Conduct of the Study Clause Samples

Conduct of the Study. 3.1 Notwithstanding anything to the contrary herein, Vaccinex shall act as the sponsor of the Study and shall own and hold the IND and/or CTA, as applicable, for the Study; provided, however, that in no event shall Vaccinex file a separate 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 or CTA for the Study the Parties will promptly meet and mutually agree on an approach to address such requirement. 3.2 Vaccinex shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Vaccinex shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Notwithstanding anything else herein to the contrary, Merck shall fully cooperate with Vaccinex to comply with such directions, including with respect to supply of Merck Compound. Vaccinex shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that 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 regarding matters related to the 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 ...

Conduct of the Study a) Institution and/or Investigator shall ensure that all persons who have involvement in the Study and who are employees, independent contractors or agents of Institution and/or Investigator, including but not limited to pharmacy, laboratory, radiology, pathology, cardiology and nursing staff (hereinafter „Research Staff”) have the knowledge and experience to undertake the Study and shall accurately, efficiently and expeditiously perform the Study in a professional and competent manner. Wherever, in this Agreement, reference is made to obligations which are incumbent on the Institution and/or Investigator for services which may be performed by Research Staff, such reference is intended to include Research Staff. b) By agreeing to the terms and conditions of this Agreement and performing the services for ▇▇▇▇▇▇▇▇, Institution and Investigator each represent and warrant that it/he/she is not in violation of any terms and conditions of any agreement for services or employment with any other individual or entity.

Conduct of the Study. (a) Institution and/or Investigator shall ensure that all persons who have involvement in the Study and who are employees, independent contractors or agents of Institution and/or Investigator, including but not limited to pharmacy, laboratory. radiology, pathology, cardiology and nursing staff (hereinafter „Research Staff”) are adequately trained, have the knowledge and experience to undertake the Study and shall accurately, efficiently and expeditiously perform the Study in a professional and competent manner in compliance with monitoring and escalation process. Institution shall ensure and warrant compliance with the provisions and requirements of this Agreement by Research Staff. Wherever, in this Agreement, reference is made to obligations which are incumbent on the Institution and/or Investigator for services which may be performed by Research Staff, such reference is intended to include Research Staff. (b) By agreeing to the terms and conditions of this Agreement and performing the services for Labcorp, Institution and Investigator each represent and warrant that it/he/she is not in violation of any terms and conditions of any agreement for services or employment with any other individual or entity. Jelikož, Zkoušející má znalosti a zkušenosti k provedení Studie a společnost Labcorp si přeje zadat Zdravotnickému zařízení a Zkoušejícímu provedení Studie. Jelikož, Zdravotnické zařízení a Zkoušející se chtějí podílet na provádění Studie; Se proto nyní Smluvní strany dohodly takto: 1. PROVEDENÍ STUDIE (a) Zdravotnické zařízení a/nebo Zkoušející zajistí, aby všechny osoby účastnící se Studie, které jsou zaměstnanci, nezávislými dodavateli nebo zástupci Zdravotnického zařízení a/nebo Zkoušejícího, zejména pracovníci lékárny, laboratoře, radiologie, patologie či kardiologie a zdravotnický personál (▇▇▇▇ ▇▇▇ "Výzkumný personál") byly odpovídajícím způsobem vyškoleny, měly znalosti a zkušenosti k provedení Studie a prováděly Studii přesně, rychle a účinně a profesionálním a kompetentním způsobem v souladu s procesem sledování a eskalace. Zdravotnické zařízení zajistí a zaručí dodržování ustanovení a požadavků této smlouvy Výzkumným personálem. Pokud ▇▇ ▇ ▇▇▇▇ Smlouvě uveden odkaz na závazky, z nichž Zdravotnickému zařízení a/nebo Zkoušejícímu plynou povinnosti vzhledem ke službám, které může poskytovat Výzkumný personál, takový odkaz je i odkazem na Výzkumný personál. (b) Udělením svého souhlasu s podmínkami této Smlouvy a provedením služby pro společnost Lab...

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 professio...

Conduct of the Study. (a) Institution and/or Investigator shall ensure that all persons who have involvement in the Study and who are employees, independent contractors or agents of Institution and/or Investigator, including but not limited to pharmacy, laboratory. radiology, pathology, cardiology and nursing staff (hereinafter „Research Staff”) are adequately trained, have the knowledge and experience to undertake the Study and shall accurately, efficiently and expeditiously perform the Study in a professional and competent manner in compliance with monitoring and escalation process. Institution shall ensure and warrant compliance with the provisions and requirements of this Agreement by Research Staff. Wherever, in this Agreement, reference is made to obligations which are incumbent on the Institution and/or Investigator for services which may be performed by Research Staff, such reference is intended to include Research Staff. (b) By agreeing to the terms and conditions of this Agreement and performing the services for Labcorp, Institution and Investigator each represent and warrant that it/he/she is not in violation of any terms and conditions of any agreement for services or employment with any other individual or entity.

Conduct of the Study. The parties agree to conduct the Study based upon the terms and conditions contained in this Agreement and in accordance with the Protocol attached as Appendix A.

Conduct of the Study. The Institution, through the applicable Principal Investigator and Sub-investigators, shall conduct each Study in accordance with this Agreement, the applicable SOW, the applicable Protocol, and the applicable investigator’s brochure for the Protocol (the “Investigator’s Brochure”), as each may be amended, and all applicable laws, rules, regulations and guidelines, as adopted into law relating to the conduct of clinical investigations, good clinical practice (GCP) principles, generally accepted medical practice, and applicable export control rules and regulations (collectively, “Applicable Laws”). For purposes of this Agreement, the term “Institution” shall include all employees, executives, officers, directors, faculty, staff and other authorized agents of the Institution. SPONSOR will use reasonable efforts to perform its applicable obligations in connection with each Study including, but not limited to, monitoring visits.

Conduct of the Study. 1. Provedení Studie 1.1 Compliance with Laws, Regulations, and Good Clinical Practices 1.1 Soulad s Právními předpisy, nařízeními a Správnou klinickou praxí

Conduct of the Study. The parties to the attached agreement (the “Agreement”) agree that the clinical trial described therein (the “Study”) will be performed in strict accordance with the applicable protocol, and any subsequent amendments thereto (the “Protocol”), applicable federal, state, and local laws, regulations and guidelines, and good clinical practices (“GCPs”). The Principal Investigator (the “Investigator”) shall review all case report forms (“CRFs”) to ensure their accuracy and completeness, shall review and understand the information in the investigator’s brochure or device labeling instructions, as applicable, shall ensure that all informed consent requirements are met, and shall ensure that all required reviews and approvals (or favorable opinions) by applicable regulatory authorities and Institutional Review Boards (“IRBs”) or Independent Ethics Committees (“IECs”) are obtained. The Investigator and the institution(s) (the “Institution”), if any, conducting the trial (jointly, the “Site”) agree to ensure that all clinical data are accurate, complete, and legible. The Site shall promptly and fully produce all data, records and information relating to the Study to Quintiles and the sponsor of the Study (the “Sponsor”) and their representatives during normal business hours, and shall assist them in promptly resolving any questions and in performing audits or reviews of original subject records, reports, or data sources. The Site agrees to cooperate with the representatives of Quintiles and Sponsor who visit the Site, and the Site agrees to ensure that the employees, agents and representatives of the Site do not harass, or otherwise create a hostile working environment for, such representatives. The Site shall use the drug, device, product or compound being tested (the “Investigational Product”), and any comparator products provided in connection with the Study, solely for the purpose of properly completing the Study and shall maintain all Investigational Product and any comparator products in a locked, secured area at all times. Upon completion or termination of the Study, the Site shall return all unused Investigational Product, comparator products, equipment, and materials and all Confidential Information (as defined below).