As filed with the Securities and Exchange Commission on October 24, 2023
Registration No. 333-273395
Delaware
(State or other jurisdiction of
incorporation or organization)
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56-2020050
(I.R.S. Employer
Identification Number)
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Stephen Thau
David Schwartz
Orrick, Herrington & Sutcliffe LLP
51 West 52nd Street
New York, NY 10019
(212) 506-5000
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Ryan A. Murr
Branden C. Berns
Gibson, Dunn & Crutcher LLP
555 Mission Street, Suite 3000
San Francisco, CA 94105
(415) 393-8200
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Large accelerated filer ☐
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Accelerated filer ☐
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Non-accelerated filer ☒
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Emerging growth company ☐
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Smaller reporting company ☒
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(i)
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6,266,521 shares of Common Stock beneficially owned by GNI USA, Inc., a Delaware corporation (“GNI USA”), previously issued to
GNI Group Ltd, a company incorporated under the laws of Japan with limited liability (“GNI Japan”), and GNI Hong Kong Limited, a company incorporated under the laws of Hong Kong with limited liability (“GNI Hong Kong Limited”), in a
private issuance pursuant to the Asset Purchase Agreement, dated December 26, 2022 (the “F351 Agreement”), and ultimately transferred to GNI USA prior to the closing of the Transactions (as defined below);
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(ii)
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123,400,000 shares of Common Stock issuable upon conversion of 12,340 shares of Convertible Preferred Stock beneficially owned
by GNI USA, previously issued to GNI Japan and GNI Hong Kong Limited in the private issuance pursuant to the F351 Agreement, and ultimately transferred to GNI USA prior to the closing of the Transactions;
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(iii)
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953,821,796 shares of Common Stock issuable to GNI USA pursuant to the Business Combination Agreement, dated December 26, 2022
(the “Business Combination Agreement”), by and among the Company, GNI USA, the individuals listed on Annex A thereto (the “Minority Holders”) and other parties thereto; and
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(iv)
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156,954,428 shares of Common Stock to be issued to the Minority Holders pursuant to the Business Combination Agreement.
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the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results;
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our ability to develop a pipeline of product candidates to address unmet needs in the treatment of organ fibrosis and other
inflammatory diseases;
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the timing, progress and results of clinical trials for Hydronidone from the Company’s Phase 2a trial and other product
candidates that the Company may develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the studies or trials will become
available and research and development programs;
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the timing, scope and likelihood of regulatory filings and approvals, including timing of investigational new drug applications
and final approval of Hydronidone from the U.S. Food and Drug Administration for the treatment of nonalcoholic steatohepatitis (“NASH”) and liver fibrosis associated with chronic hepatitis B, and any other future product candidates;
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the timing, scope or likelihood of foreign regulatory filings and approvals;
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our expectations regarding the reconsideration of its strategic alternatives in the event the Transactions are not completed;
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our expectations regarding the future pursuit of product development efforts, including whether it will pursue such efforts,
estimates regarding the expenses, future revenue, timing of any future revenue, capital requirements and need for additional financing related to such efforts, the timing of and ability of the Company to pursue such efforts and the
Company’s plans to develop and, if approved, subsequently commercialize any product candidates resulting from such efforts;
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our expectations regarding its ability to fund its operating expenses and capital expenditure requirements with its cash, cash
equivalents and investments;
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our ability to develop and advance current product candidates and programs into, and successfully complete, clinical studies;
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our manufacturing, commercialization and marketing capabilities and strategy;
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plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales
strategy;
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the need to hire additional personnel and our ability to attract and retain such personnel;
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the size of the market opportunity for our product candidates, including estimates of the number of patients who suffer from
the diseases the Company is targeting;
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expectations regarding the approval and use of our product candidates in combination with other drugs;
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expectations regarding potential for accelerated approval or other expedited regulatory designation;
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our competitive position and the success of competing therapies that are or may become available;
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estimates of the number of patients that the Company will enroll in its clinical trials;
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the beneficial characteristics and the potential safety, efficacy and therapeutic effects of our product candidates;
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our ability to obtain and maintain regulatory approval of its product candidates and its expectations regarding particular
lines of therapy;
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plans relating to the further development of our product candidates, including additional indications the Company may pursue;
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existing regulations and regulatory developments in the United States, Europe, and other jurisdictions;
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expectations regarding the impact of the COVID-19 pandemic on our business;
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our intellectual property position, including the scope of protection the Company is able to establish and maintain for
intellectual property rights covering Hydronidone, and other product candidates it may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties and our
ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;
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our continued reliance on third parties to conduct additional clinical trials of our product candidates and for the manufacture
of its product candidates for clinical trials;
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our relationships with patient advocacy groups, key opinion leaders, regulators, the research community and payors;
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our ability to obtain and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be
necessary or desirable to develop, manufacture or commercialize our product candidates;
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the pricing and reimbursement of Hydronidone, and other product candidates the Company may develop, if approved;
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the rate and degree of market acceptance and clinical utility of Hydronidone, and other product candidates the Company may
develop;
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our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
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our financial performance;
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the period over which the Company estimates its existing cash and cash equivalents will be sufficient to fund its planned
operating expenses and capital expenditure requirements;
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statements regarding the approval and closing of the Transactions;
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the timing of the consummation of the Transactions;
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our ability to solicit a sufficient number of proxies to approve the change of control resulting from the Transactions;
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satisfaction of conditions to the completion of the Transactions;
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the expected benefits of the Transactions;
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our ability to complete the Transactions;
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expectations about the continued listing of Common Stock on Nasdaq;
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the impact of laws and regulations; and
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expectations regarding the period during which the Company will qualify as a smaller reporting company under the Securities
Exchange Act of 1934, as amended (the “Exchange Act”).
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our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the SEC on March 30, 2023 (and any portions of the Proxy Statement that are incorporated by reference into our Annual Report on Form 10-K for the year ended December 31, 2022);
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our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2023 and June 30, 2023 filed with the SEC on May 15, 2023 and August
14, 2023, respectively;
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our Current Reports on Form 8-K as filed with the SEC on January 19, 2023, March 2,
2023, March 30, 2023, April 7, 2023, May 5,
2023, June 20, 2023, and August 31, 2023;
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the Proxy Statement;
and
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the Description of Catalyst Capital Stock section contained in the Proxy Statement, including any amendment or report filed for the purpose of updating such description.
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Beneficial Ownership Prior to the Date of
this Prospectus
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Beneficial Ownership Assuming the
Sale of All Shares registered pursuant
to this Prospectus
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Name
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Number of Shares
Beneficially Owned
Following
Conversion(1)
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Percent of
Outstanding
Common Stock(2)
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Number of
Shares
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Percent of
Outstanding
Common Stock
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GNI USA(3)
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1,083,488,317
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85.17%
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0
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0%
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Ping Lan(4)
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42,605,648
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3.35%
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0
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0%
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Hui Sun(5)
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34,084,519
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2.68%
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0
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0%
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Yueying Zhu(6)
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44,137,006
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3.47%
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0
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0%
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Arthur Xin-bin Cheng(7)
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36,127,255
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2.84%
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0
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0%
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(1)
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One share of Convertible Preferred Stock converts into 10,000 shares of Common Stock.
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(2)
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Based upon 1,272,151,116 shares of Common Stock outstanding assuming the conversion of all shares of Convertible Preferred Stock
that a Selling Stockholder beneficially owns into shares of Common Stock.
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(3)
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GNI USA, through entities affiliated with GNI Japan, is a wholly-owned subsidiary of GNI Japan. By virtue of such relationship,
GNI Japan may be deemed to have voting and investment power with respect to the shares held by GNI USA. Ying Luo, Ph.D. is a director, representative executive officer, president and chief executive officer and executive committee member
of GNI Japan and may be deemed to share voting and dispositive power over the shares held of record by GNI USA. The business address for GNI USA is 12730 High Bluff Drive, Suite 250, San Diego, California 92130. The address for GNI Japan
and Ying Luo, Ph.D. is c/o GNI Group Ltd., Nihonbashi-Honcho YS Bldg. 3rd Floor 2-2-2 Nihonbashi-Honcho, Chuo-ku, 103-0023 Tokyo, Japan.
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(4)
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The business address for Ping Lan is c/o Beijing Continent Pharmaceuticals Co., Ltd, Room 320507-320509, Building 5, Wangjing
SOHO Tower, Yard 1, Futong East Street, Chaoyang District, Beijing, PRC.
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(5)
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The business address for Hui Sun is c/o Beijing Continent Pharmaceuticals Co., Ltd, Room 320507-320509, Building 5, Wangjing
SOHO Tower, Yard 1, Futong East Street, Chaoyang District, Beijing, PRC.
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(6)
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The business address for Yueying Zhu is c/o Beijing Continent Pharmaceuticals Co., Ltd, Room 320507-320509, Building 5, Wangjing
SOHO Tower, Yard 1, Futong East Street, Chaoyang District, Beijing, PRC.
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(7)
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The business address for Arthur Xin-bin Cheng is c/o Beijing Continent Pharmaceuticals Co., Ltd, Room 320507-320509, Building 5,
Wangjing SOHO Tower, Yard 1, Futong East Street, Chaoyang District, Beijing, PRC.
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on the Nasdaq, in the over-the-counter market or on any other national securities exchange on which our securities are listed
or traded;
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in privately negotiated transactions;
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in underwritten offerings;
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in ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
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in a block trade in which the broker-dealer will attempt to sell the offered shares as agent but may position and resell a
portion of the block as principal to facilitate the transaction;
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through purchases by a broker-dealer as principal and resale by the broker-dealer for its account pursuant to this prospectus;
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through the writing of options (including put or call options), whether the options are listed on an options exchange or
otherwise;
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through the distribution of the shares by any Selling Stockholder to its partners, members or stockholders;
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in short sales entered into after the effective date of the registration statement of which this prospectus is a part;
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by pledge to secured debts and other obligations;
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through delayed delivery arrangements;
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an exchange distribution in accordance with the rules of the applicable exchange;
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through delayed delivery arrangements;
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to or through underwriters or agents;
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“at the market” or through market makers or into an existing market for the securities;
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through trading plans entered into by a Selling Stockholder pursuant to Rule 10b5-1 under the Exchange Act that are in place at
the time of an offering pursuant to this prospectus and any applicable prospectus supplement hereto that provide for periodic sales of securities on the basis of parameters described in such trading plans; or
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a combination of any such methods of sale.
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ITEM 14.
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Other Expenses of Issuance and Distributions.
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Registration fee – Securities and Exchange Commission
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$57,152.93
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Printing and engraving expenses
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*
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Legal fees and expenses
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*
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Accounting fees and expenses
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*
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Transfer agent fees and expenses
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*
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Miscellaneous
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Total
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*
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*
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These fees are calculated based on the securities offered and the number of issuances and accordingly cannot be defined at this
time.
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ITEM 15.
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Indemnification of Directors and Officers.
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for any breach of the director’s duty of loyalty to us or our stockholders;
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for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law;
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under Section 174 of the Delaware General Corporation Law; or
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for any transaction from which the director derived an improper personal benefit.
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ITEM 16.
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Exhibits.
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Incorporated by reference herein
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Exhibit
No.
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Description
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Form
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File No.
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Filing Date
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Filed
Herewith
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Asset Purchase Agreement, dated December 26, 2022, by and among Catalyst
Biosciences, Inc., GNI Japan, and GNI Hong Kong Limited
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8-K
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000-51173
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December 27, 2022
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Agreement and Amendment to Asset Purchase Agreement, dated as of March 29, 2023,
by and among Catalyst, GNI Japan and GNI Hong Kong Limited.
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8-K
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000-51173
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March 30, 2023
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Business Combination Agreement, dated December 26, 2022, by and among Catalyst
Biosciences, Inc., GNI USA, Inc., GNI Japan, GNI Hong Kong Limited, Shanghai Genomics, Inc., the individuals listed on Annex A thereto and Continent Pharmaceuticals Inc.
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8-K
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000-51173
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December 27, 2022
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Amendment to Business Combination Agreement, dated as of March 29, 2023, by and
among Catalyst, GNI USA, GNI Japan, GNI Hong Kong Limited, Shanghai Genomics Inc., the Minority Holders and CPI.
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8-K
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000-51173
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March 30, 2023
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Second Amendment to Business Combination Agreement, dated as of August 30, 2023,
by and among Catalyst, GNI USA, GNI Japan, GNI Hong Kong Limited, Shanghai Genomics Inc. and CPI.
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8-K
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000-51173
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August 31, 2023
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Contingent Value Rights Agreement, dated as of December 26, 2022, between
Catalyst and American Stock Transfer & Trust Company, LLC
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S-3
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333-273395
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July 24, 2023
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Amendment to Contingent Value Rights Agreement, dated as of March 29, 2023,
executed by Catalyst.
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8-K
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000-51173
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March 30, 2023
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Fourth Amended and Restated Certificate of Incorporation of the Registrant
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S-8
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333-133881
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May 8, 2006
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Incorporated by reference herein
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Exhibit
No.
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Description
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Form
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File No.
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Filing Date
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Filed
Herewith
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Certificate of Amendment to the Fourth Amended and Restated Certificate of
Incorporation of the Registrant
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8-K
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000-51173
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August 20, 2015
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Second Certificate of Amendment to the Fourth Amended and Restated Certificate
of Incorporation of the Registrant
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8-K
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000-51173
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February 10, 2017
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Certificate of Designation of Series X Convertible Preferred Stock
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8-K
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000-51173
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December 27, 2022
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Certificate of Designation of Series Y Preferred Stock
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8-K
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000-51173
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June 20, 2023
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Certificate of Elimination for Catalyst’s Series Y Preferred Stock.
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8-K
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000-51173
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August 31, 2023
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Amended and Restated Bylaws of the Registrant
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8-K
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000-51173
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December 27, 2022
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Opinion of Orrick, Herrington & Sutcliffe LLP
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S-3/A
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333-273395
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October 13, 2023
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Consent of EisnerAmper LLP
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X
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Consent of Ernst & Young Hua Ming LLP
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X
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Consent of Orrick, Herrington & Sutcliffe LLP (contained in Exhibit 5.1)
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S-3/A
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333-273395
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October 13, 2023
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Power of Attorney (contained in the signature page hereto)
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S-3
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333-273395
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July 24, 2023
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Filing Fee Table
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S-3
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333-273395
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July 24, 2023
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ITEM 17.
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Undertakings.
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(a)
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The undersigned registrant hereby undertakes:
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(1)
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To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
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(i)
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To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
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(ii)
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To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume
of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Filing Fee Table” filed as an
exhibit in the effective registration statement; and
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(iii)
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To include any material information with respect to the plan of distribution not previously disclosed in the registration
statement or any material change to such information in the registration statement; provided, however, that paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) do not apply if the information
required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934
that are incorporated by reference herein in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.
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(2)
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That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall
be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering
thereof.
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(3)
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To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold
at the termination of the offering.
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(4)
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That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
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(i)
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If the registrant is relying on Rule 430B,
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(A)
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Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as
of the date the filed prospectus was deemed part of and included in the registration statement; and
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(B)
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Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in
reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and
included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As
provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the
registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no
statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference herein into the registration statement or prospectus that is part
of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the
registration statement or made in any such document immediately prior to such effective date;
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(ii)
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If the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is
first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated
or deemed incorporated by reference herein into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any
statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.
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(5)
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The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933,
each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of
the Securities Exchange Act of 1934) that is incorporated by reference herein in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
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(6)
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Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and
controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as
expressed in the Securities Act of 1933 and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer
or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will,
unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the
Securities Act of 1933 and will be governed by the final adjudication of such issue.
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(7)
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The undersigned registrant hereby undertakes that: in a registration statement permitted by Rule 430A,
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(i)
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For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus
filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b) (1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this
registration statement as of the time it was declared effective; and
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(ii)
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For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a
form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
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Catalyst Biosciences, Inc.
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By:
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/s/ Nassim Usman, Ph.D.
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Nassim Usman, Ph.D.
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President and Chief Executive Officer
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Signature
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Title
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Date
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/s/ Nassim Usman, Ph.D.
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President and Chief Executive Officer, Director
(Principal Executive Officer)
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October 24, 2023
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Nassim Usman, Ph.D.
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*
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Interim Chief Financial Officer
(Interim Principal Financial Officer and
Principal Accounting Officer)
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October 24, 2023
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Seline Miller
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*
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Chairman of the Board
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October 24, 2023
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Ying Luo, Ph.D.
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*
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Director
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October 24, 2023
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Augustine Lawlor
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*
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Director
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October 24, 2023
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Thomas Eastling
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*
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Director
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October 24, 2023
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Andrea Hunt
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*By:
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/s/ Nassim Usman, Ph.D.
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Nassim Usman, Ph.D.
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Attorney-in-Fact
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