Common use of Conduct of the Study Clause in Contracts

Conduct of the Study. 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 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, and as such is an intended third- party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the 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 (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), to 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 this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and certify that Study Personnel will) conduct the Study in a diligent, efficient, and skilful manner, in strict compliance with the terms and conditions of this Agreement, the Protocol including subsequent amendments, any specific Study Instructions, Applicable Law, 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 commit any negligent acts or any wilful misconduct in connection with the Study. Neither Institution nor Investigator nor any Study Personnel shall make any unauthorized warranties to any person (including Subjects) concerning the product being tested in the Study. Institution and Investigator accept responsibility for the acts and omissions of all 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 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, obtain the prior Subject's written informed consent to participate in 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 the Protocol, in compliance with Applicable Law, especially data protection law. Each Subject’s written informed consent shall be in a form that is in accordance with the Protocol, the Applicable Law and as agreed upon with the Sponsor. 2.9 Investigator shall enroll the number of duly qualified (according to the Protocol) Subjects for the Study as set forth in Exhibit A and shall do so according to the timetable set forth in Exhibit A. Notwithstanding the foregoing, Investigator 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.

Conduct of the Study. 2.1 Institution agrees, and commits itself to CRO, to allow Investigator and other Study Personnel to conduct the Study at Institution, and declares 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 declares warrants that he/she is employed by Institution. Investigator shall 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, and as such is an intended third- party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the 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 (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), to 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 this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and certify warrant that Study Personnel will) conduct the Study in a diligent, efficient, and skilful manner, in strict compliance with the terms and conditions of this Agreement, the Protocol including subsequent amendments, any specific Study Instructions, Applicable Law, 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 commit any negligent acts or any wilful misconduct in connection with the Study. Neither Institution nor Investigator nor any Study Personnel shall make any unauthorized warranties to any person (including Subjects) concerning the product being tested in the Study. Institution and Investigator accept responsibility for the acts and omissions of all 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 the EC’s favourable opinionletter 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, obtain the prior Subject's written informed consent to participate in 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 the Protocol, in compliance with Applicable Law, especially data protection law. Each Subject’s written informed consent shall be in a form that is in accordance with the Protocol, the Applicable Law and as agreed upon with the SponsorSponsor 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. 2.9 Investigator shall enroll the number of duly qualified (according to the Protocol) Subjects for the Study as set forth in Exhibit A and shall do so according to the timetable set forth in Exhibit A. Notwithstanding the foregoing, Investigator 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.

Conduct of the Study. 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 Institution3.1. Investigator Incyte shall 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 act as the sponsor of the Study, shall take the lead role in conducting the Study and as such is an intended third- party beneficiary of this Agreement, whereas SPONSOR transfers any or all of shall hold the SPONSOR's IND relating to the Study-related functions to CRO in compliance . The IND held by Incyte will be filed with ICH-GCP, sec. 5the Center for Biologics Evaluation and Research (CBER) at FDA. 2.13.2. In addition to the foregoing, Investigator and Institution agree Incyte shall ensure 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 (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), to SPONSOR. All references to SPONSOR herein (whether is performed 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 accordance 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 this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and certify that Study Personnel will) conduct the Study in a diligent, efficient, and skilful manner, in strict compliance with the terms and conditions of this Agreement, the Protocol including subsequent amendments, any specific Study Instructions, and all Applicable Law, including GCP. 3.3. Incyte shall ensure all requirements 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, 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 Institution or facilityStudy. Advaxis shall have the right (but no obligation) to participate in any discussions with a Regulatory Authority regarding matters related to the 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 other professional standards applicable documents or instruments necessary to their professional industries 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. 3.5. Each Party shall maintain reports and fields. Neither Institution nor Investigator nor any Study Personnel shall commit any negligent acts or any wilful misconduct all related documentation in good scientific manner and in compliance with Applicable Law in connection with the Study. Neither Institution nor Investigator nor Incyte shall provide to Advaxis all Study information and documentation reasonably requested by Advaxis to enable Advaxis to comply with any Study Personnel of its legal, regulatory and/or contractual obligations, or any request by any Regulatory Authority, related to the Advaxis Compound. 3.6. Incyte shall make any unauthorized warranties provide to any person (including Subjects) concerning the product being tested in the Study. Institution and Investigator accept responsibility for the acts and omissions Advaxis copies of all Study Personnel in Clinical Data (except 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 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, obtain the prior Subject's written informed consent to participate in 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 the Protocol, in compliance with Applicable Law, especially data protection law. Each Subject’s written informed consent shall be in a form that is in accordance with the Protocol, the Applicable Law and as agreed upon with the Sponsor. 2.9 Investigator shall enroll the number of duly qualified (according to the Protocol) Subjects for the Study Sample Testing Results as set forth in Exhibit A 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 do so according be provided to Advaxis no less than once every three (3) months, if available. Incyte shall ensure that all patient authorizations and consents required under HIPAA, the EU Data Protection Directive or any other similar Applicable Law in connection with the Study permit such sharing of Clinical Data with Advaxis. 3.7. All Clinical Data, including raw data, records and results, generated under the Study, except for Sample Testing Results specific to the timetable set forth Incyte Compound or the Advaxis Compound, shall be jointly owned by Incyte and Advaxis. 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 Exhibit A. Notwithstanding 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 foregoingSample Testing conducted by or on behalf of Advaxis, Investigator agrees 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 SPONSOR these restrictions shall no longer apply once the Sample Testing Results or CRO may unilaterally revise portions thereof are available to the number of Subjects that Investigator shall enroll, and/or the timeframe for such enrollment, via Study Instructions at any timepublic.

Conduct of the Study. 2.1 Institution agrees, and commits itself to CRO, to allow Investigator and other Study Personnel to conduct the Study at Institution, and declares 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 declares warrants that he/she is employed by Institution. Investigator shall 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, and as such is an intended third- party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the 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 (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), to 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 this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and certify warrant that Study Personnel will) conduct the Study in a diligent, efficient, and skilful manner, in strict compliance with the terms and conditions of this Agreement, the Protocol including subsequent amendments, any specific Study Instructions, Applicable Law, 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 commit any negligent acts or any wilful misconduct in connection with the Study. Neither Institution nor Investigator nor any Study Personnel shall make any unauthorized warranties to any person (including Subjects) concerning the product being tested in the Study. Institution and Investigator accept responsibility for the acts and omissions of all 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 the EC’s favourable opinionletter 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, obtain the prior Subject's written informed consent to participate in 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 the Protocol, in compliance with Applicable Law, especially data protection law. Each Subject’s written informed consent shall be in a form that is in accordance with the Protocol, the Applicable Law and as agreed upon with the Sponsor. 2.9 Investigator shall enroll the number of duly qualified (according to the Protocol) Subjects for the Study as set forth in Exhibit A and shall do so according to the timetable set forth in Exhibit A. Notwithstanding the foregoing, Investigator 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.

Conduct of the Study. 2.1 Institution agrees, and commits itself to CRO, to allow Investigator and other Study Personnel to conduct the Study at InstitutionInstitution at Fakultná nemocnica Trnava, Neurologické oddelenie, A. ▇▇▇▇▇▇▇ ▇▇, ▇▇▇ ▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ and declares warrants that Investigator and other Study Personnel are employed by Institution. 2.2 Investigator agrees, and commits itself himself to CRO, to conduct the Study at Institution and declares warrants that he/she he is employed by Institution. Investigator shall 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, and as such is an intended third- third-party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the SPONSOR's Study-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 (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), to 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 this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and certify warrant that Study Personnel will) conduct the Study in a diligent, efficient, and skilful manner, in strict compliance with the terms and conditions of this Agreement, the Protocol including subsequent amendments, any specific Study Instructions, Applicable Law, 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 commit any negligent acts or any wilful misconduct in connection with the Study. Neither Institution nor Investigator nor any Study Personnel shall make any unauthorized warranties to any person (including Subjects) concerning the product being tested in the Study. Institution and Investigator accept responsibility for the acts and omissions of all Study Personnel in the Study.any 2.6 CRO or Sponsor SPONSOR shall obtain the written approval of the appropriate Ethics Committee (EC) prior to commencement of the Study and will furnish Investigator with the EC’s favourable opinionletter 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, obtain the prior Subject's written informed consent to participate in 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 the Protocol, in compliance with Applicable Law, especially data protection lawlaw and the GDPR. Each Subject’s written informed consent shall be in a form that is in accordance with the Protocol, the Applicable Law and as agreed upon with the Sponsor. 2.9 Investigator shall enroll the number of duly qualified (according to the Protocol) Subjects for the Study as set forth in Exhibit A and shall do so according to the timetable set forth in Exhibit A. Notwithstanding the foregoing, Investigator 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.

Conduct of the Study. 2.1 Institution agrees, and commits itself to CRO, to allow Investigator and other Study Personnel to conduct the Study at Institution, and declares 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 declares warrants that he/she is employed by Institution. Investigator shall 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, and as such is an intended third- party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the 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 (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), to 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 this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and certify warrant that Study Personnel will) conduct the Study in a diligent, efficient, and skilful manner, in strict compliance with the terms and conditions of this Agreement, the Protocol including subsequent amendments, any specific Study Instructions, Applicable Law, 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 commit any negligent acts or any wilful misconduct in connection with the Study. Neither Institution nor Investigator nor any Study Personnel shall make any unauthorized warranties to any person (including Subjects) concerning the product being tested in the Study. Institution and Investigator accept responsibility for the acts and omissions of all 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 the EC’s favourable opinionletter 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, obtain the prior Subject's written informed consent to participate in 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 the Protocol, in compliance with Applicable Law, especially data protection law. Each Subject’s written informed consent shall be in a form that is in accordance with the Protocol, the Applicable Law and as agreed upon with the Sponsor. 2.9 Investigator shall enroll the number of duly qualified (according to the Protocol) Subjects for the Study as set forth in Exhibit A A1 and A2 and shall do so according to the timetable set forth in Exhibit A. A1 and A2. Notwithstanding the foregoing, Investigator 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.

Conduct of the Study. 2.1 Institution agreesEach Collaborator shall submit patient and/or regulatory data timely in accordance with and as instructed in the 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 for such Collaborator’s conduct of the Study. 2.3 Each Collaborator and Collaborating Investigator shall obtain informed consent of all Study subjects at its site in accordance with 21 CFR Part 50 and/or other applicable laws and regulations. Further, each Collaborator shall obtain IRB review and approval of the Protocol, including the informed consent form, in accordance with 21 CFR Part 56 and/or other applicable laws and regulations. Collaborator shall supply TAMHSC with evidence of IRB approval prior to receipt of funding. 2.4 Each Collaborator agrees to comply with any and all applicable laws relating to patient privacy. Each Collaborator shall take any and all reasonable and ethical actions necessary to ensure that it will be able to provide and share all Study related data to the 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 ▇▇▇▇▇▇▇▇, BCM, and commits itself CHSH. 2.5 Each Collaborator shall submit written reports to CRO, to allow Investigator and other TAMHSC summarizing the current status of the Study Personnel to conduct every six (6) months after initiation of the Study at Institution, Collaborator. The format and declares that detail of said written reports shall be according to the mutual understanding and agreement between the TAMHSC Investigator and other Study Personnel are employed by Institutionthe Collaborator Investigator. 2.2 Investigator agrees, and commits itself to CRO, to conduct 2.6 Upon completion of the Study at Institution and declares that he/she is employed by Institution. Investigator each Collaborator or upon earlier termination as set forth in Section 4.1, each Collaborator shall personally supervise submit a final written report to the other Collaborators including all relevant information concerning its conduct of the Study by Study, such final report as agreed upon between 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 CROCollaborating Investigators. 2.3 2.7 Each Collaborator shall respond to inquiries by TAMHSC and the TAMHSC Investigator regarding the conduct and Institution acknowledge that SPONSOR is the sponsor status of the Study, and as such is an intended third- party beneficiary of this Agreement, whereas SPONSOR transfers shall cooperate with TAMHSC and TAMHSC Investigator in providing any necessary information regarding financial records or all of the SPONSOR's Study-data and results 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 (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), to 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 this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and certify that Study Personnel will) conduct the Study in a diligent, efficient, and skilful manner, in strict compliance with the terms and conditions of this Agreement, the Protocol including subsequent amendments, any specific Study Instructions, Applicable Law, 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 commit any negligent acts or any wilful misconduct in connection with the Study. Neither Institution nor Investigator nor any Study Personnel shall make any unauthorized warranties to any person (including Subjects) concerning the product being tested in the Study. Institution and Investigator accept responsibility for the acts and omissions of all 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 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, obtain the prior Subject's written informed consent to participate in 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 the Protocol, in compliance with Applicable Law, especially data protection law. Each Subject’s written informed consent shall be in a form that is in accordance with the Protocol, the Applicable Law and as agreed upon with the Sponsorif requested by an administrative authority. 2.9 Investigator shall enroll the number of duly qualified (according to the Protocol) Subjects for the Study as set forth in Exhibit A and shall do so according to the timetable set forth in Exhibit A. Notwithstanding the foregoing, Investigator 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.

Conduct of the Study. 2.1 1.1 Institution agrees, and commits itself to CRO, agrees to allow Investigator and other Institution staff and agents (“Study Personnel Personnel”) to conduct the Study at Institution, and declares Study. The Institution warrants that the Investigator and other Study Personnel are employed by Institution. 2.2 Investigator agrees, and commits itself to CRO, to conduct is a member of the Study at Institution and declares that he/she is employed by active staff of the Institution. Investigator shall personally 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 conduct of the Study by the Study Personnel at the Institution, 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, and as such is an intended third- party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the 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 (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), to 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 instancesapplicable law. 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 this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, hereby agree to (and certify warrant that Study Personnel will) conduct the Study in a diligent, efficient, and skilful manner, in strict compliance with the terms and conditions of this Agreement, the Protocol including any subsequent amendmentsamendments thereto, any specific Study Instructionsinstructions from SPONSOR or CRO, Applicable Lawapplicable law, rules, regulations and guidelines of relevant health authorities, all requirements policies of the Institution or facilityInstitution, and any other professional standards applicable to their professional industries and fieldsfields including, but not limited to applicable version(s) of the World Medical Association Declaration of Helsinki. Neither Institution nor The Investigator nor or any Study Personnel shall not commit any negligent acts or any wilful willful misconduct in connection with the Study. Neither Institution nor Investigator nor any Study Personnel shall make any unauthorized warranties to any person (including Subjects) concerning the product being tested in the Study. Institution and Investigator accept responsibility for the acts and omissions performance of all Study Personnel in the Study. 2.6 1.3 The parties will fulfill their respective obligations to the applicable Institutional Review Board (IRB) or Ethics Committee (EC) at the Institution. SPONSOR or CRO or Sponsor shall obtain the written approval of the appropriate Ethics Committee (EC) Institute’s IRB/EC prior to commencement of the Study and will furnish Investigator with the IRB/EC’s favourable opinion. 2.7 letter of approval. If required by Applicable Lawapplicable law, SPONSOR or CRO shall make, or procure that SPONSOR makes, 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. 2.8 1.4 Investigator shall, prior to a Subjectsubject’s participation in the Study, obtain the prior Subject's subject’s written informed consent to participate in the Study. Investigator shall not make any written or oral promises, statements or other representations to Study as well as for processing subjects (whether or not formally documented in the informed consent forms) that SPONSOR or CRO will provide any form of Personal Data from compensation, reimbursement or payment, medical treatment and/or any other support or thing of value, except to the Subject including the public disclosure, transfer and processing of data collected in accordance with extent expressly provided within this Agreement or the Protocol, . Investigator shall comply with applicable laws when obtaining Study subjects’ consent to participate in compliance with Applicable Law, especially data protection lawthe Study. Each Subject’s written informed consent Investigator shall be in a form solely responsible for ensuring that is in accordance with the Protocolsuch consents and authorizations are duly obtained. Investigator shall be responsible for any claim, the Applicable Law and as agreed upon with the Sponsorloss, damages, suit, proceeding, cost or expense arising out of any failure to obtain any such consent or authorization. 2.9 1.5 Investigator shall enroll the number of duly qualified (according to the Protocol) Subjects patients for the Study as set forth in Exhibit A and shall do so according to the timetable set forth in Exhibit A. Notwithstanding the foregoing, Investigator agrees that SPONSOR or CRO may unilaterally revise the number of Subjects subjects that Investigator shall enroll, and/or the timeframe for such enrollment, via Study Instructions 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 as mandated by the study protocol, after the end or the premature termination of the Study. Investigator shall follow Protocol instructions for the reporting of any serious adverse event. 1.7 Investigator agrees that they are not presently under any agreement or obligation which conflicts with the duties and obligations owed to SPONSOR or CRO under this Agreement, and further agree not to undertake any such obligation or agreement during the course 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’’), to government or political party officials, 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 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 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 Study; otherwise the terms of this Agreement shall prevail.