Document:

Document

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
    
			
	CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT

This CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT (this “Agreement”), made as of 1 August, 2022 (the “Effective Date”), is by and between Context Therapeutics Inc., having a place of business at 2001 Market Street, Suite 3915, Unit# 15, Philadelphia, PA 19103 USA (“Context”), and Berlin-Chemie AG - Menarini Group, having a place of business at Glienicker Weg 125,12489 Berlin, Germany (“Menarini”). Context and Menarini are each referred to herein individually as a “Party” and collectively the “Parties”.  

RECITALS 

A.    Context owns or otherwise controls and is developing the Context Compound (as defined below) for the treatment of certain tumor types.
B.    Menarini owns or otherwise controls and is developing the Menarini Compound (as defined below) for the treatment of certain tumor types.
C.    Context desires to sponsor one or more clinical trials in which the Menarini Compound and the Context Compound would be dosed in combination.
D.    Context and Menarini, consistent with the terms of this Agreement, desire to collaborate as more fully described herein, including by Menarini providing the Menarini Compound for the Study (as defined below).
E.    Menarini grants Elacestrant License to Context under the conditions and restrictions of Elacestrant License Agreements and Context hereby agrees to abide by the conditions and restrictions of Elacestrant License Agreements. 
NOW, THEREFORE, in consideration of the premises and of the following mutual promises, covenants and conditions, the Parties, intending to be legally bound, mutually agree as follows:

1.    Definitions

For all purposes of this Agreement, the capitalized terms defined in this Article 1 and throughout this Agreement shall have the meanings herein specified.
1.1    “Adverse Event” (also known as “AE”) means any untoward medical occurrence in a patient after administration of a pharmaceutical product, which does not necessarily have to have a causal relationship with Study treatment as further defined in the Pharmacovigilance Agreement.
1.2    “Affiliate” means, with respect to either Party, a firm, corporation or other entity which directly or indirectly owns or controls said Party, or is owned or controlled by said Party, or is under common ownership or control with said Party. The word “control” means (i) the direct or indirect ownership of fifty percent (50%) or more of the outstanding voting securities of a legal entity, or (ii) possession, directly or indirectly, of the power to direct the management or policies of a legal entity, whether through the ownership of voting securities, contract rights, voting rights, corporate governance or otherwise.
1.3    “Agreement” means this agreement, as amended by the Parties from time to time, and as set forth in the preamble.
1.4    “Alliance Manager” has the meaning set forth in Section 3.11.

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1.5    “Applicable Law” means all federal, state, local, national and regional statutes, laws, rules, regulations and directives in the Territory applicable to a particular activity hereunder, including performance of clinical trials, medical treatment and the processing and protection of personal and medical data, that may be in effect from time to time, including those promulgated by the United States Food and Drug Administration (“FDA”), national regulatory authorities, the European Medicines Agency (“EMA”) and any successor agency to the FDA or EMA or any agency or authority performing some or all of the functions of the FDA or EMA in any jurisdiction outside the United States or the European Union (each a “Regulatory Authority” and collectively, “Regulatory Authorities”), and including without limitation cGMP and GCP (each as defined below); all data protection requirements such as those specified in the EU General Data Protection Regulation 2016/679 and the regulations issued under the United States Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); export control and economic sanctions regulations which prohibit the shipment of United States-origin products and technology to certain restricted countries, entities and individuals; anti-bribery and anti-corruption laws pertaining to interactions with government agents, officials and representatives; laws and regulations governing payments to healthcare providers; and any United States or other country’s or jurisdiction’s successor or replacement statutes, laws, rules, regulations and directives relating to the foregoing.
1.6    “Business Day” means any day other than a Saturday, Sunday, or any public holiday in the country where the applicable obligations are to be performed.
1.7    “Calendar Quarter” means a three-month period beginning on January 1st, April 1st, July 1st, or October 1st.
1.8    “Calendar Year” means a one-year period beginning on January 1st and ending on December 31st.
1.9    “cGMP” means the current Good Manufacturing Practices officially published and interpreted by EMA, FDA and other applicable Regulatory Authorities that may be in effect from time to time and are applicable to the Manufacture of the Compounds.
1.10    “Clinical Data” means all data (including raw data) and results generated under the Study, other than Sample Testing Results.
1.11    “Commercially Reasonable Efforts” means the level of efforts and resources required to perform obligations under this Agreement in a sustained manner consistent with the efforts that a similarly situated pharmaceutical company would typically devote to its respective obligations under this Agreement, a study of similar potential at a similar stage of compounds development, profit potential or strategic value resulting from its own research efforts, based on conditions then prevailing.
1.12    “Compounds” means the Context Compound and the Menarini Compound. A “Compound” means the Context Compound or the Menarini Compound, as applicable.
1.13    “Combination” means the use or method of using the Menarini Compound and the Context Compound in concomitant or sequential administration but always administered as separate compounds.
1.14    “Confidential Information” means any information, Know-How or other proprietary information or materials furnished to one Party by or on behalf of the other Party pursuant to this Agreement, except to the extent that such information or materials: (a) was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the other Party, as demonstrated by competent evidence; (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party; (c) became generally available to the public or otherwise part of the 

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public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; (d) was disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others; or (e) was subsequently developed by the receiving Party without use of the Confidential Information, as demonstrated by competent evidence.
1.15    “Context” has the meaning set forth in the preamble.
1.16    “Context Compound” means ONA-XR (onapristone extended-release formulation) to be provided as 10mg and 20mg film coated extended release tablets packaged in high-density polyethylene bottles and closures, with 60 tablets per bottle, with clinical use labels (or in such other form as Context reasonably deems appropriate for the Study).
1.17    “Continuing Party” has the meaning set forth in Section 10.1.2.
1.18    “CTA” means an application to a Regulatory Authority for purposes of requesting the ability to start or continue a clinical trial.
1.19    “Data Sharing and Sample Testing Schedule” means the schedule attached hereto as Schedule I.
1.20    “Defending Party” has the meaning set forth in Section 14.2.3.
1.21    “Disposition Package” has the meaning set forth in Section 8.7.1.
1.22    “Dispute” has the meaning set forth in Section 21.1.
1.23    “Effective Date” has the meaning set forth in the preamble.
1.24    “Eisai” means Eisai Co., Ltd., a corporation organized and existing under the laws of Japan, with its registered office at 6-10 Koishikawa 4-chome, Bunkyo-ku, Tokyo, 112-8088, Japan.
1.25    “Elacestrant License” means a license granted under the Elacestrant License Agreements.
1.26    “Elacestrant License Agreements” collectively means (a) License Agreement entered into by and between Eisai Co. Ltd. and Radius Health, Inc., dated June 29, 2006 and amended on February 26, 2015, and (b) License Agreement entered into by and between Radius Pharmaceuticals, Inc. and Berlin-Chemie AG – Menarini Group, dated July 23, 2020.
1.27    “EMA” has the meaning set forth in the definition of Applicable Law.
1.28    “FDA” has the meaning set forth in the definition of Applicable Law.
1.29    “Filing Party” has the meaning set forth in Section 10.1.2.  
1.30    “First Party” has the meaning set forth in Section 8.17.
1.31    “Further Transaction” means any sale, divestment (or any other form of disposal) or license by Context to a Third Party to manufacture, develop, promote, distribute, market or sell the Context Compound or product containing the Context Compound, with respect to one or more of the countries of the world, where such transaction or deal solely involves the Context Compound (and any combination product containing the Context Compound, which combination is under Context control); provided for the purposes of clarity, the following shall not be considered a Further Transaction: (i) a sale, merger or similar transaction involving Context, as a company, to a Third Party, and (ii) the subcontracting or grant of a license to a contract manufacturer, contract salesforce organization (CSO) services, or a contract research organization for the purpose of researching, developing, manufacturing or promoting (using a CSO) the Context Compound for Context, or (iii) pre-clinical studies and clinical trials not otherwise restricted by the last sentence of Section 2.6(B).
1.32    “GCP” means the Good Clinical Practices officially published by EMA, FDA and the International Conference on Harmonisation of Technical Requirements for Registration of 

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Pharmaceuticals for Human Use (ICH) that may be in effect from time to time and are applicable to the clinical testing of the Compounds.
1.33    “Government Official” means: (a) any officer or employee of a government or any department, agency or instrument of a government; (b) any person acting in an official capacity for or on behalf of a government or any department, agency, or instrument of a government; (c) any officer or employee of a company or business owned in whole or part by a government; (d) any officer or employee of a public international organization such as the World Bank or United Nations; (e) any officer or employee of a political party or any person acting in an official capacity on behalf of a political party; and/or (f) any candidate for political office; who, when such Government Official is acting in an official capacity, or in an official decision-making role, has responsibility for performing regulatory inspections, government authorizations or licenses, or otherwise has the capacity to take decisions with the potential to affect the business of either of the Parties.
1.34    “HIPAA” has the meaning set forth in the definition of Applicable Law.
1.35    “IND” means the Investigational New Drug Application filed or to be filed with the FDA as described in Title 21 of the U.S. Code of Federal Regulations, Part 312, and the equivalent application in the jurisdictions outside the United States, including an “Investigational Medicinal Product Dossier” filed or to be filed with the Regulatory Authorities in the European Union.
1.36    “Inventions” means all inventions and discoveries, whether or not patentable, which are made or conceived in the performance of the Study and/or which are made or conceived by a Party through use of the Clinical Data or Sample Testing Results.
1.37    “Joint Development Committee” or “JDC” has the meaning set forth in Section 3.11.
1.38    “Jointly Owned Invention” has the meaning set forth in Section 10.1.1.
1.39    “Joint Patent Application” has the meaning set forth in Section 10.1.2.
1.40    “Joint Patent” means a patent that issues from a Joint Patent Application.
1.41    “Know-How” means any proprietary invention, innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, including manufacturing, use, process, structural, operational and other data and information, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable, that is not generally known or otherwise in the public domain.
1.42    “Liability” has the meaning set forth in Section 14.2.1.
1.43    “Manufacture,” “Manufactured,” or “Manufacturing” means all stages of the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch, and supply, as applicable.
1.44    “Manufacturer's Release” or “Release” means the formal quality operations of a material. Subsequent to release, a material may be used in further processing.
1.45    “Manufacturing Costs” means the costs of Manufacturing the applicable Compound, as calculated consistent with GAAP or IFRS and include [***].
1.46    “Manufacturing Site” means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.6 (Changes to Manufacturing).
1.47    “Menarini” has the meaning set forth in the preamble.

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1.48    “Menarini Compound” means elacestrant 400 mg and 100 mg tablets, packaged in high-density polyethylene bottles with 30 tablets each without clinical trial medication label.
1.49    “Non-Conformance” means, with respect to a given unit of Compound an event that deviates from an approved cGMP requirement with respect to the applicable Compound, such as a procedure, Specification, or operating parameter, or that requires an investigation to assess impact to the quality of the applicable Compound 
1.50    “Non-filing Party” has the meaning set forth in Section 10.1.2.
1.51    “Opting-out Party” has the meaning set forth in Section 10.1.2.
1.52    “Other Party” has the meaning set forth in Section 14.2.3.
1.53    “Party” has the meaning set forth in the preamble.
1.54    “Permitted Use” has the meaning set forth in Section 3.10.
1.55    “Pharmacovigilance Agreement” means that certain pharmacovigilance agreement entered into by the Parties prior to the initiation of the Study and regarding the Compounds and incorporated herein by reference.
1.56    “Project Manager” has the meaning set forth in Section 3.11.
1.57    “Protocol” means the written documentation that describes the Study and sets forth specific activities to be performed as part of the Study conduct, a summary of which is attached hereto as Appendix A.
1.58    “Quality Agreement” means that certain quality agreement as shall be entered into by the Parties prior to the commencement of the Study regarding the Menarini Compound and incorporated herein by reference.
1.59    “Regulatory Approvals” means any and all permissions (other than the Manufacturing approvals) required to be obtained from Regulatory Authorities and any other competent authority for the development, registration, importation, use (including in clinical trials), distribution, sale and marketing of a Compound in the United States, Europe, or other applicable jurisdictions for use in humans, including any pricing or reimbursement approvals.
1.60    “Regulatory Authorities” has the meaning set forth in the definition of Applicable Law.
1.61    “Related Agreements” means the Pharmacovigilance Agreement and the Quality Agreement.
1.62    “Samples” means urine, blood and tissue samples taken, in accordance with the Protocol, from patients participating in the Study.
1.63    “Sample Testing” means the analyses to be performed by Context in accordance with the Protocol using the applicable Samples.
1.64    “Sample Testing Results” means those results arising from the Sample Testing which are to be shared between Context and Menarini, as set forth in the Data Sharing and Sample Testing Schedule.
1.65    “Second Party” has the meaning set forth in Section 8.17.
1.66    “Specifications” means, with respect to a given Compound, the set of requirements for such Compound as set by each Party.
1.67    “Study” means the open-label, phase 1b-2 study of ELacestrant, in combination with ONApristone in patients with advanced or metastatic estrogen receptor-positive, progesterone receptor-positive, HER2-negative breast cancer (ELONA), as further described in the Study Synopsis set forth in Appendix A hereto.
1.68    “Study Completion” has the meaning set forth in Section 3.8.

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1.69    “Sunshine Laws” means Applicable Laws requiring collection, reporting and disclosure of POTVs to certain healthcare providers, entities and individuals.  These Applicable Laws may include relevant provisions of the Patient Protection and Affordable Health Care Act of 2010 and implementing regulations thereunder.
1.70    “Territory” means anywhere in the world.
1.71    “Third Party” means any person or entity other than Menarini, Context or their respective Affiliates.
1.72    “VAT” “has the meaning set forth in Section 8.16.

2.    Scope of the Agreement

2.1    Each Party shall contribute to the Study as set forth in this Agreement.
2.2    Each Party agrees to act in good faith in performing its obligations under this Agreement and each Related Agreement and shall notify the other Party as promptly as possible in the event of any Manufacturing delay that is likely to adversely affect supply of its Compound or Compounds as contemplated by this Agreement.
2.3    Parties’ undertakings with respect to quality of the Compounds.
2.3.1    Menarini agrees to use its Commercially Reasonable Efforts to Manufacture (or have Manufactured) and supply (or have supplied) the Menarini Compound for purposes of the Study as set forth in Article 8, and Menarini hereby represents and warrants to Context that, at the time of Delivery of the Menarini Compound, such Menarini Compound shall: (A) have been Manufactured and supplied in compliance with: (i) the Specifications for the Menarini Compound; (ii) the Quality Agreement; and (iii) all Applicable Law, including cGMP and health, safety, and environmental protections, and (B) shall be free of Non-Conformance. 
2.3.2    Context agrees to use its Commercially Reasonable Efforts to Manufacture (or have Manufactured) and deliver (or have delivered) the Context Compound for purposes of the Study and Context hereby represents and warrants to Menarini that, at the time of delivery of the Context Compound to subjects involved in the Study, such Context Compound shall: (A) have been Manufactured and supplied in compliance with: (i) the Specifications for the Context Compound; and (ii) all Applicable Law, including cGMP and health, safety, and environmental protections, and (B) shall be free of Non-Conformance. 
2.3.3    Without limiting the foregoing, each Party is responsible for obtaining all regulatory approvals (including facility licenses) that are required to Manufacture its Compounds in accordance with Applicable Law (provided that for clarity, Context shall be responsible for obtaining Regulatory Approvals for the Study as set forth in Section 3.4).
2.4    Each Party shall have the right to delegate or subcontract any portion of its obligations solely related to the Study hereunder: (i) to its own Affiliates, without the other Party's written consent; or (ii) to Third Parties (which, in relation to the manufacture of any additional Menarini Compound or Context Compound after the Effective Date shall be with a reputable manufacturer). Each Party shall remain solely and fully liable for the performance of its subcontractors. Each Party shall ensure that each of its subcontractors performs its obligations pursuant to the terms of this Agreement, including the Appendices attached hereto. Each Party shall use Commercially Reasonable Efforts to obtain and maintain copies of documents relating to the obligations performed by such subcontractors that are held by 

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or under the control of such subcontractors and that are required to be provided to the other Party under this Agreement.
2.5    Other than as set forth in this Agreement, this Agreement does not create any obligation on the part of Context to provide the Context Compound for any activities other than the Study, nor does it create any obligation on the part of Menarini to provide the Menarini Compound for any activities other than the Study.
2.6    (A) Subject to paragraph (B) below, nothing in this Agreement shall (i) prohibit either Party from performing clinical studies other than the Study relating to its own Compounds, either individually or in combination with any other compound or product, in any therapeutic area, or (ii) create an exclusive relationship between the Parties with respect to any Compound (without prejudice to Section 20.2 below). 
(B) Notwithstanding the foregoing, the Parties agree that Context shall not, without the prior written consent of Menarini (which consent shall be at Menarini’s sole discretion), include in the Study any additional trial arms which includes any antiestrogen compounds other than the Menarini Compound.  In addition, until the earlier of (i) Study completion, (ii) the termination of the Study or this Agreement, (iii) FDA providing a complete response letter (“CRL”) to the application for approval for the Menarini Compound that does not ultimately lead to approval of the Menarini Compound within six (6) months of such initial CRL, or (iv) Menarini’s breach of the terms of this Agreement, Context will not, without the prior written consent of Menarini (which consent shall be at Menarini’s sole discretion), conduct a clinical trial in humans with an orally administered selective estrogen receptor degrader, other than the Menarini Compound, in patients with advanced or metastatic estrogen receptor-positive, progesterone receptor-positive, HER2-negative breast cancer. 
2.7    Notwithstanding any other section to the contrary in any case, Menarini grants Elacestrant License to Context under the conditions and restrictions of Elacestrant License Agreements. Context hereby agrees to abide by the conditions and restrictions of Elacestrant License Agreements. If there is any discrepancy between the provisions of this Agreement and Elacestrant License Agreements, the provisions of Elacestrant License Agreements shall prevail and apply to the Parties.
     
3.    Conduct of the Study

3.1    Context shall act as the sponsor of the Study and shall hold the IND relating to the Study; provided, however, that in no event shall Context file a separate IND for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests a separate IND for the Study, the Parties will meet to discuss an approach to address such requirement, with Context having final decision-making authority regarding such separate IND, provided that Context shall reasonably consider any input provided by Menarini.     
3.2    Prior to the initiation of the Study or as may otherwise be necessary during the course of the Study, either Party shall share with the other Party any information related to the pre-clinical and clinical studies it performed regarding their respective Compound, as may be reasonably requested by the other Party in view of the evaluation of the Study.     
3.3    Context agrees that the Study shall be performed in accordance with this Agreement, its obligations under the Related Agreements, the Protocol and all Applicable Law, including GCP, other than any Study activities to be performed by Menarini for which Menarini shall ensure that such Study activities are performed in accordance with this Agreement, its obligations under the Related Agreements, and all Applicable Law, including GCP. In the event that any Regulatory Authority, ethics committee or institutional review board has 

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questions related to the Protocol or the conduct of the Study that relate to the Menarini Compound, Menarini will provide reasonable assistance in responding to such questions.
3.4    Context agrees that all its Study activities shall be in compliance with all directions from, and that have been agreed with, any Regulatory Authority and/or ethics committee with jurisdiction over the Study. Further, Context shall ensure that all Regulatory Approvals from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are obtained prior to initiating performance of the Study (in particular and to the extent applicable, Context will follow the FDA Guidance on co-development of two or more investigational drugs). Context shall participate in and, if required, lead any and all discussions with any Regulatory Authority regarding the Study, provided, however, that Menarini shall have the right (but no obligation) to participate in any such discussions. Menarini grants to Context a non-exclusive, non-transferable (except in connection with a permitted assignment, sublicense or subcontract) “right of reference” (as defined in 21 CFR 314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant part of the Territory, with respect to Menarini’s Regulatory Approvals for the Menarini Compound, as necessary for Context to prepare, submit and maintain Regulatory Approvals for the Study. Further, Menarini shall provide to Context a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate such right of reference. 
3.5    Notwithstanding anything to the contrary in this Agreement, neither Party shall have any right to access the other Party's CMC Data (as hereinafter defined) with respect to its Compounds unless it is requested or required by the Regulatory Authority. If necessary, each Party shall authorize FDA and other applicable Regulatory Authorities to cross-reference the U.S. and EU Regulatory Approvals of its Compound to provide data access to the other Party solely to the extent necessary to support conduct of the Study. If the cross-references to such Regulatory Approvals are not deemed sufficient by a Regulatory Authority in any given country, then such Party shall file the complete CMC components of the Common Technical Document for its Compound (the “CMC Data”) with such Regulatory Authority, with a letter of authorization for the other Party to cross-reference the CMC Data for the review of the CTA; however, the other Party shall have no right to directly access the CMC Data. If direct access to CMC Data of the other Party is required for any regulatory filing submission, the Parties will discuss in good faith a potential solution; however in the absence of an agreement, the Parties shall refrain from using the CMC Data for any such filing.
3.6    In addition to the foregoing, Menarini shall use its Commercially Reasonable Efforts to: (i) provide the first tranche of Menarini Compound described in Appendix B to Context no later than [***] days from the written order from Context, and (ii) provide such other documents and information as may be requested by a Regulatory Authority, to the extent such documents and information are reasonably available to Menarini. 
3.7    Context shall maintain reports and all related documentation in good scientific manner and in compliance with Applicable Law. Each Party shall provide to the other all Study information and documentation reasonably requested by such other Party to enable it to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or, subject to Section 3.4 and Section 3.5 above, such Party's Compounds, (ii) conduct the Sample Testing (in the case of Context), (iii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4, and (iv) in the case of Menarini, determine whether the Study has been performed by Context in accordance with this Agreement.
3.8    Context shall own all Clinical Data. Context hereby grants Menarini a worldwide, perpetual, fully paid up, royalty free, sublicensable limited license to use the Clinical Data and Sample 

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Testing Results for the Permitted Use as set forth in Section 3.10. Context shall provide to Menarini copies of all Clinical Data, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines and a complete copy of the Clinical Data shall be provided to Menarini no later than [***] days following Study Completion. To the extent applicable, each Party shall provide to the other Party with pharmacokinetics data regarding their respective Compounds on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines. “Study Completion” shall be deemed to occur upon lock of the Study database. Context shall ensure that all patient authorizations and consents required under HIPAA or any other similar Applicable Law in connection with the Study permit such sharing of Clinical Data with Menarini.
3.9    Subject to Section 3.8, Context shall own all Sample Testing Results, whether the testing is conducted by or on behalf of Context and/or Menarini. Context shall provide to Menarini the Sample Testing Results for the Sample Testing conducted by or on behalf of Context, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Likewise, Menarini shall not perform any Sample Testing without the prior written consent of Context. Menarini shall provide to Context the Sample Testing Results for the Sample Testing conducted by or on behalf of Menarini, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. 
3.10    Except to the extent otherwise agreed in writing and signed by authorized representatives of each Party, each Party shall use the Clinical Data and Sample Testing Results for the purposes of (i) publications in compliance with Section 12, (ii) further research, development and exploitation of the Context Compound (in the case of Context as the using Party), including seeking and maintaining Regulatory Approval of the Context Compound (including label extensions), (iii) further research, development and exploitation of the Menarini Compound (in the case of Menarini as the using Party), including seeking and maintaining Regulatory Approval of the Menarini Compound (including label extensions) and (iv) filing and prosecuting patent applications for Inventions and enforcing any resulting patents (collectively, the “Permitted Use”). The Parties agree to provide sufficient quantities of their Compounds for interference testing in bioanalytical or proprietary assays in order to confirm, as applicable, that their Compound does not interfere with the other Party's assay performance. Initial experiments may be performed to determine impact to assay performance and will follow a validated protocol and/or standard operating procedure.
3.11    Joint Development Committee. The Parties shall form a joint development team (the “Joint Development Committee” or “JDC”) made up of an equal number of representatives of Context and Menarini, which shall initially be set as two (2) representatives from and selected by each Party, which shall have responsibility for coordinating all activities between the Parties under, and pursuant to, this Agreement. Each Party shall designate a project manager (the “Project Manager”) who may or may not be part of the JDC and who shall be responsible for implementing and coordinating activities and facilitating the exchange of scientific information between the Parties with respect to the Study. The JDC shall meet as soon as practicable after the Effective Date and then no less than twice yearly, and more often as reasonably considered necessary at the request of either Party, to provide an update on Study progress. Prior to any such meeting, the Context Project Manager shall provide an update in writing to the Menarini Project Manager, which update shall contain 

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information about overall Study progress, recruitment status, interim analysis (if results are available), final analysis and other information relevant to the conduct of the Study. In addition to a Project Manager, each Party shall designate an alliance manager (the “Alliance Manager”), who may or may not be the Project Manager and/or a member of the JDC, and who shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information and shall serve as the primary point of contact for any issues arising under this Agreement. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention to the JDC any matters or issues either of them reasonably believes should be discussed and shall have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises, and the Alliance Managers cannot or do not, after good faith efforts, reach agreement on such issue, the issue shall be elevated to the Chief Medical Officer for Context and the Chief Medical Officer for Menarini. If the Parties cannot agree, Context shall have final decision making rights on all operational issues and regulatory strategies relating to the Study, except that Context may not make changes to the Study which may materially impact the Menarini Compound without the written consent of Menarini, which shall not be unreasonably withheld, conditioned or delayed; provided that, in all cases, such consent or written explanation for why such consent is being withheld, conditioned or delayed shall be provided within [***] days of Context's request for Menarini's consent; and provided further that if Menarini fails to provide such written explanation within such fifteen [***] day period, then Menarini shall be deemed to have provided its consent. 
3.12    Each Party shall also appoint a supply chain representative to hold telephone discussions at a mutually agreed-upon frequency to review the quantities of Menarini Compound and Context Compound needed for the Study (in accordance with Article 8 and Appendix B) and any other supply chain issues that may arise during the Study.
3.13    A Party may change its representatives on the JDC and its Project Manager and Alliance Manager by giving the other Party written notice thereof.
3.14    Context shall provide Menarini with (i) an electronic draft of the final Study report for Menarini to provide comments to Context within [***] days of receipt of such draft final Study report and (ii) the final version of the final Study report promptly after it is issued. Context shall consider in good faith any comments provided by Menarini on the draft of the final Study report and shall not include any statements relating to the Menarini Compound which have not been approved by Menarini, approval of which shall not be unreasonably withheld, conditioned or delayed.
3.15    Notwithstanding anything in this Agreement to the contrary, but without prejudice to Section 2.6 and Section 20.2, each Party acknowledges and agrees that the other Party may have present or future business activities or opportunities, including business activities or opportunities with Third Parties, involving antiestrogen compounds, in the case of Context, or antiprogesterone compounds, in the case of Menarini, or other similar products, programs, technologies or processes. Accordingly, each Party acknowledges and agrees that nothing in this Agreement shall be construed as a representation or inference that the other Party will not develop for itself, or enter into business relationships with other Third Parties regarding, any products, programs, studies (including combination studies), technologies or processes that are similar to or that may compete with the Combination or any other product, program, technology or process, including antiestrogens or antiprogesterones, provided that the Clinical Data, Sample Testing Results, Jointly Owned Inventions, and Confidential Information are not used or disclosed in connection therewith in violation of this Agreement.

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3.16    Nothing in this Agreement, but without prejudice to Section 20.2, shall prohibit or restrict a Party from licensing, assigning or otherwise transferring to an Affiliate or Third Party its rights to its Compound and the related Clinical Data, Confidential Information (not including any Confidential Information solely owned by the other Party), Sample Testing Results or Jointly Owned Inventions; provided, however, that in the case of any such license, assignment or transfer, the licensee, assignee or transferee shall agree in writing to use such Clinical Data, Confidential Information, Sample Testing Results and Jointly Owned Inventions only for the Permitted Use and any other use expressly permitted by this Agreement and to otherwise be bound by the terms of this Agreement. 

4.    Protocol and Related Documents

4.1    A summary of the initial Protocol, entitled “Protocol Summary”, has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A. Context shall have the final decision regarding the contents of the Protocol; provided, however, that any material changes to the Protocol materially impacting the Menarini Compound shall require Menarini's prior written consent, not to be unreasonably withheld, conditioned or delayed. Any such proposed changes will be sent in writing to Menarini's Project Manager and Menarini's Alliance Manager. Menarini will provide such consent, or a written explanation for why such consent is being withheld, within [***] days of receiving a copy of Context's requested changes; provided that if Menarini fails to provide such written explanation within such [***] day period, then Menarini shall be deemed to have consented to such change or changes.
4.2    Context shall prepare the patient informed consent form for the Study (which shall include any required consent for the Sample Testing) in consultation with Menarini (it being understood and agreed that the portion of the informed consent form relating to the Menarini Compound will be timely provided to Context by Menarini). Any changes to such form that relate to the Menarini Compound shall be subject to Menarini's review and prior written consent, not to be unreasonably withheld, conditioned or delayed. Any such proposed changes will be sent in writing to Menarini's Project Manager and Menarini's Alliance Manager. Menarini will provide such consent, or a written explanation for why such consent is being withheld, within [***] days of receiving a copy of Context's requested changes; provided that if Menarini fails to provide such written explanation within such [***] day period, then Menarini shall be deemed to have consented to such change or changes.
4.3    Within a reasonable time after the Effective Date, the Parties shall enter into an agreement related to the collection of financial disclosure information from “clinical investigators” involved in the Study and the certification and/or disclosure of the same in accordance with all Applicable Law, including, but not limited to, Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA guidance documents. Among other things, such agreement will provide (a) for Context to track and collect from all “clinical investigators” involved in the Study either separate certification and/or disclosure forms for each of Context and Menarini (which for clarity, Menarini shall provide Context with such certification and/or disclosure form to be sent to “clinical investigators”) or one (1) “combined” certification and/or disclosure form for both Context and Menarini and (b) that Context will be responsible for preparing and submitting the Financial Disclosure Module 1.3.4 components to the FDA for any Regulatory Approvals in connection with the Study. For purposes of this Section 4.3, the term “clinical investigators” shall have the meaning set forth in Part 54.2(d) of Title 21 of the United States Code of Federal Regulations.

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4.4    Within a reasonable time after the Effective Date, the Parties shall negotiate in good faith and enter into a Quality Agreement and a Pharmacovigilance Agreement. For clarity, transfer of the Menarini Compound and the initiation of the Study cannot take place before the Quality Agreement and the Pharmacovigilance Agreement are in effect.

4.5    Sunshine Laws. 

4.5.1    For purposes of compliance with reporting obligations under Sunshine Laws, as between the Parties, Context represents that it is not, as of the Effective Date and to the best of its knowledge, subject to reporting obligations under the Sunshine Laws.  Therefore, as between the Parties, and to the extent they are required by law, Menarini will report payments or other transfers of value (“POTV”) made by Context or any Third Party contract research organization used to conduct the Study related to the conduct of the Study and any applicable associated contractor engagements as required under the Sunshine Laws for the Study.  Menarini shall request delayed publication for any reported POTV for the Study as permitted under the Sunshine Laws and if consistent with Menarini’s normal business practices.  In the event that Context becomes responsible for reporting POTV for studies sponsored by it in a given country during the term of this Agreement, Context shall provide written notification to Menarini and the Parties will meet to confer to discuss how they wish to handle reporting thereafter.  Interpretation of the Sunshine Laws for purposes of reporting any POTV by a Party shall be in such Party’s sole discretion so long as the interpretation complies with Applicable Law.
4.5.2    Context (i) will provide (to the extent in the possession of Context), or will utilize Commercially Reasonable Efforts to obligate and ensure that each Third Party contract research organization used to conduct the Study and other applicable Third Party contractors for the Study provides, Menarini with any information requested by Menarini as Menarini may reasonably determine is necessary for Menarini to comply with its reporting obligations under Sunshine Laws (with such amounts paid to, or at the direction of, healthcare providers, teaching hospitals and/or any other persons for whom POTVs must be reported under Sunshine Laws to be reported to Menarini within a reasonable time period specified by Menarini) and (ii) will reasonably cooperate with, and will utilize Commercially Reasonable Efforts to obligate and ensure that each Third Party contract research organization used to conduct the Study and other applicable Third Party contractors for the Study reasonably cooperates with, Menarini in connection with its compliance with such Sunshine Laws.  The form in which Context provides any such information shall be mutually agreed but sufficient to enable Menarini to comply with its reporting obligations and Menarini may disclose any information that it believes is necessary to comply with Sunshine Laws.  Without limiting the foregoing, Menarini shall have the right to allocate POTVs in connection with this Agreement in any required reporting under Sunshine Laws in accordance with its normal business practices. These obligations shall survive the expiration and termination of this Agreement to the extent necessary for Menarini to comply with Sunshine Laws.  Context shall not be required to provide any information to Menarini that is subject to disclosure pursuant to Context’s own obligations under the Sunshine Laws.
 
5.    Adverse Event Reporting

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Context will be solely responsible for compliance with all Applicable Law pertaining to safety reporting for the Study and related activities. Prior to the initiation of the Study, the Parties will have executed the Pharmacovigilance Agreement to ensure the exchange of relevant safety data and Adverse Event reporting within appropriate timeframes and in an appropriate format to enable the Parties to fulfill local and international regulatory reporting obligations and to facilitate appropriate safety reviews.

6.    Term and Termination

6.1    The term of this Agreement shall commence on the Effective Date and shall continue in full force and effect until completion of all of the obligations of the Parties hereunder or until terminated by either Party pursuant to this Article 6.
6.2    In the event that Menarini reasonably and in good faith believes that the Menarini Compound is being used in the Study in an unsafe manner and notifies Context in writing of the grounds for such belief, and Context fails to promptly incorporate (subject to approval by applicable Regulatory Authorities or Institutional Review Boards) changes into the Protocol reasonably requested by Menarini to address such issue or to otherwise reasonably and in good faith address such issue, Menarini may terminate this Agreement and the supply of the Menarini Compound effective upon written notice to Context and upon the safe transition of patients out of the Study.  
6.3    Either Party may terminate this Agreement if the other Party commits a material breach of this Agreement, and such material breach continues for thirty (30) days after receipt of written notice thereof from the non-breaching Party; provided that if such material breach cannot reasonably be cured within thirty (30) days, the breaching Party shall be given a reasonable period of time to cure such breach.
6.4    If either Party determines in good faith, based on a review of the Clinical Data, Sample Testing Results or other Study-related Know-How or other information, that the Study may unreasonably affect patient safety, such Party shall promptly notify the other Party of such determination. The Party receiving such notice may propose modifications to the Study to address the safety issue identified by the other Party and, if the notifying Party agrees, shall act to immediately implement such modifications; provided, however, that after discussions, if the Parties cannot agree on a plan to address the concerns then the notifying Party need not wait for the other Party to propose modifications and may instead terminate this Agreement immediately upon written notice to such other Party. If the Parties agree to cease the Study, the Parties shall reasonably cooperate towards an orderly wind-down of the Study in a manner medically necessary to safely transition patients out of the Study.
6.5    In the event that any Regulatory Authority takes any action, or raises any objection that substantively functions, (i) to suspend or terminate the Study or (ii) that prevents a Party from supplying, in the case of Context, the Context Compound and, in the case of Menarini, the Menarini Compound, for purposes of the Study, then the Parties shall meet promptly to discuss such matter in good faith and determine a reasonable approach to such matter. If after discussions, the Parties cannot agree on a plan to address the concerns and such matter is still unresolved, then either Party may terminate this Agreement immediately upon written notice to such other Party; provided, however, that the Parties shall reasonably cooperate towards an orderly wind-down or completion of the Study in a manner medically necessary to safely transition patients out of the Study.  Additionally, if either Party reasonably believes that the Study data shows (e.g., through an interim analysis or other 

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data read out) evidence of lack of efficacy and/or futility of the Study and if such Party is therefore considering terminating the Study, then such Party shall notify the other Party and both Parties shall discuss in good faith.  If the Parties agree that the Study shows evidence of lack of efficacy and/or futility of the Study, then either Party may terminate this Agreement, provided that the Parties shall reasonably cooperate towards an orderly wind-down of the Study in a manner medically necessary to safely transition patients out of the Study.  If the Parties are in disagreement on the possible evidence of lack of efficacy or futility of the Study, then the Parties shall mutually appoint a third-party expert (“Arbitrator”) in the field of the Study who shall advise on the matter, and the decision of the Arbitrator shall be final and binding upon the Parties. The Arbitrator shall decide without any particular procedure but after reasonably hearing information presented by the Parties. The costs of such Arbitrator shall be equally (50%/50%) borne by the Parties, and if the Arbitrator finally determines that the Study shows evidence of lack of efficacy and/or futility of the Study such that a reasonable and prudent company would decide to terminate such Study, either Party may terminate this Agreement and the Parties shall reasonably cooperate towards an orderly wind-down of the Study in a manner medically necessary to safely transition patients out of the Study.    
6.6    In the event that this Agreement is terminated for any reason other than a termination by Context for Menarini's material breach pursuant to Section 6.3, Context shall, at Menarini's sole discretion, promptly either return or destroy all unused Menarini Compound pursuant to Menarini's instructions. If Menarini requests that Context destroy the unused Menarini Compound, Context shall provide written certification of such destruction. For clarity, in the event this Agreement is terminated for any reason, then Context shall have the continuing right to use any Menarini Compound in its possession solely to wind down the Study.
6.7    Either Party shall be entitled to terminate this Agreement immediately upon written notice to the other Party, if such other Party materially fails to perform any of its obligations under Section 13.3 or materially breaches any representation or warranty contained in Section 13.3. Additionally, should: (i) it be documentarily evidenced that the Study budget is exceeding or is anticipated to exceed the estimated budget amount by more than [***] of the amount set forth in the initial statement of work (covering the entire Study as described in the Study Synopsis in Appendix A) between Context and the primary contract research organization engaged by Context to perform the Study (the “Primary CRO”); and (ii) Context reasonably determines not to cover such additional costs and expenses, then, if Context intends to terminate the Study, Context shall notify Menarini in writing with such reasonable details and documentary evidence and the Parties shall discuss in good faith a potential solution, and if the Parties are unable to find a solution within [***] days of Context’s notice to Menarini regarding this matter, then Context may terminate the Study and this Agreement effective upon written notice to Menarini, provided that further to such termination, the Parties shall reasonably cooperate towards an orderly wind-down of the Study in a manner medically necessary to safely transition patients out of the Study.  The non-terminating Party shall have no claim against the terminating Party for compensation for any loss of whatever nature by virtue of the termination of this Agreement in accordance with this Section 6.7.
6.8    The provisions of this Section 6.8 and Sections 3.5, 3.7, 3.8, 3.9, 3.10, 6.4 (with respect to the cooperation in winding down the Study), 6.5 (with respect to the cooperation in winding down the Study), 6.6, 6.7 (no claim for termination), 6.9, 6.10, 13.2, 13.4, 14.2 (Indemnification),14.3 (Limitation of Liability), and Articles 1 (Definitions), 5 (Adverse Event Reporting), 7 (Costs of Study), 9 (Confidentiality), 10 (Intellectual Property), 11 (Reprints; Rights of Cross-Reference), 12 (Press Releases and Publications), 15 (Use of Name), 20.1 

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and 20.2, to the extent provided therein (Additional Obligations), 21 (Dispute Resolution and Jurisdiction), 22 (Notices), 23 (Relationship of the Parties) and 25 (Construction) shall survive the expiration or termination of this Agreement; provided, however, that in the event Menarini terminates this Agreement pursuant to Sections 6.4 or 6.5 (and Context continues the Study), or Context terminates this Agreement pursuant to Section 6.3 for Menarini’s breach of contract, then Menarini's rights contained in Section 3.8, 20.2 and Article 11, shall not survive the termination of this Agreement.
6.9    Termination of this Agreement shall be without prejudice to any claim or right of action of either Party against the other Party for any prior breach of this Agreement.
6.10    Upon termination of this Agreement, each Party and its Affiliates shall promptly return to the other Party or destroy any Confidential Information of the other Party (other than Clinical Data, Sample Testing Results, and Inventions) furnished to the receiving Party by the other Party, except that the receiving Party shall have the right to retain one copy for record-keeping purposes.

7.    Costs of Study

The Parties agree that (i) Menarini shall provide the Menarini Compound for use in the Study, as described in Article 8, at no cost to Context; (ii) Context shall bear all other costs associated with the conduct of the Study, including that Context shall provide the Context Compound for use in the Study; and (iii) Menarini shall provide cfNA analysis of the anonymized blood samples of all Study patients and shall bear the costs of testing, as further described in Appendix C (which shall be considered Clinical Data and/or Sample Testing Results, as appropriate), provided that Context shall be responsible for shipments of the anonymized blood samples and shall bear all costs associated with such shipments, as further described in Appendix C. The Parties shall use Commercially Reasonable Efforts so that the anonymized blood samples cannot be related to a specific individual patient by Context.  Should the Parties determine and/or reasonably believe that the anonymized blood samples may be related by Context to a specific individual patient, then the Parties shall work together to take such reasonable steps and enter into appropriate data processing agreement(s) compliant with Applicable Laws regarding such samples.   
For the avoidance of doubt, Context will not be required to reimburse Menarini for any costs or expenses incurred by Menarini or its Affiliates in connection with the Study, and Menarini will not be required to reimburse Context for any costs or expenses incurred by Context or its Affiliates in connection with the Study.

8.    Supply and Use of the Compound

8.1    Supply of the Compounds. Appendix B (the “Supply Agreement”) sets out the quantities of the Menarini Compound that Menarini shall use its Commercially Reasonable Efforts to supply, or cause to be supplied, and the timelines for such supply, in each case, for use in the Study, including any extensions thereto. In the event that Context determines that the quantities of the Menarini Compounds set forth in the Supply Agreement are not sufficient to complete the Study (due, for example, to the addition of Study Sites or countries, or subject withdrawal from the Study) or any extension of the Study (due, for example, to patients having a durable response beyond the initial Study timeframe), Context shall so notify Menarini, and the Parties shall discuss in good faith regarding additional quantities of Menarini Compounds to be provided and the schedule on which such additional quantities may be provided. Each Party shall also provide to the other Party a contact person for the 

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supply of its Compound or Compounds under this Agreement. Notwithstanding the foregoing, or anything to the contrary herein, in the event that either Party is not supplying Compound in accordance with the terms of this Agreement, or is allocating under Section 8.10, then the other Party shall have no obligation to supply its Compound or Compounds or may allocate proportionally.
8.2    Minimum Shelf-Life Requirements. Each Party shall use Commercially Reasonable Efforts to supply its Compound or Compounds hereunder with an adequate remaining shelf life at the time of Delivery to meet the Study requirements in accordance with Appendix B.
8.3    Provision of Compounds.
8.3.1    Menarini will use its Commercially Reasonable Efforts to deliver, at its own cost, the Menarini Compound to Context's, or its designee's, location as specified by Context in the written order (“Delivery” with respect to such Menarini Compound). Title and risk of loss for the Menarini Compound shall transfer from Menarini to Context at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Menarini Compound shall be borne by Context. Context will, or will cause its designee to: (i) take delivery of the Menarini Compound supplied hereunder; (ii) subsequently label and pack (in accordance with Section 8.4) and promptly ship the Menarini Compound to the Study sites, in compliance with cGMP, GCP and other Applicable Law; and (iii) provide, from time to time at the reasonable request of Menarini, the following information: any applicable chain of custody forms; in-transport temperature recorder(s); records and receipt verification documentation; such other transport or storage documentation as may be reasonably requested by Menarini (to the extent within Context's possession or control); and usage and inventory reconciliation documentation related to the Menarini Compound.
8.3.2    Context is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the Context Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the Context Compound supplied hereunder. Context shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law. For purposes of this Agreement, the “Delivery” of a given quantity of the Context Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.
8.4    Labeling and Packaging; Use, Handling and Storage.
8.4.1    Menarini shall provide the Menarini Compound to Context in the U.S. in such form as reasonably requested by Context and reasonably approved by the JDC, and Context shall be responsible for labeling, packaging, and leafleting such Menarini Compound in accordance with the Study requirements and otherwise in accordance with all Applicable Law, including cGMP, GCP, and health, safety and environmental protections.
8.4.2    Context shall (i) use the Menarini Compound solely for purposes of performing the Study; (ii) not use the Menarini Compound in any manner inconsistent with this Agreement or for any commercial purpose; and (iii) use, store, transport, handle and dispose of the Menarini Compound in compliance with the Quality Agreement and Applicable Laws. Context shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Menarini Compound, and in particular shall not analyze the Menarini Compound by physical, chemical or biochemical means except as necessary to perform its obligations under this Agreement.

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8.5    Product Specifications. A certificate of analysis and safety data sheet shall accompany each shipment of the Menarini Compound to Context as shall be further clarified in the Quality Agreement. Upon request, Context shall provide Menarini with a certificate of analysis covering each shipment of Context Compound used in the Study.
8.6    Changes to Manufacturing. Each Party may make changes from time to time to its Compound or the Manufacturing Site in compliance with the Quality Agreement (with respect to the Menarini Compound) and this Agreement (with respect to the Context Compound) and as prior discussed in the JDC.
8.7    Product Testing; Noncompliance
8.7.1    After Manufacturer's Release. After Manufacturer's Release of Menarini Compound and concurrently with Delivery of the Compound to Context, Menarini shall provide Context with such certificates and documentation as are described in the Quality Agreement (“Disposition Package”). Context shall take all steps necessary to determine that the Context Compound or Menarini Compound, as applicable, is suitable for release before making such Context Compound or Menarini Compound, as applicable, available for human use, and Menarini shall provide cooperation or assistance as reasonably requested by Context in connection with such determination with respect to the Menarini Compound. Context shall be responsible for storage and maintenance of Menarini Compound until it is tested and/or released, which storage and maintenance shall be in compliance with the Specifications for the applicable Menarini Compound, and Applicable Law, and shall be responsible for any failure of the Menarini Compound to meet the Specifications to the extent caused by shipping, storage, or handling conditions after Delivery to Context hereunder.
8.7.2    Non-Conformance.
a.    In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer's Release)), such Party shall notify the other Party upon identification of the Non-Conformance. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies).
b.    In the event that any proposed or actual shipment of Menarini Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Context, then unless otherwise agreed to by the Parties, Menarini shall promptly replace such Menarini Compound as is found to have a Non-Conformance (with respect to Menarini Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Context with respect to any Menarini Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) prompt replacement of such Menarini Compound as set forth in this Section 8.7.2(b), and (ii) indemnification under Section 14.2 (to the extent applicable); provided, for clarity, that Context shall not be deemed to be waiving any rights under Section 8.15. In the event that Menarini Compound is lost or damaged after Delivery, the Parties shall discuss a replacement supply at reasonable cost (which shall not exceed Menarini’s direct cost of goods of the Menarini Compound, including shipment costs plus [***]) and reasonable timelines. For the avoidance of doubt, Menarini shall have no obligation to provide replacement Menarini Compound for any Menarini Compound supplied hereunder other than such Menarini Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to Context. Menarini shall be responsible for any costs incurred by Context in connection 

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with the return or destruction of any Menarini Compound supplied hereunder that is found to have a Non-Conformance caused by Menarini. 
c.    Context shall be responsible for, and Menarini shall have no obligations or liability with respect to, any Context Compound supplied hereunder that is found to have a Non-Conformance. Context shall replace any Context Compound as is found to have a Non-Conformance (with respect to Context Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Menarini with respect to any Context Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Context Compound as set forth in this Section 8.7.2(c), and (ii) indemnification under Section 14.2 (to the extent applicable); provided, for clarity, that Menarini shall not be deemed to be waiving any rights under Section 8.15.
8.8    Resolution of Discrepancies. Disagreements regarding any determination of Non-Conformance by Context shall be resolved by representatives of both Parties.
8.9    Investigations. The process for investigations of any Non-Conformance shall be handled in accordance with each Party’s procedures.
8.10    Shortage: Allocation. In the event that a Party's Compound is in short supply as a result of a Manufacturing disruption, Manufacturing difficulties or other similar event - in each case, for causes beyond such Party’s reasonable control - such that a Party reasonably believes in good faith that it will not be able to fulfill its supply obligations hereunder with respect to such Compound, such Party will provide prompt written notice to the other Party thereof (including the shipments of Compound hereunder expected to be impacted and the quantity of its Compound that such Party reasonably determines it will be able to supply) and the Parties will promptly discuss such situation (including how the quantity of Compound that such Party is able to supply hereunder will be allocated within the Study). In such event, the Party experiencing such shortage shall (i) use its Commercially Reasonable Efforts to remedy the situation giving rise to such shortage and to take action to minimize the impact of the shortage on the Study, and (ii) allocate to the other Party an amount of Compound at least proportionate to the total amount of the Compound shipments hereunder expected to be impacted by the shortage divided by the total demand for the Compound for the impacted time period.
8.11    Records. Each Party shall maintain complete and accurate records in all material respects pertaining to its Manufacture of its Compound or Compounds supplied hereunder.
8.12    Quality. Quality matters related to the Manufacture of the Menarini Compound shall be governed by the terms of the Quality Agreement in addition to the relevant quality provisions of this Agreement. Quality matters related to the Manufacture of the Context Compound shall be governed by the relevant quality provisions of this Agreement.
8.13    Quality Control. Each Party shall implement and perform operating procedures and controls for sampling, stability and other testing of its Compound or Compounds, and for validation, documentation and release of its Compound or Compounds and such other quality assurance and quality control procedures as are required by the Specifications and cGMPs, and (with respect to the Menarini Compound) the Quality Agreement.
8.14    Audits and Inspections. No routine GMP and/or GCP audits will be performed, provided that senior quality management of both Parties may agree to hold any such audit or inspection. To the extent allowed by any agreement(s) with a Third Party, the GMP and/or GCP documentation, GMP and/or GCP reports, and CAPA plans from the Context manufacturing of any Context Compound to be used in the Study shall be shared with Menarini upon 

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reasonable request (such request not to occur more than once in any twelve (12) month period). Parties shall bear their own costs of such audits.
8.15    Recalls. Recalls of the Menarini Compound shall be governed by the terms of the Quality Agreement.  Recalls of the Context Compound shall be addressed in accordance with the applicable regulations and laws and as Context otherwise deems appropriate.
8.16    VAT. It is understood and agreed between the Parties that any payments made, and any other consideration given under this Agreement are each exclusive of any value added or similar tax (“VAT”), which shall be added thereon as applicable and at the relevant rate. Subject to Section 8.17, where VAT is properly charged by the supplying Party and added to a payment made or other consideration provided (as applicable) under this Agreement, the Party making the payment or providing the other consideration (as applicable) will pay the amount of VAT properly chargeable only on receipt of a valid tax invoice from the supplying Party issued in accordance with the laws and regulations of the country in which the VAT is chargeable. Each Party agrees that it shall provide to the other Party any information and copies of any documents within its control to the extent reasonably requested by the other Party for the purposes of (i) determining the amount of VAT chargeable on any supply made under this Agreement, (ii) establishing the place of supply for VAT purposes, or (iii) complying with its VAT reporting or accounting obligations.
8.17    Where one Party or its Affiliate (the “First Party”) is treated as making supply of goods or services in a particular jurisdiction (for VAT purposes) for non-cash consideration, and the other Party or its Affiliate (the “Second Party”) is treated as receiving such supply in the same jurisdiction, thus resulting in an amount of VAT being properly chargeable on such supply, the Second Party shall only be obliged to pay to the First Party the amount of VAT properly chargeable on such supply (and no other amount). The Second Party shall pay such VAT to the First Party on receipt of a valid VAT invoice from the First Party (issued in accordance with the laws and regulations of the jurisdiction in which the VAT is properly chargeable). The Parties agree to (i) use their reasonable endeavors to determine and agree the value of the supply that has been made and, as a result, the corresponding amount of VAT that is properly chargeable, and (ii) provide to each other any information or copies of documents in their control as are reasonably necessary to evidence that such supply will take, or has taken, place in the same jurisdiction (for VAT purposes).

9.    Confidentiality

9.1    Subject to Section 13.3.8, Menarini and Context agree to hold in confidence any Confidential Information provided by the other Party, and neither Party shall use Confidential Information of the other Party except for the performance of the Study and for the Permitted Use and any other use expressly permitted by this Agreement. Neither Party shall, without the prior written permission of the other Party, disclose any Confidential Information of the other Party to any Third Party except to the extent disclosure (i) is required by Applicable Law; (ii) is pursuant to the terms of this Agreement; or (iii) is necessary for the conduct of the Study, and in each case ((i) through (iii)) provided that the disclosing Party shall provide reasonable advance notice to the other Party before making such disclosure. For the avoidance of doubt: (A) Context may, without Menarini's consent, disclose Confidential Information to clinical trial sites and clinical trial investigators performing the Study, the data safety monitoring and advisory board relating to the Study, the Third Party clinical research organization(s) supporting Context with the Study, and Regulatory Authorities working with Context on the Study, in each case to the extent necessary for the performance of the Study 

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and provided that such persons (other than governmental entities) are bound by an obligation of confidentiality at least as stringent as the obligations contained herein and further provided that Context shall remain liable towards Menarini for any unauthorized use or disclosure of the Confidential Information by these subjects; and (B) Menarini may, without Context's consent, disclose, on a need to know basis (and, if applicable, only to the extent required by any contractual obligations), Confidential Information to its, its Affiliates and Menarini Compound licensors, directors, officers, employees and consultants to the extent necessary for the performance of its obligations or exploitation of its rights hereunder, provided that Menarini shall remain liable to Context for any unauthorized use or disclosure of the Confidential Information by any of these parties.
9.2    Inventions that constitute Confidential Information and are jointly owned by the Parties shall constitute the Confidential Information of both Parties.
a.    Menarini shall have the right to (i) use Clinical Data and Sample Testing Results in connection with its independent development, commercialization or other exploitation of any proprietary Menarini compound including the Menarini Compound (alone or in combination with the Context Compound and/or other pharmaceutical agents) without the consent of, or any obligation to account to, Context; and (ii) disclose such Confidential Information to Third Parties consistent with Section 3.10 and Articles 10, 11, 12 and 20.2.
b.    Context shall have the right to (i) use its Confidential Information, Clinical Data and Sample Testing Results, as well as any Sample Testing Results that may arise from Menarini performing such testing, in connection with its independent development, commercialization or other exploitation of any proprietary Context compound including the Context Compound (alone or in combination with the Menarini Compound and/or other pharmaceutical agents) without the consent of, or any obligation to account to, Menarini; and (ii) disclose such Confidential Information to Third Parties consistent with Section 3.10 and Articles 10, 11, 12 and 20.2.
9.3    Inventions that constitute Confidential Information and are solely owned by one Party shall constitute the Confidential Information of that Party. Context may use and disclose to Third Parties any Context solely owned Confidential Information for any purpose without obligation or accounting to Menarini. Similarly, Menarini may use and disclose to Third Parties any Menarini solely owned Confidential Information for any purpose without obligation or accounting to Context.
9.4    All Confidential Information containing personal identifiable data shall be handled in accordance with all data protection and privacy laws, rules, and regulations applicable to such Party.
9.5    The obligations of confidentiality in this Section 9 shall remain in full force and effect until each piece of Confidential Information falls in the public domain, through no breach of this Section 9 by any of the Parties.

10.    Intellectual Property
10.1    Joint Ownership and Prosecution.
10.1.1    Subject to Sections 10.2 and 10.3, as between the Parties, all rights to all Inventions invented after the Effective Date relating to the combined use of the Menarini Compound and the Context Compound (each a “Jointly Owned Invention”) shall belong jointly to Menarini and Context. For those countries where a specific license is required for a joint owner of a Jointly Owned Invention to practice such Jointly Owned 

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Invention in such countries, (i) Context hereby grants to Menarini a perpetual, irrevocable, non-exclusive, worldwide, royalty-free, fully paid-up license, transferable and sublicensable, under Context's right, title and interest in and to all Jointly Owned Inventions to use such Jointly Owned Inventions for the Permitted Use and any other use expressly permitted by this Agreement, and (ii) Menarini hereby grants to Context a perpetual, irrevocable, non-exclusive, worldwide, royalty-free, fully paid-up license, transferable and sublicensable, under Menarini's right, title and interest in and to all Jointly Owned Inventions to use such Jointly Owned Inventions for the Permitted Use and any other use expressly permitted by this Agreement. For clarity, the terms of this Agreement do not provide Menarini or Context with any rights, title or interest or any license to the other Party's background intellectual property except as expressly provided for herein and necessary for the Parties to conduct the Study.  For further clarity, any license to the other Party's background intellectual property granted by either Party to the other Party hereunder shall be non-exclusive, royalty-free, non-transferrable, non-sublicensable, and to be exploited only to the extent strictly necessary for the conduct of the Study.  For the avoidance of doubt and except as expressly provided herein, (i) Context’s right to exploit each Jointly Owned Invention shall not otherwise provide Context any rights to the Menarini Compound, and (ii) Menarini’s right to exploit each Jointly Owned Invention shall not otherwise provide Menarini any rights to the Context Compound. 
10.1.2    Promptly following the Effective Date, patent representatives of each of the Parties shall meet (in person, videoconference, or by telephone) to discuss the patenting strategy for any Jointly Owned Inventions which may arise under this Agreement. In particular, the Parties shall discuss which Party will file a patent application (including any provisional, substitution, divisional, continuation, continuation in part, reissue, renewal, reexamination, extension, supplementary protection certificate and the like) in respect of any Jointly Owned Invention (each, a “Joint Patent Application”) and whether the Parties wish to appoint Joint Patent Counsel. In any event, the Parties shall consult and reasonably cooperate with one another in the preparation, filing, prosecution (including prosecution strategy) and maintenance of such patent application and shall equally share the expenses associated with the Joint Patent Applications. In the event that one Party (the “Filing Party”) wishes to file a patent application for a Jointly Owned Invention and the other Party (the “Non-filing Party”) does not want to file any patent application for such Jointly Owned Invention or does not want to file in a particular country, the Non-filing Party shall execute such documents and perform such acts at the Filing Party's expense as may be reasonably necessary to effect an assignment of such Jointly Owned Invention to the Filing Party (in such country or all countries, as applicable) in a timely manner to allow the Filing Party to prosecute such patent application. Likewise, if a Party (the “Opting-out Party”) wishes to discontinue the prosecution and maintenance of a Joint Patent Application, the other Party, at its sole option (the “Continuing Party”), may continue such prosecution and maintenance. In such event, the Opting-out Party shall execute such documents and perform such acts at the Continuing Party's expense as may be reasonably necessary to effect an assignment of such Joint Patent Application to the Continuing Party (in such country or all countries, as applicable) in a timely manner to allow the Continuing Party to prosecute and maintain such patent application. Any Joint Patent Application or Jointly Owned Invention so assigned shall thereafter be owned solely by the Continuing Party or Filing Party (as applicable), and except as otherwise set forth herein, the Opting-out Party or Non-filing Party (as applicable) shall have no right to practice under such Joint 

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Patent Application or any patent claiming such Jointly Owned Invention in the applicable country or countries and, for the avoidance of doubt, any such patent, when issued, shall not be a Joint Patent. 
10.1.3    Except as expressly provided in Sections 3.10 10.1.2 and in furtherance and not in limitation of Section 9.1, each Party agrees to make no patent application based on the other Party's Confidential Information, and to give no assistance to any Third Party for such application, without the other Party's prior written authorization.
10.1.4    Menarini shall have the first right to initiate legal action to enforce all Joint Patents against infringement, and to protect all Jointly Owned Inventions from misappropriation, by any Third Party where such infringement or misappropriation results from the development or sale of an antiestrogen, or to defend any declaratory judgment action relating thereto, at its sole expense. In the event that Menarini fails to initiate or defend such action within [***] days after being first notified of such infringement or misappropriation, Context shall have the right to do so at its sole expense. Context shall have the first right to initiate legal action to enforce all Joint Patents against infringement and to protect all Jointly Owned Inventions from misappropriation, by any Third Party where such infringement or misappropriation results from the development or sale of an antiprogesterone, or to defend any declaratory judgment action relating thereto, at its sole expense. In the event that Context fails to initiate or defend such action within [***] after being first notified of such infringement, Menarini shall have the right to do so at its sole expense. In the event that legal action to enforce Joint Patents will involve infringement or misappropriation resulting from the development or sale of a molecule or molecules that is/are or include(s) both an antiestrogen and an antiprogesterone, the Parties shall work together to coordinate such action and shall share the costs and expenses of such litigation equally. For clarity, if the alleged infringer is selling or intending to sell only one of either an antiestrogen or an antiprogesterone, then the foregoing obligation to share the costs and expenses of such litigation shall not apply.
10.1.5    If one Party brings any prosecution or enforcement action or proceeding against a Third Party with respect to any Joint Patent, the second Party agrees to be joined as a party plaintiff where necessary and to give the first Party reasonable assistance and authority to file and prosecute the suit. The costs and expenses of the Party bringing suit under this Section 10.1.5 shall be borne by such Party, and any damages or other monetary awards recovered shall be shared as follows: (i) the amount of such recovery actually received by the Party controlling such action shall be first applied to the out-of-pocket costs of the Party controlling the action; (ii) the remaining balance shall next be applied to the out-of-pocket costs of the Party incurred in such action; and then (iii) any remaining proceeds shall be divided evenly between Menarini and Context. A settlement or consent judgment or other voluntary final disposition of a suit under this Section 10.1.5 may not be entered into without the consent of the Party not bringing the suit.
10.2    Inventions Owned or Otherwise Controlled by Menarini. Notwithstanding Section 10.1, the Parties agree that, as between the Parties,  all rights to Inventions relating to the Menarini Compound other than Inventions relating to the combined use of the Menarini Compound and the Context Compound (including, but not limited to, (a) the composition of matter of the Menarini Compound, (b) a method of manufacture or formulation of the Menarini Compound as a monotherapy, and/or (c) the use or a method of use of the Menarini Compound as a monotherapy or as used with other agents, antibodies or compounds (other than an Invention pertaining, whether generically or specifically, to the composition of matter, method of manufacture or formulation, or the use or a method of use of both the Context Compound and the Menarini Compound)) are the exclusive property of Menarini. Menarini shall be 

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entitled to file in its own name relevant patent applications and to own resultant patent rights for any such Invention. For the avoidance of doubt, any Invention generically encompassing the Menarini Compound (and not any Context proprietary compound including the Context Compound) within its scope, even where the Menarini Compound is not disclosed per se, is the exclusive property of Menarini.  For clarity, nothing in this Agreement shall be construed to grant Context any right or license under the patents and know-how owned or otherwise controlled by Menarini with respect to the Menarini Compound other than the limited rights expressly granted herein.
10.3    Inventions Owned by Context. Notwithstanding Section 10.1, the Parties agree that all rights to Inventions relating to the Context Compound other than Inventions relating to the combined use of the Menarini Compound and the Context Compound (including but not limited to (a) the composition of matter of the Context Compound, (b) a method of manufacture or formulation of the Context Compound as a monotherapy, and/or (c) a method of use of the Context Compound as a monotherapy or as used with other agents, antibodies or compounds (other than an Invention pertaining, whether generically or specifically, to the composition of matter, method of manufacture or formulation, or a method of use of both the Context Compound and the Menarini Compound)) are the exclusive property of Context. Context shall be entitled to file in its own name relevant patent applications and to own resultant patent rights for any such Invention. For the avoidance of doubt, any Invention generically encompassing the Context Compound (and not any Menarini proprietary compound including the Menarini Compound) within its scope, even where the Context Compound is not disclosed per se, is the exclusive property of Context.
10.4    Notwithstanding any provision of this Article 10 to the contrary, the Parties agree that all Inventions invented after the Effective Date relating to the Menarini Compound shall be subject to provisions of the Elacestrant License Agreements. In the event of any inconsistency between the Elacestrant License Agreements and this Agreement, the terms of the Elacestrant License Agreements shall prevail and apply to the Parties. Without limiting the foregoing, the Parties agree that all Inventions invented after the Effective Date relating to the Menarini Compound shall be promptly disclosed to Eisai.

11.    Reprints; Rights of Cross-Reference

Consistent with applicable copyright and other laws, each Party may use, refer to, and disseminate reprints of scientific, medical, and other published articles and materials from journals, conferences and/or symposia relating to the Study which disclose the name of a Party, provided such use does not constitute an endorsement of any commercial product or service by the other Party.

12.    Press Releases and Publications

12.1    The Parties will mutually agree (not to be unreasonably withheld, conditioned or delayed) on the content and timing of any press release with respect to this Agreement or the Study; provided that Context may make public disclosures concerning this Agreement and/or the Study as required by Applicable Law or the rules of any exchange on which its securities are traded.
12.2    To the extent required by Applicable Law or in accordance with Context's policies, Context will register the Study with the Clinical Trials Registry located at www.clinicaltrials.gov. Context is committed to timely publication of the results following Study Completion, after taking appropriate action to secure intellectual property rights (if any) arising from the Study. 

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The publication of the results of the Study will be in accordance with the Protocol. Menarini agrees not to publish any results of the Study involving the Context Compound prior to the timely publication of such Study results by Context.
12.3    Each Party shall use reasonable efforts to publish or present scientific papers dealing with the Study in accordance with accepted scientific practice. Each Party may issue a press release related to any scientific presentation or publication regarding the Study in a form mutually agreed to by the Parties (not to be unreasonably withheld, conditioned or delayed) or as otherwise required by Applicable Law.
12.4    The Parties agree that prior to submission of the results of the Study for publication or presentation or any other dissemination of results including oral dissemination, the publishing Party shall invite the other to comment on the content of the material to be published or presented according to the following procedure:
(i)    At least [***] days prior to submission for publication of any paper, letter, or any other publication, or [***] days prior to submission for presentation of any abstract, poster, talk or any other presentation, the publishing Party shall provide to the other Party the full details of the proposed publication or presentation in an electronic version (email attachment). Upon written request from the other Party, the publishing Party agrees not to submit data for publication/presentation for an additional [***] days in order to allow for actions to be taken to preserve rights for patent protection.
(ii)    The publishing Party shall give reasonable consideration to any request by the other Party made within the periods mentioned in clause (i) above to modify the publication and the Parties shall work in good faith and in a timely manner to resolve any issue regarding the content for publication.
(iii)    The publishing Party shall remove all Confidential Information of the other Party before finalizing the publication.
12.5    Context agrees to identify Menarini and acknowledge Menarini's support in any press release and any other publication or presentation of the results of the Study.

13.    Representations and Warranties; Disclaimers

13.1    Each of Menarini and Context represents and warrants to the other that it has the full right and authority to enter into this Agreement and that this Agreement (i) constitutes a legal and valid obligation binding upon such Party, enforceable in accordance with its terms and (ii) does not conflict with any provision of any agreement such Party is otherwise a party to.
13.2    Context does not undertake that the Study shall lead to any particular result, nor is the success of the Study guaranteed. Neither Party accepts any responsibility for any use that the other Party may make of the Clinical Data nor for advice or information given in connection therewith.
13.3    Anti-Corruption.
13.3.1    In performing their respective obligations hereunder, the Parties acknowledge that the corporate policies of Menarini and Context and their respective Affiliates require that each Party's business be conducted within the letter and spirit of the law. By signing this Agreement, each Party agrees to conduct the business contemplated herein in a manner which is consistent with all Applicable Law, including the U.S. Foreign Corrupt Practices Act, good business ethics, and its ethics and other corporate policies, and to abide by the spirit of the other Party's applicable ethics and compliance guidelines which may be provided by such other Party from time to time. 

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13.3.2    Specifically, each Party agrees that it has not, and covenants that it, its Affiliates, and its and its Affiliates' directors, employees, officers, and anyone acting on its behalf, will not, in connection with the performance of this Agreement, directly or indirectly, make, promise, authorize, ratify or offer to make, or take any action in furtherance of, any payment or transfer of anything of value for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; or improperly assisting it in obtaining or retaining business for it or the other Party, or in any way with the purpose or effect of public or commercial bribery.
13.3.3    Each Party shall not contact, or otherwise knowingly meet with, any Government Official for the purpose of discussing activities arising out of or in connection with this Agreement, without the prior written approval of the other Party, except where such meeting is consistent with the purpose and terms of this Agreement and in compliance with Applicable Law.
13.3.4    Each Party represents that: (i) it has no impediment to enter into the transaction contemplated in this Agreement; (ii) it is not excluded, debarred, suspended, proposed for suspension or debarment, or otherwise ineligible for government programs; and (iii) it has not and will not use in any capacity the services of any person or Subcontractor debarred under Applicable Law with respect to activities to be performed under this Agreement.
13.3.5    Each Party represents and warrants that except as disclosed to the other in writing prior to the commencement of this Agreement: (i) it does not have any interest which directly or indirectly conflicts with its proper and ethical performance of this Agreement; (ii) it shall maintain arm's length relations with all Third Parties with which it deals for or on behalf of the other in performance of this Agreement; and (iii) it has provided complete and accurate information and documentation to the other Party, the other Party's Affiliates and its and their personnel in the course of due diligence conducted by the other Party for this Agreement, including disclosure of any officers, employees, owners or persons directly or indirectly retained by such Party in relation to the performance of this Agreement who are Government Officials or relatives of Government Officials. Each Party shall make all further disclosures as necessary to the other Party to ensure the information provided remains complete and accurate throughout the term of this Agreement. Subject to the foregoing, each Party agrees that it shall not hire or retain any Government Official to assist in its performance of this Agreement, with the sole exception of conduct of or participation in clinical trials under this Agreement, provided that such hiring or retention shall be subject to the completion by the hiring or retaining Party of a satisfactory anti-corruption and bribery (e.g., FCPA) due diligence review of such Government Official. Each Party further covenants that any future information and documentation submitted to the other Party as part of further due diligence or a certification shall be complete and accurate.
13.3.6    Each Party shall have the right during the term of this Agreement, and for a period of two (2) years following termination of this Agreement, to conduct an investigation and audit of the other Party's activities, books and records, to the extent they relate to that other Party's performance under this Agreement, to verify compliance with the terms of this Section 13.3. Such other Party shall cooperate fully with such investigation or audit, the scope, method, nature, and duration of which shall be at the sole reasonable discretion of the Party requesting such audit.

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13.3.7    Each Party shall ensure that all transactions under the Agreement are properly and accurately recorded in all material respects on its books and records and that each document upon which entries in such books and records are based is complete and accurate in all material respects. Each Party further represents, warrants, and covenants that all books, records, invoices and other documents relating to payments and expenses under this Agreement are and shall be complete and accurate and reflect in reasonable detail the character and amount of transactions and expenditures. Each Party must maintain a system of internal accounting controls reasonably designed to ensure that no off-the-books or similar funds or accounts will be maintained or used in connection with this Agreement.
13.3.8    Each Party agrees that in the event that the other Party believes in good faith that there has been a possible violation of any provision of Section 13.3, such other Party may make full disclosure of such belief and related information needed to support such belief at any time and for any reason to any competent government bodies and its agencies, and to whoever such Party determines in good faith has a legitimate need to know.
13.3.9    Each Party shall comply with its own ethical business practices policy and any Corporate Integrity Agreement to which it is subject, and shall conduct its Study-related activities in accordance with Applicable Law. Each Party agrees to ensure that all of its employees involved in performing its obligations under this Agreement are made specifically aware of the compliance requirements under this Section 13.3. In addition, each Party agrees to ensure that all such employees have either participated in compliance training conducted by such Party or such employees have been informed of such Party’s policies regarding anti-bribery and corruption, prior to his/her performance of any obligations or activities under this Agreement. Each Party further agrees to certify its continuing compliance with the requirements under this Section 13.3 on a periodic basis during the term of this Agreement in such form as may be reasonably requested by the other Party.
13.4    EXCEPT AS EXPRESSLY PROVIDED HEREIN, CONTEXT MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE CONTEXT COMPOUND, AND ANY WARRANTY THAT THE CONTEXT COMPOUND DOES NOT INFRINGE THIRD PARTIES INTELLECTUAL PROPERTY RIGHTS, AND MENARINI MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE MENARINI COMPOUNDS, AND ANY WARRANTY THAT THE MENARINI COMPOUND DOES NOT INFRINGE THIRD PARTIES INTELLECTUAL PROPERTY RIGHTS.

14.    Insurance: Indemnification: Limitation of Liability

14.1    Insurance. Without limiting its obligations and liability under this Agreement, each Party shall effect and maintain, at its own expense, with reputable insurance companies, a General Third Party Liability and Product Liability Insurance policy with a limit of liability not lower than $[***] ([***] US Dollars) for any one occurrence or series of occurrences arising out of any one event or series of events. 
Context shall or shall procure that the sponsor of the Study, purchase a Clinical Trial Liability Insurance policy extended to product liability risks, covering all subjects participating in the 

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Study. Such Clinical Trial Insurance policy shall be fully compliant with local laws and regulations applicable in the country where the Study is performed. Any deductibles, policy exclusions or uncovered risks will remain at the sole costs and expenses of the Party which subscribed the policy. 
Context shall use Commercially Reasonable Efforts to include in its contract with the Primary CRO that such Primary CRO shall maintain a professional liability insurance policy with limits of liability not lower than $[***] ([***] US Dollars).
Notwithstanding the foregoing, either Party shall maintain such insurance coverage during the term of this Agreement and, thereafter, for a minimum of 5 (five) years after the expiration or termination of this Agreement. 
Upon request of a Party, the other Party shall provide the requesting Party with a certificate of insurance issued by the insurer or by the broker which shall include the details of its insurance policy, including, at least, the name of the insurer, the insured business activity, the policy number, the effective date, the expiration date and the limits of liability applied.
If either Party fails to maintain in force any of its own insurance policies as above, the other Party shall have the right (but not the obligation) to maintain any relevant insurance coverage by paying the relevant premiums in place of the defaulting Party, with the right to be fully reimbursed by the Party which has failed to maintain the policies required under this Agreement.
14.2    Indemnification.
14.2.1    Indemnification by Menarini. Menarini agrees to defend, indemnify and hold harmless Context, its Affiliates, and its and their employees, directors, subcontractors and agents from and against any loss, damage, reasonable costs and expenses (including reasonable attorneys' fees and expenses) incurred in connection with any claim, proceeding, or investigation by a Third Party arising out of this Agreement or the Study (a “Liability”), to the extent that such Liability (A) was caused by (i) negligence or willful misconduct on the part of Menarini (or any of its Affiliates, or its and their employees, directors, subcontractors or agents); (ii) a breach on the part of Menarini of any of its representations and warranties or any other covenants or obligations of Menarini under this Agreement; or (iii) a breach of Applicable Law by Menarini ; or (B) is determined to be attributable to the Menarini Compound, including any infringement of Third Parties intellectual property rights deriving from the Menarini Compound.
14.2.2    Indemnification by Context. Context agrees to defend, indemnify and hold harmless Menarini, its Affiliates, and its and their employees, directors, subcontractors and agents from and against any Liability to the extent that such Liability (A) was caused by (i) negligence or willful misconduct on the part of Context (or any of its Affiliates, or its and their employees, directors, subcontractors or agents); (ii) a breach on the part of Context of any of its representations and warranties or any other covenants or obligations of Context under this Agreement; or (iii) a breach of Applicable Law by Context; or (B) is determined to be attributable to the Context Compound, including any infringement of Third Parties intellectual property rights deriving from the Context Compound.
14.2.3    Procedure. The obligations of Context and Menarini under this Section 14.2 are conditioned upon the delivery of written notice to Context or Menarini, as the case might be, of any potential Liability within a reasonable time after a Party becomes aware of such potential Liability. A Party will have the right to assume the defense of 

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any suit or claim related to the Liability (using counsel reasonably satisfactory to the other Party) if it has assumed responsibility for the suit or claim in writing. The other Party may participate in (but not control) the defense thereof at its sole cost and expense. The Party controlling such defense (the “Defending Party”) shall keep the other Party (the “Other Party”) advised of the status of such action, suit, proceeding or claim and the defense thereof and shall reasonably consider recommendations made by the Other Party with respect thereto. The Defending Party shall not agree to any settlement of such action, suit, proceeding or claim without the prior written consent of the Other Party, which shall not be unreasonably withheld, conditioned or delayed. The Defending Party shall not agree to any settlement of such action, suit, proceeding or claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Other Party from all liability with respect thereto or that imposes any liability or obligation on the Other Party without the prior written consent of the Other Party.  The Defending Party shall have no liability for any settlement entered into by the Other Party without the Defending Party’s prior written consent.
14.2.4    Study Patients. Menarini shall not offer compensation on behalf of Context to any Study subject or bind Context to any indemnification obligations in favor of any Study subject. Likewise, Context shall not offer compensation on behalf of Menarini to any Study subject or bind Menarini to any indemnification obligations in favor of any Study subject.  
14.3    LIMITATION OF LIABILITY. IN NO EVENT SHALL EITHER PARTY (OR ANY OF ITS AFFILIATES OR SUBCONTRACTORS) BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS OR DAMAGES FOR LOST OPPORTUNITIES), WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF THIS AGREEMENT. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, IN  NO EVENT SHALL THE LIABILITY OF EITHER PARTY HEREUNDER BE LIMITED OR EXCLUDED IN CASE OF: (i) FRAUD, GROSS NEGLIGENCE OR WILFUL MISCONDUCT, (ii) THIRD PARTY CLAIMS INDEMNIFIABLE UNDER SECTION 14.2 ABOVE, (iii) DAMAGES ARISING OUT OF, OR RELATED TO, A PARTY'S BREACH OF ITS OBLIGATIONS UNDER THIS AGREEMENT TO USE, DISCLOSE, LICENSE, ASSIGN OR OTHERWISE TRANSFER SAMPLE TESTING RESULTS, CLINICAL DATA, CONFIDENTIAL INFORMATION AND JOINTLY-OWNED INVENTIONS.

15.    Use of Name
Except as expressly provided herein, neither Party shall have any right, express or implied, to use in any manner the name or other designation of the other Party or any other trade name, trademark, or logo of the other Party for any purpose in connection with the performance of this Agreement.  To the extent required, or Context determines may be necessary (in its sole discretion), to be disclosed by Context in connection with any filings with the Securities and Exchange Commission, any regulatory agency or similar regulatory or exchange frameworks, Context shall have the right to include in such filings such information relating to this Agreement and/or a copy of this Agreement, without notice to Menarini.

16.    Force Majeure

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If in the performance of this Agreement, one of the Parties is prevented, hindered, or delayed by reason of any cause beyond such Party’s reasonable control (e.g., war, riots, pandemic, fire, strike, governmental laws, etc.), such Party shall be excused from performance to the extent that it is necessarily prevented, hindered, or delayed (“Force Majeure”). The nonperforming Party will notify the other Party of such Force Majeure within ten (10) days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance will be of no greater scope and no longer duration than is necessary and the non-performing Party will use Commercially Reasonable Efforts to remedy its inability to perform.

17.    Entire Agreement; Modification
This Agreement, together with the Related Agreements, constitutes the sole, full and complete agreement by and between the Parties with respect to the subject matter of this Agreement, and all prior agreements, understandings, promises and representations, whether written or oral, with respect thereto are superseded by this Agreement. No amendments, changes, additions, deletions, or modifications to or of this Agreement shall be valid unless reduced to writing and signed by the Parties hereto.

18.    Assignment and Sub-Contracting
Other than as provided for in Section 2.4, neither Party shall assign or transfer this Agreement without the prior written consent of the other Party; provided, however, that either Party may assign all or any part of this Agreement without the other Party’s consent (i) to a Third Party that merges with, consolidates with or acquires substantially all of the assets or voting control of the assigning Party or (ii) to a Third Party that acquires all the rights of the assigning Party to the Menarini Compound, in the case of the Menarini Compound, or the Context Compound, in the case of Context, or (iii) to one or more of its Affiliates’, and any and all rights and obligations of either Party may be exercised or performed by its Affiliates, provided that such Affiliates agree to be bound by this Agreement. Any breach by a Party’s Affiliate, or merging/acquiring entity pursuant to section (i) or (ii) of the preceding sentence, of any such Party’s obligations under this Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s merging/acquiring entity or Affiliate. Each Party shall remain primarily liable for any acts or omissions of its Affiliates.

19.    Invalid Provision
If any provision of this Agreement is held to be illegal, invalid, or unenforceable, the remaining provisions shall remain in full force and effect and will not be affected by the illegal, invalid, or unenforceable provision. In lieu of the illegal, invalid or unenforceable provision, the Parties shall negotiate in good faith to agree upon a reasonable provision that is legal, valid, and enforceable to carry out as nearly as practicable the original intention of the entire Agreement.

20.    Additional Obligations

20.1    Should a Party reasonably determine that the Study was successful such that a subsequent clinical trial with the Combination, including additional, expansion or registrational study (the “Phase 3 Study”) could reasonably be performed, such Party shall notify the other Party’s Alliance Manager.  Promptly after receipt of such notice, the Parties shall meet to discuss in good faith (i) the potential design and cost sharing for such Phase 3 Study; and (ii) the Protocol for such Phase 3 Study.  Should the Parties fail to agree on the terms for such Phase 3 Study, and should one Party (the “Phase 3 Party”) wish to pursue a Phase 3 Study, 

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	ACTIVE/117982251.1 

the other Party shall nevertheless use Commercially Reasonable Efforts to provide (i) the Menarini Compound (in such case where Context is the Phase 3 Party) or the Context Compound (in such case where Menarini is the Phase 3 Party) at reasonable cost (which shall not exceed the non-Phase 3 Party’s direct cost of goods for the Compound, including shipment costs plus [***]) and in such quantities and pursuant to such reasonable timelines as the Phase 3 Party reasonably deems necessary, and (ii) a “right of reference” as necessary for the Phase 3 Party to prepare, submit and maintain regulatory submissions related to the Phase 3 Study and related Regulatory Approvals. The Phase 3 Party shall consider in good faith all comments to the Protocol that the other Party may provide, and the Phase 3 Party shall not insert in the Protocol anything that may materially impact the Menarini Compound (in such case where Context is the Phase 3 Party) or the Context Compound (in such case where Menarini is the Phase 3 Party) without the other Party’s prior written consent, not to be unreasonably withheld, conditioned or delayed, unless a particular change is required by Applicable Laws or an applicable IRB/ethics committee. Additionally, the Phase 3 Party shall give the other Party access to the entire documentation of the Phase 3 Study and shall permit the other Party to interact with any Regulatory Authority with respect to the Phase 3 Study. In any event (regardless if an agreement on Phase 3 Study is achieved between the Parties), the Parties shall discuss in good faith the potential for a mutually beneficial exploitation of the Phase 3 Study results and data. 
20.2    If at any time prior to three (3) months after the database lock of the Study Context receives a bona-fide written offer from a Third Party regarding a potential Further Transaction, Context shall notify Menarini in writing of Context’s receipt of such offer (“Further Transaction Notice”), without any obligation to provide any details regarding the terms of, or party(ies), to such Third-Party offer; provided however, that no such notice shall be required if providing such notice (i) would result in conflict with any Applicable Law (including the rules of any exchange on which Context’s securities are traded), or (ii) may require public disclosure pursuant to Applicable Law or the rules of any exchange on which Context’s securities are traded (pursuant to written advice obtained by Context external legal counsel which advice shall be shared with Menarini in such a way and to the extent providing such advice to Menarini does not waive Context’s attorney-client privilege). After receipt of the Further Transaction Notice, if Menarini desires to pursue a Further Transaction, then Menarini shall promptly notify Context in writing that sets forth the proposed terms for such Further Transaction (“Menarini Response”), which Context shall consider in good faith.  In no event shall Context share the results generated under the Study with any Third Party in connection with any intended potential Further Transaction until such results have been publicly disclosed in accordance with the terms of this Agreement. Furthermore, in no event shall Menarini share the results generated under the Study with any Third Party (other than its licensors) until such results have been publicly disclosed in accordance with the terms of this Agreement. Any obligations of Context set forth in this Section 20.2 shall immediately terminate upon (i) Menarini’s breach of any terms of this Agreement, (ii) FDA providing a complete response letter (“CRL”) to the application for approval  for the Menarini Compound that does not ultimately lead to approval of the Menarini Compound within six (6) months of such initial CRL, (iii) the termination or expiration of this Agreement, or termination of the Study, (iv) Menarini’s failure to provide the Menarini Response setting forth reasonable terms (as Context determines in its sole discretion) within [***] days of Menarini’s receipt of a Further Transaction Notice, or (v) Menarini and Context’s failure to come to definitive terms regarding a transaction within [***] days of Menarini’s receipt of a Further Transaction Notice.

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	ACTIVE/117982251.1 

     
21.    Governing Law     
     
21.1    The Parties shall attempt in good faith to settle all disputes arising out of or in connection with this Agreement in an amicable manner. Any claim, dispute or controversy arising out of or relating to this Agreement, including the breach, termination, or validity hereof or thereof (each, a “Dispute”), shall be governed by and construed in accordance with the substantive laws of the State of New York, without giving effect to its choice of law principles.  The Parties hereby consent to the exclusive jurisdiction and venue in the state or federal courts located in New York City, Southern District, New York to resolve any dispute which cannot be resolved amicably by the Parties.
21.2    Nothing contained in this Agreement shall deny either Party the right to seek injunctive or other equitable relief from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm, and such an action may be filed or maintained notwithstanding any ongoing discussions between the Parties.
21.3    Menarini acknowledges that it is aware (and any representative who receives Confidential Information has or will be advised) that federal and state securities laws prohibit any person who has material non-public information about a company or its securities from purchasing or selling securities of such company, or from communicating such information to other persons, under circumstances in which it is foreseeable that such person may purchase or sell such securities. Menarini covenants to refrain from using or communicating material non-public information provided by or on behalf of Context in violation of such securities laws.

22.         Notices
All notices or other communications that are required or permitted hereunder shall be in writing and delivered personally, sent by electronic mail (and promptly confirmed by personal delivery or overnight courier), or sent by internationally recognized overnight courier addressed as follows:
If to Context, to:

Context Therapeutics Inc.
2001 Market Street, 
Suite 3915, Unit#15  
Philadelphia, PA 19103 USA
Attn: Martin Lehr, Chief Executive Officer
Email: [***]

     with a required copy to:

Context Therapeutics Inc.
2001 Market Street, 
Suite 3915, Unit#15 
Philadelphia, PA 19103 USA
Attn: Alex Levit, Chief Legal Officer 
Email: [***]
Attn: Context’s Alliance Manager

If to Menarini, to:

Berlin-Chemie AG
Glienicker Weg 125, 12849 Berlin
Attn: President of the Board of Directors

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	ACTIVE/117982251.1 

Email: [***]

    with a required copy to: 

Berlin-Chemie AG
Glienicker Weg 125, 12849 Berlin
Attn: Head of Legal Department
Email: [***]
Attn: Menarini’s Alliance Manager
Email: [***]

23.    Relationship of the Parties
The relationship between the Parties is and shall be that of independent contractors, and does not and shall not constitute a partnership, joint venture, agency, or fiduciary relationship. Neither Party shall have the authority to make any statements, representations, or commitments of any kind, or take any actions, which are binding on the other Party, except with the prior written consent of the other Party to do so.  All persons employed by a Party will be the employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party.

24.    Counterparts and Due Execution
This Agreement and any amendment may be executed in two (2) or more counterparts (including by way of electronic transmission), each of which shall be deemed an original, but all of which together shall constitute one and the same instrument, notwithstanding any electronic transmission, storage, and printing of copies of this Agreement from computers or printers. When executed by the Parties, this Agreement shall constitute an original instrument, notwithstanding any electronic transmission, storage, and printing of copies of this Agreement from computers or printers. For clarity, signatures transmitted via PDF shall be treated as original signatures.

25.    Construction
Except where the context otherwise requires, wherever used, the singular will include the plural, the plural the singular, the use of any gender will be applicable to all genders, and the word “or” is used in the inclusive sense (and/or). Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The captions of this Agreement are for convenience of reference only and in no way define, describe, extend, or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term “including” as used herein shall be deemed to be followed by the phrase “without limitation” or like expression. The term “will” as used herein means shall. References to “Article,” “Section” or “Appendix” are references to the numbered sections of this Agreement and the appendices attached to this Agreement, unless expressly stated otherwise. Except where the context otherwise requires, references to this “Agreement” shall include the appendices attached to this Agreement. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction will be applied against either Party hereto.
[Remainder of page intentionally left blank.]

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	ACTIVE/117982251.1 

IN WITNESS WHEREOF, the respective representatives of the Parties have executed this Agreement as of the Effective Date.

Context Therapeutics Inc.

By:   /s/ Martin Lehr    
Name: Martin Lehr
Title: Chief Executive Officer

Berlin-Chemie AG

By:   /s/ Dr. Attilio Sebastio    
Name: Dr Attilio Sebastio
Title: Chief Financial Officer

By:   /s/ Dr. Luca Lastrucci    
Name: Dr. Luca Lastrucci
Title: Chairman of the Executive Board

Page 33 of 37
			
	ACTIVE/117982251.1 

Appendix A
			
	STUDY SYNOPSIS

[***]

Page 34 of 37
			
	ACTIVE/117982251.1 

			
	Appendix B
Supply of Compounds

[***]

Page 35 of 37
			
	ACTIVE/117982251.1 

Schedule I
			
	DATA SHARING AND SAMPLE TESTING SCHEDULE

[***]

     
     
   

Page 36 of 37
			
	ACTIVE/117982251.1 

Appendix C 
TESTING OF cfNA IN BLOOD SAMPLES    

[***]

Page 37 of 37
			
	ACTIVE/117982251.1EX-4.30

 Exhibit 4.30 

[SERIES 1/2] COMMON STOCK PURCHASE WARRANT 

PALISADE BIO, INC. 
  

			
	Warrant Shares: _______	  	Issue Date: _______ __, 2022

 CUSIP: 
 ISIN: 

THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, CEDE & CO. or its assigns
(the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the Shareholder Approval Date (as defined below) (the “Initial Exercise
Date”) and on or prior to 5:00 p.m. (New York City time) on _____ __, 202____1 (the “Termination Date”) but not thereafter, to subscribe for and purchase from Palisade
Bio, Inc., a Delaware corporation (the “Company”), up to ______ shares (as subject to adjustment hereunder, the “Warrant Shares”) of Common Stock. The purchase price of one share of Common Stock under this Warrant
shall be equal to the Exercise Price, as defined in Section 2(b). This Warrant shall initially be issued and maintained in the form of a security held in book-entry form and the Depository Trust Company or its nominee (“DTC”)
shall initially be the sole registered holder of this Warrant, subject to a Holder’s right to elect to receive a Warrant in certificated form pursuant to the terms of the Warrant Agency Agreement, in which case this sentence shall not apply.

 Section 1. Definitions. In addition to the terms defined elsewhere in this Warrant, the following terms
have the meanings indicated in this Section 1: 
 “Affiliate” means any Person that, directly or
indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 405 under the Securities Act. 

“Bid Price” means, for any date, the price determined by the first of the following clauses that applies:
(a) if the Common Stock is then listed or quoted on a Trading Market, the bid price of the Common Stock for the time in question (or the nearest preceding date) on the Trading Market on which the Common Stock is then listed or quoted as
reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the volume weighted average price of the Common Stock for such date (or
the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Common Stock is not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Common Stock are then reported on the Pink Open Market (or a similar
organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (d) in all other cases, the fair market value of a share of Common Stock as determined by an
independent appraiser selected in good faith by the Holders of a majority in interest of the Warrants then outstanding and reasonably acceptable to the Company, the fees and expenses of which shall be paid by the Company. 

 

	1 	 Insert the date that is the 5 year anniversary of the issue date for Series 2 and 1 year anniversary for Series
1; provided, however, that, if such date is not a Trading Day, insert the immediately following Trading Day. 

  
 1 

 “Board of Directors” means the board of directors of the
Company. 
 “Business Day” means any day other than Saturday, Sunday or other day on which commercial banks
in The City of New York are authorized or required by law to remain closed; provided, however, for clarification, commercial banks shall not be deemed to be authorized or required by law to remain closed due to “stay at
home”, “shelter-in-place”, “non-essential employee” or any other similar orders or restrictions or
the closure of any physical branch locations at the direction of any governmental authority so long as the electronic funds transfer systems (including for wire transfers) of commercial banks in The City of New York generally are open for use by
customers on such day. 
 “Commission” means the United States Securities and Exchange Commission. 

“Common Stock” means the common stock of the Company, par value $0.01 per share, and any other class of
securities into which such securities may hereafter be reclassified or changed. 
 “Common Stock
Equivalents” means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, right, option, warrant or other
instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock. 

“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations
promulgated thereunder. 
 “Exempt Issuance” means the issuance of (a) shares of Common Stock, options,
or other equity awards to employees, consultants, officers or directors of the Company pursuant to any stock or option plan or other equity incentive plan duly adopted for such purpose by a majority of the
non-employee members of the Board of Directors or a majority of the members of a committee of non-employee directors established for such purpose for services rendered
to the Company; provided, however, the number of shares issued to consultants shall not exceed 300,000 (subject to adjustment for forward and reverse stock splits and the like) during the 90 days following the closing date of the offering set forth
in the Registration Statement, (b) securities upon the exercise or exchange of or conversion of any securities issued pursuant to the Underwriting Agreement and/or other securities exercisable or exchangeable for or convertible into shares of
Common Stock issued and outstanding on the date of this Warrant, provided that such securities have not been amended since the date of this Warrant to increase the number of such securities or to decrease the exercise price, exchange price or
conversion price of such securities or to extend the term of such securities, (c) common stock purchase warrants and the warrant shares issuable upon exercise thereof issued to the Representative (as defined below) as compensation for services
rendered to Company in connection with the offering set forth in the Registration Statement, and (d) securities issued pursuant to acquisitions or strategic 

  
 2 

 
transactions approved by a majority of the disinterested directors of the Company, provided that such securities are issued as “restricted securities” (as defined in Rule 144 of the
Securities Act) and carry no registration rights that require or permit the filing of any registration statement in connection therewith within ninety (90) days following the closing date of the offering set forth in the Registration Statement,
and provided that any such issuance shall only be to a Person (or to the equity holders of a Person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business synergistic with the business of the
Company and shall provide to the Company additional benefits in addition to the investment of funds, but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose
primary business is investing in securities. 
 “Person” means an individual or corporation, partnership,
trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind. 

“Registration Statement” means the Company’s registration statement on Form S-1 (File No. 333-265769). 
 “Reverse Stock Split Date” means the
first date following the Initial Exercise Date on which a reverse stock split of the Common Stock is approved and deemed effective. 

“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated
thereunder. 
 “Shareholder Approval” means such approval as may be required by the applicable rules and
regulations of the Nasdaq Stock Market (or any successor entity) from the shareholders of the Company with respect to issuance of all of the Warrants and the Warrant Shares upon the exercise thereof and Section 3(e) of this Warrant. 

“Shareholder Approval Date” means the date Shareholder Approval is received and deemed effective under
Delaware law. 
 “Subsidiary” means any subsidiary of the Company and shall, where applicable, also include
any direct or indirect subsidiary of the Company formed or acquired after the date hereof. 
 “Trading Day”
means a day on which the Common Stock is traded on a Trading Market. 
 “Trading Market” means any of the
following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question: the NYSE American, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market or the New York Stock Exchange
(or any successors to any of the foregoing). 

  
 3 

 “Transfer Agent” means American Stock Transfer &
Trust Company, LLC, the current transfer agent of the Company, with a mailing address of 6201 15th Avenue, Brooklyn, New York 11219 and an email address of ReorgWarrants@ASTFINANCIAL.com, and any successor transfer agent of the Company. 

“Trigger Date” means the 6th Trading Day immediately following the Reverse Stock Split Date. 

“Underwriting Agreement” means the underwriting agreement, dated as of August __2022, among the Company and
Ladenburg Thalmann & Co. Inc. as representative of the underwriters named therein (the “Representative”), as amended, modified or supplemented from time to time in accordance with its terms. 

“Variable Rate Transaction” means a transaction in which the Company (i) issues or sells any debt or
equity securities that are convertible into, exchangeable or exercisable for, or include the right to receive, additional shares of Common Stock either (A) at a conversion price, exercise price or exchange rate or other price that is based
upon, and/or varies with, the trading prices of or quotations for the shares of Common Stock at any time after the initial issuance of such debt or equity securities or (B) with a conversion, exercise or exchange price that is subject to being
reset at some future date after the initial issuance of such debt or equity security or upon the occurrence of specified or contingent events directly or indirectly related to the business of the Company or the market for the Common Stock or
(ii) enters into, or effects a transaction under, any agreement, including, but not limited to, an equity line of credit, whereby the Company may issue securities at a future determined price; provided however, that after ninety (90) days
following the closing date of the offering covered by the Registration Statement, the Company shall be permitted to enter into and effect sales of its Common Stock pursuant to an
at-the-market offering facility with the Representative. 

“VWAP” means, for any date, the price determined by the first of the following clauses that applies:
(a) if the Common Stock is then listed or quoted on a Trading Market, the daily volume weighted average price of the Common Stock for such date (or the nearest preceding date) on the Trading Market on which the Common Stock is then listed or
quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the volume weighted average price of the Common Stock for such
date (or the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Common Stock is not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Common Stock are then reported on the Pink Open Market (or a similar
organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (d) in all other cases, the fair market value of a share of Common Stock as determined by an
independent appraiser selected in good faith by the holders of a majority in interest of the Warrants then outstanding and reasonably acceptable to the Company, the fees and expenses of which shall be paid by the Company. 

“Warrant Agency Agreement” means that certain warrant agency agreement, dated on or about the Initial Exercise
Date, between the Company and the Warrant Agent. 

  
 4 

 “Warrant Agent” means the Transfer Agent and any successor
warrant agent of the Company. 
 “Warrants” means this Warrant and other Common Stock purchase warrants
issued by the Company pursuant to the Registration Statement. 
 Section 2. Exercise. 

a) Exercise of Warrant. Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at
any time or times on or after the Initial Exercise Date and on or before the Termination Date by delivery to the Company of a duly executed PDF copy submitted by e-mail (or
e-mail attachment) of the Notice of Exercise in the form annexed hereto (the “Notice of Exercise”). Within the earlier of (i) two (2) Trading Days and (ii) the number of Trading Days
comprising the Standard Settlement Period (as defined in Section 2(d)(i) herein) following the date of exercise as aforesaid, the Holder shall deliver the aggregate Exercise Price to the Company for the shares specified in the applicable Notice
of Exercise by wire transfer or cashier’s check drawn on a United States bank unless the cashless exercise procedure specified in Section 2(c) below is specified in the applicable Notice of Exercise. No ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise be required. Notwithstanding anything herein to the
contrary, the Holder shall not be required to physically surrender this Warrant to the Company until the Holder has purchased all of the Warrant Shares available hereunder and the Warrant has been exercised in full, in which case, the Holder shall
surrender this Warrant to the Company for cancellation as soon as reasonably practicable of the date on which the final Notice of Exercise is delivered to the Company. Partial exercises of this Warrant resulting in purchases of a portion of the
total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant Shares purchased. The Holder and the Company
shall maintain records showing the number of Warrant Shares purchased and the date of such purchases. The Company shall deliver any objection to any Notice of Exercise within one (1) Business Day of receipt of such notice. The Holder and any
assignee, by acceptance of this Warrant, acknowledge and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the number of Warrant Shares available for purchase hereunder at
any given time may be less than the amount stated on the face hereof. 
 Notwithstanding the foregoing in this
Section 2(a), a holder whose interest in this Warrant is a beneficial interest in certificate(s) representing this Warrant held in book-entry form through DTC (or another established clearing corporation performing similar functions), shall
effect exercises made pursuant to this Section 2(a) by delivering to DTC (or such other clearing corporation, as applicable) the appropriate instruction form for exercise, complying with the procedures to effect exercise that are required by
DTC (or such other clearing corporation, as applicable), subject to a Holder’s right to elect to receive a Warrant in certificated form pursuant to the terms of the Warrant Agency Agreement, in which case this sentence shall not apply. 

  
 5 

 b) Exercise Price. The exercise price per share of Common Stock under
this Warrant shall be $_____, subject to adjustment hereunder (the “Exercise Price”). In addition, on the Trigger Date, the Exercise Price shall be reduced, and only reduced, to the lesser of (i) the then Exercise Price and
(ii) 90% of the average of the VWAPs for the five (5) Trading Day period immediately prior to the Trigger Date (the “Reset Exercise Price”, which shall thereafter be the new Exercise Price, subject to further adjustment
hereunder, and such 5 Trading Day period shall be referred to herein as a “Reset Measurement Period”). The Company shall notify each Holder of the applicable adjustment to the Exercise Price as of such date (each notice, a
“Trigger Date Adjustment Notice”). For purposes of clarification, whether or not the Company provides a Trigger Date Adjustment Notice pursuant to this Section 2(b), each Holder shall only be required to pay the Reset Exercise
Price with respect to such exercise, regardless of whether a Holder accurately refers to such price in any Notice of Exercise. If the aggregate Exercise Price paid by the Holder exceeds the amount that should have been paid based on the Reset
Exercise Price, the Company shall promptly return any excess aggregate Exercise Price to the Holder. Any adjustment to the Exercise Price pursuant to this Section shall be effective retroactively to the first Trading Day of such Reset Measurement
Period. 
 c) Cashless Exercise. If at the time of exercise hereof there is no effective registration statement
registering, or the prospectus contained therein is not available for the issuance of the Warrant Shares to the Holder, then this Warrant may also be exercised, in whole or in part, at such time by means of a “cashless exercise” in which
the Holder shall be entitled to receive a number of Warrant Shares equal to the quotient obtained by dividing [(A-B) (X)] by (A), where: 

 

	 	(A) =	 as applicable: (i) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of
Exercise if such Notice of Exercise is (1) both executed and delivered pursuant to Section 2(a) hereof on a day that is not a Trading Day or (2) both executed and delivered pursuant to Section 2(a) hereof on a Trading Day prior
to the opening of “regular trading hours” (as defined in Rule 600(b) of Regulation NMS promulgated under the federal securities laws) on such Trading Day, (ii) at the option of the Holder, either (y) the VWAP on the Trading Day
immediately preceding the date of the applicable Notice of Exercise or (z) the Bid Price of the Common Stock on the principal Trading Market as reported by Bloomberg L.P. (“Bloomberg”) as of the time of the Holder’s
execution of the applicable Notice of Exercise if such Notice of Exercise is executed during “regular trading hours” on a Trading Day and is delivered within two (2) hours thereafter (including until two (2) hours after the close
of “regular trading hours” on a Trading Day) pursuant to Section 2(a) hereof or (iii) the VWAP on the date of the applicable Notice of Exercise if the date of such Notice of Exercise is a Trading Day and such Notice of Exercise
is both executed and delivered pursuant to Section 2(a) hereof after the close of “regular trading hours” on such Trading Day; 

  

	 	(B) =	 the Exercise Price of this Warrant, as adjusted hereunder; and 

  
 6 

	 	(X) =	 the number of Warrant Shares that would be issuable upon exercise of this Warrant in accordance with the terms
of this Warrant if such exercise were by means of a cash exercise rather than a cashless exercise. 

 If
Warrant Shares are issued in such a cashless exercise, the parties acknowledge and agree that in accordance with Section 3(a)(9) of the Securities Act, the Warrant Shares shall take on the registered characteristics of the Warrants being
exercised. The Company agrees not to take any position contrary to this Section 2(c). 
 Notwithstanding anything herein
to the contrary, on the Termination Date, this Warrant shall be automatically exercised via cashless exercise pursuant to this Section 2(c). 

d) Mechanics of Exercise. 

i. Delivery of Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder to be transmitted by the
Transfer Agent to the Holder by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company through its Deposit or Withdrawal at Custodian system (“DWAC”) if the Company is
then a participant in such system and either (A) there is an effective registration statement permitting the issuance of the Warrant Shares to or resale of the Warrant Shares by Holder or (B) this Warrant is being exercised via cashless
exercise, and otherwise by physical delivery of a certificate, registered in the Company’s share register in the name of the Holder or its designee, for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise to
the address specified by the Holder in the Notice of Exercise by the date that is the earliest of (i) two (2) Trading Days after the delivery to the Company of the Notice of Exercise, (ii) one (1) Trading Day after delivery of the
aggregate Exercise Price to the Company and (iii) the number of Trading Days comprising the Standard Settlement Period after the delivery to the Company of the Notice of Exercise (such date, the “Warrant Share Delivery
Date”).    Upon delivery of the Notice of Exercise, the Holder shall be deemed for all corporate purposes to have become the holder of record of the Warrant Shares with respect to which this Warrant has been exercised,
irrespective of the date of delivery of the Warrant Shares, provided that payment of the aggregate Exercise Price (other than in the case of a cashless exercise) is received within the earlier of (i) two (2) Trading Days and (ii) the
number of Trading Days comprising the Standard Settlement Period following delivery of the Notice of Exercise. If the Company fails for any reason to deliver to the Holder the Warrant Shares subject to a Notice of Exercise by the Warrant Share
Delivery Date, the Company shall pay to the Holder, in cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based on the VWAP of the Common Stock on the date of the applicable Notice of
Exercise), $10 per Trading Day (increasing to $20 per Trading Day on the third Trading Day after the Warrant Share Delivery Date) for each Trading Day after such Warrant Share Delivery 

  
 7 

 
Date until such Warrant Shares are delivered or Holder rescinds such exercise. The Company agrees to maintain a transfer agent that is a participant in the FAST program so long as this Warrant
remains outstanding and exercisable. As used herein, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, on the Company’s primary Trading Market with respect to the Common
Stock as in effect on the date of delivery of the Notice of Exercise. 
 ii. Delivery of New Warrants Upon Exercise.
If this Warrant shall have been exercised in part, the Company shall, at the request of a Holder and upon surrender of this Warrant certificate, at the time of delivery of the Warrant Shares, deliver to the Holder a new Warrant evidencing the rights
of the Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new Warrant shall in all other respects be identical with this Warrant. 

iii. Rescission Rights. If the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares
pursuant to Section 2(d)(i) by the Warrant Share Delivery Date, then the Holder will have the right to rescind such exercise. 

iv. Compensation for Buy-In on Failure to Timely Deliver Warrant Shares Upon
Exercise. In addition to any other rights available to the Holder, if the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares in accordance with the provisions of Section 2(d)(i) above pursuant to an
exercise on or before the Warrant Share Delivery Date and the Holder has paid any required Exercise Price for the portion of this Warrant being exercised on or prior to such Warrant Share Delivery Date (or utilized cashless exercise, if available),
and if after such date the Holder is required by its broker to purchase (in an open market transaction or otherwise) or the Holder’s brokerage firm otherwise purchases, shares of Common Stock to deliver in satisfaction of a sale by the Holder
of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “Buy-In”), then the Company shall (A) pay in cash to the Holder the amount, if any, by which
(x) the Holder’s total purchase price (including customary brokerage commissions, if any) for the shares of Common Stock so purchased exceeds (y) the amount obtained by multiplying (1) the number of Warrant Shares that the
Company was required to deliver to the Holder in connection with the exercise at issue times (2) the price at which the sell order giving rise to such purchase obligation was executed, and (B) at the option of the Holder, either reinstate
the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded) or deliver to the Holder the number of shares of Common Stock that would have been
issued had the Company timely complied with its exercise and delivery obligations hereunder. For example, if the Holder purchases Common Stock having a total purchase price of 

  
 8 

 
$11,000 to cover a Buy-In with respect to an attempted exercise of shares of Common Stock with an aggregate sale price giving rise to such purchase
obligation of $10,000, under clause (A) of the immediately preceding sentence the Company shall be required to pay the Holder $1,000. The Holder shall provide the Company written notice indicating the amounts payable to the Holder in respect of
the Buy-In and, upon request of the Company, evidence of the amount of such loss. Nothing herein shall limit a Holder’s right to pursue any other remedies available to it hereunder, at law or in equity
including, without limitation, a decree of specific performance and/or injunctive relief with respect to the Company’s failure to timely deliver shares of Common Stock upon exercise of the Warrant as required pursuant to the terms hereof. 

v. No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the
exercise of this Warrant. As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall, at its election, either pay a cash adjustment in respect of such final fraction in an amount
equal to such fraction multiplied by the Exercise Price or round up to the next whole share. 
 vi. Charges, Taxes and
Expenses. Issuance of Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other incidental expense in respect of the issuance of such Warrant Shares, all of which taxes and expenses shall be paid by the
Company, and such Warrant Shares shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided, however, that, in the event that Warrant Shares are to be issued in a name other than the
name of the Holder, this Warrant when surrendered for exercise shall be accompanied by the Assignment Form attached hereto duly executed by the Holder and the Company may require, as a condition thereto, the payment of a sum sufficient to reimburse
it for any transfer tax incidental thereto. The Company shall pay all Transfer Agent fees required for same-day processing of any Notice of Exercise and all fees to the Depository Trust Company (or another
established clearing corporation performing similar functions) required for same-day electronic delivery of the Warrant Shares. 

vii. Closing of Books. The Company will not close its stockholder books or records in any manner which prevents the
timely exercise of this Warrant, pursuant to the terms hereof. 
 e) Holder’s Exercise Limitations. The Company
shall not effect any exercise of this Warrant, and a Holder shall not have the right to exercise any portion of this Warrant, pursuant to Section 2 or otherwise, to the extent that after giving effect to such issuance after exercise as set
forth on the applicable Notice of Exercise, the Holder (together with the Holder’s Affiliates, and any other Persons acting as a group together with the Holder or any of the Holder’s Affiliates (such Persons, collectively,
“Attribution  

  
 9 

 
Parties”)), would beneficially own in excess of the Beneficial Ownership Limitation (as defined below). For purposes of the foregoing sentence, the number of shares of Common
Stock beneficially owned by the Holder and its Affiliates and Attribution Parties shall include the number of shares of Common Stock held by the Holder, its Affiliates and Attribution Parties plus the number of shares of Common Stock issuable upon
exercise of this Warrant with respect to which such determination is being made, but shall exclude the number of shares of Common Stock which would be issuable upon (i) exercise of the remaining, nonexercised portion of this Warrant
beneficially owned by the Holder or any of its Affiliates or Attribution Parties and (ii) exercise or conversion of the unexercised or nonconverted portion of any other securities of the Company (including, without limitation, any other Common
Stock Equivalents) subject to a limitation on conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates or Attribution Parties. Except as set forth in the preceding sentence,
for purposes of this Section 2(e), beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, it being acknowledged by the Holder that the Company is
not representing to the Holder that such calculation is in compliance with Section 13(d) of the Exchange Act and the Holder is solely responsible for any schedules required to be filed in accordance therewith. To the extent that the limitation
contained in this Section 2(e) applies, the determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates and Attribution Parties) and of which portion of this Warrant is
exercisable shall be in the sole discretion of the Holder, and the submission of a Notice of Exercise shall be deemed to be the Holder’s determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder
together with any Affiliates and Attribution Parties) and of which portion of this Warrant is exercisable, in each case subject to the Beneficial Ownership Limitation. To ensure compliance with this restriction, each Holder will be deemed to
represent to the Company each time it delivers a Notice of Exercise that such Notice of Exercise has not violated the restrictions set forth in this paragraph, and the Company shall have no obligation to verify or confirm the accuracy of such
determination. In addition, a determination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder. For purposes of this
Section 2(e), in determining the number of outstanding shares of Common Stock, a Holder may rely on the number of outstanding shares of Common Stock as reflected in (A) the Company’s most recent periodic or annual report filed with
the Commission, as the case may be, (B) a more recent public announcement by the Company or (C) a more recent written notice by the Company or the Transfer Agent setting forth the number of shares of Common Stock outstanding (the
“Reported Outstanding Share Number”). If the Company receives an Exercise Notice from the Holder at a time when the actual number of outstanding shares of Common Stock is less than the Reported Outstanding Share Number, the Company
shall (i) promptly notify the Holder in writing of the number of shares of Common Stock then outstanding and, to the extent that such Exercise Notice would otherwise cause the Holder’s beneficial ownership, as determined pursuant to this
Section 2(e), to exceed the lesser of the Beneficial Ownership Limitation and Maximum Percentage, the Holder must notify the Company of a reduced number of Warrant Shares to be purchased pursuant to such Exercise Notice (the number of shares by
which such purchase is reduced, the 

  
 10 

 
“Reduction Shares”) and (ii) as soon as reasonably practicable, the Company shall return to the Holder any exercise price paid by the Holder for the Reduction
Shares. Upon the written or oral request of a Holder, the Company shall within two (2) Trading Days confirm orally and in writing to the Holder the number of shares of Common Stock then outstanding. In any case, the number of
outstanding shares of Common Stock shall be determined after giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holder or its Affiliates or Attribution Parties since the date as of which such
number of outstanding shares of Common Stock was reported. The “Beneficial Ownership Limitation” shall be 4.99% (or, upon election by a Holder prior to the issuance of any Warrants, 9.99%) of the number of shares of the Common Stock
outstanding immediately after giving effect to the issuance of shares of Common Stock issuable upon exercise of this Warrant. The Holder, upon notice to the Company, may increase or decrease the Beneficial Ownership Limitation provisions of this
Section 2(e), provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock upon exercise of this
Warrant held by the Holder and the provisions of this Section 2(e) shall continue to apply. Any increase in the Beneficial Ownership Limitation will not be effective until the 61st day after
such notice is delivered to the Company. The provisions of this paragraph shall be construed and implemented in a manner otherwise than in strict conformity with the terms of this Section 2(e) to correct this paragraph (or any portion hereof)
which may be defective or inconsistent with the intended Beneficial Ownership Limitation herein contained or to make changes or supplements necessary or desirable to properly give effect to such limitation. The limitations contained in this
paragraph shall apply to a successor holder of this Warrant. 
 f) Call Provision. Subject to the provisions of
Section 2(e) and this Section 2(f), if, after the Initial Exercise Date, (i) the VWAP for any 30 consecutive Trading Days (the “Call Measurement Period,” which 30 consecutive Trading Day period shall not have
commenced until after the Initial Exercise Date) exceeds $____2 (subject to adjustment for forward and reverse stock splits, recapitalizations, stock dividends and the like after the Initial
Exercise Date), (ii) the average daily volume for such Call Measurement Period exceeds $500,000 per Trading Day and (iii) the Holder is not in possession of any information that constitutes, or might constitute, material non-public information which was provided by the Company, any of its Subsidiaries, or any of their officers, directors, employees, agents or Affiliates, then the Company may, within one (1) Trading Day of the
end of such Call Measurement Period, call for cancellation of all or any portion of this Warrant for which a Notice of Exercise has not yet been delivered (such right, a “Call”) for consideration equal to $0.001 per Warrant Share.
To exercise this right, the Company must deliver to the Holder an irrevocable written notice (a “Call Notice”), indicating therein the portion of unexercised portion of this Warrant to which such notice applies. If the conditions
set forth below for such Call are satisfied from the period from the date of the Call Notice through and including the Call Date (as defined below), then any portion of this Warrant subject to such Call Notice for which a Notice of Exercise shall
not have been received by the Call Date will be cancelled at 6:30 p.m. (New York City time) on the tenth Trading Day after the date the Call Notice is received by the Holder (such date and 

 

	2 	 300% of the then Exercise Price. 

  
 11 

 
time, the “Call Date”). Any unexercised portion of this Warrant to which the Call Notice does not pertain will be unaffected by such Call Notice. In furtherance thereof, the
Company covenants and agrees that it will honor all Notices of Exercise with respect to Warrant Shares subject to a Call Notice that are tendered through 6:30 p.m. (New York City time) on the Call Date. The parties agree that any Notice of Exercise
delivered following a Call Notice which calls less than all of the Warrants shall first reduce to zero the number of Warrant Shares subject to such Call Notice prior to reducing the remaining Warrant Shares available for purchase under this Warrant.
For example, if (A) this Warrant then permits the Holder to acquire 100 Warrant Shares, (B) a Call Notice pertains to 75 Warrant Shares, and (C) prior to 6:30 p.m. (New York City time) on the Call Date the Holder tenders a Notice of
Exercise in respect of 50 Warrant Shares, then (x) on the Call Date the right under this Warrant to acquire 25 Warrant Shares will be automatically cancelled, (y) the Company, in the time and manner required under this Warrant, will have
issued and delivered to the Holder 50 Warrant Shares in respect of the exercises following receipt of the Call Notice, and (z) the Holder may, until the Termination Date, exercise this Warrant for 25 Warrant Shares (subject to adjustment as
herein provided and subject to subsequent Call Notices). Subject again to the provisions of this Section 2(f), the Company may deliver subsequent Call Notices for any portion of this Warrant for which the Holder shall not have delivered a
Notice of Exercise. Notwithstanding anything to the contrary set forth in this Warrant, the Company may not deliver a Call Notice or require the cancellation of this Warrant (and any such Call Notice shall be void), unless, from the beginning of the
Call Measurement Period through the Call Date, (1) the Company shall have honored in accordance with the terms of this Warrant all Notices of Exercise delivered by 6:30 p.m. (New York City time) on the Call Date, and (2) a registration
statement shall be effective as to all Warrant Shares and the prospectus thereunder available for use by the Company for the sale of all such Warrant Shares to the Holder, and (3) the Common Stock shall be listed or quoted for trading on the
Trading Market, and (4) there is a sufficient number of authorized shares of Common Stock for issuance of all Warrant Shares, and (5) the issuance of all Warrant Shares subject to a Call Notice shall not cause a breach of any provision of
Section 2(e) herein. The Company’s right to call the Warrants under this Section 2(f) shall be exercised ratably among the Holders based on each Holder’s initial purchase of Warrants. 

Section 3. Certain Adjustments. 

a) Stock Dividends and Splits. If the Company, at any time while this Warrant is outstanding: (i) pays a stock
dividend or otherwise makes a distribution or distributions on shares of its Common Stock or any other equity or equity equivalent securities payable in shares of Common Stock (which, for avoidance of doubt, shall not include any shares of Common
Stock issued by the Company upon exercise of this Warrant), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines (including by way of reverse stock split) outstanding shares of Common Stock into a
smaller number of shares, or (iv) issues by reclassification of shares of the Common Stock any shares of capital stock of the Company, then in each case the Exercise Price shall be multiplied by a fraction of which the numerator shall be the
number of shares of Common Stock (excluding treasury shares, if any) outstanding immediately before such event and of which the denominator shall be the number of shares of Common Stock (excluding 

  
 12 

 
treasury shares, if any) outstanding immediately after such event, and the number of shares issuable upon exercise of this Warrant shall be proportionately adjusted such that the aggregate
Exercise Price of this Warrant shall remain unchanged. Any adjustment made pursuant to this Section 3(a) shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or
distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re-classification. 

b) Subsequent Rights Offerings. In addition to any adjustments pursuant to Section 3(a) above, if at any time the
Company grants, issues or sells any Common Stock Equivalents or rights to purchase stock, warrants, securities or other property pro rata to the record holders of any class of shares of Common Stock other than an Exempt Issuance (the
“Purchase Rights”), then the Holder will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder would have acquired if the Holder had held the number of shares of
Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date on which a record is taken for the
grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the grant, issue or sale of such Purchase Rights (provided, however, that, to
the extent that the Holder’s right to participate in any such Purchase Right would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Purchase Right to such extent
(or beneficial ownership of such shares of Common Stock as a result of such Purchase Right to such extent) and such Purchase Right to such extent shall be held in abeyance for the Holder until such time, if ever, as its right thereto would not
result in the Holder exceeding the Beneficial Ownership Limitation). 
 c) Pro Rata Distributions. During such time as
this Warrant is outstanding, if the Company shall declare or make any dividend or other distribution of its assets (or rights to acquire its assets) to holders of shares of Common Stock, other than as in Section 3(a), by way of return of
capital or otherwise (including, without limitation, any distribution of cash, stock or other securities, property or options by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar
transaction) (a “Distribution”), at any time after the issuance of this Warrant, then, in each such case, the Holder shall be entitled to participate in such Distribution to the same extent that the Holder would have participated
therein if the Holder had held the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation)
immediately before the date of which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the participation in such Distribution
(provided, however, that, to the extent that the Holder’s right to participate in any such Distribution would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate
in such Distribution to such extent (or in the beneficial ownership of any shares of Common Stock as a result of such Distribution to such extent) and the portion of such Distribution shall be held in abeyance for the benefit of the Holder until
such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation). 

  
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 d) Fundamental Transaction. If, at any time while this Warrant is
outstanding, (i) the Company, directly or indirectly, in one or more related transactions effects any merger or consolidation of the Company with or into another Person, (ii) the Company, directly or indirectly, effects any sale, lease,
license, assignment, transfer, conveyance or other disposition of all or substantially all of its assets in one or a series of related transactions, (iii) any, direct or indirect, purchase offer, tender offer or exchange offer (whether by the
Company or another Person) is completed pursuant to which holders of Common Stock are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the holders of more than 50% of the outstanding
Common Stock or more than 50% of the voting power of the common equity of the Company, (iv) the Company, directly or indirectly, in one or more related transactions effects any reclassification, reorganization or recapitalization of the Common
Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property, or (v) the Company, directly or indirectly, in one or more related transactions
consummates a stock or share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off, merger or scheme of arrangement) with another Person
or group of Persons whereby such other Person or group acquires more than 50% of the outstanding shares of Common Stock or more than 50% of the voting power of the common equity of the Company (each a “Fundamental Transaction”),
then, upon any subsequent exercise of this Warrant, the Holder shall have the right to receive, for each Warrant Share that would have been issuable upon such exercise immediately prior to the occurrence of such Fundamental Transaction, at the
option of the Holder (without regard to any limitation in Section 2(e) on the exercise of this Warrant), the number of shares of Common Stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and
any additional consideration (the “Alternate Consideration”) receivable as a result of such Fundamental Transaction by a holder of the number of shares of Common Stock for which this Warrant is exercisable immediately prior to such
Fundamental Transaction (without regard to any limitation in Section 2(e) on the exercise of this Warrant). For purposes of any such exercise, the determination of the Exercise Price shall be appropriately adjusted to apply to such Alternate
Consideration based on the amount of Alternate Consideration issuable in respect of one share of Common Stock in such Fundamental Transaction, and the Company shall apportion the Exercise Price among the Alternate Consideration in a reasonable
manner reflecting the relative value of any different components of the Alternate Consideration. If holders of Common Stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder
shall be given the same choice as to the Alternate Consideration it receives upon any exercise of this Warrant following such Fundamental Transaction. Notwithstanding anything to the contrary, in the event of a Fundamental Transaction, the Company
or any Successor Entity (as defined below) shall, at the Holder’s option, exercisable at any time concurrently with, or within 30 days after, the consummation of the Fundamental Transaction (or, if later, the date of the public

  
 14 

 
announcement of the applicable Fundamental Transaction), purchase this Warrant from the Holder by paying to the Holder an amount of cash equal to the Black Scholes Value (as defined below) of the
remaining unexercised portion of this Warrant on the date of the consummation of such Fundamental Transaction; provided, however, that, if the Fundamental Transaction is not within the Company’s control, including not
approved by the Company’s Board of Directors, the Holder shall only be entitled to receive from the Company or any Successor Entity the same type or form of consideration (and in the same proportion), at the Black Scholes Value of the
unexercised portion of this Warrant, that is being offered and paid to the holders of Common Stock of the Company in connection with the Fundamental Transaction, whether that consideration be in the form of cash, stock or any combination thereof, or
whether the holders of Common Stock are given the choice to receive from among alternative forms of consideration in connection with the Fundamental Transaction; provided, further, that if holders of Common Stock of the Company are not
offered or paid any consideration in such Fundamental Transaction, such holders of Common Stock will be deemed to have received common stock of the Successor Entity (which Entity may be the Company following such Fundamental Transaction) in such
Fundamental Transaction. “Black Scholes Value” means the value of this Warrant calculated using the Black-Scholes Option Pricing Model obtained from the “OV” function on Bloomberg determined as of the day immediately
following the public announcement of the applicable contemplated Fundamental Transaction, or, if such contemplated Fundamental Transaction is not publicly announced, the date such Fundamental Transaction has occurred or is consummated, for pricing
purposes and reflecting (A) a risk-free interest rate corresponding to the U.S. Treasury rate for a period equal to the time between the date of the public announcement of the applicable Fundamental Transaction and the Termination Date,
(B) an expected volatility equal to the greater of 100% and the 100 day volatility obtained from the HVT function on Bloomberg (determined utilizing a 365 day annualization factor) as of the Trading Day immediately following the public
announcement of the applicable contemplated Fundamental Transaction, (C) the underlying price per share used in such calculation shall be the greater of (i) the sum of the price per share being offered in cash, if any, plus the value of
any non-cash consideration, if any, being offered in such Fundamental Transactionand (ii) the highest VWAP during the period beginning on the Trading Day immediately preceding the public announcement of
the applicable contemplated Fundamental Transaction (or the consummation of the applicable Fundamental Transaction, if earlier) and ending on the Trading Day of the Holder’s request pursuant to this Section 3(e) and (D) a remaining option
time equal to the time between the date of the public announcement of the applicable contemplated Fundamental Transaction and the Termination Date and (E) a zero cost of borrow. The payment of the Black Scholes Value will be made by wire
transfer of immediately available funds (or such other consideration) within the later of (i) five Business Days of the Holder’s election and (ii) the date of consummation of the Fundamental Transaction. The Company shall cause any
successor entity in a Fundamental 

  
 15 

 
Transaction in which the Company is not the survivor (the “Successor Entity”) to assume in writing all of the obligations of the Company under this Warrant in accordance with the
provisions of this Section 3(d) pursuant to written agreements in form and substance reasonably satisfactory to the holders of Warrants representing at least a majority of the shares of Common Stock underlying the Warrants covered by the
Registration Statement (the “Required Holders”) and approved by the Required Holders (without unreasonable delay) prior to such Fundamental Transaction and shall, at the option of the Holder, deliver to the Holder in exchange for
this Warrant a security of the Successor Entity evidenced by a written instrument substantially similar in form and substance to this Warrant which is exercisable for a corresponding number of shares of capital stock of such Successor Entity (or its
parent entity) equivalent to the shares of Common Stock acquirable and receivable upon exercise of this Warrant (without regard to any limitations on the exercise of this Warrant) prior to or concurrent with such Fundamental Transaction, and with an
exercise price which applies the exercise price hereunder to such shares of capital stock (but taking into account the relative value of the shares of Common Stock pursuant to such Fundamental Transaction and the value of such shares of capital
stock, such number of shares of capital stock and such exercise price being for the purpose of protecting the economic value of this Warrant immediately prior to the consummation of such Fundamental Transaction), and which is reasonably satisfactory
in form and substance to the Holder. Upon the occurrence of any such Fundamental Transaction, the Successor Entity shall be added to the term “Company” under this Warrant (so that from and after the occurrence or consummation of such
Fundamental Transaction, each and every provision of this Warrant referring to the “Company” shall refer instead to each of the Company and the Successor Entity or Successor Entities, jointly and severally), and the Successor Entity or
Successor Entities, jointly and severally with the Company, may exercise every right and power of the Company prior thereto and the Successor Entity or Successor Entities shall assume all of the obligations of the Company prior thereto under this
Warrant with the same effect as if the Company and such Successor Entity or Successor Entities, jointly and severally, had been named as the Company herein. 

e) Subsequent Equity Sales. If the Company or any Subsidiary thereof, as applicable, at any time while this Warrant is
outstanding, shall sell, enter into an agreement to sell, or grant any option to purchase, or sell or grant any right to reprice, or otherwise dispose of or issue (or announce any offer, sale, grant or any option to purchase or other disposition)
any Common Stock or Common Stock Equivalents, at an effective price per share less than the Exercise Price then in effect (such lower price, the “Base Share Price” and such issuances collectively, a “Dilutive
Issuance”) (it being understood and agreed that if the holder of the Common Stock or Common Stock Equivalents so issued shall at any time, whether by operation of purchase price adjustments, reset provisions, floating conversion, exercise
or exchange prices or otherwise, or due to warrants, options or rights per share which are issued in connection with such issuance, be entitled to receive shares of Common Stock at an effective price per share that is less than the Exercise Price,
such issuance shall be deemed to have occurred for less than the Exercise Price on such date of the Dilutive Issuance at such effective price), then simultaneously with the consummation (or, if earlier, the announcement) of each Dilutive Issuance
the Exercise Price shall be reduced and only reduced to equal the Base Share Price. Notwithstanding the foregoing, no adjustments shall be made, paid or issued under this Section 3(e) in respect of an Exempt

  
 16 

 
Issuance. The Company shall notify the Holder, in writing, no later than the Trading Day following the issuance or deemed issuance of any Common Stock or Common Stock Equivalents subject to this
Section 3(e), indicating therein the applicable issuance price, or applicable reset price, exchange price, conversion price and other pricing terms (such notice, the “Dilutive Issuance Notice”). For purposes of clarification,
whether or not the Company provides a Dilutive Issuance Notice pursuant to this Section 3(e), upon the occurrence of any Dilutive Issuance, the Holder is entitled to receive a number of Warrant Shares based upon the Base Share Price regardless
of whether the Holder accurately refers to the Base Share Price in the Notice of Exercise. If the Company enters into a Variable Rate Transaction, the Company shall be deemed to have issued Common Stock or Common Stock Equivalents at the lowest
possible price, conversion price or exercise price at which such securities may be issued, converted or exercised. Notwithstanding anything to the contrary in this Section 3(e), if, after the Initial Exercise Date, (i) the VWAP for any 20
Trading Days in any 30 consecutive Trading Days (the “Measurement Period,” which 30 consecutive Trading Day period shall not have commenced until after the Initial Exercise Date) exceeds $____3 (subject to adjustment for forward and reverse stock splits, recapitalizations, stock dividends and the like after the Initial Exercise Date), and (ii) the average daily volume for such
Measurement Period exceeds $200,000 per Trading Day, then this Section 3(e) shall cease having any force or effect (the “Ratchet Termination Date”). The Company shall notify the Holders in writing, no later than two
(2) Trading Days following the Ratchet Termination Date, that the terms and conditions of this Section 3(e) are no longer in force or effect. 

f) Calculations. All calculations under this Section 3 shall be made to the nearest cent or the nearest 1/100th of
a share, as the case may be. For purposes of this Section 3, the number of shares of Common Stock deemed to be issued and outstanding as of a given date shall be the sum of the number of shares of Common Stock (excluding treasury shares, if
any) issued and outstanding. 
 g) Notice to Holder. 

i. Adjustment to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this
Section 3, the Company shall promptly deliver to the Holder by email a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts
requiring such adjustment. 
 ii. Notice to Allow Exercise by Holder. If (A) the Company shall declare a
dividend (or any other distribution in whatever form) on the Common Stock, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Common Stock, (C) the Company shall authorize the granting to all
holders of the Common Stock rights or warrants to subscribe for or purchase any shares of capital stock of any class or of any rights, (D) the approval of any stockholders of the Company shall be 

 

	3 	 300% of the then Exercise Price. 

  
 17 

 
required in connection with any reclassification of the Common Stock, any consolidation or merger to which the Company (or any of its Subsidiaries) is a party, any sale or transfer of all or
substantially all of its assets, or any compulsory share exchange whereby the Common Stock is converted into other securities, cash or property, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding
up of the affairs of the Company, then, in each case, the Company shall cause to be delivered by email to the Holder at its last email address as it shall appear upon the Warrant Register of the Company, at least 10 calendar days prior to the
applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the
date as of which the holders of the Common Stock of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, sale, transfer
or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Common Stock of record shall be entitled to exchange their shares of the Common Stock for securities, cash or other property
deliverable upon such reclassification, consolidation, merger, sale, transfer or share exchange; provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action
required to be specified in such notice. To the extent that any notice provided in this Warrant constitutes, or contains, material, non-public information regarding the Company or any of the Subsidiaries, the
Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K. The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of
such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein. 

h) Voluntary Adjustment By Company. Subject to the rules and regulations of the Trading Market, the Company may at any
time during the term of this Warrant reduce the then current Exercise Price to any amount and for any period of time deemed appropriate by the board of directors of the Company. The Company may extend the duration of this Warrants by delaying the
Termination Date; provided, however, that the Company will provide notice of not less than ten (10) days to the Holder. 

Section 4. Transfer of Warrant. 

a) Transferability. Subject to compliance with any applicable securities laws, this Warrant and all rights hereunder
(including, without limitation, any registration rights) are transferable, in whole or in part, upon surrender of this Warrant at the principal office of the Company or its designated agent, together with a written assignment of this Warrant
substantially in the form attached hereto duly executed by the Holder or its agent or attorney and funds sufficient to pay any transfer taxes payable upon the making of such transfer. Upon such surrender and, if required, such payment, the Company
shall execute 

  
 18 

 
and deliver a new Warrant or Warrants in the name of the assignee or assignees, as applicable, and in the denomination or denominations specified in such instrument of assignment, and shall issue
to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this Warrant shall promptly be cancelled. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this
Warrant to the Company unless the Holder has assigned this Warrant in full, in which case, the Holder shall surrender this Warrant to the Company within three (3) Trading Days of the date on which the Holder delivers an assignment form to the
Company assigning this Warrant in full. The Warrant, if properly assigned in accordance herewith, may be exercised by a new holder for the purchase of Warrant Shares without having a new Warrant issued. 

b) New Warrants. If this Warrant is not held in global form through DTC (or any successor depositary), this Warrant may
be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder or its
agent or attorney. Subject to compliance with Section 4(a), as to any transfer which may be involved in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be
divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges shall be dated the initial issuance date of this Warrant and shall be identical with this Warrant except as to the number of Warrant Shares issuable
pursuant thereto. 
 c) Warrant Register. The Warrant Agent shall register this Warrant, upon records to be maintained
by the Warrant Agent for that purpose (the “Warrant Register”), in the name of the record Holder hereof from time to time. The Company and the Warrant Agent may deem and treat the registered Holder of this Warrant as the absolute
owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary. 

Section 5. Miscellaneous. 

a) No Rights as Stockholder Until Exercise; No Settlement in Cash. This Warrant does not entitle the Holder to any
voting rights, dividends or other rights as a stockholder of the Company prior to the exercise hereof as set forth in Section 2(d)(i), except as expressly set forth in Section 3. Without limiting any rights of a Holder to receive Warrant
Shares on a “cashless exercise” pursuant to Section 2(c) or to receive cash payments pursuant to Section 2(d)(i) and Section 2(d)(iv) herein, in no event shall the Company be required to net cash settle an exercise of this
Warrant. 
 b) Loss, Theft, Destruction or Mutilation of Warrant. The Company covenants that upon receipt by the
Company or the Warrant Agent of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any stock certificate relating to the Warrant Shares, and in case of loss, theft or destruction, of indemnity or
security reasonably satisfactory to it (which, in the case of the Warrant, shall not include the posting of any bond), and upon surrender and cancellation of such Warrant or stock certificate, if mutilated, the Company will make and deliver a new
Warrant or stock certificate of like tenor and dated as of such cancellation, in lieu of such Warrant or stock certificate. 

  
 19 

 c) Saturdays, Sundays, Holidays, etc. If the last or appointed day
for the taking of any action or the expiration of any right required or granted herein shall not be a Business Day, then such action may be taken or such right may be exercised on the next succeeding Business Day. 

d) Authorized Shares. 

The Company covenants that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued
Common Stock a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. The Company further covenants that its issuance of this Warrant shall constitute full authority
to its officers who are charged with the duty of issuing the necessary Warrant Shares upon the exercise of the purchase rights under this Warrant. The Company will take all such reasonable action as may be necessary to assure that such Warrant
Shares may be issued as provided herein without violation of any applicable law or regulation, or of any requirements of the Trading Market upon which the Common Stock may be listed. The Company covenants that all Warrant Shares which may be issued
upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant Shares in accordance herewith, be duly authorized, validly issued, fully paid
and nonassessable and free from all taxes, liens and charges created by the Company in respect of the issue thereof (other than taxes in respect of any transfer occurring contemporaneously with such issue). 

Except and to the extent as waived or consented to by the Holder, the Company shall not by any action, including, without
limitation, amending its certificate of incorporation or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or
performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate to protect the rights of Holder as set forth
in this Warrant against impairment. Without limiting the generality of the foregoing, the Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately prior to such increase
in par value, (ii) take all such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially
reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant. 

  
 20 

 Before taking any action which would result in an adjustment in the number
of Warrant Shares for which this Warrant is exercisable or in the Exercise Price, the Company shall obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory body or bodies having
jurisdiction thereof. 
 e) Governing Law. All questions concerning the construction, validity, enforcement and
interpretation of this Warrant shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof. Each party agrees that all legal proceedings
concerning the interpretations, enforcement and defense of the transactions contemplated by this Warrant (whether brought against a party hereto or their respective affiliates, directors, officers, shareholders, partners, members, employees or
agents) shall be commenced exclusively in the state and federal courts sitting in the City of New York. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, Borough of
Manhattan for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim
that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper or is an inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents
to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Warrant
and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law. If either party
shall commence an action, suit or proceeding to enforce any provisions of this Warrant, the prevailing party in such action, suit or proceeding shall be reimbursed by the other party for their reasonable attorneys’ fees and other costs and
expenses incurred with the investigation, preparation and prosecution of such action or proceeding. 
 f)
Restrictions. The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant, if not registered, and the Holder does not utilize cashless exercise, will have restrictions upon resale imposed by state and federal
securities laws. 
 g) Nonwaiver and Expenses. No course of dealing or any delay or failure to exercise any right
hereunder on the part of Holder shall operate as a waiver of such right or otherwise prejudice the Holder’s rights, powers or remedies. Without limiting any other provision of this Warrant, if the Company willfully and knowingly fails to comply
with any provision of this Warrant, which results in any material damages to the Holder, the Company shall pay to the Holder such amounts as shall be sufficient to cover any costs and expenses including, but not limited to, reasonable
attorneys’ fees, including those of appellate proceedings, incurred by the Holder in collecting any amounts due pursuant hereto or in otherwise enforcing any of its rights, powers or remedies hereunder. 

  
 21 

 h) Notices. Any and all notices or other communications or deliveries
to be provided by the Holders hereunder including, without limitation, any Notice of Exercise, shall be in writing and delivered personally, by e-mail, or sent by a nationally recognized overnight courier
service, addressed to the Company, at Palisade Bio, Inc., 7750 El Camino Real, Suite 5200, Carlsbad, CA 92009, Attention: Chief Financial Officer, email address: info@palisadebio.com, or such other email address or address as the Company may specify
for such purposes by notice to the Holders. Any and all notices or other communications or deliveries to be provided by the Company hereunder shall be in writing and delivered personally, by e-mail, or sent by
a nationally recognized overnight courier service addressed to each Holder at the e-mail address or address of such Holder appearing on the books of the Company. Any notice or other communication or deliveries
hereunder shall be deemed given and effective on the earliest of (i) the date of transmission, if such notice or communication is delivered via e-mail at the e-mail
address set forth in this Section prior to 5:30 p.m. (New York City time) on any date, (ii) the next Trading Day after the date of transmission, if such notice or communication is delivered via e-mail at
the e-mail address set forth in this Section on a day that is not a Trading Day or later than 5:30 p.m. (New York City time) on any Trading Day, (iii) the second Trading Day following the date of mailing,
if sent by U.S. nationally recognized overnight courier service, or (iv) upon actual receipt by the party to whom such notice is required to be given. Notwithstanding any other provision of this Warrant, as to any Warrant not held in
certificated form, where this Warrant provides for notice of any event to a Holder, such notice shall be sufficiently given if given to DTC (or any successor depository) pursuant to the procedures of DTC (or such successor depository). 

i) Limitation of Liability. No provision hereof, in the absence of any affirmative action by the Holder to exercise this
Warrant to purchase Warrant Shares, and no enumeration herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the purchase price of any Common Stock or as a stockholder of the Company, whether such
liability is asserted by the Company or by creditors of the Company. 
 j) Remedies. The Holder, in addition to being
entitled to exercise all rights granted by law, including recovery of damages, will be entitled to specific performance of its rights under this Warrant. The Company agrees that monetary damages would not be adequate compensation for any loss
incurred by reason of a breach by it of the provisions of this Warrant and hereby agrees to waive and not to assert the defense in any action for specific performance that a remedy at law would be adequate. 

k) Successors and Assigns. Subject to applicable securities laws, this Warrant and the rights and obligations evidenced
hereby shall inure to the benefit of and be binding upon the successors and permitted assigns of the Company and the successors and permitted assigns of Holder. The provisions of this Warrant are intended to be for the benefit of any Holder from
time to time of this Warrant and shall be enforceable by the Holder or holder of Warrant Shares. 

  
 22 

 l) Amendment. This Warrant may be modified or amended or the
provisions hereof waived with the written consent of the Company, on the one hand, and Holders or the beneficial owner of this Warrants representing more than 50% of the Warrant Shares issuable under the Warrants then-outstanding as of the date such
consent is sought, on the other hand. 
 m) Severability. Wherever possible, each provision of this Warrant shall be
interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such provision shall be ineffective to the extent of such prohibition or
invalidity, without invalidating the remainder of such provisions or the remaining provisions of this Warrant. 
 n)
Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant. 

o) Warrant Agency Agreement. If this Warrant is held in global form through DTC (or any successor depositary), this
Warrant is issued subject to the Warrant Agency Agreement. To the extent any provision of this Warrant conflicts with the express provisions of the Warrant Agency Agreement, the provisions of this Warrant shall govern and be controlling. 

******************** 

(Signature Page Follows) 

  
 23 

 IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer
thereunto duly authorized as of the date first above indicated. 
  

			
	PALISADE BIO, INC.
		
	By:	 	                 

Name:
 Title:

  
 24 

 NOTICE OF EXERCISE 

TO: PALISADE BIO, INC. 
 (1) The undersigned
hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant (only if exercised in full), and tenders herewith payment of the exercise price in full, together with all applicable transfer taxes, if
any. 
 (2) Payment shall take the form of (check applicable box): 

[    ] in lawful money of the United States; or 

[    ] if permitted the cancellation of such number of Warrant Shares as is necessary, in accordance with the formula set
forth in subsection 2(c), to exercise this Warrant with respect to the maximum number of Warrant Shares purchasable pursuant to the cashless exercise procedure set forth in subsection 2(c). 

(3) Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below: 

_________________________________ 
 The Warrant
Shares shall be delivered to the following DWAC Account Number: 
 _________________________________ 

_________________________________ 

_________________________________ 
 [SIGNATURE
OF HOLDER] 
 Name of Investing Entity: ______________________________________________________________________________________ 

Signature of Authorized Signatory of Investing Entity: ________________________________________________________________ 

Name of Authorized Signatory: __________________________________________________________________________________ 

Title of Authorized Signatory: __________________________________________________________________________________ 

Date: ______________________________________________________________________________________________________ 

 ASSIGNMENT FORM 

(To assign the foregoing Warrant, execute this form and supply required information. Do not use this form to purchase shares.) 

FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby assigned to 

 

			
	Name:	  	
		  	  
 (Please Print)

		
	Address:	  	  

	     
 Phone Number:

 
 Email Address:
	  	 (Please Print)

    
  

 

		
		  	
		
	Dated: _______________ __, ______	  	
		
	Holder’s Signature:_____________________	  	
		
	Holder’s Address:______________________

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