UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-Q

 

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2019

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ___________ to _____________.

 

Commission file number 0-20713

 

CASI PHARMACEUTICALS, INC .

(Exact name of registrant as specified in its charter)

 

Delaware 58-1959440
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)  

 

9620 Medical Center Drive, Suite 300

Rockville, Maryland

(Address of principal executive offices)

 

20850

(Zip code)

 

(240) 864-2600

(Registrant’s telephone number, including area code)

 

(Former name, former address and former fiscal year, if changed since last report)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

 

YES x     NO ¨

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

 

YES x     NO ¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer  ¨   Accelerated filer  þ   Non-accelerated filer ¨  

Smaller reporting company  þ

Emerging growth

company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

Indicate by checkmark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 

YES ¨     NO x

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of exchange on which registered
Common Stock CASI Nasdaq Capital Market

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the most recent practicable date.

 

Class   Outstanding at August 2, 2019
Common Stock $.01 Par Value   95,717,052

 

 

 

 

 

 

CASI PHARMACEUTICALS, INC.

Table of Contents

 

    PAGE
PART I. FINANCIAL INFORMATION  
     
Item 1 -- Consolidated Financial Statements  
     
Unaudited Condensed Consolidated Balance Sheets as of June 30, 2019 and December 31, 2018 4
     
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2019 and 2018 5
     
Unaudited Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2019 and 2018 6
     
Unaudited Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2019 and 2018 7
     
Notes to Unaudited Condensed Consolidated Financial Statements 8
     
Item 2 -- Management’s Discussion and Analysis of Financial Condition and Results of Operations 20
     
Item 3 -- Quantitative and Qualitative Disclosures About Market Risk 26
     
Item 4 -- Controls and Procedures 26
     
Part II.   OTHER INFORMATION  
     
Item 1 -- Legal Proceedings 27
     
Item 1A -- Risk Factors 27
     
Item 2 -- Unregistered Sales of Equity Securities and Use of Proceeds 28
     
Item 3 -- Defaults Upon Senior Securities 28
     
Item 4 -- Mine Safety Disclosures 28
     
Item 5 -- Other Information 28
     
Item 6 -- Exhibits 28
     
EXHIBIT INDEX 29
     
SIGNATURES 30

 

2  

 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This report contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements also may be included in other statements that we make. All statements that are not descriptions of historical facts are forward-looking statements. These statements can generally be identified by the use of forward-looking terminology such as “believes,” “expects,” “intends,” “may,” “will,” “should,” or “anticipates” or similar terminology. These forward-looking statements include, among others, statements regarding the timing of our clinical trials, our cash position and future expenses, and our future revenues.

 

Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including: the difficulty of executing our business strategy in China;  our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the FDA, China National Medical Products Administration, or other regulatory authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; the volatility in the market price of our common stock; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with CID-103, CNCT19, and our product candidates; risks associated with CID-103, CNCT19, and our other early-stage products under development; risks that results in preclinical and early clinical models are not necessarily indicative of later clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our products; and our dependence on third parties. Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition. We caution readers not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission (“SEC”), which are available at www.sec.gov .

 

3  

 

 

PART I. FINANCIAL INFORMATION

 

ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS

 

CASI Pharmaceuticals, Inc.

Unaudited Condensed Consolidated Balance Sheets

 

    June 30, 2019     December 31, 2018  
          (Note 1)  
ASSETS                
Current assets:                
Cash and cash equivalents   $ 70,251,858     $ 84,204,809  
Investment in equity securities, at fair value    

716,658

      912,200  
Inventories     672,697       282,709  
Prepaid expenses and other     8,968,099       7,164,902  
Total current assets    

80,609,312

      92,564,620  
                 
Property and equipment, net     1,335,330       1,750,630  
Intangible assets, net    

18,191,694

      18,784,727  

Long-term investments

   

13,897,760

     

-

 
Other assets     3,056,164       310,024  
Total assets   $

117,090,260

    $ 113,410,001  
                 
LIABILITIES, REDEEMABLE NONCONTROLLING INTEREST AND STOCKHOLDERS' EQUITY                
Current liabilities:                
Accounts payable   $

2,321,499

    $ 968,048  
Accrued liabilities    

2,361,276

      1,406,434  
Note payable, net of discount     1,499,757       1,499,462  
Total current liabilities     6,182,532       3,873,944  
                 
Other liabilities     1,633,261       73,591  
Total liabilities     7,815,793       3,947,535  
                 
Commitments and contingencies (Note 16)                
                 
Redeemable noncontrolling interest, at redemption value (Note 8)     20,236,834       -  
                 
Stockholders' equity:                
Preferred stock, $1.00 par value; 5,000,000 shares authorized and 0 shares issued and outstanding     -       -  
Common stock, $.01 par value: 250,000,000 shares and 170,000,000 shares authorized at June 30, 2019 and December 31, 2018, respectively; 95,796,597 shares and 95,366,813 shares issued at June 30, 2019 and December 31, 2018; 95,717,052 shares and 95,287,268 shares outstanding at June 30, 2019 and December 31, 2018, respectively     957,965       953,667  
Additional paid-in capital     600,569,013       596,710,648  
Treasury stock, at cost:  79,545 shares held at June 30, 2019 and December 31, 2018     (8,034,244 )     (8,034,244 )
Accumulated other comprehensive loss     (2,027,024 )     (1,226,320 )
Accumulated deficit     (502,428,077 )     (478,941,285 )
Total stockholders' equity    

89,037,633

      109,462,466  
Total liabilities, redeemable noncontrolling interest and stockholders' equity   $

117,090,260

    $ 113,410,001  

 

See accompanying condensed notes.

 

4  

 

 

CASI Pharmaceuticals, Inc.

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss

 

    Three Months Ended     Six Months Ended  
    June 30, 2019     June 30, 2018     June 30, 2019     June 30, 2018  
Revenues:                                
   Product sales   $ -     $ -     $ -     $ -  
                                 
Costs and expenses:                                
   Research and development     2,979,228       1,729,470       5,593,885       3,426,703  
   General and administrative     6,982,227       4,042,347       12,691,914       5,345,469  
   Acquired in-process research and development     5,848,886       -       5,848,886       686,998  
      15,810,341       5,771,817       24,134,685       9,459,170  
                                 
Interest income, net     (320,462 )     (13,072 )     (369,046 )     (19,801 )
Foreign exchange gains     (479,540 )     -       (550,649 )     -  
Change in fair value of investment in equity securities     240,931       101,038       195,542       11,325  
Net loss     (15,251,270 )     (5,859,783 )     (23,410,532 )     (9,450,694 )
Less: Income attributable to redeemable noncontrolling interest     61,901       -       76, 260       -  
Net loss attributable to CASI Pharmaceuticals, Inc.     (15,313,171 )     (5,859,783 )     (23,486,792 )     (9,450,694 )
                                 
Net loss per share (basic and diluted)   $ (0.16 )   $ (0.07 )   $ (0.25 )   $ (0.12 )
Weighted average number of common shares outstanding (basic and diluted)     95,717,052       86,029,692       95,683,598       78,663,271  
                                 
Comprehensive loss:                                
Net loss   $ (15,251,270 )   $ (5,859,783 )   $ (23,410,532 )   $ (9,450,694 )
Foreign currency translation adjustment     (1,112,489 )     (1,066,893 )     (800,704 )     (539,642 )
Total comprehensive loss   $ (16,363,759 )   $ (6,926,676 )   $ (24,211,236 )   $ (9,990,336 )
Less: Comprehensive income attributable to redeemable noncontrolling interest     61,901       -       76,260       -  
Comprehensive loss attributable to common stockholders   $ (16,425,660 )   $ (6,926,676 )   $ (24,287,496 )   $ (9,990,336 )

 

5  

 

 

CASI Pharmaceuticals, Inc.

Unaudited Condensed Consolidated Statements of Stockholders’ Equity

 

    Preferred Stock     Common Stock     Treasury     Additional
Paid-in
    Accumulated
Other
Comprehensive
    Accumulated        
    Shares     Amount     Shares     Amount     Stock     Capital     Loss     Deficit     Total  
Balance at March 31, 2019     -     $ -       95,717,052     $ 957,965     $ (8,034,244 )   $ 599,301,966     $ (914,535 )   $ (487,114,906 )   $ 104,196,246  
Accretion of redeemable noncontrolling interest     -       -       -       -       -       (158,016 )     -       -       (158,016 )
Stock issuance costs     -       -       -       -       -       (1,499 )     -       -       (1,499 )
Stock-based compensation expense, net of forfeitures     -       -       -       -       -       1,426,562       -       -       1,426,562  
Foreign currency translation adjustment     -       -       -       -       -       -       (1,112,489 )     -       (1,112,489 )
Net loss attributable to CASI Pharmaceuticals, Inc.     -       -       -       -       -       -       -       (15,313,171 )     (15,313,171 )
                                                                         
Balance at June 30, 2019     -     $ -       95,717,052     $ 957,965     $ (8,034,244 )   $ 600,569,013     $ (2,027,024 )   $ (502,428,077 )   $ 89,037,633  

 

    Preferred Stock     Common Stock     Treasury     Additional
Paid-in
    Accumulated
Other
Comprehensive
    Accumulated        
    Shares     Amount     Shares     Amount     Stock     Capital     Loss     Deficit     Total  
Balance at December 31, 2018     -     $ -       95,287,268     $ 953,667     $ (8,034,244 )   $ 596,710,648     $ (1,226,320 )   $ (478,941,285 )   $ 109,462,466  
Accretion of redeemable noncontrolling interest     -       -       -       -       -       (160,574 )     -       -       (160,574 )
Issuance of common stock for options exercised     -       -       18,262       183       -       38,119       -       -       38,302  
Repurchase of stock options to satisfy tax withholding obligations     -       -       -       -       -       (11,749 )     -       -       (11,749 )
Issuance of common stock from exercise of warrants     -       -       411,522       4,115       -       691,357       -       -       695,472  
Stock issuance costs     -       -       -       -       -       (8,196 )     -       -       (8,196 )
Stock-based compensation expense, net of forfeitures     -       -       -       -       -       3,309,408       -       -       3,309,408  
Foreign currency translation adjustment     -       -       -       -       -       -       (800,704 )     -       (800,704 )
Net loss attributable to CASI Pharmaceuticals, Inc.     -       -       -       -       -       -       -       (23,486,792 )     (23,486,792 )
                                                                         
Balance at June 30, 2019     -     $ -       95,717,052     $ 957,965     $ (8,034,244 )   $ 600,569,013     $ (2,027,024 )   $ (502,428,077 )   $ 89,037,633  

 

    Preferred Stock     Common Stock     Treasury     Additional
Paid-in
    Common Stock     Accumulated
Other
Comprehensive
    Accumulated        
    Shares     Amount     Shares     Amount     Stock     Capital     to Be Issued     Loss     Deficit     Total  
Balance at March 31, 2018     -     $       -       79,641,876     $ 797,214     $ (8,034,244 )   $ 529,389,427     $ -     $ 527,251     $ (455,060,628 )   $ 67,619,020  
Issuance of common stock and warrants pursuant to financing agreements     -       -       6,388,887       63,888       -       20,636,111       -       -       -       20,699,999  
Issuance of common stock for options exercised     -       -       49,869       499       -       78,312       -       -       -       78,811  
Repurchase of stock options to satisfy tax withholding obligations     -       -       -       -       -       (54,284 )     -       -       -       (54,284 )
Issuance of common stock from exercise of warrants     -       -       428,855       4,289       -       925,729       -       -       -       930,018  
Common stock to be issued     -       -       -       -       -       -       56,858       -       -       56,858  
Stock issuance costs     -       -       -       -       -       (433,781 )     -       -       -       (433,781 )
Stock-based compensation expense, net of forfeitures     -       -       -       -       -       1,552,179       -       -       -       1,552,179  
Foreign currency translation adjustment     -       -       -       -       -       -       -       (1,066,893 )     -       (1,066,893 )
Net loss attributable to CASI Pharmaceuticals, Inc.     -       -       -       -       -       -       -       -       (5,859,783 )     (5,859,783 )
                                                                                 
Balance at June 30, 2018           $ -       86,509,487     $ 865,890     $ (8,034,244 )   $ 552,093,693     $ 56,858     $ (539,642 )   $ (460,920,411 )   $ 83,522,144  

 

    Preferred Stock     Common Stock     Treasury     Additional
Paid-in
    Common Stock     Accumulated
Other
Comprehensive
    Accumulated        
    Shares     Amount     Shares     Amount     Stock     Capital     to Be Issued     Loss     Deficit     Total  
Balance at December 31, 2017     -     $ -       69,822,080     $ 699,015     $ (8,034,244 )   $ 498,577,372     $ -     $ -     $ (452,702,029 )   $ 38,540,114  
Correction of immaterial error in prior year and cumulative effect adjustment due to the adoption of ASU 2016-01        -         -       -       -       -       -       -       -       1,232,312       1,232,312  
Issuance of common stock and warrants pursuant to financing agreements     -       -       15,575,339       155,753       -       50,334,463       -       -       -       50,490,216  
Issuance of common stock for options exercised     -       -       107,083       1,071       -       175,762       -       -       -       176,833  
Repurchase of stock options to satisfy tax withholding obligations     -       -       -       -       -       (54,284 )     -       -       -       (54,284 )
Issuance of common stock from exercise of warrants     -       -       1,004,985       10,051       -       1,893,627       -       -       -       1,903,678  
Common stock to be issued     -       -       -       -       -       -       56,858       -       -       56,858  
Stock issuance costs     -       -       -       -       -       (645,466 )     -       -       -       (645,466 )
Stock-based compensation expense, net of forfeitures     -       -       -       -       -       1,812,219       -       -       -       1,812,219  
Foreign currency translation adjustment     -       -       -       -       -       -       -       (539,642 )     -       (539,642 )
Net loss attributable to CASI Pharmaceuticals, Inc.     -       -       -       -       -       -       -       -       (9,450,694 )     (9,450,694 )
                                                                                 
Balance at June 30, 2018     -     $ -       86,509,487     $ 865,890     $ (8,034,244 )   $ 552,093,693     $ 56,858     $ (539,642 )   $ (460,920,411 )   $ 83,522,144  

 

See accompanying condensed notes.

 

6  

 

 

CASI Pharmaceuticals, Inc.

Unaudited Condensed Consolidated Statements of Cash Flows

 

    Six Months Ended  
    June 30, 2019     June 30, 2018  
CASH FLOWS FROM OPERATING ACTIVITIES                
Net loss   $ (23,410,532 )   $ (9,450,694 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization for property and equipment     624,014       141,717  

Loss on disposal of property and equipment

    1,136       -  
Amortization of intangible assets     775,305       597,354  

Loss on disposal of intangible assets
    48,391       -  
Stock-based compensation expense     3,309,408       1,812,219  
Acquired in-process research and development     5,848,886       552,863  
Change in fair value of investment in equity securities     195,542       11,325  
Non-cash interest     295       354  
Changes in operating assets and liabilities:                
Inventory     (389,988 )     (429,973 )
Prepaid expenses and other assets     (1,996,089 )     (221,861 )
Accounts payable    

1,357,330

      4,312  
Payable to related party     -       (2,228,366 )
Accrued liabilities and other liabilities     (40,287 )     (134,695 )
Net cash used in operating activities     (13,676,589 )     (9,345,445 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES                
Proceeds from sale of furniture and equipment     29       -  
Purchases of property and equipment     (331,437 )     (726,445 )
Cash paid for acquired in-process research and development     (5,848,886 )     -  
Cash paid to acquire equity securities in Black Belt Tx Limited     (2,249,600 )     -  
Cash paid to acquire equity securities in Juventas Cell Therapy Ltd     (11,788,400 )     -  
Acquisition of abbreviated new drug applications and related items     -       (18,607,848 )
Net cash used in investing activities     (20,218,294 )     (19,334,293 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES                
Stock issuance costs     (8,196 )     (645,466 )
Proceeds from sale of common stock and warrants     -       50,490,216  
Cash contribution from redeemable noncontrolling interest     20,000,000       -  
Proceeds from exercise of stock options     38,302       176,833  
Repurchase of stock options to satisfy tax withholding obligations     (11,749 )     (54,284 )
Proceeds from exercise of warrants     695,472       1,960,536  
Net cash provided by financing activities     20,713,829       51,927,835  
                 
Effect of exchange rate changes on cash and cash equivalents     (771,897 )     (522,354 )
Net increase (decrease) in cash and cash equivalents     (13,952,951 )     22,725,743  
                 
Cash and cash equivalents at beginning of period     84,204,809       43,489,935  
Cash and cash equivalents at end of period   $ 70,251,858     $ 66,215,678  
                 
Supplemental disclosure of cash flow information:                
Interest paid   $ -     $ -  
Income taxes paid   $ -     $ -  

 

See accompanying condensed notes.

 

7  

 

 

CASI Pharmaceuticals, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

  

1.            Basis of Presentation

 

CASI Pharmaceuticals, Inc. (“CASI” or the “Company”) (Nasdaq: CASI) is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, U.S., and throughout the world. The Company is focused on acquiring, licensing, developing and commercializing products in hematology oncology as well as other therapeutic areas of unmet medical need. The Company intends to execute its plan to become a leading platform to launch medicines in the greater China market leveraging its China-based regulatory and commercial competencies and its global drug development expertise.

 

The Company’s China operations are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (Beijing) Co., Ltd. (“CASI China”), which is based in Beijing, China. CASI China has established China operations that are growing as the Company continues to further in-license or acquire products for its pipeline.

 

The accompanying condensed consolidated financial statements include the accounts of the Company and its subsidiaries, in which CASI, directly or indirectly, has a controlling financial interest. These subsidiaries include Miikana Therapeutics, Inc. (“Miikana”), CASI China, CASI Pharmaceuticals (Wuxi) Co., Ltd. (“CASI Wuxi”), and CASI Biopharmaceuticals (WUXI) Co., Ltd. (“CASI Biopharmaceuticals”). CASI China is a non-stock Chinese entity with 100% of its interest owned by CASI. CASI China received approval for a business license from the Beijing Industry and Commercial Administration in August 2012 and has operating facilities in Beijing. CASI Wuxi was established on December 26, 2018 in China to develop a manufacturing capability in China in 2019. CASI Biopharmaceuticals is a wholly owned subsidiary of CASI Wuxi and was established in April 2019. The Company controls CASI Wuxi through 80% voting rights (see Note 8). Accordingly, the financial statements of CASI Wuxi have been consolidated in the Company’s consolidated financial statements since its inception. All inter-company balances and transactions have been eliminated in consolidation. The Company currently operates in one operating segment, which is the development of innovative therapeutics addressing cancer and other unmet medical needs for the global market.

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, such condensed consolidated financial statements do not include all of the information and disclosures required by U.S. generally accepted accounting principles for complete consolidated financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. The accompanying December 31, 2018 financial information was derived from the Company’s audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018. Operating results for the three and six month periods ended June 30, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019 or any other future period. For further information, refer to the Company’s audited consolidated financial statements and footnotes thereto included in its Form 10-K for the year ended December 31, 2018.

 

Certain line items in the prior-year unaudited condensed consolidated statement of cash flows relating to the acquired in-process research and development and inventory have been reclassified to conform to the December 31, 2018 presentation resulting in an increase in net cash used in operating activities and a decrease in net cash used in investing activities by $564,000 for the six months ended June 30, 2018. Inventory in the amount of $282,709 as of December 31, 2018, which was included in prepaid expenses and other, has been separately presented on the condensed consolidated balance sheet as of December 31, 2018.

 

Liquidity Risks and Management’s Plans

 

Since inception, the Company has incurred significant losses from operations and has incurred an accumulated deficit of $502.4 million.   The Company expects to continue to incur operating losses for the foreseeable future due to, among other factors, its continuing clinical and development activities.

  

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Taking into consideration the cash balance as of June 30, 2019, the Company believes that it has sufficient resources to fund its operations at least through August 9, 2020. As of June 30, 2019, approximately $8.7 million of the Company’s cash balance was held by CASI China, and approximately $29.0 million was held by CASI Wuxi. The Company intends to continue to exercise tight controls over operating expenditures and will continue to pursue opportunities, as required, to raise additional capital and will also actively pursue non- or less-dilutive capital raising arrangements in China to support the Company’s dual-country approach to drug development.

 

2.            New License and Investment Agreements

 

Black Belt Therapeutics Limited:

 

In April 2019, the Company entered into a license agreement with Black Belt Therapeutics Limited  (“Black Belt”) for exclusive worldwide rights to the investigational anti-CD38 monoclonal antibody (Mab) TSK011010. TSK011010 is at the IND/IMPD submission stage of development, with Phase 1 trials targeted to start in early 2020. CASI is responsible for all development and commercialization activities of the TSK011010. Under the terms of the agreement, CASI obtained global rights to TSK011010 for an upfront payment of 5 million euros ($5,657,500) as well as certain milestone and royalty payments. Because TSK011010 underlying the acquired rights has not reached technological feasibility and have no alternative uses, the Company expensed 5 million euros as acquired in-process research and development in the accompanying condensed consolidated statement of operations and comprehensive loss.

 

The Company also invested 2 million euros ($2,249,600), representing 15% shareholding, as an equity investment in Black Belt TX Ltd, a newly established company of Black Belt focusing on novel immuno-oncology targets (see Note 4).

   

Juventas Cell Therapy:

 

Juventas Cell Therapy Ltd. (“Juventas”) is a China-based domestic company located in Tianjin City, China engaged in cell therapy. The company’s lead product, CNCT19, devolved from the CD19 CAR-T, is used to treat cancer patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma. Through its commercial collaboration with CASI, Juventas targets to be the first domestic company to launch a CD19 CAR-T in China.

 

In June 2019, the Company entered into a license agreement for exclusive worldwide license and commercialization rights to an autologous anti-CD19 T-cell therapy product (CNCT19) from Juventas. Juventas will continue to develop CNCT19 with CASI’s participation on the steering committee. CASI will be responsible for payment of certain future development milestones and sales royalties. All contingent payments will be recognized when the subsequent milestones are probable to be met.

 

CASI Biopharmaceuticals also invested RMB 80 million (approximately $11.6 million), representing 16.3% shareholding, as an equity investment in Juventas  (see Note 4) .

 

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3.            New Accounting Pronouncements

 

Recently Adopted Pronouncements

 

Effective January 1, 2019, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2016-02, Leases (“Topic 842”). The guidance amends the accounting requirements for leases and requires lessees to recognize assets and liabilities related to long-term leases on the balance sheets and expands disclosure requirements regarding leasing arrangements. The guidance is effective for reporting periods beginning after December 15, 2018 and early adoption is permitted. The guidance must be adopted on a modified retrospective basis and provides for certain practical expedients. The Company adopted this guidance effective January 1, 2019 using the following practical expedients:

 

· the Company did not reassess if any expired or existing contracts are or contain leases
· the Company did not reassess the classification of any expired or existing leases.

 

Additionally, the Company made ongoing accounting policy elections whereby it (i) does not recognize Right-of-use (“ROU”) assets or lease liabilities for short-term leases (those with original terms of 12-months or less) and (ii) combines lease and non-lease components for facilities leases, which primarily relate to ancillary expenses such as common area maintenance charges and management fees of operating leases.

 

Upon adoption of the new guidance on January 1, 2019, the Company recorded right of use assets of approximately $3.0 million and recognized lease liabilities of approximately $3.2 million; there was no cumulative effect impact to accumulated deficit as of January 1, 2019. No adjustments were made to prior comparative periods.

 

In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. The new guidance requires a customer in a cloud computing arrangement (i.e., hosting arrangement) that is a service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to capitalize as assets or expense as incurred. Capitalized implementation costs related to a hosting arrangement that is a service contract will be amortized over the term of the hosting arrangement, beginning when the module or component of the hosting arrangement is ready for its intended use. The update is effective for calendar-year public business entities in 2020. For all other calendar-year entities, it is effective for annual periods beginning in 2021 and interim periods in 2022. Early adoption is permitted. The Company early adopted this guidance effective January 1, 2019. The net impact to the financial statements was approximately $140,000 of capitalized cost.

 

There are no other recently issued accounting pronouncements that are expected to have a material effect on the Company's financial position, results of operations or cash flows.

 

4.            Investment in Equity Securities, at fair value and long-term investments

 

The Company has an equity investment in the common stock of a publicly traded company. The fair value of this security was measured using its quoted market price, a Level 1 input as of June 30, 2019 and December 31, 2018 (see Note 13). The following table summarizes the Company’s investment as of June 30, 2019:

Description   Classification   Cost     Gross
unrealized
gains
    Aggregate fair
value
 
Common stock   Investment   $ -     $ 716,658     $ 716,658  

 

Unrealized losses on the Company’s equity investment for the six months ended June 30, 2019 and 2018 were $195,542 and $11,325, respectively, and are recognized as change in fair value of investment in equity securities in the accompanying condensed consolidated statements of operations and comprehensive loss.

 

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In April 2019, in conjunction with its license agreement entered into with Black Belt, the Company made a 2 million euro ($2,249,600) equity investment in a newly established, privately held UK Company (see Note 2).

 

In June 2019, in conjunction with its license agreement entered into with Juventas, a subsidiary of the Company made an RMB 80 million ($11,648,160) equity investment in Juventas, a privately held, China-based company (see Note 2).

 

As the Company does not have significant influence over operating and financial policies of Black Belt TX Ltd and Juventas , and the equity interests do not have readily determinable fair value, the investments in Black Belt TX Ltd and Juventas are stated at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment. The Company did not record any adjustments or impairments during the quarter ended June 30, 2019.

 

5.            Inventories

 

Inventories consist of EVOMELA finished goods and raw materials to be used in production of ANDAs and are stated at the lower of cost or net realizable value. Cost is determined using a first-in, first-out method.

 

The carrying value of finished goods inventory was approximately $490,000 and raw materials was approximately $180,000 as of June 30, 2019 and the carry value of raw materials was approximately $280,000 as of December 31, 2018, which are included in “Inventories” in the accompanying condensed consolidated balance sheets.

 

6.            Leases

 

As discussed in Note 3, effective January 1, 2019, the Company adopted Topic 842. At the inception of a contract, the Company determines if the arrangement is, or contains, a lease. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Rent expense is recognized on a straight-line basis over the lease term.

 

The Company has made certain accounting policy elections whereby it (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12-months or less) and (ii) combines lease and non-lease components for facilities leases, which primarily relate to ancillary expenses such as common area maintenance charges and management fees of its operating leases. Operating lease ROU assets are included in other assets (noncurrent) and operating lease liabilities (see below) are included in accrued liabilities and other liabilities (noncurrent) in the condensed consolidated balance sheets as of June 30, 2019. As of June 30, 2019, the Company did not have any finance leases.

 

All of the Company’s existing leases as of June 30, 2019 are classified as operating leases. As of June 30, 2019, the Company has four material operating leases for facilities and office equipment with remaining terms expiring from 2021 through 2022 and a weighted average remaining lease term of 2.49 years. The Company has fair value renewal options for many of the Company’s existing leases, none of which have considered reasonably certain of being exercised or included in the minimum lease term. Discount rates used in the calculation of the lease liability is 5.4%. The discount rates reflect the estimated incremental borrowing rate, which includes an assessment of the credit rating to determine the rate that the Company would have to pay to borrow, on a collateralized basis for a similar term, an amount equal to the lease payments in a similar economic environment.

 

Rent expense for the six months ended June 30, 2019 consisted of approximately $611,000 of total operating lease cost. There was no variable lease costs or sublease income for the six months ended June 30, 2019.

 

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The impact of Topic 842 on the June 30, 2019 condensed consolidated balance sheet was as follows:

 

    June 30, 2019  
Other assets   $ 2,716,440  
         
Accrued liabilities   1,147,039  
Other liabilities     1,633,261  
Total lease liabilities   $ 2,780,300  

 

Supplemental cash flow information related to leases was as follows:

 

    Six Month
Period ended
 
    June 30, 2019  
Cash paid for amounts included in the measurement of lease liabilities:        
Operating cash flows   $ 610,904  
         
Right of use assets obtained in exchange for lease obligations:   $ 2,716,440  

 

A maturity analysis of our operating leases as of June 30, 2019 follows:

 

Future undiscounted cash flows:

 

2019 (remaining six months)   $ 653,517  
2020     1,337,379  
2021     892,337  
2022     190,419  
Thereafter     -  
Total     3,073,652  
         
Discount factor     (293,352 )
Lease liability     2,780,300  
Amounts due within 12 months
    1,147,039  
Non-current lease liability   $ 1,633,261  

 

In 2018 the Company entered into a lease on behalf of CASI Wuxi. As of June 30, 2019, the underlying asset of the lease has not been made available for use by the Company. The minimum lease payments for this lease, totaling approximately $3,789,000, beginning in November 2019 and expiring in 2024, are not included in the above table.

 

As previously disclosed in the consolidated financial statements for the year ended December 31, 2018 and under the previous lease standard (Topic 840), future minimum annual lease payments for the years subsequent to December 31, 2018 and in aggregate are as follows:

 

2019   $ 1,311,707  
2020     1,297,102  
2021     856,832  
2022     129,918  
Thereafter     -  
Total minimum payments   $ 3,595,559  

 

Rental expense for the year ended December 31, 2018 was approximately $916,000.

 

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7.            Intangible Assets

 

Intangible assets include ANDAs that were acquired as part of 2018 asset acquisitions and include for previously marketed generic products and capitalized cost related to a cloud computing arrangement (CCA). These intangible assets were originally recorded at relative estimated fair values based on the purchase price for the asset acquisitions and are stated net of accumulated amortization.

 

The ANDAs are being amortized over their estimated useful lives of 13 years, using the straight-line method. Management reviews finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable, in a manner similar to that for property and equipment. Loss on disposal of $48,391 related to the withdraw al of ANDAs was recognized in the three months ended March 31, 2019 and classified as research and development expenses. The cloud computing arrangement is being amortized over its useful life of 5 years.

 

Net definite-lived intangible assets at June 30, 2019, excluding the withdrawn ANDAs discussed above consists of the following:

 

Asset   Gross Value     Accumulated Amortization     Estimated useful lives
ANDAs   $

 18,160,527

    $ (1,963,578 )   13 years
TDF ANDA  

1,972,815

    (105,563 )   13 years
CCA   141,659     (14,166 )   5 years
Total   $

20,275,001

    $ (2,083,307 )    

  

Expected future amortization expense is as follows as of June 30, 2019:

 

2019 (remaining six months)   $

788,346

 
2020    

1,576,692

 
2021    

1,576,692

 
2022    

1,576,692

 
2023    

1,576,692

 
2024 and thereafter    

11,096,580

 

  

8.            Redeemable Noncontrolling Interest

 

As discussed in Note 1, on December 26, 2018 , the Company, together with Wuxi Jintou Huicun Investment Enterprise, a limited partnership organized under Chinese law (“Wuxi LP”) established CASI Wuxi to build and operate a manufacturing facility in the Wuxi Huishan Economic Development Zone in Jiangsu Province, China. The Company holds 80% of the equity interests in CASI Wuxi and will invest, over time, $80 million in CASI Wuxi. The Company’s investment will consist of (i) $21 million in cash (paid in February 2019), (ii) a transfer of selected ANDAs valued at $30 million (transferred in May 2019), and (iii) an additional $29 million cash payment within three years from the date of establishment of CASI Wuxi. Wuxi LP holds 20% of the equity interest in CASI Wuxi through its investment in RMB of $20 million in cash (paid in March 2019). As the transfer of ANDAs valued at $30 million was to the Company’s consolidated subsidiary (CASI Wuxi), the Company recognized the transfer of the ANDAs at their carrying value and did not recognize a gain on the transfer.

 

Pursuant to the investment contract between the Company and Wuxi LP and Articles of Association of CASI Wuxi, the Company has the call option to purchase the 20% equity interest in CASI Wuxi held by Wuxi LP at any time within 5 years from the date of establishment of CASI Wuxi (i.e. up to December 26, 2023). Wuxi LP has the put option to require the Company to redeem the 20% equity interest in CASI Wuxi at any time after December 26, 2023. The redemption value under both the Company’s embedded put option and Wuxi LP’s embedded call option is equal to $20 million plus interest at the bank loan interest rate issued by the People's Bank of China for the period beginning with the initial capital contribution by Wuxi LP to the date of redemption. In addition, Wuxi LP has the put option to require the Company to redeem the 20% equity interest in CASI Wuxi at $20 million upon the occurrence of any of the following conditions: (i) the Company fails to fulfill its investment obligation to CASI Wuxi; (ii) CASI Wuxi suffers serious losses, discontinued operation, dissolution, goes into process of bankruptcy liquidation; or (iii) the Company substantially violates the investment contract and Articles of Association of CASI Wuxi.

 

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The investment of Wuxi LP in CASI Wuxi is treated as redeemable noncontrolling interest and is classified outside of permanent equity on the consolidated balance sheets because (1) the noncontrolling interest is not mandatorily redeemable financial instruments, and (2) it is redeemable at the option of the holder, or upon the occurrence of an event that is not solely within the control of the Company. The Company initially recorded the redeemable noncontrolling interest at its fair value of $20 million. The carrying amount of the redeemable noncontrolling interest is subsequently recorded at the greater of the amount of (1) the initial carrying amount, increased or decreased for the redeemable noncontrolling interest’s share of net income or loss in CASI Wuxi or (2) the redemption value, assuming the noncontrolling interest is redeemable at the balance sheet date. Accretion of the carrying amount of redeemable noncontrolling interests to the redemption value is recorded in additional paid-in capital.

 

Changes in redeemable noncontrolling interest during the three and six month periods ended June 30, 2019 are as follows:

 

      Three month period       Six month period  
Balance at beginning of period   $ 20,016,917     $ -  
Cash contribution by Wuxi LP     -       20,000,000  
Share of CASI Wuxi net income     61,901       76,260  
Accretion of redeemable noncontrolling interest     158,016       160,574  
Balance as of June 30, 2019   $ 20,236,834     $ 20,236,834  

 

9.           Stockholders’ Equity

 

Stock purchase warrants activity for the six months ended June 30, 2019 is as follows:

  

        Number of
Warrants
      Weighted Average
Exercise Price
 
Outstanding at January 1, 2019     11,781,825     $ 3.98  
   Issued     -     $ -  
   Exercised     (411,522 )   $ 1.69  
   Expired     -     $ -  
Outstanding at June 30, 2019     11,370,303     $ 4.06  
Exercisable at June 30, 2019     11,370,303     $ 4.06  

 

All outstanding warrants are equity classified.

 

10.         Net Loss Per Share

 

Net loss per share (basic and diluted) was computed by dividing net loss attributable to common stockholders, considering the accretions to redemption value of the redeemable noncontrolling interest, by the weighted average number of shares of common stock outstanding. Outstanding stock options and warrants totaling 29,900,340 and 28,476,069 as of June 30, 2019 and 2018, respectively, were anti-dilutive and, therefore, were not included in the computation of weighted average shares used in computing diluted loss per share.

 

11.         Stock-Based Compensation

 

In June 2019, the Company’s stockholders approved an amendment to the 2011 Long-Term Incentive Plan, increasing the number of shares of common stock reserved for issuance from 20,230,000 to 25,230,000 to be available for grants and awards.

 

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As of June 30, 2019, a total of 11,708,053 shares remained available for grant under the Company’s 2011 Long-Term Incentive Plan.

 

The Company’s net loss for the six months ended June 30, 2019 and 2018 includes $3,309,408 and $1,812,219, respectively, of non-cash compensation expense related to the Company’s share-based compensation awards. The compensation expense related to the Company’s share-based compensation arrangements is recorded as components of general and administrative expense and research and development expense, as follows:

 

    Six Month Period ended June 30,  
    2019     2018  
Research and development   $ 263,570     $ 162,516  
General and administrative     3,045,838       1,649,703  
Share-based compensation expense   $ 3,309,408     $ 1,812,219  

 

Compensation expense related to stock options is recognized over the requisite service period, which is generally the option vesting term of up to five years. Awards with performance conditions are expensed when it is probable that the performance condition will be achieved. For the six months ended June 30, 2019, approximately $42,800 was expensed for share awards with performance conditions that became probable during that period. For the six months ended June 30, 2018, approximately $15,500 was expensed for share awards with performance conditions that became probable during that period.

 

The Company uses the Black-Scholes-Merton valuation model to estimate the fair value of service based and performance-based stock options granted to employees. Option valuation models, including Black-Scholes-Merton, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. These assumptions include the risk- free rate of interest, expected dividend yield, expected volatility, and the expected life of the award. Following are the weighted-average assumptions used in valuing the stock options granted to employees during the six-month periods ended June 30, 2019 and 2018:

 

    Six Month Period ended June 30,  
    2019     2018  
Expected volatility     77.43 %     78.97 %
Risk free interest rate     1.88 %     2.79 %
Expected term of option     6.04 years       5 .65 years  
Expected dividend yield     0.00 %     0.00 %

  

The weighted average fair value of stock options granted during the six-month periods ended June 30, 2019 and 2018 were $2.20 and $4.53, respectively.

 

A summary of the Company's stock option plans and of changes in options outstanding under the plans during the six-month period ended June 30, 2019 is as follows:

 

    Number of
Options
    Weighted
Average
Exercise
Price
 
Outstanding at January 1, 2019     18,429,308     $ 2.44  
   Exercised     (21,362 )   $ 1.79  
   Granted     5,424,808     $ 2.99  
   Expired     (4,090 )   $ 1.87  
   Forfeited     (1,298,627 )   $ 1.02  
   Cancelled     (4,000,000 )   $ 3.22  
Outstanding at June 30, 2019     18,530,037     $ 2.54  
Exercisable at June 30, 2019     11,135,336     $ 1.81  

 

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Cash received from option exercises under all share-based payment arrangements for the six months ended June 30, 2019 and 2018 was $38,302 and $176,833, respectively.

 

During the quarter ended June 30, 2019, the 4 million shares of a performance-based option award to the Company’s Chairman and CEO was cancelled, which was accompanied by a concurrent grant of replacement award. The replacement grant of stock options was approved by the Company’s stockholders at the 2019 Annual Meeting on June 20, 2019. Under the terms of the grant, he received a stock option covering 4 million shares of common stock, at an exercise price of $2.85, vesting at the earlier of (i) the completion of a transformative event by the Company as determined in the discretion of the Compensation Committee and (ii) the second anniversary of the date of his appointment as CEO on April 2, 2019.

 

12.         Income Taxes

 

At December 31, 2018, the Company had a $3.0 million unrecognized tax benefit. The Company recorded a full valuation allowance on the net deferred tax asset recognized in the consolidated financial statements as of December 31, 2018.

 

During the six months ended June 30, 2019, there were no material changes to the measurement of unrecognized tax benefits in various taxing jurisdictions. The Company recognizes interest and penalties related to uncertain tax positions as a component of income tax expense.

 

The tax returns for all years in the Company’s major tax jurisdictions are not settled as of June 30, 2019. Due to the existence of tax attribute carryforwards (which are currently offset by a full valuation allowance), the Company treats all years’ tax positions as unsettled due to the taxing authorities’ ability to modify these attributes.

 

13.         Fair Value Measurements

 

The majority of the Company’s financial instruments (consisting principally of cash and cash equivalents, accounts payable and accrued liabilities) are carried at cost which approximates their fair values due to the short-term nature of the instruments. The Company’s investment in equity securities is carried at fair value (see Note 4). The Company’s note payable is carried at amortized cost which approximates fair value due to its classification as a short-term note payable.

 

Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework which prioritizes and ranks the level of observability of inputs used in measuring fair value. These tiers include: 

  

  · Level 1—Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

 

  · Level 2—Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities. 

 

  · Level 3—Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.

 

Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis  

 

The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the hierarchy.

 

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The Company has an equity investment in the common stock of publicly traded company. The Company’s investment in this equity security is carried at its estimated fair value, with changes in fair value reported in the consolidated statement of operations and comprehensive loss each reporting period (see Note 4). The fair value of the common stock is based on quoted market price for the investee’s common stock, a Level 1 input.

 

The following tables presents the Company’s financial assets and liabilities accounted for at fair value on a recurring basis as of June 30, 2019 and December 31, 2018, by level within the fair value hierarchy:

 

Description   Fair Value at
June 30, 2019
    Level 1     Level 2     Level 3  
Investment in common stock   $ 716,658     $ 716,658     $ -     $ -  
                                 
Description   Fair Value at
December 31, 2018
    Level 1     Level 2     Level 3  
Investment in common stock   $ 912,200     $ 912,200     $ -     $ -  

 

Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis  

 

The Company has no financial assets and liabilities that are measured at fair value on a non-recurring basis.

 

Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis

 

The Company has no non-financial assets and liabilities that are measured at fair value on a recurring basis.

 

Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis

 

The Company has no non-financial assets and liabilities that are measured at fair value on a non-recurring basis.

 

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14.          Related Party Transactions

 

In June 2019, CASI Pharmaceuticals, Inc. entered into a license agreement for exclusive worldwide license and commercialization rights to CNCT19 from Juventas (see Note 2). Transactions with Juventas are considered to be related party transactions as t he Company’s CEO and Chairman is the chairman and one of the founding shareholders of Juventas. A committee of independent directors of CASI negotiated the terms of the investment and license agreements and recommended that the board of directors approve the transaction. The Company’s CEO did not participate in the committee’s deliberations or the board of directors’ approval of the transaction.

 

There were no other material transactions entered into with Juventas during the six months ended June 30, 2019 and 2018.

 

The Company has supply agreements with Spectrum Pharmaceuticals, Inc. (“Spectrum”) for the purchase of EVOMELA, ZEVALIN, and MARQIBO in China for quality testing purposes to support CASI’s application for import drug registration and for commercialization purposes. The former CEO of Spectrum is also a member of CASI’s Board, and Spectrum is a greater than 10% shareholder of the Company.

 

In 2018, the Company entered into commercial purchase obligation commitments for EVOMELA from Spectrum totaling approximately $9.2 million. As of June 30, 2019, the Company paid $7.625 million as a deposit for these commitments to purchase of EVOMELA. The Company received the first shipment of EVOMELA of approximately $480,000 in June 2019. The Company has also incurred estimated expenses of approximately $263,000 related to other material costs associated with EVOMELA. There were no other materials purchased from Spectrum during the six months ended June 30, 2019 or 2018.

 

The advance payments made to Spectrum are included in the prepaid expenses and other in the accompanying condensed consolidated balance sheets, of which $7.625 million was recorded as of June 30, 2019 and $4.6 million recorded as of December 31, 2018. As of June 30, 2019, and December 31, 2018, the Company included accrued expenses payable to Spectrum of $743,000 and $0 respectively in the accompanying condensed consolidated balance sheets.

 

15.          Acrotech License Arrangements

 

The Company has certain product rights and perpetual exclusive licenses from Acrotech to develop and commercialize the following commercial oncology drugs and drug candidates in the greater China region (which includes China, Taiwan, Hong Kong and Macau) (the “Territories”):

 

- Melphalan Hydrochloride For Injection (EVOMELA)(“EVOMELA”);
- Ibritumomab Tiuxetan (ZEVALIN) (“ZEVALIN”); and
- Vincristine Sulfate Liposome Injection (MARQIBO) , (“MARQIBO”).

 

CASI is responsible for developing and commercializing these three drugs in the Territories, including the submission of import drug registration applications and conducting confirmatory clinical trials as needed.

 

In March 2016, Spectrum, the former owner of EVOMELA, ZEVALIN and MARQIBO, received notification from the U.S. Food and Drug Administration (“FDA”) of the grant of approval of its New Drug Application (NDA) for EVOMELA primarily for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. In December 2016, the China National Medical Products Administration (“NMPA”) accepted for review the Company’s import drug registration application for EVOMELA and in 2017 granted priority review of the import drug registration clinical trial application (CTA). On December 3, 2018 the Company received NMPA’s approval for importation, marketing and sales in China for EVOMELA. The Company is building an internal commercial team to prepare for the commercial launch EVOMELA in 2019. The Company is also preparing for a post-marketing study.

 

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The Company is in various stages of the regulatory and development process to obtain marketing approval for ZEVALIN and MARQIBO in its territorial region, with ZEVALIN commercially available in Hong Kong. In 2017, the NMPA accepted for review the Company’s import drug registration for ZEVALIN including both the antibody kit and the radioactive Yttrium-90 component. On February 12, 2019, the Company received NMPA’s approval of the Company’s CTA to allow for a confirmatory registration trial to evaluate the efficacy and safety of ZEVALIN. In 2016, the NMPA accepted for review the Company’s import drug registration application for MARQIBO. On March 4, 2019 the Company received NMPA’s approval of the Company’s CTA to allow for a confirmatory registration trial to evaluate the efficacy and safety of MARQIBO. The Company intends to advance both of these products.

 

16.          Commitments

 

In 2018, the Company entered into purchase obligation commitments for EVOMELA from Spectrum for approximately $9.2 million (see Note 14). The Company expects all of the EVOMELA product to be delivered in 2019 (of which $480,000 was delivered in June 2019). As of June 30, 2019, the Company paid approximately $7.6 million of cumulative deposits for the purchase of EVOMELA ($4.6 million as of December 31, 2018). The deposits made to Spectrum are included in the prepaid expense and other in the accompanying condensed consolidated balance sheets.

 

In 2018, the Company committed to invest $80 million in CASI Wuxi, of which $21 million in cash was invested in February 2019 and ANDAs with a fair value of $37 million were transferred in May 2019 (see Note 8).

 

In conjunction with both the Black Belt and Juventus agreements entered into during the three months ended June 30, 2019 (see Note 2), the Company is responsible for certain milestone and royalty payments. As of June 30, 2019, no milestones have been achieved.

 

17.         Subsequent Event

 

On July 19, 2019, the Company entered into an Open Market Sale Agreement SM with Jefferies LLC (the “Open Market Agreement”). Pursuant to the terms of the Open Market Agreement, the Company may sell from time to time, at its option, shares of the Company’s common stock, through Jefferies LLC (“Jefferies”), as sales agent, with an aggregate sales price of up to $30,000,000.

 

Any sales of shares pursuant to the Open Market Agreement will be made under the Company’s effective “shelf” registration statement on Form S-3 (File No. 333-222046) which became effective on December 22, 2017 and the related prospectus supplement and the accompanying prospectus, as filed with the SEC on July 19, 2019.

 

On July 19, 2019, the Company entered into an amendment (the “Amendment”) to its Common Stock Sales Agreement with H.C. Wainwright & Co., LLC dated February 23, 2018 (the “Original Agreement”). Pursuant to the terms of the Amendment, the maximum amount that may be sold under the Original Agreement has been reduced to $20 million. The Amendment also harmonizes certain provisions of the Original Agreement with the Open Market Agreement with Jefferies and waives any breach of the terms, covenants, or conditions of the Original Agreement, if any, arising from the Company entering into the Open Market Agreement with Jefferies.

 

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

 

OVERVIEW  

 

We are a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and high quality pharmaceutical products in China, U.S., and throughout the world. We are focused on acquiring, licensing, developing and commercializing products in hematology oncology as well as other therapeutic areas of unmet medical need. We intend to execute our plan to become a leader by launching medicines in the greater China market leveraging our China-based regulatory and commercial competencies and our global drug development expertise. Our operations in China are conducted through our wholly-owned subsidiary, CASI Pharmaceuticals (Beijing) Co., Ltd. (“CASI China”), which is located in Beijing, China.

 

Our product pipeline features the following: (1) an autologous anti-CD19 T-cell therapy product (CNCT19) being developed for the treatment of B-ALL and NHL; (2) CID-103, an anti-CD38 monoclonal antibody being developed for the treatment of multiple myeloma and other CD38 positive hematological cancers; (3) three U.S. Food and Drug Administration (“FDA”) approved hematology oncology drugs in-licensed from Acrotech Biopharma LLC and its affiliates (“Acrotech”) for which we have exclusive rights to the greater China market, consisting of Melphalan Hydrochloride for Injection (EVOMELA ® ), Ibritumomab Tiuxetan (ZEVALIN ® ) and Vincristine Sulfate Liposome Injection (MARQIBO ® ), and (4) a portfolio of FDA-approved and pending abbreviated new drug applications (“ANDAs”), including entecavir and tenofovir disoproxil fumarate (TDF) indicated for the treatment of hepatitis B virus. We intend to prioritize a select subset of the ANDAs for product registration and commercialization in China.

 

We believe our product mix reflects a risk-balanced approach between products in various stages of development, between products that are branded and non-branded, and between products that are proprietary and generic. We intend to continue building a significant product pipeline of high quality pharmaceuticals, as well as innovative drug candidates for commercialization in China and for the rest of the world. For in-licensed products, we use a market-oriented approach to identify pharmaceutical candidates that we believe have the potential for gaining widespread market acceptance, either globally or in China, and for which development can be accelerated under our drug development strategy. For our FDA-approved ANDAs, we intend to select and commercialize certain niche products from the portfolio that complement our therapeutic focus areas and which offer unique market and cost-effective manufacturing opportunities in China and/or in the U.S.

 

We believe the China operations offer a significant market and growth potential due to the extraordinary increase in demand for high quality medicine coupled with regulatory reforms in China that make it easier for global pharmaceutical companies to introduce new pharmaceutical products into the country. We will continue to in-license clinical-stage and late-stage drug candidates, and leverage our cross-border operations and expertise, and hope to be the partner of choice to provide access to the China market. We expect the implementation of our plans will include leveraging our resources and expertise in both the U.S. and China so that we can maximize development and clinical strategies concurrently under U.S. FDA and China National Medical Products Administration (“NMPA”) regulatory regimes.

 

In order to capitalize on the drug development and capital resources available in China, we are doing business in China through our wholly-owned China-based subsidiary that will execute the China portion of our drug development strategy, including conducting clinical trials in China, pursuing local funding opportunities and strategic collaborations, and implementing our commercial launches. In December 2018, we received NMPA approval of Melphalan Hydrochloride For Injection (EVOMELA), for :

 

· use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma, and
· the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

 

We intend to begin commercializing this drug through CASI China beginning in 2019 using EVOMELA supplied through our licensor, Spectrum Pharmaceuticals, Inc. and its suppliers. Melphalan Hydrochloride for Injection (EVOMELA ® ) (as well as Ibritumomab Tiuxetan (ZEVALIN ® ) and Vincristine Sulfate Liposome Injection (MARQIBO ® ) was transferred from Spectrum to Acrotech in March 2019, accordingly, all future needs will be sourced from Acrotech and its suppliers, or other approved alternative suppliers.

 

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We have assembled an internal commercial team to prepare for the launch of our first commercial product, Melphalan Hydrochloride for Injection (EVOMELA) in 2019. As part of the strategy to support our future clinical and commercial manufacturing needs and to manage our supply chain for certain products, on December 26, 2018, we established CASI Pharmaceuticals (Wuxi) Co., Ltd. (“CASI Wuxi”) in China to construct a cGMP manufacturing facility in Wuxi, China. The site is currently in the design and engineering phase with construction expected to begin in 2020. Through CASI China, we will focus on the China market devoting more resources and investment going forward.

 

Since inception, the Company has incurred significant losses from operations and has incurred an accumulated deficit of $502.4 million.   The Company expects to continue to incur operating losses for the foreseeable future due to, among other factors, its continuing clinical and development activities.

 

Taking into consideration the cash balance as of June 30, 2019, the Company believes that it has sufficient resources to fund its operations at least through August 9, 2020. As of June 30, 2019, approximately $8.7 million of the Company’s cash balance was held by CASI China, and approximately $29.0 million was held by CASI Wuxi. The Company intends to continue to exercise tight controls over operating expenditures and will continue to pursue opportunities, as required, to raise additional capital and will also actively pursue non- or less-dilutive capital raising arrangements in China to support the Company’s dual-country approach to drug development.

 

Additional funds raised by issuing equity securities may result in dilution to existing stockholders.

 

RESULTS OF OPERATIONS

 

Six Months Ended June 30, 2019 Compared with Six Months Ended June 30, 2018

 

Operating Items

 

Revenues and Cost of Product Sales

 

There were no revenues recorded for the six months ended June 30, 2019 and 2018.

 

Research and Development Expenses

 

Research and development (R&D) expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with internal and contract preclinical testing and clinical trials of our product candidates, including the costs of manufacturing drug substance and drug product, regulatory maintenance costs, facilities expenses, and amortization expense of acquired ANDAs.

 

Research and development expenses for the six months ended June 30, 2019 were $5.6 million, compared with $3.4 million for the six months ended June 30, 2018. The increase in R&D expenses primarily reflects higher regulatory costs associated with our ANDAs in 2019, consulting and manufacturing related services, as well as an increase in personnel costs due to growth in the number of employees.

 

Included in our research and development expenses for the six month period ended June 30, 2019 are direct project costs of $2.8 million related to our ANDAs acquired in 2018, $596,000 for drugs in-licensed from Spectrum, and $747,000 for preclinical development activities primarily in China. Research and development expenses for the six month period ended June 30, 2018 included direct project costs of $829,000 related to our ANDAs acquired in January 2018, $316,000 for drugs in-licensed from Spectrum, and $886,000 for preclinical development activities primarily in China.

 

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General and Administrative Expenses

 

General and administrative expenses include compensation and other expenses related to finance, business development and administrative personnel, professional services, investor relations and facilities.

 

General and administrative expenses for the six months ended June 30, 2019 were $12.7 million, compared with $5.3 million for the six months ended June 30, 2018. The increase was related to a combination of factors primarily related to the Company’s growth in China. These factors include an increase in salary, benefits and recruitment expense and facilities costs due to increases in head count to prepare for the anticipated launch of the Company’s first commercial product (EVOMELA), professional services fees (including audit and legal services), and an increase in non-cash stock compensation expense largely attributed to stock options issued to the President of CASI China and other employees.

 

Acquired in-process Research and Development

 

Acquired in-process R&D expenses for the six months ended June 30, 2019 were $5.8 million, compared with $0.7 million for the six months ended June 30, 2018. The six months ended June 30, 2019 amount included the acquired Black Belt license and the six months ended June 30, 2018 expense included certain amounts associated with the acquired ANDAs in January 2018.

 

Non-Operating Items

 

Interest income, net

 

Interest income, net for the six months ended June 30, 2019 was $369,000 compared with $20,000 for the six months ended June 30, 2018. The increase in interest income is mainly due to higher cash balances and cash management strategies implemented by the Company during 2019.

 

Change in fair value of investment in equity securities

 

The change in fair value of investment in equity securities for the six months ended June 30, 2019 and 2018 was $195,542 and $11,325, respectively. The changes represent unrealized losses on the Company’s equity investment securities.

 

Foreign exchange gains

 

Foreign exchange gains for the six months ended June 30, 2019 was $551,000 compared with $0 for the six months ended June 30, 2018. The foreign exchange gains recorded in the condensed consolidated financial statements are primarily due to USD denominated cash accounts that are held by held by our Chinese subsidiaries.

 

Three Months Ended June 30, 2019 Compared with Three Months Ended June 30, 2018

 

Operating Items

 

Revenues and Cost of Product Sales

 

There were no revenues recorded for the three months ended June 30, 2019 and 2018.

 

Research and Development Expenses

 

Research and development expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with internal and contract preclinical testing and clinical trials of our product candidates, including the costs of manufacturing drug substance and drug product, regulatory maintenance costs, facilities expenses, and amortization expense of acquired ANDAs.

 

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Research and development expenses for the three months ended June 30, 2019 were $3.0 million, compared with $1.7 million for the three months ended June 30, 2018. The increase in R&D expenses primarily reflects higher regulatory costs associated with our ANDAs in 2019, consulting and manufacturing related services, as well as an increase in personnel costs due to growth in the number of employees.

 

Included in our research and development expenses for the three-month period ended June 30, 2019 are direct project costs of $1.3 million related to our ANDAs acquired in 2018, $331,000 for drugs in-licensed from Spectrum, and $424,000 for preclinical development activities primarily in China.  Research and development expenses for the three-month period ended June 30, 2018 included direct project costs of $388,000 related to our ANDAs acquired in January 2018, $174,000 for drugs in-licensed from Spectrum, and $388,000 for preclinical development activities primarily in China. 

 

General and Administrative Expenses

 

General and administrative expenses include compensation and other expenses related to finance, business development and administrative personnel, professional services, investor relations and facilities.

 

General and administrative expenses for the three months ended June 30, 2019 were $7.0 million, compared with $4.0 million for the three months ended June 30, 2018. The increase was related to a combination of factors primarily related to the Company’s growth in China. These factors include an increase in salary, benefits and recruitment expense and facilities costs due to increases in head count to prepare for the anticipated launch of the Company’s first commercial product (EVOMELA), professional services fees (including audit and legal services), and an increase in non-cash stock compensation expense largely attributed to stock options issued to the President of CASI China and other employees.

 

Acquired in-process Research and Development

 

Acquired in-process R&D expenses for the three months ended June 30, 2019 were $5.8 million, compared with $0 million for the three months ended June 30, 2018. The increase of $5.8 million is due to the acquired Black Belt license in April 2019.

 

Non-Operating Items

 

Interest income, net

 

Interest income, net for the three months ended June 30, 2019 was $320,000, compared with $13,000 for the three months ended June 30, 2018. The increase in interest income is mainly due to higher cash balances and cash management strategies implemented by the Company during 2019.

 

Change in fair value of investment in equity securities

 

The change in fair value of investment in equity securities for the three months ended June 30, 2019 and 2018 was $240,931 and $101,038, respectively. The changes representing unrealized losses on the Company’s equity investment securities.

 

Foreign exchange gains

 

Foreign exchange gains for the three months ended June 30, 2019 was $480,000, compared with $0 for the three months ended June 30, 2018. The foreign exchange gains recorded on the financial statements is primarily due to USD denominated cash accounts that are held by our Chinese subsidiaries.

 

Research and Development Discussion

 

We expect the majority of our research and development expenses for the remainder of 2019 to be devoted to advancing our in-licensed products towards market approval in China, the technology transfer activities and regulatory support associated with our ANDA portfolio, and our early-stage candidates in preclinical development. We expect our expenses for the remainder of 2019 to increase based on our commercial and clinical development plan. Completion of clinical development may take several years or more, but the length of time generally varies substantially according to the type, complexity, novelty and intended use of a product candidate.

 

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We estimate that clinical trials of the type we generally conduct are typically completed over the following timelines:

 

Global FDA Trial:

 

CLINICAL PHASE ESTIMATED
COMPLETION
PERIOD
Phase 1 1-2 Years
Phase 2 2-3 Years
Phase 3 2-4 Years

 

Local NMPA Trial:

 

CLINICAL PHASE ESTIMATED
COMPLETION
PERIOD
Phase 1 1 Year                 
Phase 2 2 Years
Phase 3 2-3 Years

 

The duration and the cost of clinical trials may vary significantly over the life of a project as a result of differences arising during the clinical trial protocol, including, among others, the following:

 

- the number of patients that ultimately participate in the trial;

 

- the duration of patient follow-up that seems appropriate in view of the results;

 

- the number of clinical sites included in the trials; and

 

- the length of time required to enroll suitable patient subjects.

 

We test our potential product candidates in numerous preclinical studies to identify indications for which they may be product candidates. We may conduct multiple clinical trials to cover a variety of indications for each product candidate. As we obtain results from trials, we may elect to discontinue clinical trials for certain indications in order to focus our resources on more promising indications.

 

Our proprietary product candidates have also not yet achieved regulatory approval, which is required before we can market them as therapeutic products. In order to proceed to subsequent clinical trial stages and to ultimately achieve regulatory approval, regulatory agencies must conclude that our clinical data establish safety and efficacy. Historically, the results from preclinical testing and early clinical trials have often not been predictive of results obtained in later clinical trials. A number of new drugs and biologics have shown promising results in clinical trials, but subsequently failed to establish sufficient safety and efficacy data to obtain necessary regulatory approvals.

 

Our business strategy includes being opportunistic with collaborative arrangements with third parties to complete the development and commercialization of our product candidates. In the event that third parties take over the clinical trial process for one of our product candidates, the estimated completion date would largely be under the control of that third party rather than us. We cannot forecast with any degree of certainty which proprietary products or indications, if any, will be subject to future collaborative arrangements, in whole or in part, and how such arrangements would affect our capital requirements.

 

As a result of the uncertainties discussed above, among others, we are unable to estimate the duration and completion costs of our research and development projects. Our inability to complete our research and development projects in a timely manner or our failure to enter into collaborative agreements, when appropriate, could significantly increase our capital requirements and could adversely impact our liquidity. These uncertainties could force us to seek additional, external sources of financing from time to time in order to continue with our business strategy. There can be no assurance that we will be able to successfully access external sources of financing in the future. Our inability to raise additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the future success of our business.

 

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LIQUIDITY AND CAPITAL RESOURCES

 

To date, we have been engaged primarily in research and development activities. As a result, we have incurred and expect to continue to incur operating losses in 2019 and the foreseeable future before we commercialize any products and penetrate significant markets such as China. Based on our current plans, we expect our current available cash and cash equivalents to meet our cash requirements for at least through August 9, 2020.

 

We will require significant additional funding to fund operations until such time, if ever, we become profitable. We intend to augment our cash balances by pursuing other forms of capital infusion, including strategic alliances or collaborative development opportunities with organizations that have capabilities and/or products that are complementary to our capabilities and products in order to continue the development of our potential product candidates that we intend to pursue to commercialization. If we seek strategic alliances, licenses, or other alternative arrangements, such as arrangements with collaborative partners or others, to raise further financing, we may need to relinquish rights to certain of our existing product candidates, or products we would otherwise seek to develop or commercialize on our own, or to license the rights to our product candidates on terms that are not favorable to us.

 

We will continue to seek to raise additional capital to fund our commercialization efforts, expansion of our operations, research and development, and for the acquisition of new product candidates, if any. We intend to explore one or more of the following alternatives to raise additional capital:

 

· selling additional equity securities;
· out-licensing product candidates to one or more corporate partners;
· completing an outright sale of non-priority assets; and/or
· engaging in one or more strategic transactions.

 

We also will continue to manage our cash resources prudently and cost-effectively.

 

There can be no assurance that adequate additional financing under such arrangements will be available to us on terms that we deem acceptable, if at all. If additional funds are raised by issuing equity securities, dilution to existing stockholders may result, or the equity securities may have rights, preferences, or privileges senior to those of the holders of our common stock. If we fail to obtain additional capital when needed, we may be required to delay or scale back our commercialization efforts, our advancement of the Spectrum products, and the ANDA products, or plans for other product candidates, if any.

 

At June 30, 2019, we had cash and cash equivalents of approximately $70.3 million, with working capital of approximately $74.4 million. As of June 30, 2019, approximately $8.7 million of the Company’s cash balance was held by the Company’s wholly-owned subsidiary in China and approximately $29.0 million was held by CASI Wuxi.

 

FINANCING ACTIVITIES

 

“Shelf” Registration Statement

 

We have an effective shelf registration statement, which allows us to sell debt or equity securities in one or more offerings up to a total public offering price of $100 million. We believe that this shelf registration statement currently provides us additional flexibility with regard to potential financings that we may undertake when market conditions permit or our financial condition may require.

 

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Sales Agreements

 

On February 23, 2018, the Company entered into a Common Stock Sales Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“HCW”). Pursuant to the terms of the Sales Agreement, the Company may sell from time to time, at its option, shares of the Company’s common stock, through HCW, as sales agent. On July 19, 2019, the Company entered into an amendment to the Sales Agreement reducing the maximum amount that may be sold under the Sales Agreement to $20 million.

 

Any sales of shares pursuant to the Sales Agreement will be made under the Company’s effective “shelf” registration statement on Form S-3 (File No. 333-222046) which became effective on December 22, 2017 (the “Registration Statement”) and the related prospectus supplement and the accompanying prospectus, as filed with the SEC on February 23, 2018.

 

In 2018, the Company issued 143,248 shares under the Sales Agreement resulting in net proceeds to the Company of approximately $475,000. As of June 30, 2019, approximately $19.5 million remained available under the Sales Agreement.

 

On July 19, 2019, the Company entered into an Open Market Sale Agreement SM with Jefferies LLC (the “Open Market Agreement”). Pursuant to the terms of the Open Market Agreement, the Company may elect to sell from time to time, at its option, up to $30 million in shares of the Company’s common stock, through Jefferies LLC, as sales agent.

 

Any sales of shares pursuant to the Open Market Agreement will be made under the Company’s Registration Statement and the related prospectus supplement and the accompanying prospectus, as filed with the SEC on July 19, 2019.

 

INFLATION AND INTEREST RATE CHANGES

 

Management does not believe that our working capital needs are sensitive to inflation and changes in interest rates.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

The primary objective of our investment activities is to preserve our capital until it is required to fund operations while at the same time maximizing the income we receive from our investments without incurring investment market volatility risk. Our investment income is sensitive to the general level of U.S. and China interest rates. In this regard, changes in the U.S. and China interest rates affect the interest earned on our cash and cash equivalents. Due to the short-term nature of our cash and cash equivalent holdings, a 10% movement in market interest rates would not materially impact the total fair market value of our portfolio as of June 30, 2019.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

Based on an evaluation under the supervision and with the participation of the Company’s management, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) were effective as of June 30, 2019 to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission rules and forms and (ii) accumulated and communicated to the Company’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

 

We believe that a controls system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.

 

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Changes in Internal Control Over Financial Reporting

 

During the first quarter of 2019, we implemented a new financial system that is designed to improve the efficiency and effectiveness of our operational and financial accounting processes. This implementation is expected to continue through 2019. Consistent with any process change that we implement, the design of the internal controls has and will continue to be evaluated for effectiveness as part of our overall assessment of the effectiveness of our disclosure controls and procedures. We expect that the implementation of this system will improve our internal controls over financial reporting.

 

Other than the implementation of a new financial system noted previously, there have been no changes in our internal control over financial reporting during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

We are subject in the normal course of business to various legal proceedings in which claims for monetary or other damages may be asserted. Management does not believe such legal proceedings, unless otherwise disclosed herein, are material.

 

ITEM 1A. RISK FACTORS

 

In addition to the risk factors set forth in Part I - Item 1A - “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2018, (the “2018 10-K”), investors should carefully consider the following risk factors. These risks should be read in conjunction with the risk factors set forth in the 2018 10-K and the other information contained in this report and our other filings with the SEC.

 

If we are unable to protect our intellectual property rights our business and competitive position would be harmed.

 

We have in-licensed worldwide rights to an investigational anti-CD38 monoclonal antibody and an anti-CD19 T-cell therapy product candidate, and we may in-license other product candidates in the future.  Our success, competitive position and future revenues with respect to these product candidates will depend, in part, on our ability to protect our intellectual property.  We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our proprietary rights are covered by valid and enforceable patents or are effectively maintained as trade secrets. We attempt to protect our proprietary position by maintaining trade secrets and by filing U.S. and foreign patent applications related to our in-licensed technology, inventions and improvements that are important to the development of our business. Our failure to do so may adversely affect our business and competitive position.

 

The patent positions of biotechnology and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. We may not be able to protect our intellectual property rights throughout the world. No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date in the United States or in many jurisdictions outside of the United States. Changes in either the patent laws or interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property and therefore we cannot predict with certainty whether any patent applications that we have filed or that we may file in the future will be approved, will cover our products or product candidates or that any resulting patents will be enforced. In addition, third parties may challenge, seek to invalidate, limit the scope of or circumvent any of our patents, once they are issued. Thus, any patents that we own or license from third parties or joint venture or development partners may not provide any protection against competitors. Any patent applications that we have filed or that we may file in the future, or those we may license from third parties or joint venture or development partners, may not result in patents being issued. Moreover, disputes between our licensing or joint development partners and us may arise over license scope, or ownership, assignment, inventorship and/or rights to use or commercialize patent or other proprietary rights, which may adversely impact our ability to obtain and protect our proprietary technology and products. Also, patent rights may not provide us with adequate proprietary protection or competitive advantages against competitors with similar technologies or products.

 

Patent protection for our anti-CD19 T-cell therapy product candidate may not be available and may be subject to infringement claims in China and other countries.

 

Although we have entered into a worldwide licensing and commercialization rights agreement with Juventas Cell Therapy Ltd., a China-based domestic company, for an autologous anti-CD19 T-cell therapy product candidate, Juventas retains ownership of, and all other rights to, the intellectual property rights associated with this product candidate. As a result, we are dependent on Juventas  to ensure that its proprietary rights are covered by valid and enforceable patents or are effectively maintained as trade secrets.  Juventas has not filed patent applications covering this product candidate in China or in other countries.  Accordingly, even if we are successful in commercializing an anti-CD19 T-cell therapy in China, Juventas may be unable to obtain intellectual property rights in China or in other countries, including the United States.  As a result, we may be unable to prevent other companies from competing with us or alleging infringement by competitors. The lack of patent protection may limit our ability to sell our product and may severely and adversely affect our financial results, business and business prospects.

 

  27  

 

 

Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could harm our business.

 

In addition, third parties may assert patent or other intellectual property infringement claims against us, Juventas, or our other licensors arising  from the manufacture, use and sale of our current or future product candidates in China or in any other jurisdictions we ultimately commercialize in.  The validity of our current or future patents or patent applications or those of our licensors may be challenged in litigation, interference or derivation proceedings, opposition, post grant review, inter partes review, or other similar enforcement and revocation proceedings, provoked by third parties or brought by us. Our patents could be found invalid, unenforceable, or their scope significantly reduced.

 

An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Our defense of litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing products or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.

 

We have agreed not to develop or seek to commercialize any T-cell therapy product specifically binding to CD19.

 

Under the terms of our license agreement with Juventas Cell Therapy Ltd., unless otherwise agreed to by Juventas or specifically permitted under the license, we have agreed not to develop or seek to commercialize any other T-cell therapy product specifically binding to CD19 during the term of the license agreement and for three years thereafter.  We also have agreed not to market or sell any such products during this period of time.  As a result, we may not be able to develop or collaborate on other similar T-cell therapy products that could lead to a  viable commercial product and could cause us to miss valuable future opportunities thus potentially severely and adversely affect our financial results, business and business prospects.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

Not applicable.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

Not applicable.

 

ITEM 6. EXHIBITS

 

1.1   Open Market Sale Agreement SM by and between CASI Pharmaceuticals, Inc. and Jefferies LLC dated July 19, 2019 (incorporated by reference from Exhibit 1.1 to our Current Report on Form 8-K filed on (July 19, 2019)
1.2   Amendment No. 1 to Common Stock Sales Agreement by and between CASI Pharmaceuticals, Inc. and H.C. Wainwright & Co., LLC dated July 19, 2019 (incorporated by reference from Exhibit 1.3 to our Current Report on Form 8-K filed on July 19, 2019)
3.1   Amended and Restated Certificate of Incorporation**
10.1   Exclusive License Agreement by and between CASI Pharmaceuticals, Inc. and Juventas Cell Therapy Ltd. effective June 15, 2019 +**
10.2   Investment Agreement in respect of Juventas Cell Therapy Ltd. executed June 15, 2019+**
31.1   Rule 13a-14(a) Certification of Chief Executive Officer**
31.2   Rule 13a-14(a) Certification of Chief Financial Officer**
32.1   Section 1350 Certification of Chief Executive Officer**
32.2   Section 1350 Certification of Chief Financial Officer**
101   The following financial information from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, formatted in eXtensible Business Reporting Language (XBRL):  (i) Unaudited Condensed Consolidated Balance Sheets at June 30, 2019 and December 31, 2018, (ii) Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2019 and 2018, (iii) Unaudited Condensed Consolidated Statement of Stockholders’ Equity for the Three and Six Months Ended June 30, 2019 and 2018, (iv) Unaudited Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2019 and 2018, and (v) Notes to Unaudited Condensed Consolidated Financial Statements.**

 

+            Certain portions of this exhibit have been omitted based upon a request for confidential treatment under 17 C.F.R. §§200.80(b)(4) and 230.406. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions have been filed separately with the SEC pursuant to our confidential treatment request.

 

**          Filed Herewith

 

  28  

 

 

EXHIBIT INDEX    

 

1.1   Open Market Sale Agreement SM by and between CASI Pharmaceuticals, Inc. and Jefferies LLC dated July 19, 2019 (incorporated by reference from Exhibit 1.1 to our Current Report on Form 8-K filed on (July 19, 2019)
1.2   Amendment No. 1 to Common Stock Sales Agreement by and between CASI Pharmaceuticals, Inc. and H.C. Wainwright & Co., LLC dated July 19, 2019 (incorporated by reference from Exhibit 1.3 to our Current Report on Form 8-K filed on July 19, 2019)
3.1   Amended and Restated Certificate of Incorporation**
10.1   Exclusive License Agreement by and between CASI Pharmaceuticals, Inc. and Juventas Cell Therapy Ltd. effective June 15, 2019 +**
10.2   Investment Agreement in respect of Juventas Cell Therapy Ltd. executed June 15, 2019+**
31.1   Rule 13a-14(a) Certification of Chief Executive Officer**
31.2   Rule 13a-14(a) Certification of Chief Financial Officer**
32.1   Section 1350 Certification of Chief Executive Officer**
32.2   Section 1350 Certification of Chief Financial Officer**
101   The following financial information from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, formatted in eXtensible Business Reporting Language (XBRL):  (i) Unaudited Condensed Consolidated Balance Sheets at June 30, 2019 and December 31, 2018, (ii) Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2019 and 2018, (iii) Unaudited Condensed Consolidated Statement of Stockholders’ Equity for the Three and Six Months Ended June 30, 2019 and 2018, (iv) Unaudited Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2019 and 2018, and (v) Notes to Unaudited Condensed Consolidated Financial Statements.**

 

+            Certain portions of this exhibit have been omitted based upon a request for confidential treatment under 17 C.F.R. §§200.80(b)(4) and 230.406. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions have been filed separately with the SEC pursuant to our confidential treatment request.

 

**          Filed Herewith

 

  29  

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

  

  CASI PHARMACEUTICALS, INC.
  (Registrant)
   
   
Date: August 9, 2019 /s/ Wei-Wu He
  Wei-Wu He
  Chief Executive Officer
   
   
Date: August 9, 2019 /s/George Chi
  George Chi
  Chief Financial Officer

 

  30  

 

Exhibit 3.1

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 

 

 

Exhibit 10.1

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission.

***Triple asterisks denote omissions.

 

EXCLUSIVE LICENSE AGREEMENT

 

This Exclusive License Agreement (“ Agreement ”), effective as of June 15, 2019 (Beijing Time, “ Effective Date ”), is entered into between:

 

(i) Juventas Cell Therapy Ltd., a company duly organized and existing under the laws of PRC, having its principal office at Building 5, No.8, No.8, Haitai Development, Huayuan Industrial Zone, Tianjin Binhai High-tech Zone, Tianjin City, China (hereinafter referred to as “ Juventas ” or the “ Licensor ”, which, unless contrary to the context or meaning thereof, shall include its successors and assigns); and
(ii) CASI Pharmaceuticals, Inc., a company duly organized and existing under the laws of Delaware , having its principal office at 9620 Medical Center Drive, Suite 300, Rockville, Maryland 20850 (hereinafter referred to as “ CASI ” or the “ Licensee ”, which, unless contrary to the context or meaning thereof, shall include permitted successors and assigns).

 

(Juventas and CASI are each referred hereto as a “ Party ” and both the “ Parties ”.)

 

RECITALS

 

A.           Licensor has acquired, developed and/or accumulated patents, proprietary technology or formulas, clinical data, know-how and other confidential information related to the development and manufacturing of one developed candidate autologous T-cell therapy product with a scFv specifically binding to CD19.

 

B.           Licensor owns or has the right to license the information, including the patents, proprietary technology and formulas, clinical data, know-how and other confidential information associated with the Licensed Product (as defined below).

 

C.           Licensee desires to obtain, and Licensor has agreed to grant, a license to offer for sale, market, distribute and sell (collectively, “ Commercialize ” or “ Commercialization ”) the Licensed Product as more particularly described herein.

 

D.           Subject to the terms and conditions as more particularly described herein, Juventas or its designated manufacturer will be the exclusive manufacturer and supplier of the Licensed Product for CASI.

 

AGREEMENT

 

NOW, THEREFORE, in consideration of the foregoing preliminary statements, the mutual agreements and covenants set out herein, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

 

  1  

 

 

Section I.

Definitions

 

As used in this Agreement, the following capitalized terms shall have the following meanings:

 

1.1          “ Affiliate ” means any Person that directly or indirectly controls, is controlled by or is under common control with a person or entity, but only for so long as said control shall continue. As used herein, the term “control” or “controlled by” means: (a) ownership, directly or indirectly, of more than 50% of the voting securities of the applicable party; or (b) possession of the power to direct or cause the direction of the business, management and policies of a person whether by ownership, contract or otherwise. Solely for the purpose of defining “Affiliate” herein, Juventas shall not be deemed as an Affiliate of CASI.

 

1.2          “ Annual Net Sales ” means total Net Sales of the Licensed Product in a particular Calendar Year.

 

1.3          “ Calendar Quarter ” means a period of three (3) consecutive months ending on the last day of March, June, September, or December, respectively.

 

1.4          “ Commercially Reasonable Efforts ” means, with respect to the efforts to be exerted by a Party to achieve any objective, the reasonable efforts to accomplish such objective as a similarly situated party in the pharmaceutical industry would normally use to accomplish a similar objective in its own interests under similar circumstances.

 

1.5          “ Change of Control ” means (a) any Person becomes the beneficial owner, directly or indirectly, of 50% or more of the outstanding equity interests of a Party, or (b) a Party ceases to own and control, of record and beneficially, more than 50% of each class of outstanding voting equity interests of the Party.

 

1.6          “ Chairperson ” means the chairperson of the JSC or JDC as defined in Section 4.2 and Section 4.6.

 

1.7          “ China Territory ” means the People’s Republic of China, and for the purpose of defining “China Territory” only, including Macau and Taiwan and Hong Kong.

 

1.8          “ Clinical Development ” means a human clinical trial of a compound or product for an indication as required prior to the market of a medical product.

 

1.9          “ CMC ” means the regulatory submission for Chemistry, Manufacturing, and Controls of the Licensed Product as required by the FDA, the EMEA or the NMPA prior to and during the clinical trials in humans or any comparable submissions to any Governmental or Regulatory Authority within the Territory.

 

1.10        “ Commercialize ” or “ Commercialization ” has the meaning given to such term in Recitals of this Agreement.

 

  2  

 

 

1.11         “ Cost of Goods ” or “ COGS ” means Juventas’ (and/or its contract manufacturer’s) costs of (i) materials, excipients, packaging and labeling material (including package insert); (ii) direct line costs, including direct labor of employees (including basic wages, labor and related payroll taxes and benefits) incurred or spent in the actual production, filling, packaging and labeling of the Licensed Product, including without limitation for quality assurance, purchasing and manufacturing facility operations; (iii) overhead (including operating expenses, indirect labor and related payroll taxes and benefits, depreciation, amortization, taxes, insurance, rent, equipment repairs and maintenance, energy costs and supplies) incurred or spent in support of the actual production, filling, packaging and labeling of the Licensed Product; and

(iv) any other costs with respect to the manufacture of the Licensed Product.

 

1.12        “ Commercialization Plan ” has the meaning given to such term in Section 3.8 of this Agreement

 

1.13        “ EMEA ” means the European Medicines Agency, or any successor entity thereto.

 

1.14        “ Ex-China Territory ” means the rest of the world outside the China Territory.

 

1.15        “ Field ” means all therapeutic uses of the Licensed Product.

 

1.16        “ FDA ” means the U.S. Food and Drug Administration, or any successor entity thereto.

 

1.17        “ First Commercial Sale ” means the first sale of the Licensed Product in any part of the Territory after Regulatory Approval for the Licensed Product has been granted, or otherwise permitted, by a Regulatory Authority of the Territory such as NMPA. For the avoidance of doubt, the First Commercial Sale does not include any sale or supply of any product for the sole purpose of clinical trials.

 

1.18        “ GMP ” means current Good Manufacturing Practices as defined in Parts 210 and 211 of Title 21 of the U.S. Code of Federal Regulations, as may be amended from time to time, or any successor thereto and foreign equivalents thereof, including, where referring to activities in China, the Guidelines on Good Manufacturing Practices specific to the Licensed Product, or such practices as may be as otherwise required by the NMPA, including under the Quality Administrative Standard for Drug Manufacturing as well as any requirements issued pursuant to the Regulation of Drug Manufacturing Administrative Procedures issued by the NMPA.

  

1.19        “ GMP Manufacturing Facility ” means any manufacturing facility that meets the GMP.

  

1.20        “ Governmental or Regulatory Authority ” means: (a) the National Medical Products Administration of the People’s Republic of China (the “ NMPA ”) and any other national, federal, provincial, state, municipal or other governmental body, (b) any international or multi- lateral body, (c) any subdivision, ministry, department, secretariat, bureau, agency, commission, board, instrumentality or authority of any of the foregoing governments or bodies, (d) any quasi- governmental or private body exercising any regulatory, expropriation or taxing authority under or for any of the foregoing governments or bodies, or (e) any international, multi-lateral or multi-national judicial, quasi-judicial, arbitration or administrative court, grand jury, tribunal, commission, board or panel.

 

  3  

 

 

1.21        “ IND ” means any investigational new drug application filed with the FDA, the EMEA or the NMPA prior to beginning clinical trials in humans or any comparable application filed with any Governmental or Regulatory Authority within the Territory.

 

1.22        “ Intellectual Property ” means all registered patents, patent applications, inventions or discoveries (whether or not patentable), copyrights, copyright applications, domain names, Licensed Product specifications, data, trade secrets, trade dress, know-how and all other intellectual property rights, and all related documentation or other tangible expressions thereof, including the proprietary information set forth on Exhibit A attached hereto as will be updated from time to time, which are necessary to the Commercialization of the Licensed Product in the Territory, but excluding any intellectual property solely relating to the development and manufacture of the Licensed Product.

 

1.23        “ Improvements ” means any inventions, discoveries, know-how, clinical data or other proprietary information related to any Licensed Product created, generated or acquired by either Party during the Term of this Agreement.

 

1.24         JDC has the meaning given to such term in Section 4.5 of this Agreement

 

1.25         JSC has the meaning given to such term in Section 4.1 of this Agreement

 

1.26        “ Laws ” means: (a) all constitutions, treaties, laws, statutes, codes, ordinances, guidance, orders, decrees, rules, regulations, and municipal by-laws, (b) all judgments, orders, writs, injunctions, decisions, rulings, decrees and awards of any governmental, regulatory or judicial authority, and (c) all policies, practices and guidelines of any governmental or regulatory authority.

 

1.27        “ Licensor Product Liability Claims ” means all Product Liability Claims that arise in the Territory and are attributable to the activities conducted by the Licensor with regard to the Licensed Product.

 

1.28        “ Losses ” means any and all claims, liabilities, losses, damages, fees, penalties, judgments, awards, interest, costs and expenses (including, without limitation, reasonable attorneys’ fees and expenses and court’s costs) incurred by a Party to this Agreement, or any Affiliate thereof, resulting from a third party Proceeding against either Party.

 

1.29        “ NDA ” means a New Drug Application filed with the FDA, the EMEA, and the NMPA to obtain approval for commercial sale or use of the Licensed Product as a pharmaceutical or medicinal product in any formulation or dosage form (excluding any pricing and reimbursement approvals) or any comparable application filed with any Governmental or Regulatory Authority within the Territory.

 

1.30        “ Net Sales ” means the gross amount invoiced for sales of the Licensed Product by Licensee, or Affiliates or its permitted sublicensee to any Third Party in the Territory, less the following amounts: (i) sales taxes or other taxes separately stated on the Licensed Product invoice; (ii) shipping and insurances charges separately stated on the Licensed Product invoice; and (iii) price adjustments, credits, refunds or deductions for returned or defective Licensed Product, all to the extent reasonably demonstrated by CASI by written records, provided that such calculation is not in violation of the Generally Accepted Accounting Principles (GAAP) of the United States. Notwithstanding anything in this Agreement to the contrary, the transfer of the Licensed Product between or among CASI and any of its Affiliates and sublicensees will not be considered a sale.

 

 

  4  

 

 

1.31        “ Non-Royalty Sublicense Income ” means any and all payments received from a sublicense by CASI, in consideration of the grant of a sublicense, including but not limited to upfront and milestone payments, license maintenance fees and the fair market value of any non- cash consideration, but excluding payments made by a sublicensee as a royalty on Net Sales of the Licensed Product sold by such sublicensee.

 

1.32        “ Proceedings ” means claims, suits, actions, investigations or proceedings.

 

1.33        “ Person ” means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.

 

1.34        “ Licensed Product ” means one developed candidate autologous T-cell therapy product with a scFv specifically binding to CD19, which is identified by Juventas as an internal reference number CNCT19.

 

1.35        “ PRC ” means People’s Republic of China, but for the purpose only of this Agreement, shall exclude Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan.

 

1.36         “Phase II Clinical Trial ” means a human clinical trial of a compound or product for an indication conducted in the PRC, the principal purpose of which is a determination of safety and efficacy for such indication or indications in a target patient population over a range of doses and to provide the rational and provide the basis for the design of phase III clinical trial studies and the determination of dosing regimens, as more fully defined in Article 31 of Provisions for

Drug Registration (2007 Revision) ( 《药品注册管理办法( 2007 修订)》 , or its successor regulation.

 

1.37        “ Product Liability Claim ” means any third-party Proceedings involving any actual or alleged death or bodily injury arising out of or resulting from the use of Licensed Product.

 

1.38        “ Regulatory Approval ” means approval or registration by any Governmental or Regulatory Authority in the Territory as necessary for the manufacturing, distribution, promotion and sale of the Licensed Product or otherwise permitting the manufacture or sale of the Licensed Product.

 

1.39        “ R&D Plan ” has the meaning given to such term in Section 3.7 of this Agreement.

 

  5  

 

 

1.40        “ Restricted Products ” has the meaning given to such term in Section 2.8 of this Agreement.

 

1.41        “ Supply Agreement ” has the meaning given to such term in Section 5.1 of this Agreement.

 

1.42        “ Territory ” means worldwide.

 

1.43        “ Term ” has the meaning given to such term in Section 8.1 of this Agreement.

 

1.44        “ Third Party ” means any Person other than a Party or an Affiliate of a Party.

 

1.45         Trademark means any word, phrase, slogan, design, symbol or product packaging used or intended to be used to identify the Licensed Product or distinguish it from competitive or related products. For clarification, the “ Licensor Trademarks ” means “ 合源生物 ” and “Juventas” and any other trademarks, logos or branding used by Licensor in connection with the Licensed Product.

 

Section II.

Grant of Exclusive License

 

2.1           Grant of License .

 

(a)           Exclusivity . Subject to the terms and conditions set forth herein, Licensor hereby grants to Licensee during the Term, an exclusive license (the “ License ”) in the Field in the Territory under the Intellectual Property and Improvements solely to Commercialize the Licensed Product. During the Term of this Agreement, Licensor and its Affiliates shall not by themselves or through a third party to Commercialize any Licensed Product. For the sake of clarity, Juventas has no obligation to provide CASI with any information or material that is not necessary for Commercialization of the Licensed Product and Parties agree that Juventas retains the right to use the Intellectual Property to develop and Commercialize any product other than Licensed Product.

 

(b)           Responsibility of Commercialization . CASI shall use Commercially Reasonable Efforts, including the use of third-party experts and external consultants at its own cost, to Commercialize the Licensed Product in the Territory in which necessary approvals from Governmental or Regulatory Authorities in such region have been obtained by Juventas for the Commercialization of the Licensed Product.

 

(c)           Right of First Negotiation . The Parties acknowledge and agree that during the Term of this Agreement, if one combination of the Licensed Product with other active drug ingredients will result in a new product from a regulatory point of view and Juventas intends to grant any third party the Commercialization rights of such new product, CASI shall have the first right to negotiate for any Commercialization rights in and to such new product in the Territory in terms and conditions to be further negotiated by the Parties. In the event the Parties are unable to reach an agreement on terms within sixty (60) days from the date that Licensor notifies Licensee that such new product are available in the Territory, then Licensor may offer such rights in and to such new product in the Territory to a third party, provided that the terms and conditions offered to the third party shall not be more favorable than those offered to Licensee. If Licensor desires to offer such rights to new product on more favorable terms than those last offered to Licensee, Licensor shall first offer such terms for the new product to Licensee as set forth herein and the negotiation period of sixty (60) days shall be renewed and recalculated.

 

  6  

 

 

2.2           Trademarks .

 

(a)          Juventas grants to CASI an exclusive license to use the Licensor Trademarks in the Territory and solely in connection with the Licensed Product. CASI shall use the Licensor Trademarks solely in connection with its Commercialization of the Licensed Product in the Territory. All use of the Licensor Trademarks by CASI will inure to the purpose of this Agreement. CASI shall not register or attempt to register any of the Licensor Trademarks in any jurisdiction in the Territory, or otherwise, without the prior written consent of Juventas, and in the event that CASI does register any of the Licensor Trademarks in the Territory (the “ Territory Trademarks ”), such Territory Trademarks that are identical to, similarly confusing with or use the Licensor Trademarks shall be transferred and assigned to Juventas upon expiration or termination of this Agreement or its earlier request. However, for clarity purpose, this Section 2.2 does not restrict CASI from developing, creation, registering or using its own trademarks solely to indicate CASI as a distributor of the Licensed Product. CASI’s use of the Licensor Trademarks shall comply with laws and regulations related to labeling and advertising in the Territory and other applicable Laws.

 

2.3           Right to Sublicense . Licensee shall have the right to sublicense the licensed rights to its Affiliates, distributors and/or sublicensees or non-affiliates provided that the Licensor’s prior written consent has been obtained, which consent shall not be unreasonably withheld. In the event that Licensee engages any Affiliate, distributor and/or sublicensee in connection with the Commercialization of the Licensed Product(s), such Affiliate, distributor and/or sublicensee shall have the right to use the License and the Licensor Trademarks subject to the terms and conditions herein and solely in connection with the Licensed Product.

 

2.4           Ownership and Preservation . Licensor retains ownership of, and all other rights to, the Intellectual Property. Licensor shall use Commercially Reasonable Efforts to preserve and maintain the Intellectual Property in the Territory and shall pay any periodic filing or administrative fees associated therewith. Licensor shall keep Licensee informed regarding the prosecution and maintenance of licensed patents or patent applications in the Territory, if any, included in the licensed Intellectual Property. In addition, if the Licensor fails to preserve or maintain the Intellectual Property in the Territory and refuses to preserve or maintain the Intellectual Property after receipt of reminder of Licensee, Licensee may, at its own discretion and cost, take all necessary actions to ensure such preservation and maintenance.

 

2.5           Improvements. Parties agree that all right, title and interest in and to the Improvements shall be the sole and exclusive property of Juventas. CASI shall, and shall cause their employees to make full and prompt disclosure to Juventas of all Improvements. CASI hereby assign and transfer, without additional consideration, to Juventas all right, title and interest that CASI and their employees may have in and to any and all Improvements throughout the world. CASI shall and shall cause their employees to timely execute, or cause to be executed, all papers necessary to effect and perfect the assignment and transfer of all right, title and interest that CASI and their employees may have in and to any and all Improvements to Juventas.

 

  7  

 

 

2.6          For the avoidance of doubt, nothing in this Agreement shall be construed to confer any rights upon CASI to modify or reversely engineer the Licensed Product. Without prior written consent of Juventas, CASI shall not further develop or file regulatory filing for the Licensed Product. Any and all information, materials, data and results developed by CASI in violation of this provision shall be solely owned by Juventas.

 

2.7           Conversion to No-exclusive . Despite anything to the contrary in this Agreement, any exclusive license granted under this Agreement will immediately become non-exclusive and any rights to sublicense will immediately terminate only if [***]. Determinations of total market share shall be made based on IQVIA market data (formerly IMS Health), or any successor thereto, calculated on the basis of number of units sold (subject to adjustments for package sizes, product dosage or strength, and similar factors, as reasonably determined by the Parties).

 

2.8           Non-competition . CASI irrevocably and unconditionally agrees with and undertakes to Juventas that, unless with prior written consent of Juventas or specially permitted by this Agreement, during the Term of this Agreement and [***] years thereafter, (1) CASI shall not engage in development or Commercialization of any T-cell therapy product specifically binding to CD19 (“ Restricted Products ”) other than the Licensed Product; and (2) CASI shall not market or sell any Restricted Products in the Territory.

 

Section III.

Parties’ Responsibilities

 

3.1           Overview . Subject to this Section III, it is the intent of the Parties that Juventas will have sole responsibility for the activities related to preclinical and clinical development of the Licensed Product until the receipt of Regulatory Approvals required for Commercialization of the Licensed Product in the Territory, and CASI will have sole responsibility, with Commercially Reasonable Efforts, for the activities related to the Commercialization of the Licensed Product in the Territory. Juventas’s preclinical and clinical development of the Licensed Product shall be subject to the review and/or approval of JSC as further set out in Section IV. For the sake of clarity, the Parties shall bear their own costs related to their responsibilities set out under this Agreement.

 

3.2           Juventas’ Responsibilities . Juventas will be responsible for all research and development activities for the Licensed Product in the Territory, in particular:

 

(a)           IND Filings and CMC Development . Upon execution of this Agreement, Juventas shall continue in IND filings and CMC development in accordance with the R&D Plan (as defined below), including preparing and submitting relevant application forms and such other materials as may be required by applicable Government or Regulatory Authority in the Territory. Juventas will be solely responsible for compliance with CMC requirements.

 

  8  

 

 

(b)           GMP Manufacturing Facility . Juventas will use Commercially Reasonable Efforts to establish its own GMP Manufacturing Facility or a third-party GMP Manufacturing Facility. Upon commencement of manufacturing of the Licensed Product at the GMP Manufacturing Facility, Licensor shall be solely responsible for the manufacture and supply of the Licensed Product for Licensee’s sale and distribution in the Territory. Licensor shall be solely responsible for all costs and expenses incurred in relation to the GMP Manufacturing Facility, including development, construction, validation, equipment, regulatory and operational expenses. Juventas will be solely responsible for compliance of the GMP Manufacturing Facility with all Applicable Laws in the Territory.

 

(c)           Clinical Development . Juventas shall be responsible for Clinical Development of the Licensed Product in the Territory and for all indications by itself or through a third party and bear all relevant costs and expenses incurred. Juventas will own and have responsibility and control of the necessary regulatory submissions to all applicable Government or Regulatory Authority in the Territory.

 

(d)           NDA Filings . Upon and from the execution of this Agreement, Juventas shall use Commercially Reasonable Efforts to obtain, control and maintain NDA approvals in the Territory for the Licensed Product in accordance with the R&D Plan, including preparing and submitting a product dossier and such other materials as may be required for classification and approval of the Licensed Product for the sale and marketing in the Territory by the NMPA or other applicable Government or Regulatory Authority in the Territory. Juventas shall bear all costs associated with obtaining and maintaining all Regulatory Approvals in the Territory, including all costs associated with any regulatory filings related to the Licensed Product, and any post- marketing studies necessary to obtain or maintain Regulatory Approval.

 

(e)           Other Responsibilities . In addition to the specified responsibilities under subsection (a) to (d) above, Juventas shall use Commercially Reasonable Efforts, including the use of third party experts and external consultants at its own cost, to complete registration with all Governmental or Regulatory Authorities in the Territory, as well as other formalities which may be necessary in order to complete the regulatory and clinical process for the manufacturing, distribution, marketing and sale of the Licensed Product in the Territory. The shipping responsibility of the Licensed Product is subject to a separately Supply Agreement to be further negotiated by the Parties.

 

3.3           CASI’s Responsibilities . Licensor shall be responsible for the commercialization, marketing, strategy, pricing, promotion, market targeting, branding, distribution and sale of the Licensed Product in the Territory, in particular:

 

(a)           Promotion Efforts . Provided that Licensor has obtained all Governmental Approvals for the sale and distribution of the Licensed Product, Licensee shall use Commercially Reasonable Efforts to Commercialize the Licensed Product in the Territory.

 

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(b)           Promotion Materials . CASI shall prepare promotion material at its own cost but shall not use major promotion materials until receipt of Juventas’s prior consent, which consent shall not be unreasonably withheld. However, Licensee shall remain solely responsible for such materials’ compliance with applicable Laws.

 

3.4           Costs of Development . All costs of the development of the Licensed Product related to activities provided in Section 3.1 shall be the responsibility of and borne by Juventas, including the cost of the services and materials provided by Third Parties and the cost of the manufacture and supply of Licensed Product.

 

3.5           Governmental Correspondence . Licensee shall be responsible to respond to inquiries, notice or correspondence from Governmental or Regulatory Authority in relation to the Commercialization of the Licensed Product. Licensor shall be responsible to respond to all other inquiries, notice or correspondence from Governmental or Regulatory Authority in relation to the Licensed Product. Both Parties shall provide reasonable assistance to the other Party for their provision of such respond.

 

3.6           Regulatory Information . Each Party shall provide the other Party with all reasonable assistance and take all actions reasonably requested by the other Party that are necessary to enable the other Party to comply with any Law applicable to the Licensed Product. Such assistance and actions shall include, among other things, keeping the other Party informed, commencing within five (5) business days of notification of any action by, or notification or other information which it receives (directly or indirectly) from any Governmental or Regulatory Authority which: (a) raises any material concerns regarding the safety or efficacy of the Licensed Product; (b) indicates or suggests a potential material liability for either Party to third parties arising in connection with the Licensed Product or (c) is reasonably likely to lead to a field alert report, recall or market withdrawal of the Licensed Product; provided, that neither Party shall be obliged to disclose information in breach of any existing contractual restrictions.

 

3.7           Research and Development Plan .

 

(a)          Within six months after the execution of this Agreement, Juventas shall form a research and development plan that further lays out the responsibilities and liabilities of Juventas for the research, filing and production of the Licensed Product (the “ R&D Plan ”) and submit to JSC for approval. The R&D Plan shall include (a) a high-level summary of the research and development activities to be undertaken by Juventas and its Affiliates with respect to the research and development of the Licensed Product, including the activities to be taken during the stages of IND filing, CMC development, GMP manufacturing and NDA and the expected timeline for each stage; and (b) a detailed provision for divisions of risks and liabilities of the Parties in different situations.

 

(b)          The R&D Plan shall be updated on a semi-annual basis and amended from time to time. Any update or amendment shall be submitted to and is subject to the review and approval by the Joint Steering Committee in accordance with the procedures provided in Section IV below.

 

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3.8           Commercialization Plan .

 

(a)          Within six months after the execution of this Agreement, CASI shall form a Commercialization plan that further lays out the responsibilities and liabilities of CASI for the Commercialization of the Licensed Product (the “ Commercialization Plan ”) and submit to JCC for approval. The Commercialization Plan shall include a high-level summary of the Commercialization activities to be undertaken by CASI and its Affiliates with respect to the marketing strategy, promotion materials and third-party agents.

 

Section IV.

Joint Steering Committee and Joint Development Committee

 

4.1           Joint Steering Committee . The Parties shall establish a joint steering committee (the “ JSC ”) to coordinate and oversee activities for which the Parties collaborate, to oversee the development efforts, to provide a decision-making structure and to provide a forum for discussion of matters relating to the development and Commercialization of the Licensed Product.

 

4.2           Membership of JSC . The JSC shall be comprised of an equal number of representatives from each of CASI and Juventas and unless otherwise agreed such number shall be two (2) senior representatives from each of CASI and Juventas. Either Party may replace its respective JSC representatives at any time with prior notice to the other Party, provided, that such replacement is of comparable authority and scope of functional responsibility within that Party’s organization as the person he or she is replacing. CASI shall select one of its representatives as the chairperson for the JSC (the “ Chairperson ”) who shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting (which agenda will include every matter requested by either Party), and preparing and issuing minutes of each meeting within thirty

(30) days thereafter.

 

4.3           Decisions of JSC . The JSC shall make decisions unanimously. In the event that the JSC cannot reach an agreement regarding any matter within the JSC’s authority for a period of twenty (20) days, then the dispute shall promptly be submitted to the senior executive officers of Juventas and CASI for resolution. If the dispute remains unresolved for twenty (20) days after submission to such persons, then the senior executive of Juventas shall have final decision-making authority on matters related to the R&D Plan; provided, however, that the senior executive of CASI shall have final decision-making authority with respect to disputes regarding the Commercialization of the Licensed Product including pricing and sales force deployment, in the Territory.

 

4.4           Responsibilities of JSC . The JSC shall perform the following functions, some or all of which may be addressed directly at each meeting of the JSC:

 

(a)          monitor progress of activities under the R&D Plan;

 

(b)          review and approve amendments to the R&D Plan;

 

(c)          provide a forum for the Parties to keep CASI informed with respect to Juventas’ material activities under the R&D Plan;

 

(d)          discuss strategy for the preparation, filing, prosecution and maintenance of the Intellectual Property related to the Licensed Product; and

 

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(e)          such other responsibilities as may be assigned to the JSC pursuant to this Agreement or as may be mutually agreed by the Parties from time to time.

 

4.5           Joint Development Committee . The Parties will establish a Joint Development Committee (the “ JDC ”) to facilitate cooperation and information transfer on the development of the Licensed Product. The JDC will provide a decision-making structure and forum for discussion of matters relating to the development of the Licensed Product, approve development plans and resources.

 

4.6           Membership of JDC . The JDC shall be comprised of an equal number of representatives from each of CASI and Juventas and unless otherwise agreed such number shall be two (2) senior representatives from each of CASI and Juventas. Either Party may replace its respective JDC representatives at any time with prior notice to the other Party, provided, that such replacement is of comparable authority and scope of functional responsibility within that Party’s organization as the person he or she is replacing. Unless otherwise agreed by the Parties, the JDC shall have at least one representative with relevant decision-making authority from each Party such that the JDC is able to effectuate all of its decisions within the scope of its responsibilities. CASI shall select one of its representatives as the chairperson for the JDC (the “ Chairperson ”) who shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting (which agenda will include every matter requested by either Party), and preparing and issuing minutes of each meeting within thirty (30) days thereafter.

 

4.7           Decisions of JDC . In the event that the JDC cannot reach an agreement regarding any matter within the JDC’s authority for a period of twenty (20) days, then the dispute shall promptly be submitted to the JSC for resolution.

 

4.8           Responsibilities of JDC . The JDC shall perform the following functions, some or all of which may be addressed directly at each meeting of the JDC:

 

(a)          overseeing, reviewing and monitoring activities under this Agreement including, without limitation, any clinical trials proposed to be conducted;

 

(b)          facilitating access to and the exchange of information between the Parties related to the development of the Licensed Product and

 

(c)          undertaking and/or approving such other matters as are specifically provided for under the Agreement.

 

Section V.

Supply of Licensed Product

 

5.1           Supply of Licensed Product . Juventas shall by itself or through a designated manufacturer, completes construction of its GMP Manufacturing Facility, which is fully functional, and, commences manufacturing of the Licensed Product pursuant to the terms and conditions of this Agreement. Subject to the applicable terms in a separate Supply Agreement, Juventas or its designated manufacturer shall be the exclusive manufacturer and supplier of the Licensed Product to CASI. Juventas shall promptly notify CASI when the GMP Manufacturing Facility is complete and operations are ready to commence. Juventas shall supply the Licensed Product to CASI pursuant to a separate supply agreement (“ Supply Agreement ”) to be executed between the Parties within a reasonable time upon execution of this Agreement. The potential business plan for CASI to build manufacturing capability of the Licensed Product, if any, will be discussed by the Parties. If CASI intends to manufacture the Licensed Product in the Territory, Parties shall negotiate the terms and conditions in good faith.

 

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5.2           Supply Price . Juventas shall supply CASI with the Licensed Product in accordance with this Agreement and a separate Supply Agreement. The supply price for the Licensed Product from Juventas to CASI will be [***]:

 

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

 

[***]

 

Section VI.

Milestone and Royalty Payments

 

6.1           Milestone Payment . A non-refundable and non-creditable milestone payment of [***] shall be paid to Licensor upon the initiation of the first Phase II Clinical Trial with the Licensed Product in accordance with the timeline provided under Section 6.3.

 

6.2           Royalty and Non-Royalty Sublicense Payments .

 

(a)           Licensed Product Royalty . Subject to the terms and conditions set forth in the remainder of this Section 6.2, CASI shall pay to Juventas the following royalties on Annual Net Sales of the Licensed Product in the Territory:

 

A.           China Territory. CASI will pay to Juventas a royalty on Net Sales of the Licensed Product in the China Territory on an annual basis at the [***].

 

B.           Ex-China Territory: CASI will pay to Juventas a royalty on Net Sales of the Licensed Product in the Territory on an annual basis at the following rates:

 

i).           For the portion of aggregate Annual Net Sales of all Licensed Product in the Ex-China Territory equal to or less than [***] in any calendar year, [***] of such portion of such Annual Net Sales;

 

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(ii).         For the portion of aggregate Annual Net Sales of all Licensed Product in the Ex-China Territory more than [***] but no more than [***] in any calendar year, [***] of such portion of such Annual Net Sales;

 

(iii).        For the portion of aggregate Annual Net Sales of all Licensed Product in the Ex-China Territory more than [***] but no more than [***] in any calendar year, [***] of such portion of such Annual Net Sales; and

 

(iv).        For the portion of aggregate Annual Net Sales of all Licensed Product in the Ex-China Territory more than [***] in any calendar year, [***] of such portion of such Annual Net Sales.

 

(b)           Non-Royalty Sublicense Income . If CASI sublicenses its rights under this Agreement to any Person pursuant to Section 2.3, CASI shall pay [***] of the Non-Royalty Sublicense Income of such sublicense to Juventas.

 

(c)           Payment Reports . During the Term, following the First Commercial Sale of the Licensed Product in any country or region in the Territory, CASI shall furnish to Juventas a written report (each, a “Payment Report”) within [***] days after the end of each Calendar Quarter showing the Non-Royalty Sublicense Income, Net Sales of each Licensed Product in China Territory and Ex-China Territory and the royalties payable under this Agreement, along with (i) the Non-Royalty Sublicense Income obtained in the Calendar Quarter, (ii) gross sales of the Licensed Product in China Territory and Ex-China Territory, (iii) Net Sales in the relevant Calendar Quarter in China Territory and Ex-China Territory, (iv) all relevant exchange rate conversions in accordance with Section 6.5, (v) all deductions and (vi) the amount of any payment due from CASI to Juventas.

 

6.3           Method of Payments . All payments due from CASI to Juventas under this Agreement shall be paid by CASI or its designated party in RMB by wire transfer to a bank account designated in writing by Juventas. With respect to any payment due under this Section VI, Juventas shall provide CASI an original invoice for the due payment and CASI or its designated party shall make such payment by the [***] day of the month immediately following receipt of the original invoice.

 

6.4           Withholding Taxes . Royalties and milestone payments shall be paid by CASI to Juventas, after deduction of any applicable withholding taxes. Prior to any payment by CASI to Juventas, CASI shall provide to Juventas any forms required to attest Juventas’s fiscal domiciliation in order to allow CASI to claim application of the reduced rate of withholding tax provided for in any applicable bilateral fiscal convention. Juventas shall promptly return such forms to CASI. In the event Juventas fails to promptly return such forms duly filled and signed, CASI shall declare and pay withholding tax at the common law rate of the applicable corporate income tax, and such tax shall then be deducted from the corresponding payment by CASI to Juventas. CASI shall pay withholding tax to the proper taxing authority and proof of payment of such tax shall be secured and sent to Juventas as evidence of such payment. If, in the opinion of either Party, the provisions of this Section 6.4 become extremely burdensome, the Parties agree to meet and discuss such other options as may be available to them. For the avoidance of doubt, Juventas shall still be solely responsible for its own compliance with applicable tax law and CASI shall not be liable for any Juventas’ tax violations in relations to any tax withholdings under this Section 6.4.

 

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6.5           Currency . With respect to sales of the Licensed Product invoiced in RMB, the Net Sales and the amounts due hereunder will be expressed in RMB. With respect to sales of Licensed Product invoiced in a currency other than RMB, the gross sales, Net Sales and royalties payable shall be expressed in the currency of the invoice issued by the Party making the sale together with the RMB equivalent of the royalty payable and the equivalent in the currency used for calculating the applicable royalty rates, calculated using the rate of exchange published in the Wall Street Journal for such currency on the last Business Day of the relevant Calendar Quarter.

 

6.6           Default Payment . In addition to all other rights and remedies hereunder or at law or in equity, CASI shall pay an interest for any and all payment defaulted by CASI under this Agreement. The interest shall accrue on the amount of payment defaulted by CASI, from its due date up to the date of full payment, at a rate of [***] and shall be paid in RMB by wire transfer to a bank account designated by Juventas. Such interest shall accrue from day to day and be computed on the basis of a three hundred and sixty (360) day per year and the actual number of days elapsed.

 

6.7           Audit . Juventas shall have the right during the Term of this Agreement and for [***] after termination of this Agreement to engage an independent auditor that is mutually agreed to by Juventas and reasonably acceptable to CASI to examine the relevant records from time-to-time, as may be necessary to verify compliance with the terms of this Agreement. Such audit shall be requested in writing at least [***] days in advance, and shall be conducted during CASI’s normal business hours and otherwise in a manner that minimizes any interference to CASI’s business operations. In order to fulfill the auditing, the independent auditor so selected shall have the right to access, examine, review and copy all books or accounts of CASI, relevant procurement/distribution agreements and other purchase/sales contracts, purchase/sales orders, operation records, tax paid to local government, and itemized tax for the Licensed Product, and to discuss the business, operations and conditions of CASI with its respective directors, officers, employees, accounts, auditors, financial advisors, legal counsel and investment bankers, to the extent reasonably deemed by Juventas as necessary for determining the accuracy of the report provided by CASI pursuant to Section 6.2(c). CASI shall not unreasonably restrict the independent auditor’s access to premises of CASI during normal business hours. In the event that any independent auditor discovers an underpayment, CASI shall promptly pay to Juventas the amount of such underpayment. The fees charged by such independent auditor shall be paid by Juventas. However, CASI shall pay such fees, provided that if such auditor uncovers an underpayment of fees of [***] or more by CASI.

 

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Section VII.

Representations, Warranties and Covenants

 

7.1           Licensor Representations, Warranties and Covenants . Licensor hereby represents, warrants and covenants to Licensee, as of the Effective Date, as follows:

 

(a)          the execution, delivery and performance by Licensor of this Agreement and the consummation of the transactions contemplated hereby are within Licensor’s corporate powers and have been duly authorized by all necessary corporate action on the part of Licensor. This Agreement constitutes the legal, valid and binding obligation of Licensor, enforceable against Licensor in accordance with its terms

 

(b)          the execution, delivery and performance of this Agreement by Licensor will not violate: (i) any Laws or any order of any Governmental or Regulatory Authority; or (ii) any provision of Licensor’s certificate of incorporation or other organizational documents;

 

(c)          to the knowledge of Licensor, none of the Intellectual Property existing as of the Effective Date has been adjudged invalid, unenforceable or unpatentable by any Governmental or Regulatory Authority of competent jurisdiction, and all such Intellectual Property existing as of the Effective Date are valid and enforceable.

 

(d)          To the knowledge of Licensor, (a) the exploitation of Licensed Product based upon the Intellectual Property as it exists on the Effective Date does not infringe any issued patent or any pending patent of any person and (b) the use of the Intellectual Property by Licensee pursuant to the terms of this Agreement, and Licensee’s exercise of its rights hereunder in connection therewith, does not infringe, misappropriate or otherwise violate the trade secret rights or copyrights of any other Person. No written claim or demand of any Third Party has been made, or to the knowledge of Licensor, is threatened against Licensor and there is no proceeding, or action, claim (including regarding infringement of Intellectual Property), complaint, demand, suit, proceeding, or arbitration brought by a third party, pending, or, to the knowledge of Licensor, threatened, as of the Effective Date, against Licensor, and in each case involving any of the Intellectual Property or Licensed Product existing as of the Effective Date or the exploitation of the foregoing and (i) challenging any rights of Licensor in any such Intellectual Property or Licensed Product, (ii) alleging that any issued patent within such Intellectual Property is invalid or unenforceable, (iii) alleging that the use of any Intellectual Property existing as of the Effective Date infringes any issued patent of a third party or infringes, misappropriates or otherwise violates the Intellectual Property rights of any Person, (iv) challenging the transactions contemplated by this Agreement or (v) asserting that the manufacture, use, sale, offer for sale or importation of Licensed Product or the processes used to make Licensed Product is or was infringing or otherwise violates or violated any Intellectual Property of any Person.

 

(e)          Licensor is and has been in compliance in all material respects with all applicable Laws applicable to and in connection with the exploitation of the Intellectual Property and the Licensed Product. There are no, and there have not been any issued judicial orders, writs, injunctions, decrees, judgments or stipulations in force against Licensor with respect to the Intellectual Property or Licensed Product that would reasonably be expected to have a material adverse effect on the ability of Licensee to exploit the Licensed Product in the Field in the Licensee Territory in compliance with all applicable Laws.

 

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(f)           To the knowledge of Licensor, no third party has infringed, misappropriated or otherwise violated any Intellectual Property.

 

(g)          The Intellectual Property owned by Licensor or both controlled by and prosecuted by Licensor and, to the knowledge of Licensor, the Intellectual Property controlled but not prosecuted by Licensor have been maintained properly in accordance with all applicable Laws, including disclosure of all prior art to the relevant patent authority to the extent required by applicable Laws, and with all applicable fees due with respect thereto having been paid.

 

(h)          To the knowledge of Licensor, the scientific, technical and other information relating to the Intellectual Property and Licensed Product disclosed or made available by Licensor or any of its representatives to Licensee in writing in the electronic data room has been true and correct in all respects.

 

(i)           Licensor is not currently assisting any third party in preparation for or in connection with filing an IND with respect to the Licensed Product.

 

(j)           Licensor has the unrestricted right to grant to Licensee the rights in the Intellectual Property in the Territory that are being granted to Licensee under this Agreement upon the terms set forth herein. Licensor has granted any license or sublicense to any rights in the Intellectual Property in the Territory to any Third Party that are in conflict with the rights granted to Licensee in this Agreement.

 

(k)          Licensor has taken reasonable and customary measures to maintain and protect, as applicable, the confidentiality of its or their owned Confidential Information within the Intellectual Property. Notwithstanding the foregoing, Licensor and its Affiliates may disclose Confidential Information to (a) Third Parties under an obligation of confidentiality with respect to such information, (b) Governmental Authorities or Regulatory Authorities in order to obtain patents or develop or submit Regulatory Filings for products, and (c) the extent required by Law.

 

(l)           All employees, consultants, contractors and other persons who have contributed to the design, creation, conception, reduction to practice or invention of any Intellectual Property in the Intellectual Property or the Intellectual Property have entered into written agreements with Licensor assigning to Licensor all rights relating to such design, conception, reduction to practice, invention or Intellectual Property.

 

(m)         The Licensor in compliance with all applicable Laws in relation to the reporting of adverse events in relation to clinical studies of the Licensed Products.

 

(n)          To the knowledge of Licensor, all clinical studies and nonclinical studies sponsored by Licensor relating to the Licensed Product have been and are being conducted in material compliance with applicable Laws, including Laws, rules, regulations and guidance restricting the use and disclosure of individually identifiable health information. Licensor has not received any written notices or other written correspondence from any Governmental or Regulatory Authority with respect to any ongoing clinical studies and nonclinical studies relating to the Licensed Product requiring the termination, suspension or material modification of such clinical studies and nonclinical studies.

 

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(o)          Licensor and its employees have never been (i) debarred or (ii) convicted of a crime for which a Person can be debarred under Section 306(a) of the U.S. Generic Drug Enforcement Act of 1992 (Section 306(a) or (b)) or similar Laws of any other jurisdiction.

 

7.2           Licensee Representations, Warranties and Covenants . Licensee hereby represents, warrants and covenants to Licensor as follows:

 

(a)          the execution, delivery and performance of this Agreement by Licensee and the consummation of the transactions contemplated hereby are within the Licensee’s corporate powers and have been duly authorized by all necessary corporate action on the part of Licensee. This Agreement constitutes the legal, valid and binding obligations of the Licensee, enforceable against the Licensee in accordance with its terms;

 

(b)          Licensee will be properly registered, licensed and qualified, and have all requisite power and authority under its organizational documents and in accordance with applicable Laws to market and sell Licensed Product in the Territory, and to conduct its business and perform its obligations hereunder and, during the Term and any extensions thereof, it shall take all action as may be required and necessary to obtain and keep current any governmental licenses, permits, registrations and approvals that are necessary for it to develop, make, market and sell the Licensed Product and carry out its other activities hereunder;

 

(c)          the execution, delivery and performance of this Agreement by Licensee will not violate: (i) any Laws or any order of any Governmental or Regulatory Authority; or (ii) any provision of Licensee’s certificate of incorporation or other organizational documents;

 

(d)          Licensee shall carry out its obligations and activities under this Agreement (including without limitation the marketing, promotion, distribution and sale of the Licensed Product) in accordance with: (i) the terms hereof and (ii) all applicable Laws; and

 

(e)          Licensee and its employees have never been (i) debarred or (ii) convicted of a crime for which a Person can be debarred under Section 306(a) of the U.S. Generic Drug Enforcement Act of 1992 (Section 306(a) or (b) or similar Laws of any other jurisdiction.

 

Section VIII.

Term and Termination

 

8.1           Term . Unless terminated in accordance with Section 8.2, the term of this Agreement shall be as long as CASI or its distributors and/or sublicensees Commercializes the Licensed Product (the “ Term ”).

 

8.2           Termination .

 

(a)           Termination for Material Breach . Either Party may terminate this Agreement for a material breach of this Agreement by the other Party if the breaching Party fails to cure any such breach within [***] calendar days after receipt of written notice from the non- breaching Party specifying such breach. In the event the Supply Agreement is terminated by either Party as the result of a material breach of the terms of the Supply Agreement by the other Party, this Agreement shall be deemed to be terminated at the same time.

 

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(b)           Termination for Insolvency or Bankruptcy . Either Party may immediately terminate this Agreement upon written notice to the other Party in the event that: (i) the other Party is declared insolvent or bankrupt by a court of competent jurisdiction; (ii) a voluntary petition of bankruptcy or reorganization is filed in any court of competent jurisdiction by such other Party; (iii) this Agreement is assigned by such other Party for the benefit of creditors; or (iv) an involuntary petition of bankruptcy or reorganization is filed against the other Party or its assets and such petition is not dismissed within [***] days of filing.

 

(c)           Termination for Governmental Action . Either Party may terminate this Agreement upon [***] days prior written notice in the event that any Governmental or Regulatory Authority takes any action or raises any objection that prevents Licensee from making, having made, marketing, promoting, importing, purchasing or selling Licensed Product, or that has the effect of making any of the transactions contemplated by this Agreement unlawful.

 

(d)           Termination for Failure to Close under the Investment Agreement . The Parties entered into an Investment Agreement dated June 15, 2019 with other parties under which CASI intended to make certain equity investment into Juventas in the amount of RMB80,000,000 upon Closing (as defined in the Investment Agreement). Juventas may terminate this Agreement immediately upon written notice to CASI if, for any reason, the Closing fails to occur.

 

(e)          Termination for Change of Control. Either Party may terminate this Agreement upon [***] days prior written notice if the other Party is subject to a Change of Control.

 

8.3           Effect of Termination . On the date of termination or expiration of this Agreement, (a) all rights and obligations granted under or imposed by this Agreement will cease and terminate, except as set forth herein and in Section 8.4, (b) all license granted to CASI under this Agreement shall terminate, (c) CASI shall cease its use and, upon request, within 30 days either return to Juventas or destroy (and certify as to such destruction) all Juventas’ Confidential Information, including any copies thereof, (d) CASI shall promptly deliver to Juventas all information, documents and other materials, which belong to the Improvements or are necessary for Juventas to Commercialize the Licensed Product and (e) CASI or its Affiliates shall not engage in development, marketing or sale of the Licensed Product in the Territory before [***] anniversary after the termination or expiration of this Agreement. Notwithstanding the foregoing, unless this Agreement was terminated by Licensor due to Licensee’s breach of this Agreement, Licensee shall have the right to sell and distribute its existing inventory of Licensed Product, not including products in process of manufacture, subject to the terms of this Agreement and payment of applicable royalties to Licensor as set forth in Section 6.2 above. Such expiration or termination shall not affect any claim, demand, liability or right of a Party arising pursuant to this Agreement prior to the expiration or termination hereof. For the avoidance of doubt, termination or expiration of this Agreement shall not affect a Party’s right to seek damages from the responsible Party for actions or omissions occurring prior to such termination or expiration.

 

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8.4           Survival . The following provisions shall survive any termination or expiration of this Agreement: Section 2.4, Section 2.5, Section 2.8, Section 8.3, Section IX, Section X and Section XI.

 

Section IX.

Confidentiality and Press Releases

 

9.1           Confidential Information . Except to the extent otherwise agreed in writing, the Parties agree that the receiving Party (the “ Receiving Party ”) shall keep confidential and shall not publish or otherwise disclose or use for any purpose other than as provided for in this Agreement any confidential and proprietary information and materials, patentable or otherwise, in any form (written, oral, photographic, electronic, magnetic, or otherwise) which is disclosed to it by the other Party (the “ Disclosing Party ”) or is otherwise received, accessed or developed by a Receiving Party in the course of performing its obligations under this Agreement, including, but not limited to, all information concerning the Intellectual Property, Licensed Product(s), the contents of this Agreement and any other technical and business information of whatever nature (collectively, “ Confidential Information ”). Without limiting the generality of the foregoing, the Receiving Party may disclose the Confidential Information only to the Receiving Party’s officers, employees, consultants, agents (the “ Representatives ”) who have a need to know the Confidential Information in connection with the transaction contemplated hereby and which Representatives are contractually or otherwise legally bound to hold and use the Confidential Information in substantial accordance with the terms herein. The Receiving Party shall guarantee the full performance by the Representatives of the confidentiality obligation set forth herein. Intellectual Property and Improvements shall be the Juventas’ Confidential Information.

 

9.2           Exclusions . The obligations of confidentiality and non-use set forth in Section 9.1 shall not apply to any portion of the Confidential Information which the Receiving Party is able to establish by competent proof: (i) was already legally in the possession of the Receiving Party, at the time of disclosure by the Disclosing Party; (ii) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party; (iii) became generally available to the public or was otherwise part of the public domain after its disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement; or (iv) was disclosed to the Receiving Party by a third party provided that the Confidential Information was disclosed by such third party in non-violation of any confidentiality obligation.

 

9.3           Exceptions . The obligations of this Section IX shall not apply to Confidential Information that: (i) is submitted to a Governmental or Regulatory Authority to facilitate the issuance of any registrations for the Licensed Product or the Intellectual Property, provided that the Disclosing Party is informed of such submission and the required Confidential Information in advance of the disclosure and reasonable measures shall be taken to assure confidential treatment of such information where permitted; (ii) is provided by the Receiving Party to third parties under confidentiality agreements having provisions at least as stringent as those in this Agreement, and solely for consulting, funding, merger or acquisition activity, external testing and marketing trials with respect to any of the subject matter of this Agreement; or (iii) is otherwise required to be disclosed in compliance with applicable Laws (including, without limitation and for the avoidance of doubt, the requirements of any securities regulatory authorities or any stock exchange on which securities issued by a Party are traded) or order by a court or other governmental or regulatory authority having competent jurisdiction; provided, that, if a Party is required to make any such disclosure of the other Party’s Confidential Information such Party will give reasonable advance written notice to the other Party of such disclosure requirement and will use its best efforts to secure confidential treatment of such Confidential Information required to be disclosed.

 

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9.4           Remedies . Each Party shall be entitled, in addition to any other right or remedy it may have, at law or in equity, to seek an injunction from any court of competent jurisdiction, without the posting of any bond or other security, enjoining or restraining the other Party from any violation or threatened violation of this Section IX.

 

9.5           Duration . All obligations of confidentiality, limited use and non-disclosure imposed by this Section IX with respect to any and all items of Confidential Information shall expire five years after the termination of this Agreement, unless a longer period is prescribed by Law.

 

9.6           Press Releases . Except as required by Law (including requirements of applicable securities administrators or any other stock exchange on which securities issued by a Party are traded) or any governmental or regulatory authority, neither Party shall make any press release or other public announcement relating to the Agreement or the transactions described herein without the prior written consent of the other Party, which consent will not be unreasonably withheld. Subject to the foregoing, each Party shall use Commercially Reasonable Efforts to provide the other Party an opportunity to review any press release or similar public statement related to this Agreement or Licensed Product prior to publicly releasing such press release.

 

Section X.

Indemnification

 

10.1         Indemnification by Licensor . Licensor shall defend, indemnify and hold harmless Licensee, its Affiliates, officers, directors, employees and agents against any and all Losses arising out of, in connection with or attributable to: (a) Licensor’s breach of any representation, warranty or covenant under this Agreement; (b) any negligent or wrongful act or omission on the part of Licensor, its Affiliates, officers, directors, employees, agents or representatives except, in each case, to the extent that any such Losses are caused by the negligence or wrongful act(s) of Licensee, its Affiliates, officers, directors, employees or agents; and (c) any Licensor Product Liability Claims except, in each case, to the extent that any such Losses are caused by the negligence or wrongful act(s) of Licensee, its Affiliates, officers, directors, employees or agents.

 

10.2         Indemnification by Licensee . Licensee shall defend, indemnify and hold harmless Licensor, its Affiliates, officers, directors, employees and agents against any and all Losses arising out of, in connection with or attributable to: (a) Licensee’s breach of any representation, warranty or covenant under this Agreement, (b) the promotion, marketing, sale or distribution of the Licensed Product(s) by Licensee in any part of the Territory or any negligent or wrongful act or omission on the part of Licensee, its Affiliates, officers, directors, employees, agents, sublicensees or representatives except, in each case, to the extent that any such Losses are caused by the negligence or wrongful act(s) of Licensor, its Affiliates, officers, directors, employees or agents.

 

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10.3         Procedures . The Party seeking indemnification under this Section X (the “ Indemnified Party ”) shall give prompt notice to the Party against whom indemnity is sought (the “ Indemnifying Party ”) of the assertion or commencement of any Proceeding in respect of which indemnity may be sought under this Section X and will provide the Indemnifying Party such information with respect thereto that the Indemnifying Party may reasonably request. The failure to give such notice will relieve the Indemnifying Party of any liability hereunder only to the extent that the Indemnifying Party has suffered actual prejudice thereby. The Indemnifying Party shall assume and control the defense and settlement of any such action, suit or Proceeding at its own expense. The Indemnified Party shall, if requested by the Indemnifying Party, cooperate in all reasonable respects in such defense, at the Indemnifying Party’s expense, subject to the following. The Indemnified Party will be entitled at its own expense to participate in such defense and to employ separate counsel for such purpose. For so long as the Indemnifying Party is diligently defending any Proceeding pursuant to this Section X, the Indemnifying Party will not be liable under this Section X for any settlement effected without its consent. No Party to this Agreement shall make any admission, compromise or settlement which includes terms which adversely impact the other Party without the other Party’s prior written consent.

 

10.4          Infringement Claims .

 

(a)           Procedure . If either Party learns of or develops a basis for an infringement, unauthorized use, misappropriation or ownership claim or threatened infringement or other such claim (an “ Infringement ”) by or against a third party with respect to the Intellectual Property or the Licensed Product in the Territory, such Party shall promptly notify the other Party in writing and shall promptly provide such other Party with available evidence of such Infringement. Licensor shall have the first right, but not the obligation, to institute or defend Infringement actions against or by any such third parties in the Territory. If, in any such instance, Licensee does not secure actual cessation of such Infringement or institute or respond to an Infringement proceeding within 90 days of learning of such Infringement, then Licensor may institute or defend such Infringement action. Each Party maintaining any such Infringement action shall keep the other Party reasonably informed as to the status of such action. Each Party shall execute all necessary and proper documents, take such actions as shall be appropriate to allow the other Party to maintain any such Infringement action and shall otherwise cooperate in the maintenance of any such action (including, without limitation, consenting to being named as a Party thereto).

 

(b)           Costs and Expenses . The costs and expenses of instituting an Infringement action (including fees of attorneys and other professionals) against a third party shall be borne by the Party maintaining the action. The costs of defending an Infringement action for infringement in the Territory shall be borne by the Licensor, including any amounts to be paid in settlement or as finally awarded by a court, unless such action results from unauthorized Improvements made by Licensee or use of the Intellectual Property other than as licensed herein .

 

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(c)           Allocation of Award for Third Party Infringement . In the event that any Infringement action instituted by Licensor and/or Licensee proceeds to judgment or settlement, any award paid by third parties as a result of such an Infringement action (whether by way of settlement or otherwise) shall be applied first to reimburse the costs and expenses incurred by the Parties with respect to such action and any remaining funds shall be allocated as follows: (i) if Licensor has maintained such action alone, Licensor shall be entitled to retain such remaining funds; (ii) if Licensee has maintained such action alone, Licensee shall be entitled to retain such remaining funds; or (iii) if the Parties have cooperated in maintaining such action, the Parties shall allocate such remaining funds between themselves in the same proportion as they have agreed to bear the expenses of maintaining such action or as otherwise agreed by the Parties in writing.

 

(d)           Infringement on Third Party Rights; License Required . If, in the course of any Infringement action by a third party instituted against Licensor or Licensee, a license to any third party patent becomes necessary in order for Licensee to enjoy the rights to the Licensed Product contemplated by this Agreement, then Licensee will be entitled to enter into such a license on terms and conditions as are required by the third party, and Licensee will be entitled to deduct from royalties otherwise payable under this Agreement during any quarter one half of the royalty payments during such quarter to the third party in respect of such third party’s patent; provided, further, that in no event shall the royalty rate payable under this Agreement after giving effect to such credit be reduced by more than twenty five percent (25%). Licensee shall keep Licensor fully informed of any such license negotiations and the Parties shall cooperate in good faith to minimize the amounts payable with respect to any such third-party intellectual property.

 

10.5         Consequential Damages . Neither Party to this Agreement shall be liable to or otherwise responsible to the other Party hereto for any loss of profits, diminution in value, or incidental, indirect, consequential, special, exemplary or punitive damages that arise out of or relate to this Agreement or the performance or breach hereof or otherwise and whether in contract, tort, strict liability or otherwise; provided, that, the foregoing limitation shall not apply: (i) to a Party’s third party indemnification obligations pursuant to Sections 10.1 and 10.2 above, (ii) to any personal injury or property damage caused by the grossly negligent or willful misconduct of a Party, or (iii) to any violation of applicable Law.

 

Section XI.

Miscellaneous

 

11.1         Choice of Law; Jurisdiction . This Agreement shall be governed by and construed exclusively in accordance with the laws of Hong Kong, without regard to conflicts of law rules. The language of this Agreement shall be English. Except as expressly set forth below, any dispute, controversy or claim arising out of or in relation to this Agreement, or breach hereof, shall be first settled through amicable negotiations between the Parties. If these negotiations do not result in an amicable resolution, then arbitration shall be sought in accordance with Section 11.2 found below.

 

11.2         Arbitration . Any dispute, controversy, difference or claim arising out of or relating to this contract, including the existence, validity, interpretation, performance, breach or termination thereof or any dispute regarding non-contractual obligations arising out of or relating to it shall be referred to and finally resolved by arbitration administered by the Hong Kong International Arbitration Centre (HKIAC) under the HKIAC Administered Arbitration Rules in force when the Notice of Arbitration is submitted. Each Party shall pay its or his own expenses of such arbitration, and the fees and expenses of the arbitrator shall be paid by the non-prevailing Party.

 

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11.3         Waiver . The waiver by any Party of a breach of any provision of this Agreement shall not operate, or be construed, as a waiver of any subsequent breach.

 

11.4         Modification . No change, modification, or waiver of any terms of this Agreement shall be valid unless it is in writing and signed by both Parties.

 

11.5         Entire Agreement . This Agreement constitutes the entire agreement between the Parties with respect to the subject matter hereof and thereof, and supersede all prior agreements and understandings, whether oral or written, between the Parties, it being understood that any information exchanged under a confidentiality or nondisclosure entered into prior to the date hereof shall be treated as Confidential Information disclosed under this Agreement.

 

11.6         Force Majeure . If the actual performance of any obligations under this Agreement is prevented by any act of God (such as fire, flood, earthquake or other natural cause), terrorist events, riots, insurrections, declared or undeclared war or national emergency, governmental action or inaction unrelated to Licensed Product or the Parties’ acts or omissions, or other similar event outside the reasonable control of a Party, the Party affected by such event (a “ Force Majeure ”) shall be excused on a day-by-day basis to the extent of the prevention; provided, that such Party notifies the other Party as soon as practicable of the nature and expected duration of the claimed Force Majeure, uses all Commercially Reasonable Efforts to avoid or remove the causes of nonperformance and resumes performance promptly after the causes have been removed. If either Party is unable to perform its obligations under this Agreement due to a Force Majeure event for a period in excess of 90 days, the other Party may terminate this Agreement.

 

11.7         Assignment . Licensee shall not be entitled to assign its rights or delegate its obligations hereunder in whole or in part without the express prior written consent of Licensor, which consent shall not be unreasonably withheld or delayed. The foregoing notwithstanding, no consent shall be required for the assignment of this Agreement in connection with a change in control or a sale of all or substantially all of the assets of Licensee so long as Licensee is then in full compliance with the terms of this Agreement and the successor or assignee agrees in a writing enforceable by Licensor to be bound by the terms of this Agreement.

 

11.8         Independent Contractor . This Agreement shall not be construed as constituting a partnership, joint venture or any other form of legal association that would impose liability upon one Party for the act or failure to act of the other Party, or as providing either Party with the right, power or authority (express or implied) to create any duty or obligation of the other Party.

 

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11.9         Headings . The headings have been inserted for convenience only and are not to be considered when interpreting the provisions of this Agreement.

 

11.10       Counterparts . This Agreement may be executed in multiple counterparts, each of which will be deemed an original, but all of which together shall constitute one and the same instrument.

 

11.11       Severability . Each provision of this Agreement will to the extent possible be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement.

 

11.12       Notices . All notices or other communications hereunder shall be deemed sufficient if given in writing, via registered mail (return receipt requested), postage paid, or by reputable international delivery service (e.g. FedEx) or by courier addressed to the appropriate Party at the address set forth below, or at such other place as such Party may designate in writing to the other Party.

 

If to Licensor: Juventas Cell Therapy Ltd.
Attn: Yiping Deng (邓一平)
Address: 1103, Building No.3, Huamao Center, 77 Jianguo Road, Chaoyang District, Beijing, China 100025
Email: [***]
Tel: [***]
   
If to Licensee: CASI Pharmaceuticals, Inc.
Attn: George Chi
Address:

9620 Medical Center Drive, Suite 300

Rockville, Maryland 20850

Email: [***]
Tel: [***]

 

All such notices shall be effective upon receipt.

 

11.13       Insurance . Each Party shall have and maintain such types and amounts of liability insurance covering the manufacture, use and sale of the Licensed Product as is normal and customary in the pharmaceutical industry generally for Parties similarly situated, and shall upon request provide the other Party with a copy of its policies of insurance in that regard, along with any amendments and revisions thereto.

 

[Signatures on following page]

 

  25  

 

 

IN WITNESS WHEREOF, this Exclusive License Agreement has been executed by a duly authorized officer of each Patty as of the Effective Date.

 

  “Licensor”
   
  JUVENTAS CELL THERAPY LTD.
   
  By: /s/ Lulu Lv
  Name: Lulu Lv
  Title: Authorized Representative

 

     

 

  

IN WITNESS WHEREOF, this Exclusive License Agreement has been executed by a duly authorized officer of each Party as of the Effective Date.

 

  “Licensee”
   
  CASI PHARMACEUTICALS, INC.
   
  By: /s/ George Chi
  Name: George Chi
  Title: Chief Financial Officer

 

     

 

Exhibit 10.2

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission.

***Triple asterisks denote omissions.

 

Execution Version

 

INVESTMENT AGREEMENT

 

in respect of

 

JUVENTAS CELL THERAPY LTD.

(合源生物科技(天津)有限公司)

 

     

 

 

TABLE OF CONTENTS

 

1. Definition and Interpretation 5
2. The Transaction 14
3. Conditions Precedent 15
4. Closing 17
5. Warrantors’ Representations and Warranties 17
6. Series A Investors and Series A+ Investors’ Representations and Warranties 27
7. Covenants of the Founding Shareholders and the Company 28
8. Mutual Covenants 30
9. Shareholders’ Meetings 30
10. Board of Directors and Officers 31
11. Information and Inspection Rights 35
12. Dividend 36
13. Pre-Emptive Right 36
14. Anti-dilution Right 37
15. Prohibition on Transfer of Equity Interest 38
16. Rights of First Refusal 39
17. Right of Co-Sale. 40
18. Liquidation Preferences. 40
19. Redemption. 42
20. Drag Along Rights. 44
21. Most Favoured Investor. 45
22. Additional Agreements; Covenants. 46
23. Limitations on Use of Name 47
24. Assignments and Transfers 47
25. Termination or Amendment of The Privilege. 47
26. Qualified IPO 48
27. Accounting Matters 48
28. Confidentiality and Announcements 48
29. Default and Indemnification 50
30. Independent Nature of Obligations and Rights of Series A+ Investors 50
31. Termination 50
32. Dispute Resolution and Governing Law 51
33. Miscellaneous 52

 

EXHIBITS  
Exhibit A Capitalization Table
Exhibit B Company Information
Exhibit C Disclosure Schedule
Exhibit D List of Key Employees

 

     

 

 

THIS INVESTMENT AGREEMENT (this “Agreement”) is executed as of June 15, 2019 (Beijing Time, the “ Execution Date ”), by and among:

 

1. JUVENTAS CELL THERAPY LTD ( 合源生物科技 ( 天津 ) 有限公司 ) (the “ Company ”), a company with limited liability established under the laws of the PRC whose Unified Social Credit Code is 91120116MA06D8BX5T, with its registered office at Building 5, No.8, Haitai Development Third Road, Huayuan Industrial District (Outer Ring), Binhai High-Tech Zone, Tianjin;

 

2. [*** ], a partnership with limited liability established under the laws of the PRC, with its registered office at [***];

 

3. [*** ], together with [*** ], “ Founding Shareholders ”), a partnership with limited liability established under the laws of the PRC, with its registered office at [***];

 

4. [*** ], a company limited by shares established under the laws of the PRC, with its registered office at [*** ];

 

5. [*** ], a partnership with limited liability established under the laws of the PRC, with its registered office at [*** ];

 

6. [*** ], a partnership with limited liability established under the laws of the PRC, with its registered office at [*** ];

 

7. [*** ], a partnership with limited liability established under the laws of the PRC, with its registered office at [*** ];

 

8. [*** ], a partnership with limited liability established under the laws of the PRC, with its registered office at [*** ];

 

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9. [*** ], a partnership with limited liability established under the laws of the PRC, with its registered office at [*** ];

 

10. [*** ], together with [*** ], the “ Series A Investors ”), a partnership with limited liability established under the laws of the PRC, with its registered office at Room 205-2, Building 25, 128 Yongfeng Road, Daxie Development Zone, Ningbo City, Zhejiang Province;

 

11. CASI Biopharmaceuticals (WUXI) Co., Ltd. (凯信生物医药(无锡)有限公司) (“ CASI ”), a company with limited liability established under the laws of the PRC, with its registered office at C10402, No. 1699, Huishan Avenue, Huishan Economic Development Zone, Wuxi; and

 

12. [*** ], the “ Series A+ Investors ”) , a company with limited liability established under the laws of the PRC, with its registered office at [*** ].

 

(for the avoidance of doubt, with respect to RMB 1,666,667 of registered capital held by [*** ] according to the Series A Investment Agreement, [*** ] shall be regarded as Series A Investor; with respect to RMB 1,175,439 of registered capital held by [*** ] according to this Agreement, [*** ] shall be regarded as Series A+ Investor; each party referenced above, a “ Party ” and collectively, the “ Parties ”; Series A Investors and Series A+ Investors, each the “ Investor ” and collectively the “ Investors ”).

 

WHEREAS:

 

(A) The Company is a company with limited liability duly organized and validly existing under the laws of PRC engaged in research, development, manufacturing or selling of any technology or product in relation to cellular immunotherapy, including without limitation CAR-T, CAR-NK, and TIL.

 

(B) The Company desires to increase new registered capital of RMB 12,929,825 (the “ Increased Capital ”). The Series A+ Investors desires to subscribe all the Increased Capital pursuant to the terms and conditions set forth in this Agreement (the “ Transaction ”);

 

(C) The Founding Shareholders, the Series A Investors, the Series A+ Investors and the Company agree to consummate the Transaction pursuant to the terms and conditions set forth in this Agreement.

 

The Parties hereby agree as follows:

 

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1. Definition and Interpretation

 

1.1 Unless the context otherwise requires, the following words and expressions shall have the following meanings:

 

Accounts   means the Company’s audited balance sheets and profit and loss statements and unaudited management accounts (including the notes in each case) as at the Account Date, which have been provided to the Series A+ Investors;
     
Account Date   means March 31, 2019;
     
Addition Equity   has the meaning given to such term in Section 13.1 of this Agreement;
     
Affiliate   means, (i) in the case of a person other than a natural person, any other person Controlled by, Controlling or under the common Control with the specified person; (ii) in the case of a person who is a natural person, any other person Controlled by such person directly or indirectly, or is a direct relative of such person.
     
Amended Articles   means the amended articles of association of the Company in the form to the satisfactory of the Series A+ Investors;
     
Applicable Laws   means, with respect to any subject person, all applicable (i) constitutions, treaties, statutes, laws (including the common law), codes, rules, regulations, ordinances or orders issued by any Governmental Authority, and (ii) notices, orders, decisions, injunctions, judgments, awards and decrees issued by, or agreements with, any Governmental Authority;
     
Anti-dilution Right   has the meaning given to such term in Section 14.1 of this Agreement;
     
Anti-dilution Indemnification   has the meaning given to such term in Section 14.2.2 of this Agreement;
     
Articles of Association   means the articles of association of the Company, as amended from time to time;

 

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Auditor   means the auditor of the Company;
     
Board   means the Company’s board of directors;
     
Business   means the business currently being conducted or to be conducted by the Company, namely research, development, manufacturing or selling of any technology or product in relation to cellular immunotherapy, including without limitation CAR-T, CAR-NK, and TIL;
     
Business Day   means any day other than a Saturday or Sunday or a public holiday in the PRC and the United States;
     
Capital Increase Notice   has the meaning given to such term in Section 13.1 of this Agreement;
     
Chairman   means the Chairman of the Board of Directors;
     
Closing   means  the  consummation  of  the  Transaction  pursuant  to Section 4 of this Agreement;
     
Closing Date   means the date on which Closing takes place;
     
Company Affiliate   has the meaning given to such term in Section 5.17.1 of this Agreement;
     
Conditions Precedent   means the conditions precedent to Closing as specified in Section 3;
     
Consents   means any consent, approval, verification, authorization, waiver, license, exemption, acknowledgement or order of, registration or filing with, or report or notice to, any person or any Governmental Authority;
     
Contract   means a legally binding contract, agreement, understanding, indenture, note, bond, loan, instrument, lease, mortgage, franchise or license;
     
Control   means: (i) direct or indirect ownership of more than fifty percent (50%) of the share capital or other ownership interest in a subject person, or (ii) the right to exercise more than fifty percent (50%) of the voting rights in such subject person or (iii) the contractual right to designate more than half of the members of such subject person’s board of directors or similar executive body or (iv) the power to direct the management or policies of such subject person, through contractual arrangements or otherwise; and “ Controlled by ” or any similar term shall be construed accordingly;

 

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Director   means a director of the Board of the Company;
     
Disclosure   means any full and fair disclosure made by any Warrantors and the Company as set out in the Disclosure Schedule;
     
Disclosure Schedule   means the letter attached in Exhibit C of this Agreement;
     
Distributable Proceeds   has the meaning given to such term in Section 18.2.4 of this Agreement;
     
Drag Along Shareholder   has the meaning given to such term in Section 20.1 of this Agreement;
     
Drag Along Sale   has the meaning given to such term in Section 20.1 of this Agreement;
     
Dragged Shareholders   has the meaning given to such term in Section 20.2 of this Agreement;
     
Equity Security   means, with respect to any subject person, any share, Shareholder interest, partnership interest,  sponsor right  or registered capital, joint venture interest or other ownership interest, and any option, warrant or other security which is directly or indirectly convertible into, or exercisable or exchangeable for such share, Shareholder interest, partnership interest, sponsor right or registered capital, joint venture interest or other ownership interest (whether or not such derivative security is directly issued by such subject person);
     
Encumbrance   means a mortgage, charge, pledge, lien, option, restriction, right of first refusal, right of pre-emption, third-party right or interest, other encumbrance or security interest of any kind, or any other type of preferential arrangement having similar effect  (including,  without  limitation,  a  title  transfer  or retention arrangement);

 

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Exhibit(s)   means all the exhibits attached as an integral part of this Agreement;
     
Extra Equity   has the meaning given to such term in Section 14.2.1 of this Agreement;
     
FCPA   has the meaning given to such term in Section 5.17.1 of this Agreement;
     
Governmental Authority   means any court, tribunal, arbitrator, authority, agency, commission, official or other instrumentality of the PRC, and any domestic or foreign legislative institution, state, county, city or other political sub-division related to this Agreement;
     
Government Official   has the meaning given to such term in Section 5.17.1 of this Agreement;
     
Government Entity   has the meaning given to such term in Section 5.17.1 of this Agreement;
     
Increased Capital   has the meaning given to such terms in Recital (B);
     
Intellectual Property Rights   means all titles and licenses to inventions, patents, designs, databases, copyrights (including rights in computer software), internet domain names, know-how, logos, trade names and trademarks and any other intellectual property rights, in each case whether registered or unregistered and including applications for the grant of any of the foregoing and all rights or forms of protection having equivalent or similar effect to any of the foregoing, which may subsist anywhere in the world to the extent owned or used by the Company;
     
Investment Price   means  the  Series  A  Investment  Price  and/or  Series  A+ Investment Price attached hereto in Exhibit A;
     
Key Employee   means all employees and personnel listed in Exhibit D.
     
Liquidation Preference   has the meaning given to such term in Section 18.1.1 of this Agreement;
  8  

 

 

Material Adverse Change   means any change or event which results in Material Adverse Effect;
     
Material Adverse Effect   means any change, event or effect that (i) is or would be materially adverse to the business, operations, assets, liabilities, conditions (financial or otherwise) or results of operations or prospects of the Company, (ii) is or would materially impair the validity or enforceability of this Agreement or any other Transaction Document, or (iii) is or would materially and adversely affect the ability of any of the Founding Shareholders and/or the Company to perform its obligations under this Agreement, or otherwise in connection with the Transaction contemplated hereunder;
     
Material Contract   has the meaning given to such term in Section 5.13.1 of this Agreement.
     
Money Laundering Law   has the meaning given to such term in Section 5.18.1 of this Agreement;
     
Non-Requesting Holder   has the meaning given to such term in Section 19.1.8 of this Agreement;
     
Offer Equity   has the meaning given to such term in Section 16.1 of this Agreement;
     
Offeror   has the meaning given to such term in Section 20.1 of this Agreement;
     
Officer   means, with respect to the Company or its Affiliate, the chief executive officer, vice chief executive officer, chief financial officer, chief operation officer (or any other officer bearing equivalent duties);
     
Ordinary Course of Business   means the ordinary course of business of the Company, consistent with past customary practice, including with respect to maintenance of books and records, payment of expenses and payables, making of capital expenditures, performance of maintenance and repairs necessary to maintain facilities and equipment in good operating condition (normal wear and tear excepted), collection of accounts receivables, payment of employee compensation, maintenance of insurance, cash and other normal business operation;

 

  9  

 

 

Oversubscription Right   has the meaning given to such term in Section 13.3 of this Agreement;
     
Permitted Transferee   has the meaning given to such term in Section 15.2 of this Agreement;
     
Post-closing Valuation   means the valuation of the Company immediately after the Closing;
     
PRC   means the People’s Republic of China, which, for the purpose of this Agreement, does not include Hong Kong Special Administration Region (the “ Hong Kong ”), Macao Special Administration Region (the “ Macao ”) and Taiwan;
     
Pre-emptive Right   has the meaning given to such term in Section 13.1 of this Agreement;
     
Pre-closing Valuation   means the valuation of the Company prior to the Closing, which is made on the basis of the management forecast provided by the Company and unanimously recognized by the Parties;
     
Proposed Transfer   has the meaning given to such term in Section 16.1 of this Agreement;
     
Purchasing Holders   has the meaning given to such term in Section 16.2.2 of this Agreement;
     
Qualified IPO   means the initial public offering and listing of the equity interest/shares of the Company (or any other entity holding all the equity interest of the Company which is acceptable to the Series A+ Investors and the Founding Shareholders) on the main board of Hong Kong Stock Exchange or any other stock exchange approved by the Board;
     
Redemption Date   has the meaning given to such term in Section 19.1.9 of this Agreement;
     
Redemption Right   has the meaning given to such term in Section 19.1.2 of this Agreement;

 

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Re-allotment Notice   has the meaning given to such term in Section 16.2.2 of this Agreement;
     
Related Party   means: (a) any direct or indirect shareholder of a subject person or its Subsidiaries, (b) any director or officer of a subject person or its Subsidiaries, (c) any entity Controlled by, or any close family member (including parents, spouse, children, brothers and sisters) of, any person referred to in (a) or (b) above, or (d) any other Affiliate of a subject person or its Subsidiaries;
     
Related Party Transaction   has the meaning given to such term in Section 22.1 of this Agreement;
     
Redemption Price   has the meaning given to such term in Section 19.1.5 of this Agreement;
     
Redemption Requesting Notice   has the meaning given to such term in Section 19.1.7 of this Agreement;
     
Remaining Addition Equity   has the meaning given to such term in Section 13.3 of this Agreement;
     
RMB   means Renminbi, the lawful currency of the PRC;
     
Restricted Business   has the meaning given to such term in Section 7.4.1 of this Agreement;
     
Second  Capital  Increase Notice   has the meaning given to such term in Section 13.3 of this Agreement;
     
Selling Holder   has the meaning given to such term in Section 17.1 of this Agreement;
     
Series A Investment Agreement   The Investment Agreement dated December 17, 2018 entered into by and among the Company, the Founding Shareholders and the Series A Investors (except [*** ]) and the Supplemental Agreement dated May 21, 2019 entered into by and among the Company, the Founding Shareholders and the Series A Investors;

 

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Series A Redemption Price   has the meaning given to such term in Section 19.2.2 of this Agreement;
     
Series A Redemption Right   has the meaning given to such term in Section 19.1.2 of this Agreement;
     
Series A+ Redemption Price   has the meaning given to such term in Section19.2.1 of this Agreement;
     
Series A+ Redemption Right   has the meaning given to such term in Section 19.1.1 of this Agreement;
     
Shareholder   Means the shareholder of the Company holding equity interest of the Company;
     
Shareholders’ Meetings   means   the   Annual   Shareholders’   Meetings   or   Interim Shareholders’ Meetings;
     
Subscription Price   means the consideration for the Increased Capital payable by the Series A+ Investors to the Company pursuant to the terms and conditions of this Agreement;
     
Subsidiary   means any person Controlled by a subject person from time to time;
     
Taxation ” or “ Tax   means all income and other taxes, including but not limited to capital gains taxes, real estate transfer taxes, value added taxes, stamp duties, deed taxes, energy taxes, social security fees, duties, imports, charges, and withholding taxes, other taxes of any nature whatsoever charged by any authority, including all costs, penalties and interest relating thereto;
     
Transaction   has the meaning given to such term in Recital (B);
     
Transaction Documents   means this Agreement, the Amended Articles and any other documents executed pursuant thereto or in connection therewith;
     
Transfer Notice   has the meaning given to such term in Section 16.1 of this Agreement;

 

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Warrantors   has the meaning given to such term in Section  5 of this Agreement;
     
Wholly-owned Company   has the meaning given to such term in Section 15.2 of this Agreement;

 

1.2 Unless otherwise provided in this Agreement or otherwise defined by the context, the following terms referred to in this Agreement shall be interpreted as follows:

 

(a) Directly or Indirectly. The term “directly or indirectly” means, directly, or through one or more intermediate persons or through contractual or other arrangements, and “direct or indirect” has the correlative meaning;

 

(b) Headings. Headings are included for convenience only and shall not affect the construction of any provision of this Agreement;

 

(c) Include not Limiting. “Include,” “including,” “are inclusive of” and similar expressions are not expressions of limitation and shall be construed as if followed by the words “without limitation”;

 

(d) Person. Unless otherwise provided in this Agreement, the word “person” includes any individual, corporation, partnership, limited partnership, proprietorship, association, limited liability company, firm, trust, estate, other entity or governmental bureau;

 

(e) References to Documents. References to this Agreement include the Exhibits, which form an integral part hereof. The words “hereof,” “hereunder” and “hereto,” and words of like import, unless the context requires otherwise, refer to this Agreement as a whole and not to any particular Section hereof or Exhibit hereto. A reference to any document (including this Agreement) is to that document as amended, consolidated, supplemented, novated or replaced from time to time;

 

(f) Laws. References to any Law include all Laws amending, varying, consolidating or replacing all or part of such Law.

 

(g) Time. If a period of time is specified and dates from a given day or the day of a given act or event, such period shall be calculated exclusive of that day;

 

(h) Writing. References to writing and written include any mode of reproducing words in a legible and non-transitory form including emails and faxes;

 

(i) Successor and Assignee. References to Parties include their respective successors and assigns;

 

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(j) Material. Unless otherwise provided in this Agreement, “material” shall refer to a monetary threshold of [*** ] or more, provided that the value of a series of related transactions in respect of the same subject shall be aggregated for such purposes;

 

(k) Representations, Warranties and Covenants. Unless otherwise provided in this Agreement, all warranties, representations, indemnities, covenants, agreements and obligations given or entered by more than one person are given or entered into severally unless otherwise specified;

 

(l) Drafting. This Agreement has been negotiated jointly and reviewed by the Parties and their respective counsel. Thus, this Agreement shall be deemed to be the joint work product of the Parties and in the event of any ambiguity, no presumption or burden of proof shall arise favouring or disfavouring any Party by virtue of the actual or claimed authorship of any of the provisions of this Agreement.

 

2. The Transaction

 

2.1 Subscription

 

Subject to and on the terms and conditions of this Agreement, the Company shall increase, and the Series A+ Investors shall subscribe, the Increased Capital free of any Encumbrance on the Closing Date. Subject to and on the terms and conditions of this Agreement, the Series A+ Investors shall pay the Subscription Price in the amount of RMB 110,000,000 to the Company on the Closing Date, [*** ] of the Subscription Price shall pay up the Increased Capital and the remaining of the Subscription Price shall be calculated as “capital surplus”, among which:

 

(a) CASI shall pay RMB 80,000,000 to the Company on the Closing Date, [*** ] of which shall pay up the Increased Capital and the remaining part shall be calculated as “capital surplus”.
(b) [*** ] shall pay RMB 20,000,000 to the Company on the Closing Date, [*** ] of which shall pay up the Increased Capital and the remaining part shall be calculated as “capital surplus”;
(c) [*** ] shall pay RMB 10,000,000 to the Company on the Closing Date, [*** ] of which shall pay up the Increased Capital and the remaining part shall be calculated as “capital surplus”.

 

Upon Closing, the Increased Capital held by the Series A+ Investors shall represent [*** ] of the total equity interest of the Company (on a fully diluted basis). The shareholding structure of the Company immediately prior to and after Closing is set forth in Exhibit A.

 

2.2 Valuation

 

The Parties acknowledge that, the Subscription Price for the Increased Capital is based on the Pre-closing Valuation of the Company. The Pre-closing Valuation of the Company is [*** ] and the Post-closing Valuation of the Company is [*** ].

 

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2.3 Use of Proceeds

 

Subject to the terms and conditions hereof, the Parties agree that the Subscription Price shall only be used by the Company as working capital for the Business and for other related capital expenditure. The Company shall not use the Subscription Price to repay any loan.

 

2.4 Waiver

 

The Founding Shareholders and Series A Investors shall waive any and all right (including but not limited to pre-emption right, veto rights, rights to receive notice) with respect to the Transaction under the Series A Investment Agreement, Articles of Associations, any other instrument, document or agreement, or Applicable Laws.

 

2.5 Change of Registration and Filing

 

The Founding Shareholders and the Company shall be in charge of the change of registration and filing of this Transaction in Governmental Authorities. The Series A Investors and the Series A+ Investors shall provide necessary cooperation.

 

3. Conditions Precedent

 

3.1 Conditions Precedent to Obligations of the Series A+ Investors

 

The performance of the closing obligations set forth in Section 3.1 by the Series A+ Investors are subject to the satisfaction of the following conditions (“ Conditions Precedent ”) on or prior to the Closing Date, any or all of which may be waived by the Series A+ Investors in writing in its sole discretion:

 

3.1.1 The representations and warranties made by the Warrantors under Section 5 are true, correct and complete on the Execution Date and the Closing Date.

 

3.1.2 During the period between the Execution Date and the Closing Date, no Material Adverse Changes has occurred to the Company, including, without limitation, the rights of the Series A+ Investors hereunder, the business, operations, affairs, prospects, properties, assets, existing and potential liabilities, profits or conditions (financial or otherwise) of the Company, and the ability of the Company, the Founding Shareholders and/or Series A Investors to consummate the Transaction contemplated hereby or to perform its or his obligations hereunder or under any other Transaction Document.

 

3.1.3 There exists no valid injunction, restraining order or any other that prohibits the consummation of the Transaction or restricting the Business of the Company, which has a Material Adverse Effect on the Company; there exists no pending or threatened legal action or governmental investigation, which, if adversely determined, would reasonably be expected to result in any such injunction or order that has such Material Adverse Effect on the Company.

 

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3.1.4 The Founding Shareholders, the Series A Investors and the Company shall have performed and complied with all agreements, obligations and conditions contained in this Agreement that are required to be performed or complied with by it on or before the Closing.

 

3.1.5 The Warrantors shall have obtained all authorizations, approvals, waivers or permits of the Persons and Governmental Authorities necessary for the consummation of the Transaction. All such authorizations, approvals, waivers and permits shall be effective as of the Closing.

 

3.1.6 The Warrantors shall have obtained all corporate and other proceedings in connection with the transactions contemplated at the Closing and all documents incident thereto (including but not limited to the resolutions of Shareholders and Boards of Directors (as applicable) of the Company) required to approve the Transaction Documents and the transaction thereunder.

 

3.1.7 The Series A+ Investors shall have completed the due diligence investigation of the Company and any corrective items identified by the Series A+ Investors shall have been corrected and the results of the due diligence investigation in legal, financial, managerial, commercial and technological aspects shall be satisfactory to the Series A+ Investors. Without limiting the foregoing, the Series A+ Investors shall have received from the Company all documents and other materials requested by the Series A+ Investors for the purpose of examining and determining the rights in and to any technology, products and proprietary rights now used, proposed to be used in, or necessary to, the business as now conducted and proposed to be conducted by the Company, and the status of its ownership rights in and to all such technology, products and proprietary rights shall be satisfactory to the Series A+ Investors in its sole discretion.

 

3.1.8 The Company has provided to the Series A+ Investors a copy of the resolutions duly passed by the Board, which shall set forth: (i) approval of the Transaction, this Agreement and the Exhibits attached hereto by the Company; (ii) approval of the entry into and performance of this Agreement and the other Transaction Documents by the Company; and (iii) approval of the increase of the Increased Capital for subscription by the Series A+ Investors.

 

3.1.9 The Amended Articles of the Company shall have been duly amended and restated by all necessary actions of the Board of the Company and adopted by all the Shareholders of the Company in the form and substance satisfactory to the Series A+ Investors.

 

3.1.10 The Company has delivered to the Series A+ Investors a business plan and budget for the twelve

(12) months immediately following the Closing and other financial statements reasonably required by the Series A+ Investors and such business plan and budget shall be reasonably satisfactory to the Series A+ Investors.

 

3.1.11 The PRC counsel to the Company shall have delivered to the Series A+ Investors a legal opinion dated as of the date of the Closing addressed to such Series A+ Investors in form and substance satisfactory to such Series A+ Investors opining on the legality of the Transaction.

 

3.1.12 The Warrantors shall have executed and delivered to such Series A+ Investors a scanned copy of certificate of the Company dated as of the Closing stating that the conditions specified in Section 3.1 have been fulfilled as of the Closing.

 

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3.2 Obligations to Satisfy the Conditions Precedent

 

Each of the Company and Founding Shareholders shall use its or his commercially reasonable efforts to ensure the satisfaction of the Conditions Precedent set forth in Section 3.1 as soon as possible.

 

4. Closing

 

4.1 Closing

 

Subject to the satisfaction by the Warrantors of the conditions set forth in this Agreement (including but not limited those under Section 3.1), Closing shall take place remotely via the exchange of documents and signatures on a date specified by the Parties, or by another method or at another time and date and at another location to be mutually agreed by the Parties, which date shall be no later than five (5) Business Days after the satisfaction or waiver of each condition to such Closing set forth in Section 3.1 (other than conditions that by their nature are to be satisfied at the Closing, but subject to the satisfaction or waiver of such conditions). The date on which the Closing shall be held is referred to in this Agreement as the “ Closing Date ”.

 

4.2 Actions to be Taken by the Company on the Closing Date On the Closing Date, the Company shall:

 

4.2.1 deliver a duly signed capital contribution certificate ( 出资证明书 ) evidencing that the Increased Capital have been registered in the name of the Series A+ Investors;

 

4.2.2 deliver a duly issued Shareholders’ Register ( 股东名册 ) of the Company, evidencing the valid subscription of the Increased Capital by the Series A+ Investors in accordance with Section 2.1.

 

4.3 Documents to be Delivered and/or Actions to be Taken by the Company after Closing

 

The Company shall, within thirty (30) days of Closing, file the Amended Articles with the Administration of Industry and Commerce, and deliver to the Series A+ Investors the record for such filing.

 

5. Warrantors’ Representations and Warranties

 

Subject to the Disclosure Schedule, each of the Company and the Founding Shareholders, (collectively, the “ Warrantors ”) jointly and severally makes the following representations and warranties to the Series A+ Investors on the Execution Date, and such representations and warranties shall be made repeatedly on the Closing Date:

 

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5.1 Existence/Authority

 

Such Party (if it is not a natural person) is duly organised and validly existing under the laws of its place of incorporation, and such Party has the power and authority to enter into this Agreement and perform its obligations contemplated hereby; such Party (if it is not a natural person) has the capacity to enter into and perform its obligations contemplated under this Agreement and any other Transaction Document.

 

5.2 Authorisation

 

The execution, delivery and performance by such Party of this Agreement has been duly authorised and this Agreement will be binding upon such Party in accordance with its terms and can be enforced against such Party.

 

5.3 No Conflict

 

The execution, delivery and performance of this Agreement and any other Transaction Document by such Party do not and/or will not:

 

(a) violate, conflict with or constitute a default under any provision of such Party’s constitutional documents or Applicable Laws;

 

(b) conflict with or result in a breach of any agreement to which such Party is a party or by which its properties are bound;

 

(c) violate any judgment, order, injunction, decree or award of any court, administrative agency or governmental body against, or binding upon, such Party or its properties; or

 

(d) constitute a violation of any Applicable Laws applicable to such Party or its properties.

 

5.4 No Consents

 

The execution, delivery and performance by such Party of this Agreement and any other Transaction Documents and the consummation of this Transaction are not subject to any approval from such Party’s shareholders, creditors, stakeholders or any other person, or any consent or approval of, or notification to or filing with, any Governmental Authority, other than those Consents and approvals to be obtained as of the Closing Date as set forth in the Conditions Precedent.

 

5.5 Legal Proceedings

 

There is no pending or threatened actions, litigations or proceedings against such Party or its properties before any court, arbitration tribunal, administrative or governmental body, which, if adversely determined, would impair such Party’s ability to perform its obligations under Agreement or any other Transaction Documents to which such Party is a party.

 

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5.6 Information

 

5.6.1 General Representations

 

All information in writing or any other form which has been provided by or on behalf of the Warrantors to the Series A+ Investors or its advisors in the course of the negotiations leading to this Agreement is true, complete and accurate and there are no material omissions. All facts that may have any Material Adverse Effect on the Company or their business have been Disclosed to the Series A+ Investors.

 

5.6.2 Equity Interest

 

(a) No person other than the Founding Shareholders and the Series A Investors owns any equity interest in the Company or has any claim, right or interest in or to the Company. The Company has no obligation (contingent or otherwise) to purchase, redeem or otherwise acquire any of its registered capital or to pay any dividend or make any other distribution.

 

(b) The Company has the power to increase the Increased Capital for subscription by the Series A+ Investors on the terms of this Agreement and no consent is required from any third party for such issuance. No claim has been made by any person that it or he has any right to subscribe any or all of the Increased Capital. The Increased Capital, when increased and paid for as provided in this Agreement, will be duly and validly increased and fully paid up. There are no current or future restrictions on transfer of any Increased Capital except for the restrictions imposed by the applicable securities law and the Transaction Documents. Upon Closing, the Increased Capital will represent [*** ] of the total equity interest of the Company (on a fully diluted basis) and the Increased Capital shall be free of any Encumbrance.

 

(c) The shareholding structure and other particulars of the Company (i) specified in Part I of Exhibit A is true, complete and accurate until immediately prior to the Closing, and (ii) specified in Part II of Exhibit A is true, complete and accurate at the consummation of the Closing.

 

(d) The Company is not an Affiliate of Juventas Therapeutics, Inc., a business entity with address at 3615 Superior Avenue Suite 4403B Cleveland, OH 44114;

 

5.6.3 Options and Encumbrance

 

None of the Warrantors has granted any right to obtain or receive any equity interest in the Company, or any right to receive any part of the profits or dividends of the Company, and there exists no Encumbrance over the Equity Security of the Company.

 

5.6.4 Company Status / Business Operation

 

(a) The Company has been duly incorporated, validly existing and duly registered. The Company has obtained necessary power and authority to own and operate its assets and properties, and to conduct its business in the current manner. As of the Closing Date, the information of the Company set forth in Exhibit B is true, complete and accurate. The Company is not insolvent, or has not commenced any bankruptcy or liquidation process, and no receiver or administer has been appointed in respect of the Company. The Company holds no direct or indirect interest in any other person;

 

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(b) The Company has not conducted the business of the development and application of human stem cells, gene diagnosis and therapeutic technologies.

 

5.7 Corporate Documents

 

5.7.1 Articles of Association

 

The Articles of Association of the Company provided to the Series A+ Investors are complete, true and accurate.

 

5.7.2 Governmental Authority

 

All reports, resolutions and other documents in relation to the Company that are required to be filed with or submitted to any Governmental Authority have been duly filed or submitted.

 

5.7.3 Consents

 

The Company has obtained any and all Consents to conduct its business as required by Applicable Laws and such Consents still remain valid.

 

5.8 Accounts

 

5.8.1 Accounts

 

The Warrantors have delivered to Series A+ Investors the audited consolidated balance sheets, cash flow statements and income statements of the Company for the fiscal year ending December 31, 2018 prepared by certified public accountant in accordance with PRC GAAP. Subject to the audit report issued by a certified public accountant, (a) the Accounts are true and accurate in all material respects and present a true and fair view of the assets, liabilities and financial positions of the Company as at the Account Date; (b) there has been no Material Adverse Change in the financial position of the Company since the Account Date; and (c) the Company has no liability of any nature other than those Disclosed in the Accounts.

 

5.8.2 Accounting Principles

 

Subject to (i) the changes of Applicable Laws and any changes that are specifically noted in the Accounts and (ii) the changes in the accounting principles that are specifically noted in the Accounts, the accounting principles adopted by the Company are compliant with Applicable Laws.

 

5.8.3 Books and Financial Records

 

All the Accounts, books and financial and other records of the Company are completely, properly and accurately maintained and prepared. All such Accounts, books and records that are required to be possessed by the Company according to Applicable Laws are in the possession of the Company.

 

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5.9 Changes since the Account Date

 

Since the Account Date, except as contemplated by this Agreement, there has not been:

 

5.9.1 any material change in the assets, liabilities, financial condition or operations of the Company reflected in the financial statements, other than changes in the Ordinary Course of Business, or other changes which would not reasonably be expected to have a Material Adverse Effect on the Company;

 

5.9.2 any resignation or termination of any Key Employee of the Company;

 

5.9.3 any satisfaction or discharge of any lien or payment of any obligation by the Company, except for those made in the Ordinary Course of Business or those that are not material to the assets, properties, financial condition, or operation of such entities (as such business is presently conducted);

 

5.9.4 any change, amendment to or termination of a Material Contract (as defined in Section 5.13.1 below);

 

5.9.5 any material change in any compensation arrangement or agreement with any Key Employee of the Company;

 

5.9.6 any sale, assignment or transfer of any Intellectual Property of the Company, other than in the Ordinary Course of Business or which would not reasonably be expected to have a Material Adverse Effect on the Company;

 

5.9.7 any declaration, setting aside or payment or other distribution in respect of the Company’s capital, or any direct or indirect redemption, purchase or other acquisition of any of such shares by the Company other than the repurchase of capital from employees, officers, directors or consultants pursuant to agreements approved by the Board of such Person;

 

5.9.8 any failure to conduct business in the ordinary course, inconsistent with such Company’s past practices;

 

5.9.9 any damages, destruction or loss, whether or not covered by insurance, materially and adversely affecting the assets, properties, financial condition, operation or business of the Company;

 

5.9.10 any event or condition of any character which might have a Material Adverse Effect on the assets, properties, financial condition, operation or business of the Company, but excluding any of the foregoing resulting from general economic conditions or from conditions that generally affect the industry of such Company (other than changes that have a materially disproportionate effect on such Person); or

 

5.9.11 any agreement or commitment by the Company to do any of the things described in this Section 5.9 except pursuant to this Agreement or the Ancillary Agreements.

 

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5.10 Taxes

 

5.10.1 General

 

The Company has complied with Applicable Laws on Taxation and has filed all tax returns in respect of all Taxes payable by it in a timely manner in accordance with Applicable Laws. All the information contained in such tax returns is true, accurate and not materially misleading. The Company has paid in full all Taxes payable by it in a timely manner in accordance with Applicable Laws.

 

5.10.2 No Illegal Payment

 

The Company has not made any payment to any person, which is illegal under Applicable Laws.

 

5.11 Employment

 

The Company has complied with Applicable Laws in relation to labour relationship, labour conditions and payment of social security and housing fund. Exception as otherwise disclosed in the Disclosure Schedule, there are no stock incentive plans, equity or profit distribution plans or other incentive plans in favour of any director, officers or employees of the Company. There are no outstanding disputes between the Company and its employees which may have any Material Adverse Effect.

 

5.12 Assets and Liabilities

 

5.12.1 Title and Condition

 

The Company does not own any real properties.

 

The Company has good and marketable title to all its personal properties and any other assets and any other rights and interests. These exist no liens or other Encumbrances over such properties and assets. There are no valid planning or Applicable Laws that will prohibit or restrict the Company from operating its business with its assets or leased properties in a manner currently conducted. The assets of the Company (including the leased properties) constitute all assets, properties and rights necessary or important for its independent and continuous business operation.

 

5.12.2 Leased Properties

 

Except as Disclosed in the Accounts, the Company has not incurred off-balance sheet liability (current or contingent) during the acquisition, transfer or disposal of any of its leased properties.

 

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5.12.3 Intellectual Property Rights

 

(a) The Company owns or otherwise has the right or license to use all Intellectual Property material to its Business as currently conducted without any violation or infringement of the rights of others, free and clear of all liens. The Company, to its best knowledge, will provide the Series A+ Investors with a complete and accurate list of all Intellectual Property owned, licensed to or used by the Company that are material for its independent and continuous business operation, whether registered or not, and a complete and accurate list of all licenses granted by the Company to any third party with respect to any Intellectual Property. There is no pending or, to the best knowledge of the Warrantors, threatened, claim or litigation against the Company, contesting the right to use its Intellectual Property, asserting the misuse thereof, or asserting the infringement or other violation of any Intellectual Property of any third party. All material inventions and material know-how conceived by the employees of the Company and related to the businesses of such Person were “works for hire,” and all right, title, and interest therein, including any application therefore, were transferred and assigned to the Company.

   

(b) With respect to any Intellectual Property Right owned by the Company:

 

(i) the Company has taken all reasonable and necessary steps to protect and maintain such Intellectual Property Right; and

 

(ii) none of such Intellectual Property Right will lapse or become invalid in whole or in part as a result of the execution and performance of this Agreement and the other Transaction Documents or the Closing of this Transaction.

 

(c) With respect to any Intellectual Property Rights used by the Company:

 

(i) the Company has the lawful right to use such Intellectual Property Right in accordance with necessary license agreements, permits or similar agreements;

 

(ii) the license agreements, permits and similar agreements above remain valid and effective;

 

(iii) none of such license agreements, permits and similar agreements will terminate or become invalid in whole or in part as a result of the execution and performance of this Agreement and the other Transaction Documents or the Closing of this Transaction.

 

(d) The Company has not infringed the Intellectual Property Rights of any other person. No person has made any claim that the Company has infringed any Intellectual Property of such person and no facts or circumstances exist which would reasonably be expected to give rise to any such claim.

 

(e) To the best knowledge of the Warrantors, none of the employees of the Company owns, directly or indirectly, any intellectual property right which is similar to the Intellectual Property or related with the Business conducted by the Company.

 

(f) To the best knowledge of the Warrantors, none of the Key Employees or employees of the Company are obligated under any contract (including a contract of employment), or subject to any judgment, decree or order of any court or administrative agency, that would interfere with the use of his or her best efforts to promote the interests of the Company, or that would conflict with the Business of the Company as presently conducted, unless otherwise agreed by the Series A+ Investors in writing. To the best knowledge of the Company, it will not be necessary to utilize in the course of the Company’ business operations any inventions of any of the employees of the Company, the Key Employees made prior to their employment by such Company, except for inventions that have been validly and properly assigned or licensed to the Company as of the date hereof.

 

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5.13 Contracts

 

5.13.1 List of Contracts

 

The Disclosure Schedule provided by the Company contains a complete and accurate list of all Contracts as of the Execution Date to which the Company is a party, and that will involve ( i ) any Contract entered into during the Ordinary Course of Business of the Company in excess of [*** ], ( ii ) any Contract entered into beyond the Ordinary Course of Business of the Company and the amount of which is in excess of [*** ], and ( iii ) the sale, issuance, grant, exercise, award, purchase, repurchase or redemption of any Equity Securities, ( iv ) any provisions providing for exclusivity, “change in control”, “most favoured nations”, rights of first refusal or first negotiation or similar rights, or grants a power of attorney, agency or similar authority, ( v ) a loan, an extension of credit, a guaranty, surety, deed of trust, or the grant of a Lien, ( vi ) the establishment, contribution to, or operation of a partnership, joint venture, alliance or similar entity, or involving a sharing of profits or losses (including joint development and joint marketing Contracts), or any investment in, loan to or acquisition or sale of the securities, equity interests or assets of any Person, ( vii ) a Governmental Authority, state-owned enterprise, or sole-source supplier of any material product or service (other than utilities), and ( viii ) any Contracts that affect the assets, properties, financial condition, operation or business of the Company in material respects, including but not limited to any Contract having an effective term of more than three (3) year or payments in excess of [*** ] (collectively, the “ Material Contracts ”).

 

5.13.2 Validity of Contracts

 

(a) To the knowledge of the Company, there are no circumstances where any material agreement or other transactions to which the Company is a party may be declared to be void or be terminated. None of the Company has received any notice of any intention to terminate, refuse to perform or invalidate any such agreement or transaction;

 

(b) To the knowledge of the Company, there are no breaches by any person with whom the Company has entered into any agreement or arrangement, which may have any Material Adverse Effect on the financial or operational conditions or prospects of the Company and no circumstances exist that may give rise to any such breach.

 

5.13.3 Unusual Contracts

 

The Company is not a party to any long-term and onerous agreement that is not consistent with usual business practice other than those entered into in the Ordinary Course of Business.

 

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5.13.4 Related Party Transactions

 

Other than those Disclosed to the Series A+ Investors by the Company to its best knowledge, there are no material contracts, understandings or transactions between the Company, on the one hand, and any of its Related Parties, on the other hand. All the contracts, understandings and transactions between the Company, on the one hand, and any of its Related Parties, on the other hand, as Disclosed in writing to the Series A+ Investors, are entered into on arm’s length terms.

 

5.14 Litigation and Other Disputes

 

(a) The Company has not been involved in any litigation, arbitration, prosecution or any other legal proceedings (whether as a plaintiff, defendant or third party) which would or may have any Material Adverse Effect on the Company. There is no pending or threatened legal proceeding against the Company or any person where the Company may be held liable for the action or default of such person, which would or may have any Material Adverse Effect on the Company;

 

(b) The Company is not currently involved in proceedings or investigations before any Governmental Authority (whether judicial or quasi-judicial), which, if adversely determined, may have Material Adverse Effect on the Business or value of the assets of the Company;

 

(c) There is no pending or threatened legal action, litigation or proceeding against Founding Shareholders or in respect of their respective assets at any court, arbitration tribunal, administrative or governmental body, which, if adversely determined, may have Material Adverse Effect on the rights, ownership or interests of or in the equity interest of the Company held by the Founding Shareholders, and no facts or events exist which may lead to such litigation or proceedings.

 

5.15 Insurance

 

The Company has taken out insurance policies from the insurers set forth in the Disclosure Schedule as required for the operation of the Business and by the Applicable Laws. The relevant insurance policies remain in full effect and all the insurance premium payable thereunder have been paid. The Company has not received any notice for cancelation or termination of any such insurance policy and the Company has complied with the terms and conditions of such insurance policies.

 

5.16 Compliance

 

5.16.1 The Company is in all materials respects in compliance with all Applicable Laws that are applicable to it or to the conduct or operation of its business or the ownership or use of any of its assets or properties, including any PRC governmental claims arising under any PRC Applicable Laws that may require the registration or licensing of any Intellectual Property but excluding any third-party claims.

 

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5.16.2 To the best knowledge of the Company, no event has occurred and no circumstance exists that (with or without notice or lapse of time) (i) may constitute or result in a violation by the Company of, or a failure on the part of the Company to comply with, in material respects, any Applicable Laws applicable to the Company, or (ii) may give rise to any obligation on the part of the Company to undertake, or to bear all or any portion of the cost of, any remedial action of any nature.

 

5.16.3 The Company has not received any written notice from any Governmental Authority regarding

(i)       any actual, alleged, possible, or potential violation of, or failure to comply with, any Applicable Laws, or (ii) any actual, alleged, possible, or potential obligation on the part of the Company to undertake, or to bear all or any portion of the cost of, any remedial action of any nature.

 

5.16.4 To the Company’s best knowledge, no Company, nor any director, agent, employee or any other person acting for or on behalf of the Company, has directly or indirectly established or maintained any fund or assets in which the Company shall have proprietary rights that have not been recorded in the books and records of such person.

 

5.16.5 Each of the Key Employees and other employees of the Company has entered into an employment agreement with the Company in accordance with the PRC Applicable Laws.

 

5.17 Compliance with Anti-bribery Laws.

 

5.17.1 None of the Company or any director, officer, and to the best knowledge of the Warrantors, any agent, employee, affiliate or any other person acting for or on behalf of the foregoing (individually and collectively, a “ Company Affiliate ”), is aware of or has taken any action, directly or indirectly, that would result in a violation of or has violated the U.S. Foreign Corrupt Practices Act, as amended (“ FCPA ”), as amended, or any other applicable anti-bribery or anti- corruption laws, including, without limitation, using any corporate funds for any unlawful contribution, gift, entertainment or other unlawful payments to any foreign or domestic governmental official or employee from corporate funds, nor has any Company Affiliate offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, to any officer, employee or any other person acting in an official capacity for any Government Entity, as defined below, to any political party or official thereof or to any candidate for political office (individually and collectively, a “ Government Official ”) or to any person under circumstances where such Company Affiliate knew or was aware of a high probability that all or a portion of such money or thing of value would be offered, given or promised, directly or indirectly, to any Government Official, for the purpose of:

 

(a) influencing any act or decision of such Government Official in his official capacity;

 

(b) inducing such Government Official to do or omit to do any act in relation to his lawful duty;

 

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(c) securing any improper advantage; or

 

(d) inducing such Government Official to influence or affect any act or decision of any Government Entity, in order to assist the Company in obtaining or retaining business for or with or directing business to the Company or its Subsidiary or in connection with receiving any approval of the transactions contemplated herein. None of the Company Affiliate has accepted anything of value for any of the purposes listed in subsections (a) through (d) of this Section. As used in this Section 5.17, “ Government Entity ” means any government or any department, agency or instrumentality thereof, including any entity or enterprise owned or controlled by a government, or a public international organization.

 

5.18 Compliance with Anti-money Laundering Laws.

 

5.18.1 The operations of the Company and its Subsidiaries are and have been conducted at all times in compliance with applicable anti-money laundering statutes of all jurisdictions, including, without limitation, all U.S. anti-money laundering laws, the rule and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any governmental or regulatory agency (collectively, the “ Money Laundering Laws ”); and no action, suit or proceeding by or before any court or governmental or regulatory agency, authority or body or any arbitrator involving the Company or any of its Subsidiaries with respect to the Money Laundering Laws is pending or, to the knowledge of the Warrantors, threatened.

 

5.1 Environmental and Safety Laws.

 

The Company is not in material respects in violation of any Application Laws relating to the environment or occupational health and safety and no material expenditures are or will be required in order to comply with any such existing Applicable Laws.

 

6. Series A Investors and Series A+ Investors’ Representations and Warranties

 

6.1 Existence/Authority

 

Such Party (if it is not a natural person) is duly organised and validly existing under the laws of its place of incorporation, and such Party has the power and authority to enter into this Agreement and perform its obligations contemplated hereby; such Party (if it is not a natural person) has the capacity to enter into and perform his obligations contemplated under this Agreement and any other Transaction Document.

 

6.2 Authorisation

 

The execution, delivery and performance by such Party of this Agreement has been duly authorised and this Agreement will be binding upon such Party in accordance with its terms and can be enforced against such Party.

 

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6.3 Purchase for Own Account

 

The equity interest in the Company acquired or to be acquired by each Series A+ Investors is acquired for investment for the own account of such Investor (and/or its Affiliates), not as a nominee or agent of anyone else, and not with a present view to the resale or distribution of any part thereof, and that such Investor has no present intention of selling, granting any participation in, or otherwise distributing the same.

 

7. Covenants of the Founding Shareholders and the Company

 

7.1 Pre-Closing Covenants

 

Until Closing Date, the Founding Shareholders shall cause the Company to continue to operate in the Ordinary Course of Business. The Founding Shareholders shall cause the Company not to take any action that is inconsistent with the past business practices or sound business judgment. Without limiting the generality of the foregoing, until the Closing Date, the Founding Shareholders shall cause the Company to maintain all their assets in their present state (except reasonable wear and tear), and shall maintain the Company’s relationship with its customers, suppliers, vendors, employees, salespeople and any other persons having business relations with the Company. Without limiting the generality of the foregoing, during the period between the Execution Date and the Closing Date, unless otherwise expressly provided in this Agreement, (i) the Founding Shareholders and the Company shall ensure that the Company will not amend its charter documents, issue or transfer any equity or debt securities, and (ii) none of the Founding Shareholders may directly or indirectly transfer its equity interest of the Company in whatever manner or create any Encumbrance thereon.

 

7.2 Timely Notification

 

If, at any time prior the Closing Date, any of the Founding Shareholders or the Company becomes aware of any the following facts or events, such Founding Shareholders or the Company shall promptly notify the Series A+ Investors in writing: (i) there is material discrepancy between the information disclosed by the Founding Shareholders and the Company to the Series A+ Investors and the actual circumstances; and (ii) there is any material discrepancy between any representations, warranties or covenants hereunder and the actual circumstances, or any such representations, warranties or covenants are misleading in any material respect, which, in each case, may affect the determination of the Series A+ Investors as to the Pre-closing Valuation of the Company and the consummation of this Transaction.

 

7.3 Compliance with Applicable Laws

 

7.3.1 After the Closing Date, the Founding Shareholders shall cause the Company to continue to operate in the Ordinary Course of Business, and cause the Company to continue to comply with Applicable Laws in all material respects, including without limitation to the rules and regulations in relation to the Business, Intellectual Property Rights, foreign investment, anti- trust, tax, labour, social security and housing fund and foreign exchange, to ensure the Company operate its Business as going concern and meet the requirements for a Qualified IPO. The Company shall ensure that the Company and its Shareholders shall complete the registration and other procedures as required by Applicable Laws and shall not adversely affect the distribution of any profits or dividends or any other distribution to the Series A+ Investors.

 

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7.3.2 The Company undertakes to CASI that after the Closing Date, unless otherwise agreed by CASI, as long as CASI holds any equity interest in the Company, it will not conduct the business of the development and application of human stem cells, gene diagnosis and therapeutic technologies.

 

7.4 Non-compete

 

7.4.1 Each of the Founding Shareholders undertakes to the Series A+ Investors that, they will not either on their own account or through any of their Affiliates, or in conjunction with or on behalf of any other person: (i) directly or indirectly, own, manage, engage in, operate, control, work for, consult with, render services for, do business with, maintain any interest in (proprietary, financial or otherwise) or participate in the ownership, management, operation or control of, any business, whether in corporate, proprietorship or partnership form or otherwise, that is the same, similar to, or otherwise competes with any principal business of any member of the Company (a “ Restricted Business ”), or otherwise carry out any Restricted Business; (ii) act as the shareholder, director, employee, partner, consultant, agent or representative of any entity described in subsection (i) above; (iii) solicit or entice away or attempt to solicit or entice away from any member of the Company, any person, firm, company or organization who is an employee or a customer, client, representative, agent or correspondent of such member of the Company or in the habit of dealing with such member of the Company.

 

7.4.2 In the event any entity directly or indirectly established, managed or controlled by the Founding Shareholders, engages or will engage in any Restricted Business, the Founding Shareholders agrees, and the Founding Shareholders shall cause such entity, to disclose the related information to the Company and the Series A+ Investors and transfer such business and/or assets to the Company immediately.

 

7.5 Accounting Principles

 

The Company shall maintain the accounting principles and financial systems as required by Applicable Laws and listing rules for a Qualified IPO.

 

7.6 Establishment of Branch Office in Beijing

 

The Company shall establish a branch company or a Subsidiary in Beijing to conduct business within three (3) months after the Closing Date.

 

7.7 Compliance of Social Security Payment

 

The Company shall procure its branch company or Subsidiary in Beijing to pay relevant social security premiums for its employees located in Beijing as soon as practicable.

 

7.8 Elimination of Adverse Effects of Environmental Matters

 

The Company shall, within twelve (12) months after the Closing Date or such other period agreed by CASI, eliminate the adverse effects of failure to acquire relevant approval of environmental impact assessment and acceptance of environmental impact assessment regarding its laboratory currently in use.

 

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7.9 Compliance of Intellectual Property Management

 

Within three (3) months upon the Closing, the Company shall initiate the filing for application of the following words and image as the trademark of the Company: “ 合源生物 ”, “JUVENTAS” and “ ”.]

 

8. Mutual Covenants

 

8.1 Reasonable Efforts

 

Each Party agrees to use its reasonable commercial efforts to take or cause to be taken all actions and do or cause to be done all things necessary, proper or advisable to satisfy the terms and conditions of this Agreement and to consummate the Transaction. Each Party shall use its commercially reasonable efforts to obtain all necessary clearances, waivers, Consents and approvals and to effect all necessary registrations and filings required for the consummation of this Transaction.

 

8.2 Further Assurances

 

Each Party shall cooperate with the other Party and/or the Company and/or each Party’s Affiliates and shall execute and deliver to the other Party and/or the Company and/or its Affiliates such other instruments and documents and take such other actions as may be reasonably requested from time to time in order to carry out, evidence and confirm their rights and the intended purpose of this Agreement.

 

9. Shareholders’ Meetings

 

9.1 Annual Shareholders’ Meetings

 

An Annual Shareholders’ Meeting shall be held once a year. The Board of Directors shall give all Shareholders at least thirty (30) days’ prior written notice (unless a longer period is required by Applicable Laws) and shall include in such notice all matters to be dealt with at such Annual Shareholders’ Meeting.

 

9.2 Interim Shareholders’ Meetings

 

An Interim Shareholders’ Meeting shall be called by the Board whenever it deems necessary or otherwise convened in accordance with Applicable Laws. The Board shall give all Shareholders at least fifteen (15) days’ prior written notice (unless a longer period is required by Applicable Laws) and shall include in such notice all matters to be dealt with at such Interim Shareholders Meeting.

 

9.3 Convening

 

All Shareholders’ Meetings shall be convened at Tianjin or Beijing or such other place approved by a simple majority of shareholders. All Shareholders’ Meetings shall be convened in accordance with Amended Articles and this Agreement. The Shareholders may attend the Shareholders’ Meetings in person or by proxy, or participate in the Shareholders’ Meetings by telephone conference call, video conference call or by means of any other similar communication equipment, provided that each participant shall be able to communicate instantaneously and normally ; and such participation shall constitute presence in person provided that the minutes of the Shareholders’ Meetings are thereafter signed by all Shareholders who are entitled to vote at and participated in such meeting.

 

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9.4 Voting

 

The Shareholders of the Company shall vote according to its equity percentage at the Shareholders’ Meeting.

 

9.5 Quorum

 

The presence of at least Shareholders representing an aggregate of no less than fifty (50%) of the Registered Capital of the Company (or their respective duly appointed proxies) (including at least Investors representing an aggregate of no less than fifty percent (50%) of the Registered Capital held by all Investors) shall constitute a quorum to convene a Shareholders’ Meeting.

 

9.6 Resolutions of Shareholders’ Meetings

 

Subject to Section 10.4, resolutions of a Shareholders’ Meeting shall be passed only if approved by an affirmative vote of Shareholders representing more than fifty percent (50%) of the equity interest which are held by the Shareholders present in person or by proxy at such meeting.

 

9.7 Written Resolutions

 

Subject to Section 10.4, written resolutions signed by all the Shareholders entitled to receive notice of a Shareholders’ Meeting shall be as valid and effective for all purposes as resolutions of the Shareholders duly passed at a Shareholders’ Meeting duly convened, held and constituted.

 

10. Board of Directors and Officers

 

10.1 Composition of the Board

 

10.1.1 The management of the Company shall be vested in the Board of Directors consisting of three (3) Directors from the date on which the Directors referred to in Section 10.1.2 below are appointed and during the term of this Agreement.

 

10.1.2 During the term of this Agreement:

 

(a) the Founding Shareholder shall be entitled to nominate for election two (2) Directors with voting rights;

 

(b) [*** ] shall be entitled to nominate for election one (1) Director with voting rights and one observer without voting right;

 

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(c) The Board and the board of directors of each of the Company’s Subsidiaries (if applicable) shall have one (1) observer designated by CASI (“ CASI Observer ”). CASI Observer shall have the right to attend board or board committee meetings of the Company and each of its Subsidiaries in a non-voting observer capacity (whether in person, by telephone or other). Each of the Company and its Subsidiaries shall provide to the CASI Observer, concurrently with the members of the board and all committees thereof, and in the same manner, notice of such meetings and a copy of all materials provided to such members of the Board and all committees thereof; provided, however, that the CASI Observer shall agree to hold in confidence and trust and to act in a fiduciary manner with respect to all information so provided. Notwithstanding anything to the contrary, such CASI Observer may disclose any information to its appointer or any of its Affiliates or to any person to whom disclosure would be permitted in accordance with this Agreement.

 

(d) the Chairman shall be nominated for election by the Founding Shareholders.

 

10.1.3 On the Closing Date, the Parties shall procure that the nominees of each Shareholder nominated in accordance with the preceding Section 10.1.2 shall be appointed as Directors.

 

10.1.4 Each of the Shareholders undertakes to vote for election of any nominee for Director as proposed from time to time by a Shareholder, and further undertakes to vote for removal of any Director nominated by a Shareholder if so requested by such Shareholder.

 

10.1.5 A Director may be removed by the Shareholder by whom such Director is nominated (but not by any other Shareholder) upon written notice of removal. Such Shareholder shall send such removal notice to the Board of Directors. The Board of Directors shall notify the other Shareholders of such removal. All Shareholders shall take all necessary actions (including convening a Shareholders’ Meeting when necessary or upon request) to give effect to such removal and to the appointment of the new Director nominated by such Shareholder.

 

10.1.6 In the event of a vacancy in the Board of Directors due to the death, retirement, resignation or removal of any Director, a new Director shall be nominated in place of the deceased, retired, resigned or removed Director. Such nomination shall be made by the Shareholder who nominated the deceased, retired, resigned or removed Director by written notice to the Board of Directors with a copy to the other Shareholders. All Shareholders shall take all necessary actions to procure and ensure the election of the newly nominated individual to the Board of Directors (including convening a Shareholders’ Meeting when necessary or upon request).

 

10.2 Meetings of the Board of Directors

 

10.2.1 The meetings of the Board of Directors shall:

 

(a) be convened every six (6) months at which all matters relating to the operation, management and other activities of the Company shall be discussed; and

 

(b) be called by the Chairman at such reasonable time as he may determine to be necessary or desirable. The meeting of the Board of Directors shall be held in Tianjin, Beijing or such other place approved by a simple majority of the Directors. A meeting of the Board of Directors shall be held upon at least fifteen (15) Business Days’ prior written notice to all Directors and the observer appointed by Series A Investor, and the notice shall state the agenda, date, time and place for the meeting, provided that a shorter notice period is permissible with the written consent of a simple majority of the Directors.

 

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10.2.2 A Director may authorize another Director to attend a meeting of the Board of Directors, provided that a notice of authorization shall be duly signed by such authorizing Director and deposited with the Company or a written notice shall be given to the Company at least one (1) Business Day before the meeting of the Board of Directors.

 

10.2.3 The quorum for a meeting of the Board of Directors shall be the presence, whether in person or by due authorization of another Director, of all directors with voting rights.

 

10.2.4 Directors may participate in a meeting of the Board of Directors by means of telephone conference call, video conference call or similar communication equipment whereby each participant shall be able to communicate instantaneously and normally; and such participation shall constitute presence in person provided that the minutes of such meeting are thereafter signed by all Directors with voting rights who participated in such meeting.

 

10.3 Resolutions of the Board of Directors

 

10.3.1 Each Director with voting rights shall be entitled to one (1) vote (except that in the event that a Director accepts authorizations from one or more Directors, such Director being authorized shall be entitled to cast such additional votes in an amount equal to the number of Directors who grant authorizations to such Director).

 

10.4 Notwithstanding anything otherwise provided in this Agreement or other Transaction Documents, without prior written consent by the director appointed by [*** ], the Company shall not take, and the Founding Shareholders shall procure that the Company not take any of the actions set forth below, or any action or omission of action with same effect, and any resolution passed in violation of the foregoing shall be null and void:

 

10.4.1 issue or sell any Equity Securities, conduct any equity financing or incur any obligations therefrom;

 

10.4.2 amend any Investor’s equity interest and/or rights, preferences, privileges, powers, or the restrictions provided for the benefit of Investors hereunder;

 

10.4.3 amend any provisions in the Articles of Associations of the Company;

 

10.4.4 make any distribution of profits amongst the Shareholders by way of dividend (interim and final) or otherwise;

 

10.4.5 change the number of Directors of the Company;

 

10.4.6 conduct any merger, consolidation, or other corporate reorganization or any transaction or series of transactions in which in excess of fifty percent (50%) of the Company’s or the Company’s controlling shareholder’s voting power is transferred;

 

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10.4.7 sell or dispose of the whole or a substantial part of the assets of the Company;

 

10.4.8 sell, transfer, encumber or otherwise dispose of any trademarks, patents or other intellectual property owned by the Company beyond the Ordinary Course of Business;

 

10.4.9 create or amend the employee stock ownership plan;

 

10.4.10 increase the salary (and bonus) of any management personnel whose salary in excess of RMB 800,000 with a raise of more than 15% a year;

 

10.4.11 incur any indebtedness or loan in excess of RMB1,000,000 (or its equivalence in other currency or currencies) in one transaction or in excess of RMB1,000,000 (or its equivalence in other currency or currencies) at any time in any fiscal year;

 

10.4.12 conduct any transaction with any shareholder, director, senior executive, employee or the Affiliates of the foregoing;

 

10.4.13 purchase any real-estate in excess of RMB1,000,000;

 

10.4.14 approve the annual budget of the Company;

 

10.4.15 appointment or replacement of the general manager, vice general manager, chief financial officer, chief technical officer, chief sales officer, secretary of Board and their salary;

 

10.4.16 appoint or change the Auditors of the Company;

 

10.4.17 redeem the Equity Securities of the Company;

 

10.4.18 conduct any matters relating to the winding up, takeover, bankruptcy or liquidation of the Company;

 

10.4.19 cease to conduct or carry on the business of the Company substantially as now conducted or change any part of its business activities;

 

10.4.20 conduct any or a series of transactions in excess of RMB1,000,000 on an accumulative basis beyond the Ordinary Course of Business of the Company within the consecutive 12 months; conduct the above matters by any of the subsidiaries of the Company (if any); and

 

10.4.21 conduct any other matters which reasonably be expected to cause Material Adverse Effect to the Investors.

 

Regarding matters specified in Sections 10.4.1, 10.4.2, 10.4.3, 10.4.6, 10.4.7, 10.4.8, 10.4.18 and other matters stipulated under Article 43 of the PRC Company Law, affirmative vote by the shareholders representing more than two thirds of the voting rights (on a fully diluted basis) in the Company shall be required.

 

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10.5 Subject to Section 10.4 in this Agreement, any of the matters required to be approved by the Board shall be adopted by a simple majority of the directors.

 

10.6 Appointment of Officers of the Company

 

All Officers of the Company shall be appointed by the Board of Directors.

 

11. Information and Inspection Rights

 

11.1 Delivery of Financial Statements.

 

11.1.1 For so long as each Investor continues to hold any equity interest, the Company shall deliver to such Investor the following documents or reports:

 

(a) Before the end of February every year, a consolidated unaudited financial statement of the Company for the prior fiscal year;

 

(b) Within one hundred twenty (120) days after the end of each fiscal year of the Company, a consolidated, annual financial statements for the Company, audited and certified by a well- known independent certified public accountant satisfactory to the Company and the Investors;

 

(c) Within forty-five (45) days after the end of each quarter, an unaudited consolidated quarterly financial statement for the Company;

 

(d) No later than thirty (30) days before the end of prior fiscal year, an annual consolidated budget of the Company;

 

(e) Copies of all documents or other information as determined by the board of directors of the Company, all documents or information sent to any Investor or any reports publicly filed by the Company with any relevant securities exchange, regulatory authority or governmental agency; and

 

(f) Within one month upon the written request by any Investor, such other information as such Investor shall reasonably request, including but not limited to: (1) information related to the interest of the Investors; (2) information necessary for the audit of the Investors; and (3) information necessary for the compliance of request of competent authorities of Investor.

 

11.1.2 All the financial statements to be provided to each Investor pursuant to this Section 11.1 shall be prepared in conformance with PRC GAAP and shall consolidate all of the financial results of the Company. All the information (including without limitation the financial statements) provided by the Company to the Investor pursuant to this Section 11.1 shall be verified and certified as true, correct and not misleading by the Chief Executive Officer and the Chief Financial Officer of the Company.

 

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11.2 Inspection.

 

Each member of the Company shall permit each Investor or any independent auditor or legal counsel appointed by the Investor to visit and inspect during normal business hours following reasonable notice by the Investor to such member of the Company and in a manner so as not to interfere with the normal business operations of the Company, any of the properties of the Company, and examine the books of account and records of the Company, and discuss the affairs, finances and accounts of the Company with the directors, officers, management employees, accountants, legal counsel and investment bankers of the Company, all at such reasonable times as may be requested in writing by the Investor. The Investors shall have the right to request an independent audit review on the Company and the Company and the Founding Shareholders shall cooperate with such audit.

 

12. Dividend

 

Subject to the PRC Applicable Laws and the Articles of Association of the Company, the Board of Directors may declare dividends and distributions on equity interest in issue and authorise payment of the dividends or distributions out of the funds of the Company lawfully available therefor.

 

13. Pre-Emptive Right

 

13.1 Until the completion of a Qualified IPO, in the event that the Company proposes to issue equity interest or any other Equity Securities (the “ Addition Equity ”), the Company shall give a written notice (the “ Capital Increase Notice ”) to the Investor which shall include the amount, subscription price, category of shares, the identity of the third party with intent to subscribe the Addition Equity and other information relating to the Addition Equity. Each of the Investors is entitled to subscribe up to its pro rata share (calculated on an as converted basis) of the Addition Equity on equivalent terms and conditions upon receiving the Capital Increase Notice from the Company (the “ Pre-emptive Right ”).

 

13.2 The Investors shall reply in writing within thirty (30) days upon receipt of the Capital Increase Notice as to whether to exercise the Pre-emptive Right, and failure to reply in writing within the given period shall be deemed a waiver to exercise its Pre-emptive Right.

 

13.3 If any Investor with Pre-emptive Right fails or waives to exercise its Pre-emptive Right in full, the Company shall give a written notice to other Investors who exercise the Pre-emptive Right (the “ Second Capital Increase Notice ”), and such Shareholders with Pre-emptive Rights who exercised in full their Pre-emptive Right is entitled to (the “ Oversubscription Right ”), but not obligated to, subscribe the unsubscribed part of the Addition Equity (“ Remaining Addition Equity ”) under equivalent terms and conditions, until all the Addition Equity have been subscribed by the Investors with Pre-emptive Rights. Such other Investors with Pre-emptive Right shall reply in writing as to whether to exercise its Oversubscription Right within ten (10) days upon receiving the Second Capital Increase Notice, and failure to reply in writing shall be deemed as a waiver to exercise its Oversubscription Right. In the event more than one of such other Shareholders with Pre-emptive Right exercised their Oversubscription Right, such other Shareholders with Pre-emptive Right shall consult friendly with each other as to the Remaining Addition Equity to determine the amount each such Shareholder with Pre-emptive Right can subscribe. In the event such Investors fail to reach an agreement, each such Investors is entitled to subscribe such number of Remaining Addition Equity equal to the lesser of (i) the subscription amount included in its written response to the Second Capital Increase Notice and (ii) the product obtained by multiplying the number of the Remaining Addition Equity by a fraction, the numerator of which is the number of equity interest (calculated on an as converted basis) held by such Investor with Pre-emptive Right and the denominator of which is the total number of equity interest (calculated on an as converted basis) held by all the Investors who exercised the Oversubscription Right.

 

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13.4 Where the Addition Equity have not been fully subscribed by the Investors with Pre-emptive Right, the Founding Shareholders is entitled to subscribe unsubscribed part of the Addition Equity, or otherwise the third party specified in the Capital Increase Notice is entitled to subscribe the unsubscribed part of the Addition Equity upon expiration of the period set forth in Section 13.1, or within ninety (90) days after receiving the written waivers of all Shareholders with Pre-emptive Right, at the price and on terms and conditions as provided in the Capital Increase Notice.

 

13.5 The Pre-emptive Right shall not apply in the following situations: (1) issuance of equity interest by the Company pursuant to employee option plan, stock incentive plan or other benefit plan approved by the Shareholders’ Meeting or the Board of Directors; and (2) in the event the consent provided in Section 10.4 has been obtained (if needed), issuance of securities by the Company as consideration for acquiring or merging with other enterprises.

 

14. Anti-dilution Right

 

14.1 In the event that the Company proposes to issue Additional Equity, upon the notice under 13.1 hereunder, the Investor whose Investment Price (as adjusted for share dividends, share subdivisions, combinations, consolidations and the like) is higher than the price of such Additional Equity shall be able to exercise the Anti-dilution Right in this Section 14 (“ Anti- dilution Right ”) to make the investment price of RMB1 registered capital of the equity interest held by such Investor equals to the price of Additional Equity.

 

14.2 The Investors shall be entitled to the following:

 

14.2.1 (a) acquire extra Equity Securities (“ Extra Equity ”) from the Company at zero consideration or the lowest price permitted by Applicable Laws and regulations; Extra Equity shall be the equity interest of the Investors supposed to be owned based on its Investment Price and the price of Additional Equity, minus the equity interest actually owned by such Investors; or (b) in case the Company fails to issue the Extra Equity, request the Founding Shareholder to transfer Extra Equity to the Investor; and

 

14.2.2 All tax, fees and expense incurred by the Parties arising out of or in connection with the excise of Anti-dilution Right shall be borne by the Company and Founding Shareholders (if applicable) and the Company and Founding Shareholders (if applicable) shall indemnify such Investors if such Investors have paid any such tax, fees and expense (“ Anti-dilution Indemnification ”).

 

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14.3 The Extra Equity shall be issued and the Anti-dilution Indemnification shall be paid within six (6) months upon notice under Section 13.1, or otherwise a default interest of 0.1% of the value of Extra Equity and Anti-dilution Indemnification per day shall accrue and be paid by the Company and Founding Shareholders to the Investors entitled to Anti-dilution Right hereunder.

 

14.4 Anti-dilution Right shall not apply to situation under Section 13.5.

 

15. Prohibition on Transfer of Equity Interest

 

15.1 Transfer Restriction by Founding Shareholders

 

Each Founding Shareholders (each a “ Restricted Shareholder ”), regardless of any such holder’s employment status with any member of the Company, may not (i) transfer, sell, assign, pledge, hypothecate, or otherwise encumber or dispose of in any way or otherwise grant any interest or right with respect to, directly or indirectly, any interest in any Equity Interests in the Company now or hereafter owned or held directly or indirectly by him or her, (ii) enter into any equity arrangement agreement or other similar agreements with regard to the transfer of all or part of his or her economic interest and risk, or (iii) announce any intent that would result in the transactions mentioned in the above (i) or (ii) (“ Transfer ”) prior to a Qualified IPO, unless otherwise approved by the Board in writing prior to such Transfer. For the purposes hereof, redemption or repurchase of the Equity Interests in The Company from a Restricted Shareholder by the Company pursuant to a repurchase right or right of first refusal held by the Company in the event of a termination of employment or consulting relationship or pursuant to any Transaction Document or the ESOP shall not be prohibited under this Section.

 

15.2 Permitted Transfer.

 

Notwithstanding the provisions of this Section 15.1, any Restricted Shareholder may sell or otherwise assign, with or without consideration, up to one hundred percent (100%) of the equity interest now or hereafter held by such Shareholder, to an entity wholly-owned by such holder (“ Wholly-Owned Company ”), to a spouse or child of such holder, or to a trust, custodian, trustee, or other fiduciary for the account of any of the foregoing, to a trust for such holder’s account, or to the other Restricted Shareholders (together with the Wholly-Owned Company, collectively, the “ Permitted Transferees ” and each, a “ Permitted Transferee ”), provided that (i) only transfer to Permitted Transferees is permitted; (ii) any transfer by any Restricted Shareholder to a non-Permitted Transferee shall require the prior consent of the Investors, (iii) each such Permitted Transferee, prior to the completion of the sale, transfer, or assignment, shall have executed documents, in form and substance satisfactory to the Investors, assuming the obligations of the Restricted Shareholders under the Restated Articles and this Agreement by executing a deed of adherence in form and substance satisfactory to the Company.

 

15.3 Prohibited Transfers Void.

 

Any direct or indirect transfer of the equity interests in the Company by a Restricted Shareholder not made in compliance with this Agreement shall be null and void as against the Company, and shall not be recorded on the register of Shareholders nor recognized by the Company.

 

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15.4 Change in Control.

 

The Parties agree that, for purposes of the transfer restrictions in this Agreement, a transaction or series of transactions that result in a change of ownership of the Equity Securities of a Restricted Shareholder (if applicable) shall be deemed to constitute a Transfer of such Restricted Shareholder’s Equity Interests in the Company.

 

15.5 Transfer by the Investors

 

Any investor shall have the right to assign all or part of its equity interest in the Company to any thirty party, provided that such transferee shall (i) execute a joinder agreement and shall become a Party to this Agreement; and (ii) not be a competitor of the Company. A Competitor shall mean any company that directly competes with the Company, specifically, such company’s principal business shall be research, development, manufacturing or selling of any technology or product in relation to cellular immunotherapy, including without limitation CAR- T, CAR-NK, and TIL.

 

16. Rights of First Refusal

 

16.1 Transfer Notice.

 

Prior to the closing of a Qualified IPO, subject to Section 15.1, if a Restricted Shareholder proposes to transfer all or part of the Equity Interests in the Company to one or more third parties (a “ Proposed Transfer ”, and such holder a “ Transferor ”), then the Transferor shall give the Investor written notice of the Transferor’s intention to make the Proposed Transfer (“ Transfer Notice ”), which shall include (i) a description of the Equity Interests in the Company to be transferred (“ Offer Equity ”), (ii) the identity of the prospective transferee and (iii) the consideration and the material terms and conditions upon which the Proposed Transfer is to be made. The Transfer Notice shall certify that the Transferor has received a firm offer from the prospective transferee and in good faith believes a binding agreement for the Proposed Transfer is obtainable on the terms set forth in the Transfer Notice. The Transfer Notice is irrevocable.

 

16.2 Investor’s Option.

 

16.2.1 Subject to the Investors’ exercising of their rights of co-sale set forth in Section 16.1, each Investor shall have an option for a period of thirty (30) days following the Investor’s receipt of the Transfer Notice to elect to purchase its respective pro rata of the Offer Equity at the same price and subject to the same material terms and conditions as described in the Transfer Notice.

 

16.2.2 If any Investor fails to exercise such purchase option pursuant to this Section 16.2, the Transferor shall give notice of such failure (“ Re-allotment Notice ”) to each other Investor that elected to purchase its entire pro rata of the Offer Equity (“ Purchasing Holders ”). Such Re- allotment Notice may be made by telephone if confirmed in writing within three (3) days. The Purchasing Holders shall have a right of re-allotment such that they shall have ten (10) days from the date such Re-allotment Notice was given to elect to increase the number of Offer Equity they agreed to purchase.

 

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17. Right of Co-Sale.

 

17.1 To the extent the Investors do not exercise their respective right of first refusal as to all of the Offer Equity pursuant to Section 16, each Investor that did not exercise its right of first refusal as to any of the Offer Equity pursuant to Section 16 shall have the right to participate in such sale of Equity Interests in the Company on the same terms and conditions as specified in the Transfer Notice by notifying the Transferor in writing within thirty (30) days after receipt of the Transfer Notice referred to in Section 16.1 (such Investor, a “ Selling Holder ”). Such Selling Holder’s notice to the Transferor shall indicate the number of Equity Securities or JV Equity the Selling Holder wishes to sell under its right to participate. To the extent one or more of the Investors exercise such right of participation in accordance with the terms and conditions set forth below, the number of Equity Interests that the Transferor may sell in the Proposed Transfer shall be correspondingly reduced.

 

17.2 The Selling Holders may elect to sell such number of Equity Interests in The Company that in aggregate equals to the total number of Offer Equity on pro rata basis. Each Selling Holder may elect to sell such number of Equity Securities that equals to the product of (i) the aggregate number of the Offer Equity being transferred following the exercise or expiration of all rights of first refusal pursuant to Section 16 hereof multiplied by (ii) a fraction, the numerator of which is the number of equity interest (on a Fully-Diluted basis) owned by the Selling Holder on the date of the Transfer Notice and the denominator of which is the total number of equity interest (on a Fully-Diluted basis) owned by all Selling Holders and the selling Restricted Shareholder on the date of the Transfer Notice.

 

17.3 To the extent that any prospective purchaser prohibits the participation of a Selling Holder exercising its co-sale rights hereunder in a Proposed Transfer or otherwise refuses to purchase equity interests or other securities from a Selling Holder exercising its co-sale rights hereunder, the Transferor shall not sell to such prospective purchaser any Equity Interests in the Company unless and until, simultaneously with such sale, the Transferor shall purchase from such Selling Holder such equity interests that such Selling Holder would otherwise be entitled to sell to the prospective purchaser pursuant to its co-sale rights for the same consideration and on the same terms and conditions as the proposed transfer described in the Transfer Notice.

 

18. Liquidation Preferences.

 

18.1 Liquidation Preference.

 

Upon the occurrence of any Liquidation Event, distributions to Holders shall be made in the following manner:

 

18.1.1 Before any distribution or payment shall be made to the Founding Shareholders, each of the Investors shall be entitled to receive, on parity with each other, an amount equal to one hundred percent (100%) of the its Investment Price as specified in this Agreement and the Series A Investment Agreement, plus interests at the rate of eight percent (8%) of the Investment Price per annum, and all declared and accrued but unpaid dividends owed to such Investor (“ Liquidation Preference ”);

 

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18.1.2 If, upon any Liquidation Event, the Distributable Proceeds are insufficient to make payment of the foregoing amounts in full on all Investors, then such assets shall be distributed among the Investors rateably in proportion to the full amounts to which they would otherwise be respectively entitled thereon.

 

18.1.3 After full payment of the Liquidation Preference to the Investors, the remaining Distributable Proceeds shall be distributed rateably among the Founding Shareholders, the Series A Investors and Series A+ Investors.

 

18.2 Liquidation Event.

 

The following events shall constitute a Liquidation Event unless waived by the Investors:

 

18.2.1 any consolidation, amalgamation or merger of any of the Company with or into any Person, or any other corporate reorganization, including a sale or acquisition of Equity Securities of the Company, in which the shareholders immediately before such transaction own less than fifty percent (50%) of the Company’s voting power immediately after such transaction;

 

18.2.2 a sale of all or substantially all of the assets of the Company taken as a whole; or

 

18.2.3 the exclusive licensing of all or substantially all of the intellectual property of the Company taken as a whole to a third party; or

 

18.2.4 a liquidation, dissolution or winding up of any of the Company.

 

and upon any such event, any proceeds resulting to all the shareholders and/or the Company therefrom (“ Distributable Proceeds ”) shall be distributed to all the Shareholders in accordance with the terms of this Section 18.

 

18.3 Re-allotment of Liquidation Distribution.

 

In the event that upon the occurrence of any Liquidation Event and due to the requirements of Applicable Laws, distributions are not made in accordance with Section 18, the Shareholders who receives more amount than it should have received under Section 18 shall re-allot the distributions in accordance with Section 18 by means including transferring the distributions it receives to those negatively impacted Shareholders.

 

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19. Redemption.

 

19.1 Redemption Event.

 

19.1.1 Upon occurrence of any of the following event: (1) the Company fails to file the application for the Qualified IPO, or does not agree to the Qualified IPO, or 100% of its equity interest fails to be acquired by a third party before the [*** ] anniversary of the Closing Date, (2) any of the Founding Shareholders or the Company materially breaches any of the Transaction Documents or materially breaches any Applicable Laws which cause the Material Adverse Effect to the Company, or the Company is unable to perform a qualified IPO; or (3) once any other equity interest held by other Investors become redeemable and such Investors have made the redemption requests to the Company and/or [*** ], as requested by any Series A+ Investor (“ Series A+ Redemption Right ”), the Company and/or [*** ] shall redeem all or a portion of the then equity interest of the Series A+ Investor at the applicable Redemption Price. For the avoidance of doubt, the foregoing redemption obligations of [*** ] hereunder shall only be limited to the equity securities held by them in the Company.

 

19.1.2 Upon occurrence of any of the following event: (1) the Company fails to file the application for the Qualified IPO or does not agree to the Qualified IPO, or 100% of its equity interest fails to be acquired by a third party before the [*** ] anniversary of the Series A closing date, or (2) any of the Founding Shareholders or the Company materially breaches any of the Transaction Documents or materially breaches any applicable laws which cause the material adverse effect to the Company, or the Company is unable to perform a qualified IPO; or (3) once any other equity interest held by other Investors become redeemable and such Investors have made the redemption requests to the Company and [*** ], as requested by the any Series A Investor (“ Series A Redemption Right ”, together with the Series A+ redemption right, the “ Redemption Right ”), the Company and/or [*** ] shall redeem all or a portion of the then equity interest of the Series A Investors at the applicable Redemption Price. For the avoidance of doubt, the foregoing redemption obligations of [*** ] hereunder shall only be limited to the equity securities held by them in the Company.

 

19.1.3 Redemption Price.

 

19.1.4 The redemption price for each Series A+ Investor shall be an amount equal to one hundred percent (100%) of the Series A+ Investment Price as attached herein in Exhibit A, plus interests at the rate of eight percent (8%) of the Series A+ Investment Price per annum (in the case of a partial-year, the interests shall be accrued on a daily basis for the actual period from the date of payment of the Series A+ Investment Price made by the Series A+ Investor to the date on which the Series A+ Investor actually receives the Series A+ Redemption Price, with 360 days deemed as a complete year), and all dividends declared and unpaid with respect to such equity interest (as adjusted for any share splits, share dividends, combinations, recapitalizations or similar transactions) (“ Series A+ Redemption Price ”).

 

19.1.5 The redemption price for each Series A Investor shall be an amount equal to one hundred percent (100%) of the Series A Investment Price as attached herein in Exhibit A, plus interests at the rate of eight percent (8%) of the Series A Investment Price per annum (in the case of a partial-year, the interest shall be accrued on a daily basis for the actual period from the date of payment of the Series A Investment Price made by the Series A Investor to the date on which the Series A Investor actually receives the Series A Redemption Price, with 360 days deemed as a complete year), and all dividends declared and unpaid with respect to such equity interest (as adjusted for any share splits, share dividends, combinations, recapitalizations or similar transactions) (“ Series A Redemption Price ”, together with Series A+ Redemption Price, the “ Redemption Price ”).

 

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19.1.6 Procedure.

 

19.1.7 If any Investor intends to exercise the Redemption Right, such Investor shall deliver a notice of redemption by hand or by mail to the Company and [*** ] (“ Redemption Requesting Notice ”), which shall include the number of equity interest to be redeemed by the Company or [*** ].

 

19.1.8 Upon receipt of any Redemption Notice, the Company and/or [*** ] shall promptly give written notice of the redemption request to each non-requesting Investor entitled to exercise the Redemption Rights (“ Non-Requesting Holder(s) ”) stating the existence of such request, the Redemption Date and the mechanics of redemption. Within ten (10) days after receiving such notice from the Company, the Non-Requesting Holder(s) shall decide whether to require the Company or [*** ] to redeem all or part of the then outstanding Equity Securities such Non-Requesting Holder(s) hold(s) on the same date and issue the Redemption Requesting Notice to the Company. During the ten (10)-day period, the Company or [*** ] shall not redeem any of the Equity Securities requested for redemption. For avoidance of any doubt, if any Investor decides not to exercise the Redemption right or fails to issue any Redemption Requesting Notice within the ten (10)-day period, such non-exercise or failure to issue the notice shall not be deemed as a waiver of the Redemption Right, nor shall the Redemption Right of the Investor be deemed as terminated or lapsed therefor.

 

19.1.9 Within fifteen (15) days following the date of the Redemption Requesting Notice, the Company or [*** ] shall issue to all the Investors requesting to exercise the Redemption Right a notice, stating the date on which the Equity Securities are to be redeemed (“ Redemption Date ”), provided, however, that the Redemption Date shall be no later than one hundred and eighty (180) days following the date of the Redemption Notice.

 

19.1.10 On the Redemption Date, the Company or [*** ] shall pay the Redemption Price to the Investors requesting to exercise the Redemption Rights and the corresponding Equity Securities held by such holder shall be redeemed.

 

19.1.11 If the Company or [*** ] fails to comply with the Redemption Requesting Notice within one hundred and eighty (180) days following the date of the Redemption Requesting Notice, a default interest of 0.1% per day shall accrue and be paid by the Company and/or [*** ] to such Investors requesting to exercise the Redemption Rights.

 

19.2 Preference.

 

To the extent permitted by law, the Company shall ensure that the profits of the Company’s Subsidiaries (if any) for the time being available for distribution shall be paid to it by way of dividend if and to the extent that, but for such payment, the Company or [*** ] would not itself otherwise have sufficient profits available for distribution to make any redemption of the Equity Securities required to be made pursuant to this Section 19.

 

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19.3 Priority

 

If the Company has insufficient funds to repurchased all the equity interest of Investors requested to be redeemed on the date of redemption, the funds that are legally available shall nonetheless be paid and applied on the Redemption Date in a pro-rata manner against each Investors requested to be redeemed first in accordance with the relative full amounts owed thereon, and the shortfall shall be paid and applied from time to time out of legally available funds immediately as and when such funds become legally available in a pro-rata manner against each Investors requested to be redeemed in accordance with the relative remaining amounts owed thereon.

 

19.4 Liability of [*** ]

 

The aggregate liabilities of [*** ] hereunder shall not exceed the total Equity Securities of the Company held by [*** ] directly and indirectly (including the dividend, distributions on liquidation or any other proceeds from such Equity Securities).

 

20. Drag Along Rights.

 

20.1 Drag Along Sale

 

If the Company fails to file the application for the Qualified IPO, or does not agree to the Qualified IPO, or 100% of its equity interest fails to be acquired by a third party before the [*** ] anniversary of the Closing Date, and a proposed sale, whether or not structured as a merger, reorganization, asset sale, share sale, sale of control of the Company, or otherwise to any Person (the “ Offeror ”) is approved by the all the Investors (“ Drag Along Shareholders ”), with an implied valuation of the Company of no less than [*** ], such deal shall constitute a “ Drag Along Sale” .

 

20.2 Obligations of Holders in Drag Along Sale

 

In the event of a Drag Along Sale, the Drag Along Shareholders shall have the right to request all other shareholders (“ Dragged Shareholders ”) to agree to the Drag Along Sale and sell up to all of the Equity Interests in the Company and/or up to all of the assets of the Company to the buyer in the Drag Along Sale. Upon request of the Drag Along Shareholders, the Company shall promptly notify in writing each Holder and the material terms and conditions of such proposed Drag Along Sale, whereupon all Holders shall, in accordance with instructions received from the Company at the direction of the Drag Along Shareholders, agree to such Drag Along Sale and take the following actions:

 

20.2.1 sell, at the same time as the Drag Along Shareholders sell to the buyer in the Drag Along Sale, all of its Equity Interests in the Company or the same percentage of its Equity Interests in the Company as the Drag Along Shareholders sell, on the same terms and conditions as were agreed to by the Drag Along Shareholders; provided, however, that such terms and conditions, including with respect to price paid or received per unit of the Equity Interests in the Company, may differ as between different classes of Equity Interests in the Company in accordance with their relative Liquidation Preferences as set forth in this Agreement;

 

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20.2.2 vote all of its Equity Interests in the Company, and instruct the Directors (if any) appointed by such holders to vote (a) in favour of such Drag Along Sale, (b) against any other consolidation, recapitalization, amalgamation, merger, sale of securities, sale of assets, business combination, or transaction that would interfere with, delay, restrict, or otherwise adversely affect such Drag Along Sale, and (c) against any action or agreement that would result in a breach of any covenant, representation or warranty or any other obligation or agreement of the Company under the definitive agreement(s) related to such Drag Along Sale or that could result in any of the conditions to the closing obligations under such agreement(s) not being fulfilled, and, in connection therewith, to be present (in person or by proxy) at all relevant meetings of the Shareholders of the Company (or adjournments thereof) or to approve and execute all relevant written consents in lieu of a meeting;

 

20.2.3 not exercise any dissenters’ or appraisal rights under Applicable Laws with respect to such Drag Along Sale;

 

20.2.4 take all necessary actions in connection with the consummation of such Drag Along Sale as reasonably requested by the Drag Along Shareholders, including but not limited to the execution and delivery of any share transfer or other agreements prepared in connection with such Drag Along Sale, and the delivery, at the closing of such Drag Along Sale involving a sale of stock, of all certificates or options representing stock held or controlled by such Holder, duly endorsed for transfer or accompanied by a duly executed share transfer form, or affidavits and indemnity undertakings with respect to lost certificates.

 

20.3 Requirement on Drag Along Sale

 

In any such Drag Along Sale, (i) each Holder shall bear a proportionate share (based upon the relative proceeds received in such transaction) of the Drag Along Shareholders’ expenses incurred in the transaction, including, without limitation, legal, accounting and investment banking fees and expenses, and (ii) each Holder shall severally, not jointly, join on a pro rata basis (based upon the relative proceeds received in such transaction) in any indemnification or other obligations that are part of the terms and conditions of such Drag Along Sale (other than those that relate specifically to a particular Holder, such as indemnification with respect to representations and warranties given by such Holder regarding such Holder’s title to and ownership of equity interest, due authorization, enforceability, and no conflicts, which shall instead be given solely by such Holder) but only up to the net proceeds paid to such Holder in connection with such Drag Along Sale.

 

21. Most Favoured Investor.

 

Unless otherwise provided under the Transaction Documents, in the event the Company grants any Shareholders (including Series A Investors) any rights, privileges or protections more favourable than those granted to the Series A+ Investors, the Series A+ Investors shall, at its option, be entitled to the same rights, privileges or protections pari passu with the other Shareholders without additional consideration.

 

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22. Additional Agreements; Covenants.

 

22.1 Related-Party Transactions.

 

Prior to the closing of the Qualified IPO, except for the transactions contemplated under this Agreement, any and all transactions (“ Related Party Transactions ”) between the Company on one side, and any of the Founding Shareholders, the senior managers, the directors, the shareholders of the Company or the Affiliates of such Persons on the other side, shall be negotiated and entered into on an arms-length basis, and any Related Party Transaction between the Company on one side and CASI or its Affiliates on the other side shall be approved by CASI. Besides, any Related Party Transaction with the value of RMB800,000 or more shall be disclosed and informed to CASI.

 

22.2 Compliance with Laws; Registrations.

 

22.2.1 Without limiting the generality of the foregoing, each of the Founding Shareholders and the Company shall ensure that all filings and registrations with the Governmental Authorities so required by them shall be duly completed in accordance with the relevant rules and regulations, including without limitation any such filings and registrations with the Ministry of Commerce, the State Administration for Market Regulation, the State Administration for Foreign Exchange, tax bureau, customs authorities, product registration authorities, health regulatory authorities, and the local counterpart of each of the aforementioned Governmental Authorities, in each case, as applicable.

 

22.3 Intellectual Property Protection.

 

The Founding Shareholders and the Company shall take all reasonable steps to protect the material intellectual property rights of the Company, including without limitation (a) registering their material respective trademarks, brand names, domain names and copyrights, and (b) requiring each employee and consultant of each the Company to enter into an employment agreement in form and substance reasonably acceptable to the Investors, a confidential information and intellectual property assignment agreement and a non-competition and non- solicitation agreement requiring such persons to protect and keep confidential the Company’s confidential information, intellectual property and trade secrets, prohibiting such persons from competing with such the Company for a reasonable time after their termination of employment with the Company, and requiring such persons to assign all ownership rights in their work product to the Company, in each case in form and substance reasonably acceptable to the Investors.

 

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22.4 Internal Control System.

 

The Company shall maintain their books and records in accordance with sound business practices and implement and maintain an adequate system of procedures and controls with respect to finance, management, and accounting that meets international standards of good practice and is reasonably satisfactory to the Investors to provide reasonable assurance that (i) transactions by it are executed in accordance with management’s general or specific authorization, (ii) transactions by it are recorded as necessary to permit preparation of financial statements in conformity with PRC GAAP or IFRS and to maintain asset accountability, (iii) access to assets of it is permitted only in accordance with management’s general or specific authorization, (iv) the recorded inventory of assets is compared with the existing tangible assets at reasonable intervals and appropriate action is taken with respect to any material differences, (v) segregating duties for cash deposits, cash reconciliation, cash payment, proper approval is established, and (vi) no personal assets or bank accounts of the employees, directors, officers are mingled with the corporate assets or corporate bank account, and the Company will not use any personal bank accounts of any employees, directors, officers thereof during the operation of the business.

 

23. Limitations on Use of Name

 

The Parties other than the Series A+ Investors and their respective Affiliates undertake that without the prior written consent of the Series A+ Investors, they shall not use trade names, trademarks and/or logos of the Series A+ Investors or its Affiliates (including but not limited to “CASI”), or present itself as a business partner of the Series A+ Investors or its Affiliates or otherwise make similar representations. Without the written consent of the Series A+ Investors, the Parties other than the Series A+ Investors or their Affiliates must not cause a third party to make any press release or announcement regarding this Agreement or the subscription for equity interest of the Company by the Series A+ Investors or otherwise make any disclosure to any third party in connection therewith.

 

24. Assignments and Transfers

 

Except as otherwise provided herein, this Agreement and the rights and obligations of the Parties hereunder shall not be assigned, transferred or otherwise disposed to a third party without prior written consent of other Parties. Notwithstanding the aforesaid, (i) the rights of any Investors hereunder are assignable to its Affiliate; and, (ii) the rights of any Investors hereunder are assignable to any third party in connection with the Transfer of the Equity Interests in the Company held by such Investors but only to the extent of such transfer, provided, however, that (x) the transferor shall, subject to prior to the effectiveness of such transfer, furnish to the Company written notice of the name and address of such transferee and the Equity Securities that are being assigned to such transferee, and (y) such transferee shall, concurrently with the effectiveness of such transfer, become a party to this Agreement as an Investor and be subject to all applicable restrictions set forth in this Agreement.

 

25. Termination or Amendment of The Privilege.

 

25.1 The rights and covenants set forth in Sections 10.4, 11, 13, 14, 15, 16, 17, 18, 19, 20 and 21 shall terminate and be of no further force or effect upon the earlier occurrence of (a) the closing of a Qualified IPO, or (b) a Liquidation Event.

 

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25.2 If the Company reforms or restructures as an outbound holding company and listed overseas, which causes adverse effect on all or part of the investors’ rights and privileges hereunder, the Company, the Founding Shareholders shall cooperate with the Series A+ Investors to take all necessary measures to guarantee the rights and privileges of the Series A+ Investors hereunder reflecting in the outbound holding company, and the Series A+ Investors shall make reasonable commercial efforts to cooperate with the Company, the Founding Shareholders to accomplish the reform or restructure. The specific arrangements of the bearing of the fees, expense and taxes shall be otherwise discussed and agreed by the Parties then.

 

26. Qualified IPO

 

The Company shall form a working group and establish coordination mechanism, engage intermediary agencies and make efforts to complete the Qualified IPO, if a Shareholders’ Meeting decides that the Company has satisfied the conditions for Qualified IPO. The Founding Shareholders shall make reasonable efforts to promote the Qualified IPO.

 

27. Accounting Matters

 

27.1 Fiscal Year.

 

The fiscal year of the Company shall commence on the 1 st day of January and end on the 31 st day of December of each year, unless otherwise determined by the Board of Directors.

 

27.2 Full Records.

 

All assets, liabilities and transactions involving the Company shall be recorded fully in its official records and fully disclosed to the Auditor, and the financial statements of the Company and other The Company shall be prepared in accordance with applicable accounting principles.

 

28. Confidentiality and Announcements

 

28.1 Confidentiality

 

28.1.1 In this Section, “Confidential Information” means all information disclosed (whether in writing, orally or by any other means and whether directly or indirectly) by a person (the “Disclosing Party”) to another person (the “Receiving Party”) including information relating to the Disclosing Party’s customers, internal policies, products, operations, processes, plans or intentions, know-how, trade secrets, intellectual property, market opportunities and business affairs, financial information and pricing information, except that the confidentiality obligations shall not apply if and to the extent that:

 

(a) the Confidential Information is in the public domain other than by the fault of the Receiving Party;

 

(b) the Confidential Information was previously known to the Receiving Party prior to receipt from the Disclosing Party; and

 

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(c) the Confidential Information was rightfully disclosed to the Receiving Party by a third person without a breach of such third person’s obligation of confidentiality.

 

28.1.2 All Parties may not, during the term of this Agreement and notwithstanding termination of this Agreement, disclose the Confidential Information of each other and of the Company and its Subsidiaries to any person except with the prior written consent of the Disclosing Party or for the performance of its obligations under this Agreement.

 

28.1.3 Without limiting the generality of the foregoing, each Party shall and shall ensure its representatives on the Board of the Company shall:

 

(a) instruct and require all of its employees and agents who have access to the Confidential Information to maintain the confidentiality thereof;

 

(b) disclose the Confidential Information to its Affiliates, its and its Affiliates’ respective Directors, employees, agents, advisors, investor, prospective investor, financing resources and prospective acquirers only on a need-to-know basis, provided that each such individual shall be bound by the same confidentiality obligation as the Parties; and

 

(c) take such reasonable action to limit disclosure of the Confidential Information. If the Receiving Party of such Confidential Information is served with any subpoena or other compulsory judicial or administrative process requesting Confidential Information of any Disclosing Party or if the disclosure of such Confidential Information is required by Law or any stock exchange or regulatory requirement, the Receiving Party will immediately notify the Disclosing Party of such Confidential Information in order that the Disclosing Party may take such action as it deems necessary to protect its interest and the Receiving Party shall co-operate with the Disclosing Party to limit the scope and use of the information to be disclosed subject to limitations under the relevant Law

 

28.1.4 This provision shall survive the termination of this Agreement with respect to any Party, and the restriction on disclosure of Confidential Information shall continue to apply for all purposes for a period of five (5) years from such termination with respect to any Party, provided however, such restrictions shall not apply to information which ceases to be Confidential Information.

 

28.2 Publicity

 

No Party shall issue, publish or disseminate or cause to be issued, published or disseminated any press release or public communication relating to this Agreement or any agreement in connection herewith or any of the transactions contemplated herein or therein; provided, however, a Party or its holding companies may make any disclosure it believes in good faith and upon advice of counsel that (a) the disclosure is required by Applicable Law, or (b) the disclosure is required by the rules of the stock exchange where the relevant Party is listed or intends to be listed. Prior to such disclosure, such Party shall consult with the other Parties.

 

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29. Default and Indemnification

 

29.1 In the event any Party (the “ Defaulting Party ”) is in breach of this Agreement, including any breach of the representations in this Agreement, the other Parties shall be entitled to an indemnification for its losses caused by such breach, in addition to any other rights such Parties are entitled to under this Agreement.

 

29.2 Subject to the other provisions of this Section, the Defaulting Party shall indemnify any other Party (the “ Indemnified Parties ”) against their losses and hold them harmless under the following circumstances: (i) the Defaulting Party breaches any of its representations and warranties hereunder or any of such representations and warranties are not true; (ii) the Defaulting Party breaches or fails to perform its covenants, agreements, undertakings or obligations hereunder, unless such breach or failure have been waived by the other Parties in writing.

 

29.3 In the event any Party is in breach of this Agreement, the other Parties shall be entitled to, in addition to any other rights they may have under this Agreement, request the specific performance by the Defaulting Party of its relevant obligations hereunder.

 

29.4 Notwithstanding anything to the contrary herein, this Section shall survive the termination of this Agreement.

 

30. Independent Nature of Obligations and Rights of Series A+ Investors

 

30.1 The obligations of each Series A+ Investor under this Agreement and the other Transaction Documents are several and not joint, and no Series A+ Investor is responsible in any way for the performance or conduct of any other Series A+ Investors in connection with the transactions contemplated hereby. Nothing contained herein or in any other Transaction Document, and no action taken by any Series A+ Investor pursuant hereto or thereto, shall be or shall be deemed to constitute a partnership, association, joint venture, or joint group with respect to the Series A+ Investor. Each Series A+ Investor agrees that no other Series A+ Investor has acted as an agent for such Series A+ Investor in connection with the transactions contemplated hereby.

 

31. Termination

 

31.1 Term

 

This Agreement shall become effective on the Execution Date and continue to be valid during the existence of the Company unless terminated earlier in accordance with this Agreement. For avoidance of doubt, if any of the Series A+ Investors fails to execute this Agreement, this Agreement will be binding upon the Company, other Series A+ Investors who have executed this Agreement and other signing Parties.

 

31.2 Termination

 

This Agreement may be terminated:

 

(a) immediately by unanimous agreement in writing of all the Parties;

 

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(b) by the Company upon written notice to the Series A+ Investor, in the event the Series A+ Investor fails to perform its obligation to pay Subscription Price within forty-five (45) days after the Closing Date; and

 

(c) by the Series A+ Investor upon written notice to the other Parties, in the event the Conditions Precedent set forth in Section 3.1 are not satisfied or waived by the Series A+ Investor in accordance with Section 3.1 within six (6) months of the Execution Date.

 

When this Agreement is terminated by any Party pursuant to Section 31.2, no Party shall have any rights or claims against the others, save for those in respect of a breach of this Agreement prior to such termination.

 

31.3 Consequences

 

The termination or expiry of this Agreement shall be without prejudice to any rights and obligations of any Party as at the date of termination and shall not relieve any Party from any liability to any other Party that exists at the time of such termination.

 

32. Dispute Resolution and Governing Law

 

32.1 Governing Law

 

The terms of this Agreement shall be governed by and construed and enforced in accordance with the laws of PRC without regard to its principles of conflicts of laws.

 

32.2 Dispute Resolution

 

32.2.1 The Parties to this Agreement shall seek to resolve any dispute or claim arising out of or in relation to this Agreement by friendly consultation. Any Party may notify any other Party of its desire for a consultation to resolve such dispute or claim.

 

32.2.2 If the Parties are unable to resolve a dispute or claim arising out of or in relation to this Agreement, including any question regarding its existence, validity or termination, within a period of ten (10) Business Days from the date on which a notice is given under Section 32.2.1, any Party may submit such dispute or claim to the Hong Kong International Arbitration Centre in accordance with and subject to its rules of procedure then in force.

 

32.2.3 The arbitration tribunal shall consist of three (3) arbitrators to be appointed according to the arbitration rules of the Hong Kong International Arbitration Centre.

 

32.2.4 Any arbitration award will be final and binding on the Parties and may be enforced by courts of any relevant jurisdiction, including the PRC. The Parties must enforce any arbitral award without delay and all the Parties agree to waive any right to claim or appeal to any courts in connection with any question arising in the course of arbitration or with respect to any arbitral award.

 

32.2.5 The arbitration will be conducted in Hong Kong in English and Chinese.

 

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32.2.6 The non-prevailing Party shall bear the costs of arbitration (including the prevailing Party’s reasonable attorney’s fees).

 

32.2.7 Despite the existence of a dispute which is the subject of either friendly consultation or arbitration, the Parties:

 

(a) may exercise their remaining respective rights; and

 

(b) must perform their remaining respective obligations, under this Agreement, except in respect of those matters that are the subject of the dispute.

 

33. Miscellaneous

 

33.1 Further Assurances

 

The Parties shall, and shall use their respective reasonable endeavours to procure that any necessary third persons shall execute and perform all such further deeds, documents, assurances, acts and things as any of the Parties may reasonably require by notice in writing to the others for the purposes of giving such Party the full benefit of all the provisions of this Agreement.

 

33.2 Entire Agreement

 

This Agreement and other Transaction Documents constitute the entire agreement among the Parties relating to the Transaction hereof and supersede any prior agreements, understandings or discussions among the Parties. In the event of discrepancies between this Agreement and the Series A Investment Agreement, this Agreement shall prevail.

 

33.3 Succession and Assignment

 

The terms and conditions of this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. No Party may assign either this Agreement or any of its rights, interests, or obligations hereunder without the prior written consent of the other Parties, provided, however, that the Series A+ Investor may (i) assign any of their rights and interests hereunder to one or more of their Affiliates and (ii) designate one or more of their Affiliates to perform all or certain of their obligations hereunder (in which case the Series A+ Investor shall remain liable for the performance of all its obligations hereunder).

 

33.4 Notice

 

All notices and other communications transmitted to any Party pursuant hereto shall be in writing in Chinese and English and delivered by hand or by prepaid courier (in each case the recipient shall execute the return receipt) to the mailing address set forth below, or by facsimile or email as set forth below, or to such other mailing address, facsimile or email as a Party may from time to time notify the other Parties:

 

To CASI :      c/o CASI (Beijing) Pharmaceuticals Co., Ltd.

 

Address: [*** ]

 

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Telephone: [*** ]
   
Fax: /
   
Attention: Larry (Wei) Zhang
   
Email: [*** ]
   
To [*** ]:  
   
Address: [*** ]
   
Telephone: [*** ]
   
Fax: [*** ]
   
Attention: [*** ]
   
Email: [*** ]
   
To [*** ]:  
   
Address: [*** ]
   
Telephone: [*** ]
   
Fax: /  
   
Attention: [*** ]
   
Email: [*** ]
   
To the Company, the Founding Shareholders :
   
Address: [*** ]
   
Telephone: [*** ]
   
Fax: /  
   
Attention: [*** ]
   
Email: [*** ]
   
To [*** ]:  

 

  53  

 

  

  Address: [*** ]
     
  Telephone: [*** ]
     
  Fax: /  
     
  Attention: [*** ]
     
  Email: [*** ]
     
To [*** ]:  
     
  Address: [*** ]
     
  Telephone: [*** ]
     
  Fax: /  
     
  Attention: [*** ]
     
  Email: [*** ]
     
To [*** ]:  
     
  Address: [*** ]
     
  Telephone: [*** ]
     
  Fax: [*** ]
     
  Attention: [*** ]
     
  Email: [*** ]
     
To [*** ]:  
     
  Address: [*** ]
     
  Telephone: [*** ]
     
  Fax: /  
     
  Attention: [*** ]
     
  Email: [*** ]

 

  54  

 

 

To [*** ]:  
   
  Address: [*** ]
     
  Telephone: [*** ]
     
  Fax: [*** ]
     
  Attention: [*** ]
     
  Email: [*** ]
     
To [*** ]:  
     
  Address: [*** ]
     
  Telephone: [*** ]
     
  Fax: /  
     
  Attention: [*** ]
     
  Email: [*** ]

 

Without limiting any other means by which a Party may be able to prove that a notice has been received by another Party, a notice will be deemed to be duly received:

 

(a) if sent by hand or courier, when actually delivered at the address of the recipient; or

 

(b) if sent by facsimile, upon receipt by the sender of an acknowledgment or transmission report generated by the machine from which the facsimile was sent indicating that the facsimile was sent in its entirety to the recipient’s facsimile number,

 

except that if a notice is delivered by hand, or is received by facsimile on a day which is not a Business Day, or after 5.00 pm on any Business Day, such notice will be deemed to be duly received by the recipient at 9.00 am on the first Business Day thereafter.

 

33.5 Amendments and Waivers

 

No amendment of any provision of this Agreement shall be valid unless the same is in writing and signed by all the Parties. No waiver by any Party of any default, misrepresentation, or breach of warranty or covenant under this Agreement, whether intentional or not, shall be deemed to extend to any prior or subsequent default, misrepresentation, or breach of warranty or covenant under this Agreement or affect in any way any rights arising by virtue of any prior or subsequent such occurrence.

 

33.6 Costs

 

The Parties shall bear their own costs, charges and other expenses incurred in connection with the negotiation, preparation and implementation of this Agreement and any other actions in connection herewith.

 

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33.7 Counterparts

 

This Agreement may be executed in any number of counterparts, each of which shall be an original, but all of which together shall constitute one instrument.

 

33.8 Severability

 

If any term or provision of this Agreement is or becomes invalid or unenforceable in any event or in any jurisdiction, nothing shall affect the validity or enforceability of the remaining terms and provisions of this Agreement, and nothing shall affect the validity or enforceability of such term or provision in any other event or in any other jurisdiction.

 

33.9 Incorporation of Exhibits

 

The Exhibits specified in this Agreement are incorporated by reference and constitute a part of this Agreement.

 

33.10 Language

 

This Agreement is executed in English and Chinese and both the English and Chinese versions shall be of the same legal effects.

 

(THE REMAINDER OF THIS PAGE IS INTENTIONALLY LEFT BLANK) 

 

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( SIGNATURE PAGE OF INVESTMENT AGREEMENT in respect of JUVENTAS CELL THERAPY LTD.)

 

IN WITNESS WHEREOF, the Parties hereto have caused their respective duly authorized representatives to execute this Agreement as of the date and year first above written:

 

JUVENTAS CELL THERAPY LTD.

 

Signature:   /s/ Lulu Lv  
     
Name: Luly Lv  
     
Title: Authorized Representative  

 

     

 

  

( SIGNATURE PAGE OF INVESTMENT AGREEMENT in respect of JUVENTAS CELL THERAPY LTD.)

 

IN WITNESS WHEREOF, the Parties hereto have caused their respective duly authorized representatives to execute this Agreement as of the date and year first above written:

 

CASI Biopharmaceuticals (WUXI) CO., Ltd.

 

Signature: /s/ Wei Zhang  
     
Name: WEI ZHANG  
     
Title:   Chairman  

 

     

 

  

[Signature pages of other Investors omitted]

 

     

 

Exhibit 31.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

 

I, Wei-Wu He, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of CASI Pharmaceuticals, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the condensed consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of condensed consolidated financial statements for external purposes in accordance with generally accepted accounting principles;

 

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and

 

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: August 9, 2019

 

/s/ Wei-Wu He  
Wei-Wu He  
Chief Executive Officer  

 

 

 

 

Exhibit 31.2

 

CERTIFICATION OF CHIEF FINANCIAL OFFICER

 

I, George Chi, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of CASI Pharmaceuticals, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the condensed consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of condensed consolidated financial statements for external purposes in accordance with generally accepted accounting principles;

 

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and

 

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: August 9, 2019

 

/s/ George Chi  
George Chi  
Chief Financial Officer  

 

 

 

 

Exhibit 32.1

  

CERTIFICATION BY CHIEF EXECUTIVE OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of CASI Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2019 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Wei-Wu He, as Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the dates and periods covered by the Report.

 

The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed as part of the Report or as a separate disclosure document.

 

Date:  August 9, 2019 /s/ Wei-Wu He
  Wei-Wu He
Chief Executive Officer

 

 

 

 

Exhibit 32.2

 

CERTIFICATION BY CHIEF FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of CASI Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2019 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, George Chi, as Chief Financial Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the dates and periods covered by the Report.

 

The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed as part of the Report or as a separate disclosure document.

 

Date:  August 9, 2019 /s/ George Chi
 

George Chi

Chief Financial Officer