Common use of Conduct of the Study Clause in Contracts

Conduct of the Study. 3.1 Athenex shall act as the sponsor of the Study and shall hold the IND/CTA relating to the Study; provided, however, that in no event shall Athenex file a separate IND/CTA for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests a separate IND/CTA for the Study the Parties will meet and mutually agree on an approach to address such requirement. 3.2 Athenex shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Athenex shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Further, Athenex 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. Athenex shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Lilly shall have the right (but no obligation) to participate in any discussions with a Regulatory Authority, and prior review and approval of any written communications with a Regulatory Authorty, regarding matters related to the Lilly Compound. 3.4 Athenex shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law. Athenex shall provide any Study information and documentation reasonably requested to enable Lilly 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 such the Lilly Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex in accordance with this Agreement. 3.5 Athenex shall ensure that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the Clinical Data as set forth in this Agreement, including the sharing of Clinical Data with Lilly. 3.6 All Clinical Data, including raw data and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related to the Lilly Compound, shall be jointly owned by Lilly and Athenex.

Conduct of the Study. 3.1 Athenex Notwithstanding anything to the contrary herein, Vaccinex shall act as the sponsor of the Study and shall own and hold the IND/CTA relating to IND and/or CTA, as applicable, for the Study; provided, however, that in no event shall Athenex Vaccinex file a separate IND/IND or CTA for the Study unless required by Regulatory Authorities to do so. For clarity, the Parties anticipate that Vaccinex will conduct the Study under Vaccinex’s current IND # [***] for the Vaccinex Compound. If a Regulatory Authority requests a separate IND/IND or CTA for the Study the Parties will promptly meet and mutually agree on an approach to address such requirement. 3.2 Athenex Vaccinex shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Athenex Vaccinex shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. FurtherNotwithstanding anything else herein to the contrary, Athenex Merck shall ensure that all Regulatory Approvals from any Regulatory Authority and/or ethics committee fully cooperate with jurisdiction over the Study are obtained prior Vaccinex to initiating performance comply with such directions, including with respect to supply of the StudyMerck Compound. Athenex Vaccinex shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Lilly to the extent practicable (e.g. ad hoc conversations with Regulatory Authorities requiring an immediate response will be excluded) and if not prohibited by such Regulatory Authority, Merck shall have the right (but no obligation) to have a representative participate in any discussions with a Regulatory Authority, and prior review and approval of any written communications with a Regulatory Authorty, Authority regarding matters related to the Lilly Study; provided further that the Parties acknowledge and agree that such right does not apply to discussions regarding general Study matters that are solely related to the Vaccinex Compound. Each Party grants to the other Party a non-exclusive, nontransferable (except in connection with a permitted assignment, sublicense or subcontract) “right of reference” (as defined in US FDA 21 CFR 314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant part of the Territory (only if possible, i.e., a CTA for the respective Compound was already submitted to the local Health Authorities), with respect to Study Data and results related to Compounds, solely as necessary for the other Party to prepare, submit and maintain regulatory submissions in respect of the Study related to the other Party’s Compound and Regulatory Approvals. In all other cases, where a “right of reference” is not possible, the Parties will promptly discuss in good faith and agree on how to provide the required documentation for CTA of the Study. Further, each Party shall provide to the other a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate such right of reference in form and substance reasonably requested by the other Party. Notwithstanding anything to the contrary in this Agreement, neither Party shall have any license, or right to access the other Party’s CMC data with respect to its Compound. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany. 3.4 Athenex Vaccinex shall maintain reports and all related documentation (paper or electronic versions as applicable) with respect to the Study in good scientific manner and in compliance with Applicable Law. Athenex Each Party shall provide any to the other all Study information and documentation (excluding information and documentation relating to the Sample Testing other than the Sample Testing Results themselves) reasonably requested by such other Party to enable Lilly 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 such the Lilly Party’s Compound, (ii) conduct the Sample Testing, (iii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iiiiv) to in the case of Merck, determine whether the Study has been performed by Athenex Vaccinex in accordance with this Agreement. 3.5 Athenex Each Party shall provide to the other Party copies of all Clinical Data to the extent generated by such Party, in an agreed 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; provided, however, that Clinical Data shall be provided to Merck no more than [***] or as otherwise mutually agreed by the Parties; and a complete copy of the Clinical Data shall be provided to Merck no later than [***]. Merck shall provide pharmacokinetics and anti-drug antibody data regarding Merck Compound to Vaccinex no less than [***]. “Study Completion” shall be deemed to occur upon lock of the Study database in accordance with the Protocol. Vaccinex shall use commercially reasonable efforts to ensure that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and Directive 95/46/EC or subsequent revised versions thereof or any other similar Applicable Law of the United States in connection with the Study, Study permit the use and sharing of the Clinical Data as set forth in this Agreement, including the such sharing of Clinical Data with Lilly. 3.6 All Clinical DataMerck. Vaccinex shall provide Samples to Merck as specified in the Protocol or as agreed to by the JCSC. Each Party shall use the Samples only for the Sample Testing and each Party shall be responsible for conducting the Sample Testing as set forth on the Data Sharing and Sample Testing Schedule, including raw all expenses related thereto. Merck shall own all data arising from the Sample Testing conducted by or on behalf of Merck. Merck shall provide to Vaccinex the Sample Testing Results for the Sample Testing conducted by or on behalf of Merck, in electronic form or other mutually agreeable alternate form, and resultson the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Likewise, generated Vaccinex shall own all data arising from the Sample Testing conducted by or on behalf of Vaccinex. Vaccinex shall provide to Merck the Sample Testing Results for the Sample Testing conducted by or on behalf of Vaccinex, 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. Except to the extent otherwise agreed in writing signed by authorized representatives of each Party, prior to publication or other public disclosure permitted under this Agreement, as well as each Party shall use or disclose the protocol(s), analyses, plans and any other documentation prepared by one or more Party’s Sample Testing Results only for the purposes of the Permitted Use. For clarity, after the publication of a particular item of the other Party’s Sample Testing Results/Clinical Data in compliance with and as permitted under Section 12 of this Agreement, the Parties under are permitted to use or disclose such published information. Note: Reference to “Merck” in this Agreement specifically for use in connection with the Study and related document refers to the Lilly CompoundGroup of Companies affiliated with Merck KGaA, shall be jointly owned by Lilly and AthenexDarmstadt, Germany.

Conduct of the Study. 3.1 Athenex Syndax shall act as the sponsor of the Study and shall hold the IND/CTA IND relating to the Study; provided, however, . Merck acknowledges that in no event shall Athenex Syndax intends to file a separate IND/CTA for IND covering the clinical evaluation of the Syndax Compound to treat melanoma and lung-related indications and to perform the Study unless required by Regulatory Authorities to do sounder such IND. This separate IND will not be a combination IND. If a Regulatory Authority requests a separate IND/CTA combination IND for the Study the Parties will meet and mutually agree on an approach to address such requirement. 3.2 Athenex Syndax shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Athenex Syndax shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Further, Athenex Syndax shall ensure that all necessary Regulatory Approvals from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are obtained prior to initiating performance of the Study. Athenex Syndax shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Lilly Merck shall have the right (but no obligation) to participate in any discussions with a Regulatory Authority, and prior review and approval of any written communications with a Regulatory Authorty, Authority regarding matters related to the Lilly Merck Compound. Notwithstanding anything to the contrary in this Agreement, neither Party shall have any right to access the other Party’s CMC data with respect to its Compound. Merck will authorize FDA and other applicable Regulatory Authorities to cross-reference the appropriate Merck Compound CTA to provide data access to Syndax sufficient to support conduct of the Study, which authorization will take the form of a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate a “right of reference” (as defined in US FDA 21 CFR 314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant part of the Territory. If an appropriate Merck Compound CTA is not available in a given country, Merck will file its CMC data as appropriate and grant right of reference to such CMC data; provided, however, that Syndax shall have no right to directly access the CMC data. 3.4 Athenex Syndax shall maintain reports and all related documentation (paper or electronic versions as applicable) relating to the Study in good scientific manner and in compliance with Applicable Law. Athenex Each Party shall provide any to the other all Study information and documentation (excluding information and documentation relating to the Sample Testing other than the Sample Testing Results themselves) reasonably requested by such other Party to enable Lilly 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 such the Lilly Party’s Compound, or (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether conduct the Study has been performed by Athenex in accordance with this AgreementSample Testing. 3.5 Athenex Each Party shall provide to the other Party 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. Syndax shall ensure that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and GCP or any other similar Applicable Law in connection with the Study, Study permit the use and sharing of the Clinical Data as set forth in this Agreement, including the such sharing of Clinical Data with LillyMerck. 3.6 Syndax shall provide Samples to Merck as specified in the Protocol or as agreed to by the Joint Development Committee. Each Party shall use the Samples only for the Sample Testing and each Party shall be responsible for conducting the Sample Testing related to its own Compound. Merck shall own all data arising from the Sample Testing conducted by or on behalf of Merck. Merck shall provide to Syndax the Sample Testing Results for the Sample Testing conducted by or on behalf of Merck, 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, Syndax shall own all data arising from the Sample Testing conducted by or on behalf of Syndax. Syndax shall provide to Merck the Sample Testing Results for the Sample Testing conducted by or on behalf of Syndax, 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. Except to the extent otherwise agreed in a writing signed by authorized representatives of each Party, each Party shall use the other Party’s Sample Testing Results only for the purposes of ***. Further, Merck covenants not to ***, and Syndax covenants not ***; provided, however, that the foregoing shall not prevent either Party from ***. 3.7 All Clinical Data, including raw data and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related to the Lilly Compound, shall be jointly owned by Lilly Syndax and AthenexMerck. It is understood and acknowledged by the Parties that positive Clinical Data could be used to obtain label changes for the Compounds. In such event, the Parties will enter into good faith negotiations to determine a regulatory submission strategy for the Compounds, and cost structure of the next part of the Study and/or future study(ies) that may be needed for regulatory submission for the Compounds. Merck covenants not to ***, and Syndax covenants not to ***; provided, however, that the foregoing shall not prevent either Party from ***.

Conduct of the Study. 3.1 Athenex 3.1. Incyte shall act as the sponsor of the Study, shall take the lead role in conducting the Study and shall hold the IND/CTA IND relating to the Study; provided, however, that in no event shall Athenex file a separate IND/CTA . The IND held by Incyte will be filed with the Center for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests a separate IND/CTA for the Study the Parties will meet Biologics Evaluation and mutually agree on an approach to address such requirementResearch (CBER) at FDA. 3.2 Athenex 3.2. Incyte shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Athenex 3.3. Incyte shall ensure all necessary regulatory approvals and IRB reviews and approvals are obtained prior to patient enrollment and shall be responsible for coordinating all ongoing IRB review, approval and monitoring, in compliance with 21 C.F.R. Part 56. 3.4. Incyte shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Further, Athenex Incyte shall ensure that all Regulatory Approvals from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are obtained prior to commencing or initiating performance of the Study. Athenex shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Lilly Advaxis shall have the right (but no obligation) to participate in any discussions with a Regulatory Authority, and prior review and approval of any written communications with a Regulatory Authorty, Authority regarding matters related to the Lilly Advaxis Compound. Incyte shall notify Advaxis promptly upon receipt of Regulatory Authority request for any such discussions relating to the Advaxis Compound. Advaxis will authorize FDA and other applicable regulatory authorities to cross-reference the appropriate ADXS-HPV INDs and CTAs to support conduct of the Study, and shall execute any documents or instruments necessary to allow such cross-referencing. If Advaxis’s CTA is not available in a given country, Advaxis will file its CMC data with the Regulatory Authority for such country, referencing Incyte’s CTA as appropriate. 3.4 Athenex 3.5. Each Party shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable LawLaw in connection with the Study. Athenex Incyte shall provide any to Advaxis all Study information and documentation reasonably requested by Advaxis to enable Lilly Advaxis to (i) comply with any of its legal and legal, regulatory and/or contractual obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or such the Lilly Advaxis Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex in accordance with this Agreement. 3.5 Athenex 3.6. Incyte shall provide to Advaxis copies of all Clinical Data (except the Sample Testing Results as set forth in Section 3.7), in electronic form or other mutually agreeable alternate form and on mutually agreeable timelines, provided, however, Clinical Data associated with pharmacokinetics of the Advaxis Compound shall be provided to Advaxis no less than once every three (3) months, if available. Incyte shall ensure that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and Directive or any other similar Applicable Law in connection with the Study, Study permit the use and sharing of the Clinical Data as set forth in this Agreement, including the such sharing of Clinical Data with LillyAdvaxis. 3.6 3.7. All Clinical Data, including raw data data, records and results, generated under this Agreementthe Study, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically except for use in connection with the Study and related Sample Testing Results specific to the Lilly Incyte Compound or the Advaxis Compound, shall be jointly owned by Lilly Incyte and AthenexAdvaxis. Clinical Data that is not Incyte Confidential Information may be used by Advaxis without restriction. Clinical Data that is not Advaxis Confidential Information may be used by Incyte without restriction. Each party shall bear the entire cost of any exploratory study it elects to do that is ; i) not part of the studies contemplated under this Agreement, and ii) expressly reviewed and approved by the JDC. 3.8. Each Party shall use the Samples only for the Sample Testing outlined in Appendix B. Advaxis shall pay for and own all Sample Testing Results arising from experiments conducted by or on behalf of Advaxis. Advaxis shall provide to Incyte those Sample Testing Results outlined in Appendix B for the Sample Testing conducted by or on behalf of Advaxis, in electronic form or other mutually agreeable alternate form and on the timelines specified in Appendix B. Likewise, Incyte shall pay for and own all Sample Testing Results arising from experiments conducted by or on behalf of Incyte. Incyte shall provide to Advaxis those Sample Testing Results outlined in Appendix B for the Sample Testing conducted by or on behalf of Incyte, in electronic form or other mutually agreeable alternate form and on the timelines specified in Appendix B. Each Party may use the other Party’s Sample Testing Results only for the purposes of (i) seeking Regulatory Approval for the use of its respective Compound in the Combination or as monotherapy and/or for any companion diagnostic to any pharmaceutical product containing its respective Compound and (ii) filing and prosecuting patent applications for Joint Inventions and enforcing any resulting patents in accordance with Article 10; provided, however, that these restrictions shall no longer apply once the Sample Testing Results or portions thereof are available to the public.

Conduct of the Study. 3.1 Athenex 2.1 Institution agrees, and commits itself to CRO, to allow Investigator and other Study Personnel to conduct the Study at Institution, and declares that Investigator and other Study Personnel are employed by Institution. 2.2 Investigator agrees, and commits itself to CRO, to conduct the Study at Institution and declares that he/she is employed by Institution. Investigator shall act as personally supervise the conduct of the Study by the Study Personnel to the full extent contemplated by the Protocol and by Applicable Law. Institution and Investigator agree to provide prompt advance notice to Sponsor and CRO if Investigator will be leaving the Institution or is otherwise no longer able to perform the Study. The appointment of a new Investigator must have the prior approval of Sponsor and CRO. 2.3 Investigator and Institution acknowledge that SPONSOR is the sponsor of the Study Study, and shall hold as such is an intended third- party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the IND/CTA SPONSOR's Study-related functions to CRO in compliance with ICH-GCP, sec. 5. 2.1. In addition to the foregoing, Investigator and Institution agree that CRO may disclose any and all Information and/or documents relating to this Agreement, and/or relating to Investigator’s and Institution’s participation in the Study; providedStudy (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), howeverto SPONSOR. All references to SPONSOR herein (whether in the context of delivery of Information, submission of applications, financial terms, or anything else) derive from SPONSOR’s status as such, as set out by Applicable Law and GCP regulations, and Investigator and Institution agree to all such instances. Investigator and Institution will Fully Cooperate with CRO’s requests relating to SPONSOR. 2.4 Investigator and Institution acknowledge that CRO is the recipient of Services described in this Agreement and, for the avoidance of any doubt, that SPONSOR is not the recipient of Services described in no event shall Athenex file a separate IND/CTA for this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and certify that Study Personnel will) conduct the Study unless required by Regulatory Authorities to do so. If in a Regulatory Authority requests a separate IND/CTA for diligent, efficient, and skilful manner, in strict compliance with the Study the Parties will meet terms and mutually agree on an approach to address such requirement. 3.2 Athenex shall ensure that the Study is performed in accordance with conditions of this Agreement, the Protocol and all including subsequent amendments, any specific Study Instructions, Applicable Law, including GCP. 3.3 Athenex all requirements of the Institution or facility, and any other professional standards applicable to their professional industries and fields. Neither Institution nor Investigator nor any Study Personnel shall ensure that all directions from commit any Regulatory Authority and/or ethics committee negligent acts or any wilful misconduct in connection with jurisdiction over the Study are followed. Further, Athenex 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. Athenex Neither Institution nor Investigator nor any Study Personnel shall participate make any unauthorized warranties to any person (including Subjects) concerning the product being tested in the Study. Institution and lead Investigator accept responsibility for the acts and omissions of all discussions Study Personnel in the Study. 2.6 CRO or Sponsor shall obtain the written approval of the appropriate Ethics Committee (EC) prior to commencement of the Study and will furnish Investigator with any Regulatory Authority regarding the EC’s favourable opinion. 2.7 If required by Applicable Law, CRO shall make, or procure that SPONSOR makes, the necessary submissions or notifications to the regulatory authorities. The Study may not commence until the Investigator has been informed by CRO that such authorization has been granted. 2.8 Investigator shall, prior to a Subject’s participation in the Study, provided, however, that Lilly shall have obtain the right (but no obligation) prior Subject's written informed consent to participate in any discussions the Study as well as for processing of Personal Data from the Subject including the public disclosure, transfer and processing of data collected in accordance with a Regulatory Authoritythe Protocol, and prior review and approval of any written communications with a Regulatory Authorty, regarding matters related to the Lilly Compound. 3.4 Athenex shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law, especially data protection law. Athenex Each Subject’s written informed consent shall provide any Study information and documentation reasonably requested to enable Lilly to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, be in each case, to the extent related to the Study or such the Lilly Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex form that is in accordance with this Agreementthe Protocol, the Applicable Law and as agreed upon with the Sponsor. 3.5 Athenex 2.9 Investigator shall ensure that all patient authorizations and consents, and all consents from other data subjects, enroll the number of duly qualified (according to the Protocol) Subjects for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the Clinical Data Study as set forth in this Agreement, including the sharing of Clinical Data with Lilly. 3.6 All Clinical Data, including raw data Exhibit A and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related shall do so according to the Lilly Compoundtimetable set forth in Exhibit A. Notwithstanding the foregoing, Investigator agrees that SPONSOR or CRO may unilaterally revise the number of Subjects that Investigator shall be jointly owned by Lilly and Athenexenroll, and/or the timeframe for such enrollment, via Study Instructions at any time.

Conduct of the Study. 3.1 Athenex 2.1 Institution agrees, and commits itself to CRO, to allow Investigator and other Study Personnel to conduct the Study at Institution at Fakultná nemocnica Trnava, Neurologické oddelenie, A. Xxxxxxx 00, 000 00 Xxxxxx, Xxxxxx Xxxxxxxx and warrants that Investigator and other Study Personnel are employed by Institution. 2.2 Investigator agrees, and commits himself to CRO, to conduct the Study at Institution and warrants that he is employed by Institution. Investigator shall act as personally supervise the conduct of the Study by the Study Personnel to the full extent contemplated by the Protocol and by Applicable Law. Institution and Investigator agree to provide prompt advance notice to Sponsor and CRO if Investigator will be leaving the Institution or is otherwise no longer able to perform the Study. The appointment of a new Investigator must have the prior approval of Sponsor and CRO. 2.3 Investigator and Institution acknowledge that SPONSOR is the sponsor of the Study Study, and shall hold as such is an intended third-party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the IND/CTA SPONSOR's Study- related functions to CRO in compliance with ICH-GCP, sec. 5. 2.1. In addition to the foregoing, Investigator and Institution agree that CRO may disclose any and all Information and/or documents relating to this Agreement, and/or relating to Investigator’s and Institution’s participation in the Study; providedStudy (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), howeverto SPONSOR. All references to SPONSOR herein (whether in the context of delivery of Information, submission of applications, financial terms, or anything else) derive from SPONSOR’s status as such, as set out by Applicable Law and GCP regulations, and Investigator and Institution agree to all such instances. Investigator and Institution will Fully Cooperate with CRO’s requests relating to SPONSOR. 2.4 Investigator and Institution acknowledge that CRO is the recipient of Services described in this Agreement and, for the avoidance of any doubt, that SPONSOR is not the recipient of Services described in no event shall Athenex file a separate IND/CTA for this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and warrant that Study Personnel will) conduct the Study unless required by Regulatory Authorities to do so. If in a Regulatory Authority requests a separate IND/CTA for diligent, efficient, and skilful manner, in strict compliance with the Study the Parties will meet terms and mutually agree on an approach to address such requirement. 3.2 Athenex shall ensure that the Study is performed in accordance with conditions of this Agreement, the Protocol and all including subsequent amendments, any specific Study Instructions, Applicable Law, including GCP. 3.3 Athenex all requirements of the Institution or facility, and any other professional standards applicable to their professional industries and fields. Neither Institution nor Investigator nor any Study Personnel shall ensure that all directions from commit any Regulatory Authority and/or ethics committee negligent acts or any wilful misconduct in connection with jurisdiction over the Study are followed. Further, Athenex 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. Athenex Neither Institution nor Investigator nor any 2.6 CRO or SPONSOR shall participate obtain the written approval of the appropriate Ethics Committee (EC) prior to commencement of the Study and will furnish Investigator with the EC’s letter of approval. 2.7 If required by Applicable Law, CRO shall make, or procure that SPONSOR makes, the necessary submissions or notifications to the regulatory authorities. The Study may not commence until the Investigator has been informed by CRO that such authorization has been granted. 2.8 Investigator shall, prior to a Subject’s participation in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Lilly shall have obtain the right (but no obligation) prior Subject's written informed consent to participate in any discussions the Study as well as for processing of Personal Data from the Subject including the public disclosure, transfer and processing of data collected in accordance with a Regulatory Authoritythe Protocol, and prior review and approval of any written communications with a Regulatory Authorty, regarding matters related to the Lilly Compound. 3.4 Athenex shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law, especially data protection law and the GDPR. Athenex Each Subject’s written informed consent shall provide any Study information and documentation reasonably requested to enable Lilly to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, be in each case, to the extent related to the Study or such the Lilly Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex form that is in accordance with this Agreementthe Protocol, the Applicable Law and as agreed upon with the Sponsor. 3.5 Athenex 2.9 Investigator shall ensure that all patient authorizations and consents, and all consents from other data subjects, enroll the number of duly qualified (according to the Protocol) Subjects for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the Clinical Data Study as set forth in this Agreement, including the sharing of Clinical Data with Lilly. 3.6 All Clinical Data, including raw data Exhibit A and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related shall do so according to the Lilly Compoundtimetable set forth in Exhibit A. Notwithstanding the foregoing, Investigator agrees that SPONSOR or CRO may unilaterally revise the number of Subjects that Investigator shall be jointly owned by Lilly and Athenexenroll, and/or the timeframe for such enrollment, via Study Instructions at any time.

Conduct of the Study. 3.1 Athenex shall act as The parties to the sponsor Agreement agree that the Study will be performed in strict accordance with the Protocol, all applicable laws, regulations and guidelines, and good clinical practices (“GCPs”). Investigator is responsible for the conduct of the Study at Institution and for supervising any individual or party to whom the Investigator delegates Study-related duties and functions. The Investigator shall hold review all case report forms (“CRFs”) to ensure their accuracy and completeness, shall review and understand the IND/CTA relating to information in the Study; providedinvestigator’s brochure, however, that in no event shall Athenex file a separate IND/CTA for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests a separate IND/CTA for the Study the Parties will meet and mutually agree on an approach to address such requirement. 3.2 Athenex shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Athenex shall ensure that all directions from informed consent requirements are met (including any Regulatory Authority and/or ethics committee with jurisdiction over needed authorizations for the Study are followed. Furtheruse, Athenex storage and transfer of personal data), shall ensure that all Regulatory Approvals from any Regulatory Authority and/or ethics committee with jurisdiction over the Study required reviews and approvals (or favorable opinions) by applicable regulatory authorities and Institutional Review Boards (“IRBs”) or Independent Ethics Committees (“IECs”) are obtained and shall provide a copy of such approval to IQVIA prior to initiating performance enrollment of any subjects. If the Investigator and Institution retain the services of any individual or party to perform Study-related duties and functions, the Institution and Investigator shall ensure this individual or party is qualified to perform those Study-related duties and functions and shall implement procedures to ensure the integrity of the Study-related duties and functions performed and any data generated. Athenex shall participate in CRFs will be legible and lead all discussions with any Regulatory Authority regarding the Studycompleted within five (5) business days of each patient visit or data generating event. Any requests by IQVIA for verification, provided, however, that Lilly shall have clarification or correction of data furnished on a CRF must be provided within five (5) business days of receipt of such request. Sponsor and/or IQVIA reserve(s) the right (but no obligation) to participate withhold payment in any discussions with a Regulatory Authority, and prior review and approval case of any written communications with a Regulatory Authorty, regarding matters related significant or repeated failure to perform the Lilly Compound. 3.4 Athenex shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law. Athenex shall provide any Study information and documentation reasonably requested to enable Lilly 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 such the Lilly Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex in accordance with this Agreement. 3.5 Athenex shall ensure that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the Clinical Data as tasks set forth in this Agreement, including Section 1. A sample informed consent form has been provided by the sharing of Clinical Data with Lilly. 3.6 All Clinical Data, including raw data and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically Sponsor for use in connection with the Study; any modifications to this form must be approved by IQVIA or Sponsor prior to its use, such approval not to be unreasonably withheld. The Institution thru it’s Investigator agrees to ensure that all clinical data are accurate, complete, and legible. The Institution shall promptly and fully produce all data, records and information relating to the Study to IQVIA and related to the Lilly CompoundSponsor and their representatives during normal business hours, and shall be jointly owned by Lilly assist them in promptly resolving any questions and Athenex.in performing audits or reviews of original subject PRÍLOHA A PODMIENKY ZMLUVY

Conduct of the Study. 3.1 Athenex Context shall act as the sponsor of the Study and shall hold the IND/CTA IND relating to the Study; provided, however, that in no event shall Athenex Context file a separate IND/CTA IND for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests a separate IND/CTA IND for the Study Study, the Parties will meet and mutually agree on 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 Athenex Prior to the initiation of the Study or as may otherwise be necessary during the course of the Study, either Party shall ensure 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 is shall be performed in accordance with this Agreement, its obligations under the Related Agreements, the Protocol and all Applicable Law, including GCP. 3.3 Athenex , 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 ACTIVE/117982251.1 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 from, and that have been agreed with, any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followedStudy. Further, Athenex 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 StudyStudy (in particular and to the extent applicable, Context will follow the FDA Guidance on co-development of two or more investigational drugs). Athenex Context shall participate in and, if required, lead any and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Lilly Menarini shall have the right (but no obligation) to participate in any discussions 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, and prior review and approval of any written communications with a Regulatory Authorty, regarding matters related to the Lilly Compoundextent such documents and information are reasonably available to Menarini. 3.4 Athenex 3.7 Context shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law. Athenex Each Party shall provide any to the other all Study information and documentation reasonably requested by such other Party to enable Lilly 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 or, subject to Section 3.4 and Section 3.5 above, such the Lilly CompoundParty'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 hereof2.4, and (iiiiv) to in the case of Menarini, determine whether the Study has been performed by Athenex Context in accordance with this Agreement. 3.5 Athenex 3.8 Context shall ensure that own all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data. Context hereby grants Menarini a worldwide, required under HIPAAperpetual, the EU Data Protection Directivefully paid up, EU General Data Protection Regulationroyalty free, and any other similar Applicable Law in connection with the Study, permit the sublicensable limited license to use and sharing of the Clinical Data as set forth in this Agreement, including the sharing of Clinical Data with Lilly. 3.6 All Clinical Data, including raw data and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related to the Lilly Compound, shall be jointly owned by Lilly and Athenex.Sample ACTIVE/117982251.1

Conduct of the Study. 3.1 Athenex 2.1 Each Collaborator shall act submit patient and/or regulatory data timely in accordance with and as instructed in the sponsor Protocol, including but not limited to, breaches of the Protocol of which any Collaborator becomes aware. 2.2 Each Collaborator will have its own regulatory responsibility for the Study and shall hold the IND/CTA relating to for such Collaborator’s conduct of the Study; provided, however, that in no event shall Athenex file a separate IND/CTA for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests a separate IND/CTA for the Study the Parties will meet and mutually agree on an approach to address such requirement. 3.2 Athenex 2.3 Each Collaborator and Collaborating Investigator shall ensure that the obtain informed consent of all Study is performed subjects at its site in accordance with this Agreement, the Protocol 21 CFR Part 50 and/or other applicable laws and all Applicable Law, including GCP. 3.3 Athenex shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followedregulations. Further, Athenex each Collaborator 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. Athenex shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Lilly shall have the right (but no obligation) to participate in any discussions with a Regulatory Authority, and prior obtain IRB review and approval of any written communications the Protocol, including the informed consent form, in accordance with a Regulatory Authorty, regarding matters related 21 CFR Part 56 and/or other applicable laws and regulations. Collaborator shall supply TAMHSC with evidence of IRB approval prior to the Lilly Compoundreceipt of funding. 3.4 Athenex shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law. Athenex shall provide any Study information and documentation reasonably requested 2.4 Each Collaborator agrees to enable Lilly to (i) comply with any of its legal and regulatory obligations, or all applicable laws relating to patient privacy. Each Collaborator shall take any request by any Regulatory Authority, in each case, and all reasonable and ethical actions necessary to ensure that it will be able to provide and share all Study related data to the extent related other Collaborators, such acts including, without limitation, obtaining in a manner consistent with the Health Insurance Portability and Accountability Act of 1996 and the regulations promulgated thereunder (“HIPAA”), authorization from each Study subject to provide “Protected Health Information” (as defined under HIPAA) regarding such Study subjects to TAMHSC, MD Xxxxxxxx, BCM, and CHSH. 2.5 Each Collaborator shall submit written reports to TAMHSC summarizing the current status of the Study every six (6) months after initiation of the Study at Collaborator. The format and detail of said written reports shall be according to the Study or such mutual understanding and agreement between the Lilly Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, TAMHSC Investigator and (iii) to determine whether the Collaborator Investigator. 2.6 Upon completion of the Study has been performed by Athenex in accordance with this Agreement. 3.5 Athenex shall ensure that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the Clinical Data at each Collaborator or upon earlier termination as set forth in this AgreementSection 4.1, each Collaborator shall submit a final written report to the other Collaborators including all relevant information concerning its conduct of the sharing of Clinical Data with LillyStudy, such final report as agreed upon between the Collaborating Investigators. 3.6 All Clinical Data2.7 Each Collaborator shall respond to inquiries by TAMHSC and the TAMHSC Investigator regarding the conduct and status of the Study, including raw and shall cooperate with TAMHSC and TAMHSC Investigator in providing any necessary information regarding financial records or data and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and results related to the Lilly CompoundStudy, shall be jointly owned if requested by Lilly and Athenexan administrative authority.

Conduct of the Study. 3.1 Athenex Ideaya shall act as the sponsor of the Study and shall hold the IND/CTA IND relating to the Study; provided, however, that in no event shall Athenex Ideaya file a separate IND/CTA IND for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests a separate IND/CTA IND for the Study the Parties will meet and mutually agree on an approach to address such requirement. 3.2 Athenex Ideaya shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. In the event that any Regulatory Authority, ethics committee or institutional review board has questions related to the Protocol or the conduct of the Study that relate to the Pfizer Compound, Pfizer will provide reasonable assistance in responding to such questions. 3.3 Athenex Ideaya shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Further, Athenex Ideaya 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. Athenex shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Lilly Pfizer shall have the right (but no obligation) to participate in any discussions with a Regulatory Authority, and prior review and approval of any written communications with a Regulatory Authorty, Authority regarding matters related to the Lilly Pfizer Compound. Each Party grants to the other Party a non-exclusive, non-transferable (except in connection with a permitted assignment, sublicense or subcontract) “right of reference” (as defined in US FDA 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 Clinical Data and results related to Compounds, solely as necessary for the other Party to prepare, submit and maintain regulatory submissions related to the other Party’s Compound and Regulatory Approvals. Further, each Party shall provide to the other a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate such right of reference. 3.4 Athenex Notwithstanding anything to the contrary in this Agreement, neither Party shall maintain have any right to access the other Party’s CMC data with respect to its Compounds. If necessary, Pfizer shall authorize FDA and other applicable Regulatory Authorities to cross-reference the appropriate Pfizer Compound U.S., EU and Australia Regulatory Approvals to provide data access to Ideaya 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, Pfizer 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 Ideaya to cross-reference the CMC Data for the review of the CTA; however, Ideaya shall have no right to directly access the CMC Data. Ideaya shall reimburse Pfizer for the costs for preparing the CMC Data for filing with such Regulatory Authority(ies) and related filing costs. In addition to the foregoing, Pfizer shall provide the materials described in Appendix B to Ideaya in accordance with Appendix B, and shall 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 Pfizer. Pfizer hereby agrees that it shall review Section D of the European Clinical Trials Database (EudraCT) Application Form [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. Worksheets and Medicines section of the Clinical Trial Notification (CTN) Form completed by Ideaya with respect to the Pfizer Compound for purposes of the CTA and CTN, respectively, no later than [***] days following receipt from Ideaya, provide any corrections or additions required for accuracy and completeness of such Worksheets. 3.5 Ideaya shall ensure that all reports and all related documentation (paper or electronic versions as applicable) required for the Study are maintained in good scientific manner and in compliance with Applicable Law. Athenex Each Party shall provide any to the other all Study information and documentation (excluding information and documentation relating to the Sample Testing other than the Sample Testing Results themselves) reasonably requested by such other Party to enable Lilly 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 such the Lilly Party’s Compound, (ii) conduct the Sample Testing, (iii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iiiiv) to in the case of Pfizer, determine whether the Study has been performed by Athenex Ideaya in accordance with this Agreement. 3.5 Athenex 3.6 Ideaya shall provide to Pfizer 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 Pfizer no later than [***] days following Study Completion. Pfizer shall provide pharmacokinetics data regarding the Pfizer Compound to Ideaya 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. Ideaya shall ensure that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and Directive or any other similar Applicable Law in connection with the Study, Study permit the use and sharing of the Clinical Data as set forth in this Agreement, including the such sharing of Clinical Data with LillyPfizer. 3.6 All Clinical Data, including raw data and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related to the Lilly Compound, shall be jointly owned by Lilly and Athenex.

Conduct of the Study. 3.1 Athenex 2.1 Institution agrees, and commits itself to CRO, to allow Investigator and other Study Personnel to conduct the Study at Institution, and warrants that Investigator and other Study Personnel are employed by Institution. 2.2 Investigator agrees, and commits itself to CRO, to conduct the Study at Institution and warrants that he/she is employed by Institution. Investigator shall act as personally supervise the conduct of the Study by the Study Personnel to the full extent contemplated by the Protocol and by Applicable Law. Institution and Investigator agree to provide prompt advance notice to Sponsor and CRO if Investigator will be leaving the Institution or is otherwise no longer able to perform the Study. The appointment of a new Investigator must have the prior approval of Sponsor and CRO. 2.3 Investigator and Institution acknowledge that SPONSOR is the sponsor of the Study Study, and shall hold as such is an intended third- party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the IND/CTA SPONSOR's Study-related functions to CRO in compliance with ICH-GCP, sec. 5. 2.1. In addition to the foregoing, Investigator and Institution agree that CRO may disclose any and all Information and/or documents relating to this Agreement, and/or relating to Investigator’s and Institution’s participation in the Study; providedStudy (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), howeverto SPONSOR. All references to SPONSOR herein (whether in the context of delivery of Information, submission of applications, financial terms, or anything else) derive from SPONSOR’s status as such, as set out by Applicable Law and GCP regulations, and Investigator and Institution agree to all such instances. Investigator and Institution will Fully Cooperate with CRO’s requests relating to SPONSOR. 2.4 Investigator and Institution acknowledge that CRO is the recipient of Services described in this Agreement and, for the avoidance of any doubt, that SPONSOR is not the recipient of Services described in no event shall Athenex file a separate IND/CTA for this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and warrant that Study Personnel will) conduct the Study unless required by Regulatory Authorities to do so. If in a Regulatory Authority requests a separate IND/CTA for diligent, efficient, and skilful manner, in strict compliance with the Study the Parties will meet terms and mutually agree on an approach to address such requirement. 3.2 Athenex shall ensure that the Study is performed in accordance with conditions of this Agreement, the Protocol and all including subsequent amendments, any specific Study Instructions, Applicable Law, including GCP. 3.3 Athenex all requirements of the Institution or facility, and any other professional standards applicable to their professional industries and fields. Neither Institution nor Investigator nor any Study Personnel shall ensure that all directions from commit any Regulatory Authority and/or ethics committee negligent acts or any wilful misconduct in connection with jurisdiction over the Study are followed. Further, Athenex 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. Athenex Neither Institution nor Investigator nor any Study Personnel shall participate make any unauthorized warranties to any person (including Subjects) concerning the product being tested in the Study. Institution and lead Investigator accept responsibility for the acts and omissions of all discussions Study Personnel in the Study. 2.6 CRO or Sponsor shall obtain the written approval of the appropriate Ethics Committee (EC) prior to commencement of the Study and will furnish Investigator with any Regulatory Authority regarding the EC’s letter of approval. 2.7 If required by Applicable Law, CRO shall make, or procure that SPONSOR makes, the necessary submissions or notifications to the regulatory authorities. The Study may not commence until the Investigator has been informed by CRO that such authorization has been granted. 2.8 Investigator shall, prior to a Subject’s participation in the Study, provided, however, that Lilly shall have obtain the right (but no obligation) prior Subject's written informed consent to participate in any discussions the Study as well as for processing of Personal Data from the Subject including the public disclosure, transfer and processing of data collected in accordance with a Regulatory Authoritythe Protocol, and prior review and approval of any written communications with a Regulatory Authorty, regarding matters related to the Lilly Compound. 3.4 Athenex shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law, especially data protection law. Athenex Each Subject’s written informed consent shall provide any Study information and documentation reasonably requested to enable Lilly to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, be in each case, to the extent related to the Study or such the Lilly Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex form that is in accordance with this Agreementthe Protocol, the Applicable Law and as agreed upon with the Sponsor. 3.5 Athenex 2.9 Investigator shall ensure that all patient authorizations and consents, and all consents from other data subjects, enroll the number of duly qualified (according to the Protocol) Subjects for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the Clinical Data Study as set forth in this Agreement, including the sharing of Clinical Data with Lilly. 3.6 All Clinical Data, including raw data Exhibit A1 and results, generated under this Agreement, as well as the protocol(s), analyses, plans A2 and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related shall do so according to the Lilly Compoundtimetable set forth in Exhibit A1 and A2. Notwithstanding the foregoing, Investigator agrees that SPONSOR or CRO may unilaterally revise the number of Subjects that Investigator shall be jointly owned by Lilly and Athenexenroll, and/or the timeframe for such enrollment, via Study Instructions at any time.

Conduct of the Study. 3.1 Athenex 2.1 Institution agrees, and commits itself to CRO, to allow Investigator and other Study Personnel to conduct the Study at Institution, and warrants that Investigator and other Study Personnel are employed by Institution. 2.2 Investigator agrees, and commits itself to CRO, to conduct the Study at Institution and warrants that he/she is employed by Institution. Investigator shall act as personally supervise the conduct of the Study by the Study Personnel to the full extent contemplated by the Protocol and by Applicable Law. Institution and Investigator agree to provide prompt advance notice to Sponsor and CRO if Investigator will be leaving the Institution or is otherwise no longer able to perform the Study. The appointment of a new Investigator must have the prior approval of Sponsor and CRO. 2.3 Investigator and Institution acknowledge that SPONSOR is the sponsor of the Study Study, and shall hold as such is an intended third- party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the IND/CTA SPONSOR's Study-related functions to CRO in compliance with ICH-GCP, sec. 5. 2.1. In addition to the foregoing, Investigator and Institution agree that CRO may disclose any and all Information and/or documents relating to this Agreement, and/or relating to Investigator’s and Institution’s participation in the Study; providedStudy (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), howeverto SPONSOR. All references to SPONSOR herein (whether in the context of delivery of Information, submission of applications, financial terms, or anything else) derive from SPONSOR’s status as such, as set out by Applicable Law and GCP regulations, and Investigator and Institution agree to all such instances. Investigator and Institution will Fully Cooperate with CRO’s requests relating to SPONSOR. 2.4 Investigator and Institution acknowledge that CRO is the recipient of Services described in this Agreement and, for the avoidance of any doubt, that SPONSOR is not the recipient of Services described in no event shall Athenex file a separate IND/CTA for this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and warrant that Study Personnel will) conduct the Study unless required by Regulatory Authorities to do so. If in a Regulatory Authority requests a separate IND/CTA for diligent, efficient, and skilful manner, in strict compliance with the Study the Parties will meet terms and mutually agree on an approach to address such requirement. 3.2 Athenex shall ensure that the Study is performed in accordance with conditions of this Agreement, the Protocol and all including subsequent amendments, any specific Study Instructions, Applicable Law, including GCP. 3.3 Athenex all requirements of the Institution or facility, and any other professional standards applicable to their professional industries and fields. Neither Institution nor Investigator nor any Study Personnel shall ensure that all directions from commit any Regulatory Authority and/or ethics committee negligent acts or any wilful misconduct in connection with jurisdiction over the Study are followed. Further, Athenex 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. Athenex Neither Institution nor Investigator nor any Study Personnel shall participate make any unauthorized warranties to any person (including Subjects) concerning the product being tested in the Study. Institution and lead Investigator accept responsibility for the acts and omissions of all discussions Study Personnel in the Study. 2.6 CRO or Sponsor shall obtain the written approval of the appropriate Ethics Committee (EC) prior to commencement of the Study and will furnish Investigator with any Regulatory Authority regarding the EC’s letter of approval. 2.7 If required by Applicable Law, CRO shall make, or procure that SPONSOR makes, the necessary submissions or notifications to the regulatory authorities. The Study may not commence until the Investigator has been informed by CRO that such authorization has been granted. 2.8 Investigator shall, prior to a Subject’s participation in the Study, provided, however, that Lilly shall have obtain the right (but no obligation) prior Subject's written informed consent to participate in any discussions the Study as well as for processing of Personal Data from the Subject including the public disclosure, transfer and processing of data collected in accordance with a Regulatory Authoritythe Protocol, and prior review and approval of any written communications with a Regulatory Authorty, regarding matters related to the Lilly Compound. 3.4 Athenex shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law, especially data protection law. Athenex Each Subject’s written informed consent shall provide any Study information and documentation reasonably requested to enable Lilly to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, be in each case, to the extent related to the Study or such the Lilly Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex form that is in accordance with this Agreementthe Protocol, the Applicable Law and as agreed upon with the Sponsor. 3.5 Athenex 2.9 Investigator shall ensure that all patient authorizations and consents, and all consents from other data subjects, enroll the number of duly qualified (according to the Protocol) Subjects for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the Clinical Data Study as set forth in this Agreement, including the sharing of Clinical Data with Lilly. 3.6 All Clinical Data, including raw data Exhibit A and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related shall do so according to the Lilly Compoundtimetable set forth in Exhibit A. Notwithstanding the foregoing, Investigator agrees that SPONSOR or CRO may unilaterally revise the number of Subjects that Investigator shall be jointly owned by Lilly and Athenexenroll, and/or the timeframe for such enrollment, via Study Instructions at any time.

Conduct of the Study. 3.1 Athenex 2.1 Institution agrees, and commits itself to CRO, to allow Investigator and other Study Personnel to conduct the Study at Institution, and warrants that Investigator and other Study Personnel are employed by Institution, however their participation in the Study must not cause any serious operating issues. 2.2 Investigator agrees, and commits itself to CRO, to conduct the Study at Institution and warrants that he/she is employed by Institution. Investigator shall act as personally supervise the conduct of the Study by the Study Personnel to the full extent contemplated by the Protocol and by Applicable Law. Institution and Investigator agree to provide prompt advance notice to Sponsor and CRO if Investigator will be leaving the Institution or is otherwise no longer able to perform the Study. The appointment of a new Investigator must have the prior approval of Sponsor and CRO. 2.3 Investigator and Institution acknowledge that SPONSOR is the sponsor of the Study Study, and shall hold as such is an intended third- party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the IND/CTA SPONSOR's Study-related functions to CRO in compliance with ICH-GCP, sec. 5. 2.1. In addition to the foregoing, Investigator and Institution agree that CRO may disclose any and all Information and/or documents relating to this Agreement, and/or relating to Investigator’s and Institution’s participation in the Study; providedStudy (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), howeverto SPONSOR. All references to SPONSOR herein (whether in the context of delivery of Information, submission of applications, financial terms, or anything else) derive from SPONSOR’s status as such, as set out by Applicable Law and GCP regulations, and Investigator and Institution agree to all such instances. Investigator and Institution will Fully Cooperate with CRO’s requests relating to SPONSOR. 2.4 Investigator and Institution acknowledge that CRO is the recipient of Services described in this Agreement and, for the avoidance of any doubt, that SPONSOR is not the recipient of Services described in no event shall Athenex file a separate IND/CTA for this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and warrant that Study Personnel will) conduct the Study unless required by Regulatory Authorities to do so. If in a Regulatory Authority requests a separate IND/CTA for diligent, efficient, and skilful manner, in strict compliance with the Study the Parties will meet terms and mutually agree on an approach to address such requirement. 3.2 Athenex shall ensure that the Study is performed in accordance with conditions of this Agreement, the Protocol and all including subsequent amendments, any specific Study Instructions, Applicable Law, including GCP. 3.3 Athenex all requirements of the Institution or facility, and any other professional standards applicable to their professional industries and fields. Neither Institution nor Investigator nor any Study Personnel shall ensure that all directions from commit any Regulatory Authority and/or ethics committee negligent acts or any wilful misconduct in connection with jurisdiction over the Study are followed. Further, Athenex 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. Athenex Neither Institution nor Investigator nor any Study Personnel shall participate make any unauthorized warranties to any person (including Subjects) concerning the product being tested in the Study. Institution and lead Investigator accept responsibility for the acts and omissions of all discussions Study Personnel in the Study. 2.6 CRO or Sponsor shall obtain the written approval of the appropriate Ethics Committee (EC) prior to commencement of the Study and will furnish Investigator with any Regulatory Authority regarding the EC’s letter of approval. 2.7 If required by Applicable Law, CRO shall make, or procure that SPONSOR makes, the necessary submissions or notifications to the regulatory authorities. The Study may not commence until the Investigator has been informed by CRO that such authorization has been granted. 2.8 Investigator shall, prior to a Subject’s participation in the Study, provided, however, that Lilly shall have obtain the right (but no obligation) prior Subject's written informed consent to participate in any discussions the Study as well as for processing of Personal Data from the Subject including the public disclosure, transfer and processing of data collected in accordance with a Regulatory Authoritythe Protocol, and prior review and approval of any written communications with a Regulatory Authorty, regarding matters related to the Lilly Compound. 3.4 Athenex shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law, especially data protection law. Athenex Each Subject’s written informed consent shall provide any Study information and documentation reasonably requested to enable Lilly to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, be in each case, to the extent related to the Study or such the Lilly Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex form that is in accordance with this Agreementthe Protocol, the Applicable Law and as agreed upon with the Sponsor and handed over by CRO. Sponsor or CRO, as the case may be, undertake to inform Institution and Investigator in time of the newly approved Study documents. 3.5 Athenex 2.9 Investigator shall ensure that all patient authorizations and consents, and all consents from other data subjects, enroll the number of duly qualified (according to the Protocol) Subjects for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the Clinical Data Study as set forth in this Agreement, including the sharing of Clinical Data with Lilly. 3.6 All Clinical Data, including raw data Exhibit A and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related shall do so according to the Lilly Compoundtimetable set forth in Exhibit A. Notwithstanding the foregoing, Investigator agrees that SPONSOR or CRO may unilaterally revise the number of Subjects that Investigator shall be jointly owned by Lilly and Athenexenroll, and/or the timeframe for such enrollment, via Study Instructions at any time.

Conduct of the Study. 3.1 Athenex 2.1 Institution agrees, and commits itself to CRO, to allow Investigator and other Study Personnel to conduct the Study at Institution, and warrants that Investigator and other Study Personnel are employed by Institution, however their participation in the Study must not cause any serious operating issues. Estimated duration of the Study: until 2.2 Investigator agrees, and commits itself to CRO, to conduct the Study at Institution and warrants that he/she is employed by Institution. Investigator shall act as personally supervise the conduct of the Study by the Study Personnel to the full extent contemplated by the Protocol and by Applicable Law. Institution and Investigator agree to provide prompt advance notice to Sponsor and CRO if Investigator will be leaving the Institution or is otherwise no longer able to perform the Study. The appointment of a new Investigator must have the prior approval of Sponsor and CRO. 2.3 Investigator and Institution acknowledge that SPONSOR is the sponsor of the Study Study, and shall hold as such is an intended third- party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the IND/CTA SPONSOR's Study-related functions to CRO in compliance with ICH-GCP, sec. 5. 2.1. In addition to the foregoing, Investigator and Institution agree that CRO may disclose any and all Information and/or documents relating to this Agreement, and/or relating to Investigator’s and Institution’s participation in the Study; providedStudy (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), howeverto SPONSOR. All references to SPONSOR herein (whether in the context of delivery of Information, submission of applications, financial terms, or anything else) derive from SPONSOR’s status as such, as set out by Applicable Law and GCP regulations, and Investigator and Institution agree to all such instances. Investigator and Institution will Fully Cooperate with CRO’s requests relating to SPONSOR. 2.4 Investigator and Institution acknowledge that CRO is the recipient of Services described in this Agreement and, for the avoidance of any doubt, that SPONSOR is not the recipient of Services described in no event shall Athenex file a separate IND/CTA for this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and warrant that Study Personnel will) conduct the Study unless required by Regulatory Authorities to do so. If in a Regulatory Authority requests a separate IND/CTA for diligent, efficient, and skilful manner, in strict compliance with the Study the Parties will meet terms and mutually agree on an approach to address such requirement. 3.2 Athenex shall ensure that the Study is performed in accordance with conditions of this Agreement, the Protocol and all including subsequent amendments, any specific Study Instructions, Applicable Law, including GCP. 3.3 Athenex all requirements of the Institution or facility, and any other professional standards applicable to their professional industries and fields. Neither Institution nor Investigator nor any Study Personnel shall ensure that all directions from commit any Regulatory Authority and/or ethics committee negligent acts or any wilful misconduct in connection with jurisdiction over the Study are followed. Further, Athenex 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. Athenex Neither Institution nor Investigator nor any Study Personnel shall participate make any unauthorized warranties to any person (including Subjects) concerning the product being tested in the Study. Institution and lead Investigator accept responsibility for the acts and omissions of all discussions Study Personnel in the Study. 2.6 CRO or Sponsor shall obtain the written approval of the appropriate Ethics Committee (EC) prior to commencement of the Study and will furnish Investigator with any Regulatory Authority regarding the EC’s letter of approval. 2.7 If required by Applicable Law, CRO shall make, or procure that SPONSOR makes, the necessary submissions or notifications to the regulatory authorities. The Study may not commence until the Investigator has been informed by CRO that such authorization has been granted. 2.8 Investigator shall, prior to a Subject’s participation in the Study, provided, however, that Lilly shall have obtain the right (but no obligation) prior Subject's written informed consent to participate in any discussions the Study as well as for processing of Personal Data from the Subject including the public disclosure, transfer and processing of data collected in accordance with a Regulatory Authoritythe Protocol, and prior review and approval of any written communications with a Regulatory Authorty, regarding matters related to the Lilly Compound. 3.4 Athenex shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law, especially data protection law. Athenex Each Subject’s written informed consent shall provide any Study information and documentation reasonably requested to enable Lilly to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, be in each case, to the extent related to the Study or such the Lilly Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex form that is in accordance with this Agreementthe Protocol, the Applicable Law and as agreed upon with the Sponsor and handed over by CRO. Sponsor or CRO, as the case may be, undertake to inform Institution and Investigator in time of the newly approved Study documents. 3.5 Athenex 2.9 Investigator shall ensure that all patient authorizations and consents, and all consents from other data subjects, enroll the number of duly qualified (according to the Protocol) Subjects for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the Clinical Data Study as set forth in this Agreement, including the sharing of Clinical Data with Lilly. 3.6 All Clinical Data, including raw data Exhibit A and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related shall do so according to the Lilly Compoundtimetable set forth in Exhibit A. Notwithstanding the foregoing, Investigator agrees that SPONSOR or CRO may unilaterally revise the number of Subjects that Investigator shall be jointly owned by Lilly and Athenexenroll, and/or the timeframe for such enrollment, via Study Instructions at any time.

Conduct of the Study. 3.1 Athenex 1.1 Institution agrees to allow Investigator and other Institution staff and agents (“Study Personnel”) to conduct the Study. The Institution warrants that the Investigator is a member of the active staff of the Institution. Investigator shall act as take all reasonable steps to inform all Study Personnel of all of their obligations under this Agreement and Investigator shall ensure that Study Personnel fully comply with same. 1.2 Investigator shall directly supervise the sponsor conduct of the Study and shall hold by the IND/CTA relating Study Personnel at the Institution, to the Study; provided, however, full extent contemplated by the Protocol and by applicable law. Investigator hereby agree to (and warrant that in no event shall Athenex file a separate IND/CTA for Study Personnel will) conduct the Study unless required by Regulatory Authorities to do so. If in a Regulatory Authority requests a separate IND/CTA for diligent, efficient, and skilful manner, in strict compliance with the Study the Parties will meet terms and mutually agree on an approach to address such requirement. 3.2 Athenex shall ensure that the Study is performed in accordance with conditions of this Agreement, the Protocol including any subsequent amendments thereto, any specific Study instructions from SPONSOR or CRO, applicable law, rules, regulations and guidelines of relevant health authorities, all Applicable Lawpolicies of the Institution, including GCP. 3.3 Athenex and any other professional standards applicable to their professional industries and fields including, but not limited to applicable version(s) of the World Medical Association Declaration of Helsinki. The Investigator or any Study Personnel shall ensure that all directions from not commit any Regulatory Authority and/or ethics committee negligent acts or any willful misconduct in connection with jurisdiction over the Study are followed. Further, Athenex 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. 1.3 The parties will fulfill their respective obligations to the applicable Institutional Review Board (IRB) or Ethics Committee (EC) at the Institution. Athenex SPONSOR or CRO shall participate obtain the written approval of the Institute’s IRB/EC prior to commencement of the Study and will furnish Investigator with the IRB/EC’s letter of approval. If required by applicable law, SPONSOR or CRO shall make the necessary submissions or notifications to the regulatory authorities. The Study may not commence until the Investigator has been informed by CRO that such authorization has been granted. 1.4 Investigator shall, prior to a subject’s participation in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Lilly shall have obtain the right (but no obligation) subject’s written informed consent to participate in any discussions with a Regulatory Authority, and prior review and approval of the Study. Investigator shall not make any written communications with a Regulatory Authortyor oral promises, regarding matters related statements or other representations to Study subjects (whether or not formally documented in the Lilly Compound. 3.4 Athenex shall maintain reports and all related documentation (paper informed consent forms) that SPONSOR or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law. Athenex shall CRO will provide any Study information and documentation reasonably requested to enable Lilly to (i) comply with form of compensation, reimbursement or payment, medical treatment and/or any other support or thing of its legal and regulatory obligationsvalue, or any request by any Regulatory Authority, in each case, except to the extent related expressly provided within this Agreement or the Protocol. Investigator shall comply with applicable laws when obtaining Study subjects’ consent to participate in the Study. Investigator shall be solely responsible for ensuring that such consents and authorizations are duly obtained. Investigator shall be responsible for any claim, loss, damages, suit, proceeding, cost or expense arising out of any failure to obtain any such consent or authorization. 1.5 Investigator shall enroll the number of duly qualified (according to the Protocol) patients for the Study and agrees that SPONSOR or CRO may unilaterally revise the number of subjects that Investigator shall enroll, and/or the timeframe for such enrollment, via Study instructions at any time. 1.6 In accordance with the Protocol and all applicable laws and regulations, Investigator shall maintain all necessary subject records of safety data and/or documents whether electronic, paper, or in any other form relating to the Study off site for five (5) years or such as mandated by the Lilly Compoundstudy protocol, (ii) satisfy after the end or the premature termination of the Study. Investigator shall follow Protocol instructions for the reporting of any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex in accordance with this Agreementserious adverse event. 3.5 Athenex shall ensure 1.7 Investigator agrees that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required they are not presently under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection agreement or obligation which conflicts with the Study, permit the use duties and sharing of the Clinical Data as set forth in this Agreement, including the sharing of Clinical Data with Lilly. 3.6 All Clinical Data, including raw data and results, generated obligations owed to SPONSOR or CRO under this Agreement, as well as and further agree not to undertake any such obligation or agreement during the protocol(scourse of the Study. 1.8 Investigator represents and warrants that neither they, nor any Study Personnel are officials, agents, or representatives of any government or political party or international organization where they may be in positions of authority to be able to improperly help CRO or SPONSOR obtain a business advantage. Investigator further represents and warrants that neither they nor any Study Personnel shall make any payment, either directly or indirectly, of any money or other consideration (‘’Payment’’), analysesto government or political party officials, plans and officials of international organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing (‘’Officials’’) where such Payment would constitute violation of any law, including the U.S. Foreign Corrupt Practices Act. In no event shall any Study Personnel make any Payment either directly or indirectly to Officials if such Payment is for the purpose of influencing decisions or actions with respect to the subject matter of this Agreement or any other documentation prepared aspect of CRO’s or SPONSOR’s business. Institution shall report any violation of this warranty promptly to CRO and agree to respond to any CRO inquiries about any potential violations and make appropriate records available to CRO or SPONSOR upon request. At any time upon the request of CRO, Institution agrees to promptly certify in writing their ongoing compliance (and the compliance of all other Study Personnel) with the warranties contained in this Section 1.9. 1.9 The Protocol, including any amendments thereto, constitute an integral part of this Agreement by one or more reference. In case of any inconsistency between this Agreement and the Protocol, the Protocol shall take precedence on matters of medicine, science and conduct of the Parties under Study; otherwise the terms of this Agreement specifically for use in connection with the Study and related to the Lilly Compound, shall be jointly owned by Lilly and Athenexprevail.

Conduct of the Study. 3.1 Athenex Notwithstanding anything to the contrary herein, Syndax shall act as the sponsor of the Study and shall own and hold the IND/CTA relating to IND and/or CTA, as applicable, for the Study; provided, however, that in no event shall Athenex Syndax file a separate IND/IND or CTA for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests a separate IND/IND or CTA for the Study the Parties will promptly meet and mutually agree on an approach to address such requirement. 3.2 Athenex Syndax shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Athenex Syndax shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. FurtherThe Alliance shall fully cooperate with Syndax to comply with such directions, Athenex shall ensure that all Regulatory Approvals from any Regulatory Authority and/or ethics committee including with jurisdiction over the Study are obtained prior respect to initiating performance supply of the StudyAlliance Compound. Athenex Syndax shall participate in and lead all discussions with any Regulatory Authority regarding the StudyStudy ***. Each Party grants to the other Party a non-exclusive, provided, however, that Lilly shall have the right non-transferable (but no obligation) to participate except in any discussions connection with a Regulatory Authoritypermitted assignment, sublicense or subcontract) “right of reference” (as defined in US FDA 21 CFR 314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant part of the Territory (only if possible, i.e., a CTA for the respective Compound was already submitted to the local Health Authorities), with respect to Study Data and prior review results related to Compounds, solely as necessary for the other Party to prepare, submit and approval maintain regulatory submissions of any written communications with a Regulatory Authorty, regarding matters the Study related to the Lilly other Party’s Compound and Regulatory Approvals. In all other cases, where a “right of reference” is not possible, the parties will promptly discuss in good faith on how to provide the required documentation for CTA of the Study. Further, each Party shall provide to the other a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate such right of reference. Notwithstanding anything to the contrary in this Agreement, neither Party shall have any right to access the other Party’s CMC data with respect to its Compound. 3.4 Athenex Syndax shall maintain reports and all related documentation (paper or electronic versions as applicable) with respect to the Study in good scientific manner and in compliance with Applicable Law. Athenex Each Party shall provide any to the other all Study information and documentation (excluding information and documentation relating to the Sample Testing other than the Sample Testing Results themselves) reasonably requested by such other Party to enable Lilly 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 such the Lilly Party’s Compound, (ii) conduct the Sample Testing, (iii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iiiiv) to in the case of the Alliance, determine whether the Study has been performed by Athenex Syndax in accordance with this Agreement. 3.5 Athenex Each Party shall provide to the other Party copies of all Clinical Data to the extent generated by such Party, in an agreed 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; provided, however, that Clinical Data shall be provided to the Alliance ***; and a complete copy of the Clinical Data shall be provided to the Alliance no later than *** following completion of the final Study report. The Alliance shall provide pharmacokinetics and anti-drug antibody data regarding the Alliance Compound to Syndax ***. “Study Completion” shall be deemed to occur upon lock of the Study database. Syndax shall use commercially reasonable efforts to ensure that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and Directive or any other similar Applicable Law in connection with the Study, Study permit the use and sharing of the Clinical Data as set forth in this Agreement, including the such sharing of Clinical Data with Lillythe Alliance. 3.6 All Clinical Data, including raw data and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related to the Lilly Compound, shall be jointly owned by Lilly and Athenex.