revisions to the Registration Statement, Prospectus or other documents so that, in the case of the Registration Statement or the Prospectus, as the case may be, it will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, and
 
(vi)
of the occurrence or existence of any pending corporate development with respect to the Company that the Company believes may be material and that, in the determination of the Company, makes it not in the best interest of the Company to allow continued availability of the Registration Statement or Prospectus, provided , however , in no event shall any such notice contain any information which would constitute material, non-public information regarding the Company or any of its Subsidiaries.
 
(e)   Use its best efforts to avoid the issuance of, or, if issued, obtain the withdrawal of (i) any order stopping or suspending the effectiveness of the Registration Statement, or (ii) any suspension of the qualification (or exemption from qualification) of any of the Registrable Securities for sale in any jurisdiction, at the earliest practicable moment.
 
(f)   If requested by a Holder, furnish to such Holder, without charge, at least one conformed copy of the Registration Statement and each amendment thereto, including financial statements and schedules, all documents incorporated or deemed to be incorporated therein by reference to the extent requested by such Person, and all exhibits to the extent requested by such Person (including those previously furnished or incorporated by reference) promptly after the filing of such documents with the SEC; provided , that any such item which is available on the EDGAR system (or successor thereto) need not be furnished in physical form.
 
 
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(g)   Subject to the terms of this Agreement, consent to the use of such Prospectus and each amendment or supplement thereto by each of the selling Holders in connection with the offering and sale of the Registrable Securities covered by such Prospectus and any amendment or supplement thereto, except after the giving of any notice pursuant to Section 3(d).
 
(h)    Prior to any resale of Registrable Securities by a Holder, use its commercially reasonable efforts to register or qualify or cooperate with the selling Holders in connection with the registration or qualification (or exemption from the registration or qualification) of such Registrable Securities for the resale by the Holder under the securities or Blue Sky laws of such jurisdictions within the United States as any Holder reasonably requests in writing, to keep each registration or qualification (or exemption therefrom) effective during the Effectiveness Period and to do any and all other acts or things reasonably necessary to enable the disposition in such jurisdictions of the Registrable Securities covered by each Registration Statement; provided , that, the Company shall not be required to qualify generally to do business in any jurisdiction where it is not then so qualified, subject the Company to any material tax in any such jurisdiction where it is not then so subject, or file a general consent to service of process in any such jurisdiction.
 
(i)   If requested by a Holder, cooperate with such Holder to facilitate the timely preparation and delivery of certificates representing Registrable Securities to be delivered to a transferee pursuant to the Registration Statement, which certificates shall be free, to the extent permitted by the Purchase Agreement, of all restrictive legends, and to enable such Registrable Securities to be in such denominations and registered in such names as any such Holder may request.
 
(j)   Upon the occurrence of any event contemplated by Section 3(d), as promptly as reasonably practicable under the circumstances taking into account the Company’s good faith assessment of any adverse consequences to the Company and its stockholders of the premature disclosure of such event, prepare a supplement or amendment, including a post-effective amendment, to the Registration Statement or a supplement to the related Prospectus or any document incorporated or deemed to be incorporated therein by reference, and file any other required document so that, as thereafter delivered, neither the Registration Statement nor such Prospectus will contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading. If the Company notifies the Holders in accordance with clauses (iii) through (vi) of Section 3(d) above to suspend the use of any Prospectus until the requisite changes to such Prospectus have been made, then the Holders shall suspend use of such Prospectus. The Company will use its best efforts to ensure that the use of the Prospectus may be resumed as promptly as is practicable. The Company shall be entitled to exercise its right under this Section 3(j) to suspend the availability of the Registration Statement and Prospectus, subject to the payment of partial liquidated damages otherwise required pursuant to Section 2(b), for a period not to exceed 60 calendar days (which need not be consecutive days) in any 12-month period.
 
 
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(k)   Otherwise use commercially reasonable efforts to comply with all applicable rules and regulations of the SEC under the Securities Act and the Exchange Act, including, without limitation, Rule 172 under the Securities Act, file any final Prospectus, including any supplement or amendment thereof, with the SEC pursuant to Rule 424 under the Securities Act, promptly inform the Holders in writing if, at any time during the Effectiveness Period, the Company does not satisfy the conditions specified in Rule 172 and, as a result thereof, the Holders are required to deliver a Prospectus in connection with any disposition of Registrable Securities and take such other actions as may be reasonably necessary to facilitate the registration of the Registrable Securities hereunder.
 
(l)   The Company shall use commercially reasonable efforts to maintain eligibility for use of Form S-3 (or any successor form thereto) for the registration of the resale of Registrable Securities.
 
(m)   The Company may require each selling Holder to furnish to the Company a certified statement as to the number of shares of Common Stock beneficially owned by such Holder and, if required by the SEC, the natural persons thereof that have voting and dispositive control over the shares. During any periods that the Company is unable to meet its obligations hereunder with respect to the registration of the Registrable Securities solely because any Holder fails to furnish such information within three Trading Days of the Company’s request, any liquidated damages that are accruing at such time as to such Holder only shall be tolled and any Event that may otherwise occur solely because of such delay shall be suspended as to such Holder only, until such information is delivered to the Company.
 
        4.                       
Registration Expenses . All fees and expenses incident to the performance of or compliance with the Company’s obligations under this Agreement by the Company shall be borne by the Company, whether or not any Registrable Securities are sold pursuant to the Registration Statement. The fees and expenses referred to in the foregoing sentence shall include (i) all registration and filing fees (including fees and expenses of the Company’s counsel and independent registered public accountants) (A) with respect to filings made with the SEC, (B) with respect to filings required to be made with any Trading Market on which the Common Stock is then listed for trading, and (C) in compliance with applicable state securities or Blue Sky laws reasonably agreed to by the Company in writing (including fees and disbursements of counsel for the Company in connection with Blue Sky qualifications or exemptions of the Registrable Securities), (ii) printing expenses (including expenses of printing certificates for Registrable Securities), (iii) messenger, telephone and delivery expenses, (iv) fees and disbursements of counsel for the Company, (v) Securities Act liability insurance, if the Company so desires such insurance, and (vi) fees and expenses of all other Persons retained by the Company in connection with the consummation of the transactions contemplated by this Agreement. In addition, the Company shall be responsible for all of its internal expenses incurred in connection with the consummation of the transactions contemplated by this Agreement (including all salaries and expenses of its officers and employees performing legal or accounting duties), the expense of any annual audit and the fees and expenses incurred in connection with the listing of the Registrable Securities on any securities exchange as required hereunder. In no event shall the Company be responsible for any broker or similar commissions of any Holder or, except to the extent provided for in the Transaction Documents, any legal fees or other costs of the Holders.
 
        5.                       
Indemnification .
 
 
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(a)   Indemnification by the Company . The Company shall, notwithstanding any termination of this Agreement, indemnify and hold harmless each Holder and the Holder’s Representatives, agents, brokers (including brokers who offer and sell Registrable Securities as principal as a result of a pledge or any failure to perform under a margin call of Common Stock), and investment advisors (and any other Persons with a functionally equivalent role of a Person holding such titles, notwithstanding a lack of such title or any other title) of each of them, each Person who controls any such Holder (within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act) and the officers, directors, members, stockholders, partners, agents and employees (and any other Persons with a functionally equivalent title or any other title) of each such controlling Person, to the fullest extent permitted by applicable Law, from and against any and all Losses, as incurred, arising out of or relating to (i) any untrue or alleged untrue statement of a material fact contained in the Registration Statement, any Prospectus or any form of prospectus or in any amendment or supplement thereto or in any preliminary prospectus, or arising out of or relating to any omission or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus or supplement thereto, in light of the circumstances under which they were made) not misleading or (ii) any violation or alleged violation by the Company of the Securities Act, the Exchange Act or any state securities Law, or any rule or regulation thereunder, in connection with the performance of its obligations under this Agreement, except to the extent, but only to the extent, that (A) such untrue statements or omissions are based solely upon information regarding such Holder furnished in writing to the Company by such Holder expressly for use therein, or to the extent that such information relates to such Holder or such Holder’s proposed method of distribution of Registrable Securities and was reviewed and expressly approved in writing by such Holder expressly for use in the Registration Statement, such Prospectus or in any amendment or supplement thereto (it being understood that the Holder has approved Annex A hereto for this purpose) or (B) in the case of an occurrence of an event of the type specified in Section 3(d)(iii)-(vi), the use by such Holder of an outdated, defective or otherwise unavailable Prospectus after the Company has notified such Holder in writing that the Prospectus is outdated, defective or otherwise unavailable for use by such Holder and prior to the receipt by such Holder of the Advice contemplated in Section 6(c). No investigation by any Holder or knowledge by any Holder of any facts or circumstances shall affect the Company’s indemnification obligations under this Section 5(a). The Company shall notify the Holders promptly upon becoming aware of the institution, threat or assertion of any Proceeding arising from or in connection with the transactions contemplated by this Agreement. Such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of such indemnified person and shall survive the transfer of any Registrable Securities by any of the Holders in accordance with Section 6(g).
 
(b)   Indemnification by Holders . Each Holder shall, severally and not jointly, indemnify and hold harmless the Company and its Representatives to the fullest extent permitted by applicable Law, from and against all Losses, as incurred, to the extent arising out of or based solely upon: any untrue or alleged untrue statement of a material fact contained in any Registration Statement, any Prospectus, or in any amendment or supplement thereto or in any preliminary prospectus, or arising out of or relating to any omission or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus or supplement thereto, in light of the circumstances under which they were made) not misleading (i) to the extent, but only to the extent, that such untrue statement or omission is contained in any information so furnished in writing by such Holder to the Company expressly for inclusion in such Registration Statement or such Prospectus or (ii) to the extent, but only to the extent, that such information relates to such Holder’s information provided in the Selling Stockholder Questionnaire or the proposed method of distribution of Registrable Securities and was reviewed and expressly approved in writing by such Holder expressly for use in the Registration Statement (it being understood that the Holder has approved Annex A hereto for this purpose), such Prospectus or in any amendment or supplement thereto. In no event shall the liability of a selling Holder be greater in amount than the dollar amount of the proceeds (net of all expenses paid by such Holder in connection with any claim relating to this Section 5 and the amount of any damages such Holder has otherwise been required to pay by reason of such untrue statement or omission) received by such Holder upon the sale of the Registrable Securities included in the Registration Statement giving rise to such indemnification obligation.
 
 
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(c)   Conduct of Indemnification Proceedings . If any Proceeding shall be brought or asserted against any Person entitled to indemnity hereunder (an “ Indemnified Party ”), such Indemnified Party shall promptly notify the Person from whom indemnity is sought (the “ Indemnifying Party ”) in writing, and the Indemnifying Party shall have the right to assume the defense thereof, including the employment of counsel reasonably satisfactory to the Indemnified Party and the payment of all reasonable fees and expenses incurred in connection with defense thereof; provided , that, the failure of any Indemnified Party to give such notice shall not relieve the Indemnifying Party of its obligations or liabilities pursuant to this Agreement, except (and only) to the extent that it shall be finally determined by a court of competent jurisdiction (which determination is not subject to appeal or further review) that such failure shall have materially and adversely prejudiced the Indemnifying Party.
 
               An Indemnified Party shall have the right to employ separate counsel in any such Proceeding and to participate in the defense thereof, but the fees and expenses of such counsel shall be at the expense of such Indemnified Party or Parties unless: (i) the Indemnifying Party has agreed in writing to pay such fees and expenses, (ii) the Indemnifying Party shall have failed promptly to assume the defense of such Proceeding and to employ counsel reasonably satisfactory to such Indemnified Party in any such Proceeding, or (iii) the named parties to any such Proceeding (including any impleaded parties) include both such Indemnified Party and the Indemnifying Party, and counsel to the Indemnified Party shall reasonably believe that a material conflict of interest is likely to exist if the same counsel were to represent such Indemnified Party and the Indemnifying Party (in which case, if such Indemnified Party notifies the Indemnifying Party in writing that it elects to employ separate counsel at the expense of the Indemnifying Party, the Indemnifying Party shall not have the right to assume the defense thereof and the reasonable fees and expenses of no more than one separate counsel shall be at the expense of the Indemnifying Party). The Indemnifying Party shall not be liable for any settlement of any such Proceeding effected without its written consent, which consent shall not be unreasonably withheld or delayed. No Indemnifying Party shall, without the prior written consent of the Indemnified Party, effect any settlement of any pending Proceeding in respect of which any Indemnified Party is a party, unless such settlement includes an unconditional release of such Indemnified Party from all liability on claims that are the subject matter of such Proceeding.
 
               Subject to the terms of this Agreement, all reasonable fees and expenses of the Indemnified Party (including reasonable fees and expenses to the extent incurred in connection with investigating or preparing to defend such Proceeding in a manner not inconsistent with this Section) shall be paid to the Indemnified Party, as incurred, within ten Trading Days of written notice thereof to the Indemnifying Party; provided , that, the Indemnified Party shall promptly reimburse the Indemnifying Party for that portion of such fees and expenses applicable to such actions for which such Indemnified Party is finally determined by a court of competent jurisdiction (which determination is not subject to appeal or further review) not to be entitled to indemnification hereunder.
 
 
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(d)   Contribution . If the indemnification under Section 5(a) or 5(b) is unavailable to an Indemnified Party or insufficient to hold an Indemnified Party harmless for any Losses, then each Indemnifying Party shall contribute to the amount paid or payable by such Indemnified Party, in such proportion as is appropriate to reflect the relative fault of the Indemnifying Party and Indemnified Party in connection with the actions, statements or omissions that resulted in such Losses as well as any other relevant equitable considerations. The relative fault of such Indemnifying Party and Indemnified Party shall be determined by reference to, among other things, whether any action in question, including any untrue or alleged untrue statement of a material fact or omission or alleged omission of a material fact, has been taken or made by, or relates to information supplied by, such Indemnifying Party or Indemnified Party, and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such action, statement or omission. The amount paid or payable by a party as a result of any Losses shall be deemed to include, subject to the limitations set forth in this Agreement, any reasonable attorneys’ or other reasonable fees or expenses incurred by such party in connection with any Proceeding to the extent such party would have been indemnified for such fees or expenses if the indemnification provided for in this Section was available to such party in accordance with its terms.
 
               The parties hereto agree that it would not be just and equitable if contribution pursuant to this Section 5(d) were determined by pro rata allocation or by any other method of allocation that does not take into account the equitable considerations referred to in the immediately preceding paragraph. In no event shall the contribution obligation of a Holder of Registrable Securities be greater in amount than the dollar amount of the proceeds (net of all expenses paid by such Holder in connection with any claim relating to this Section 5 and the amount of any damages such Holder has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission) received by it upon the sale of the Registrable Securities giving rise to such contribution obligation.
 
The indemnity and contribution agreements contained in this Section are in addition to any liability that the Indemnifying Parties may have to the Indemnified Parties.
 
 
        6.                       
Miscellaneous .
 
(a)   Remedies . In the event of a breach by the Company or by a Holder of any of their respective obligations under this Agreement, each Holder or the Company, as the case may be, in addition to being entitled to exercise all rights granted by law and under this Agreement, including recovery of damages, shall be entitled to seek specific performance of its rights under this Agreement. Each of the Company and each Holder agrees that monetary damages would not provide adequate compensation for any losses incurred by reason of a breach by it of any of the provisions of this Agreement and hereby further agrees that, in the event of any action for specific performance in respect of such breach, it shall not assert or shall waive the defense that a remedy at law would be adequate.
 
 
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(b)   No Piggyback on Registrations; Prohibition on Filing Other Registration Statements . Neither the Company nor any of its security holders (other than the Holders in such capacity pursuant hereto) may include securities of the Company in any Registration Statements other than the Registrable Securities. For the avoidance of doubt, the previous sentence shall not apply to any securities issued pursuant to that certain Controlled Equity Offering SM Sales Agreement, dated March 22, 2016, by and between the Company and Cantor Fitzgerald & Co. to the extent that such securities have been registered as of the date hereof on the Company’s registration statement on Form S-3 (File No. 333-210337), which was declared effective on June 17, 2016. The Company shall not file any other registration statements, other than a registration statement on Form S-4 or Form S-8, or their then-equivalents, until the date that the Registration Statement has been declared effective by the SEC.
 
(c)   Discontinued Disposition . By its acquisition of Registrable Securities, each Holder agrees that, upon receipt of a notice from the Company of the occurrence of any event of the kind described in Section 3(d)(iii) through (vi), such Holder will forthwith discontinue disposition of such Registrable Securities under the Registration Statement until it is advised in writing (the “ Advice ”) by the Company that the use of the applicable Prospectus (as it may have been supplemented or amended) may be resumed. The Company will use commercially reasonable efforts to ensure that the use of the Prospectus may be resumed as promptly as is practicable. The Company agrees and acknowledges that any periods during which the Holder is required to discontinue the disposition of the Registrable Securities hereunder shall be subject to the provisions of Section 2(b).
 
(d)   Piggy-Back Registrations . If, at any time during the Effectiveness Period, there is not an effective Registration Statement covering all of the Registrable Securities and the Company shall determine to prepare and file with the SEC a registration statement relating to an offering for its own account or the account of others under the Securities Act of any of its equity securities, other than on Form S-4 or Form S-8 (each as promulgated under the Securities Act) or their then-equivalents relating to equity securities to be issued solely in connection with any acquisition of any entity or business or equity securities issuable in connection with the Company’s employee Benefit Plans, then the Company shall deliver to each Holder a written notice of such determination and, if within 15 days after the date of the delivery of such notice, any such Holder shall so request in writing, the Company shall include in such registration statement all or any part of such Registrable Securities such Holder requests to be registered; provided , however , that the Company shall not be required to provide notice or otherwise register any Registrable Securities pursuant to this Section 6(d) that are eligible for resale pursuant to Rule 144 (without volume restrictions or current public information requirements) promulgated by the SEC pursuant to the Securities Act or that are the subject of a then-effective Registration Statement that is available for resales or other dispositions by such Holder; and provided , further , that if the Company intends to file a registration statement in connection with an underwritten public offering (an “ Underwritten Offering ”), and the managing underwriter has advised the Company in good faith that the inclusion of all of the Registrable Securities requested to be included by the Holders participating in such Underwritten Public Offering (including pursuant to this Section 6(d)) shall be limited due to market conditions, the order of priority of the securities to be included in such offering shall be: (i) first, the primary securities to be included in such Underwritten Offering; (ii) second, any securities that the Holders request to include in such Registration Statement, on a pro rata basis, based on the number of requested securities; and (iii) any other securities that are requested to be included in such Registration Statement on a pro rata basis, based on the number of requested securities.
 
 
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(e)   Amendments and Waivers . The provisions of this Agreement, including the provisions of this sentence, may not be amended, modified or supplemented, and waivers or consents to departures from the provisions hereof may not be given, unless the same shall be in writing and signed by the Company and the Holders of 51% or more of the then-outstanding Registrable Securities, provided that, if any amendment, modification or waiver disproportionately and adversely impacts a Holder (or group of Holders), the consent of such disproportionately impacted Holder (or group of Holders) shall be required. If the Registration Statement does not register all of the Registrable Securities pursuant to a waiver or amendment done in compliance with the previous sentence, then the number of Registrable Securities to be registered for each Holder shall be reduced pro rata among all Holders and each Holder shall have the right to designate which of its Registrable Securities shall be omitted from such Registration Statement. Notwithstanding the foregoing, a waiver or consent to depart from the provisions hereof with respect to a matter that relates exclusively to the rights of a Holder or some Holders and that does not directly or indirectly affect the rights of other Holders may be given only by such Holder or Holders of all of the Registrable Securities to which such waiver or consent relates; provided , however , that the provisions of this sentence may not be amended, modified, or supplemented except in accordance with the provisions of the first sentence of this Section 6(e). No consideration shall be offered or paid to any Person to amend or consent to a waiver or modification of any provision of this Agreement unless the same consideration also is offered to all of the similarly-situated parties to this Agreement.
 
(f)   Notices . Any and all notices or other communications or deliveries required or permitted to be provided hereunder shall be delivered as set forth in the Purchase Agreement.
 
(g)   Successors and Assigns . This Agreement shall inure to the benefit of and be binding upon the successors and permitted assigns of each of the parties and shall inure to the benefit of each Holder. The Company may not assign (except by merger) its rights or obligations hereunder without the prior written consent of all of the Holders of the then-outstanding Registrable Securities. Each Holder may assign their respective rights hereunder in the manner and to the Persons as permitted under Section 11.7 of the Purchase Agreement.
 
(h)   No Inconsistent Agreements . Neither the Company nor any of its Subsidiaries has entered, as of the date hereof, nor shall the Company or any of its Subsidiaries, on or after the date of this Agreement, enter into any agreement with respect to its securities, that would have the effect of impairing the rights granted to the Holders in this Agreement or otherwise conflicts with the provisions hereof. Except as set forth on Schedule 6(h) , neither the Company nor any of its Subsidiaries has previously entered into any agreement granting any registration rights with respect to any of its securities to any Person that have not been satisfied in full.
 
(i)   Execution and Counterparts . This Agreement may be executed in any number of counterparts, all of which when taken together shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to the other party, it being understood that both parties need not sign the same counterpart. In the event that any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature page were an original thereof.
 
 
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(j)   Governing Law; Enforcement . All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be determined in accordance with the provisions of the Purchase Agreement, including Sections 10.11, 10.12, 10.13 and 10.14 thereof.
 
(k)   Cumulative Remedies . The remedies provided herein are cumulative and not exclusive of any other remedies provided by Law.
 
(l)   Severability . If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction to be invalid, illegal, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions set forth herein shall remain in full force and effect and shall in no way be affected, impaired or invalidated, and the parties hereto shall use their commercially reasonable efforts to find and employ an alternative means to achieve the same or substantially the same result as that contemplated by such term, provision, covenant or restriction. It is hereby stipulated and declared to be the intention of the parties that they would have executed the remaining terms, provisions, covenants and restrictions without including any of such that may be hereafter declared invalid, illegal, void or unenforceable.
 
(m)   Interpretation . This Agreement shall be interpreted in accordance with the provisions of Section 10.3 of the Purchase Agreement.
 
(n)   Independent Nature of Holders’ Obligations and Rights . The obligations of each Holder hereunder are several and not joint with the obligations of any other Holder hereunder, and no Holder shall be responsible in any way for the performance of the obligations of any other Holder hereunder. Nothing contained herein or in any other agreement or document delivered at any closing, and no action taken by any Holder pursuant hereto or thereto, shall be deemed to constitute the Holders as a partnership, an association, a joint venture or any other kind of group or entity, or create a presumption that the Holders are in any way acting in concert or as a group or entity with respect to such obligations or the transactions contemplated by this Agreement or any other matters, and the Company acknowledges that the Holders are not acting in concert or as a group, and the Company shall not assert any such claim, with respect to such obligations or transactions. Each Holder shall be entitled to protect and enforce its rights, including without limitation the rights arising out of this Agreement, and it shall not be necessary for any other Holder to be joined as an additional party in any proceeding for such purpose. The use of a single agreement with respect to the obligations of the Company contained was solely in the control of the Company, not the action or decision of any Holder, and was done solely for the convenience of the Company and not because it was required or requested to do so by any Holder. It is expressly understood and agreed that each provision contained in this Agreement is between the Company and a Holder, solely, and not between the Company and the Holders collectively and not between and among Holders.
 (Signature Pages Follow)
 
 
 
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               IN WITNESS WHEREOF, the parties have executed and delivered this Registration Rights Agreement as of the date first written above.
 
CELLULAR BIOMEDICINE GROUP, INC.
 
 
By: /s/ Bizuo (Tony) Liu
      Name: Bizuo (Tony) Liu
      Title: Chief Executive Officer
 
 
 
 
 
[SIGNATURE PAGE OF PURCHASER FOLLOWS]
 
                                                            
 
 
16
 
 
NOVARTIS PHARMA AG
 
 
 
By: /s/ Teresa Jose
     Name: Teresa Jose
     Title: CFO, Oncology
 
 
By: /s/ Liz Barrett
     Name: Liz Barrett
     Title: CEO, Novartis Oncology
 
 
 
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Annex A
 
PLAN OF DISTRIBUTION
 
We are registering the shares of common stock on behalf of the Selling Stockholders. Each Selling Stockholder and any of their pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their securities covered hereby on the principal Trading Market or any other stock exchange, market or trading facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices. A Selling Stockholder may use any one or more of the following methods when selling securities:
 
ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
 
block trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction;
 
purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
 
exchange distributions in accordance with the rules of the applicable exchange;
 
privately negotiated transactions;
 
settlement of short sales;
 
transactions through broker-dealers that agree with the Selling Stockholders to sell a specified number of such securities at a stipulated price per security;
 
through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
 
a combination of any such methods of sale; or
 
any other method permitted pursuant to applicable law.
 
The Selling Stockholders may also sell securities under Rule 144 or any other exemption from registration under the Securities Act of 1933, as amended (the “Securities Act”), if available, rather than under this prospectus.
 
Broker-dealers engaged by the Selling Stockholders may arrange for other broker-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the Selling Stockholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2440; and in the case of a principal transaction a markup or markdown in compliance with FINRA IM-2440.
 
In connection with the sale of the securities or interests therein, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the securities in the course of hedging the positions they assume. The Selling Stockholders may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the securities to broker-dealers that in turn may sell these securities. The Selling Stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other financial institution of securities offered by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
 
 
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The Selling Stockholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Each Selling Stockholder has informed the Company that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the securities.
 
The Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the securities. The Company has agreed to indemnify the Selling Stockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.
 
We agreed to keep this prospectus effective until the date that (i) the securities constitute 4.9% or less of the outstanding shares of common stock of the Company and may be resold by the Selling Stockholders without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of similar effect or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with.
 
Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the Selling Stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common stock by the Selling Stockholders or any other person. We will make copies of this prospectus available to the Selling Stockholders and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).
 
 
                                                             
 
 
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Annex B
 
SELLING STOCKHOLDERS
 
The common stock being offered by the selling shareholders are those previously issued to the selling shareholders, and those issuable to the selling shareholders, upon exercise of the warrants. For additional information regarding the issuances of those shares of common stock and warrants, see "Private Placement of Common Shares" above. We are registering the shares of common stock in order to permit the selling shareholders to offer the shares for resale from time to time. [Description of the relationship between any selling shareholders and the Company to be provided.]
 
The table below lists the selling shareholders and other information regarding the beneficial ownership of the shares of common stock by each of the selling shareholders. The second column lists the number of shares of common stock beneficially owned by each selling shareholder, based on its ownership of the shares of common stock, as of ________, 2018, assuming exercise of the warrants held by the selling shareholders on that date, without regard to any limitations on exercises.
 
The third column lists the shares of common stock being offered by this prospectus by the selling shareholders.
 
In accordance with the terms of a registration rights agreement with the selling shareholders, this prospectus generally covers the resale of the number of shares of common stock issued to the selling shareholders in the __________________.   The fourth column assumes the sale of all of the shares offered by the selling shareholders pursuant to this prospectus.
 
The selling shareholders may sell all, some or none of their shares in this offering. See "Plan of Distribution."
 
Name of Selling Stockholder
 
Shares of Common Stock Beneficially Owned Prior to Offering
 
Maximum Number of shares of Common Stock to be Sold Pursuant to this Prospectus
 
Shares of Common Stock Beneficially Owned After Offering
 
 
 
                                                          
 
 
 
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EXHIBIT 4
 
Selling Stockholder Questionnaire
 
 
[attached hereto]
 

 
FORM OF
 
SELLING SECURITYHOLDER QUESTIONNAIRE
 
 
CELLULAR BIOMEDICINE GROUP, INC.
 
19925 STEVENS CREEK BLVD., SUITE 100
 
CUPERTINO CA 95014
 
 
 
Ladies and Gentlemen:
 
The undersigned beneficial owner (the “ Selling Securityholder ”) of securities of Cellular Biomedicine Group, Inc., a Delaware corporation (the “ Company ”), understands that the Company intends to file with the Securities and Exchange Commission a registration statement on Form S-1/S-3 (the “ Registration Statement ”). The Registration Statement registers for resale under the Securities Act of 1933, as amended (the “ Securities Act ), the securities the Selling Securityholder beneficially owns that are disclosed in response to Question 5(b) of this Questionnaire (the “ Registrable Securities ). The Company will use the information that the undersigned provides in this Questionnaire to ensure the accuracy of the Registration Statement and the related prospectus.
 
 
Certain legal consequences arise from being named as a selling securityholder in the Registration Statement and the related prospectus. Accordingly, holders and beneficial owners of securities to be registered under the Registration Statement are advised to consult their own securities counsel regarding the consequences of being named or not being named as a selling securityholder in the Registration Statement and the related prospectus.
 
 
The undersigned Selling Securityholder acknowledges that by completing, dating, executing and returning this Questionnaire to the Company, the Selling Securityholder is giving written notice to the Company of its desire to have the Registrable Securities disclosed in response to Question 5(b) of this Questionnaire included in the Registration Statement.
 
 
Please answer every question.
 
 
If the answer to any question is “none” or “not applicable,” please so state.
 
 
Name . Type or print the full legal name of the Selling Securityholder.
 
__________________________________________________________________
 
 
 
21
 
 
Contact Information . Provide the address, telephone number, fax number and email address of the Selling Securityholder.
 
 
Address:
 
_________________________
 
 
 
_________________________
 
 
Phone:
 
_________________________
 
 
Fax:
 
_________________________
 
 
E-Mail:
 
_________________________
 
 
 
Relationship with the Company . Describe the nature of any position, office or other material relationship the Selling Securityholder has had with the Company during the past three years.
 
 
______________________________________________________________________
______________________________________________________________________
 
 
Organizational Structure . Please indicate or (if applicable) describe how the Selling Securityholder is organized.
 
 
(a) Is the Selling Securityholder a natural person?
(if so, please mark the box and skip to Question 5)
 
___ Yes
 
 ___ No
 
 
(b) Is the Selling Securityholder a reporting company under the Securities Exchange Act of 1934, as amended (the " Exchange Act ")?
(if so, please mark the box and skip to Question 5)
 
___ Yes
 
 ___ No
 
 
(c) Is the Selling Securityholder a majority-owned subsidiary of a reporting company under the 1934 Act?
(if so, please mark the box and skip to Question 5)
 
___ Yes
 
 ___ No
 
 
(d) Is the Selling Securityholder a registered investment company under the Investment Company Act of 1940?
(if so, please mark the box and skip to Question 5)
 
___ Yes
 
 ___ No
 
 
 
 
22
 
 
If the answer to all of the foregoing questions is "no," please describe: (i) the exact legal description of the Selling Securityholder (e.g., corporation, partnership, limited liability company, etc.); (ii) whether the legal entity so described is managed by another entity and the exact legal description of such entity (repeat this step until the last entity described is managed by a person or persons, each of whom is described in any one of (a) through (d) above); (iii) the names of each person or persons having voting and investment control over the Company's securities that the entity owns (e.g., director(s), general partner(s), managing member(s), etc.).
 
 
Legal Description of Entity :
 
____________________________________________________________
 
Name of Entit(ies)/(y) Managing Such Entity (if any) :
 
____________________________________________________________
 
____________________________________________________________
 
Name of Entit(ies)/(y) Managing such Entit(ies)/(y) (if any) :
 
____________________________________________________________
 
____________________________________________________________
 
Name(s) of Natural Person(s) Having Voting or Investment Control Over the Shares Held by such Entit(ies)/(y) :
 
____________________________________________________________
 
 
23
 
 
Ownership of the Company’s Securities . This question covers beneficial ownership of the Company’s securities. Please consult Appendix A to this Questionnaire for information as to the meaning of “beneficial ownership.” State (a) the number of shares of the Company’s common stock (including any shares issuable upon exercise of warrants or other convertible securities) that the Selling Securityholder beneficially owned as of the date this Questionnaire is signed and (b) the number of such shares of the Company’s common stock that the Selling Securityholder wishes to have registered for resale in the Registration Statement:
 
Number of shares of common stock and other equity securities owned :
 
____________________________________________________________
 
Number of shares of common stock and other equity securities owned to be registered for resale in the Registration Statement :
 
____________________________________________________________
 
Acquisition of Shares . If the Selling Securityholder did not acquire the securities to be sold directly from the Company, please describe below the manner in which the securities were acquired including, but not limited to, the date, the name and address of the seller(s), the purchase price and pursuant to which documents (the " Acquisition Documents ") and please forward such documents as provided below.
 
__________________________________________________________________
 
 
__________________________________________________________________
 
Broker-Dealer Status .
 
 
Is the Selling Securityholder a broker-dealer?
 
___ Yes
 
 ___ No
 
 
 
 
If the answer to Section 7(a) is “yes,” did the Selling Securityholder receive the Registrable Securities as compensation for investment banking services to the Company?
Note: If the answer to 7(b) is "no," SEC guidance has indicated that the Selling Securityholder should be identified as an underwriter in the Registration Statement.
 
___ Yes
 
 ___ No
 
 ___N/A
 
 
 
Is the Selling Securityholder an affiliate of a broker-dealer?
 
___ Yes
 
 ___ No
 
 
 
 
24
 
 
If the Selling Securityholder is an affiliate of a broker-dealer, does the Selling Securityholder certify that it purchased the Registrable Securities in the ordinary course of business, and at the time of the purchase of the Registrable Securities to be resold, the Selling Securityholder had no agreements or understandings, directly or indirectly, with any person to distribute the Registrable Securities?
Note: If the answer to 7(d) is "no", SEC guidance has indicated that the Selling Securityholder should be identified as an underwriter in the Registration Statement.
 
___ Yes
 
 ___ No
 
 ___N/A
 
 
Legal Proceedings with the Company . Is the Company a party to any pending legal proceeding in which the Selling Securityholder is named as an adverse party?
 
 
 
___ Yes
 
 ___ No
 
 
 
State any exceptions here:
 
 
__________________________________________________________________
 
__________________________________________________________________
 
Reliance on Responses . The undersigned acknowledges and agrees that the Company and its legal counsel shall be entitled to rely on its responses in this Questionnaire in all matters pertaining to the Registration Statement and the sale of any Registrable Securities pursuant to the Registration Statement.
 
The undersigned hereby acknowledges and is advised of the following Interpretation A.65 of the July 1997 SEC Manual of Publicly Available Telephone Interpretations regarding short selling:
 
 
By returning this Questionnaire, the undersigned will be deemed to be aware of the foregoing interpretation.
 
 
25
 
 
If the Company is required to file a new or additional registration statement to register Registrable Securities beneficially owned by the Selling Securityholder, the undersigned hereby agrees to complete and return to the Company, upon the request of the Company, a new Questionnaire (in a form substantially similar to this Questionnaire).
 
 
If the Selling Securityholder transfers all or any portion of its Registrable Securities after the date on which the information in this Questionnaire is provided to the Company, the undersigned hereby agrees to notify the transferee(s) at the time of transfer of its rights and obligations hereunder.
 
 
By signing below, the undersigned represents that the information provided herein is accurate and complete. The undersigned agrees to promptly notify the Company of any inaccuracies or changes in the information provided herein that may occur subsequent to the date hereof at any time while the Registration Statement remains effective.
 
 
By signing below, the undersigned consents to the disclosure of the information contained herein and the inclusion of such information in the Registration Statement and the related prospectus and any amendments or supplements thereto. The undersigned understands that such information will be relied upon by the Company in connection with the preparation or amendment of the Registration Statement and the related prospectus.
 
 
 
 
[SIGNATURE PAGE FOLLOWS]
 
{00625354.DOCX.2}                                                               
 
 
26
 
 
IN WITNESS WHEREOF the undersigned, by authority duly given, has caused this Notice and Questionnaire to be executed and delivered either in person or by its duly authorized agent.
 
Dated: ___________________
Beneficial Owner: ___________________________
By:___________________________
Name:
Title:
 
 
 
AS SOON AS POSSIBLE, PLEASE FAX A COPY OF THE COMPLETED AND EXECUTED NOTICE AND QUESTIONNAIRE, AND RETURN THE ORIGINAL BY OVERNIGHT MAIL, TO:
 
Ellenoff Grossman & Schole LLP
1345 Avenue of the Americas
New York, New York 10105
Attn: Jessica Yuan, Esq.
Fax: (212) 370-7889
E-mail: jyuan@egsllp.com
 
                                                        
 
 
27
 
 
APPENDIX A
 
DEFINITION OF "BENEFICIAL OWNERSHIP"
 
1.           A "Beneficial Owner" of a security includes any person who, directly or indirectly, through any contract, arrangement, understanding, relationship or otherwise has or shares:
 
(a) Voting power which includes the power to vote, or to direct the voting of, such security; and/or
 
(b) Investment power which includes the power to dispose, or direct the disposition of, such security.
 
Please note that either voting power or investment power, or both, is sufficient for you to be considered the beneficial owner of shares.
2.           Any person who, directly or indirectly, creates or uses a trust, proxy, power of attorney, pooling arrangement or any other contract, arrangement or device with the purpose or effect of divesting such person of beneficial ownership of a security or preventing the vesting of such beneficial ownership as part of a plan or scheme to evade the reporting requirements of the federal securities acts shall be deemed to be the beneficial owner of such security.
3.           Notwithstanding the provisions of paragraph (1), a person is deemed to be the “beneficial owner” of a security if that person has the right to acquire beneficial ownership of such security within 60 days, including but not limited to any right to acquire: (a) through the exercise of any option, warrant or right; (b) through the conversion of a security; (c) pursuant to the power to revoke a trust, discretionary account or similar arrangement; or (d) pursuant to the automatic termination of a trust, discretionary account or similar arrangement; provided, however, any person who acquires a security or power specified in (a), (b) or (c) above, with the purpose or effect of changing or influencing the control of the issuer, or in connection with or as a participant in any transaction having such purpose or effect, immediately upon such acquisition shall be deemed to be the beneficial owner of the securities which may be acquired through the exercise or conversion of such security or power.
 
 
 
                                                         
 
 
28
Exhibit 10.1
 
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
 
LICENSE AND COLLABORATION AGREEMENT
 
dated as of
 
September 25, 2018
 
by and among
 
NOVARTIS PHARMA AG,
 
CELLULAR BIOMEDICINE GROUP, INC.,
 
CELLULAR BIOMEDICINE GROUP HK LTD.
 
CELLULAR BIOMEDICINE GROUP (WUXI) LTD.
(西比曼生物科技(无锡)有限公司),
 
CELLULAR BIOMEDICINE GROUP (SHANGHAI) LTD.
(西比曼生物科技(上海)有限公司),
 
and
 
SHANGHAI CELLULAR BIOPHARMACEUTICAL GROUP LTD.
(上海赛比曼生物科技有限公司)
 
 
 
                                                                  
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
TABLE OF CONTENTS
 
Page
 

 
1
DEFINITIONS AND INTERPRETATION
2
1.1
Definitions
2
1.2
Interpretation
18
2
LICENSES
19
2.1
License Grants to CBMG
19
2.2
License Grants to Novartis
20
2.3
Sublicenses; Subcontracting
20
2.4
No Other Rights
20
2.5
Exclusivity; Right of First Negotiation
21
2.6
Certain Terms of Novartis Third Party Agreements
21
3
GOVERNANCE
22
3.1
Alliance Managers
22
3.2
Joint Oversight Committee
22
3.3
Meetings of the Joint Oversight Committee
23
3.4
Sub-Committees
23
4
DISCLOSURE OF KNOW-HOW AND COOPERATION
23
4.1
Disclosure of Know-How
23
4.2
Cooperation
24
5
DEVELOPMENT
24
5.1
Development Generally
24
5.2
Development Plan and Development Budget
24
5.3
Development Activities
24
5.4
Additional CBMG Development Obligations
24
5.5
Development Costs
25
6
REGULATORY
26
6.1
Novartis Responsibility
26
6.2
CBMG Support
27
6.3
Ownership of Regulatory Documentation
27
6.4
Communication with Regulatory Authorities
27
7
MANUFACTURE
27
7.1
Manufacturing and Supply Agreement
27
7.2
Quality
27
7.3
Costs
28
8
COMMERCIALIZATION
28
8.1
Commercialization
28
8.2
Pharmacovigilance
28
 
 
 
 
9
FINANCIAL PROVISIONS
28
9.1
Collaboration Payments; Product Price
28
9.2
No Projections
29
10
PAYMENT TERMS AND REPORTS
30
10.1
Payment Terms
30
10.2
Currency; Payment Approval
30
10.3
Tax Matters
30
10.4
Permits to Make Payments; Blocked Payments
30
10.5
Records and Audit Rights
31
11
INTELLECTUAL PROPERTY
32
11.1
Ownership
32
11.2
Prosecution and Maintenance
33
11.3
Enforcement
34
11.4
Defense
35
11.5
Recovery
35
11.6
Trademarks
35
11.7
Patent Extensions
35
12
CONFIDENTIALITY
36
12.1
Duty of Confidence
36
12.2
Exceptions
36
12.3
Authorized Disclosures
37
12.4
Terms of this Agreement
37
12.5
Trade Secrets
38
13
TERM AND TERMINATION
39
13.1
Term
39
13.2
Termination for Breach
39
13.3
Termination by Novartis for Change in Applicable Law or Action of a Governmental Entity
40
13.4
Termination by Novartis for Material Safety Issue
40
13.5
Termination by Novartis for Failure to Obtain Required PRC Approvals for DLBCL
40
13.6
Termination by Novartis for Failure to Execute Ancillary Agreements
40
13.7
Termination by Novartis for Quality Audit Failure
41
13.8
Termination by Novartis for Failure to Finalize Tech Transfer Work Plans
41
13.9
Termination by Novartis for Expiration or Termination of an Ancillary Agreement
41
13.1
Termination by Novartis for Change of Control
41
13.11
Termination by Novartis for Third Party Necessary Patent Rights
41
13.12
Termination by Novartis for Termination or Diminishment of License under Novartis Third Party Agreement
41
13.13
Termination by Novartis for Loss of Market Share
41
 
 
 
 
 
13.14
Termination by Novartis for Non-Viability of Product Commercialization
41
13.15
Termination by Novartis for Divestiture of the Product
42
13.16
Termination by Novartis for Wind-Down of Product-Related Activities
42
13.17
Termination for Insolvency
42
14
EFFECTS OF EXPIRATION OR TERMINATION
42
14.1
Effects of Expiration or Termination
42
14.2
Survival
43
14.3
Accrued Obligations
43
14.4
Termination Not Sole Remedy
43
15
REPRESENTATIONS, WARRANTIES, AND COVENANTS
44
15.1
Representations and Warranties by CBMG
44
15.2
Representations and Warranties by Novartis
48
15.3
Mutual Covenants
50
15.4
Covenants by CBMG
51
15.5
No Other Warranties
52
16
INDEMNIFICATION AND LIABILITY
53
16.1
Indemnification by CBMG
53
16.2
Indemnification by Novartis
53
16.3
Indemnification Procedure
54
16.4
Special, Indirect, and Other Losses
55
16.5
No Exclusion
55
17
PUBLICATIONS AND PUBLICITY
56
17.1
Use of Names
56
17.2
Press Releases and Publicity Related to this Agreement
56
17.3
Public Disclosures and Publications Related to the Product
56
17.4
Disclosures Required By Law
56
18
MISCELLANEOUS
57
18.1
Fees and Expenses
57
18.2
Notices
57
18.3
Entire Agreement
58
18.4
Severability
58
18.5
Assignment; Binding Effect
58
18.6
Headings
58
18.7
Waiver and Amendment
59
18.8
Third Party Beneficiaries
59
18.9
Specific Performance and Other Equitable Relief
59
18.10
Negotiation of Agreement
59
18.11
Choice of Law
60
18.12
Arbitration
60
18.13
Waiver of Jury Trial
61
18.14
Performance by Affiliates
61
18.15
Counterparts; Electronic Signatures
61
 
                                                              
 
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Exhibits
 
Exhibit A:                     CBMG Patents
Exhibit B:                    
Clinical Development Plan
Exhibit C:                     Knowledge of CBMG
Exhibit D                      Required PRC Approvals
Exhibit E :                    Manufacturing and Supply Agreement Terms
Exhibit F :                    Form of Invoice
 
 
                                                               
 
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
LICENSE AND COLLABORATION AGREEMENT
 
This LICENSE AND COLLABORATION AGREEMENT (this “ Agreement ”) is made as of September 25, 2018 (the “ Effective Date ”), by and between Novartis Pharma AG, a company ( Aktiengesellschaft ) organized and existing under the laws of Switzerland, having its principal place of business at Lichtstrasse 35, 4056 Basel, Switzerland (“ Novartis ”), Cellular Biomedicine Group, Inc . , a corporation organized and existing under the laws of Delaware, having its principal place of business at 19925 Stevens Creek Blvd., Suite 100, Cupertino, California 95014, USA (“ CBMG Parent ”), Cellular Biomedicine Group HK Ltd., a company organized and existing under the laws of the Hong Kong Special Administrative Region of the People’s Republic of China, whose registered office is at Unit 402, 4 th Floor, Fairmont House, No 8, Cotton Tree Drive, Admiralty, Hong Kong (“ CBMG HK ”), Cellular Biomedicine Group (Wuxi) Ltd. ( 西比曼生物科技(无锡)有限公司 ), a company organized and existing under the laws of the PRC whose legal address is located at 1699 Huishan Boulevard, Room 1103, Huishan High Tech Park, Wuxi, China (“ CBMG Wuxi ”), Cellular Biomedicine Group Ltd. (Shanghai) Ltd. ( 西比曼生物科技(上海)有限公司 ), a company organized and existing under the laws of the PRC whose legal address is located at 333 Guiping Road, Building No.1 F6, Xuhui District, Shanghai, China (“ CBMG Shanghai ”), and Shanghai Cellular Biopharmaceutical Group Ltd. ( 上海赛比曼生物科技有限公司 ), a company organized and existing under the laws of the PRC, whose legal address is located at 85 Faladi Road, Building No.3, China (Shanghai) Pilot Free Trade Zone, Shanghai, China (“ Shanghai Cellular ”) (CBMG HK, CBMG Wuxi, CBMG Shanghai, and Shanghai Cellular, collectively, the “ CBMG Subsidiaries ”) (the CBMG Subsidiaries, together with CBMG Parent, “ CBMG ”). Novartis, CBMG Parent, and CBMG Subsidiaries are each referred to individually as a “ Party ” and, collectively, as the “ Parties .”
 
RECITALS
 
WHEREAS, CBMG and Novartis desire to enter into a collaboration under which CBMG will become Novartis’s collaboration partner and manufacturer of the Product in the Territory (as such terms are defined below);
 
WHEREAS, CBMG will manufacture and supply the Product in the Territory for use by Novartis, its Affiliates, and its designees in the Territory, on the terms and conditions set forth in this Agreement and the Ancillary Agreements (as such terms are defined below);
 
WHEREAS, concurrently with the execution and delivery of this Agreement, CBMG and Novartis are entering into that certain Share Purchase Agreement, pursuant to which Novartis will purchase from CBMG Parent, and CBMG Parent will sell to Novartis, a certain number of shares of CBMG’s common stock, par value $.001 per share (the “ Share Purchase Agreement ”); and
 
WHEREAS, subject to the terms of this Agreement, each Party is relying on the other Party with regard to its satisfaction of all legal, regulatory, contractual, and other obligations, and each Party will act independently in accordance with this Agreement and all Applicable Laws.
 
NOW, THEREFORE, in consideration of the foregoing, the representations, warranties, obligations, and agreements set forth in this Agreement, and other good and valuable consideration, the adequacy and receipt of which hereby are acknowledged, and intending to be legally bound hereby, the Parties hereby agree as follows:
 
                                                              
 
1
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
1.   DEFINITIONS AND INTERPRETATION
 
1.1   Definitions.
 
  When used in this Agreement, except as otherwise expressly provided herein, the following terms shall have the meanings set forth or referenced below.
 
Accounting Standards   means, with respect to Novartis, IFRS and, with respect to CBMG, GAAP, in each case, as generally and consistently applied throughout such Party’s organization. Each Party shall promptly notify the other Party in the event that it changes the Accounting Standards pursuant to which its records are maintained, it being understood that each Party may only use internationally recognized accounting principles ( e.g. , IFRS, GAAP, etc.).
 
Action ” means any action, suit, arbitration, or other proceeding, whether civil, criminal, or administrative, at law or in equity by or before any Governmental Entity.
 
Additional Indication ” means any Indication other than the Initial Indications.
 
Additional Indication Clinical Development Costs ” means Clinical Development Costs incurred by or on behalf of the Parties in connection with the Development of the Product for an Additional Indication in the Territory.
 
Affiliate ” means, with respect to a Person, any other Person that controls, is controlled by, or is under common control with such Person. For purposes of this Agreement, a Person will be deemed to control another Person if it owns or controls, directly or indirectly, more than fifty percent (50%) of the Equity Securities of such other Person entitled to vote in the election of directors (or, in the case that such other Person is not a corporation, for the election of the corresponding managing authority), or otherwise has the power to direct the management and policies of such other Person (including any PRC domestic capital companies not controlled through ownership of Equity Securities but through contracts under a VIE structure). The Parties acknowledge that, in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage will be substituted in the preceding sentence; provided , that such foreign investor has the power to direct the management and policies of such entity.
 
Agreement ” has the meaning set forth in the first paragraph of this Agreement.
 
Alliance Manager   has the meaning set forth in Section 3.1 .
 
Ancillary Agreements ” means the Manufacturing and Supply Agreement, the Share Purchase Agreement, the Pharmacovigilance Agreement, and any other agreements entered into by Novartis and CBMG or their respective Affiliates in connection with this Agreement.
 
 
                                                              
 
2
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Anti-Corruption Laws ” has the meaning set forth in the definition of “ Applicable Law .”
 
Applicable Law ” means, individually and collectively, any federal, state, local, national, and supra-national laws, treaties, statutes, ordinances, rules, and regulations, including any rules, regulations, guidance, guidelines, circulars, officially announced policies of any Governmental Entity(ies), and requirements of any national securities exchange or securities listing organization having the binding effect of law, including: (a) those in effect in the Territory (“ Applicable PRC Law ”); (b) cGCP, cGLP, and cGMP; and (c) those concerning bribery, corruption, or illegal payments and gratuities, including the United States Foreign Corrupt Practices Act, the Hong Kong Prevention of Bribery Ordinance, the UK Bribery Act 2010, the PRC Criminal Law, the PRC Unfair Competition Law, the Interim Regulations on Prohibition of Commercial Bribery issued by the SAIC, and any Applicable PRC Laws similar to any of the foregoing (“ Anti-Corruption Laws ”).
 
Applicable PRC Law ” has the meaning set forth in the definition of “ Applicable Law .”
 
Acquirer ” means, collectively, the Third Party referenced in the definition of Change of Control and such Third Party’s Affiliates, other than the applicable Party in the definition of Change of Control and such Party’s Affiliates, determined immediately prior to the closing of such Change of Control or the entry into a definitive agreement providing for a transaction or series of transactions that would constitute a Change of Control, as applicable.
 
Aggregate Deferral Amount ” has the meaning set forth in Section 5.5(c)(i)(B) .
 
Arbitrators ” has the meaning set forth in Section 18.12(a) .
 
Audited Party ” has the meaning set forth in Section  10.5 .
 
Auditing Party ” has the meaning set forth in Section  10.5 .
 
Auditor ” has the meaning set forth in Section  10.5 .
 
Business Day ” means a day other than a Saturday, Sunday, or a bank or other public holiday in Basel, Switzerland, New York, New York, or Shanghai, PRC.
 
Calendar Quarter ” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1, and October 1, except that the first (1 st ) Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first (1 st ) to occur of January 1, April 1, July 1, or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term.
 
Calendar Year ” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first (1 st ) Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs, and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.
 
 
                                                              
 
3
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
CAPAs ” has the meaning set forth in Section 7.2 .
 
CBMG ” has the meaning set forth in the first paragraph of this Agreement.
 
CBMG HK ” has the meaning set forth in the first paragraph of this Agreement.
 
CBMG Background Intellectual Property ” means any and all Patent Rights, Know-How, and other intellectual property rights: (a) in existence and Controlled by CBMG or its Affiliates as of the Effective Date; or (b) that arise outside of activities under this Agreement and the Ancillary Agreements and are Controlled by CBMG or its Affiliates after the Effective Date.
 
CBMG Collaboration Technology ” means: (a) any and all Know-How, compounds, data, derivatives, designs, developments, discoveries, enhancements, inventions, materials, modifications, molecules, new uses, processes, products, research results, sequences, techniques, writings, or other technology rights, whether or not patentable, in each case, that are invented, conceived, reduced to practice, or otherwise developed in the course of activities under this Agreement or any Ancillary Agreement solely by or on behalf of CBMG; and (b) any and all Patent Rights and other intellectual property rights in any of the foregoing.
 
CBMG Indemnitees ” has the meaning set forth in Section  16.1 .
 
CBMG Know-How ” means any Know-How Controlled by CBMG or any of its Affiliates as of the Effective Date or thereafter during the Term or the term of any Ancillary Agreement, as applicable (including with respect to any CBMG Collaboration Technology and CBMG’s interest in any Joint Collaboration Technology) which is: (a) necessary or useful for the Development, Manufacture, or Commercialization of the Product; or (b) related to CBMG’s serum-free medium or viral vectors.
 
CBMG Other CART ” means any CART therapy owned or controlled by CBMG other than any CART therapy targeting CD-19.
 
CBMG Parent ” has the meaning set forth in the first paragraph of this Agreement.
 
CBMG Patents ” means any Patent Rights Controlled by CBMG or any of its Affiliates as of the Effective Date or thereafter during the Term or the term of any Ancillary Agreement, as applicable (including with respect to any CBMG Collaboration Technology and CBMG’s interest in any Joint Collaboration Technology) which include claims that are: (a) necessary or useful for the Development, Manufacture, or Commercialization of the Product; or (b) related to CBMG’s serum-free medium or viral vectors, including the Patent Rights identified on Exhibit A .
 
CBMG Production Costs ” has the meaning set forth on Schedule 9.1(e) .
 
CBMG Shanghai ” has the meaning set forth in the first paragraph of this Agreement.
 
CBMG Subsidiaries ” has the meaning set forth in the first paragraph of this Agreement.
 
 
                                                              
 
4
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
CBMG Technology ” means the CBMG Know-How and the CBMG Patents.
 
CBMG Technology Tech Transfer Plan ” has the meaning set forth in Section 15.3(a) .
 
CBMG Trade Secrets ” has the meaning set forth in Section 12.5(a) .
 
CBMG Wuxi ” has the meaning set forth in the first paragraph of this Agreement.
 
CDA ” means that certain Confidentiality Agreement, by and between Novartis and CBMG Parent, dated December 4, 2017.
 
cGCP ” means the then-current ethical, scientific, and quality standards required by the FDA for designing, conducting, recording, and reporting trials that involve the participation of human subjects, as set forth in FDA regulations in 21 C.F.R. Parts 11, 50, 54, 56, and 312 and related FDA guidance documents, by the International Conference on Harmonization E6: Good Clinical Practices Consolidated Guideline, and as otherwise required by the SAMR, including those set out in, or issued pursuant to, the Drug Operation Quality Administrative Standards issued by the SAMR.
 
cGLP ” means the then-current good laboratory practices as required by the FDA under 21 C.F.R. Part 58 and all applicable FDA rules, regulations, orders, and guidances, and the requirements with respect to current good laboratory practices prescribed by the European Community, the OECD (Organization for Economic Cooperation and Development Council) and the ICH Guidelines, or as otherwise required by the SAMR, including those set out in, or issued pursuant to, the Non-Clinical Drug Research Quality Administrative Standards issued by the SAMR.
 
cGMP ” means the then-current good manufacturing practices as required by the FDA under 21 C.F.R. Parts 210 and 211 and all applicable FDA rules, regulations, orders, and guidances, and the requirements with respect to current good manufacturing practices prescribed by the European Community under provisions of The Rules Governing Medicinal Products in the European Community, Volume 4, Good Manufacturing Practices, Guidelines on Good Manufacturing Practices specific to Advanced Therapy Medicinal Products, or as otherwise required by the SAMR, including under the Quality Administrative Standard for Drug Manufacturing, any requirements issued pursuant to the Regulation of Drug Manufacturing Administrative Procedures issued by the SAMR, or the appendix thereto for biochemical drugs.
 
Change of Control   means, with respect to a Party: (a) a merger or consolidation of such Party or its parent company with a Third Party that results in the voting securities of such Party or its parent company outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity or the parent company of the surviving entity immediately after such merger or consolidation; (b) a transaction or series of related transactions pursuant to which a Third Party, together with its Affiliates, becomes the direct or indirect beneficial owner of more than fifty percent (50%) of the combined voting power of the outstanding securities of such Party or its parent company; or (c) the sale or other transfer to a Third Party of all or substantially all of such Party’s and its controlled Affiliates’ assets.
 
                                                              
 
5
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Claim   means any action, cause of action, claim, demand, proceeding, suit, or judgment brought by a Third Party.
 
Clinical Development ” means any and all pre-clinical and clinical drug or biologic development activities conducted before or after obtaining Regulatory Approval that are reasonably related to or which lead to the development, preparation, and submission of data and information to a Regulatory Authority for the purpose of obtaining, supporting, or expanding Regulatory Approval or to the appropriate body for obtaining, supporting, or expanding pricing approval, including all activities related to pharmacokinetic profiling, design, and conduct of Clinical Studies, regulatory affairs, statistical analysis, report writing, and regulatory filing creation and submission (including the services of outside advisors and consultants in connection therewith). “ Clinical Development ” does not include Technical Development.
 
Clinical Development Budget   means the budget for the Parties’ Clinical Development of the Product, which budget is included in the Clinical Development Plan.
 
Clinical Development Costs ” means the direct costs incurred by or on behalf of a Party or its Affiliates during the Term and pursuant to this Agreement for the Clinical Development of the Product, calculated as the sum of: [***].
 
Clinical Development Plan ” means the Clinical Development plan, including the Clinical Development Budget, attached as Exhibit B and any amendments thereto, as in effect from time to time in accordance with this Agreement, outlining the goals, activities, timelines, deliverables, allocation of responsibilities between the Parties, and the commitment of resources by the respective Parties with respect to the Clinical Development of the Product for purposes of obtaining Regulatory Approval in the PRC.
 
Clinical Study ” means a study in humans to obtain information regarding a product which is authorized by the SAMR, the FDA, or other applicable Regulatory Authority, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging, or efficacy of the product.
 
Collaboration Payment Term   has the meaning set forth in Section  9.1(b) .
 
Collaboration Technology ” means, collectively, the CBMG Collaboration Technology, the Novartis Collaboration Technology, and the Joint Collaboration Technology.
 
Combination Product ” has the meaning set forth in the definition of “ Net Sales .”
 
Commercialize   means to market, promote, distribute, import, export, offer to sell, or sell a pharmaceutical or biological product or conduct other commercialization activities, and “ Commercialization ” means marketing, promoting, distributing, importing, exporting, offering for sale, selling, or other commercialization activities with respect to a pharmaceutical or biological product.
 
                                                              
 
6
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Competing Infringement ” has the meaning set forth in Section  11.3(a) .
 
Competing Product   means any CART therapy targeting CD-19 other than the Product.
 
Confidential Information ” means any and all confidential or proprietary information and data and all other scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial, and commercial information or data, whether communicated in writing or orally or by any other method, which is or has been provided by or on behalf of one (1) Party to the other Party or its designee in connection with this Agreement. “Confidential Information” includes the following, which are transferred, disclosed, or made available by the disclosing Party: confidential and proprietary technical and commercial information, Know-How, amino acid and nucleic acid sequences, biochemical, cell-based, and animal assays, animal models, dosages, dosage schedules, drawings, specifications, models, or designs relating to development, manufacture, production, registration, promotion, distribution, marketing, performance, or sale(s); experimental, manufacturing, process, analytical, packaging, product, warehousing, quality control, and quality assurance and marketing specifications, standards, procedures, processes, methods, instructions, and techniques, samples, prototypes, formulae, writings of any kind, opinions, or otherwise unwritten data or in the form of computer software or computer programs; biological, chemical, or physical materials provided under this Agreement; and reports provided under this Agreement.
 
Contract ” means any written contract, agreement, or commitment.
 
Control ” or “ Controlled ” means, with respect to any Patent Rights, Know-How, or other intellectual property right, the possession, legal authority, or right (whether by ownership, license, or sublicense, other than by a license, sublicense, or other right granted (but not assignment) pursuant to this Agreement) by a Party of the ability to assign or grant to the other Party the licenses, sublicenses, or rights to access and use or disclose such Patent Rights, Know-How, or other intellectual property right as provided for in this Agreement, without paying any consideration to any Third Party (now or in the future) or violating the terms of any agreement or other arrangement with any Third Party in existence as of the time such Party would be required hereunder to grant such license, sublicense, or rights of access and use.
 
Cover ,” “ Covering ,” or “ Covered ” means, with respect to the Product, that, but for a license granted to a Person under a claim included in a Patent Right, the Development, Manufacture, or Commercialization of the Product by such Person would infringe, or contribute to or induce the infringement of, such claim, or with respect to a patent application, as if such claim was contained in an issued patent.
 
Data Protection Laws ” means any Applicable Law concerning the protection or processing or both of personal data, including the PRC Constitution, People’s Republic of China General Principles of Civil Law effective January 1, 1987, Opinions of the Supreme People’s Court on Several Issues Concerning the Implementation of the People’s Republic of China General Principles of Civil Law (Trial) effective January 26, 1988, People’s Republic of China Regulations on Employment Services and Employment Management (effective January 1, 2008), People’s Republic of China Tortious Liability Law (effective July 1, 2010), Regulating the Internet Information Service Market Order Several Provisions (effective March 15, 2012), Decision of the Standing Committee of the National People’s Congress on the Strengthening of the Protection of Network Information (effective December 28, 2012), Information Security Technology Guidelines on Personal Information Protection within Information Systems for Public and Commercial Services (effective February 1, 2013), Protection of Personal Information of Telecommunications and Internet Users Provisions (effective September 1, 2013), Amendments to the Consumer Protection Law (effective March 15, 2014), Amendments to the People’s Republic of China Criminal Law (9th set of amendments) (effective November 1, 2015), People’s Republic of China Cyber Security Law (effective June 1, 2017), People’s Republic of China General Provisions of Civil Law (effective October 1, 2017), and other Applicable Laws relating to data protection and privacy.
 
                                                              
 
7
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Deferral Amount ” has the meaning set forth in Section 5.5(c)(i)(B) .
 
Deferral Election ” has the meaning set forth in Section 5.5(c)(i)(B) .
 
Develop   or “ Development   means Clinical Development or Technical Development, as the context requires.
 
Development Budget ” means the Clinical Development Budget or the Technical Development Budget, as the context requires.
 
Development Costs ” means Clinical Development Costs or Technical Development Costs, as the context requires.
 
Development Plan ” means the Clinical Development Plan or the Technical Development Plan, as the context requires.
 
Dispute ” has the meaning set forth in Section 18.12(a) .
 
DLBCL ” means diffuse large B-cell lymphoma.
 
Effective Date ” has the meaning set forth in the first paragraph of this Agreement.
 
Equity Securities ” means, with respect to any Person that is a legal entity, any and all shares of capital stock, membership interests, units, profits interests, ownership interests, equity interests, registered capital, and other equity securities of such Person, and any right, warrant, option, call, commitment, conversion privilege, preemptive right or other right to acquire any of the foregoing, or security convertible into, exchangeable or exercisable for any of the foregoing, or any Contract providing for the acquisition of any of the foregoing.
 
FDA ” means the United States Food and Drug Administration, any successor entity thereto in the United States, or any equivalent entity outside of the United States, as applicable.
 
                                                              
 
8
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
FD&C Act ” means the United States Federal Food, Drug, and Cosmetic Act.
 
Field ” means the treatment, prevention, or diagnosis of all indications in humans.
 
Finance Officers ” has the meaning set forth in Section 5.5(c) .
 
First Commercial Sale ” means the first commercial sale in an arms’-length transaction of the Product to a Third Party by Novartis or any of its Affiliates in the Territory following receipt of applicable Regulatory Approval of the Product. For clarity, “First Commercial Sale” shall not include any distribution or other sale solely for patient assistance, named patient use, compassionate use, or test marketing programs, or non-registrational studies or similar programs or studies where the Product is supplied without charge or at the actual Manufacturing cost thereof (without allocation of indirect costs or any markup).
 
FTE ” means a full-time scientific equivalent person (i.e., one (1) fully-dedicated or multiple partially-dedicated employees aggregating to one (1) full-time employee employed or contracted by Novartis or CBMG, or their respective Affiliates, as applicable) based upon a total of [***] working hours per year (taking into account normal vacations, sick days and holidays at the Party they are employed and not being considered working days), undertaken in connection with the conduct of Development in accordance with the Development Plan. For clarity: (a) personnel who directly support Development activities (including data managers and clinical planning managers) shall constitute FTEs; and (b) personnel who do not directly support Development activities (including support functions such as managerial, financial, legal, or business development) shall not constitute FTEs.
 
FTE Costs ” means the product of: (a) the actual number of FTEs utilized in the Development of the Product in accordance with the Development Plan (including the Development Budget) after the Effective Date, as documented by the applicable Party using a reliable time tracking system; and (b) the FTE Rate.
 
FTE Rate ” means: (a) with respect to FTEs in the U.S., Switzerland, and the European Union (including, for the avoidance of doubt, the United Kingdom), the rate of [***] during Calendar Year 2018, such amount to be adjusted as of January 1, 2019 and annually thereafter by the percentage increase or decrease, if any, in the Consumer Price Index for All Urban Consumers (CPI-U) for the U.S. City Average, 1982-84 = 100, calculated by the Bureau of Labor Statistics of the U.S. and available at https://www.bls.gov/regions/new-england/data/consumerpriceindex_us_table.htm; and (b) with respect to FTEs in the PRC, the rate of [***] during Calendar Year 2018, such amount to be adjusted as of January 1, 2019 and annually thereafter by the percentage increase or decrease, if any, in the China Consumer Price Index – Health Cares, as reported by the National Bureau of Statistics of China and available at http://data.stats.gov.cn/english/easyquery.htm?cn=A01. For the avoidance of doubt, such rate is intended to cover the cost of salaries, benefits, infrastructure costs, travel, general laboratory or office supplies, postage, insurance, training, and all other general expenses and overhead items. Notwithstanding the foregoing, for any Calendar Year during the Term that is less than a full year, the above referenced rate shall be proportionately reduced to reflect such portion of FTEs for such full Calendar Year.
 
                                                              
 
9
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
GAAP ” means generally accepted accounting principles as practiced in the United States, as consistently applied.
 
Generic Version   means, with respect to the Product, a product (including a “biogeneric,” “follow-on biologic,” “follow-on biological medicine or product,” “similar biological medicine or product,” or “biosimilar product”) that is determined by the applicable Regulatory Authority or by Applicable Law to be “similar,” “comparable,” “interchangeable,” “bioequivalent,” or “biosimilar” to the Product.
 
Governmental Entity ” means any federal, state, local or foreign government, regulatory, legislative, or administrative body, or any agency, bureau, board, commission, court, department, tribunal, or other instrumentality thereof, including any Regulatory Authority.
 
Healthcare Laws ” means all Applicable Laws (including Applicable PRC Laws) that govern the research, development, testing, manufacture, handling, packaging, labeling, storage, promotion, marketing, sales, distribution, import, export, or any other use with respect to any product or product candidate, including the FD&C Act; the Public Health Service Act; the federal False Claims Act; the federal Anti-Kickback Statute; the Civil Monetary Penalty Statute; the Stark Law; the Health Insurance Portability and Accountability Act of 1996 (HIPAA); Physicians Payments Sunshine Act (Title XI of Social Security Act); the Medicare Program (Title XVIII of the Social Security Act); the Medicaid Program (Title XIX of the Social Security Act); Federal Sentencing Guidelines for Organizations; the Health Information Technology for Economic and Clinical Health Act (HITECH); the Clinical Laboratories Improvement Act (CLIA); all regulations promulgated or enforced thereunder; and analogous Applicable Law to the foregoing in any jurisdiction.
 
ICC ” has the meaning set forth in Section 18.12(b) .
 
IFRS ” means International Financial Reporting Standards, the set of accounting standards and interpretations as promulgated by the International Standards Accounting Board and as they may be updated for time to time, as consistently applied.
 
IND   means an investigational new drug application, clinical trial application, or similar application or submission for approval to conduct Clinical Studies filed with or submitted to a Regulatory Authority in the Territory in conformance with the requirements of such Regulatory Authority, and any amendments thereto.
 
Indemnification Claim Notice ” has the meaning set forth in Section  16.3(b) .
 
Indemnified Party ” has the meaning set forth in Section  16.3(b) .
 
Indemnifying Party ” has the meaning set forth in Section  16.3(b) .
 
                                                              
 
10
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Indemnitee ” means a CBMG Indemnitee or a Novartis Indemnitee, as the context requires.
 
Indication ” means a disease or pathological condition for which clinical results for such disease or condition and a separate MAA or a supplement (or other addition) to an existing MAA is required for the purpose of obtaining Regulatory Approval in the Territory.
 
Initial Indications ” means DLBCL and pALL.
 
Initial Indication Clinical Development Costs ” means Clinical Development Costs incurred by or on behalf of the Parties in connection with the Development of the Product for an Initial Indication in the Territory.
 
Initial Term ” has the meaning set forth in Section 13.1 .
 
Insolvency Event   means, in relation to either Party or an Affiliate thereof, as the case may be, any one (1) of the following: (a) that Party is the subject of voluntary or involuntary bankruptcy proceedings instituted on behalf of or against such Party (except for involuntary bankruptcy proceedings which are dismissed within sixty (60) days, or withdrawn or terminated prior to the declaration of insolvency of such Party); (b) an administrator, administrative receiver, receiver and manager, interim receiver, custodian, sequestrator, or similar officer is appointed in respect of that Party (collectively, the “ Receiver ”) and that Party has not caused the underlying action or the Receiver to be dismissed within sixty (60) days after the Receiver’s appointment; (c) the board of directors or shareholders’ meeting of such Party has passed a resolution to wind up or deregister that Party (or other through a process whereby the business is terminated and assets of such Party are distributed amongst the creditors, equityholders, or investors), or such a resolution shall have been passed, other than a resolution for the solvent reconstruction or reorganization of that Party; (d) a resolution shall have been passed by that Party or that Party’s directors or shareholders to make an application for an administration order or to appoint an administrator, liquidation committee, group, or similar body or Person; (e) that Party makes a general assignment, composition, or arrangement with or for the benefit of all or the majority of that Party’s creditors, or makes, suspends, or threatens to suspend making payments to all or the majority of that Party’s creditors; (f) any distress, execution, sequestration, or other similar process being levied or enforced upon or sued upon against the property or assets of that Party that is not discharged within seven (7) days; (g) that Party cannot repay debts that have fallen due, or its assets are insufficient to pay all of its debts, or it manifestly lacks the ability to repay its debts; or (h) in the case of any Person in the PRC, a Governmental Entity cancels or withdraws any Permit needed for that Party or its Affiliate to operate, or orders the dissolution of such Party or its Affiliate as a result of, or in connection with, any non-compliance with Applicable PRC Law.
 
JOC Co-Chairs ” has the meaning set forth in Section 3.2(b) .
 
Joint Collaboration Technology ” means: (a) any and all Know-How, compounds, data, derivatives, designs, developments, discoveries, enhancements, inventions, materials, modifications, molecules, new uses, processes, products, research results, sequences, techniques, writings, or other technology rights, whether or not patentable, in each case, that are invented, conceived, reduced to practice, or otherwise developed in the course of activities under this Agreement or any Ancillary Agreement jointly by or on behalf of both Parties; and (b) any and all Patent Rights and other intellectual property rights in any of the foregoing.
 
                                                              
 
11
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Joint Oversight Committee ” or “ JOC ” means the committee established under Section  3.2 .
 
Know-How ” means all commercial, technical, scientific, and other know-how and information, biochemical, cellular, and animal assays, animal models, trade secrets, knowledge, technology, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, specifications, data and results (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical, and analytical, preclinical, clinical, safety, Manufacturing, and quality control data and know-how, including regulatory data, study designs, and protocols), and materials, in all cases, in written, electronic, or any other form now known or hereafter developed.
 
Knowledge ” means, with respect to CBMG, the actual knowledge of those Persons listed in Exhibit C after due inquiry.
 
Look-Back Date ” has the meaning set forth in Section 15.1(e) .
 
Loss of Market Share ” means, with respect the Product in the Territory, that: (a) [***] Generic Versions of the Product has been sold by any Third Party in the Territory; (b) the Net Sales of the Product in any Calendar Quarter are less than [***] as compared with the Net Sales of the Product in the corresponding Calendar Quarter in the immediately preceding Calendar Year ( e.g. , the fourth (4 th ) Calendar Quarter of Calendar Year 2018 as compared to the fourth (4 th ) Calendar Quarter of Calendar Year 2017); or (c) the sale of the Product in the Territory is not Covered by a Valid Claim in the Territory.
 
Losses ” means any and all liability, damage, loss, cost, or expense of any nature (including reasonable attorneys’ fees and litigation expenses).
 
MAA   means an application for the authorization to market the Product in the Territory, as defined by Applicable Law and regulations and filed with the applicable Regulatory Authority.
 
Manufacture ” or “ Manufacturing ” means all activities related to the manufacture of a pharmaceutical or biological product, including manufacturing supplies, for Development or Commercialization, packaging, in-process and finished product testing, release of product or any component or ingredient thereof, quality assurance and quality control activities related to manufacturing and release of product, ongoing stability tests, storage, shipment, and regulatory activities related to any of the foregoing.
 
                                                              
 
12
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Manufacturing and Supply Agreement ” means a manufacturing and supply agreement to be entered into after the Effective Date that contains the terms and conditions set forth on Exhibit E .
 
Margin ” has the meaning set forth in Section 9.1(e) .
 
MOFCOM ” means the Ministry of Commerce of the PRC and its local authorized bodies.
 
MOST ” means the Ministry of Science and Technology of the PRC and its local authorized bodies.
 
Net Sales ” means the net sales recorded by Novartis or any of its Affiliates or sublicensees, excluding distributors and wholesalers, for any Product sold to Third Parties other than sublicensees in the Territory as determined in accordance with Novartis’s Accounting Standards as consistently applied, less a deduction of [***] for direct expenses related to the sales of the Product, distribution and warehousing expenses, and uncollectible amounts on previously-sold products.
 
(a)   The deductions booked on an accrual basis by Novartis and its Affiliates under its Accounting Standards to calculate the recorded net sales from gross sales include the following:
 
[***]
 
(b)   With respect to the calculation of Net Sales:
 
             [***]
 
 “ Novartis ” has the meaning set forth in the first paragraph of this Agreement.
 
Novartis Background Intellectual Property ” means any and all Patent Rights, Know-How, and other intellectual property rights: (a) in existence and Controlled by Novartis or its Affiliates as of the Effective Date; or (b) that arise outside of activities under this Agreement and the Ancillary Agreements and are Controlled by Novartis or its Affiliates after the Effective Date.
 
Novartis Collaboration Technology ” means: (a) any and all Know-How, compounds, data, derivatives, designs, developments, discoveries, enhancements, inventions, materials, modifications, molecules, new uses, processes, products, research results, sequences, techniques, writings, or other technology rights, whether or not patentable, in each case, that are invented, conceived, reduced to practice, or otherwise developed in the course of activities under this Agreement or any Ancillary Agreement solely by or on behalf of Novartis; and (b) any and all Patent Rights and other intellectual property rights in any of the foregoing.
 
Novartis Data Protection and Information Security Requirements ” means the requirements set forth on Schedule 15.4(c) .
 
                                                              
 
13
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Novartis Indemnitees ” has the meaning set forth in Section  16.2 .
 
Novartis Know-How ” means any Know-How Controlled by Novartis or any of its Affiliates as of the Effective Date or thereafter during the Term or the term of any Ancillary Agreement, as applicable, that is necessary for the Development or Manufacture of the Product.
 
Novartis Patents ” means any Patent Rights Controlled by Novartis or any of its Affiliates as of the Effective Date or thereafter during the Term or the term of any Ancillary Agreement, as applicable, which include claims that are necessary for the Development or Manufacture of the Product.
 
Novartis Technology ” means the Novartis Know-How and the Novartis Patents.
 
Novartis Third Party Agreements ” means any agreement between Novartis or an Affiliate thereof, on the one hand, and a Third Party, on the other hand, which is set forth on Schedule 2.6(b) .
 
Novartis Trade Secrets ” has the meaning set forth in Section 12.5(a) .
 
Order ” means any order, injunction, ruling, writ, judgment, or decree of any Governmental Entity.
 
Other Development Expenses ” means any expenses incurred for clinical materials, analytical services, or other items, in each case, to the extent provided in the Development Plan.
 
Out-of-Pocket Costs ” means direct expenses, other than Other Development Expenses, paid or payable to Third Parties which are specifically identifiable and incurred by a Party or its Affiliates for the Development of the Product in accordance with the Development Plan; provided , that such expenses shall have been recorded as income statement items in accordance with such Party’s Accounting Standards and shall not include: (a) any expenses relating to management, human resources, or finance personnel; or (b) any pre-paid amounts, capital expenditures (including amortization thereof), or items intended to be covered by the FTE Rate.
 
pALL ” means pediatric acute lymphoblastic leukemia.
 
Party ” or “ Parties ” has the meaning set forth in the first paragraph of this Agreement.
 
Patent Extensions ” has the meaning set forth in Section 11.7 .
 
Patent Rights ” means all patents and patent applications and all substitutions, divisions, continuations, and continuations-in-part, any patent issued with respect to any such patent applications, any reissue, reexamination, utility models, or designs, renewal, or extension (including any supplementary protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all counterparts thereof.
 
                                                              
 
14
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Permit ” means all clearances, orders, declarations, approvals, authorizations, qualifications, registrations, filings, certifications, consents, licenses, waivers, and permits required by any Governmental Entity(ies) or under Applicable Law.
 
Person   means any natural person, corporation, unincorporated organization, partnership, association, sole proprietorship, joint stock company, joint venture, limited liability company, trust, government, or Regulatory Authority, or any other similar entity.
 
Pharmacovigilance Agreement ” has the meaning set forth in Section  8.2 .
 
PRC ” means the People’s Republic of China, excluding the Hong Kong Special Administrative Region, the Macau Special Administrative Region, and Taiwan.
 
Product ” means Novartis’s proprietary CD-19 targeting CART therapy, generically known as tisagenlecleucel.
 
Product Marks ” has the meaning set forth in Section  11.6 .
 
Product Price ” has the meaning set forth in Section 9.1(e) .
 
Product Tech Transfer Plan ” has the meaning set forth in Section 15.3(a) .
 
Prohibited Fund ” has the meaning set forth in Section 15.1(h)(iv) .
 
Prohibited Payment ” has the meaning set forth in Section 15.1(h)(ii) .
 
Prosecution and Maintenance ” or “ Prosecute and Maintain ” means, with respect to a Patent Right, the preparation, filing, prosecution, and maintenance of such Patent Right, and re-examinations, reissues, and appeals with respect to such Patent Right, together with the initiation or defense of interferences, oppositions, or other similar proceedings with respect to the particular Patent Right, and any appeals therefrom. For clarity, “Prosecution and Maintenance” or “Prosecute and Maintain” shall not include any other enforcement actions taken with respect to a Patent Right.
 
Quality Audit ” has the meaning set forth in Section 7.2 .
 
Receiver ” has the meaning set forth in the definition of “ Insolvency Event .”
 
Regulatory Approval   means, with respect to the Product in the Territory, all approvals, registrations, licenses, or authorizations from a Regulatory Authority in the Territory that are necessary to market and sell the Product in the Territory.
 
Registration Authority ” has the meaning set forth in Section 15.3(b) .
 
Regulatory Documentation ” means all: (a) documentation comprising Regulatory Filings, marketing authorizations, Regulatory Approvals, or other Permits for any product or product candidate of CBMG or its Affiliates (or, after the Effective Date, the Product), and including pre-clinical and clinical data and information, regulatory materials, drug dossiers, master files (including Drug Master Files, as defined in 21 C.F.R. Part 314.420 and any non-U.S. equivalents), and any other reports, records, regulatory correspondence, and other materials relating to Development or Regulatory Approval for any product or product candidate of CBMG or its Affiliates (or, after the Effective Date, the Product), or required to manufacture or commercialize any product or product candidate of CBMG or its Affiliates (or, after the Effective Date, the Product), including any information that relates to pharmacology, toxicology, chemistry, manufacturing, and controls data, batch records, safety, and efficacy, and any safety database; and (b) material correspondence and other filings relating to any product or product candidate of CBMG or its Affiliates (or, after the Effective Date, the Product) submitted to or received from any Governmental Entity (including minutes and official contact reports relating to any communications with any Governmental Entity) and relevant supporting documents submitted to or received from Governmental Entities with respect thereto, including all regulatory drug lists, final versions of advertising and promotion documents, adverse event files and complaint files.
 
                                                              
 
15
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Regulatory Filings ” means any submission to a Regulatory Authority of any appropriate regulatory application (including any IND or MAA), including any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.
 
Regulatory Requirements ” has the meaning set forth in Section 15.1(g)(i) .
 
Relevant Affiliate ” means, as to either of the Parties, and as the context requires, any Affiliate of such Party that is intended to be a signatory to any of the Ancillary Agreements.
 
Renewal Term ” has the meaning set forth in Section 13.1 .
 
Representatives ” means, as to any Person, such Person’s or its Affiliates’ officers, managers, directors, employees, agents, and advisors (including attorneys, accountants, and financial advisors).
 
Required PRC Approvals ” means all Permits required for the performance of the Parties’ obligations under this Agreement and the Ancillary Agreements under Applicable PRC Law set forth on Exhibit D .
 
Restricted Activities ” has the meaning set forth in Section 2.5(b)(ii) .
 
ROFN Activities ” has the meaning set forth in Section 2.5(b)(ii) .
 
ROFN Notice ” has the meaning set forth in Section 2.5(b)(ii) .
 
Rules ” has the meaning set forth in Section 18.12(b) .
 
SAFE ” means the State Administration of Foreign Exchange of the PRC and its local authorized bodies.
 
                                                              
 
16
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
SAIC ” means the former State Administration of Industry and Commerce, now part of SAMR.
 
Sales & Collaboration Payment Report   means a written report showing each of: (a) the Net Sales of the Product in the Territory during the reporting period by Novartis and its Affiliates and sublicensees; and (b) the collaboration payments payable, in USD, which shall have accrued under this Agreement with respect to such Net Sales.
 
SAMR ” means the State Administration of Market Regulation, the Chinese regulatory body in which the former China Food and Drug Administration and SAIC functions have been merged following a restructuring, and, where the context permits, including a reference to the new State Drug Administration, and their local authorized bodies.
 
Senior Officers ” means, with respect to Novartis, CEO, Oncology Business Unit or his/her designee and, with respect to CBMG, CEO or his/her designee.
 
Shanghai Cellular ” has the meaning set forth in the first paragraph of this Agreement.
 
Share Purchase Agreement ” has the meaning set forth in the Recitals.
 
Tech Transfer Work Plans ” means the CBMG Technology Tech Transfer Plan and the Product Tech Transfer Plan.
 
Technical Development ” means any and all technical and Manufacturing-related activities, including test method development and stability testing, assay development, process development, formulation development, quality assurance and quality control development, validation and other testing, packaging development, as well as record-keeping, data and database development, management, storage, and retention activities relating to any of the foregoing.
 
Technical Development Budget   means the budget for the Parties’ Technical Development of the Product, which budget is included in the Technical Development Plan.
 
Technical Development Costs ” means the direct costs incurred by or on behalf of a Party or its Affiliates during the Term and pursuant to this Agreement for the Technical Development of the Product, calculated as the sum of: [***].
 
Technical Development Plan ” means the Technical Development plan, including the Technical Development Budget, to be agreed to by the Parties following the Effective Date and as in effect from time to time in accordance with this Agreement, outlining the goals, activities, timelines, deliverables, allocation of responsibilities between the Parties, and the commitment of resources by the respective Parties with respect to the Technical Development of the Product.
 
Term ” has the meaning set forth in Section 13.1 .
 
Territory   means the PRC.
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Third Party ” means any Person other than a Party or an Affiliate of a Party.
 
Third Party Infringement ” has the meaning set forth in Section 11.4(a) .
 
Transactions ” means the transactions contemplated by this Agreement and the Ancillary Agreements.
 
United States   means the United States of America, its territories, and its possessions.
 
USD ” means the lawful currency of the United States.
 
Valid Claim   means a claim of an issued patent Controlled by Novartis or its Affiliates that has not expired or been revoked or held invalid or unenforceable by a patent office, court, or other governmental agency of competent jurisdiction in the Territory in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period).
 
VIE ” means Variable Interest Entity.
 
1.2   Interpretation
 
.
(a)   When a reference is made to an Article, Section, clause, Schedule, or Exhibit, such reference shall be to an Article, Section, clause, or Schedule of, or Exhibit to, this Agreement unless otherwise indicated.
 
(b)   Whenever the words “include,” “includes,” “including,” or derivative or similar words are used in this Agreement, they shall be deemed to be followed by the words “without limitation.”
 
(c)   Unless the context requires otherwise, words using the singular or plural number also include the plural or singular number, respectively, the use of any gender herein shall be deemed to include the other genders, words denoting natural persons shall be deemed to include business entities and vice versa, and references to a Person are also to its permitted successors and assigns.
 
(d)   The terms “hereof,” “herein,” “hereby,” “hereto,” and derivative or similar words refer to this entire Agreement (including the Exhibits and Schedules hereto) and not merely to the specific Section, paragraph, or clause in which such word appears, and references to “the date hereof” means the date of this Agreement.
 
(e)   The phrase “to the extent” shall mean the degree to which a subject or other thing extends, and such phrase shall not mean simply “if.”
 
(f)   Unless the context requires otherwise, the word “or” shall be interpreted to mean “and/or.”
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(g)   A reference to any period of days shall be deemed to be to the relevant number of calendar days, unless the defined term “Business Day(s)” is used.
 
(h)   With respect to the determination of any period of time, unless otherwise set forth herein, “from” means “from and including,” “to” means “to but excluding,” and “through” means “through and including.”
 
(i)   References to a specific time shall refer to prevailing Eastern Time, unless otherwise indicated.
 
(j)   A reference to “$,” “USD,” “U.S. Dollars,” or “Dollars” shall mean the legal tender of the U.S.
 
(k)   A reference to “RMB” shall mean the legal tender of the People's Republic of China.
 
(l)   Unless otherwise defined, a reference to any accounting term shall have the meaning as defined under GAAP.
 
(m)   References to any Governmental Entity or Regulatory Authority shall include a reference to any successor body assuming the same or similar regulatory or administrative functions.
 
2.   LICENSES
 
2.1   License Grants to CBMG.
 
(a)   Subject to the terms and conditions of this Agreement, during the Term, Novartis hereby grants to CBMG a co-exclusive (with Novartis and its Affiliates), transferrable (pursuant to Section 18.5 ), sublicensable (pursuant to Section  2.3 ) license, under the Novartis Technology, to Manufacture the Product in the Territory solely for the Development (and solely in accordance with the Development Plan) and the Commercialization of the Product in the Territory by Novartis or its Affiliates or licensees.
 
(b)   Subject to the terms and conditions of this Agreement, during the Term, Novartis hereby grants to CBMG a non-exclusive, royalty-free, non-transferrable, sublicensable (pursuant to Section  2.3 ) license, under the Novartis Technology, solely to perform CBMG’s other activities under this Agreement, including under the Development Plan.
 
2.2   License Grants to Novartis.
 
(a)   Subject to the terms and conditions of this Agreement, CBMG hereby grants to Novartis an exclusive, worldwide, transferrable (pursuant to Section 18.5 ), sublicensable (pursuant to Section  2.3 ) license, under the CBMG Technology, to Develop, Manufacture, and Commercialize the Product in the Field.
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(b)   Subject to the terms and conditions of this Agreement, CBMG hereby grants to Novartis a non-exclusive, royalty-free, transferrable (pursuant to Section 18.5 ), sublicensable (pursuant to Section  2.3 ) license, under the CBMG Technology, to Develop, Manufacture, and Commercialize any product (including the Product), including to perform Novartis’s activities under this Agreement.
 
2.3   Sublicenses; Subcontracting.
 
 
(a)
Sublicenses .
 
(i)
Subject to Section 2.6 , CBMG shall not sublicense any of its rights under Section 2.1 to any Person without first obtaining, in each case, the prior written consent of Novartis. If CBMG grants any such sublicense following receipt of such consent, it shall provide Novartis with a copy of any executed sublicense agreement within thirty (30) days of any such agreement’s execution.
 
(ii)
Novartis may sublicense any of its rights under Section 2.2 to any Person (which sublicensed rights may be further sublicensable through multiple tiers).
 
(iii)
Each sublicense granted by a Party pursuant to this Section 2.3(a) will be subject and subordinate to this Agreement and will contain provisions consistent with the applicable terms and conditions of this Agreement. Notwithstanding anything to the contrary in any sublicense agreement, the granting Party shall remain primarily liable to the other Party for the performance of all of its obligations under, and its compliance with all provisions of, this Agreement.
 
(b)
Subcontracting .
 
(i)
CBMG shall not subcontract to any Third Party the performance of CBMG’s tasks and obligations under this Agreement or the Development Plan without first obtaining, in each case, Novartis’s prior written consent. If CBMG enters into any subcontract following receipt of such consent, it shall provide Novartis, upon Novartis’s request, with a copy of any executed subcontract agreement within thirty (30) days of any such agreement’s execution. Any subcontract permitted by this Section 2.3(b)(i) may include a sublicense of rights necessary for the performance of the subcontract as reasonably required; provided , that CBMG shall remain responsible for the performance of this Agreement and shall cause any such subcontractor to comply with all applicable terms and conditions of this Agreement.
 
(ii)
Novartis may exercise its rights and perform its obligations under this Agreement itself or through any of its Affiliates or any Third Parties.
 
2.4   No Other Rights.
 
Except as otherwise expressly provided in this Agreement, under no circumstances will a Party or any of its Affiliates, as a result of this Agreement, obtain any ownership interest, license, or other right in or to any Patent Rights, Know-How, or other intellectual property rights of the other Party, including tangible or intangible items owned, controlled, or developed by the other Party, or provided by the other Party to the receiving Party at any time, in each case, pursuant to this Agreement.
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
2.5   Exclusivity; Right of First Negotiation.
 
 
(a)   Exclusivity . During [***], CBMG shall not, and shall cause its Affiliates, licensees, and sublicensees not to, alone or with any Third Party (including through licensing any Third Party), directly or indirectly, Develop, Manufacture, or Commercialize any Competing Product in the Territory.
 
(b)   Right of First Negotiation .
 
(i)
CBMG hereby grants to Novartis the exclusive right of first negotiation, as set forth in this Section   2.5(b) , with respect to: [***].
 
(ii)
During the Term, CBMG shall not, and shall cause its Affiliates, licensees, and sublicensees not to, directly or indirectly: (A) license, transfer, sell, or otherwise grant to any Third Party any right to Develop, Manufacture, or Commercialize any CBMG Other CART in the Field; or (B) enter into a definitive agreement providing for a transaction or series of transactions that would constitute a Change of Control of CBMG (collectively, the “ Restricted Activities ”) without first complying with this Section 2.5(b) . In the event that CBMG wishes to conduct any Restricted Activities, CBMG shall notify Novartis in writing, such notice to be accompanied by the proposed scope of the Restricted Activities it wishes to conduct (such notice and accompanying information, the “ ROFN Notice ” and such Restricted Activities set forth in the ROFN Notice, the “ ROFN Activities ”). Novartis shall have [***] from the date on which it receives the ROFN Notice to notify CBMG whether Novartis wishes to exercise its right of first negotiation with respect to the ROFN Activities. Upon CBMG’s receipt of such notice, the Parties shall enter into exclusive, good-faith negotiations for a period no longer than [***] from CBMG’s receipt of such notice (unless extended upon agreement of the Parties) regarding the terms and conditions of an agreement granting Novartis rights to conduct the ROFN Activities.
 
(iii)
If, with respect to any ROFN Activities: [***], CBMG shall be permitted to undertake the proposed ROFN Activities without again complying with this Section 2.5(b) ; provided , that CBMG shall not, during such [***] period, license, transfer, sell, or otherwise grant (or offer to do any of the foregoing) to a Third Party [***]. For purposes of this Section 2.5(b)(iii) , [***]. In the event that CBMG does not, for any reason, grant rights to such Third Party with respect to such ROFN Activities within [***], then CBMG shall not be permitted to grant rights to any Third Party to conduct such ROFN Activities without again complying with this Section 2.5(b) .
 
2.6   Certain Terms of Novartis Third Party Agreements.
 
.o the extent that any license grant by Novartis to CBMG under the Novartis Technology pursuant to Section 2.1 constitutes the grant of a sublicense to CBMG of certain Novartis Technology that is not owned by Novartis or any of its Affiliates, but that is in-licensed by Novartis or any such Affiliate from a Third Party licensor pursuant to a Novartis Third Party Agreement, then:
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(a)   CBMG acknowledges that the rights and licenses under, or with respect to, the Novartis Technology granted by Novartis to CBMG under this Agreement shall be no greater in scope than those granted by such Third Party licensor to Novartis; and
 
(b)   CBMG shall comply, and shall cause its Affiliates and sublicensees to comply, with the obligations applicable to sublicensees under such Novartis Third Party Agreement.
 
3.   GOVERNANCE
 
3.1   Alliance Managers.
 
Within thirty (30) days following the Effective Date, each Party will appoint (and notify the other Party in writing with respect to the identity of) a senior representative having a general understanding of pharmaceutical and biological Development, Manufacture, and Commercialization issues to act as its alliance manager under this Agreement (each, an “ Alliance Manager ”). The Alliance Managers will serve as the lead contact point between the Parties for the purpose of providing the other Party with information on the progress of Development, Manufacture, and Commercialization of the Product and will be primarily responsible for: (a) facilitating the flow of information and otherwise promoting communication, coordination, and collaboration between the Parties; (b) providing single-point communication for seeking consensus both internally within the respective Party’s organization and together regarding key strategy and planning issues, as appropriate, including facilitating review of external corporate communications; and (c) raising cross-Party or cross-functional disputes in a timely manner. Each Party may replace its Alliance Manager by written notice to the other Party.
 
3.2   Joint Oversight Committee.
 
 
(a)   No later than (30) days after the Effective Date, the Parties shall establish the Joint Oversight Committee, which shall facilitate communications between the Parties, and monitor and provide strategic oversight with respect to the activities under this Agreement, including the Development, Manufacture, and Commercialization of the Product in the Territory, all in accordance with this Section  3.2 . The JOC shall have no decision-making authority.
 
(b)   No later than thirty (30) days after the Effective Date, each Party shall appoint three (3) representatives to the JOC, each of whom will have sufficient seniority within the applicable Party or its Affiliates and knowledge and expertise in the Development, Manufacturing, and Commercialization of products similar to the Product to make decisions arising within the scope of the JOC’s responsibilities. The JOC may change its size from time to time by mutual consent of its representatives; provided , that the JOC will consist at all times of an equal number of representatives of each of CBMG and Novartis. Each Party may replace its JOC representatives at any time upon written notice to the other Party. The JOC may invite non-representatives to participate in the discussions and meetings of the JOC; provided , that such participants are bound under written obligations of confidentiality no less protective of the Parties’ Confidential Information than those set forth in this Agreement. The JOC will be chaired by one (1) chairperson designated by Novartis and one (1) chairperson designated by CBMG (collectively, the “ JOC Co-Chairs ”), whose responsibilities will include conducting meetings, including, when feasible, ensuring that objectives for each meeting are set and achieved. Responsibility for running each meeting of the JOC will alternate between the JOC Co-Chairs from meeting-to-meeting, with Novartis’s JOC Co-Chair running the first meeting. The JOC Co-Chairs will prepare and circulate agendas and to ensure the preparation of minutes. The JOC Co-Chairs shall have no additional powers or rights beyond those held by the other JOC representatives.
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
3.3   Meetings of the Joint Oversight Committee.
 
  The JOC shall hold its initial meeting no later than sixty (60) days after the Effective Date and shall thereafter meet at least once per Calendar Quarter during the Term unless the Parties mutually agree in writing to a different frequency. No later than five (5) Business Days prior to any meeting of the JOC (or such shorter time period as the Parties may agree), the Alliance Managers will prepare and circulate an agenda for such meeting; provided , however , that either Party may propose additional topics to be included on such agenda, either prior to or in the course of such meeting. Either Party may also call a special meeting of the JOC (in person or by audio or video teleconference) by providing at least ten (10) Business Days’ prior written notice to the other Party if such Party reasonably believes that a significant matter must be addressed prior to the next scheduled meeting, in which event such Party will work with the JOC Co-Chairs and the Alliance Managers of both Parties to provide the representatives of the JOC no later than three (3) Business Days prior to the special meeting with an agenda for the meeting and materials reasonably adequate to enable an informed discussion on the matters to be considered. The JOC may meet in person or by audio or video teleconference; provided , that at least one (1) meeting per Calendar Year will be in person unless the Parties mutually agree in writing to waive such requirement. In-person JOC meetings will be held at locations alternately selected by CBMG and by Novartis. Each Party will bear the expenses of its respective JOC representatives’ participation in JOC meetings. Meetings of the JOC will be effective only if at least one (1) representative of each Party is present or participating in such meeting. The JOC Co-Chairs or their designees will send draft meeting documentation to each representative of the JOC for review and approval within ten (10) Business Days after each JOC meeting. Such documentation will be officially endorsed by the JOC at the next JOC meeting, including reflecting any differences noted by the Parties, and will be signed by the Alliance Managers.
 
3.4   Sub-Committees.
 
The JOC may, at any time it deems necessary or appropriate, establish additional joint committees and delegate such of its responsibilities as it determines appropriate to such joint committees.
 
4.   DISCLOSURE OF KNOW-HOW AND COOPERATION
 
4.1   Disclosure of Know-How
 
  As soon as reasonably practicable after the Effective Date and on a continuing basis during the Term, each Party shall, without additional consideration, disclose to the other Party copies of any Know-How: (a) in its Control; (b) in existence as of the Effective Date or which arises in the course of its performance of this Agreement; and (c) which is necessary for the other Party to exercise its rights or fulfill its obligations under this Agreement, including to perform the activities assigned to it under the Development Plan and, where the other Party is Novartis, its activities in connection with the Commercialization of the Product.
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
4.2   Cooperation.
 
From time to time during the Term, at the request of a Party, the other Party shall, without additional consideration, provide reasonable assistance to the requesting Party or its Affiliates in connection with understanding and using such Party’s Know-How for purposes consistent with licenses and rights granted to the requesting Party under this Agreement.
 
5.   DEVELOPMENT
 
5.1   Development Generally.
 
As between the Parties, Novartis shall control and be responsible in its sole discretion for the Development of the Product in the Territory. CBMG shall be responsible for conducting certain Development activities in support of Novartis’s Development efforts, as set forth in the Development Plan.
 
5.2   Development Plan and Development Budget.
 
 
()   The initial Development Plan, including the initial Development Budget, is attached as Exhibit B and shall remain in effect unless and until modified as provided herein.
 
(a)   The Development Plan and Development Budget shall at all times include a reasonably detailed written plan of the material Development activities to be performed by each Party through the end of the next Calendar Year, and the budget for such activities.
 
(b)   The Parties will review the Development Plan, including the Development Budget, for potential amendments at least once each Calendar Year and will provide any such proposed amendments to the JOC for its review and discussion. Novartis shall have sole decision-making authority with respect to amendments to the Development Plan. Following any such amendment, such Development Plan and Development Budget as amended shall be deemed to be the Development Plan and the Development Budget.
 
5.3   Development Activities.
 
CBMG shall perform the Development activities assigned to it under the Development Plan.
 
5.4   Additional CBMG Development Obligations.
 
 
(a)   No less than five (5) Business Days prior to each scheduled meeting of the JOC, CBMG will provide Novartis’s JOC representatives with a written report on the status and progress of its Development activities pursuant to the Development Plan, including information on progress versus plan, spend versus budget (on a Calendar Quarter basis), protocol deviations, notable safety and efficacy findings (including serious adverse events and events of interest from a risk management perspective), inspection, and audit findings.
 
(b)   CBMG shall make available to Novartis such information about its Development activities pursuant to the Development Plan as may be reasonably requested by Novartis from time to time.
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(c)   Novartis shall have the right to review any data generated by CBMG during the conduct of CBMG’s Development activities pursuant to the Development Plan as may be reasonably requested by Novartis from time to time.
 
(d)   CBMG shall promptly inform Novartis in writing about any unforeseen or material results, problems, difficulties, or issues in connection with its Development activities pursuant to the Development Plan.
 
(e)   CBMG shall ensure that Novartis’s authorized representatives may, during regular business hours: (i) examine and inspect CBMG’s, its Affiliates’, and its permitted subcontractors facilities used in the performance of CBMG’s Development activities pursuant to the Development Plan; and (ii) subject to Applicable Law, inspect all data, documentation, and work products relating to the activities performed by CBMG, its Affiliates, or its permitted subcontractors, in each case, generated pursuant to the Development Plan; provided , that to the extent CBMG does not have the right to permit Novartis to directly conduct inspections of CBMG’s, its Affiliates’, and its permitted subcontractors under subsections (i) or (ii) above, CBMG agrees, upon Novartis’s request, to conduct such inspections on Novartis’s behalf. The aforementioned right to inspect facilities, data, documentation, and work products may be exercised by Novartis at any time upon ten (10) Business Days’ prior written notice. Novartis shall be responsible for all costs of any inspections conducted pursuant to this Section  5.4(e) , which costs shall be considered Development Costs.
 
5.5   Development Costs.
 
(a)   Clinical Development Costs .
 
(i)
Initial Indication Clinical Development Costs . Novartis shall be responsible for [***] of Initial Indication Clinical Development Costs.
 
(ii)
Additional Indication Clinical Development Costs . Subject to Section 5.5(c) , each Party shall be responsible for [***] of Additional Indication Clinical Development Costs associated with an Additional Indication.
 
(b)   Technical Development Costs . The Parties shall agree on each Party’s responsibility for Technical Development Costs no later than the date on which the Parties finalize the Technical Development Plan.
 
(c)   Reconciliation; Deferral .
 
()   Each Party shall, within thirty (30) days following each Calendar Quarter during which it incurs Development Costs, submit to a finance officer designated by Novartis and a finance officer designated by Shanghai Cellular (the “ Finance Officers ”) a report which sets forth the Development Costs incurred by such Party during such Calendar Quarter. Each such report will specify in reasonable detail all applicable FTE Costs, Out-of-Pocket Costs, and Other Development Expenses. Within thirty (30) days after receipt of such reports, the Finance Officers shall determine whether a reconciliation payment is due from Shanghai Cellular to Novartis or from Novartis to Shanghai Cellular and, if so, the amount of such reconciliation payment, so that CBMG and Novartis share Development Costs in accordance with Sections 5.5(a) and 5.5(b) .
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(A)   If Novartis is required to pay such a reconciliation payment, then, subject to Section 5.5(c)(ii) , it shall submit such payment to Shanghai Cellular within forty-five (45) days of receipt of Shanghai Cellular’s invoice for the amount of such reconciliation payment.
 
(B)   If Shanghai Cellular is required to pay such a reconciliation payment, then, subject to Section 5.5(c)(ii) , Shanghai Cellular may elect to: (1) submit such payment to Novartis within forty-five (45) days of receipt of Novartis’s invoice for the amount of such reconciliation payment; or (2) provide written notice to Novartis of its election to irrevocably defer (each, a “ Deferral Election ”) payment of all or a portion of such reconciliation payment to Novartis until the First Commercial Sale of the Product for the applicable Additional Indication in the Territory (each deferred reconciliation payment amount, a “ Deferral Amount ,” and the aggregate amount of such deferred reconciliation payments with respect to such Additional Indication as of such First Commercial Sale, the “ Aggregate Deferral Amount ”). Upon the First Commercial Sale of the Product for the applicable Additional Indication in the Territory, an amount equal to [***] of the Aggregate Deferral Amount applicable to such Additional Indication shall immediately become due and payable to Novartis by Shanghai Cellular.
 
(i)   In the event of any disagreement with respect to the calculation of a reconciliation payment in accordance with this Section 5.5(c) , any undisputed portion of such reconciliation payment shall be paid or become eligible for offset, as applicable, in accordance with Section 5.5(c)(i)(A) or Section 5.5(c)(i)(B) , as applicable, and the remaining, disputed portion will be paid or eligible for offset, as applicable, within ten (10) Business Days after the date on which CBMG and Novartis, using good-faith efforts, resolve the dispute; provided , that if the Parties cannot resolve such dispute, it shall be resolved in accordance with Section 18.12 .
 
(d)   Parties’ Responsibility . Any expenses incurred by a Party for Development activities relating to the Product that do not fall within the definition of “Development Costs” shall be borne solely by such Party.
 
6.   REGULATORY
 
6.1   Novartis Responsibility.
 
As between the Parties, Novartis shall be solely responsible in its sole discretion for regulatory activities under this Agreement, including: (a) determining the regulatory plans and strategies for the Product; (b) making all Regulatory Filings with respect to the Product, except for those that are required to be made by CBMG or its Affiliates under Applicable Law, in which case Novartis shall have the right to review and provide its written approval prior to the submission of such Regulatory Filings to the SAMR or other relevant Regulatory Authority; (c) obtaining and maintaining all Regulatory Approvals for the Product, except for those which are required to be obtained by CBMG or its Affiliates under Applicable Law, in which case Novartis shall have the right to review and give its written approval prior to the submission of any application for such Regulatory Approvals to the SAMR or other relevant Regulatory Authority; and (d) conducting all meetings with Regulatory Authorities in connection with the Development and Regulatory Approval of the Product, in each case ((a) through (d)), in the Territory. Any such activities may be performed by Novartis, its Affiliates, or its designees.
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
6.2   CBMG Support.
 
CBMG shall cooperate with and support Novartis in connection with Novartis’s activities pursuant to Section 6.1 to the extent reasonably requested by Novartis from time to time. For the avoidance of doubt, such cooperation and support shall include the provision to Novartis of local market access and related support and advice.
 
6.3   Ownership of Regulatory Documentation.
 
All Regulatory Documentation generated under this Agreement shall be owned by and held in the name of Novartis or its designee, and any such Regulatory Documentation issued in the name of CBMG or its Affiliates shall promptly be assigned by CBMG to Novartis or its designee to the extent permitted by Applicable Law or, in the event assignment is not permitted under Applicable Law, held in trust for, or for the sole benefit of, Novartis or its designee.
 
6.4   Communication with Regulatory Authorities.
 
Novartis shall have the exclusive right to correspond or communicate with Regulatory Authorities regarding the Product in the Territory and other regulatory matters under this Agreement. Unless required by Applicable Law, CBMG and its Affiliates, sublicensees, and subcontractors shall not correspond or communicate with any Regulatory Authority regarding the Product or any other regulatory matters under this Agreement without first obtaining, in each case, Novartis’s prior written consent; provided , that, upon Novartis’s request, CBMG or its Affiliates shall attend any meeting with a Regulatory Authority in the Territory regarding the Product or any other regulatory matters under this Agreement. If CBMG or its Affiliates, sublicensees, or subcontractors receives any correspondence or other communication from a Regulatory Authority in the Territory regarding the Product or any other regulatory matter under this Agreement, CBMG shall provide Novartis with access to or copies of all such material written or electronic correspondence promptly after its receipt for Novartis’s review and comment, and shall incorporate any and all of Novartis’s comments thereto.
 
7.   MANUFACTURE
 
7.1   Manufacturing and Supply Agreement.
 
Novartis (or its Affiliate) and CBMG shall negotiate and enter into the Manufacturing and Supply Agreement within ninety (90) days after the Effective Date.
 
7.2   Quality.
 
CBMG grants to Novartis, its Affiliates, and its designees, upon reasonable prior notice, the right to inspect CBMG’s production facilities to perform a quality audit in order to confirm CBMG’s compliance with cGMP, Novartis’s quality requirements, and Applicable Law (each, a “ Quality Audit ”). If Novartis reasonably believes (as a result of a condition which it observes during a Quality Audit or otherwise) that CBMG may not be in compliance with cGMP, Novartis’s quality requirements, or Applicable Law, then the Parties shall discuss and agree upon any appropriate corrective actions to address such non-compliance (collectively, the “ CAPAs ”), and CBMG shall promptly implement such CAPAs at its sole cost and expense.
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
7.3   Costs.
 
CBMG shall bear all costs and expenses incurred by either Party in connection with or arising out of the Tech Transfer Work Plans.
 
8.   COMMERCIALIZATION
 
8.1   Commercialization.
 
.Novartis shall be solely responsible, at its cost and in its sole discretion, for the Commercialization of the Product in the Territory, including booking sales and pricing.
 
8.2   Pharmacovigilance.
 
If required by Applicable Law, within a reasonable amount of time, not to exceed six (6) months following the Effective Date, the Parties shall agree upon and implement a procedure for the mutual exchange of safety information associated with the Product. The details of the operating procedures relating to the exchange shall be the subject of a mutually-agreed upon pharmacovigilance agreement (the “ Pharmacovigilance Agreement ”). The Pharmacovigilance Agreement shall enable each Party to comply with its respective obligations under Applicable Law with regard to adverse event data collection, analysis, and reporting.
 
9.   FINANCIAL PROVISIONS
 
9.1   Collaboration Payments; Product Price
 
 
(a)   Collaboration Payment Rates . During the Collaboration Payment Term, Novartis shall make the following collaboration payments under this Section 9.1 to CBMG based on the aggregate annual Net Sales of the Product in the Territory; provided , that, notwithstanding any other provision of this Agreement, the maximum aggregate collaboration payments that CBMG will be entitled to receive in any Calendar Year based on the aggregate Net Sales of the Product in the Territory in such Calendar Year for the Initial Indications shall be [***]. In connection with (and in no event later than thirty (30) days following each amendment of the Development Plan and the Development Budget which provides for the Development of the Product for an Additional Indication in the Territory), the Parties shall agree on the maximum aggregate collaboration payments that CBMG will be entitled to receive based on Net Sales of the Product in the Territory in any Calendar Year for such Additional Indication. For clarity, the collaboration payments shall be payable only once with respect to the same unit of Product. All collaboration payments made pursuant to this Section 9.1 shall be made as provided in Article 10 .
 
Net Sales of the Product in the Territory in a Calendar Year during the Collaboration Payment Term
 
Collaboration Payment Rate
 
[***]
 
 
 
                                                              
 
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IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(b)   Collaboration Payment Term . The collaboration payments described in this Section 9.1 shall be payable on Net Sales of the Product that occur in the Territory during the Term (the “ Collaboration Payment Term ”).
 
(c)   Loss of Market Share . In the event of a Loss of Market Share for the Product in the Territory, the Net Sales of the Product in the Territory to be included as Net Sales for the purpose of the calculation of collaboration payments due under Section 9.1(a) from and after such Loss of Market Share until the end of the Collaboration Payment Term shall be reduced by [***].
 
(d)   Third Party Obligations . In the event that Novartis determines that any Patent Rights, Know-How, or other intellectual property rights Controlled by a Third Party are necessary or useful in order to Develop, Manufacture, or Commercialize the Product in the Territory, Novartis shall have the right (but not the obligation) to negotiate and acquire rights to such Patent Rights, Know-How, or other intellectual property rights through a license or otherwise (including pursuant to any settlement agreement) and to deduct from the collaboration payments payable by Novartis to CBMG on Net Sales of the Product pursuant to Section 9.1   with respect to a given Calendar Quarter [***] of the amounts paid (including [***]) by Novartis to such Third Party with respect to the Product.
 
(e)   Product Price . The price at which Novartis shall purchase and CBMG shall sell Product pursuant to the Manufacturing and Supply Agreement (the “ Product Price ”) shall in no event exceed the CBMG Production Costs per patient plus [***] thereof (the “ Margin ”); provided , that the CBMG Production Costs shall not exceed the applicable amount set forth in Schedule 9.1(e) under the heading “Product Price Cap per Calendar Year.”
 
(f)   Consideration for CBMG Collaboration Technology . The Parties acknowledge and agree that [***] reflects compensation for the CBMG Collaboration Technology licensed by CBMG to Novartis under this Agreement.
 
9.2   No Projections.
 
Novartis and CBMG each acknowledge and agree that nothing in this Agreement shall be construed as representing an estimate or projection of anticipated sales of the Product, and that the Net Sales levels set forth above or elsewhere in this Agreement or that have otherwise been discussed by the Parties are merely intended to define the collaboration payment obligations in the event such Net Sales levels are achieved. NEITHER NOVARTIS NOR CBMG MAKES ANY REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT EITHER PARTY OR ITS AFFILIATES OR SUBLICENSEES WILL BE ABLE TO SUCCESSFULLY DEVELOP OR COMMERCIALIZE THE PRODUCT OR, IF COMMERCIALIZED, THAT ANY PARTICULAR NET SALES LEVEL OF THE PRODUCT WILL BE ACHIEVED.
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
10.   PAYMENT TERMS AND REPORTS
 
10.1   Payment Terms.
 
(a)   Novartis shall provide to Shanghai Cellular a Sales & Collaboration Payment Report within forty-five (45) days after each Calendar Quarter during the Collaboration Payment Term. Shanghai Cellular shall submit an invoice substantially in the form of Exhibit F to Novartis with respect to the collaboration payment amount shown therein. Novartis shall pay to Shanghai Cellular all undisputed collaboration payment amounts within forty-five (45) days after its receipt of such invoice. Any disputes concerning collaboration payment amounts owed by Novartis to Shanghai Cellular shall be resolved in accordance with Section 18.12 .
 
(b)   All payments to be made by a Party hereunder shall, unless otherwise agreed in writing by the Parties (including pursuant to any Ancillary Agreement), be made in USD by wire transfer to such bank account as the other Party may designate. Any payment which falls due on a date which is not a Business Day may be made on the next succeeding Business Day.
 
10.2   Currency; Payment Approval.
 
All payments under this Agreement shall be payable in USD. Notwithstanding the foregoing sentence, to the extent any Ancillary Agreement provides that payments under such Ancillary Agreement shall be payable in RMB, such payments shall be made in RMB. When conversion of payments is required to be undertaken by a Party, the USD or RMB equivalent (as applicable) shall be calculated using such Party’s then-current standard exchange rate methodology as consistently applied in its external reporting.
 
10.3   Tax Matters.
 
Each Party shall be responsible for all taxes, fees, duties, levies, or similar amounts imposed on its income, assets, capital, employment, personnel, and right or license to do business. Except as otherwise provided, each Party shall be responsible for its own sales tax, use tax, excise tax, value-added tax (VAT), goods and services tax (GST), consumption tax, and similar taxes based upon its own activities under this Agreement. Each Party shall use reasonable and legal efforts to reduce tax withholding, to the extent permitted by Applicable Law, on payments made pursuant to this Agreement. In the event any payments due under this Agreement are subject to withholding tax under Applicable Law, the paying Party shall deduct the respective amount from the applicable payment and pay the withholding tax to the relevant tax authority. The paying Party shall deliver within sixty (60) days to the other Party evidence of such payment. Each Party shall make all reasonable efforts to obtain relief or reduction of withholding tax under the applicable tax treaties, including the submission or issuance of requisite forms and information. Any such amount deducted and paid to the applicable tax authority shall be deemed fully paid to the other Party in satisfaction of the applicable payment obligation under this Agreement.
 
10.4   Permits to Make Payments; Blocked Payments.
 
 
(a)   The Party making any payment due under this Agreement shall be responsible for applying for and obtaining any Permits from any Governmental Entity needed to make such payments (if any), including Permits from SAFE (if any). If, by reason of Applicable Law in the Territory, the requisite Permits cannot be obtained, then: (i) the Party which is due any payment under this Agreement may offset the amount of any such unreceived payment against any amounts payable by such Party pursuant to this Agreement or any other Ancillary Agreement; and (ii) to the extent that such Party is not able to fully offset such payment in accordance with (i), Novartis and Shanghai Cellular shall in good faith negotiate on an agreement pursuant to which such Party will receive the full benefit of the unreceived payment, subject to Applicable Law.
 
                                                              
 
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IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(b)   Subject to Applicable Law and Section 10.4(a) , if at any time legal restrictions in the Territory prevent the prompt remittance of any payments with respect to sales therein, the Party which is so prevented shall have the right and option to make such payments by depositing the payment amount in local currency to the other Party’s account in a bank or depository designated by such Party in the Territory.
 
10.5   Records and Audit Rights.
 
Each Party shall keep complete, true, and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including with respect to Development Costs, Net Sales, collaboration payments, and Product Price. Each Party will keep such books and records for at least three (3) years following the Calendar Year to which they pertain. Each Party (the “ Auditing Party ”) may, upon written request, cause an internationally-recognized independent accounting firm (the “ Auditor ”), which is reasonably acceptable to the other Party (the “ Audited Party ”), to inspect the relevant records of such Audited Party and its Affiliates to verify the payments made and amounts reported by the Audited Party and the related reports, statements, and books of accounts, as applicable. Before beginning its audit, the Auditor shall execute an undertaking acceptable to the Audited Party by which the Auditor shall agree to keep confidential all information made available to the Auditor during the audit. The Auditor shall have the right to disclose to the Auditing Party only its conclusions regarding any payments owed under this Agreement. Each Party and its Affiliates and sublicensees shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the Auditing Party. The records shall be reviewed solely to verify the accuracy of the Audited Party’s collaboration payments and other payment obligations and compliance with the financial terms of this Agreement. Such inspection right shall not be exercised more than once without cause in any Calendar Year and not more frequently than once without cause with respect to records covering any specific period of time. In addition, the Auditing Party shall only be entitled to audit the books and records of the Audited Party from the three (3) Calendar Years prior to the Calendar Year in which an audit request is made. The Auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with Applicable Law or judicial order. The Auditor shall provide its audit report and basis for any determination to the Audited Party at the time such report is provided to the Auditing Party before it is considered final. In the event that the final result of the inspection reveals an underpayment or an overpayment by either Party, the underpaid or overpaid amount shall be settled promptly. The Auditing Party shall pay for any audit, as well as its expenses associated with enforcing its rights with respect to any payments hereunder; provided , that, if an underpayment of amounts due or overpayment of amounts payable by the Auditing Party of more than twenty percent (20%) of the total payments due hereunder for the applicable year is discovered, the fees and expenses charged by the Auditor shall be paid by Audited Party.
 
                                                              
 
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IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
11.   INTELLECTUAL PROPERTY
 
11.1   Ownership.
 
 
(a)   Background Intellectual Property . As between the Parties, and subject to the licenses granted under this Agreement, each Party retains all right, title, and interest in and to all Patent Rights, Know-How, and other intellectual property rights that such Party Controls as of the Effective Date or that it develops or otherwise acquires after the Effective Date outside the performance of the activities under this Agreement or the Ancillary Agreements. Without limiting the generality of the foregoing, as between the Parties, Novartis shall own all right, title, and interest in and to the Novartis Background Intellectual Property, and CBMG shall own all right, title, and interest in and to the CBMG Background Intellectual Property.
 
(b)   Collaboration Technology .
 
(i)
All determinations of inventorship under this Agreement or the Ancillary Agreements, including with respect to Collaboration Technology, shall be made in accordance with U.S. patent law.
 
(ii)
As between the Parties, Novartis shall own all right, title, and interest in and to any and all Novartis Collaboration Technology.
 
(iii)
As between the Parties, CBMG shall own all right, title, and interest in and to any and all CBMG Collaboration Technology.
 
(iv)
Each Party shall own an equal, undivided one-half (1/2) interest in any and all Joint Collaboration Technology.
 
(v)
Each Party shall and hereby does assign to the other Party any right, title, and interest it may have in or to any Collaboration Technology, and agrees to execute such documents and take such other actions reasonably requested by the other Party to the extent necessary to give effect to the ownership allocation set forth in this Section 11.1(b) .
 
(c)   Invention Protection . Each Party shall ensure that the employees, officers, and independent contractors (excluding any sublicensees or subcontractors, each of which are subject to Section 2.3 ) of such Party or its respective Affiliates performing activities under this Agreement or any Ancillary Agreement shall, prior to commencing such work, be bound by written invention assignment obligations requiring: (i) prompt reporting of any Patent Rights, Know-How, or other intellectual property rights arising from such work; (ii) assignment to the applicable Party or Affiliate of all of his or her right, title, and interest in and to any Patent Rights, Know-How, or other intellectual property rights arising from such work; (iii) cooperation in the Prosecution and Maintenance, defense, and enforcement of any Patent Right that is required to be assigned under this Agreement; and (iv) performance of all acts and signing, executing, acknowledging, and delivering any and all documents required for effecting the obligations and purposes of this Agreement. To the extent that any employee inventors in the PRC claim rights to any invention that relates to the subject matter of this Agreement or any Ancillary Agreement (including rights to any Collaboration Technology), then the Party which suffers such Claim shall indemnify the other Party and hold such other Party harmless pursuant to Section 16.1(a) or Section 16.2(a) (as the case may be).
 
                                                              
 
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IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
11.2   Prosecution and Maintenance.
 
(a)   Background Intellectual Property . Novartis shall be solely responsible in its sole discretion for the Prosecution and Maintenance of the Novartis Background Intellectual Property at Novartis’s sole cost and expense, and CBMG shall be solely responsible for the Prosecution and Maintenance of the CBMG Background Intellectual Property at CBMG’s sole cost and expense.
 
(b)   Novartis Patents; Collaboration Technology . Novartis shall be solely responsible in its sole discretion for the Prosecution and Maintenance, at Novartis’s sole cost and expense, of: (i) the Novartis Patents; and (ii) the Patent Rights claiming or directed to any and all Collaboration Technology.
 
(c)
CBMG Patents .
 
(i)
CBMG shall, in consultation with Novartis, be responsible for the Prosecution and Maintenance of the CBMG Patents at CBMG’s cost and expense. CBMG shall consult with Novartis and keep Novartis reasonably informed of the status of such CBMG Patents, provide copies of all relevant documents in a timely manner for Novartis’s review and comment, and reasonably consider and use good-faith efforts to incorporate any and all of Novartis’s comments.
 
(ii)
CBMG shall notify Novartis in writing of any decision not to file applications for, to cease the Prosecution and Maintenance of, or to not continue to pay the expenses with respect to the Prosecution and Maintenance of, any CBMG Patent, including any decision to abandon any pending patent application or issued patent within the CBMG Patents. CBMG shall provide such notice at least ninety (90) days prior to any relevant filing or payment due date, or any other due date that requires action, in connection with such CBMG Patent or claim thereof. In such event, CBMG shall permit Novartis, at Novartis’s sole discretion, cost, and expense, to file or to continue the Prosecution and Maintenance of such CBMG Patent. If Novartis continues to Prosecute and Maintain such CBMG Patent, then:
 
(A)
Such CBMG Patent shall remain in the Control of CBMG and shall be included in the definition of “CBMG Patents” for the purpose of this Agreement;
 
(B)
CBMG shall fully cooperate with Novartis in connection with the Prosecution and Maintenance of such CBMG Patent to the extent reasonably requested by Novartis, including by providing reasonable access to relevant persons and executing all documentation reasonably requested by Novartis; and
 
                                                              
 
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IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(C)
Novartis shall keep CBMG reasonably informed of the status of such CBMG Patent and shall notify CBMG in writing at least forty-five (45) days prior to any relevant filing or payment due date of any decision not to file applications for, to cease the Prosecution and Maintenance of, or to not continue to pay the expenses of the Prosecution and Maintenance of, such CBMG Patent, including any decision to abandon any pending patent application or issued patent within such CBMG Patent, in which case CBMG shall be entitled to reassume the sole right for the Prosecution and Maintenance of such CBMG Patent at its sole discretion (subject to this Section 11.2(c) ), cost, and expense.
 
11.3   Enforcement.
 
(a)   Each Party shall promptly notify the other Party of any infringement by a Third Party of any Novartis Patent or CBMG Patent in the Territory of which it becomes aware, including any declaratory judgment, opposition, or similar action alleging the invalidity, unenforceability, or non-infringement with respect to such Novartis Patent or CBMG Patent (collectively, “ Competing Infringement ”).
 
(b)   Novartis shall have the sole right, but not the obligation, to bring and control any legal action in connection with any Competing Infringement of any Novartis Patent as it reasonably determines appropriate, at its cost and expense.
 
(c)   Novartis shall have the first right, but not the obligation, to bring and control any legal action in connection with the Competing Infringement of any CBMG Patent as it reasonably determines appropriate, at its cost and expense, and CBMG shall have the right, at its own cost and expense, to be represented in any such action by counsel of its own choice. If Novartis does not wish to bring an action with respect to, or to otherwise terminate, any such Competing Infringement of any CBMG Patent, then it shall provide written notice thereof to CBMG: (i) within sixty (60) days following the notice of alleged Competing Infringement; or (ii) prior to three (3) months before the time limit, if any, specified under Applicable Law for the filing of such actions, whichever comes first, then, upon receipt of such notice (or, if no such notice is provided by Novartis, upon the earlier of (i) and (ii)), CBMG shall have the right, but not the obligation, to bring and control any such action at its own expense and by counsel of its own choice, and Novartis shall have the right (but not the obligation), at its own expense, to be represented in any such action by counsel of its own choice; provided , however , that if Novartis notifies CBMG in writing prior to fifteen (15) days before such time limit for the filing of any such action that Novartis intends to file such action before the time limit, then Novartis shall be obligated to file such action before the time limit and to reimburse CBMG for its reasonable and documented costs and expenses (including reasonable attorneys’ and professional fees) incurred in connection with CBMG’s preparation of such action, and CBMG shall not have the right to bring and control such action.
 
(d)   At the request and expense of the Party bringing and controlling an action pursuant to Section 11.3(b) or Section 11.3(c) , the other Party shall provide reasonable assistance in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery, and joining as a party to the action if required.
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
11.4   Defense.
 
(a)   Each Party shall promptly notify the other Party of any actual or potential claim alleging that the Development, Manufacture, or Commercialization of the Product in the Territory infringes, misappropriates, or otherwise violates any Patent Rights, Know-How, or other intellectual property rights of any Third Party (“ Third Party Infringement ”). In any such instance, the Parties shall as soon as practicable thereafter discuss in good faith the best response to such notice of Third Party Infringement.
 
(b)   Novartis shall have the first right, but not the obligation, to defend any such claim of Third Party Infringement, at Novartis’s sole discretion, cost, and expense, and CBMG shall have the right to be represented in any such action by counsel of its own choice at CBMG’s sole cost and expense.
 
(c)   If Novartis declines or fails to assert its intention to defend any such claim of Third Party Infringement within ninety (90) days following its receipt or sending of a notice, as applicable, pursuant to Section   11.4(b) , then CBMG shall have the right, but not the obligation, to defend such claim of Third Party Infringement at CBMG’s sole discretion, cost, and expense, and Novartis shall have the right (but not the obligation) to be represented in any such action by counsel of its own choice at Novartis’s sole cost and expense.
 
(d)   In no event shall a Party settle or otherwise compromise any Third Party Infringement by admitting that any Novartis Patent (in the case of CBMG) or CBMG Patent (in the case of Novartis) is invalid or unenforceable without first obtaining, in each case, the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned, or delayed.
 
11.5   Recovery.
 
.Any recovery received as a result of any action under Section 11.3 or Section 11.4 shall be allocated in the following order: (a) to reimburse the Party taking legal action for the costs and expenses (including attorneys’ and professional fees) incurred by such Party in connection with such action, to the extent not previously reimbursed; (b) to reimburse the Party not taking the lead in a legal action but which joins such legal action as provided herein, for the costs and expenses (including attorneys’ and professional fees) incurred by such Party in connection with such action, to the extent not previously reimbursed; and (c) the remainder of the recovery shall be retained by Novartis.
 
11.6   Trademarks.
 
Novartis shall have the right (but not the obligation) to brand the Product using Novartis-related trademarks and any other trademarks and trade names it determines appropriate in its sole discretion for the Product, which may vary within the Territory (the “ Product Marks ”). Novartis shall own all rights in the Product Marks and shall register and maintain the Product Marks to the extent it determines reasonably necessary.
 
11.7   Patent Extensions.
 
Upon Novartis’s request, CBMG shall cooperate in obtaining patent term restoration, supplemental protection certificates or their equivalents, and patent term extensions (collectively, “ Patent Extensions ”) with respect to the CBMG Patents, where applicable, at Novartis’s sole cost and expense. If the Parties agree on a Patent Extension for a CBMG Patent, CBMG shall provide all reasonable assistance requested by Novartis, including permitting Novartis to proceed with applications for such Patent Extensions in the name of CBMG, if deemed appropriate by Novartis, and executing documents and providing any relevant information and assistance to Novartis.
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
12.   CONFIDENTIALITY
 
12.1   Duty of Confidence.
 
(a)   Subject to the other provisions of this Article  12 , all Confidential Information disclosed by a Party or its Affiliates under this Agreement shall be maintained in confidence and otherwise safeguarded by the recipient Party and, as the Party shall cause, its Affiliates. The recipient Party may only use such Confidential Information for the purposes of this Agreement and pursuant to the rights granted to the recipient Party under this Agreement. Subject to the other provisions of this Article  12 , the recipient Party and its Affiliates shall hold as confidential such Confidential Information of the other Party or its Affiliates in the same manner and with the same protection as the recipient Party maintains its own confidential information, but in any event with no less than reasonable protections which are customary in the biopharmaceutical industry. Subject to the other provisions of this Article  12 and Article 14 , a recipient Party may only disclose Confidential Information of the other Party to its Affiliates and licensees or sublicensees and their respective employees, directors, agents, contractors, consultants, and advisers, in each case, solely to the extent reasonably necessary for the purposes of, and for those matters undertaken pursuant to, this Agreement and, in the case of Novartis, in connection with the Development, Manufacture, or Commercialization of the Product outside the Territory; provided , that any such Persons is bound to maintain the confidentiality of the Confidential Information in a manner consistent with the confidentiality provisions of this Agreement.
 
(b)   Subject to Section  12.3 , CBMG shall maintain in confidence and otherwise safeguard the Novartis Know-How to the extent such Novartis Know-How is of a confidential and proprietary nature.
 
12.2   Exceptions.
 
The obligations under this Article  12 shall not apply to any information to the extent that such information:
 
(a)   is (at the time of disclosure) or becomes (after the time of disclosure) known to the public or part of the public domain through no breach of this Agreement by the recipient Party or its Affiliates;
 
(b)   was known to, or was otherwise in the possession of, the recipient Party or its Affiliates, as evidenced by written records, prior to the time of disclosure by the disclosing Party or any of its Affiliates;
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(c)   is disclosed to the recipient Party or any of its Affiliates on a non-confidential basis by a Third Party who is entitled to disclose it without breaching any confidentiality obligation to the disclosing Party or any of its Affiliates; or
 
(d)   is independently developed by or on behalf of the recipient Party or its Affiliates, as evidenced by written records, without reference to the Confidential Information disclosed by the disclosing Party or its Affiliates to the recipient Party or its Affiliates under this Agreement.
 
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the recipient Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the recipient Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the recipient Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the recipient Party, unless the combination and its principles are in the public domain or in the possession of the recipient Party.
 
12.3   Authorized Disclosures.
 
(a)   In addition to disclosures allowed under Section  12.2 , Novartis may disclose CBMG’s or its Affiliates’ Confidential Information to the extent such disclosure is necessary in the following instances: (i) in connection with the Prosecution and Maintenance of Patent Rights as permitted by this Agreement; (ii) in connection with Regulatory Filings for the Product; (iii) in connection with prosecuting or defending litigation as permitted by this Agreement; (iv) in complying with applicable court orders or governmental regulations (including securities regulations); (v) in connection with the sale of all or substantially all of its business or assets to which this Agreement relates; or (vi) to the extent otherwise necessary or appropriate in connection with exercising the licenses and other rights granted to it hereunder.
 
(b)   In addition, Novartis or its Affiliates or sublicensees may disclose CBMG’s or CBMG’s Affiliates’ Confidential Information to Third Parties as may be necessary or useful in connection with the Development or Commercialization of the Product as contemplated by this Agreement, including in connection with subcontracting transactions.
 
(c)   In the event the recipient Party is required to disclose Confidential Information of the disclosing Party pursuant to Applicable Law or in connection with bona fide legal process, including disclosures of the type contemplated by Section 12.3(a) (iv) , such disclosure shall not be deemed a breach of this Agreement; provided , that the recipient Party: (i) informs the disclosing Party as soon as reasonably practicable following it becoming aware of the required disclosure; (ii) limits the disclosure to the required purpose; and (iii) at the disclosing Party’s request and expense, assists in attempting to object to or limit the required disclosure.
 
12.4   Terms of this Agreement.
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(a)   Each of the Parties agrees not to disclose to any Third Party the terms and conditions of this Agreement without first obtaining, in each case, the prior written consent of the other Party, except that either Party may disclose this Agreement to its Affiliates, licensors, licensees, or sublicensees and their respective employees, directors, agents, contractors, consultants, and advisers, or as otherwise permitted for a disclosure of Confidential Information in this Article 12 .
 
(b)   Each Party shall give the other Parties a reasonable opportunity to review those portions of all filings with the United States Securities and Exchange Commission (or any stock exchange, including Nasdaq, or any similar regulatory agency in any country other than the United States) describing the terms and conditions of this Agreement (including any filings of this Agreement) prior to submission of such filings, and shall give due consideration to any reasonable comments by the non-filing Parties with respect to such filing, including the provisions of this Agreement for which confidential treatment should be sought.
 
12.5   Trade Secrets.
 
(a)   Either Party may, from time to time, identify and designate items of Know-How disclosed hereunder by or on behalf of such Party as being a trade secret by: (i) if such Know-How is disclosed in writing or other tangible form, marking such Know-How as “Trade Secret” or similar manner to expressly designate it as a trade secret; or (ii) if such Know-How is disclosed in any other manner, by expressly indicating that such Know-How is a trade secret at the time of initial disclosure and promptly thereafter providing the other Party a written description of such Know-How that is marked in a manner to expressly identify such Know-How and indicate it is a trade secret (such Know-How so identified and designated as a trade secret, collectively, in the case of CBMG, “ CBMG Trade Secrets ” and, in the case of Novartis, “ Novartis Trade Secrets ”).
 
(b)   Novartis shall have the right to use and disclose CBMG Trade Secrets and CBMG shall have the right to use and disclose Novartis Trade Secrets, in each case, solely to the extent permitted under this Agreement or the Manufacturing and Supply Agreement; provided , however , that: (i) any such use or disclosure shall be limited to CBMG or Novartis’s Affiliates and licensees, sublicensees, and Third Parties with whom Novartis or CBMG, as applicable, has a bona fide contractual relationship and their respective employees, directors, agents, contractors, consultants, and advisors, in each case, solely to the extent such Person is bound by written obligations of confidentiality (including of non-use and non-disclosure) as protective of such CBMG Trade Secrets or Novartis Trade Secrets, as applicable, as those set forth in this Agreement; and (ii) Novartis may use and disclose CBMG Trade Secrets and CBMG may use and disclose Novartis Trade Secrets, in each case, in accordance with Sections 12.2 and 12.3 . Novartis shall not use or disclose any CBMG Trade Secrets for any other purpose, or otherwise authorize the same. CBMG shall not use or disclose any Novartis Trade Secrets for any other purpose, or otherwise authorize the same.
 
(c)   Without limiting the foregoing, Novartis and CBMG shall take reasonable measures to protect the secrecy of and avoid disclosure and unauthorized use of the CBMG Trade Secrets and Novartis Trade Secrets, as applicable, including by taking at least those measures that it employs to protect its own trade secrets.
 
                                                              
 
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Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(d)   Neither CBMG nor any of its Affiliates shall be obligated under this Agreement or any Ancillary Agreement to disclose or transfer to Novartis or its Affiliates any trade secret of CBMG or its Affiliates, except as expressly provided under this Agreement or any Ancillary Agreement. Neither Novartis nor any of its Affiliates shall be obligated under this Agreement or any Ancillary Agreement to disclose or transfer to CBMG or its Affiliates any trade secret of Novartis or its Affiliates, except as expressly provided under this Agreement or any Ancillary Agreement.
 
(e)   For clarity: (i) CBMG Trade Secrets shall constitute Confidential Information of CBMG; and (ii) Novartis Trade Secrets shall constitute Confidential Information of Novartis.
 
(f)   In the event of a conflict or inconsistency between this Section 12.5 and any other provision of Article 12 or Section 11.1 , such other provision of Article 12 or Section 11.1 will control.
 
13.   TERM AND TERMINATION
 
13.1   Term.
 
The term of this Agreement will commence upon the Effective Date and shall continue, unless earlier terminated as permitted by this Agreement, until the ten (10)-year anniversary of the Effective Date (the “ Initial Term ”). Thereafter, this Agreement shall be automatically renewed for consecutive two (2)-year periods (each, a “ Renewal Term ”) (each Renewal Term, collectively with the Initial Term, the “ Term ”) unless terminated by Novartis by written notice to CBMG at least ninety (90) days prior to such automatic renewal.
 
13.2   Termination for Breach.
 
(a)   If either Party is in material breach of any material obligation under this Agreement, the non-breaching Party may provide written notice to the breaching Party specifying the claimed particulars of such material breach, and in the event such material breach is capable of being cured but is not cured within ninety (90) days after the receipt by the breaching Party of such notice, then subject to Section 13.2(c) , the non-breaching Party shall have the right to terminate this Agreement immediately by giving written notice to the breaching Party to such effect; provided , however , that if such breach is capable of being cured but cannot be cured within such ninety (90)-day period and the breaching Party initiates actions to cure such breach within such period and thereafter diligently pursues such actions, the non-breaching Party shall grant the breaching Party such additional period as is reasonable under the circumstances to cure such breach. For clarity, in the event that a material breach is not capable of being cured, then subject to Section 13.2(c) , the non-breaching Party shall have the right to terminate this Agreement immediately by giving written notice to the breaching Party to such effect.
 
                                                              
 
39
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(b)   In the event that Novartis is the non-breaching Party referenced in Section 13.2(a) , without limiting any of its other rights or remedies under this Agreement or otherwise, Novartis may, in lieu of exercising its right to terminate this Agreement, provide written notice to CBMG following the expiration of the applicable cure period that: (i) this Agreement shall continue in full force and effect; and (ii) from and after expiration of the applicable cure period, each collaboration payment, as calculated under Section 9.1 and payable under Section 10.1 , shall be reduced by fifty percent (50%).
 
(c)   In the event that arbitration is commenced pursuant to Section 18.12 with respect to any alleged breach hereunder, no purported termination of this Agreement pursuant to this Section  13.2 shall take effect until the resolution of such arbitration.
 
13.3   Termination by Novartis for Change in Applicable Law or Action of a Governmental Entity.
 
Novartis may terminate this Agreement upon sixty (60) days’ prior written notice where any Applicable Law is enacted or any existing Applicable Law is amended, supplemented, or otherwise modified, or any Governmental Entity takes any action, including with respect to regulation of VIEs generally or CBMG’s VIE structure specifically, any Requisition of Scientific Data, or any requisition or seizure of any of CBMG’s or its Affiliates’ other assets (including CBMG’s or its Affiliates’ manufacturing facilities) which are material to its business, in each case, in a manner which Novartis, in its sole discretion, determines renders illegal or restricts or adversely affects any activity contemplated by this Agreement. During such sixty (60)-day period, neither Party shall be obligated to perform under this Agreement to the extent that it reasonably believes such performance would violate Applicable Law. For purposes hereof, “Requisition of Scientific Data” means any instance where a Governmental Entity in the PRC requires, pursuant to Article 24 thereof, scientific data as defined under the Scientific Data Management Procedures issued by the State Council General Office with effect from March 17, 2018 to be disclosed to any Governmental Entity in the PRC.
 
13.4   Termination by Novartis for Material Safety Issue.
 
Novartis may terminate this Agreement upon sixty (60) days’ prior written notice where it determines in its sole discretion that a safety issue exists with respect to the Development, Manufacture, or Commercialization of the Product. In connection with such termination, CBMG shall provide all assistance reasonably requested by Novartis during such period as is reasonably required to identify, further characterize, and fully document such safety issue. During such sixty (60)-day period, Novartis shall not be required to undertake any Development, Manufacturing, or Commercialization activities or any other activities, in each case, which it believes would implicate a material safety issue.
 
13.5   Termination by Novartis for Failure to Obtain Required PRC Approvals for DLBCL.
 
Novartis may terminate this Agreement effective immediately where any Required PRC Approval which is necessary for the Development, Manufacture, or Commercialization of the Product for DLBCL is not obtained by the applicable Party(ies) within eighteen (18) months after the Effective Date.
 
13.6   Termination by Novartis for Failure to Execute Ancillary Agreements.
 
Novartis may terminate this Agreement effective immediately if any of the Ancillary Agreements is not executed within six (6) months after the Effective Date.
 
                                                              
 
40
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
13.7   Termination by Novartis for Quality Audit Failure.
 
Novartis may terminate this Agreement effective immediately if: (a) Novartis reasonably believes (as a result of a condition which it observes during a Quality Audit or otherwise) that CBMG may not be in compliance with cGMP, Novartis’s quality requirements, or Applicable Law; and (b) CBMG fails to successfully implement the CAPAs, as determined in Novartis’s sole discretion, within sixty (60) days following the Parties’ agreement on such CAPAs in accordance with Section 7.2 .
 
13.8   Termination by Novartis for Failure to Finalize Tech Transfer Work Plans.
 
Novartis may terminate this Agreement effective immediately if the Tech Transfer Work Plans are not finalized within thirty (30) days after the Effective Date in accordance with Section 15.3(a) .
 
13.9   Termination by Novartis for Expiration or Termination of an Ancillary Agreement.
 
Novartis may terminate this Agreement effective immediately upon the expiration or termination of any Ancillary Agreement.
 
13.10   Termination by Novartis for Change of Control.
 
Novartis may terminate this Agreement upon sixty (60) days’ prior written notice upon a Change of Control of CBMG or CBMG’s or any Affiliate’s entry into a definitive agreement providing for a transaction or series of transactions that would constitute a Change of Control of CBMG; provided , that, at the applicable time, the Acquirer: (a) is researching, developing, manufacturing, or commercializing any cell therapy or gene therapy product, service, or technology that Novartis determines competes with any cell therapy or gene therapy product, service, or technology of Novartis or any of its Affiliates; or (b) has not been, during the five (5) consecutive Calendar Years immediately preceding such time, in full compliance with all Regulatory Requirements and Novartis internal regulatory and compliance standards; or (c) is researching, developing, manufacturing, or commercializing a Competing Product; or (d) recorded greater than [***] in worldwide net sales during the prior twelve (12)-month period (in each case, (a) through (d), as determined in Novartis’s sole discretion).
 
13.11   Termination by Novartis for Third Party Necessary Patent Rights.
 
Novartis may terminate this Agreement upon sixty (60) days’ prior written notice where Novartis determines, in its sole discretion, that a Third Party Controls a Patent Right which is necessary for the Development, Manufacture, or Commercialization of the Product in the Territory.
 
13.12   Termination by Novartis for Termination or Diminishment of License under Novartis Third Party Agreement.
 
Novartis may terminate this Agreement upon sixty (60) days’ prior written notice where: (a) any Novartis Third Party Agreement is terminated; or (b) the scope or exclusivity of any license granted to Novartis under any Novartis Third Party Agreement is diminished.
 
13.13   Termination by Novartis for Loss of Market Share.
 
Novartis may terminate this Agreement upon sixty (60) days’ prior written notice in the event of a Loss of Market Share.
 
13.14   Termination by Novartis for Non-Viability of Product Commercialization.
 
Novartis may terminate this Agreement upon sixty (60) days’ prior written notice where Novartis determines, in its sole discretion, that the Commercialization of the Product in the Territory is not commercially viable.
 
                                                              
 
41
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
13.15   Termination by Novartis for Divestiture of the Product.
 
Novartis may terminate this Agreement effective immediately where Novartis sells, assigns, transfers, conveys, licenses, or otherwise divests to a Third Party any material right in and to the Product in the Territory.
 
13.16   Termination by Novartis for Wind-Down of Product-Related Activities.
 
Novartis may terminate this Agreement effective immediately where Novartis ceases all material development, manufacture, and commercialization activities with respect to the Product in the Territory.
 
13.17   Termination for Insolvency.
 
Either Party may terminate this Agreement upon written notice if an Insolvency Event occurs in relation to the other Party. If a Party becomes aware of the likely occurrence of any Insolvency Event in regard to that Party, it shall promptly so notify the other Party in sufficient time to give the other Party sufficient notice to protect its interests under this Agreement. Novartis may terminate this Agreement in the event CBMG rejects this Agreement under Section 365 of the United States Bankruptcy Code, 11 U.S.C. § 101 et seq.
 
14.   EFFECTS OF EXPIRATION OR TERMINATION
 
14.1   Effects of Expiration or Termination.
 
Upon the expiration or termination of this Agreement for any reason, the following consequences shall apply:
 
(a)   Each of CBMG’s and Novartis’s rights and obligations under this Agreement shall terminate, except as otherwise contemplated by this Article 14 .
 
(b)   Each Party shall, upon receipt of a written request from the other Party following the expiration or termination of this Agreement, promptly return to the other Party (or, where the requesting Party is CBMG, destroy) all Confidential Information of such other Party, including all reproductions and copies thereof together with all internal material and documents generated by it containing Confidential Information or references thereto, from which references the substance of the Confidential Information can be implied or understood and shall delete all references thereto stored electronically; provided , that: (i) one (1) copy of all such Confidential Information may be retained by either Party in its confidential files for archive purposes; and (ii) Novartis shall be entitled to retain and use any such Confidential Information in connection with exercising any of its rights which survive expiration or termination in accordance with this Article 14 .
 
(c)   In the event there are any ongoing Clinical Studies of the Product in the Territory as of the effective date of expiration or termination of this Agreement, at Novartis’s request, CBMG agrees to continue supporting such Clinical Studies to the extent contemplated in the Development Plan in effect as of the effective date of expiration or termination of this Agreement or, in the case of Clinical Studies being conducted by or on behalf of CBMG, at Novartis’s request, to promptly transition to Novartis or its designee CBMG’s responsibilities for such Clinical Studies or portions thereof. Development Costs incurred by the Parties in connection with any such support or transition shall be subject to cost-sharing in accordance with Section 5.5(a)(ii) .
 
                                                              
 
42
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(d)   At Novartis’s request, CBMG shall transition to Novartis any arrangement with any contractor from which CBMG or its Affiliates had arranged to obtain supply of the Product or any related materials in accordance with the Manufacturing and Supply Agreement. In addition, CBMG shall support a full technical transfer of the Product to Novartis or its designee in accordance with the Manufacturing and Supply Agreement. CBMG shall promptly provide to Novartis a copy of all data and other Know-How pertaining to the Manufacture of the Product to the extent not previously provided to Novartis, and Novartis shall have the right to use (and authorize the use of) and to disclose all such data and other Know-How following the expiration or termination of this Agreement for purposes of Manufacturing the Product and otherwise exercising its rights under this Agreement which survive termination in accordance with this Article  14 . Further, to the extent CBMG has any remaining obligations under the Tech Transfer Work Plans, CBMG shall promptly complete such activities in accordance therewith.
 
(e)   At Novartis’s request, CBMG and its Affiliates shall transfer to Novartis or its designees all Regulatory Filings and other Regulatory Documentation relating to the Product.
 
(f)   Section 12.1(b) shall cease to apply, and Novartis shall be free to use and disclose without restriction all CBMG Know-How. In addition, CBMG shall promptly provide to Novartis a copy of all such Know-How, to the extent not previously provided to Novartis.
 
14.2   Survival.
 
In addition to any other provisions of this Agreement that are elsewhere expressly stated to survive, the provisions of Articles   1 (Definitions and Interpretation), 10 (Payment Terms and Reports), 14 (Effects of Expiration or Termination), 16 (Indemnification and Liability), and 18 (Miscellaneous)   and Sections   2.2(b) (License Grants to Novartis), 2.3(a)(ii) (Sublicenses), 2.5(a) (Exclusivity), 5.5 (Development Costs), 11.1 (Ownership), 15.1 (Representations and Warranties by CBMG), 15.2 (Representations and Warranties by Novartis), and 15.5 (No Other Warranties) shall survive the expiration or termination of this Agreement for any reason, in accordance with their respective terms and conditions, and for the duration stated, and where no duration is stated, shall survive indefinitely. In addition, the provisions of Article  12 shall survive the termination or expiration of this Agreement for a period of ten (10) years.
 
14.3   Accrued Obligations.
 
Except as otherwise expressly provided herein, the expiration or termination of this Agreement for any reason shall not release either Party from any liability that, at the time of such expiration or termination, has already accrued to the other Party or that is attributable to a period of time prior to such expiration or termination, nor will any expiration or termination of this Agreement preclude either Party from pursuing all rights and remedies it may have under this Agreement, or at law or in equity, with respect to breach of this Agreement prior to such expiration or termination.
 
14.4   Termination Not Sole Remedy.
 
Termination is not the sole remedy under this Agreement and, whether or not termination is effected and notwithstanding anything contained in this Agreement to the contrary, all other remedies at law or in equity will remain available except as agreed to otherwise herein.
 
                                                              
 
43
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
15.   REPRESENTATIONS, WARRANTIES, AND COVENANTS
 
15.1   Representations and Warranties by CBMG.
 
CBMG represents and warrants to Novartis, as of the Effective Date, as follows:
 
(a)   Due Organization and Good Standing . CBMG, and each of its Relevant Affiliates, is a corporation or other entity duly organized, validly existing, and, where applicable, in good standing under the laws of its jurisdiction of organization, and has the requisite power and authority to own, lease, and operate its properties and to carry on its business as now conducted, and is qualified to do business in each jurisdiction in which the character of its properties or the nature of its business requires such qualification.
 
(b)   Authorization of Transaction . Each of CBMG and its Relevant Affiliates has all power and authority to execute, deliver, and perform its obligations under this Agreement and each Ancillary Agreement to which it is or will be a party and to consummate the transactions contemplated hereby or thereby. The execution, delivery, and performance by CBMG and its Relevant Affiliates of this Agreement and each Ancillary Agreement to which it will be a party have been duly and validly authorized by all necessary action on the part of CBMG and its Relevant Affiliates, and no other proceedings on the part of CBMG or any of its Relevant Affiliates will be necessary to authorize the execution, delivery, and performance by CBMG and its Relevant Affiliates of this Agreement or any Ancillary Agreement or to consummate the transactions contemplated hereby or thereby. Assuming due authorization, execution, and delivery by the other parties thereto, this Agreement and each Ancillary Agreement, when executed and delivered by CBMG and its Relevant Affiliates, shall constitute a valid and binding obligation of CBMG and its Relevant Affiliates, enforceable against CBMG and its Relevant Affiliates in accordance its terms (except as may be limited by bankruptcy, insolvency, fraudulent transfer, moratorium, reorganization, preference, or similar Applicable Laws of general applicability relating to or affecting the rights of creditors generally and subject to general principles of equity (regardless of whether enforcement is sought in equity or at law)).
 
(c)   Permits . No Permits are required in connection with the execution, delivery, and performance of this Agreement or any Ancillary Agreement by CBMG and its Relevant Affiliates, except for the Required PRC Approvals.
 
(d)   No Conflict or Violation . Assuming all Permits described in Section 15.1(c) have been obtained, the execution, delivery, and performance by CBMG and its Relevant Affiliates of this Agreement and the Ancillary Agreements and the consummation by CBMG and its Relevant Affiliates of the Transactions will not: (i) violate the organizational documents of CBMG or any of its Relevant Affiliates; (ii) violate in any material respect any Applicable Law applicable to CBMG or any of its Relevant Affiliates; or (iii) require a consent or approval under, conflict with, result in a violation or breach of, or constitute a default under, result in the acceleration of, create in any party the right to accelerate, terminate, or cancel (with or without notice or lapse of time or both), or result in a loss of benefit under any Contract or Permit to which CBMG or any of its Relevant Affiliates is subject, in each case, in any material respect.
 
                                                              
 
44
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(e)   Legal Proceedings . There are no, and since January 1, 2016 (the “ Look-Back Date ”), there have not been, except as set forth on Schedule 15.1(e) , any Actions pending or, to the Knowledge of CBMG, threatened against CBMG or its Affiliates: (i) which, if adversely determined, would materially and adversely impact CBMG or its Affiliates; or (ii) that challenge the validity or enforceability of this Agreement or seeks to enjoin or prohibit consummation of the Transactions, or that would reasonably be expected to impair or materially delay the CBMG’s or its Relevant Affiliates’ ability to consummate the Transactions or perform their respective obligations under this Agreement and the Ancillary Agreements. Neither CBMG nor any of its Affiliates nor any of their respective material properties or assets are subject to any outstanding Order.
 
(f)   Compliance with All Applicable Laws, including Orders and Permits .
 
(i)
CBMG and each of its Affiliates is, and since the Look-Back Date, has been, in full compliance with all Applicable Law and Orders. CBMG and its Affiliates are, and have at all times since the Look-Back Date been, conducted their respective businesses in full compliance with all Applicable Law and Orders. CBMG and each of its Affiliates possess all Permits required to conduct their respective businesses. Each such Permit is in full force and effect. Since the Look-Back Date, neither CBMG nor any Affiliate of CBMG has received any written communication from a Governmental Entity that alleges that its business has not been conducted in compliance with any such Applicable Law, Order, or Permit or threatens to revoke, restrict, or limit any Permit necessary or advisable for the operation of such business. Since the Look-Back Date, neither CBMG, nor any Affiliate of CBMG, has received any written communication from any Governmental Entity that alleges that its VIE structure (or any aspect thereof) is not in compliance with Applicable PRC Laws or alleging that it is a circumvention of the requirement for VIEs to obtain Permits, or threatening to revoke, restrict, or limit any Permit for any Affiliate within the VIE structure that is necessary or advisable for the operation of such business.
 
(ii)
CBMG and each of its Affiliates is, and since the Look-Back Date, has been, in full compliance with all Applicable Law, concerning the exportation of any products, technology, technical data, and services, including those administered by the United States Department of Commerce, the United States Department of State, and the United States Department of Treasury. CBMG and its Affiliates are in full compliance with United States and international economic and trade sanctions, including those administered by the United States Office of Foreign Assets Control.
 
(iii)
Neither CBMG nor any of its Affiliates has agreed to a material restriction on its right to conduct its business freely with any other business, including a restriction on the geographic scope of its business or a restriction on the kind of business that it is entitled to carry on. Neither CBMG nor any of its Affiliates is in breach of any provision of the PRC Anti-Monopoly Law.
 
(g)
Regulatory Matters .
 
                                                              
 
45
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(i)
Since the Look-Back Date, CBMG and its Affiliates are, and have been, in full compliance with all applicable rules, regulations, decrees, guidance, pronouncements, circulars, standards, and policies of the FDA and the SAMR and any other applicable Regulatory Authority, including cGMP, cGLP, and cGCP (collectively, “ Regulatory Requirements ”).
 
(ii)
No IND filed by or on behalf of CBMG with the FDA or the SAMR has been terminated by the FDA or the SAMR, and none of the FDA, the SAMR, or any other Regulatory Authority has recommended, commenced, or, to the Knowledge of CBMG, threatened to initiate, any action to place a clinical hold order on, or otherwise delay or suspend, proposed or ongoing Clinical Studies conducted or proposed to be conducted by or on behalf of CBMG and its Affiliates.
 
(iii)
All operations of CBMG and its Affiliates and all of the manufacturing facilities and operations of CBMG’s and its Affiliates’ suppliers of products and product candidates and the components thereof manufactured in or imported into the United States are in full compliance with applicable Regulatory Requirements, and meet the sanitation standards set by the FD&C Act. All of the operations of CBMG and its Affiliates and all of the manufacturing facilities and operations of CBMG’s and its Affiliates’ suppliers of products and product candidates and the components thereof manufactured in or imported into the PRC are in full compliance with applicable SAMR Regulatory Requirements, and all the operations of CBMG and its Affiliates and all of the manufacturing facilities and operations of CBMG’s and its Affiliates’ suppliers of products and product candidates manufactured outside of the United States or the PRC are in compliance with applicable Regulatory Requirements in each jurisdiction in which the activity takes place.
 
(iv)
(A) CBMG and its Affiliates have obtained, in accordance with Applicable Law, all Permits required under any Applicable Law or required by the SAMR, the FDA, or any other applicable Regulatory Authority for the lawful operation of their respective businesses, as presently conducted; (B) each such Permit is valid and in full force and effect; (C) there are currently no Actions pending that seek the revocation, cancellation, or adverse modification of any Permit; and (D) CBMG has no Knowledge that any of the Permits will not be renewed or extended on expiry of the current term on the same terms, or will only be extended or renewed on less favorable terms than currently in effect. All Regulatory Documentation has been maintained and retained in accordance with Applicable Law, and such Regulatory Documentation is in the possession or control of CBMG and its Affiliates.
 
(v)
CBMG and its Affiliates are not subject to any unresolved notice, citation, suspension, revocation, warning, administrative proceeding, review, or investigation by a Regulatory Authority that alleges or asserts that CBMG or any of its Affiliates has violated any applicable Healthcare Laws, including an FDA Form 483, FDA warning letter, untitled letter, or similar notice of alleged non-compliance. There has not been a recall or market withdrawal or any product or product candidates by or on behalf of CBMG or its Affiliates. CBMG and its Affiliates have complied with all adverse event reporting requirements applicable to its products and product candidates.
 
                                                              
 
46
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(vi)
All reports, documents, claims, Permits, and notices related to the conduct of the business of CBMG and its Affiliates required to be filed, maintained, or furnished to the FDA, the SAMR, and any other Regulatory Authority have been so filed, maintained, or furnished, and all such reports, documents, claims, Permits, and notices were complete and accurate in all material respects on the date filed (or were promptly corrected in or supplemented by a subsequent filing).
 
(vii)
(A) Neither CBMG nor any of its Affiliates nor, to the Knowledge of CBMG, any of their respective officers, employees, agents, or distributors, or any other Person involved in development of any data included in any filing of CBMG or its Affiliates submitted to a Regulatory Authority, has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by 21 U.S.C. § 335a, nor has any such Person been so debarred; and (B) neither CBMG nor any of its Affiliates nor, to the Knowledge of CBMG, any of their respective officers, employees, or agents, nor any other Person involved in the development of any data included in any filing of CBMG or its Affiliates submitted to a Regulatory Authority, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under 42 U.S.C. § 1320a-7, nor has any such Person been excluded from participation in such programs. Neither CBMG nor any of its Affiliates nor, to the Knowledge of CBMG, any of their respective directors, senior managers, or legal representatives is prohibited under Applicable PRC Laws from holding the current offices which they occupy within CBMG or any of its Affiliates.
 
(h)   Ethical Practices . Neither CBMG nor any of its Affiliates nor, to the Knowledge of CBMG, any of their respective directors, officers, or employees or any other Person acting for, or on behalf of, CBMG or its Affiliates has:
 
(i)
violated or is in violation of any applicable Anti-Corruption Law;
 
(ii)
made, undertaken, offered to make, promised to make, or authorized the payment or giving of any bribe, rebate, payoff, influence payment, kickback, or other payment or gift of money or anything of value (including meals or entertainment), to any officer, employee, or ceremonial office holder of any government or instrumentality thereof, any political party or supra-national organization (such as the United Nations), any political candidate, any royal family member, or any other person who is connected or associated personally with any of the foregoing, or to any non-governmental individual or entity, that is prohibited under any applicable Anti-Corruption Law or otherwise for the purpose of influencing any act or decision of such payee in his official capacity, inducing such payee to do or omit to do any act in violation of his lawful duty, securing any improper advantage or inducing such payee to use his influence with a government or instrumentality thereof to affect or influence any act or decision of such government or instrumentality, or to secure any improper advance or inducing such payee to enter into a commercial arrangement in violation of Applicable Law (each, a “ Prohibited Payment ”);
 
(iii)
been subject to any investigation by any Governmental Entity with regard to any actual or alleged Prohibited Payment;
 
                                                              
 
47
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(iv)
used funds or other assets, or made any promise or undertaking in such regard, for the establishment or maintenance of a secret or unrecorded fund (a “ Prohibited Fund ”); or
 
(v)
made any false or fictitious entries in any of CBMG’s or its Affiliates’ books or records relating to any Prohibited Payment or Prohibited Fund.
 
(i)
Data Privacy and Protection .
 
(i)
CBMG and its Affiliates have complied with each relevant requirement of all applicable Data Protection Laws.
 
(ii)
Neither CBMG nor any of its Affiliates has received a notice or allegation from a Governmental Entity or any other Person: (A) alleging noncompliance with any Data Protection Laws; (B) requiring it to change, cease using, block, or delete any personal data; (C) prohibiting the transfer of personal data to any place; or (D) requiring it to take any other type of action with respect to the collection, use, transfer, or deletion of personal information.
 
(iii)
CBMG and its Affiliates have obtained each necessary consent from data subjects and has complied with each necessary condition to permit it to process or use all relevant personal information in connection with their respective businesses and, where appropriate, any relevant purpose for which it would be necessary for Novartis to use such personal information in accordance with this Agreement and the Ancillary Agreements.
 
(j)
Intellectual Property .
 
(i)
CBMG has the right to grant all rights and licenses it purports to grant to Novartis to the CBMG Patents and the CBMG Know-How under this Agreement.
 
(ii)
CBMG has not granted any right or license to any Third Party relating to any of the CBMG Patents or the CBMG Know-How that would conflict or interfere with any of the rights or licenses granted to Novartis under this Agreement.
 
(iii)
All title in and ownership rights pertaining to any CBMG Patents and CBMG Know-How that arose out of or derived from (whether in whole or in part) the work performed by, or services rendered by, any existing or former employee of, or a consultant previously or currently engaged by CBMG or its Affiliates during his or her employment or engagement are vested in CBMG or its Affiliate, as applicable, and the relevant individuals or Persons have validly executed, either alone or with CBMG or its Affiliate, as applicable, all necessary deeds, contracts, agreements, and documentation needed to vest title and ownership rights pertaining to such CBMG Patents and CBMG Know-How in CBMG or its Affiliate in accordance with Applicable Law, and no past or present employee has any claim for employee-inventor rights against CBMG or any of its Affiliates.
 
15.2   Representations and Warranties by Novartis.
 
Novartis represents and warrants to CBMG, as of the Effective Date, as follows:
 
                                                              
 
48
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
 
(a)   Due Organization and Good Standing . Novartis, and each of its Relevant Affiliates, is duly incorporated, validly existing, and, where applicable, in good standing under the laws of its jurisdiction of organization.
 
(b)   Authorization of Transaction . Each of Novartis and its Relevant Affiliates has all power and authority to execute, deliver, and perform its obligations under this Agreement and each Ancillary Agreement to which it is or will be a party and to consummate the transactions contemplated hereby or thereby. The execution, delivery, and performance by Novartis and its Relevant Affiliates of this Agreement and each Ancillary Agreement to which it will be a party have been duly and validly authorized by all necessary action on the part of Novartis and its Relevant Affiliates, and no other proceedings on the part of Novartis or any of its Relevant Affiliates will be necessary to authorize the execution, delivery, and performance by Novartis and its Relevant Affiliates of this Agreement or any Ancillary Agreement or to consummate the transactions contemplated hereby or thereby. Assuming due authorization, execution and delivery by the other parties thereto, this Agreement and each Ancillary Agreement, when executed and delivered by Novartis and its Relevant Affiliates, shall constitute a valid and binding obligation of Novartis and its Relevant Affiliates, enforceable against Novartis and its Relevant Affiliates in accordance its terms (except as may be limited by bankruptcy, insolvency, fraudulent transfer, moratorium, reorganization, preference, or similar Applicable Law of general applicability relating to or affecting the rights of creditors generally and subject to general principles of equity (regardless of whether enforcement is sought in equity or at law)).
 
(c)   Permits . No Permits are required in connection with the execution and delivery of this Agreement or any Ancillary Agreement by Novartis and its Relevant Affiliates, except for those required in connection with the Development, Manufacture, or Commercialization of the Product in the Territory after the Effective Date.
 
(d)   No Conflict or Violation . Assuming all Permits described in Section 15.2(c) have been obtained, the execution and delivery by Novartis and its Relevant Affiliates of this Agreement and the Ancillary Agreements do not: (i) violate the organizational documents of Novartis or any of its Relevant Affiliates; (ii) violate in any material respect any Applicable Law to which Novartis or any of its Relevant Affiliates is subject; or (iii) require a consent or approval under, conflict with, result in a violation or breach of, or constitute a default under, result in the acceleration of, create in any party the right to accelerate, terminate, or cancel any Contract to which Novartis or any of its Relevant Affiliates is a party, in each case, in any material respect.
 
(e)   Legal Proceedings . There are no Actions pending or threatened in writing against Novartis which would, if adversely determined, prohibit or materially delay the consummation of the Transactions. Novartis is not subject to any Order that would reasonably be expected to materially impair or materially delay Novartis’s ability to consummate the transactions contemplated hereby.
 
(f)
Intellectual Property .
 
                                                              
 
49
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(i)
Novartis has the right to grant all rights and licenses it purports to grant to CBMG to the Novartis Patents and the Novartis Know-How under this Agreement.
 
(ii)
Novartis has not granted any right or license to any Third Party relating to any of the Novartis Patents or the Novartis Know-How that would conflict or interfere with any of the rights or licenses granted to CBMG under this Agreement.
 
(iii)
All title in and ownership rights pertaining to any Novartis Patents and Novartis Know-How that arose out of or derived from (whether in whole or in part) the work performed by, or services rendered by, any existing or former employee of, or a consultant previously or currently engaged by Novartis or its Affiliates during his or her employment or engagement are vested in Novartis or its Affiliate, as applicable, and the relevant individuals or Persons have validly executed, either alone or with Novartis or its Affiliate, as applicable, all necessary deeds, contracts, agreements, and documentation needed to vest title and ownership rights pertaining to such Novartis Patents and Novartis Know-How in Novartis or its Affiliate in accordance with Applicable Law, and no past or present employee has any claim for employee-inventor rights against Novartis or any of its Affiliates.
 
15.3   Mutual Covenants.
 
 
(a)   Technology Transfer of the CBMG Technology and the Product . The Parties shall diligently negotiate in good faith to finalize two (2) tech transfer work plans: one (1) with respect to the transfer of the CBMG Technology from CBMG to Novartis, as set forth on Schedule 15.3(a) (the “ CBMG Technology Tech Transfer Plan ”); and one (1) with respect to the transfer of the Product manufacturing process from Novartis to CBMG, which latter plan shall be attached to the Manufacturing and Supply Agreement (the “ Product Tech Transfer Plan ”) as soon as practicable after the Effective Date; provided , that such tech transfer work plans shall be finalized within thirty (30) days after the Effective Date and prior to the execution of the Manufacturing and Supply Agreement. Upon the finalization of the tech transfer work plans, such work plans shall be deemed to be the “ Tech Transfer Work Plans .” The Parties may amend the Tech Transfer Work Plans from time to time upon mutual agreement.
 
(b)   Registration . If required by Applicable Law, CBMG shall, promptly following the Effective Date and in accordance with Applicable PRC Laws, submit the following items to the competent MOFCOM registration authority in the PRC (the “ Registration Authority ”) in accordance with Applicable PRC Laws: (x) for registration of the license granted by Novartis to CBMG pursuant to Sections 2.1(a) and 2.1(b) as a technology import contract; and (y) for registration of the license granted by CBMG to Novartis pursuant to Sections 2.2(a) and 2.2(b) as a technology export contract:
 
(i)
a written application for registration of this Agreement;
 
(ii)
a duplicate copy of this Agreement; and
 
                                                              
 
50
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(iii)
other supporting documents as may be required by the relevant Registration Authority.
 
 
Novartis shall use good-faith efforts to provide reasonable assistance to CBMG in connection with the registration of this Agreement. CBMG shall: (1) obtain from the Registration Authority the “Technology Import Contract Registration Certificate” and the “Technology Export Contract Registration Certificate” in respect of this Agreement promptly following issuance thereof by the Registration Authority; and (2) provide copies of such certificates to Novartis promptly (but in no event later than five (5) Business Days) following CBMG’s receipt thereof.
 
(c)   Further Assurances . Subject to the provisions of this Agreement, each of Novartis and CBMG shall, from time to time, execute and deliver all such further instruments and take such other action as may be reasonably necessary to effectively carry out or better evidence or perfect the full intent and meaning of this Agreement.
 
(d)   Third Party Consents . Each Party, as applicable, agrees to use commercially reasonable efforts to obtain the consents for which it is responsible as set forth on Schedule 15.3(d) ; provided , that the foregoing shall not obligate either Party or its Affiliates to make any material payment or grant any other material consideration or undertake any material liability, obligation, or commitment in order to obtain such consent.
 
(e)   Compliance with Law . Each Party covenants that it shall, in performing its obligations under this Agreement (including the Development Plan), comply with Applicable Law in all jurisdictions in which any relevant activities under this Agreement take place.
 
(f)   No Debarment . Each Party covenants that no Person who is known by such Party to have been debarred under subsection (a) or (b) of Section 306 of the FD&C Act or who is prohibited under Applicable Law from acting as a director, senior manager, or legal representative will be employed by such Party in the performance of any activities under this Agreement.
 
(g)   No Disqualification . Each Party covenants that, to the knowledge of such Party, no Person on any of the FDA clinical investigator enforcement lists (including the: (i) Disqualified/Totally Restricted List; (ii) Restricted List; and (iii) Adequate Assurances List) will participate in the performance of any activities under this Agreement.
 
(h)   Insurance . Each Party covenants that it shall maintain insurance (or, with respect to Novartis, self-insure) with respect to its activities and obligations under this Agreement in such amounts as are commercially reasonable in the industry for companies conducting similar business and shall require any of its Affiliates undertaking activities under this Agreement to do the same; provided , that CBMG’s failure to comply with this Section 15.3(h) shall not be deemed a breach where such failure occurs prior to the Parties’ entry into the Manufacturing and Supply Agreement.
 
15.4   Covenants by CBMG.
 
                                                              
 
51
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(a)   Data Subjects . CBMG shall obtain, or shall cause its Affiliates to obtain, written consent from all data subjects in form and substance agreed by the Parties and in the circumstances agreed by the Parties. To the extent that, Applicable Law prevents the disclosure or transfer of any data (including data associated with Regulatory Filings, Clinical Studies, or individual patients) to, or the processing of data by, Novartis where the same is contemplated by this Agreement or any Ancillary Agreement, CBMG shall, to the extent permitted by Applicable Law, disclose or transfer the same to an entity designated by Novartis in the PRC. In the event that Applicable Law prevents disclosure or transfer of data by CBMG to, or the processing of data by, the Novartis designee, then the Parties shall negotiate in good faith to put in place arrangements that will allow Novartis to as far as permitted under Applicable Law to obtain the same rights and economic benefits as it would have been entitled to had a transfer to Novartis or a Novartis designee been permitted.
 
(b)   Non-Solicitation . During the Term, CBMG shall not, and shall cause its Affiliates not to, directly or indirectly, actively recruit, solicit, or hire any former or current employee of Novartis or its Affiliates for a period of twelve (12) months following termination of such employment, which employee has, directly or indirectly, been involved in the Development, Manufacture, or Commercialization of the Product without first obtaining, in each case, the prior written consent of Novartis.
 
(c)   Compliance with Novartis Data Protection and Information Security Requirements . CBMG shall diligently work with Novartis in good faith to finalize the Novartis Data Protection and Information Security Requirements. The Novartis Data Protection and Information Security Requirements shall be finalized prior to the time at which CBMG first processes Personal Data (as such term is defined in Part A, Section 9 of Schedule 15.4(c) ) pursuant to this Agreement or any Ancillary Agreement. From and after such time, CBMG shall comply, and shall cause its Affiliates to comply, with the Novartis Data Protection and Information Security Requirements. CBMG grants to Novartis, its Affiliates, and its designees, from time to time, upon reasonable prior notice, the right to audit CBMG’s and its Affiliates’ compliance with the Novartis Data Protection and Information Security Requirements.
 
15.5   No Other Warranties.
 
EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE  15 : (A) NO REPRESENTATION OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON BEHALF OF CBMG OR NOVARTIS; AND (B) ALL OTHER CONDITIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED, INCLUDING ANY CONDITIONS AND WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. WITHOUT LIMITING THE FOREGOING, CBMG HEREBY ACKNOWLEDGES: (1) THAT THE PRODUCT CONSTITUTES A NOVEL THERAPY AND THE MANUFACTURING PROCESS FOR THE PRODUCT IS COMPLEX AND EXPERIMENTAL IN NATURE; (2) THAT NO REPRESENTATION OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON BEHALF OF NOVARTIS WITH RESPECT TO THE MANUFACTURE OF THE PRODUCT, INCLUDING BY NOVARTIS, CBMG, OR ANY OTHER PERSON; AND (3) THE MATTERS SET FORTH ON SCHEDULE 15.5 .
 
 
                                                              
 
52
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
16.   INDEMNIFICATION AND LIABILITY
 
16.1   Indemnification by CBMG.
 
CBMG shall indemnify and hold Novartis, its Affiliates, and its sublicensees, and their respective officers, directors, and employees (the “ Novartis Indemnitees ”) harmless from any and all Losses incurred by or imposed upon the Novartis Indemnitees or any of them in connection with any Claim, in each case, to the extent arising or resulting from:
 
(a)   the Development or Manufacture of the Product by CBMG or any of its Affiliates, sublicensees, or subcontractors;
 
(b)   the negligence or willful misconduct of CBMG or any of its Affiliates, sublicensees, or subcontractors; or
 
(c)   the breach of any of the obligations, covenants, representations, or warranties made by CBMG to Novartis under this Agreement;
 
provided , however , that CBMG shall not be obliged to so indemnify and hold harmless the Novartis Indemnitees for any Claims: (x) under Sections 16.2(a) through 16.2(c) ; or (y) to the extent that such Claims arise from the breach, negligence, or willful misconduct of Novartis or any Novartis Indemnitee.
 
16.2   Indemnification by Novartis.
 
Novartis shall indemnify and hold CBMG, its Affiliates, and its sublicensees, and their respective officers, directors, and employees (the “ CBMG Indemnitees ”) harmless from any and all Losses incurred by or imposed upon the CBMG Indemnitees or any of them in connection with any Claim, in each case, to the extent arising or resulting from:
 
(a)   the Development or Commercialization of the Product in the Territory by Novartis or any of its Affiliates, sublicensees, or subcontractors;
 
(b)   the negligence or willful misconduct of Novartis or any of its Affiliates, sublicensees, or subcontractors; or
 
(c)   the breach of any of the obligations, covenants, representations, or warranties made by Novartis to CBMG under this Agreement;
 
provided , however , that Novartis shall not be obliged to so indemnify and hold harmless the CBMG Indemnitees for any Claims: (x) under Sections 16.1(a) through 16.1(c) ; or (y) to the extent that such Claims arise from the breach, negligence, or willful misconduct of CBMG or any CBMG Indemnitee.
 
 
                                                              
 
53
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
 
16.3   Indemnification Procedure.
 
(a)   For the avoidance of doubt, all indemnification claims in respect of a CBMG Indemnitee or Novartis Indemnitee shall be made solely by CBMG or Novartis, respectively.
 
(b)   A Party seeking indemnification hereunder (the “ Indemnified Party ”) shall notify the other Party (the “ Indemnifying Party ”) in writing reasonably promptly after the assertion against the Indemnified Party of any Claim or fact in respect of which the Indemnified Party intends to base a claim for indemnification hereunder (an “ Indemnification Claim Notice ”); provided , that the failure or delay to so notify the Indemnifying Party shall not relieve the Indemnifying Party of any obligation or liability that it may have to the Indemnified Party, except to the extent that the Indemnifying Party demonstrates that its ability to defend or resolve such Claim is adversely affected thereby. The Indemnification Claim Notice shall contain a description of the Claim and the nature and amount of the Claim (to the extent that the nature and amount of such Claim is known at such time). Upon the request of the Indemnifying Party, the Indemnified Party shall furnish promptly to the Indemnifying Party copies of all correspondence, communications, and official documents (including court documents) received or sent in respect of such Claim.
 
(c)   Subject to Section  16.3(d) and Section  16.3(e) , the Indemnifying Party shall have the right, upon written notice given to the Indemnified Party within thirty (30) days after receipt of the Indemnification Claim Notice and, where the Indemnifying Party is CBMG, only with Novartis’s prior written consent, to assume the defense and handling of such Claim, at the Indemnifying Party’s sole expense, in which case Section  16.3(d) shall govern. The assumption of the defense of a Claim by the Indemnifying Party shall not be construed as acknowledgement that the Indemnifying Party is liable to indemnify any Indemnitee with respect to the Claim, nor shall it constitute a waiver by the Indemnifying Party of any defenses it may assert against any Indemnified Party’s claim for indemnification. In the event that it is ultimately decided that the Indemnifying Party is not obligated to indemnify or hold an Indemnitee harmless from and against the Claim, the Indemnified Party shall reimburse the Indemnifying Party for any and all reasonable documented costs and expenses (including reasonable attorneys’ fees and costs of suit) and any losses incurred by the Indemnifying Party in its defense of the Claim. If the Indemnifying Party does not give written notice to the Indemnified Party, within thirty (30) days after receipt of the Indemnification Claim Notice, of the Indemnifying Party’s election to assume the defense and handling of such Claim or, where the Indemnifying Party is CBMG, Novartis does not provide such prior written consent, Section  16.3(e) shall govern.
 
(d)   Upon assumption of the defense of a Claim by the Indemnifying Party and, where the Indemnifying Party is CBMG, upon Novartis’s prior written consent: (i) the Indemnifying Party shall have the right to and shall assume sole control and responsibility for defending and handling the Claim; (ii) the Indemnifying Party may, at its own cost, appoint as counsel in connection with conducting the defense and handling of such Claim any law firm or counsel reasonably selected by the Indemnifying Party; (iii) the Indemnifying Party shall keep the Indemnified Party informed of the status of such Claim; and (iv) the Indemnifying Party shall have the right to settle such Claim on any terms the Indemnifying Party chooses; provided , however , that it shall not, without the prior written consent of the Indemnified Party (such consent not to be unreasonably withheld, conditioned, or delayed), agree to a settlement of any Claim which could lead to liability or create any financial or other obligation on the part of the Indemnified Party for which the Indemnified Party is not entitled to indemnification under this Agreement or which admits any wrongdoing or responsibility for the Claim on behalf of the Indemnified Party. The Indemnified Party shall cooperate with the Indemnifying Party and shall be entitled to participate in, but not control, the defense of such Claim with its own counsel and at its own expense. In particular, the Indemnified Party shall furnish such records, information, and testimony, provide witnesses, and attend such conferences, discovery proceedings, hearings, trials, and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours by the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Claim, and making the Indemnified Party, the Indemnitees, and its and their employees and agents available on a mutually convenient basis to provide additional information and explanation of any records or information provided.
 
                                                              
 
54
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(e)   If the Indemnifying Party does not assume the defense of the Indemnified Party in accordance with Section   16.3(c) , the Indemnified Party may, at the Indemnifying Party’s expense, select counsel reasonably acceptable to the Indemnifying Party in connection with conducting the defense and handling of such Claim and defend or handle such Claim in such manner as it may deem appropriate. In such event, the Indemnified Party shall keep the Indemnifying Party reasonably informed of the status of such Claim and shall not settle such Claim without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld, conditioned, or delayed. If the Indemnified Party defends or handles such Claim, the Indemnifying Party shall cooperate with the Indemnified Party, at the Indemnified Party’s request but at no expense to the Indemnified Party, and shall be entitled to participate in the defense and handling of such Claim with its own counsel and at its own expense.
 
16.4   Special, Indirect, and Other Losses.
 
NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY, OR OTHERWISE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES OR FOR LOSS OF PROFITS SUFFERED BY THE OTHER PARTY, EXCEPT TO THE EXTENT ANY SUCH DAMAGES ARE: (A) INCURRED AS A RESULT OF A BREACH OF SECTION 2.5 ; (B) INCURRED AS A RESULT OF A BREACH OF ARTICLE 12 ; (C) INCURRED AS A RESULT OF A PARTY’S GROSS NEGLIGENCE, INTENTIONAL MISCONDUCT, OR FRAUD; OR (D) REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE 16 .
 
16.5   No Exclusion.
 
Neither Party excludes any liability for death or personal injury caused by its negligence or willful misconduct or that of its officers, directors, employees, agents, sublicensees, or subcontractors.
 
                                                              
 
55
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
17.   PUBLICATIONS AND PUBLICITY
 
17.1   Use of Names.
 
Neither Party shall use the name, symbol, trademark, trade name, or logo of the other Party or its Affiliates in any press release, publication, or other form of public disclosure without first obtaining, in each case, the prior written consent of the other Party (such consent not to be unreasonably withheld, conditioned, or delayed), except for those disclosures for which consent has already been obtained. Notwithstanding the foregoing, Novartis shall be entitled to use the name of CBMG to the extent necessary or useful in connection with the Development or Commercialization of the Product.
 
17.2   Press Releases and Publicity Related to this Agreement.
 
CBMG agrees not to issue any press release or other public statement, whether oral or written, disclosing the existence of this Agreement, the terms of this Agreement, or any information relating to this Agreement without first obtaining, in each case, the prior written consent of Novartis, exercisable in its sole discretion. CBMG shall provide Novartis with any such proposed press release or other public statement no less than five (5) Business Days prior to the date on which CBMG proposes to issue (subject to obtaining Novartis’s prior written consent) such press release or other public statement.
 
17.3   Public Disclosures and Publications Related to the Product.
 
 
(a)   Subject to Section 17.2 , any proposed public disclosure (whether written, electronic, oral, or otherwise) by CBMG relating to the Product shall require, in each case, the prior written consent of Novartis (such consent not to be unreasonably withheld, conditioned, or delayed).
 
(b)   For the avoidance of doubt, Novartis or any of its Affiliates may, without any required consents from CBMG, publish or have published information about Clinical Studies related to the Product, including the results of such Clinical Studies.
 
17.4   Disclosures Required By Law.
 
Notwithstanding Section 17.1 , Section 17.2 , and Section 17.3 , each Party may make any disclosures required of it to comply with any duty of disclosure it may have pursuant to Applicable Law or the requirements of any Governmental Entity or Regulatory Authority or pursuant to the rules of any recognized stock exchange. In the event of a disclosure required by Applicable Law, the requirements of any Governmental Entity or Regulatory Authority, or the rules of any recognized stock exchange, the Parties shall coordinate with each other with respect to the timing, form, and content of such required disclosure. If so requested by the other Party, the Party subject to such obligation shall use commercially reasonable efforts to obtain an order protecting to the maximum extent possible the confidentiality of such provisions of this Agreement as reasonably requested by the other Party. If the Parties are unable to agree on the form or content of any required disclosure, such disclosure shall be limited to the minimum required as determined by the disclosing Party in consultation with its legal counsel. Without limiting the foregoing, CBMG shall provide Novartis with each proposed filing by CBMG with the United States Securities and Exchange Commission (or any stock exchange, including Nasdaq, or any similar regulatory agency in any country other than the United States) describing the terms of this Agreement (including any filings of this Agreement) at least ten (10) Business Days prior to submission of such filing, and shall reasonably consider and in good faith incorporate any and all of Novartis’s comments relating to such filing, including the provisions of this Agreement for which confidential treatment should be sought.
 
                                                              
 
56
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
18.   MISCELLANEOUS
 
18.1   Fees and Expenses.
 
Except as otherwise specified in this Agreement, each of the Parties shall bear its own costs and expenses (including investment banking and legal fees and expenses) incurred in connection with this Agreement and the transactions contemplated hereby.
 
18.2   Notices.
 
All notices, requests, consents, claims, demands, waivers, and other communications under this Agreement shall be in writing and shall be delivered personally or sent electronic transmission, by a nationally-recognized overnight courier service, or by registered or certified mail, postage and fees prepaid, to the intended recipient at such Party’s address shown below (or such other address as may be specified by such Party in a notice given in the manner provided in this Section 18.2 ). Such notice or other communication shall be deemed to have been duly given: (a) when delivered, if delivered personally (with written confirmation of receipt); (b) when sent, if sent by electronic mail (if confirmed by reply electronic mail that is not automated); provided , that any electronic mail sent at or after 5:00 p.m. prevailing Eastern Time shall be deemed to be sent at 9:00 a.m. prevailing Eastern Time on the following Business Day; (c) one (1) Business Day after being sent, if sent overnight by a nationally-recognized overnight courier service (with written proof of delivery); or (d) five (5) Business Days after being sent, if sent by registered or certified mail, return receipt requested, with postage and fees prepaid.
 
If to Novartis, to:
 
Novartis Pharma AG
Lichtstrasse 35
CH-4056 Basel, Switzerland
Attention: Global Head M&A & BD&L
 
with copies, in the case of notice to Novartis, to:
 
Novartis Pharmaceuticals Corporation
59 Route 10
East Hanover, New Jersey 07936
Attention: VP General Counsel Oncology
 
and
 
Novartis Pharmaceuticals Corporation
59 Route 10
East Hanover, New Jersey 07936
Attention: VP - Global Head Oncology BD&L
 
If to CBMG, to:
 
                                                              
 
57
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Cellular Biomedicine Group, Inc.
19925 Stevens Creek Blvd, Suite 100
Cupertino, CA 95014
Attention: Chief Legal Officer
 
with copies, in the case of notice to CBMG, to:
 
Ellenoff Grossman & Schole LLP
 1345 Avenue of the Americas
New York, New York 10105
Attention: Sarah Williams, Esq.
 
18.3   Entire Agreement.
 
This Agreement (including the Exhibits and Schedules hereto) and the Ancillary Agreements constitute the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements and understandings between the Parties, both written and oral, with respect to such subject matter; provided , however , that this Agreement shall not supersede the terms and provisions of the CDA applicable to any period prior to the Effective Date.
 
18.4   Severability.
 
If any term or provision of this Agreement or the application of any such term or provision to any Person or circumstance shall be held invalid, void, or unenforceable in any respect by a court of competent jurisdiction, the remainder of the terms and provisions of this Agreement shall remain in full force and effect and shall in no way be affected, impaired, or invalidated, so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to either Party. Upon such a determination, the Parties shall negotiate in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in an acceptable manner in order that the agreement of the Parties be consummated as originally contemplated to the fullest extent possible.
 
18.5   Assignment; Binding Effect.
 
This Agreement and the rights and obligations hereunder are not assignable (by operation of law or otherwise) by CBMG unless such assignment is consented to in writing by Novartis. This Agreement and the rights and obligations hereunder are assignable (by operation of law or otherwise) by Novartis: (a) to any of its Affiliates, upon prior written notice to CBMG; and (b) to any Third Party, upon CBMG’s prior written consent, not to be unreasonably withheld, conditioned, or delayed. Subject to the foregoing, this Agreement and all the provisions hereof shall be binding upon and shall inure to the benefit of the Parties and their respective successors and permitted assigns. Notwithstanding the foregoing, no assignment shall relieve the assigning Party of any of its obligations hereunder. Any purported assignment in violation of this Section 18.5 shall be null and void.
 
18.6   Headings.
 
The headings contained in this Agreement are inserted for convenience only and shall not be considered in interpreting or construing any of the provisions contained in this Agreement.
 
 
                                                              
 
58
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
18.7   Waiver and Amendment.
 
This Agreement may be amended, modified, or supplemented only by a written mutual agreement executed and delivered by each of the Parties. Except as otherwise provided in this Agreement, any provision of this Agreement may be waived by the Party entitled to the benefits thereof only by a written instrument signed by the Party granting such waiver. No failure or delay by either Party in exercising any right, power, or privilege under this Agreement shall operate as a waiver thereof, nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power, or privilege.
 
18.8   Third Party Beneficiaries.
 
This Agreement is for the sole benefit of the Parties and their permitted successors and assigns, and nothing herein express or implied shall give or be construed to give to any Person, other than the Parties and such permitted successors and assigns, any legal or equitable rights hereunder, except with respect to Novartis Indemnitees and CBMG Indemnitees, who are Third Parties, solely with respect to Article 16 .
 
18.9   Specific Performance and Other Equitable Relief.
 
The Parties hereby expressly recognize and acknowledge that immediate, extensive, and irreparable damage would result, no adequate remedy at law would exist, and damages would be difficult to determine in the event that any provision of this Agreement is not performed in accordance with its specific terms or otherwise breached. It is hereby agreed, notwithstanding the intent of the Parties to submit claims to arbitration in accordance with Section 18.12 , that the Parties shall be entitled to specific performance of the terms hereof and immediate injunctive relief and other equitable relief, without the necessity of proving the inadequacy of money damages as a remedy, and the Parties further hereby agree to waive any requirement for the securing or posting of a bond in connection with the obtaining of such injunctive or other equitable relief. The Parties further agree not to assert that a remedy of injunctive relief, specific performance, or other equitable relief is unenforceable, invalid, contrary to law, or inequitable for any reason, nor to assert that a remedy of monetary damages would provide an adequate remedy. Such remedies, and any and all other remedies provided for in this Agreement, shall, however, be cumulative in nature and not exclusive and shall be in addition to any other remedies whatsoever which either Party may otherwise have. Each of the Parties hereby acknowledges that the existence of any other remedy contemplated by this Agreement does not diminish the availability of specific performance of the obligations hereunder or any other injunctive relief. Each of the Parties further acknowledges and agrees that injunctive relief or specific performance will not cause an undue hardship to such Party.
 
18.10   Negotiation of Agreement.
 
Each of Novartis and CBMG acknowledges that it has been represented by independent counsel of its choice throughout all negotiations that have preceded the execution of this Agreement and that it has executed the same with consent and upon the advice of said independent counsel. Each Party and its counsel cooperated in the drafting and preparation of this Agreement and the documents referred to herein, and any and all drafts relating thereto shall be deemed the work product of the Parties and may not be construed against either Party by reason of its preparation. Accordingly, any rule of Applicable Law or any legal decision that would require interpretation of any ambiguities in this Agreement against the Party that drafted it is of no application and is hereby expressly waived. The provisions of this Agreement shall be interpreted in a reasonable manner to effect the intentions of the Parties and this Agreement.
 
                                                              
 
59
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
18.11   Choice of Law.
 
This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware applicable to agreements made and to be performed entirely within such State, without regard to the conflict of laws principles of such State to the extent that the laws of another jurisdiction would be required thereby.
 
18.12   Arbitration.
 
 
(a)   Any claim, dispute, or controversy of whatever nature arising among the Parties out of or in connection with this Agreement, including any action or claim based on tort, contract, or statute (including any claims of breach or violation of statutory or common law protections from discrimination, harassment, and hostile working environment), or concerning the interpretation, effect, termination, validity, performance, or breach of this Agreement (each, a “ Dispute ”), shall be resolved in accordance with this Section 18.12 .
 
(b)   The Parties shall use good-faith efforts to resolve each Dispute. Notwithstanding the foregoing, any Dispute that a Party in its absolute discretion considers cannot otherwise be resolved shall be referred in writing by such Party to the Senior Officers. The Senior Officers will attempt to resolve any such Dispute within fifteen (15) calendar days after the referral of the Dispute. If the Senior Officers are unavailable or unable to resolve a Dispute within the fifteen (15)-calendar day period, then the Dispute shall be resolved by final and binding arbitration under the Rules of Arbitration of the International Chamber of Commerce (the “ ICC ”) (the “ Rules ”) before a panel of three (3) arbitrators (collectively, the “ Arbitrators ”) appointed in accordance with the said Rules; provided , however , that the president of the arbitral tribunal shall be appointed by mutual agreement of the co-Arbitrators.
 
(c)   The seat of arbitration shall be New York, New York, United States of America. The language of arbitration shall be English. The Expedited Procedure Provisions of the Rules shall not apply. The Parties shall make every effort to conduct the arbitration in an expeditious and cost-effective manner, having regard to the complexity and value of the Dispute. The Parties shall aspire to work with the arbitral tribunal to complete the arbitration within ninety (90) days after selection of the third (3 rd ) Arbitrator.
 
(d)   The decision or award rendered by the Arbitrators shall be final and non-appealable, and judgment may be entered upon it in accordance with Applicable Law in any court of competent jurisdiction. The Arbitrators shall be authorized to award compensatory damages, but shall not be authorized to reform, modify, or materially change this Agreement or any other agreements contemplated hereunder.
 
(e)   Each Party shall bear its own attorneys’ fees, costs, and disbursements arising out of the arbitration and the costs of the Arbitrator selected by it, and shall pay an equal share of the fees and costs of the president of the arbitral tribunal and the ICC administrative expenses; provided , however , that the Arbitrators shall be authorized to determine whether a Party is the prevailing Party, and, if so, to award to that prevailing Party reimbursement for its reasonable attorneys’ fees, costs, and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), or the fees and costs of the Arbitrators and the ICC administrative expenses.
 
                                                              
 
60
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
(f)   Nothing contained in this Agreement shall deny any Party the right to seek specific performance or injunctive or other equitable relief in accordance with Section 18.9 .
 
18.13   Waiver of Jury Trial.
 
TO THE EXTENT NOT PROHIBITED BY APPLICABLE LAW THAT CANNOT BE WAIVED, THE PARTIES HEREBY WAIVE, AND COVENANT THAT THEY WILL NOT ASSERT (WHETHER AS PLAINTIFF, DEFENDANT, OR OTHERWISE), ANY RIGHT TO TRIAL BY JURY IN ANY ACTION ARISING IN WHOLE OR IN PART UNDER OR IN CONNECTION WITH THIS AGREEMENT OR ANY OF THE CONTEMPLATED TRANSACTIONS, WHETHER NOW EXISTING OR HEREAFTER ARISING, AND WHETHER SOUNDING IN CONTRACT, TORT, OR OTHERWISE. EACH PARTY CERTIFIES AND ACKNOWLEDGES THAT: (A) NO REPRESENTATIVE OF THE OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER; (B) EACH PARTY UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS OF THIS WAIVER; (C) EACH PARTY MAKES THIS WAIVER VOLUNTARILY; AND (D) EACH PARTY HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION  18.13 . THE PARTIES AGREE THAT ANY OF THEM MAY FILE A COPY OF THIS PARAGRAPH WITH ANY COURT AS WRITTEN EVIDENCE OF THE KNOWING, VOLUNTARY, AND BARGAINED-FOR AGREEMENT AMONG THE PARTIES IRREVOCABLY TO WAIVE THEIR RIGHTS TO TRIAL BY JURY IN ANY PROCEEDING WHATSOEVER AMONG THEM RELATING TO THIS AGREEMENT OR ANY OF THE CONTEMPLATED TRANSACTIONS AND WILL INSTEAD BE TRIED IN A COURT OF COMPETENT JURISDICTION BY A JUDGE SITTING WITHOUT A JURY.
 
18.14   Performance by Affiliates.
 
.CBMG acknowledges and accepts that Novartis may exercise its rights and perform its obligations under this Agreement either directly or through one (1) or more of its Affiliates. Novartis’s Affiliates shall have the benefit of all rights of Novartis under this Agreement, but not be subject to Novartis’s obligations, unless expressly provided under this Agreement or to the extent that an Affiliate is exercising a right hereunder, or in the case of a permitted assignment. Accordingly, “Novartis” shall be interpreted to mean “Novartis or its Affiliates” where necessary to give Novartis’s Affiliates the benefit of the rights provided to Novartis under this Agreement and the ability to perform its obligations under this Agreement; provided , that Novartis shall remain responsible for the acts and omissions, including financial liabilities, of its Affiliates.
 
18.15   Counterparts; Electronic Signatures.
 
This Agreement may be executed in any number of counterparts, each of which, when executed, shall be deemed to be an original and all of which together shall be deemed to be one (1) and the same instrument binding upon all of the Parties, notwithstanding the fact that both Parties are not signatory to the original or the same counterpart. For purposes of this Agreement, .PDF and other electronic signatures shall be deemed originals.
 
[ Remainder of Page Intentionally Left Blank ]
 
  61
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives.
 
 
 
 
NOVARTIS PHARMA AG
 
 
 
 
 
 
By:  
/s/  Teresa Jose
 
 
 
Teresa Jose
 
 
 
CFO, Oncology
 

 
 
Company Name
 
 
 
 
 
 
By:  
/s/  Liz Barret
 
 
 
Liz Barret
 
 
 
CEO, Novartis Oncology
 
 
 
 
CELLULAR BIOMEDICINE GROUP, INC.
 
 
 
 
 
 
By:  
/s/  Bizuo (Tony) LIU
 
 
 
Bizuo (Tony) LIU
 
 
 
CEO
 
 

                                                              
 
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
CELLULAR BIOMEDICINE GROUP HK LTD.
 
 
 
By:            
/s/AndrewChan                                                                  
Name:                       
Andrew Chan
Title:                       
Director
 
 
C ELLULAR BIOMEDICINE GROUP (WUXI) LTD. ( 西比曼生物科技(无锡)有限公司 )
(Company seal)
 
 
By:            
/s/ Bizuo (Tony) LIU
(sign and affix company chop)
Name:                       
Bizuo (Tony) LIU
Title:                       
Legal Representative
 
CELLULAR BIOMEDICINE GROUP (SHANGHAI) LTD.
( 西比曼生物科技(上海)有限公司)
(Company seal)
 
 
By:            
/s/ Bizuo (Tony) LIU
(sign and affix company chop)
Name:                       
Bizuo (Tony) LIU
Title:                       
Legal Representative
 
 
SHANGHAI CELLULAR BIOPHARMACEUTICAL GROUP LTD.
(上海赛比曼生物科技有限公司)
(Company seal)
 
 
By:            
/s/ Bizuo (Tony) LIU
(sign and affix company chop)
Name:                       
Bizuo (Tony) LIU
Title:                       
Legal Representative
 
 
 
 
 
Exhibit A
 
CBMG Patents
 
* * *
 
No.
Patent Titles
China
PCT
[***]
 
{00625357.DOCX.1}                                                                  
A-1
 
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
Exhibit B 1
 
Clinical Development Plan
 
* * *
 
( INITIAL PLAN - Subject to Change based on CFDA Health Authority Discussions)
 
Novartis intends to seek agreement with CFDA that local clinical trial data are not required to support KYMRIAH registration in China, given final regulation issued on 10-July 2018 by China’s State Drug Administration accepting foreign clinical trial data towards new drug approvals, given that following conditions are met:
 
  compliance with ICH GCP requirements;
  support for the efficacy and safety profile of the intended indications; and
  a lack of ethnic differences that affect the efficacy and safety profile of product
 
In event that CFDA will still require a local China study to support registration in each pursued indication, for reasons such as significant manufacturing process changes intended for commercial product not studied to date in clinical trial setting, or post-approval commitment(s), the following study proposals would be considered, subject to negotiation and alignment with CFDA:
 
Study 1: For treatment of pediatric and young adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL)
 
Study Purpose
 
To demonstrate the efficacy and safety of tisagenlecleucel strategy in Chinese pediatric and young adult relapsed and refractory B-cell Acute lymphoblastic leukemia (ALL).
 
Primary Objective
 
Evaluate the efficacy of tisagenlecleucel treatment strategy in Chinese patients as measured by [***], which includes [***]
 
Treatment Arms
 
Single-arm design:
A target per-protocol dose of tisagenlecleucel transduced cells for pediatric patients will consist of [***].
 
Sample Size
 
[***]patients treated with tisagenlecleucel (It is anticipated that approximately [***] patients would need to be enrolled to ensure at least [***] patients successfully infused.)
 
Timelines
 
[***]
 
 
 
                                                              
 
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
 
 
Study 2: For treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplantation
 
Study Purpose
 
To demonstrate the efficacy and safety of tisagenlecleucel strategy in Chinese adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma
 
Primary Objective
 
 
  To evaluate the efficacy of tisagenlecleucel treatment strategy in Chinese patients , defined as [***]
Treatment Arms
 
Single-arm design
A single target [***].
 
Sample Size
 
[***] patients treated with tisagenlecleucel (It is anticipated that approximately [***] patients would need to be enrolled to ensure at least [***] patients successfully infused.)
 
Timelines
 
[***]
 
1 The initial Clinical Development Plan does not include any budgetary figures given the responsibility allocation for Initial Indication Clinical Development Costs in Section 5.5(a)(i).
 

 
 
Exhibit C
 
Knowledge of CBMG
 
* * *
 
Bizuo (Tony) Liu, CEO
                                                             
 
 
 
Exhibit D
 
Required PRC Approvals
 
* * *
PART A : MATTERS RELATED TO DRUG COMMERCIALIZATION, MANUFACTURING AND DISTRIBUTION
 
[***]
 
PART B : MATTERS RELATING TO THE TRANSACTION (Note that these are all post-closing filings)
 
Item
 
Matter
 
Required filing/registration/filing
 
Agency
 
Responsible Party
 
1)  
 
 
Technology licensing
 
Technology import registration
 
MOFCOM
 
[***]
 
2)  
 
 
Share acquisition
 
Update round-tripping investment registration information, to the extent reasonably required under Applicable PRC Law, for existing PRC resident shareholders of CMBG Parent to reflect changes to filed information with SAFE resulting from the transactions contemplated by the Share Purchase Agreement
 
SAFE
 
[***]
 
 
 
 
 
Exhibit E
 
Manufacturing and Supply Agreement Terms
 
[***]
 
 
 
 
Confidential Treatment Requested by Cellular Biomedicine Group, Inc
IRS Employer Identification No. 86-1032927
Confidential treatment requested with respect to certain portions hereof denoted with “[***]”
 
 
 
 
 
Exhibit F
 
Form of Invoice
 
[ Attached .]
 
 
 
 
 
 
 
 
  Exhibit 10.2
 
 

 
                                  SHARE PURCHASE AGREEMENT
 
 
 
dated as of
 
 
 
September 25, 2018
 
 
 
by and among
 
 
 
NOVARTIS PHARMA AG,
 
 
 
CELLULAR BIOMEDICINE GROUP, INC.,
 
 
 
and, solely for purposes of Article IV,
 
 
 
SHANGHAI CELLULAR BIOPHARMACEUTICAL GROUP LTD.
 
( 上海赛比曼生物科技有限公司 )
 
 

 
                                                     
 
 
 
 
 
TABLE OF CONTENTS
 
Article I DEFINITIONS
 
1
1.1
Certain Defined Terms
1
Article II PURCHASE AND SALE OF SHARES
 
8
2.1
Purchase of Shares
8
2.2
Closing
8
Article III CLOSING DELIVERABLES AND CLOSING CONDITIONS
8
3.1
Closing Deliveries by the Company
8
3.2
Closing Deliveries by the Purchaser
8
3.3
Conditions to Obligations of the Company
9
3.4
Conditions to Obligations of the Purchaser
9
Article IV REPRESENTATIONS AND WARRANTIES OF CBMG
10
4.1
Organization; Capitalization; Subsidiaries
10
4.2
Authorization
11
4.3
Valid Issuance of the Shares
11
4.4
No Conflict
12
4.5
Application of Takeover Protections
12
4.6
Consents
12
4.7
SEC Filings; Financial Statements
12
4.8
Solvency
13
4.9
Absence of Certain Changes
13
4.10
Compliance with Laws and Agreements
13
4.11
No Disagreements with Accountants and Lawyers
14
4.12
Intellectual Property
15
4.13
Employee Benefits
16
4.14
Taxes
16
4.15
Environmental Laws
16
4.16
Title
17
4.17
Insurance
17
4.18
Sarbanes-Oxley Act
17
4.19
Regulatory Matters
17
4.20
Ethical Practices
18
4.21
Litigation; Legal Matters
19
4.22
Data Privacy and Protection
29
 
 
 
 
4.23
Controls and Procedures
29
4.24
Registration and Listing of Shares
20
4.25
Price of Common Stock
20
4.26
Status
20
4.27
General Solicitation; No Integration or Aggregation
21
4.28
Brokers and Finders
21
4.29
No Directed Selling Efforts
21
4.3
Anti-Money Laundering
21
4.31
Reliance by the Purchaser
21
Article V REPRESENTATIONS AND WARRANTIES OF THE PURCHASER
21
5.1
Organization and Qualification
21
5.2
Authorization
21
5.3
No Conflict
22
5.4
No Registration of the Shares
22
5.5
Sophistication
22
5.6
Intent
22
5.7
Investment Experience
22
5.8
Independent Investigation
23
5.9
Not a Broker-Dealer
22
5.10
Not an Underwriter
23
5.11
Reliance on Representations and Warranties
23
5.12
Regulation S Exemption
23
5.13
Foreign Investors
24
5.14
No Governmental Review
24
5.15
Anti Money Laundering Law Compliance
24
Article VI LEGENDS, ETC.
 
24
6.1
Legend
24
6.2
The Purchaser’s Compliance
25
6.3
Company’s Refusal to Register Transfer of Shares
25
Article VII OTHER AGREEMENTS
 
25
7.1
Further Assurances
25
7.2
Confidentiality
25
7.3
Publicity
26
7.4
Registration
26
7.5
Reports under the Exchange Act
26
Article VIII TERMINATION
 
26
 
 
 
 
8.1
Pre-Closing Termination
27
8.2
Effect of Pre-Closing Termination
27
8.3
Post-Closing Termination
27
8.4
Effect of Post-Closing Termination
28
Article IX INDEMNIFICATION
 
28
9.1
Survival
28
9.2
Indemnification by the Company
28
9.3
Indemnification by the Purchaser
28
9.4
Indemnification Procedures
29
9.5
Limitations on Indemnification
30
9.6
General Indemnification Provisions
30
Article X GENERAL PROVISIONS
 
31
10.1
Expenses, Taxes, Etc.
31
10.2
Notices
31
10.3
Interpretation
32
10.4
Conflict Between Agreements
33
10.5
Severability
33
10.6
No Third-Party Beneficiaries
33
10.7
Assignment
33
10.8
Amendment; Waiver
33
10.9
Remedies; Specific Performance
33
10.10
Mutual Drafting
34
10.11
Governing Law
34
10.12
Arbitration
34
10.13
Consent to Jurisdiction; Waivers
35
10.14
WAIVER OF TRIAL BY JURY
35
10.15
Counterparts
35
10.16
Entire Agreement
35
 
 
 
 
                                                                      
 
 
 
SHARE PURCHASE AGREEMENT
 
This SHARE PURCHASE AGREEMENT (this “ Agreement ”), is made and entered into as of September 25, 2018, by and among Cellular Biomedicine Group, Inc., a Delaware corporation with its principal place of business at 19925 Stevens Creek Blvd., Suite 100, Cupertino, California 95014 U.S.A. (the “ Company ”), Shanghai Cellular Biopharmaceutical Group Ltd. ( 上海赛比曼生物科技有限公司 ), a company organized and existing under laws of the PRC, whose legal address is located at 85 Faladi Road, Building No.3, China (Shanghai) Pilot Free Trade Zone, Shanghai, China ( “ CBMG Shanghai ”) (solely for purposes of Article IV), (CBMG Shanghai, together with the Company, “ CBMG ”), and Novartis Pharma AG, a company ( Aktiengesellschaft ) organized and existing under the laws of Switzerland, with its principal place of business at Lichtstrasse 35, 4056 Basel, Switzerland (the “ Purchaser ”).
 
RECITALS
 
WHEREAS, CBMG and Purchaser desire to enter into a collaboration under which CBMG will become Purchaser’s exclusive manufacturer of the Product in the Territory, and CBMG will manufacture and supply, the Product in the Territory for use by Purchaser, its Affiliates, and its designees in the Territory, on the terms and conditions set forth in that certain License and Collaboration Agreement, by and among CBMG, certain of its Affiliates, and Purchaser, dated as of the date hereof (the “ License and Collaboration Agreement ”), and certain ancillary agreements entered into in connection therewith (as such terms are defined below); and
 
WHEREAS, the Company wishes to issue and sell to the Purchaser, and the Purchaser wishes to subscribe for and purchase from the Company, shares of Common Stock of the Company, par value $0.001 per share (the “ Common Stock ”), upon the terms and subject to the conditions set forth herein.
 
NOW, THEREFORE, in consideration of the premises and the respective representations, warranties, covenants and agreements herein contained and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:
 
ARTICLE I
 
DEFINITIONS
 
1.1   Certain Defined Terms.
 
As used in this Agreement, except as expressly provided herein, the following terms shall have the following meanings:
 
Action ” means any notice of noncompliance or violation, or any claim, demand, charge, action, suit, litigation, audit, settlement, complaint, stipulation, assessment or arbitration, or any request (including any request for information), review, inquiry, hearing, proceeding or investigation, an opposition, revocation, reexamination, interference or similar proceeding by any Person or by or before any Governmental Authority.
 
Administrator ” is defined in Section 10.12(a).
 
Affiliate ” means, with respect to a Person, any other Person that controls, is controlled by, or is under common control with such Person. For purposes of this Agreement, a Person will be deemed to control another Person if it owns or controls, directly or indirectly, more than fifty percent (50%) of the equity securities of such other Person entitled to vote in the election of directors (or, in the case that such other Person is not a corporation, for the election of the corresponding managing authority), or otherwise has the power to direct the management and policies of such other Person (including any PRC domestic capital companies not controlled through ownership of equity securities but through contracts under a VIE structure). The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage will be substituted in the preceding sentence; provided , that such foreign investor has the power to direct the management and policies of such entity.
 
 
1
 
 
Agreement ” is defined in the preamble.
 
Anti-Corruption Laws ” means any applicable Law concerning bribery, corruption, or illegal payments and gratuities, including the United States Foreign Corrupt Practices Act, the Hong Kong Prevention of Bribery Ordinance, the UK Bribery Act 2010, the PRC Criminal Law, the PRC Unfair Competition Law, the Interim Regulations on Prohibition of Commercial Bribery issued by the SAIC, and any applicable PRC Laws similar to any of the foregoing.
 
Anti-Money Laundering Laws ” is defined in Section 4.30.
 
Arbitration Claim ” is defined in Section 10.12(a).
 
Arbitrators ” is defined in Section 10.12(a).
 
Basket ” is defined in Section 9.5(a).
 
Benefit Plan ” means any employee benefit plan as defined in Section 3(3) of ERISA and all other employee benefit practices or arrangements, including any such practices or arrangements providing severance pay, sick leave, vacation pay, salary continuation for disability, retirement benefits, deferred compensation, bonus pay, incentive pay, stock options or other stock-based compensation, hospitalization insurance, medical insurance, life insurance, scholarships or tuition reimbursement, maintained by the Company or any of its Subsidiaries or to which the Company or any of its Subsidiaries is obligated to contribute for employees or former employees.
 
Business Day ” means a day that is a Monday, Tuesday, Wednesday, Thursday or Friday and is not a day on which banking institutions in New York, New York or Basel, Switzerland generally are authorized or obligated by law, regulation or executive order to close.
 
CBMG ” is defined in the preamble.
 
CBMG Shanghai ” is defined in the preamble.
 
cGCP ” means the then-current ethical, scientific, and quality standards required by the FDA for designing, conducting, recording, and reporting trials that involve the participation of human subjects, as set forth in FDA regulations in 21 C.F.R. Parts 11, 50, 54, 56, and 312 and related FDA guidance documents, by the International Conference on Harmonization E6: Good Clinical Practices Consolidated Guideline, and as otherwise required by the SAMR, including those set out in, or issued pursuant to, the Drug Operation Quality Administrative Standards issued by the SAMR.
 
 “ cGLP ” means the then-current good laboratory practices as required by the FDA under 21 C.F.R. Part 58 and all applicable FDA rules, regulations, orders, and guidances, and the requirements with respect to current good laboratory practices prescribed by the European Community, the OECD (Organization for Economic Cooperation and Development Council) and the ICH Guidelines, or as otherwise required by the SAMR, including those set out in, or issued pursuant to, the Non-Clinical Drug Research Quality Administrative Standards issued by the SAMR.
 
 
2
 
 
cGMP ” means the then-current good manufacturing practices as required by the FDA under 21 C.F.R. Parts 210 and 211 and all applicable FDA rules, regulations, orders, and guidances, and the requirements with respect to current good manufacturing practices prescribed by the European Community under provisions of “The Rules Governing Medicinal Products in the European Community, Volume 4, Good Manufacturing Practices, Annex 13, Manufacture of Investigational Medicinal Products, July 2003,” or as otherwise required by the SAMR, including under the Quality Administrative Standard for Drug Manufacturing, any requirements issued pursuant to the Regulation of Drug Manufacturing Administrative Procedures issued by the SAMR, or the appendix thereto for biochemical drugs.
 
Closing ” is defined in Section 2.2.
 
Closing Date ” is defined in Section 2.2.
 
Code ” means the Internal Revenue Code of 1986, as amended.
 
Common Stock ” is defined in the preamble.
 
Company ” is defined in the preamble.
 
Company Indemnified Parties ” is defined in Section 9.3.
 
Company Intellectual Property ” means any Intellectual Property Rights used, sold, licensed, controlled, or otherwise exploited by the Company and its Subsidiaries in the operation of their business as presently conducted or reasonably expected to be conducted.
 
Contract ” means any contract, agreement, binding arrangement, commitment or understanding, bond, note, indenture, mortgage, debt instrument, license (or any other contract, agreement or binding arrangement concerning Intellectual Property Rights), franchise, lease or other instrument or obligation of any kind, written or oral (including any amendments or other modifications thereto).
 
Data Protection Law ” means any applicable Law concerning the protection or processing or both of personal data, including the PRC Constitution, People’s Republic of China General Principles of Civil Law effective January 1, 1987, Opinions of the Supreme People’s Court on Several Issues Concerning the Implementation of the People’s Republic of China General Principles of Civil Law (Trial) effective January 26, 1988, People’s Republic of China Regulations on Employment Services and Employment Management (effective January 1, 2008), People’s Republic of China Tortious Liability Law (effective July 1, 2010), Regulating the Internet Information Service Market Order Several Provisions (effective March 15, 2012), Decision of the Standing Committee of the National People’s Congress on the Strengthening of the Protection of Network Information (effective December 28, 2012), Information Security Technology Guidelines on Personal Information Protection within Information Systems for Public and Commercial Services (effective February 1, 2013), Protection of Personal Information of Telecommunications and Internet Users Provisions (effective September 1, 2013), Amendments to the Consumer Protection Law (effective March 15, 2014), Amendments to the People’s Republic of China Criminal Law (9th set of amendments) (effective November 1, 2015), People’s Republic of China Cyber Security Law (effective June 1, 2017), People’s Republic of China General Provisions of Civil Law (effective October 1, 2017), and other applicable Laws relating to data protection and privacy.
 
Disqualification Event ” is defined in Section 4.10(c).
 
Environmental Laws ” is defined in Section 4.15.
 
 
3
 
 
ERISA ” means the Employee Retirement Income Security Act of 1974, as amended.
 
Exchange Act ” means the Securities Exchange Act of 1934, as amended.
 
FDA ” means the United States Food and Drug Administration, and any successor agency thereto.
 
FINRA ” is defined in Section 5.9.
 
Financial Statements ” is defined in Section 4.7(b).
 
GAAP ” means generally accepted accounting principles as practiced in the United States, as consistently applied.
 
Governmental Authority ” means any federal or national, state or provincial, municipal or local government, governmental authority, regulatory, legislative or administrative body, governmental commission, department, board, bureau, agency or instrumentality, political subdivision, court, tribunal, official arbitrator or arbitral body in each case whether domestic or foreign, including any Regulatory Authority.
 
Healthcare Laws ” means all applicable Laws that govern the research, development, testing, manufacture, handling, packaging, labeling, storage, promotion, marketing, sales, distribution, import, export, or any other use with respect to any product or product candidate, including the Federal Food, Drug, and Cosmetic Act, as amended; the Public Health Service Act; the federal False Claims Act; the federal Anti-Kickback Statute; the Civil Monetary Penalty Statute; the Stark Law; the Health Insurance Portability and Accountability Act of 1996 (HIPAA); Physicians Payments Sunshine Act (Title XI of Social Security Act); the Medicare Program (Title XVIII of the Social Security Act); the Medicaid Program (Title XIX of the Social Security Act); Federal Sentencing Guidelines for Organizations; the Health Information Technology for Economic and Clinical Health Act (HITECH); the Clinical Laboratories Improvement Act (CLIA); all regulations promulgated or enforced thereunder; and analogous applicable Law to the foregoing in any jurisdiction, including the PRC.
 
IND ” means an investigational new drug application, clinical trial application, or similar application or submission for approval to conduct clinical studies filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority, and any amendments thereto.
 
Indemnification Cap ” is defined in Section 9.5(a).
 
Indemnitee ” is defined in Section 9.4(a).
 
Indemnitor ” is defined in Section 9.4(a).
 
Intellectual Property Rights ” means all (a) patents and patent applications (such applications including, but not limited to, all international (PCT) applications, substitutions, re-examinations, reissues, divisions, renewals, extensions, provisionals, non-provisionals, continuations and continuations-in-part) in any country or patent granting region (“ Patents ”); (b) copyrights, copyright registrations and applications therefor, and copyrightable works, including all rights of authorship, use, publication, reproduction, distribution, performance, preparation of derivative works, transformation, and rights of ownership of copyrightable works and all rights to register and obtain renewals and extensions of registrations; (c) registered and unregistered trade names, logos, common law trademarks and service marks, trademark and service mark registrations and applications therefor; (d) commercial, technical, scientific, and other know-how and information, biochemical, cellular, and animal assays, animal models, trade secrets, knowledge, technology, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, specifications, data and results (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical, and analytical, preclinical, clinical, safety, manufacturing, and quality control data and know-how, including regulatory data, study designs, and protocols), and materials, in all cases, in written, electronic, or any other form (“ Know-How ”); (e) domain names and (f) any similar or equivalent rights to any of the foregoing (as applicable).
 
 
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IRS ” means the U.S. Internal Revenue Service or any successor thereto.
 
Issuer Covered Person ” is defined in Section 4.10(c).
 
Know-How ” is defined in the definition of “Intellectual Property Rights”.
 
Knowledge of the Company ” or “ Company’s Knowledge ” means the knowledge of a particular matter by an Exchange Act Section 16 officer of the Company, after due inquiry under the circumstances.
 
Law ” means, individually and collectively, any federal, state, local, national, and supra-national laws, treaties, statutes, ordinances, rules, and regulations, including any rules, regulations, guidance, guidelines, circulars, officially announced policies of any Governmental Authority(ies), and requirements of any national securities exchange or securities listing organization having the binding effect of law, including cGCP, cGLP, and cGMP.
 
Liabilities ” means any and all debts, liabilities and obligations of any nature whatsoever, whether accrued or fixed, absolute or contingent, mature or unmatured or determined or determinable, including those arising under any Law, Action, Order or Contract.
 
License and Collaboration Agreement ” is defined in the recitals to this Agreement.
 
Lien ” means any interest (including any security interest), pledge, mortgage, lien, encumbrance, charge, claim or other right of third parties, whether created by law or in equity, including any such restriction on the use, voting, transfer, receipt of income or other exercise of any attributes of ownership.
 
Loss ” is defined in Section 9.2.
 
Material Adverse Effect ” means, with respect to the Company, any event, fact, condition, change, circumstance, occurrence or effect, which, either individually or in the aggregate with all other events, facts, conditions, changes, circumstances, occurrences or effects, (a) that has a material adverse effect on the business, properties, prospects, assets, Liabilities, condition (financial or otherwise), operations, licenses or other franchises or results of operations of business, or materially diminish the value of the business or its assets or materially increase the liabilities or (b) that materially impairs or delays the ability of the Company to perform its obligations under this Agreement or to consummate the transactions contemplated hereby and thereby; provided , however , no adverse effect or change resulting from any change, circumstance or effect relating to any of the following will be taken into account in determining whether there has been or will be a Material Adverse Effect under subclause (a) of this definition: (i) the economy in general, (ii) securities markets, regulatory or political conditions in the United States or China (including terrorism or the escalation of any war, whether declared or undeclared or other hostilities), (iii) changes in applicable Laws or GAAP or the application or interpretation thereof, (iv) the industry in which the Company’s or the Company’s business operates and not specifically relating to the business or (v) a natural disaster ( provided , that in the cases of clauses (i) through (v), the Company’s business is not disproportionately affected by such event as compared to other similar companies and businesses in similar industries and geographic regions as the Company’s business).
 
 
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MOST ” means the PRC Ministry of Science and Technology and its local authorized bodies.
 
OFAC ” means the United States Office of Foreign Assets Control and any successor thereto.
 
Order ” means any order, writ, ruling, judgment, injunction, decree, stipulation, determination or award entered by or with any Governmental Authority.
 
Patent ” is defined in the definition of “Intellectual Property Rights”.
 
Permit ” means any federal, state, local, foreign or other third-party permit, grant, easement, consent, approval, authorization, exemption, license, franchise, concession, ratification, permission, clearance, certification, confirmation, endorsement, waiver, certification, order, declaration, filing, designation, product registration, rating, registration or qualification that is or has been issued, granted, given or otherwise made available by or under the authority of any Governmental Authority or other Person under applicable Law.
 
Permitted Exceptions ” means bankruptcy, insolvency, reorganization, moratorium or other similar Laws affecting the enforcement of creditors’ rights generally and general principles of equity (regardless of whether enforceability is considered in a proceeding at law or in equity).
 
Person ” shall include any individual, trust, firm, corporation, limited liability company, unincorporated organization, partnership, sole proprietorship, joint stock company, joint venture, Governmental Authority or other entity or association, whether acting in an individual, fiduciary or any other capacity.
 
Personally Identifiable Information ” means any information that alone or in combination with other information held by the Company or any of its Subsidiaries can be used to specifically identify an individual Person, including such Person’s name, street address, telephone number, e-mail address, photograph, social security number, driver’s license number, passport number, customer or account number, and health information (including protected health information (as defined in 45 C.F.R. § 160.103) and comparable information under other applicable Law).
 
PRC ” means the People’s Republic of China, excluding, for the purpose of this Agreement, the Hong Kong Special Administrative Region, the Macau Special Administrative Region and Taiwan.
 
Product ” is defined in the License and Collaboration Agreement.
 
Prohibited Fund ” is defined in Section 4.20(d).
 
Prohibited Payment ” is defined in Section 4.20(b).
 
Purchase Price ” is defined in Section 2.1.
 
Purchaser ” is defined in the preamble.
 
Purchaser Indemnified Parties ” is defined in Section 9.2.
 
Registration Rights Agreement ” means the Registration Rights Agreement to be entered into between the Company and the Purchaser, in the form attached hereto as Exhibit 3 .
 
 
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 “ Regulatory Authority ” means the FDA, the SAMR, MOST, and any other federal, state, local or foreign Governmental Authority that regulates CBMG’s research, development, testing, manufacture, handling, packaging, labeling, storage, promotion, marketing, sales, distribution, import, or export.
 
Regulatory Documentation ” means all (a) documentation comprising the applications, marketing authorizations, Permits or Regulatory Authorizations for any Company product or product candidate, including any IND, and all amendments and supplements thereto, and including pre-clinical and clinical data and information, regulatory materials, drug dossiers, master files (including Drug Master Files, as defined in 21 C.F.R. Part 314.420 and any non-U.S. equivalents), and any other reports, records, regulatory correspondence, and other materials relating to development or Regulatory Authorization for any product or product candidate of the Company or its Subsidiaries, or required to manufacture or commercialize any product or product candidate of the Company or its Subsidiaries, including any information that relates to pharmacology, toxicology, chemistry, manufacturing, and controls data, batch records, safety, and efficacy, and any safety database, and (b) material correspondence and other filings relating to any product or product candidate of the Company or any of its Subsidiaries submitted to or received from any Governmental Authority (including minutes and official contact reports relating to any communications with any Governmental Authority) and relevant supporting documents submitted to or received from Governmental Authorities with respect thereto, including all regulatory drug lists, final versions of advertising and promotion documents, adverse event files and complaint files.
 
Regulatory Requirements ” is defined in Section 4.19(a).
 
Representative ” means, as to any Person, such Person’s Affiliates and its and their managers, directors, officers, employees, agents and advisors (including financial advisors, counsel and accountants).
 
Rule 144 ” means Rule 144 promulgated under the Securities Act.
 
SAMR ” means the State Administration of Market Regulation, the Chinese regulatory body in which the former China Food and Drug Administration and State Administration of Industry and Commerce functions have been merged, following a restructuring, and its local authorized bodies.
 
SEC ” means U.S. Securities and Exchange Commission and any successor thereto.
 
Securities Act ” means the Securities Act of 1933, as amended.
 
SEC Filings ” mean any forms, reports and documents filed or furnished (including such documents, as supplemented and amended since the times of filing) by the Company with the SEC under the Exchange Act or the Securities Act filed prior to the date of this Agreement.
 
Shares ” is defined in Section 2.1.
 
Special Reps ” is defined in Section 9.1.
 
Survival Date ” is defined in Section 9.1.
 
Tax ” means any applicable federal, state, local or foreign income, gross receipts, license, payroll, parking, employment, excise, severance, stamp, occupation, premium, windfall profits, environmental, natural resources, customs duties, capital stock, franchise, profits, withholding, social security (or similar), payroll, unemployment, disability, real property, personal property, sales, use, transfer, registration, value added, alternative or add-on minimum, estimated tax, or other tax of any kind whatsoever, including any interest, penalty, or addition thereto, whether disputed or not, including such item for which Liability arises from the application of Treasury Regulation 1.1502-6, as a transferee or successor-in-interest, by contract or otherwise, and any Liability assumed or arising as a result of being, having been, or ceasing to be a member of any affiliated group (as defined in Section 1504(a) of the Internal revenue Service Code) (or being included or required to be included in any Tax Return relating thereto) or as a result of any Tax indemnity, Tax sharing, Tax allocation or similar Contract.
 
 
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Territory ” is defined in the License and Collaboration Agreement.
 
Third Party ” shall mean any Person that is not a Party to this Agreement or an Affiliate of a Party to this Agreement.
 
Transaction Documents ” means this Agreement and the Registration Rights Agreement.
 
VIE ” means Variable Interest Entity.
 
ARTICLE II
 
PURCHASE AND SALE OF SHARES
 
2.1   Purchase of Shares.
 
  Upon the terms and subject to the conditions herein set forth, the Company hereby agrees to sell and deliver to the Purchaser, and the Purchaser hereby agrees to purchase and acquire from the Company, 1,458,257 shares (the “ Shares” ) of Common Stock at the purchase price of Twenty-Seven U.S. Dollars and Forty-Three Cents ($27.43) per share, which purchase price is equivalent to 130% of the volume-weighted average price of the Company’s Common Stock as displayed under the heading “Bloomberg VWAP” on Bloomberg page “CBMG <equity> AQR” for the twenty (20) consecutive trading days prior to the date hereof, for an aggregate purchase price of Thirty-Nine Million, Nine Hundred Ninety-Nine Thousand, Nine-Hundred Eighty Nine U.S. Dollars and Fifty-One Cents ($39,999,989.51) (the “ Purchase Price ”).
 
2.2   Closing.
 
  The purchase and sale of the Shares shall take place remotely via the exchange of documents and signatures, at 10:00 a.m. EST, on or about September 26, 2018, or at such other time and place as the Company and the Purchaser mutually agree upon in writing (which time and place are designated as the “ Closing ” and such date is designated as the “ Closing Date ”).
 
ARTICLE III
 
CLOSING DELIVERABLES AND CLOSING CONDITIONS
 
3.1   Closing Deliveries by the Company.
 
At the Closing, the Company shall deliver or cause to be delivered to the Purchaser:
 
(a)   a legal opinion of Company counsel, substantially in the form agreed to prior to the execution of this Agreement;
 
(b)   a duly issued book-entry certificate evidencing the number of Shares sold in exchange for the Purchase Price paid at the Closing registered in the name of the Purchaser;
 
(c)   an executed counterpart of the Registration Rights Agreement; and
 
(d)   a certificate of a duly authorized officer of the Company, dated as of the Closing Date, certifying as to the matters set forth in Section 3.4(a) and 3.4(b).
 
3.2   Closing Deliveries by the Purchaser.
 
At the Closing, the Purchaser shall deliver to the Company:
 
 
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(a)   the Purchase Price, by wire transfer in immediately available funds in US dollars to the bank account designated by the Company and provided in Exhibit 2 to this Agreement;
 
(b)   an executed counterpart of the Registration Rights Agreement; and
 
(c)    a certificate of a duly authorized officer of such Purchaser, dated as of the Closing Date, certifying as to the matters set forth in Section 3.3(a) and 3.3(b).
 
3.3   Conditions to Obligations of the Company.
 
The obligations of the Company to consummate the transactions contemplated by this Agreement shall be subject to the fulfillment or written waiver, at or prior to the Closing, of each of the following conditions:
 
(a)   Representations and Warranties . The representations and warranties of the Purchaser shall be true and correct (disregarding all “materiality”, “Material Adverse Effect”, or similar qualifications, which shall be given no effect) in all material respects as of each date when made and as of the Closing Date, as though made at that time (except for representations and warranties that speak as of a specific date).
 
(b)   Covenants . The Purchaser shall have performed, satisfied and complied in all material respects with the covenants, agreements and conditions required by this Agreement to be performed, satisfied or complied with by the Purchaser at or prior to the Closing Date.
 
(c)   No Order . No Governmental Authority shall have enacted, issued, promulgated, enforced or entered any Law or Order (whether temporary, preliminary or permanent) that has the effect of making the transactions contemplated by the Transaction Documents illegal or otherwise restraining or prohibiting the consummation of such transactions; and
 
(d)   Qualifications . All authorizations, approvals or permits, if any, of any governmental authority or regulatory body of the United States or of any state that are required in connection with the lawful issuance and sale of the Shares pursuant to this Agreement shall be obtained and effective as of the Closing.
 
3.4   Conditions to Obligations of the Purchaser.
 
The obligations of the Purchaser to consummate the transactions contemplated by this Agreement shall be subject to the fulfillment or written waiver, at or prior to the Closing, of each of the following conditions:
 
(a)   Representations and Warranties . The representations and warranties of the Company shall be true and correct (disregarding all “materiality”, “Material Adverse Effect”, or similar qualifications, which shall be given no effect) in all material respects as of the date when made and as of Closing Date as though made at such time (except for representations and warranties that speak as of a specific date).
 
(b)   Covenants . The Company shall have performed, satisfied and complied in all material respects with the covenants, agreements and conditions required by this Agreement to be performed, satisfied or complied with by the Company at or prior to the Closing Date.
 
 
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(c)   License and Collaboration Agreement . The License and Collaboration Agreement shall be in full force and effect.
 
(d)   No Order . No Governmental Authority shall have enacted, issued, promulgated, enforced or entered any Law or Governmental Order (whether temporary, preliminary or permanent) that has the effect of making the transactions contemplated by the Transaction Documents illegal or otherwise restraining or prohibiting the consummation of such transactions;
 
(e)   No Material Adverse Change . There shall not have occurred prior to the Closing any event or transaction reasonably likely to have a Material Adverse Effect. From the date hereof to the Closing Date, trading in the Common Stock shall not have been suspended by the SEC or the Nasdaq Global Market and, at any time prior to the Closing Date, trading in securities generally as reported by Bloomberg L.P. shall not have been suspended or limited, or minimum prices shall not have been established on securities whose trades are reported by such service, or on the Nasdaq Global Market, nor shall a banking moratorium have been declared by either the United States or New York State authorities, nor shall there have occurred any material outbreak or escalation of hostilities or other national or international calamity of such magnitude in its effect on, or any material adverse change in, any financial market which, in each case, in the reasonable judgment of the Purchaser, makes it impracticable or inadvisable to purchase the Shares at the Closing.
 
(f)   Nasdaq Listing . The Shares shall have been approved for listing on the Nasdaq Global Market, subject to official notice of issuance.
 
ARTICLE IV
 
REPRESENTATIONS AND WARRANTIES OF CBMG
 
CBMG, jointly and severally, represents and warrants to the Purchaser, as of the date of this Agreement and as of the Closing Date, as follows:
 
4.1   Organization; Capitalization; Subsidiaries.
 
(a)   The Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, and has the requisite power and authority to own, lease and operate its properties and to carry on its business as now conducted, and is qualified to do business in each jurisdiction in which the character of its properties or the nature of its business requires such qualification.
 
(b)   Exhibit 1 hereto sets forth all of the Affiliates, including subsidiaries, of the Company and their respective ownership of corporate interests and relationship to the Company as of the date hereof and as of the Closing Date (the “ Subsidiaries ”). Each of the Subsidiaries is a corporation or other organization duly organized, validly existing and in good standing (where relevant) under the laws of its jurisdiction of organization, and has full corporate power and authority to own, use and operate its assets and to conduct its business as and where it is being conducted. Except for employee stock options granted in the normal course of business and as set forth in Section 4.1(c) below, there are no other securities, options, warrants, calls, rights, commitments or agreements of any character to which the Company is bound to issue, deliver, sell, repurchase or redeem, or cause to be issued, delivered, sold, repurchased or redeemed, any of its corporate interests or obligating the Company to sell, transfer, deliver, assign, convey or purchase or cause to be sold, transferred, delivered, assigned, conveyed or purchased any corporate interests in the Company.
 
 
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(c)   Neither the Company nor any of its Subsidiaries is in violation nor default of any of the provisions of its respective certificate or articles of incorporation, bylaws, or other organizational or charter documents. Each of the Company and its Subsidiaries is duly qualified to conduct business and is in good standing as a foreign corporation or other entity in each jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, would not have or reasonably be expected to result in a Material Adverse Effect.
 
(d)   As of the date of this Agreement, the authorized shares of capital stock of the Company consist of 300,000,000 shares of Common Stock and 50,000,000 shares of preferred stock. As of June 30, 2018, (i) the total number of outstanding shares of Common Stock was 16,942,470, the total number of shares of Common Stock issuable pursuant to outstanding options and other rights to acquire Common Stock was 1,928,944 and the total number of shares of Common Stock maintained for future issuance under the Company’s Benefit Plans (exclusive of outstanding options and other rights to acquire Common Stock) was 901,449 and (ii) no shares of preferred stock or options or rights to acquire preferred stock were outstanding. Since June 30, 2018 through the date hereof, (i) the Company has only issued options or other rights to acquire Common Stock in the ordinary course of business consistent with past practice and (ii) the only shares of capital stock issued by the Company were pursuant to outstanding options and other rights to purchase Common Stock. All such issued and outstanding shares of Common Stock have been duly authorized and validly issued and are fully paid and nonassessable, have been issued in compliance with all federal and state securities laws, and were not issued in violation of or subject to any preemptive, co-sale or other rights to subscribe for or purchase securities. No dividends have been declared or paid with respect to the shares of Common Stock. There are no securities or instruments containing anti-dilution provisions that will be triggered by the issuance of the Shares.
 
4.2   Authorization.
 
  The Company has full power and authority to enter into this Agreement and the other Transaction Documents and to consummate the transactions contemplated hereby and thereby and to perform its obligations hereunder and thereunder. The execution and delivery of this Agreement and the other Transaction Documents and the consummation of the transactions contemplated hereby and thereby have been duly authorized by all necessary corporate action on the part of the Company, its officers, directors, and stockholders. The execution, delivery, and performance of the Transaction Documents by the Company, the issuance of the Shares, and the consummation of the other transactions contemplated herein do not require any approval of the Company’s stockholders. Assuming this Agreement constitutes a legal and binding agreement of the Purchaser, this Agreement constitutes a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as such enforceability may be limited by the Permitted Exceptions. Upon their respective execution by the Company and the other parties thereto, and assuming that they constitute legal and binding agreements of the other parties thereto, each of the other Transaction Documents will constitute a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as such enforceability may be limited by the Permitted Exceptions.
 
4.3   Valid Issuance of the Shares.
 
  The Shares to be issued to the Purchaser pursuant to this Agreement are duly authorized and, when issued and delivered in accordance with the terms of this Agreement, will be validly issued, fully paid and non-assessable and free and clear of all liens, and will not be subject to preemptive rights, rights of first refusal, purchase options, call options, subscription rights or other similar rights of stockholders of the Company, other than restrictions on transfer under this Agreement, applicable state and federal securities laws and liens or encumbrances created by or imposed by the Purchaser. Assuming the accuracy of the representations made by the Purchaser in Article V, the Shares will be issued to the Purchaser in compliance with applicable exemptions from (i) the registration and prospectus delivery requirements of the Securities Act, (ii) the registration and qualification requirements of applicable securities Laws of states of the United States. The Company satisfies the registrant requirements for the use of a registration statement on Form S-3 to register the Shares for resale by the Purchaser under the Securities Act.
 
 
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4.4   No Conflict.
 
  The execution, delivery and performance of this Agreement and the other Transaction Documents by the Company, the issuance of the Shares and the consummation of the other transactions contemplated hereby and thereby do not and will not (i) violate any provision of the Certificate of Incorporation or Bylaws of the Company, (ii) conflict with or result in any violation of or default (with or without notice or lapse of time, or both) under, or give rise to a right of termination, cancellation or acceleration of any obligation, a change of control right or to a loss of a benefit under any agreement or instrument, credit facility, franchise, Permit, Order, or Law applicable to the Company or its Subsidiaries or their respective properties or assets, or (iii) result in a violation of any Law, Order, or other restriction of any court or other Governmental Authority to which the Company or its Subsidiaries are subject (including federal and state securities laws and regulations) and the rules and regulations of any self-regulatory organization to which the Company or its securities are subject, or by which any property or asset of the Company or its Subsidiaries are bound or affected, except, in the case of clauses (ii) and (iii), as would not, individually or in the aggregate, be reasonably expected to be material to the Company.
 
4.5   Application of Takeover Protections.
 
  The Company and its Board of Directors have taken all necessary action, if any, in order to render inapplicable any control share acquisition, business combination, poison pill (including any distribution under a rights agreement) or other similar anti-takeover provision under the Company’s certificate of incorporation (or similar charter documents) or the laws of its state of incorporation that is or could become applicable to the Purchaser as a result of the Purchaser and the Company fulfilling their obligations or exercising their rights under the Transaction Documents, including as a result of the Company’s issuance of the Shares and the Purchaser’s ownership of the Shares.
 
4.6   Consents.
 
No consent, approval, authorization, filing with or order of or registration with, any Governmental Authority is required in connection with the transactions contemplated by this Agreement or the other Transaction Documents, except such as have been or will be obtained or made under the Securities Act or the Exchange Act, and such as may be required under the securities, or blue sky, laws of any state or foreign jurisdiction in connection with the offer and sale of the Shares by the Company in the manner contemplated herein.
 
4.7   SEC Filings; Financial Statements.
 
(a)   The Company has filed all required registration statements, prospectuses, reports, schedules, forms, statements and other documents required by be filed by it with the SEC since December 31, 2015. The information contained or incorporated by reference in the SEC Filings was true and correct in all material respects as of the respective dates of the filing thereof with the SEC (or if amended or superseded by a filing prior to the date of this Agreement, then on the date of such filing); and, as of such respective dates, the SEC Filings did not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading. All of the SEC Filings, as of their respective dates, complied as to form in all material respects with the applicable requirements of the Securities Act and the Exchange Act and the rules and regulations promulgated thereunder. All agreements that were required to be filed as exhibits to the SEC Filings under Item 601 of Regulation S-K to which the Company is a party, or the property or assets of the Company are is subject, have been filed as exhibits to the applicable SEC Filings, and other than as contemplated by this Agreement, the Company has not entered into any agreements that are required to be filed but for which the required deadline for filing has not yet occurred.
 
 
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(b)   The financial statements of the Company included in the SEC Filings (collectively, the “ Financial Statements ”) fairly present in all material respects the consolidated financial position of the Company and its Subsidiaries as of the dates indicated, and the results of its operations and cash flows for the periods therein specified, all in accordance with GAAP throughout the periods therein specified (except as otherwise noted therein, and in the case of quarterly financial statements, except for the absence of footnote disclosure and subject, in the case of interim periods, to normal year-end adjustments).
 
(c)   Except as disclosed in the SEC Filings made since January 1, 2018, the Company and its Subsidiaries have not incurred any material liabilities that are of a nature that would be required to be disclosed on a balance sheet of the Company and its Subsidiaries or the footnotes thereto prepared in conformity with GAAP, other than liabilities incurred in the ordinary course of business since June 30, 2018.
 
(d)   Except as set forth in the SEC Filings made since January 1, 2018, none of the officers or directors of the Company or any Subsidiary and, to the Knowledge of the Company, none of the employees of the Company or any Subsidiary is presently a party to any transaction with the Company or any Subsidiary (other than for services as employees, officers and directors), including any Contract or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to or from, providing for the borrowing of money from or lending of money to or otherwise requiring payments to or from any officer, director or such employee or, to the knowledge of the Company, any entity in which any officer, director, or any such employee has a substantial interest or is an officer, director, trustee, stockholder, member or partner, in each case in excess of $120,000, other than for (i) payment of salary or consulting fees for services rendered, (ii) reimbursement for expenses incurred on behalf of the Company in the ordinary course of business and consistent with customary practices and (iii) other employee benefits, including stock option agreements under any stock option plan of the Company.
 
4.8   Solvency.
 
Based on the consolidated financial condition of the Company as of the Closing Date, after giving effect to the receipt by the Company of the proceeds from the sale of the Shares hereunder: (i) the fair saleable value of the Company’s assets exceeds the amount that will be required to be paid on or in respect of the Company’s existing debts and other liabilities (including known contingent liabilities) as they mature and (ii) the current cash flow of the Company, together with the proceeds the Company would receive, were it to liquidate all of its assets, after taking into account all anticipated uses of the cash, would be sufficient to pay all amounts on or in respect of its liabilities when such amounts are required to be paid. The Company does not intend to incur debts beyond its ability to pay such debts as they mature (taking into account the timing and amounts of cash to be payable on or in respect of its debt). To the Knowledge of the Company, there are no facts or circumstances which lead it to believe that it will file for reorganization or liquidation under the bankruptcy or reorganization laws of any jurisdiction within one year from the Closing Date. Neither the Company nor any Subsidiary is in default with respect to any Indebtedness. For the purposes of this Agreement, “ Indebtedness ” means (x) any liabilities for borrowed money or amounts owed in excess of $50,000 (other than trade accounts payable incurred in the ordinary course of business), (y) all guaranties, endorsements and other contingent obligations in respect of indebtedness of others, whether or not the same are or should be reflected in the Company’s consolidated balance sheet (or the notes thereto), except guaranties by endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of business; and (z) the present value of any lease payments in excess of $50,000 due under leases required to be capitalized in accordance with GAAP.
 
4.9   Absence of Certain Changes.
 
.Since June 30, 2018, there have not been any changes, circumstances, conditions or events which, individually or in the aggregate, have had, or would reasonably be expected to have, a Material Adverse Effect.
 
4.10   Compliance with Laws and Agreements
 
 
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(a)   Each of the Company and its Subsidiaries is and has been, in material compliance with all applicable Law and Orders. The Company and its Subsidiaries are, and have at all times, conducted their respective businesses in material compliance with all applicable Law and Orders. Except as disclosed in Schedule 4.10(a) herein, the Company and its Subsidiaries possess all material Permits required to conduct their respective businesses. To the Knowledge of the Company, each such Permit is in full force and effect. Neither the Company nor any of its Subsidiaries has received any written communication from a Governmental Authority that alleges that its business has not been conducted in compliance in any material respect with any such applicable Law, Order or Permit or threatens to revoke, restrict, or limit any Permit necessary or advisable for the operation of such business. Neither the Company nor any of its Subsidiaries has received any written communication from any Governmental Authority that alleges that its VIE structure (or any aspect thereof) is not in compliance with applicable PRC Laws or alleging that it is a circumvention of the requirement for VIEs to obtain Permits, or threatening to revoke, restrict or limit any Permit for any Affiliate within the VIE structure that is necessary or advisable for the operation of such business.
 
(b)   The Company and its Subsidiaries are and have been, in full compliance with all applicable Law concerning the exportation of any product, technology, technical data, and services, including applicable PRC Law and those Laws administered by the United States Department of Commerce, the United States Department of State, and the United States Department of Treasury. The Company and its Subsidiaries are in full compliance with United States and international economic and trade sanctions, including those administered by OFAC. Neither the Company nor its Subsidiaries nor, to the Company’s Knowledge, any director, officer, agent, employee or Affiliate of the Company or its Subsidiaries is currently subject to any sanctions administered by OFAC.
 
(c)   None of the Company, any of its predecessors, any affiliated issuer, any director, executive officer, other officer of the Company, any beneficial owner of twenty percent (20%) or more of the Company’s outstanding voting equity securities, calculated on the basis of voting power, nor any promoter (as that term is defined in Rule 405 under the Securities Act) connected with the Company in any capacity at the time of sale (each, an “ Issuer Covered Person ”) is subject to any of the “Bad Actor” disqualifications described in Rule 506(d)(1)(i) to (viii) under the Securities Act (a “ Disqualification Event ”), except for a Disqualification Event covered by Rule 506(d)(2) or (d)(3). The Company has exercised reasonable care to determine whether any Issuer Covered Person is subject to a Disqualification Event.
 
(d)   Except as would not be material to the Company and its Subsidiaries, neither the Company nor its Subsidiaries is in default under or in violation of (and no event has occurred that has not been waived that, with notice or lapse of time or both, would result in a default by the Company or any Subsidiary under), nor has the Company or any Subsidiary received notice of a claim that it is in default under or that it is in violation of, (i) any indenture, loan or credit agreement or (ii) any other agreement or instrument to which it is a party or by which it or any of its properties is bound (whether or not such default or violation has been waived).
 
(e)   Neither the Company nor any of its Subsidiaries has agreed to a material restriction on its right to conduct its business freely with any other business, including a restriction on the geographic scope of its business or a restriction on the kind of business that it is entitled to carry on. Neither the Company nor any of its Subsidiaries is in breach of any provision of the PRC Anti-Monopoly Law.
 
4.11   No Disagreements with Accountants and Lawyers.
 
There are no disagreements of any kind presently existing, or reasonably anticipated by the Company to arise, between the Company and the accountants and lawyers formerly or presently employed by the Company, and the Company is current with respect to any fees owed to its accountants and lawyers which could affect the Company’s ability to perform any of its obligations under any of the Transaction Documents.
 
 
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4.12   Intellectual Property.
 
(a)   The Company (together with its Subsidiaries) solely and exclusively owns or has obtained valid and enforceable licenses for, free and clear of all liens or encumbrances, all Intellectual Property Rights necessary for its business as now conducted and currently proposed to be conducted, and the conduct of its current and proposed business does not infringe or misappropriate any Intellectual Property Rights of any third party. Neither the Company nor any of its Subsidiaries have received any written communications of any alleged infringement, misappropriation or breach of any Intellectual Property Rights of others. There are no outstanding options, licenses, agreements, claims, encumbrances or shared ownership of interests of any kind relating to anything referred to above in this Section 4.12 that is to any extent owned by or exclusively licensed to the Company or any of its Subsidiaries, nor is the Company or any of its Subsidiaries bound by or a party to any options, licenses or agreements of any kind with respect to the Intellectual Property Rights of any other person or entity, except, in any case, for standard end-user, object code, internal-use software license and support/maintenance agreements for software that is not and will not be incorporated into, or used to provide or develop, the Company’s products or services.
 
(b)   Neither the Company nor any of its Subsidiaries is aware that any of its employees or independent contractors are obligated under any Contract or subject to any Order of any Governmental Authority, that would interfere with the use of such employee’s or independent contractor’s best efforts to promote the interest of the Company or that would conflict with the Company’s business as now conducted. Neither the execution nor delivery of this Agreement nor the conduct of the Company’s business as now conducted or as proposed to be conducted, will, to the Company’s Knowledge, conflict with or result in a breach of the terms, conditions or provisions of, or constitute a default under, any Contract under which any such employee or independent contractor is now obligated. The Company does not believe it is or will be necessary to use any Intellectual Property Rights of any of its employees made prior to their employment by the Company.
 
(c)   The Company has not received any communications alleging that the Company has violated or, by conducting its business as proposed, would violate any Intellectual Property Rights of any other Person, and to the Company’s Knowledge there is no potential basis for such an allegation or of any reason to believe that such an allegation may be forthcoming. There are no Orders, settlement agreements or stipulations to which the Company or any of its Subsidiaries is a party or by which the Company or any of its Subsidiaries is bound that restricts the Company’s or any Subsidiary’s rights to use any Intellectual Property Rights in the operation of its business as currently conducted.
 
(d)   Except as disclosed in SEC Filings made since January 1, 2018, there is no material pending or, to the Company’s Knowledge, threatened Action: (i) challenging the Company’s rights in or to any of the Company Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such Action; or (ii) challenging the validity, enforceability or scope of any Company Intellectual Property, and, to the Company’s Knowledge, there are no facts which would form a reasonable basis for any such Action.
 
(e)   The Company has complied with the terms of each agreement pursuant to which Intellectual Property Rights have been licensed to the Company in all material respects, and all such agreements are in full force and effect.
 
(f)   To the Company’s Knowledge, there are no material defects in any of the Patents included in the Company Intellectual Property. In particular, to the Company’s knowledge, all priority claims of the Company Intellectual Property are valid, and all claims in such Patents are entitled to the priority claims made. To the Company’s Knowledge, no granted Patents or pending Patent applications of the Company Intellectual Property violate the Paris Convention Treaty. To the Knowledge of the Company, all Patents of the Company Intellectual Property claim priority to all applicable prior filed and/or co-pending Patent applications.
 
 
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(g)   The Company has taken reasonable and customary actions to protect its rights in, and to prevent the unauthorized use and disclosure of, material trade secrets and confidential business information (including confidential ideas, research and development information, Know-How, formulas, compositions, technical data, designs, drawings, specifications, research records, records of inventions, test information, financial, marketing and business data, supplier lists and information, and business plans) owned by the Company, and, to the Knowledge of the Company, there has been no unauthorized use or disclosure of such material trade secrets and confidential business information.
 
4.13   Employee Benefits.
 
(a)   Each Benefit Plan has been established and administered in all material respects in accordance with its terms and in compliance with the applicable provisions of ERISA, the Code and other applicable Laws. The Company and its Subsidiaries are in compliance in all material respects with all federal, state, local and foreign requirements regarding employment. As of the date hereof, there is no material labor dispute, strike or work stoppage against the Company or any of its Subsidiaries pending or, to the Knowledge of the Company, threatened which may interfere with the business activities of the Company or any of its Subsidiaries.
 
(b)   Each stock option granted by the Company under the Company’s stock option plan was granted (i) in accordance with the terms of the Company’s stock option plan and (ii) with an exercise price at least equal to the fair market value of the Common Stock on the date such stock option would be considered granted under GAAP and applicable Law. No stock option granted under the Company’s stock option plan has been backdated. The Company has not knowingly granted, and there is no and has been no Company policy or practice to knowingly grant, stock options prior to, or otherwise knowingly coordinate the grant of stock options with, the release or other public announcement of material information regarding the Company or its Subsidiaries or their financial results or prospects.
 
4.14   Taxes.
 
(a)   The Company and its Subsidiaries have filed all federal, state, local and other Tax returns which it has been required to file which relate to or might in any way affect its assets and/or its business.  Each such return is true and accurate in all material respects.  The Company has timely paid all Taxes due with respect to the taxable periods covered by such Tax returns and all other Taxes (whether or not shown on any Tax return). There are no Liens with respect to Taxes on any of its assets (other than statutory Liens for current Taxes not yet due and payable).
 
(b)   There are no pending or, to the Knowledge of the Company, threatened audits, investigations, disputes, notices of deficiency, claims or other Actions for or relating to any Taxes of the Company which would reasonably be expected to result in any Liens on its assets or result in any material liability of the Company for any Tax.
 
4.15   Environmental Laws.
 
The Company (i) is in compliance in all material respects with any and all applicable Laws relating to the protection of human health and safety, the environment or hazardous or toxic substances or wastes, pollutants or contaminants (“ Environmental Laws ”), (ii) has received all material Permits, licenses or other approvals required under applicable Environmental Laws to conduct its business and (iii) is in compliance in all material respects with all terms and conditions of any such Permit. There are no material costs or liabilities associated with Environmental Laws, including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with Environmental Laws or any permit, license or approval, any related constraints on operating activities and any potential liabilities to third parties.
 
 
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4.16   Title.
 
The Company has good and marketable title to all personal property owned by it that is material to the business of the Company, free and clear of all liens, encumbrances and defects except as described in the SEC Filings made since January 1, 2018 or such as do not materially affect the value of such property and do not interfere with the use made and proposed to be made of such property by the Company. Any real property and buildings held under lease by the Company is held under valid, subsisting and enforceable leases with such exceptions as are not material and do not interfere with the use made and proposed to be made of such property and buildings by the Company. The Company does not own any real property.
 
4.17   Insurance.
 
  The Company maintains insurance underwritten by insurers of recognized financial responsibility, of the types and in the amounts that are prudent and customary in the operation of the business of the Company and its Subsidiaries as presently conducted or reasonably expected to be conducted (but excluding any business that may be conducted pursuant to the License and Collaboration Agreement) and covering all risks which are customarily insured against, with such deductibles as are customary for companies in the same or similar business, all of which insurance is in full force and effect. Neither the Company nor any of its Subsidiaries has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or obtain similar coverage from similar insurers as may be necessary to continue the business of the Company and its Subsidiaries (excluding any business that may be conducted pursuant to the License and Collaboration Agreement) without a material increase in cost.
 
4.18   Sarbanes-Oxley Act.
 
The Company is in compliance in all material respects with all applicable requirements of the Sarbanes-Oxley Act of 2002 and applicable rules and regulations promulgated by the SEC thereunder.
 
4.19   Regulatory Matters.
 
(a)   The Company and its Subsidiaries are and have been in compliance in all material respects with all applicable rules, regulations, decrees, guidance, pronouncements, circulars, standards and policies of the FDA and the SAMR and any other applicable Regulatory Authority, including cGMP, cGLP, and cGCP (collectively, “ Regulatory Requirements ”).
 
(b)   No IND filed by or on behalf of the Company with the FDA or SAMR has been terminated by the FDA or SAMR, and none of the FDA, the SAMR, or any other Regulatory Authority has recommended, commenced, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise delay or suspend, proposed or ongoing clinical investigations or trials conducted or proposed to be conducted by or on behalf of the Company and its Subsidiaries.
 
(c)   All operations of the Company and its Subsidiaries and all of the manufacturing facilities and operations of the Company’s and its Subsidiaries’ suppliers of products and product candidates and the components thereof manufactured in or imported into the United States are in compliance with applicable Regulatory Requirements, and meet sanitation standards set by the Federal Food, Drug and Cosmetic Act of 1938, as amended. All of the operations of the Company and its Subsidiaries and all of the manufacturing facilities and operations of the Company’s and its Subsidiaries’ suppliers of products and product candidates and the components thereof manufactured in or imported into the PRC are in compliance with applicable SAMR Regulatory Requirements, and all the operations of the Company and its Subsidiaries and all of the manufacturing facilities and operations of the Company’s and its Subsidiaries’ suppliers of products and product candidates manufactured outside of the United States or the PRC are in compliance with applicable Regulatory Requirements in each jurisdiction in which the activity takes place.
 
 
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(d)   Except as would not be material to the Company and its Subsidiaries, (i) the Company and its Subsidiaries have obtained, in accordance with applicable Law, all Permits required under any applicable Law or required by the SAMR, FDA or any other applicable Regulatory Authority for the lawful operation of their respective businesses, as presently conducted, (ii) each such Permit is valid and in full force and effect, (iii) there are currently no Actions pending that seek the revocation, cancellation or adverse modification of any Permit; and (iv) to the Knowledge of the Company, there is no expectation nor awareness that any of the Permits will not be renewed or extended on expiry of the current term on the same terms, or will only be extended or renewed on less favorable terms than currently. All Regulatory Documentation has been maintained and retained in accordance with applicable Laws, and such Regulatory Documentation is in the possession or control of the Company and its Subsidiaries.
 
(e)   The Company and its Subsidiaries are not subject to any unresolved notice, citation, suspension, revocation, warning, administrative proceeding, review or investigation or other Action by a Regulatory Authority that alleges or asserts that the Company or its Subsidiaries has violated any applicable Healthcare Laws, including an FDA Form 483, FDA warning letter, untitled letter, or similar notice of alleged non-compliance. There has not been a recall or market withdrawal or any product candidates by or on behalf of the Company or its Subsidiaries. The Company and its Subsidiaries have complied with all adverse event reporting requirements applicable to its product candidates.
 
(f)   All material reports, documents, claims, permits and notices related to the conduct of the business of the Company and its Subsidiaries required to be filed, maintained or furnished to the FDA, the SAMR, any Regulatory Authority have been so filed, maintained or furnished, and all such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were promptly corrected in or supplemented by a subsequent filing).
 
(g)   (i) Neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any of their respective officers, employees, agents, or distributors, or any other Person involved in development of any data included in any filing of the Company or its Subsidiaries submitted to a Regulatory Authority has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by 21 U.S.C. § 335a, nor has any such Person been so debarred, and (ii) neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any of their respective officers, employees or agents, nor any other Person involved in the development of any data included in any filing of the Company or its Subsidiaries submitted to a Regulatory Authority has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under 42 U.S.C. § 1320a-7, nor has any such Person been excluded from participation in such programs. Neither the Company nor any of its Subsidiaries nor, to the Knowledge of the Company, any of their respective directors, senior managers or legal representatives is prohibited under applicable PRC Laws from holding the current offices which they occupy within the Company or any of its Subsidiaries.
 
4.20   Ethical Practices.
 
Neither the Company nor any of its Subsidiaries, to the Company’s Knowledge, any of their respective directors, officers or employees or any other Person acting for, or on behalf of, the Company or its Subsidiaries has:
 
(a)   violated or is in violation of any applicable Anti-Corruption Law;
 
 
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(b)   made, undertaken, offered to make, promised to make or authorized the payment or giving of any bribe, rebate, payoff, influence payment, kickback or other payment or gift of money or anything of value (including meals or entertainment), to any officer, employee or ceremonial office holder of any government or instrumentality thereof, any political party or supra-national organization (such as the United Nations), any political candidate, any royal family member or any other person who is connected or associated personally with any of the foregoing, or to any non-governmental individual or entity, that is prohibited under any applicable Anti-Corruption Law or otherwise for the purpose of influencing any act or decision of such payee in his official capacity, inducing such payee to do or omit to do any act in violation of his lawful duty, securing any improper advantage or inducing such payee to use his influence with a government or instrumentality thereof to affect or influence any act or decision of such government or instrumentality or to secure any improper advance or inducing such payee to enter into a commercial arrangement in violation of applicable Law (each, a “ Prohibited Payment ”);
 
(c)   been subject to any investigation by any Governmental Authority with regard to any actual or alleged Prohibited Payment;
 
(d)   used funds or other assets, or made any promise or undertaking in such regard, for the establishment or maintenance of a secret or unrecorded fund (a “ Prohibited Fund ”); or
 
(e)   made any false or fictitious entries in any of the Company’s or any of its Subsidiaries’ books or records relating to any Prohibited Payment or Prohibited Fund.
 
4.21   Litigation; Legal Matters,
 
  There is no Action pending or, to the Knowledge of the Company, threatened, whether at law or in equity, or before or by any Governmental Authority, nor any Order of any Governmental Authority which, if adversely determined, would materially and adversely impact the Company or its Subsidiaries (without regard to the availability of insurance) or that would reasonably be expected to impair or materially delay the Company’s ability to consummate the transactions contemplated by this Agreement or the other Transaction Documents or perform its obligations hereunder or thereunder, and the Company has no Knowledge of any valid basis for any such Action. Except as disclosed in the SEC Filings, neither the Company nor its Subsidiaries, nor any director or officer thereof, is, or within the last ten years has been, the subject of any action involving a claim of violation of or liability under federal or state securities laws relating to the Company or a claim of breach of fiduciary duty relating to the Company.
 
4.22   Data Privacy and Protection.
 
(a)   The Company and its Subsidiaries have complied with each relevant requirement of all applicable Data Protection Laws.
 
(b)   Neither the Company nor any of its Subsidiaries has received a notice or allegation from a Governmental Authority or any other Person: (i) alleging noncompliance with any Data Protection Laws; (ii) requiring it to change, cease using, block or delete any personal data; (iii) prohibiting the transfer of personal data to any place; or (iv) requiring it to take any other type of action with respect to the collection, use, transfer, or deletion of personal information.
 
(c)   The Company and its Subsidiaries have obtained each necessary consent from data subjects and has complied with each necessary condition to permit it to process or use all relevant personal information in connection with their respective businesses and, where appropriate, any relevant purpose for which it would be necessary for Purchaser to use such personal information.
 
4.23   Controls and Procedures.
 
 
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(a)   The Company has established and maintains disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) that are effective in all material respects to ensure that material information relating to the Company, including CBMG Shanghai, is made known to its chief executive officer and chief financial officer by others within those entities. The Company’s certifying officers have evaluated the effectiveness of the Company’s controls and procedures as of December 31, 2017. The Company presented in its Annual Report on Form 10-K for the fiscal year ended December 31, 2017 the conclusions of the certifying officers about the effectiveness of the disclosure controls and procedures based on their evaluations as of December 31, 2017. Since December 31, 2017, there have been no significant changes in the Company’s internal controls (as such term is defined in Item 307(b) of Regulation S-K under the Exchange Act) or, to the Company’s Knowledge, in other factors that could significantly affect the Company’s internal controls.
 
(b)   The Company maintains a system of internal accounting controls sufficient to provide reasonable assurances that (i) transactions are executed in accordance with management’s general or specific authorization, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain accountability for assets, (iii) access to assets is permitted only in accordance with management’s general or specific authorization, and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences.
 
4.24   Registration and Listing of Shares
 
. Except for the rights set forth in this Agreement and the Registration Rights Agreement, the Company has disclosed in the SEC Filings all rights any Person has to require the Company to register securities of the Company, and registration statements have previously been declared effective covering the resale of all such securities. The Common Stock is registered pursuant to Section 12(b) of the Exchange Act, and the Company has taken no action designed to, or which to the Company’s Knowledge is likely to have the effect of, terminating the registration of the Common Stock under the Exchange Act, nor has the Company received any notification that the SEC is contemplating terminating such registration. The Common Stock is listed on the Nasdaq Global Market, and the Company has no action pending to delist the Common Stock from Nasdaq Global Market, nor has the Company received any notification that the Nasdaq Global Market is currently contemplating terminating such listing. The Company has not received any notice from the Nasdaq Global Market to the effect that the Company is not in compliance with the listing or maintenance requirements of the Nasdaq Global Market. The Company is, and has no reason to believe that it will not in the foreseeable future continue to be, in compliance with all such listing and maintenance requirements. The Common Stock is currently eligible for electronic transfer through the Depository Trust Company or another established clearing corporation and the Company is current in payment of the fees to the Depository Trust Company (or such other established clearing corporation) in connection with such electronic transfer.
 
4.25   Price of Common Stock.
 
The Company has not taken, nor will it take, directly or indirectly, any action designed to stabilize or manipulate the price of the Common Stock.
 
4.26   Status.
 
(a)   The Company is not, and immediately after receipt of payment for the Common Stock will not be, an “investment company” within the meaning of the Investment Company Act of 1940, as amended.
 
(b)   The Company meets the requirements of Rule 144(i)(2) under the Securities Act.
 
(c)   The Company is not and has never been a U.S. real property holding corporation within the meaning of Section 897 of the Code, and the Company shall so certify upon Purchaser’s request.
 
 
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4.27   General Solicitation; No Integration or Aggregation.
 
Neither the Company nor any other person or entity authorized by the Company to act on its behalf has engaged in a general solicitation or general advertising (within the meaning of Regulation D of the Securities Act) of investors with respect to offers or sales of Common Stock. The Company has not, directly or indirectly, sold, offered for sale, solicited offers to buy or otherwise negotiated in respect of, any security (as defined in the Securities Act) which, to its knowledge, is or will be (i) integrated with the Securities sold pursuant to this Agreement for purposes of the Securities Act or (ii) aggregated with prior offerings by the Company for the purposes of the rules and regulations of the Nasdaq Global Market.
 
4.28   Brokers and Finders.
 
Neither the Company nor any other Person authorized by the Company to act on its behalf has retained, utilized or been represented by any broker or finder in connection with the transactions contemplated by this Agreement whose fees the Purchaser would be required to pay.
 
4.29   No Directed Selling Efforts.
 
None of the Company or any of its Affiliates engaged in any directed selling efforts within the meaning of Regulation S of the Securities Act (“ Regulation S ”) in connection with the transactions contemplated by this Agreement, and all such persons have complied with the offering restrictions requirement of Regulation S.
 
4.30   Anti-Money Laundering.
 
  The operations of the Company and is Subsidiaries and Representatives are and have been at all times conducted in compliance with, its issuance of the Shares hereunder will not violate, and the Company has instituted and maintains policies and procedures designed to ensure continued compliance with, the anti-money laundering laws, regulations or government guidance regarding anti-money laundering, and international anti-money laundering principals or procedures of the United States, Hong Kong, PRC, including the Currency and Foreign Transactions Reporting Act of 1970, as amended, and applicable rules and regulations thereunder, and any related or similar applicable Laws administered or enforced by any Governmental Authority (collectively, the “ Anti Money Laundering Laws ”), and no Action by or before any Governmental Authority or arbitrator involving the Company or its Subsidiaries with respect to the Anti Money Laundering Laws is pending or, to the Knowledge of the Company, threatened.
 
4.31   Reliance by the Purchaser.
 
The Company acknowledges that the Purchaser will rely upon the truth and accuracy of, and the Company’s compliance with, the representations, warranties, agreements, acknowledgements and understandings of the Company set forth herein.
 
ARTICLE V
 
REPRESENTATIONS AND WARRANTIES OF THE PURCHASER
 
The Purchaser represents and warrants to the Company, as of the date of this Agreement and as of the Closing Date, as follows:
 
5.1   Organization and Qualification.
 
The Purchaser is a company ( Aktiengesellschaft ) duly organized, validly existing and in good standing (if applicable) under the laws of Switzerland, and has the requisite power and authority to own, lease and operate its properties and to carry on its business as now conducted, and is qualified to do business in each jurisdiction in which the character of its properties or the nature of its business requires such qualification.
 
5.2   Authorization.
 
The Purchaser has full power and authority to enter into this Agreement and the other Transaction Documents and to consummate the transactions contemplated hereby and thereby and to perform its obligations hereunder and thereunder. The execution and delivery of this Agreement and the other Transaction Documents and the consummation of the transactions contemplated hereby and thereby have been duly authorized by all necessary corporate action on the part of the Purchaser, its officers, directors, and stockholders. Assuming this Agreement constitutes a legal and binding agreement of the Company, this Agreement constitutes a legal, valid and binding obligation of the Purchaser, enforceable against the Purchaser in accordance with its terms, except as such enforceability may be limited by the Permitted Exceptions.
 
 
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5.3   No Conflict.
 
The execution, delivery and performance of this Agreement and the other Transaction Documents by the Purchaser, and the consummation of the transactions contemplated hereby and thereby do not and will not (a) violate any provision of the constituent documents of the Purchaser, (b) violate or conflict with any Law or Order to which the Purchaser is bound or subject, or (c) conflict with or result in any violation of or default (with or without notice or lapse of time, or both) under, any material Contract or Permit to which the Purchaser is a party or by which its properties or assets may be bound or subject, other than, in each case, such violations or conflicts which not reasonably be expected to have a material adverse effect on Purchaser’s ability to consummate the transactions contemplated by the Transaction Documents.
 
5.4   No Registration of the Shares.
 
  The Purchaser acknowledges that it is aware that (a) the Shares have not been registered under the Securities Act and that the Shares must continue to be held by Purchaser unless a subsequent disposition thereof is registered under the Securities Act or is exempt from such registration, and in each case in accordance with any applicable securities laws of any state of the United States; (b) exemption from the Securities Act, including any exemption for limited sales in routine brokers’ transactions pursuant to Rule 144, depends on the satisfaction of various conditions, including the time and manner of sale, the holding period, and on requirements relating to the Company which are outside of the Purchaser’s control and which the Company is under no obligation to and may not be able to satisfy, and that, if applicable, Rule 144 may afford the basis for sales only in limited amounts.
 
5.5   Sophistication.
 
  The Purchaser is an “accredited investor” as that term is defined in Rule 501(a) under Regulation D promulgated pursuant to the Securities Act. The Purchaser is capable of evaluating the merits and risk of its investment, and has not been organized for the purpose of acquiring Shares.
 
5.6   Intent.
 
  The Purchaser is purchasing the Shares solely for investment purposes, for the Purchaser’s own account, and not with a view towards the distribution or dissemination thereof. The Purchaser has no present arrangement to sell the Shares to or through any person or entity.
 
5.7   Investment Experience.
 
  The Purchaser, or the Purchaser’s professional advisors, have such knowledge and experience in finance, securities, taxation, investments and other business matters as to evaluate investments of the kind described in this Agreement. By reason of the business and financial experience of the Purchaser or its professional advisors (who are not affiliated with or compensated in any way by the Company or any of its affiliates or selling agents), the Purchaser can protect its own interests in connection with the transactions described in this Agreement. The Purchaser is able to afford the loss of its entire investment in the Shares.
 
5.8   Independent Investigation.
 
  The Purchaser is familiar with the business, operations and financial condition of the Company and has had an opportunity to ask questions of, and receive answers from, the Company’s officers and directors concerning the Company and the terms and conditions of the offering of the Shares and has had access to such other information concerning the Company as the Purchaser has requested. The Purchaser has consulted, to the extent it deemed appropriate, with its own advisers as to the financial, tax, legal and related matters concerning an investment in the Shares, and on that basis believes that its investment in the Shares is suitable and appropriate for it. The Purchaser acknowledges that it has had the opportunity to review this Agreement, the exhibits hereto and the transactions contemplated by this Agreement with its own legal counsel and investment and tax advisors.
 
 
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5.9   Not a Broker-Dealer.
 
  The Purchaser is neither a registered representative under the Financial Industry Regulatory Authority (“ FINRA ”), a member of FINRA or associated or Affiliated (as defined below) with any member of FINRA, nor a broker-dealer registered with the SEC under the Exchange Act or engaged in a business that would require it to be so registered, nor is it an Affiliate of a broker-dealer or any Person engaged in a business that would require it to be registered as a broker-dealer. In the event such Purchaser is a member of FINRA, or associated or Affiliated with a member of FINRA, such Purchaser agrees, if requested by FINRA, to sign a lock-up, the form of which shall be satisfactory to FINRA with respect to the Securities. “Affiliate” means, with respect to any specified Person: (i) if such Person is an individual, the spouse of that Person and, if deceased or disabled, his heirs, executors, or legal representatives, if applicable, or any trusts for the benefit of such individual or such individual’s spouse and/or lineal descendants, or (ii) otherwise, another Person that directly, or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with, the Person specified. As used in this definition, “control” shall mean the possession, directly or indirectly, of the power to cause the direction of the management and policies of a Person, whether through the ownership of voting securities or by contract or other written instrument. “Person” shall mean an individual, entity, corporation, partnership, association, limited liability company, limited liability partnership, joint-stock company, trust or unincorporated organization.
 
5.10   Not an Underwriter.
 
  The Purchaser is not an underwriter of the Securities, nor is it an Affiliate of an underwriter of the Securities.
 
5.11   Reliance on Representations and Warranties.
 
  The Purchaser understands that the Shares are being offered and sold to such Purchaser in reliance on exemptions contained in specific provisions of United States federal and state securities laws and that the Company is relying upon the truth and accuracy of the representations, warranties, agreements, acknowledgments and understandings of the Purchaser set forth in this Agreement in order to determine the applicability of the exemptions contained in such provisions.
 
5.12   Regulation S Exemption.
 
(a)   The Purchaser is not (i) a U.S. person (as defined in Rule 902(k) under the Securities Act) (ii) an affiliate (as defined in Rule 501(b) under the Securities Act) of the Company, or (iii) acquiring the Shares for the account or benefit of a U.S. person.
 
(b)   At the time of the origination of contact concerning this Agreement and the date of the execution and delivery of this Agreement, the Purchaser was outside of the United States.
 
(c)   The Purchaser will not, during the period commencing on the date of issuance of the Shares and ending on the six (6)-month anniversary of such date, or such shorter period as may be permitted by Regulation S or other applicable securities law (the “ Restricted Period ”), offer, sell, pledge or otherwise transfer the Shares in the United States, or to a U.S. Person for the account or for the benefit of a U.S. Person, or otherwise in a manner that is not in compliance with Regulation S under the Securities Act.
 
(d)   The Purchaser will, after expiration of the Restricted Period, offer, sell, pledge or otherwise transfer the Shares only pursuant to registration under the Securities Act or an available exemption therefrom and in accordance with all applicable state and foreign securities laws.
 
(e)   The Purchaser was not in the United States engaged in, and prior to the expiration of the Restricted Period will not engage in, any short selling of or any hedging transaction with respect to the Shares, including any put, call or other option transaction, option writing or equity swap.
 
 
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(f)   Neither the Purchaser nor or any Person acting on its behalf has engaged in any directed selling efforts to a U.S. Person with respect to the Shares and the Purchaser and any Person acting on its behalf has complied and will comply with the “offering restrictions” requirements of Regulation S under the Securities Act.
 
(g)   The transactions contemplated by this Agreement have not been pre-arranged with a Purchaser located in the United States or with a U.S. Person, and are not part of a plan or scheme to evade the registration requirements of the Securities Act.
 
(h)   Neither the Purchaser nor any person acting on its behalf has undertaken or carried out any activity for the purpose of, or that could reasonably be expected to have the effect of, conditioning the market in the United States, its territories or possessions, for any of the Shares. The Purchaser agrees not to cause any advertisement of the Shares to be published in any newspaper or periodical or posted in any public place and not to issue any circular relating to the Shares, except such advertisements that include the statements required by Regulation S under the Securities Act, and only offshore and not in the U.S. or its territories, and only in compliance with any local applicable securities laws.
 
5.13   Foreign Investors.
 
  The Purchaser has satisfied itself as to the full observance of the laws of its jurisdiction in connection with any invitation to subscribe for the Shares or any use of this Agreement, including (i) the legal requirements within its jurisdiction for the purchase of the Shares, (ii) any foreign exchange restrictions applicable to such purchase, (iii) any governmental or other consents that may need to be obtained, and (iv) the income tax and other tax consequences, if any, that may be relevant to the purchase, holding, redemption, sale, or transfer of the Shares. Such Purchaser’s subscription and payment for and continued beneficial ownership of the Shares will not violate any applicable securities or other laws of the Purchaser’s jurisdiction.
 
5.14   No Governmental Review.
 
The Purchaser is aware that no federal or state agency has (i) made any finding or determination as to the fairness of this investment, (ii) made any recommendation or endorsement of the Shares or the Company, or (iii) guaranteed or insured any investment in the Shares or any investment made by the Company.
 
5.15   Anti Money Laundering Law Compliance.
 
The Purchaser, its Affiliates and each of their respective Representatives has not violated, its purchase of the Shares will not violate, and it has instituted and maintains policies and procedures designed to ensure continued compliance with Anti Money Laundering Laws, and no Proceeding by or before any Governmental Authority or arbitrator involving the Purchaser with respect to the Anti Money Laundering Laws is pending has been threatened in writing.
 
ARTICLE VI
 
LEGENDS, ETC.
 
6.1   Legend.
 
(a)   Each certificate representing the Shares shall be endorsed with the following legends, in addition to any other legend required to be placed thereon by applicable federal or state securities laws:
 
“THESE SECURITIES ARE BEING OFFERED TO INVESTORS WHO ARE NOT U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE SECURITIES ACT OF 1933, AS AMENDED (“THE SECURITIES ACT”)) AND WITHOUT REGISTRATION WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION UNDER THE SECURITIES ACT IN RELIANCE UPON REGULATION S PROMULGATED UNDER THE SECURITIES ACT. TRANSFER OF THESE SECURITIES IS PROHIBITED, EXCEPT IN ACCORDANCE WITH THE PROVISIONS OF REGULATION S PROMULGATED UNDER THE SECURITIES ACT, PURSUANT TO REGISTRATION UNDER THE SECURITIES ACT, OR PURSUANT TO AVAILABLE EXEMPTION FROM REGISTRATION. HEDGING TRANSACTIONS MAY NOT BE CONDUCTED UNLESS IN COMPLIANCE WITH THE SECURITIES ACT.”
 
 
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(b)   No instrument evidencing the Shares, whether certificated or uncertificated, shall contain any legend (including the legend set forth in Section 6.1(a)): (i) while a registration statement covering the resale of such security is effective under the Securities Act, (ii) following any sale of such Shares pursuant to Rule 144, (iii) if such Shares are eligible for sale under Rule 144 without volume or manner-of-sale restrictions or (iv) if such legend is not required under applicable requirements of the Securities Act (including judicial interpretations and pronouncements issued by the staff of the SEC). The Company shall cause its counsel to issue a legal opinion to the transfer agent if required by to effect the removal of the legend hereunder. The Company agrees that at such time as such legend is no longer required under this Section 6.1(b), it will, as soon as practicable but no later than three (3) Business Days following the delivery by the Purchaser to the Company or the transfer agent of an instrument representing Shares, as applicable, issued with a restrictive legend, deliver or cause to be delivered to such Purchaser a certificate or book-entry (at the election of the Purchaser, provided that absent instructions to the contrary, the default shall be book-entry) representing such Shares that is free from all restrictive and other legends. The Company may not make any notation on its records or give instructions to the transfer agent that enlarge the restrictions on transfer set forth in this Section 6.1. Instruments for Shares, whether certificated or uncertificated, subject to legend removal hereunder shall be transmitted by the transfer agent to the Purchaser by crediting the account of the Purchaser’s prime broker with the Depository Trust Company System as directed by the Purchaser.
 
6.2   The Purchaser’s Compliance.
 
Nothing in this Article VI shall affect in any way each Purchaser’s obligations and agreement to comply with all applicable securities laws upon resale of the Shares.
 
6.3   Company’s Refusal to Register Transfer of Shares.
 
The Company shall refuse to register any transfer of the Shares not made (i) pursuant to an effective registration statement filed under the Securities Act, or (ii) pursuant to an available exemption from the registration requirements of the Securities Act.
 
ARTICLE VII
 
OTHER AGREEMENTS
 
7.1   Further Assurances.
 
In the event that at any time after the Closing Date any further action is reasonably necessary to carry out the purposes of this Agreement, each of the parties will take such further action (including the execution and delivery of such further instruments and documents) as the other parties reasonably may request, at the sole cost and expense of the requesting party(ies) (unless otherwise specified herein or unless such requesting party(ies) is entitled to indemnification therefor under Article IX , in which case, the costs and expense will be borne by the parties as set forth in Article IX ).
 
7.2   Confidentiality.
 
The Purchaser shall, and shall cause its Affiliates to (a) treat and hold in strict confidence any confidential or proprietary information relating to the information obtained from the Purchaser’s due diligence of the Company (“ Confidential Information ”), and will not use for any purpose, nor directly or indirectly disclose, distribute, publish, disseminate or otherwise make available to any third party any of the Confidential Information without the Company’s prior written consent; (b) in the event that the Purchaser or any of its Affiliates becomes legally compelled to disclose any Confidential Information, provide the Company with prompt written notice of such requirement so that the Company or an Affiliate thereof may seek a protective order or other remedy or waive compliance with this Section 7.2; (c) in the event that such protective order or other remedy is not obtained, or the Company waives compliance with this Section 7.2, furnish only that portion of such Confidential Information which is legally required to be provided as advised in writing by outside counsel and to exercise their commercially reasonable efforts to obtain assurances that confidential treatment will be accorded such Confidential Information; (d) to the extent permitted by applicable Law, promptly furnish (prior to, at, or as soon as practicable following, the Closing) to the Company any and all copies (in whatever form or medium) of all such Confidential Information and to destroy any and all additional copies of such Confidential Information and any analyses, compilations, studies or other documents prepared, in whole or in part, on the basis thereof; provided, however , that Confidential Information shall not include any information to the extent that such information (i) is (at the time of disclosure) or becomes (after the time of disclosure) known to the public or part of the public domain through no breach of this Agreement by Purchaser or its Affiliates; (ii) was known to, or was otherwise in the possession of, the Purchaser or its Affiliates, as evidenced by written records, prior to the time of disclosure by the Company; (iii) is disclosed to the Purchaser or any of its Affiliates on a non-confidential basis by a Third Party who is entitled to disclose it without breaching any confidentiality obligation to the Company or any of its Affiliates; or (iv) is independently developed by or on behalf of the Purchaser or its Affiliates, as evidenced by written records, without reference to the Confidential Information disclosed by the Company or its Affiliates to the Purchaser or its Affiliates under this Agreement. The Purchaser agrees and acknowledges that remedies at law for any breach of its obligations under this Section 7.2 are inadequate and that in addition thereto the Company (or an Affiliate thereof) shall be entitled to seek equitable relief, including injunction and specific performance, in the event of any such breach.
 
 
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7.3   Publicity.
 
  Neither the Company nor the Purchaser shall issue any press release or other public statement with respect to this Agreement or the transactions contemplated hereby without the prior consent of the other party (which consent shall not be unreasonably withheld, conditioned or delayed), except as such release or statement may be required, based upon the reasonable advice of counsel, by applicable Law or the rules and regulations of any stock exchange upon which the securities of the Company or the Purchaser or its direct or indirect parent entity are listed, or the requirements of any self-regulatory body, in which case the party required to make the release or statement shall, to the extent reasonably practicable under the circumstances, allow the other party reasonable time to review and comment upon such release or announcement in advance of such issuance. Without limiting the foregoing, any party so obligated shall provide the other party with a reasonable opportunity to review and request confidential treatment of this Agreement pursuant to applicable rules under the Exchange Act and the Freedom of Information Act and the rules promulgated thereunder to permit the filing of a redacted exhibit. The party so obligated shall give due consideration to the other party’s request, which shall include consultation with such party’s outside securities counsel, and, if agreed by the parties, use reasonable efforts to obtain such confidential treatment or permission to redact such exhibit, provided that there is no assurance that such request will be granted by the SEC and the SEC may require filing of the Agreement in full. Notwithstanding the foregoing, without prior submission to, or approval of, the other party, either party may issue press releases or public announcements which incorporate information concerning this Agreement which information was included in a press release or public disclosure which was previously disclosed in accordance with the terms of this Agreement.
 
7.4   Registration.
 
The Company shall comply with all terms and conditions of the Registration Rights Agreement until the termination thereof in accordance with its terms.
 
7.5   Reports under the Exchange Act.
 
With a view to making available to the Purchaser the benefits of Rule 144 and any other rule or regulation of the SEC that may at any time permit Purchaser to sell securities of the Company to the public without registration, the Company shall use its commercially reasonable efforts, until Purchaser no longer owns any Shares, to:
 
 
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(a)   make and keep available adequate current public information, as those terms are understood and defined in Rule 144;
 
(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; and
 
(c)   furnish to the Purchaser, forthwith upon request (i) to the extent accurate, a written statement by the Company that it has complied with the reporting requirements of Rule 144, the Securities Act, and the Exchange Act, or that it qualifies as a registrant whose securities may be resold pursuant to Form S-3; and (ii) such other information as may be reasonably requested in availing the Purchaser of any rule or regulation of the SEC that permits the selling of any such securities without registration.
 
ARTICLE VIII                                 
 
TERMINATION
 
8.1   Pre-Closing Termination
 
.
 
(a)   This Agreement may be terminated at any time prior to the Closing:
 
(i)   by either the Purchaser or the Company, if any Order restraining, enjoining or otherwise prohibiting the transactions contemplated by this Agreement shall have become final and non-appealable;
 
(ii)   by the Company, if the Purchaser shall have breached any of its representations, warranties, covenants or agreements contained in this Agreement such that a condition set forth in Section 3.3 cannot be satisfied;
 
(iii)   by the Purchaser, if the Company shall have breached any of its representations, warranties, covenants or agreements contained in this Agreement such that a condition set forth in Section 3.4 cannot be satisfied; or
 
(iv)   by the mutual written consent of the Company and the Purchaser.
 
(b)   This Agreement shall terminate automatically, with no action by either party, upon the termination of the License and Collaboration Agreement prior to the Closing.
 
8.2   Effect of Pre-Closing Termination.
 
In the event of termination of this Agreement pursuant to Section 8.1, this Agreement shall forthwith become void and there shall be no liability on the part of any party hereto, except that nothing herein shall relieve any party hereto from liability for fraud or any willful breach of any provision of this Agreement. Sections 7.2 and 7.3 and Article X shall survive any termination of this Agreement pursuant to Section 8.1.
 
8.3   Post-Closing Termination.
 
Following the Closing, if the Company breaches any obligation under the Registration Rights Agreement, including the occurrence of an Event (as defined in the Registration Rights Agreement), Purchaser may by written notice to the Company, in addition to any remedies available to Purchaser under the Registration Rights Agreement, terminate this Agreement.
 
 
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8.4   Effect of Post-Closing Termination.
 
If Purchaser terminates this Agreement after the Closing pursuant to Section 8.3, the Company shall, within ten (10) Business Days of receipt of notice of termination, repurchase the Shares from the Purchaser at the Purchase Price and the Registration Rights Agreement shall be deemed to be terminated. Sections 7.2 and 7.3, this Article VIII, Article IX (with respect to any Losses accruing before the repurchase of the Shares pursuant to this Section 8.4), and Article X shall survive any termination of this Agreement pursuant to Section 8.2.
 
ARTICLE IX
 
INDEMNIFICATION
 
9.1   Survival.
 
  All representations and warranties of the Company and the Purchaser contained in this Agreement (including all certificates, documents, instruments and undertakings furnished pursuant to this Agreement) shall survive the Closing through and until the second (2 nd ) anniversary of the Closing Date; provided   however that the representations and warranties contained in Sections 4.1 (Organization; Capitalization; Subsidiaries), 4.2 (Authorization), 5.1 (Organization and Qualification), and 5.2 (Authorization) (such representations and warranties collectively, the “ Special Reps ”) shall survive indefinitely (in each case, the date until each such representation and warranty shall survive is herein referred to as the “ Survival Date ”). If written notice of a claim for breach of any representation or warranty has been given on or before the applicable Survival Date for such representation or warranty, then the relevant representations and warranties shall survive as to such claim, until the claim has been finally resolved. All covenants, obligations and agreements of the parties contained in this Agreement which, by their terms, are to be satisfied on or prior to the Closing Date shall terminate on the Closing Date, and all other covenants, obligations, and agreements in this Agreement, including all indemnification obligations, shall survive the Closing indefinitely and continue until fully performed in accordance with their terms.
 
9.2   Indemnification by the Company.
 
Except as otherwise limited by this Article IX , the Company shall indemnify, defend and hold harmless the Purchaser, its Affiliates, any assignee or successor thereof, and each officer, director, manager, employee, agent and Representative of each of the foregoing (collectively, the “ Purchaser Indemnified Parties ”) from and against, and shall pay or reimburse the Purchaser Indemnified Parties for, any and all losses, Actions, Orders, Liabilities, damages, diminution in value, taxes, interest, penalties, Liens, amounts paid in settlement, costs and expenses (including reasonable expenses of investigation and court costs and reasonable attorneys’ fees and expenses), (any of the foregoing, a “ Loss ”) suffered or incurred by, or imposed upon, any Purchaser Indemnified Party arising in whole or in part out of or relating to or resulting directly or indirectly from:
 
(a)   any breach of any representation or warranty of CBMG in this Agreement as of the Closing Date;
 
(b)   the failure of the Company to comply with any of its covenants, agreements, or other obligations in this Agreement; or
 
(c)   enforcing the Purchaser Indemnified Parties’ indemnification rights provided for hereunder.
 
9.3   Indemnification by the Purchaser.
 
Except as otherwise limited by this Article IX , the Purchaser shall indemnify, defend and hold harmless the Company, its Affiliates and each officer, manager, employee, agent and Representative of each of the foregoing (collectively, the “ Company Indemnified Parties ”) from and against, and shall pay or reimburse the Company Indemnified Parties for, any and all Losses, suffered or incurred by, or imposed upon, any the Company Indemnified Party to the extent arising out of or relating to:
 
 
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(a)   any breach of any representation or warranty of the Purchaser in this Agreement as of the Closing Date;
 
(b)   the failure of the Purchaser to comply with any of its covenants, agreements, or other obligations in this Agreement; or
 
(c)   enforcing the Company Indemnified Parties’ indemnification rights provided for hereunder.
 
9.4   Indemnification Procedures.
 
(a)   For the purposes of this Agreement, (i) the term “ Indemnitee ” shall refer to the Person or Persons indemnified, or entitled, or claiming to be entitled, to be indemnified, pursuant to the provisions of Section 9.2 or 9.3, as the case may be, and (ii) the term “ Indemnitor ” shall refer to the Person or Persons having the obligation, or which the Indemnitee purports has the obligation, to indemnify pursuant to such provisions.
 
(b)   In the case of any claim for indemnification under this Agreement arising from a claim of a Third Party (including any Governmental Authority), an Indemnitee must give prompt written notice to the Indemnitor, no later than thirty (30) days after the Indemnitee’s receipt of notice of such claim; provided that the failure to give such notice will not relieve an Indemnitor of its indemnification obligations except (and only) to the extent that it shall be finally determined by a court of competent jurisdiction (which determination is not subject to appeal or further review) that the Indemnitor is actually and materially harmed thereby.
 
(c)   The Indemnitor will have the right to defend and to direct the defense against any such claim in its name and at its expense, and with counsel selected by the Indemnitor, unless (i) the Indemnitor fails to acknowledge fully its obligations to the Indemnitee within fifteen (15) days after receiving notice of such Third Party claim or contests, in whole or in part, its indemnification obligations therefor, (ii) the applicable Third Party claimant is a Governmental Authority, (iii) there is a conflict of interest between the Indemnitee and the Indemnitor in the conduct of such defense, as determined by the Indemnitee’s counsel in its reasonable judgment, (iv) the applicable Third Party alleges claims of fraud, willful misconduct or intentional misrepresentation, or (v) such claim is criminal in nature, could reasonably be expected to lead to criminal proceedings, or seeks an injunction or other equitable relief against the Indemnitee, in which case, the Indemnitee shall have the right to employ separate counsel in any such proceeding and to participate in the defense thereof, and the fees and expenses of such counsel shall be at the expense of the Indemnitor. In any case not covered by subclauses (i) through (v) of the preceding sentence, the Indemnitee shall retain its right to participate in the defense of any claim with counsel selected by it, subject to the Indemnitor’s right to direct the defense, but the fees and disbursements of such counsel will be at the expense of the Indemnitee. If the Indemnitor elects, and is entitled, to defend such claim, it shall within fifteen (15) days (or sooner, if the nature of the claim so requires) notify the Indemnitee of its intent to do so, and the Indemnitee shall, at the request and expense of the Indemnitor, cooperate in the defense of such claim. If the Indemnitor elects not to, or is not entitled under this Section 9.4(c) to, defend such claim, fails to notify the Indemnitee of its election as herein provided or refuses to acknowledge or contests its obligation to indemnify under this Agreement, the Indemnitee may pay, compromise or defend such claim. The Indemnitor’s right to direct the defense will include the right to compromise or enter into an agreement settling any claim by a Third Party; provided that no such compromise or settlement will (i) obligate the Indemnitee to agree to any settlement that requires the taking or restriction of any action by the Indemnitee (other than the delivery of a release for such claim and customary confidentiality obligations) or provides for any relief (including competition restrictions) other than the payment of monetary damages not fully indemnified by the Indemnitor or (ii) fail to provide a full and final release of the Indemnitee from all liability on claims that are the subject matter of such proceeding with no admission of liability, in each case except with the prior written consent of the Indemnitee in its sole discretion.
 
 
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(d)   Any indemnification claim that does not arise from a Third Party claim must be asserted by a written notice to the Indemnitor. The Indemnitor will have a period of thirty (30) days after receipt of such notice within which to respond thereto. If the Indemnitor does not respond within such thirty (30) days, the Indemnitor will be deemed to have accepted responsibility for the Losses set forth in such notice and will have no further right to contest the validity of such notice. If the Indemnitor responds within such thirty (30) days after the receipt of the notice and rejects such claim in whole or in part, the Indemnitee will be free to pursue such remedies as may be available to it under this Agreement or applicable Law.
 
9.5   Limitations on Indemnification.
 
(a)   No Indemnitor shall be liable for an indemnification claim made under Section 9.2(a) or Section 9.3(a) as the case may be: (i) for which a claim for indemnification is not asserted hereunder on or before the applicable Survival Date, (ii) to the extent Losses incurred by the Purchaser Indemnified Parties in the aggregate under Section 9.2(a) or by the Company Indemnified Parties in the aggregate under Section 9.3(a), as applicable, exceed an amount equal to the Purchase Price (the “ Indemnification Cap ”); and (iii) unless and until the Losses of the Purchaser Indemnified Parties collectively, or of the Company Indemnified Parties collectively, as applicable, exceed an aggregate amount equal to $200,000 (the “ Basket ”), in which case the applicable Indemnitor(s) shall be obligated to the Indemnitee(s) for the amount of such Losses of the Indemnitee(s) that exceed the Basket; provided , however , that the Basket and the Indemnification Cap shall not apply to (x) indemnification claims to the extent amounts are actually paid under insurance policies maintained by the Indemnitor (or any of its Affiliates), (y) indemnification claims based, in whole or in part, on fraud, willful misconduct or intentional misrepresentation and (z) indemnification claims based, in whole or in part, on the breach of any of the Special Reps as of the Closing Date.
 
(b)   The Basket and the Indemnification Cap shall apply only to indemnification claims made under Section 9.2(a) or Section 9.3(a) and shall not affect or apply to any other indemnification claim made pursuant to this Agreement, including those asserted under any other clause of Section 9.2 or Section 9.3.
 
9.6   General Indemnification Provisions.
 
(a)   The amount of any Losses suffered or incurred by any Indemnitee shall be reduced by the amount of any insurance proceeds or other cash receipts paid to the Indemnitee or any Affiliate thereof as a reimbursement with respect to such Losses (and no right of subrogation shall accrue to any insurer hereunder, except to the extent that such waiver of subrogation would prejudice any applicable insurance coverage), including any indemnification received by the Indemnitee or such Affiliate from an unrelated party with respect to such Losses, net of the costs of collection and any related anticipated future increases in insurance premiums resulting from such Loss or insurance payment.
 
(b)   No investigation by the Purchaser or Knowledge of the Purchaser of a breach of a representation or warranty of the Company shall affect the representations and warranties of the Company or the recourse available to the Purchaser under any provision of this Agreement (including Article IX ) with respect thereto.
 
(c)   Notwithstanding anything in this Agreement to the contrary, for purposes of application of the indemnification provisions of this Article IX , the amount of any Loss arising from the breach of any representation, warranty, covenant, obligation or agreement contained in this Agreement shall be the entire amount of any Loss actually incurred by the respective Indemnitee as a result of such breach and not just that portion of the Loss that exceeds the relevant level of materiality, if any.
 
 
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(d)   Any indemnification obligation of an Indemnitor under this Article IX will be paid in cash within three (3) Business Days after the determination of such obligation in accordance with Section 9.4.
 
ARTICLE X
 
GENERAL PROVISIONS
 
10.1   Expenses, Taxes, Etc.
 
  Except as otherwise expressly provided in this Agreement, each party will pay all fees and expenses incurred by it in connection with the negotiation, execution, delivery of, and the performance under, the Transaction Documents and the consummation of the transactions contemplated thereby
 
10.2   Notices.
  Any notice, request, instruction or other document to be given hereunder by a party hereto shall be in writing and shall be deemed to have been given, (i) when received if given in person or by courier or a courier service, (ii) on the date of transmission if sent by email (with affirmative confirmation of receipt, and provided, that the party providing notice shall within two (2) Business Days provide notice by another method under this Section 10.2) or (iii) five (5) Business Days after being deposited in the U.S. mail, certified or registered mail, postage prepaid:
 
If to the Company, to:
 
Andy Chan
19925 Stevens Creek Blvd., Ste 100
Cupertino, CA 95014
Email: andy.chan@cellbiomedgroup.com
with a copy (which will not constitute notice) to:
 
Ellenoff Grossman Schole LLP
1345 Avenue of the Americas
New York, NY 10105
Attn: Sarah Williams, Esq
Email: swilliams@egsllp.com
 
If to the Purchaser, to:
 
Novartis Pharma AG
Lichtstrasse 35
CH-4056 Basel, Switzerland
Attn: Global Head M&A & BD&L
Email: nigel.sheail@novartis.com
 
and
 
Novartis Pharmaceuticals Corporation
59 Route 10
East Hanover, New Jersey 07936
Attn: VP General Counsel OncologyEmail: david.tolman@novartis.com
 
and
 
Novartis Pharmaceuticals Corporation
59 Route 10
East Hanover, New Jersey 07936Attn: VP - Global Head Oncology BD&LEmail: syed.kazmi@novartis.com
with a copy (which will not constitute notice) to:
Hogan Lovells US LLP875 Avenue of the AmericasNew York, NY 10022Attn: Adam H. GoldenEmail: adam.golden@hoganlovells.com
 
or to such other individual or address as a party hereto may designate for itself by notice given as herein provided.
 
 
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10.3   Interpretation.
 
The headings and subheadings of this Agreement are for reference and convenience purposes only and in no way modify, interpret or construe the meaning of specific provisions of the Agreement. In this Agreement, unless the context otherwise requires: (i) whenever required by the context, any pronoun used in this Agreement shall include the corresponding masculine, feminine or neuter forms, and the singular form of nouns, pronouns and verbs shall include the plural and vice versa; (ii) reference to any Person includes such Person’s successors and permitted assigns, and reference to a Person in a particular capacity excludes such Person in any other capacity; (iii) any accounting term used and not otherwise defined in this Agreement has the meaning assigned to such term in accordance with GAAP; (iv) “including” (and with correlative meaning “include”) means including without limiting the generality of any description preceding or succeeding such term and shall be deemed in each case to be followed by the words “without limitation”; (v) the words “herein,” “hereto,” and “hereby” and other words of similar import in this Agreement shall be deemed in each case to refer to this Agreement as a whole and not to any particular Section or other subdivision of this Agreement; (vi) the word “if” and other words of similar import when used herein shall be deemed in each case to be followed by the phrase “and only if”; (vii) the term “or” means “and/or”; (viii) reference to any Law means such Law as amended, modified, codified or reenacted, in whole or in part, and in effect from time to time, including rules and regulations promulgated thereunder; (ix) any Law or Order defined or referred to herein or in any agreement or instrument that is referred to herein means such Law or Order as from time to time amended, modified or supplemented, including by succession of comparable successor statutes, regulations, rules or orders; (x) except as otherwise indicated, all references in this Agreement to the words “Section” and “Exhibit” are intended to refer to Sections and Exhibits to this Agreement; and (xi) any reference to this Agreement includes all Exhibits to this Agreement, which are incorporated herein by reference.
 
 
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10.4   Conflict Between Agreements.
 
In the event of any inconsistency, conflict or ambiguity as to the rights and obligations of the parties under this Agreement and the terms of any other Transaction Document, the terms of this Agreement shall control and supersede any such inconsistency, conflict or ambiguity.
 
10.5   Severability.
 
In case any one or more of the provisions contained in this Agreement should be held invalid, illegal or unenforceable in any respect, the validity, legality, and enforceability of the remaining provisions will not in any way be affected or impaired. Any illegal or unenforceable term will be deemed to be void and of no force and effect only to the minimum extent necessary to bring such term within the provisions of applicable Law and such term, as so modified, and the balance of this Agreement will then be fully enforceable. The parties will substitute for any invalid, illegal or unenforceable provision a suitable and equitable provision that carries out, so far as may be valid, legal and enforceable, the intent and purpose of such invalid, illegal or unenforceable provision.
 
10.6   No Third-Party Beneficiaries
 
Except for the indemnification rights of the Purchaser Indemnified Parties and the Company Indemnified Parties set forth herein, this Agreement is for the sole benefit of the parties hereto and their successors and permitted assigns and nothing herein expressed or implied shall give or be construed to give to any Person, other than the parties hereto and such successors and permitted assigns, any legal or equitable rights hereunder.
 
10.7   Assignment
 
This Agreement and the rights hereunder are not assignable (by operation of Law or otherwise) by either party unless such assignment is consented to in writing by the other party, except that Purchaser may assign any or all of its rights, interests and obligations under this Agreement to any Affiliate, and the Company (on its own behalf and on behalf of CBMG Shanghai) shall be deemed to have consented hereto to such assignment.  Subject to the preceding sentence, this Agreement and all the provisions hereof shall be binding upon and shall inure to the benefit of the parties and their respective successors and permitted assigns. Notwithstanding the foregoing, no assignment shall relieve the assigning party of any of its obligations hereunder. Any purported assignment in violation of this Section 10.7 shall be null and void
 
10.8   Amendment; Waiver
 
This Agreement may not be amended or modified except by an instrument in writing signed by each of the parties hereto. Neither the failure nor any delay by any party in exercising any right, power or privilege under this Agreement will operate as a waiver of such right, power or privilege, and single or partial exercise of any such right, power or privilege will preclude any other or further exercise of such right, power or privilege or the exercise of any other right, power or privilege. To the maximum extent permitted by applicable Law, (i) no Action or right arising out of this Agreement can be discharged by one party, in whole or in part, by a waiver or renunciation of the Action or right unless in a writing signed by the party against which such waiver or renunciation is charged; (ii) no waiver that may be given by a party will be applicable except in the specific instance for which it is given; (iii) no extension of time granted by any party for the performance of any obligation or act by any other party will be deemed to be an extension of time for the performance of any other obligation or act hereunder; and (iv) no notice to or demand on one party will be deemed to be a waiver of any obligation of such party or of the right of the party giving such notice or demand to take further action without notice or demand as provided in this Agreement or the documents referred to in this Agreement.
 
10.9   Remedies; Specific Performance
 
. Except as specifically set forth in this Agreement, any party having any rights under any provision of this Agreement will have all rights and remedies set forth in this Agreement and all rights and remedies which such party may have been granted at any time under any other Contract and all of the rights which such party may have under any applicable Law. Notwithstanding the intent of the parties to submit claims to arbitration as set forth in Section 10.12, except as specifically set forth in this Agreement, any such party will be entitled to (a) enforce such rights specifically, without posting a bond or other security, (b) to recover damages by reason of a breach of any provision of this Agreement and (c) to exercise all other rights granted by applicable Law. The exercise of any remedy by a party will not preclude the exercise of any other remedy by such party. In the event of a breach by either party of their respective obligations under this Agreement, the other party, in addition to being entitled to exercise all rights granted by law and under this Agreement, including recovery of damages, shall be entitled to seek specific performance of its rights under this Agreement. Each of the parties further agrees that monetary damages would not provide adequate compensation for any losses incurred by reason of a breach by it of any of the provisions of this Agreement, and hereby further agrees that, in the event of an action for specific performance in respect of such breach, it shall not assert or shall waive the defense that a remedy at law would have been adequate.
 
 
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10.10   Mutual Drafting
 
The parties acknowledge and agree that: (a) this Agreement is the result of negotiations between the parties and will not be deemed or construed as having been drafted by any one party, (b) each party and its counsel have reviewed and negotiated the terms and provisions of this Agreement and the other Transactional Documents and have contributed to their revision, (c) the rule of construction to the effect that any ambiguities are resolved against the drafting party will not be employed in the interpretation of this Agreement, (d) neither the drafting history nor the negotiating history of this Agreement or the other Transactional Documents may be used or referred to in connection with the construction or interpretation thereof, and (e) the terms and provisions of this Agreement will be construed fairly as to all parties hereto and not in favor of or against any party, regardless of which party was generally responsible for the preparation of this Agreement.
 
10.11   Governing Law
 
This Agreement shall be governed by, and construed in accordance with, the laws of the State of New York (without giving effect to its choice of law principles).
 
10.12   Arbitration
 
(a)   Any claim, dispute, or controversy of whatever nature arising among the Parties out of or relating to this Agreement, including any action or claim based on tort, contract, or statute (including any claims of breach or violation of statutory or common law protections from discrimination, harassment and hostile working environment), or concerning the interpretation, effect, termination, validity, performance, or breach of this Agreement (each, an “ Arbitration Claim ”), shall be resolved by final and binding arbitration before a panel of three (3) arbitrators (collectively, the “ Arbitrators ”). One (1) Arbitrator shall be chosen by the Company and one (1) Arbitrator shall be chosen by Purchaser, in each case, within fifteen (15) days from the notice of initiation of arbitration. The third (3 rd ) Arbitrator shall be chosen by mutual agreement of the Arbitrator chosen by the Company and the Arbitrator chosen by Purchaser within fifteen (15) days of the date that the last of such Arbitrators was appointed; provided , that if the third (3 rd ) Arbitrator is not chosen within such fifteen (15)-day period, it shall be chosen by the Administrator. The arbitration shall be administered by the International Chamber of Commerce (the “ Administrator ”) in accordance with its then-existing arbitration rules or procedures regarding commercial or business disputes in force at the time the Arbitration Claim is submitted. The arbitration shall be held in New York, New York, United States of America. The Arbitrators shall be instructed by the Parties to complete the arbitration within ninety (90) days after selection of the third (3 rd ) Arbitrator.
 
(b)   The Arbitrators shall, within fifteen (15) days after the conclusion of the arbitration hearing, issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including any injunctive or equitable relief and the calculation of any damages awarded. The decision or award rendered by the Arbitrators shall be final and non-appealable, and judgment may be entered upon it in accordance with Applicable Law in any court of competent jurisdiction. The Arbitrators shall be authorized to award compensatory damages, but shall not be authorized to reform, modify, or materially change this Agreement or any other agreements contemplated hereunder.
 
 
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(c)   Each Party shall bear its own attorneys’ fees, costs, and disbursements arising out of the arbitration and the costs of the Arbitrator selected by it, and shall pay an equal share of the fees and costs of the third (3 rd ) Arbitrator and the Administrator; provided , however , that the Arbitrators shall be authorized to determine whether a Party is the prevailing Party, and, if so, to award to that prevailing Party reimbursement for its reasonable attorneys’ fees, costs, and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), or the fees and costs of the Administrator and the Arbitrators.
 
(d)   Nothing contained in this Agreement shall deny any Party the right to seek specific performance or injunctive or other equitable relief in accordance with Section 10.9.
 
10.13   Consent to Jurisdiction; Waivers.
 
For purposes of any Action arising out of or in connection with this Agreement or any transaction contemplated hereby, each of the parties hereto (a) irrevocably submits to the exclusive jurisdiction and venue of any state or federal court located within New York County, State of New York, (b) agrees that service of any process, summons, notice or document by U.S. registered mail to such party’s respective address set forth in Section 10.2 shall be effective service of process for any Action with respect to any matters to which it has submitted to jurisdiction in this Section 10.13, and (c) waives and covenants not to assert or plead, by way of motion, as a defense or otherwise, in any such Action, any claim that it is not subject personally to the jurisdiction of such court, that the Action is brought in an inconvenient forum, that the venue of the Action is improper or that this Agreement or the subject matter hereof may not be enforced in or by such court, and hereby agrees not to challenge such jurisdiction or venue by reason of any offsets or counterclaims in any such Action.
 
10.14   WAIVER OF TRIAL BY JURY.
 
THE PARTIES HERETO HEREBY KNOWINGLY, VOLUNTARILY AND INTENTIONALLY WAIVE, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE RIGHT ANY PARTY MAY HAVE TO A TRIAL BY JURY IN RESPECT TO ANY LITIGATION BASED HEREON, OR ARISING OUT OF, UNDER, OR IN CONNECTION WITH THIS AGREEMENT AND ANY AGREEMENT CONTEMPLATED TO BE EXECUTED IN CONNECTION HEREWITH, OR ANY COURSE OF CONDUCT, COURSE OF DEALING, STATEMENTS (WHETHER VERBAL OR WRITTEN) OR ACTIONS OF ANY PARTY IN CONNECTION WITH SUCH AGREEMENTS.
 
10.15   Counterparts.
 
This Agreement may be executed in one or more counterparts, and by the different parties hereto in separate counterparts, each of which when executed shall be deemed to be an original but all of which taken together shall constitute one and the same agreement. A photocopy, faxed, scanned and/or emailed copy of this Agreement or any signature page to this Agreement, shall have the same validity and enforceability as an originally signed copy.
 
10.16   Entire Agreement.
 
This Agreement, together with other Transaction Documents, constitutes the entire agreement among the parties hereto with respect to the subject matter hereof and supersedes all prior agreements and undertakings, both written and oral, with respect to the subject matter hereof.
 
[Remainder of Page Intentionally Left Blank; Signatures Appear on Following Page]
 
                                                                    
 
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed and delivered as of the date first written above.
 
 
the Company :
 
CELLULAR BIOMEDICINE GROUP, INC.
 
 
By:       /s/ Bizuo (Tony) LIU  
Name:  Bizuo (Tony) LIU
Title:    Chief Executive Officer
 
 
CBMG Shanghai (solely for purposes of Article IV) :
 
SHANGHAI CELLULAR
BIOPHARMACEUTICAL GROUP LTD.
( 上海赛比曼生物科技有限公司 )
(company seal)
 
By:       /s/ Bizuo (Tony) LIU
(sign and affix CBMG Shanghai company chop)
Name: Bizuo (Tony) LIU
Title:   Legal Representative
 
 
 

 
 
36
 
 
 
the Purchaser :
 
NOVARTIS PHARMA AG
 
 
 
By:      /s/ Teresa Jose
Name: Teresa Jose
Title:    CFO, Oncology
 
 
 
 
 
By:       /s/ Liz Barrett
Name:  Liz Barrett
Title:    CEO, Novartis Oncology
 
 
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EXHIBIT 1
 
Company Subsidiaries
 
 
                                                                           
 
  EXHIBIT 99.1
 
 
Cellular Biomedicine Group Enters Into Strategic Licensing and Collaboration Agreement with a Global Leader in CAR-T Cell Therapy for Patients in China
 
Collaboration with Novartis includes $40 million equity investment in CBMG for 1,458,257 shares at $27.43/share
CBMG to license select proprietary technology to Novartis for global use
CBMG to manufacture and supply Kymriah® (tisagenlecleucel) in China
 
SHANGHAI and CUPERTINO, Calif., September 27, 2018 (PRNEWSWIRE) –   Cellular Biomedicine Group Inc . (NASDAQ: CBMG) today announced it has entered into a strategic licensing and collaboration agreement with Novartis to manufacture and supply the CAR-T cell therapy Kymriah® ( tisagenlecleucel) in China. Novartis will be the exclusive holder of the marketing license.
 
Upon the closing of the licensing and collaboration agreement, CBMG – a clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases – will receive $40 million in an equity purchase from Novartis at $27.43/share for approximately 9% equity. Novartis will receive certain royalty-free intellectual property worldwide rights to certain CBMG CAR-T related technology. CBMG will receive a single-digit escalating percentage collaboration payment based on net product sales. CBMG will receive a mark-up from Novartis on the manufacturing cost. CBMG will take the lead in the manufacturing process, and Novartis will lead distribution, regulatory and commercialization efforts in China.
 
“This collaboration with Novartis reflects our shared commitment to bringing the first marketed CAR-T cell therapy Kymriah, a transformative treatment option currently approved in the United States, European Union and Canada for two difficult-to-treat cancers, to China where the number of patients in need remains the highest in the world,” said Tony Liu, Chief Executive Officer, CBMG. “Together with Novartis, we hope to bring the first CAR-T cell therapy to patients in China. In addition, we continue to focus on developing CBMG’s pipeline of immuno-oncology assets.”
 
“Novartis is committed to bringing new hope to children and adults who are suffering from aggressive forms of blood cancer and currently have limited therapeutic options. We are proud to collaborate with CBMG in China to expand our Kymriah manufacturing capabilities and the potential to facilitate safe and seamless delivery of this innovative, one-time treatment to patients in need,” said Pascal Touchon, Senior VP and Global Head, Cell & Gene, Novartis Oncology.
 
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. (NASDAQ: CBMG ) develops proprietary cell therapies for the treatment of cancer and degenerative diseases. We conduct immuno-oncology and stem cell clinical trials in China using products from our integrated GMP laboratory. Our GMP facilities in China, consisting of 12 independent cell production lines, are designed and managed according to both China and U.S. GMP standards.  Our Shanghai facility includes a ”Joint Laboratory of Cell Therapy” with GE Healthcare and a “Joint Cell Therapy Technology Innovation and Application Center” with Thermo Fisher Scientific, whose partnerships focus on improving manufacturing processes for cell therapies. The CBMG pipeline includes preclinical compounds targeting CD20-, CD22- and B-cell maturation antigen (BCMA)-specific CAR-T compounds, and T-cell receptor (TCR) and tumor infiltrating lymphocyte (TIL) technologies. A Phase IIb trial in China for Rejoin® autologous Human Adipose-derived Mesenchymal Progenitor Cell (haMPC) for the treatment of Knee Osteoarthritis (KOA) as well as a Phase I trial in China for AlloJoin™ (CBMG’s “Off-the-Shelf” haMPC) for the treatment of KOA are ongoing. CBMG is included in the broad-market Russell 3000® Index and the small-cap Russell 2000® Index, and the Loncar China BioPharma index. To learn more about CBMG, please visit  www.cellbiomedgroup.com .
 
 
 
 
Forward-Looking Statements
 
 
Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts and may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include those regarding our ability to implement our plans, strategies and objectives for future operations, including regulatory approval of our IND applications, our plan to configure part of our Shanghai facility with GE Healthcare’s FlexFactory platform, our ability to execute on our obligations under the terms of our licensing and collaboration arrangement with Novartis, our ability to execute on proposed new products, services or development thereof, results of our clinical research and development, regulatory infrastructure governing cell therapy and cellular biopharmaceuticals, our ability to enter into agreements with any necessary manufacturing, marketing and/or distribution partners for purposes of commercialization, our ability to seek intellectual property rights for our product candidates, competition in the industry in which we operate, overall market conditions, any statements or assumptions underlying any of the foregoing and other risks detailed from time to time in CBMG’s reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. Forward-looking statements may be identified by terms such as “may,” “will,” “expects,” “plans,” “intends,” “estimates,” “potential,” or “continue,” or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law. 
 
 
Kymriah® is a registered trademark of Novartis AG. Please see the full Prescribing Information for Kymriah, including Boxed WARNING and Medication Guide at www.Kymriah.com . Kymriah is approved for certain indications in the United States, the European Union and Canada. 
 
Contact:
Jenn Gordon
Spectrum Science Communications
+1 202-957-7795
jgordon@spectrumscience.com
 
 
 
 
CBMG Press Room                                                                                                                                 www.CellBioMedGroup.com
PR201811