INFLARX N.V.
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Date: December 21, 2022
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By:
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/s/ Niels Riedemann
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Name:
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Niels Riedemann
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Title:
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Chief Executive Officer
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Exhibit No.
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Description
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Addendum No. 3, dated as of December 21, 2022, between InflaRx GmbH and Staidson (Beijing) BioPharmaceuticals Co., Ltd., to the Co-Development Agreement, dated as of December 28, 2016 between InflaRx GmbH and Staidson (Beijing)
BioPharmaceuticals Co., Ltd. (as successor to Beijing Defengrei Biotechnology Co. Ltd. (BDB))
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Share Purchase Agreement, dated as of December 21, 2022, between InflaRx N.V. and Staidson Hong Kong Investment Company Limited
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Press Release, dated December 21, 2022
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A. |
Staidson and INFLARX have executed a Co-Development Agreement effective December 28, 2015, as amended through an Addendum I effective as of December 28, 2015 and Addendum II effective as of November 09, 2021 with respect to monoclonal
anti-human complement C5a antibodies and INFLARX issued certain confirmation and authorization letters thereunder (collectively, the "Co-Development Agreement").The Co-Development Agreement was
assigned from Beijing Defengrei Biotechnology Co. Ltd (BDB) to Staidson by execution of the Addendum II. The Co-Development Agreement covers, amongst others, the development of Staidson’s’ development candidate BDB-1.
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B. |
INFLARX completed and published results of a Phase III PANAMO-trial of its C5a-antibody vilobelimab to treat critically ill, invasively mechanically ventilated COVID-19 patients.
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C. |
Staidson intends to pursue a regulatory filing of BDB-1 in the Territory for the indication COVID-19and to obtain regional NDA for BDB-1 in the Territory with certain support of INFLARX.
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D. |
In order to support Staidson’s regulatory filing as mentioned in Preamble C. above, Staidson wishes to license certain INFLARX’ clinical and regulatory documents generated in the course of INFLARX’ development of vilobelimab, including
but not limited to clinical study results of the PANAMO-trial.
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1. |
Amendment of Article 1 of the Co-Development Agreement (Definitions)
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1.47 |
“Regulatory Documents License” shall have the meaning as defined in Section 14.1.
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1.48 |
“Regulatory Documents” shall mean clinical, technical and regulatory data and documents owned or controlled by INFLARX regarding vilobelimab which are reasonably useful for Staidson to file a
marketing application with CDE or NMPA for BDB-1 in the License Field, such documents defined in Attachment III to the Co-Development Agreement. Any and all Regulatory Documents shall
constitute INFLARX Intellectual Property according to Section 1.33 of the Co-Development Agreement and INFLARX Confidential Information according to Section 1.14 of the Co-Development Agreement.
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1.49 |
“License Field” shall mean treatment and/or measures of prevention in the indication of COVID-19 including associated syndromes such as pneumonia, ARDS and sepsis.
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1.50 |
“Regulatory Documents License Term” shall mean the time period from the effective date of the Addendum III of the Co-Development Agreement until and for as long as Staidson generates Net Sales for
BDB-1 in the License Field, unless terminated early by INFLARX according to Section 14.2.
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1.51 |
“CDE” shall mean the Center for Drug Evaluation of NMPA.
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1.52 |
“EMA” shall mean the European Medicines Agency.
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1.53 |
“FDA” shall mean the United States Food and Drug Administration.
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1.54 |
“NDA” shall mean a New Drug Application with the FDA.
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1.55 |
“NMPA” shall mean the Chinese National Medical Products Administration.
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2. |
Amendment of Section 2.2 of the Co-Development Agreement (Frame of Co-Development)
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3. |
New Article 14 of the Co-Development Agreement (“Regulatory Documents License”)
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14.1 |
Regulatory Documents License. INFLARX grants to Staidson for the Regulatory Documents License Term an exclusive royalty-bearing license, without the right to grant sublicenses, to use the Regulatory Documents for a marketing
application of BDB-1 in the License Field in the Territory (“Regulatory Documents License”).
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14.2 |
Termination of License. INFLARX shall be entitled to terminate the Regulatory Documents License in writing without notice period in the event that(i) Staidson has not submitted BDB-1 a filing for Regulatory Approval to the NMPA in
the License Fields prior to December 31, 2023, or (ii) Staidson breached its non-competition obligation as set forth in Section 14.12.
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14.3 |
Consequences of License Termination. If INFLARX terminates the Regulatory Documents License in accordance with Section 14.2, the license granted to Staidson under Section 14.1 shall cease immediately and Staidson shall cease
immediately any use of Regulatory Documents, and shall return or destroy any and all portions of received Regulatory Documents within 14 days, such return or destruction to be confirmed by Staidson in writing without undue delay.
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14.4 |
Royalties to be paid to INFLARX. Instead of royalty payments in the amount of 5% as agreed upon in Section 7.1 for Net Sales for Products containing BDB-1 and/or BDB-2, Staidson shall pay to INFLARX for the granting of the
Regulatory Documents License and during the Regulatory Documents License Term royalties amounting to 10% of Staidson’s Net Sales in the License Field for Products containing BDB-1. For the avoidance of doubt, Section 7.8 of the
Co-Development Agreement shall remain unaffected.
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14.5 |
Off-label Use. Until receipt of any additional Regulatory Approval for BDB-1 in the Territory in any indication other than the License Field, any off-label use and related sales of the Product occurring after the Regulatory
Approval of BDB-1 for one or more indications of the License Field, and such Regulatory Approval has been achieved on the basis of the Regulatory Documents License, shall be considered as sales subject to Section 14.4 and be treated
equivalent to sales occurring related to the approved indication.
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14.6 |
Taxes. Any payment subject to Section 14.4 and Section 14.5 by Staidson as Paying Party shall be exclusive of, and Staidson shall be responsible for the payment, of any applicable taxes within China, including but not limited to
any withholding tax, and other fees of any nature imposed by or under the authority of any Chinese or other applicable government authority.
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14.7 |
Payment and late payments of Royalties. The Parties agree that royalty payments according to Section 14.4 shall be made quarterly and shall be due upon the last day of the following calendar quarter. Besides, Section 7.3 and
Section 7.5 shall apply for any royalty payments according to Section 14.4.
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14.8 |
Royalty Reports. Section 7.4 shall apply for any Net Sales and Products sold during the License Term.
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14.9 |
Record & Audits. Section 7.7 shall apply for any royalty payment according to Section 14.4.
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14.10 |
Forecasts. Staidson shall submit written quarterly forecasts and calculations covering a forecasted period of time of 12 calendar months, including revenue and Net Sales estimates and anticipated costs and expenses to INFLARX from
any Regulatory Approval of BDB-1 in the License Field in the Territory. Such forecasts shall be submitted by Staidson until the end of the calendar month following the end of a calendar quarter.
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14.11 |
No Representation or Warranties. Notwithstanding Article 9 (Warranties and Liability), the following shall apply: The Regulatory Documents are provided to Staidson “as is” with no warranties, express or implied, or representations
and INFLARX expressly disclaims any warranties of merchantability, fitness for a particular purpose, or non-infringement of third party patents. Staidson shall use the Regulatory Documents at its own expense and risk and shall hold INFLARX
harmless at all times of any liabilities, claims for damages or personal injuries and any costs and expenses which might occur in connection with the use and handling of the Regulatory Documents, unless Staidson can prove and document that
and if so to which extent such damages or injuries were due to gross negligence or willful misconduct on the part of INFLARX. Staidson shall use any and all Regulatory Documents provided by INFLARX in compliance with all applicable laws and
regulations.
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14.12 | Non-compete. |
14.12.1 |
In September 2021, Staidson initiated Phase I clinical trials under a US IND for STSA-1002, and Phase I clinical trials under NMPA IND for STSA-1002 (collectively, “Staidson Phase I Trial”), an
anti-C5a mAB. STSA-1002 is unrelated to vilobelimab or BDB-1 and not subject to the Co-Development Agreement. To maintain the mutually beneficial spirit of the Co-Development Agreement, Staidson shall not develop and/or market STSA-1002
worldwide in the License Field. The support provided by INFLARX through the Regulatory Documents License is exclusively targeted at BDB-1 and therefore the Regulatory Documents License to Regulatory Documents shall be exclusively limited to
BDB-1 in the License Field and shall not be used for the support of any development and/or marketing of any other product in development by Staidson worldwide.
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14.12.2 |
Notwithstanding the foregoing, Staidson shall be entitled to continue the conduct and to complete the Staidson Phase I Trial , and any further development of STSA-1002 for the indication COVID-19 shall constitute a breach of the
non-competition obligation of Staidson subject to this Section 14.12.
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14.12.3 |
The non-competition obligation of Staidson under this Section 14.12 shall become null and void, if (i) the NMPA does not grant a Regulatory Approval of BDB-1 in the License Field in the Territory after Staidson’s submission to NMPA for
Regulatory Approval, (ii) the Regulatory Documents License is terminated in accordance with Section 14.2, or (iii) if the Co-Development Agreement is effectively terminated.
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14.13 |
Press Release. InflaRx N.V. and Staidson, both being stock listed companies are subject to certain disclosure obligations. Notwithstanding Section 8.7, the Parties shall use reasonable efforts to liaise with each other on timing
and content of any publication regarding the Regulatory Documents License, including any release on form 6-k, being subject to applicable laws and stock market regulations in the US and P.R. China.
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14.14 |
Survival. The following provisions shall survive any termination of the Regulatory Documents License and termination of the Co-Development Agreement: Section 14.3, Section 14.8, Section 14.9, Section 14.11, and Section 14.13
through Section 14.14.
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4. |
Amendment of Section 9.2(i) of the Co-Development Agreement (Staidson Warranties and Limitation of Liability)
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9.2(i) |
Staidson warrants to INFLARX that it will strictly adhere to all obligations established within this Agreement, including but not limited to those under Article, 4, Article 5 and Article 14.
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5. |
Amendment of Article 12 of the Co-Development Agreement (Miscellaneous Provisions)
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6. |
New Attachment III of the Co-Development Agreement (“Regulatory Documents”)
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a) |
INFLARX’clinical documents related to COVID-19:
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b) |
INFLARX’ written communications with the German Paul-Ehrlich-Institute (PEI), the EMA and with the FDA on vilobelimab NDA application, including meeting minutes with such regulatory authorities
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c) |
Vilobelimab CMC-related documents such as COA relevant to the PANAMO trial
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d) |
Other relevant regulatory documents upon request from regulatory agencies
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7. |
Miscellaneous
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FOR InflaRx GmbH:
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FOR Staidson (Beijing)
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BioPharmaceuticals Co., Ltd.
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By /s/ Dr. Thomas Taapken
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By /s/ Chao Wang
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(Dr. Thomas Taapken, CFO)
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(Chao Wang, CEO)
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Date: December 21, 2022
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Date: December 21, 2022
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FOR InflaRx GmbH:
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By /s/ i.V. Prof. Renfeng Guo
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(i.V. Prof. Renfeng Guo, CSO)
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Date: December 21, 2022
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INFLARX N.V.
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By:
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/s/ Niels Riedemann
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Name: Niels Riedemann
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Title: Chief Executive Officer
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STAIDSON HONG KONG INVESTMENT COMPANY LIMITED
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By:
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/s/ Zhiwen Zhou
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Name: Zhiwen Zhou
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Title: President
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1 |
DEFINITIONS AND INTERPRETATION
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1.1 |
Definitions
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1.1.1 |
In this Deed the following definitions shall apply:
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Aggregate Issue Price
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The aggregate issue price for the Purchased Shares, being USD [2,500,000][7,500,000].
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AST Register
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The register kept by the Transfer Agent with respect to Ordinary Shares.
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CEO
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The Company’s Chief Executive Officer.
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Deed
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This deed of issue.
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Investor
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Staidson Hong Kong Investment Company Limited
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Ordinary Shares
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Ordinary shares in the Company’s capital, having a nominal value of EUR 0.12 each.
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Purchased Shares
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[number] Ordinary Shares.
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Share Purchase Agreement
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The share purchase agreement entered into by the Company and the Investor regarding the sale and issuance of the Purchased Shares, dated December 21, 2022.
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Transfer Agent
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American Stock Transfer & Trust Company, LLC, in its capacity as the Company’s transfer agent.
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1.2 |
Interpretation
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1.2.1 |
Terms that are defined in the singular have a corresponding meaning in the plural and vice versa.
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1.2.2 |
Although this Deed has been drafted in the English language, this Deed pertains to Dutch legal concepts. Any consequence of the use of English words and expressions in this Deed under any law other than Dutch law shall be disregarded.
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1.2.3 |
The titles and headings in this Deed are for construction purposes as well as for reference. No party may derive any rights from such titles and headings.
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2 |
ISSUANCE
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2.1 |
Issuance of Purchased Shares
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2.1.1 |
In giving effect to the Company’s obligations under the Share Purchase Agreement, the Company hereby issues the Purchased Shares to the Transfer Agent for inclusion of the Purchased Shares in the AST Register and for delivery by the
Transfer Agent of the Purchased Shares in book-entry form (either directly or through the facilities of The Depository Trust Company) to the Investor.
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2.1.2 |
Upon the Purchased Shares being included in the AST Register, the Transfer Agent shall be considered to have accepted the Purchased Shares for delivery in book-entry form (either directly or through the facilities of The Depository Trust Company) to the Investor.
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2.1.3 |
This Deed also constitutes a resolution of the CEO, passed under delegation and authorization by the Board, to issue the Purchased Shares pursuant to this Deed and to exclude any statutory pre-emption rights in respect thereof.
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2.2 |
Payment
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2.2.1 |
The Aggregate Issue Price for the Purchased Shares has been satisfied in accordance with the terms of the Share Purchase Agreement and the Company grants a discharge for the payment thereof.
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2.2.2 |
To the extent that the Aggregate Issue Price for the Purchased Shares exceeds the aggregate nominal value of the Purchased Shares, such excess shall be considered to be share premium and shall be added to the Company’s share premium
reserve attached to the Ordinary Shares.
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2.3 |
Registration
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2.3.1 |
Promptly following the execution of this Deed, the Company shall (i) register the present issuance of the Purchased Shares in its register within the meaning of Section 2:85 of the Dutch Civil Code and (ii) cause the Transfer Agent to
register the Purchased Shares in the register maintained by the Transfer Agent in respect of the Ordinary Shares.
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3 |
MISCELLANEOUS PROVISIONS
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3.1 |
No rescission or nullification
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3.1.1 |
To the extent permitted by law, the Company waives its rights to rescind or nullify or to demand the rescission, nullification or amendment of this Deed, in whole or in part, on any grounds whatsoever.
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3.2 |
Governing law
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3.2.1 |
Without prejudice to the relevant provisions of Chapters 4 and 5 of Title 10 of Book 10 of the Dutch Civil Code, this Deed shall be governed by and construed in accordance with the laws of the Netherlands.
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3.3 |
Jurisdiction
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3.3.1 |
Any dispute in connection with this Deed shall be submitted to the exclusive jurisdiction of the competent court in Amsterdam, the Netherlands.
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InflaRx will provide access to certain clinical, manufacturing and regulatory documentation for vilobelimab to facilitate STS’s regulatory filings in China
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STS plans to request regulatory approval in China for its own anti-C5a-antibody BDB-001 for the treatment of COVID-19 based on InflaRx’s technology in-licensed by STS
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InflaRx will receive 10% royalties on net sales of BDB-001 for the treatment of COVID-19 in China
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STS to make an additional USD 2.5 million investment in InflaRx at a price of USD 5.00 per share
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Option for InflaRx to request STS makes a further USD 7.5 million investment in InflaRx
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