Common use of Use and Return of Investigational Product and Equipment Clause in Contracts

Use and Return of Investigational Product and Equipment. SPONSOR or the SPONSOR’s designee shall ensure appropriate and timely supply of the Study Drug necessary for the performance of the Study. The Study Drug shall be supplied, free of charge, to Institution’s pharmacy. Institution hereby undertakes to ensure that the Study Drug be stored separately from other medication in the pharmacy, and its preparation, inspecting, preserving and dispensing (hereinafter only “Study Drug Handling”) be performed in compliance with Protocol and Study Instructions, and the Applicable Law, as well as the terms and conditions stipulated by LEK-12 Directive issued by State Institute for Drug Control. The Study Drug shall be delivered to the building of Institution´s Pharmacy on Mon-Fri from 7:00 am to 2:00 pm. Institution shall appoint agent/agents meeting professional qualification criteria for the medical position of a pharmacist or pharmaceutical assistant pursuant to Applicable law, who shall be responsible for Study Drug Handling and keeping full records thereon. Immediately after appointing such agent, Institution shall notify CRO in writing of the name and surname of the appointee(s) along with the appropriate contact details, if applicable. Investigator hereby undertakes to draw the Study Drug from Institution’s pharmacy in compliance with the Protocol and in doses required for each individual Study subject visit. The Institution hereby undertakes to perform/ensure safe liquidation/disposal of unused Study Drug (as hazardous waste) at Sponsor’s sole expense in accordance with the Applicable Law, if requested to do so by SPONSOR or CRO. Institution and Investigator shall comply with all Applicable Laws and regulations governing the disposition or destruction of Investigational Product and any instructions from CRO or the Sponsor that are not inconsistent with such laws and regulations. Sponsor, CRO or a duly authorized agent of Sponsor/CRO, may provide Institution or Investigator with equipment for use by Institution or Investigator in the conduct or reporting of the Study. Investigator and/ or Institution may use Equipment only for purposes of this Study (or upon Sponsor approval also for other Studies of Sponsor at the Institution). Any equipment and materials shall remain the sole and exclusive property of Sponsor, CRO or a duly authorized agent of Sponsor as the case may be. After completion of Study conduct or at an earlier time specified by CRO or Sponsor, Institution will arrange for return of any equipment or materials at Sponsor’s expense, to Sponsor/CRO or a location designated by CRO or Sponsor. If any equipment is delivered to Institution, a separate loan agreement will be entered into.

Use and Return of Investigational Product and Equipment. SPONSOR or the SPONSOR’s designee shall ensure appropriate and timely supply of the Study Drug necessary for the performance of the Study. The Study Drug shall be supplied, free of charge, to Institution’s pharmacy. Institution hereby undertakes to ensure that the Study Drug be stored separately from other medication in the pharmacy, and its preparation, inspecting, preserving and dispensing (hereinafter only “Study Drug Handling”) be performed in compliance with Protocol and Study Instructions, and the Applicable Law, as well as the terms and conditions stipulated by LEK-12 Directive issued by State Institute for Drug Control. The Study Drug shall be delivered to the building of Institution´s Pharmacy on Mon-Fri from 7:00 am to 2:00 pm. Institution shall appoint agent/agents meeting professional qualification criteria for the medical position of a pharmacist or pharmaceutical assistant pursuant to Applicable law, who shall be responsible for Study Drug Handling and keeping full records thereon. Immediately after appointing such agent, Institution shall notify CRO in writing of the name and surname of the appointee(s) along with the appropriate contact details, if applicable. Investigator hereby undertakes to draw the Study Drug from Institution’s pharmacy in compliance with the Protocol and in doses required for each individual Study subject visitProtocol. The Institution hereby undertakes to perform/ensure safe liquidation/disposal of unused Study Drug (as hazardous waste) at Sponsor’s sole expense in accordance with the Applicable Law, if requested to do so by SPONSOR or CRO. Institution and Investigator shall comply with all Applicable Laws and regulations governing the disposition or destruction of Investigational Product and any instructions from CRO or the Sponsor that are not inconsistent with such laws and regulations. Sponsor, CRO or a duly authorized agent of Sponsor/CRO, may provide Institution or Investigator with equipment for use by Institution or Investigator in the conduct or reporting of the Study. Investigator and/ or Institution may use Equipment only for purposes of this Study (or upon Sponsor approval also for other Studies of Sponsor at the Institution). Any equipment and materials shall remain the sole and exclusive property of Sponsor, CRO or a duly authorized agent of Sponsor as the case may be. After completion of Study conduct or at an earlier time specified by CRO or Sponsor, Institution will arrange for return of any equipment or materials at Sponsor’s expense, to Sponsor/CRO or a location designated by CRO or Sponsor. If any equipment is delivered to Institution, a separate loan agreement will be entered into.

Use and Return of Investigational Product and Equipment. SPONSOR or the SPONSOR’s designee shall ensure appropriate and timely supply of the Study Drug necessary for the performance of the Study. The Study Drug shall be supplied, supplied free of charge, charge to Institution’s pharmacy. Institution hereby undertakes to ensure that the Study Drug be stored separately from other medication in the pharmacy, and its preparation, inspecting, preserving and dispensing (hereinafter only “Study Drug Handling”) be performed in compliance with Protocol and Study Instructions, and the Applicable Law, as well as the terms and conditions stipulated by LEK-12 Directive issued by State Institute for Drug Control. The Study Drug shall be delivered to the building of Institution´s Pharmacy on Mon-Fri from 7:00 am to 2:00 pm. Institution shall appoint agent/agents meeting professional qualification criteria for the medical position of a pharmacist or pharmaceutical assistant pursuant to Applicable law, who shall be responsible for Study Drug Handling and keeping full records thereon. Immediately after appointing such agent, Institution shall notify CRO in writing of the name and surname of the appointee(s) along with the appropriate contact details, if applicable. Investigator hereby undertakes to draw the Study Drug from Institution’s pharmacy in compliance with the Protocol and in doses required for each individual Study subject visit. The Institution hereby undertakes to perform/ensure safe liquidation/disposal of unused Study Drug (as hazardous waste) at Sponsor’s sole expense of Sponsor in accordance with the Applicable Law, if requested to do so by SPONSOR or CRO. Institution and Investigator shall comply with all Applicable Laws and regulations governing the disposition or destruction of Investigational Product and any instructions from CRO or the Sponsor that are not inconsistent with such laws and regulations. Sponsor, CRO or a duly authorized agent of Sponsor/CRO, may provide Institution or Investigator with equipment for use by Institution or Investigator in the conduct or reporting of the Study. Investigator and/ or Institution may use Equipment only for purposes of this Study (or upon Sponsor approval also for other Studies of Sponsor at the Institution). The following equipment will be provided to the Institution/Investigator: Apple Air 2 iPad Price: In case that any property of Sponsor/CRO will be lent to the Institution, a separate equipment loan agreement will be concluded. Any equipment and materials material shall remain the sole and exclusive property of Sponsor, CRO or a duly authorized agent of Sponsor as the case may be. After completion of Study conduct or at an earlier time specified by CRO or Sponsor, Institution will arrange for return of any equipment or materials at Sponsor’s expense, to Sponsor/CRO or a location designated by CRO or Sponsor. If any equipment is delivered to Institution, a separate loan agreement will be entered into.

Use and Return of Investigational Product and Equipment. SPONSOR or the SPONSOR’s designee shall ensure appropriate and timely supply of the Study Drug necessary for the performance of the Study. The Study Drug shall be supplied, free of charge, to Institution’s pharmacy. Institution hereby undertakes to ensure that the Study Drug be stored separately from other medication in the pharmacyInstitution´s First Clinic of Neurology, and its preparation, inspecting, preserving and dispensing (hereinafter only “Study Drug Handling”) be performed in compliance with Protocol and Study Instructions, and the Applicable Law, as well as the terms and conditions stipulated by LEK-12 Directive issued by State Institute for Drug Control. The Study Drug shall be delivered to the building of Institution´s Pharmacy on Mon-Fri from 7:00 am to 2:00 pm. Institution shall appoint agent/agents meeting professional qualification criteria for the medical position of a pharmacist or pharmaceutical assistant pursuant to Applicable law, who shall be responsible for Study Drug Handling and keeping full records thereon. Immediately after appointing such agent, Institution shall notify CRO in writing of the name and surname of the appointee(s) along with the appropriate contact details, if applicable. Investigator hereby undertakes to draw the Study Drug from Institution’s pharmacy in compliance with the Protocol and in doses required for each individual Study subject visitProtocol. The Institution hereby undertakes to perform/ensure safe liquidation/disposal of unused Study Drug (as hazardous waste) at Sponsor’s Sponsor´s sole expense in accordance with the Applicable Law, if requested to do so by SPONSOR or CRO. Institution and Investigator shall comply with all Applicable Laws and regulations governing the disposition or destruction of Investigational Product and any instructions from CRO or the Sponsor that are not inconsistent with such laws and regulations. Sponsor, CRO or a duly authorized agent of Sponsor/CRO, may provide Institution or Investigator with equipment for use by Institution or Investigator in the conduct or reporting of the Study. Investigator and/ or Institution may use Equipment only for purposes of this Study (or upon Sponsor approval also for other Studies of Sponsor at the Institution). Any equipment and materials shall remain the sole and exclusive property of Sponsor, CRO or a duly authorized agent of Sponsor as the case may be. After completion of Study conduct or at an earlier time specified by CRO or Sponsor, Institution will arrange for return of any equipment or materials at Sponsor’s expense, to Sponsor/CRO or a location designated by CRO or Sponsor. If The following equipment will be provided to the Institution/Investigator: Apple Air 2 iPad Price: 500 EUR While the Investigator/Institution have the Equipment in possession, such Equipment shall be used in accordance with any equipment manuals, user manuals or instructions for use. SPONSOR or CRO shall bear all costs in connection with the delivery, installation and return of the Equipment. SPONSOR or CRO undertake to ensure the take-over or collection of the Equipment from the Institution or to ensure disposal of the Equipment at the expense of SPONSOR or CRO, as soon as possible and appropriate. All repairs and service of the Equipment, its routine maintenance and necessary spare parts as well as the prescribed checks, inspections and revisions of the Equipment shall be paid for by SPONSOR or CRO. When the Equipment is delivered handed over to Institution, a separate loan agreement the responsible employee from the Instrumentation or Informatics Departments of the Institution (depending on the type of Equipment) must be present. This responsible employee will be entered intosign the hand over report and SPONSOR or CRO shall give him/her all related documents (i.e. CE certificate and user manual).

Use and Return of Investigational Product and Equipment. SPONSOR or the SPONSOR’s designee shall ensure appropriate and timely supply of the Study Drug necessary for the performance of the Study. The Study Drug shall be supplied, free of charge, to Institution’s pharmacy. Institution hereby undertakes to ensure that the Study Drug be stored separately from other medication in the pharmacy, and its preparation, inspecting, preserving and dispensing (hereinafter only “Study Drug Handling”) be performed in compliance with Protocol and Study Instructions, and the Applicable Law, as well as the terms and conditions stipulated by LEK-12 Directive issued by State Institute for Drug Control. The Study Drug shall be delivered to the building of Institution´s Pharmacy on Mon-Fri from 7:00 am to 2:00 pm. Institution shall appoint agent/agents meeting professional qualification criteria for the medical position of a pharmacist or pharmaceutical assistant pursuant to Applicable law, who shall be responsible for Study Drug Handling and keeping full records thereon. Immediately after appointing such agent, Institution shall notify CRO in writing of the name and surname of the appointee(s) along with the appropriate contact details, if applicable. Prior to the first delivery of the Study Drug, the responsible pharmacist shall be trained in all obligations under the Agreement, shall be provided with the "Pharmacy File" documentation and with contact information (email, telephone) of the Study monitor. Consignments of the Study Drug will be labelled with the name of the responsible pharmacist and address of the Institution´s pharmacy. Investigator hereby undertakes to draw the Study Drug from Institution’s pharmacy in compliance with the Protocol and in doses required for each individual Study subject visitProtocol. The Institution hereby undertakes to perform/ensure safe liquidation/disposal of unused Study Drug (as hazardous waste) at Sponsor’s sole expense in accordance with the Applicable Law, if requested to do so by SPONSOR or CRO. Institution and Investigator shall comply with all Applicable Laws and regulations governing the disposition or destruction of Investigational Product and any instructions from CRO or the Sponsor that are not inconsistent with such laws and regulations. Sponsor, CRO or a duly authorized agent of Sponsor/CRO, may provide Institution or Investigator with equipment for use by Institution or Investigator in the conduct or reporting of the Study. Investigator and/ or Institution may use Equipment only for purposes of this Study (or upon Sponsor approval also for other Studies of Sponsor at the Institution). The following equipment will be provided to the Institution/Investigator: Apple Air 2 iPad Any equipment and materials shall remain the sole and exclusive property of Sponsor, CRO or a duly authorized agent of Sponsor as the case may be. After completion of Study conduct or at an earlier time specified by CRO or Sponsor, Institution will arrange for return of any equipment or materials at Sponsor’s expense, to Sponsor/CRO or a location designated by CRO or Sponsor. If any equipment is delivered to Institution, a separate loan agreement will be entered into.

Use and Return of Investigational Product and Equipment. SPONSOR Sponsor or the SPONSOR’s designee a duly authorized agent of Sponsor, shall ensure appropriate and timely supply Provider or Investigator with sufficient amount of the Study Drug necessary Investigational Product (medical product containing avelumab, irinotecan or paclitaxel for the performance of the Study. The Study Drug shall be supplied, free of charge, to Institution’s pharmacy. Institution hereby undertakes to ensure that the Study Drug be stored separately from other medication active substance) as described in the pharmacy, and its preparation, inspecting, preserving and dispensing (hereinafter only “Study Drug Handling”) be performed in compliance with Protocol and Study Instructions, and the Applicable LawProtocol. Investigational Product, as well as any other material, supplied by the terms and conditions stipulated by LEK-12 Directive issued by State Institute for Drug Control. The Study Drug Sponsor shall be delivered solely to the building Pharmacy of Institution´s Pharmacy on Mon-Fri the Provider, within the regular working hours (i.e. from 7:00 am 7.00 a.m. to 2:00 pm3.30 p.m.). Institution Such deliveries shall appoint agent/agents meeting professional qualification criteria be clearly identified and addressed to the Provider’s employee responsible for pharmaceutical aspects of the Study The Site shall use the Investigational Product and any comparator products provided in connection with the Study, solely for the medical position purpose of properly completing the Study and shall maintain the Investigational Product as specified by Sponsor and according to applicable laws and regulations, including storage in a pharmacist or pharmaceutical assistant pursuant to Applicable lawlocked, who secured area at all times. Destruction of opened and unused Investigational Product shall be responsible for Study Drug Handling and keeping full records thereon. Immediately handled by the Provider, immediately after appointing such agent, Institution shall notify CRO in writing the preparation and/or dilution of the name and surname Investigational Product. In the event that the Provider performs the Investigational Product destruction, the Provider shall include information of the appointee(s) along with said destruction in a form provided by the appropriate contact detailsSponsor (providing that the form contains a section intended for completion of information about such destruction). Upon completion or termination of the Study, if applicable. Investigator hereby undertakes to draw the Study Drug from InstitutionSite shall return or destroy, at Sponsor’s pharmacy in compliance with option, the Protocol Investigational Product, comparator products, and in doses required for each individual Study subject visit. The Institution hereby undertakes to perform/ensure safe liquidation/disposal of unused Study Drug materials and all Confidential Information (as hazardous wastedefined below) at Sponsor’s sole expense in accordance with the Applicable Law, if requested to do so by SPONSOR or CROexpense. Institution Provider and Investigator shall comply with all Applicable Laws laws and regulations governing the disposition or destruction of Investigational Product and any instructions from CRO Quintiles or the Sponsor that are not inconsistent with such laws and regulations. Sponsor, CRO or a duly authorized agent of Sponsor/CRO, may provide Institution or Investigator with equipment for use by Institution or Investigator in the conduct or reporting of the Study. Investigator and/ or Institution may use Equipment only for purposes of this Study (or upon Sponsor approval also for other Studies of Sponsor at the Institution). Any equipment and materials material shall remain the sole and exclusive property of Sponsor, CRO or a duly authorized agent of Sponsor as the case may be. After completion of Study conduct or at an earlier time specified by CRO or Sponsor, Institution will arrange for The Site shall return of any equipment or materials provided by Sponsor for use in the Study unless and until Sponsor and Provider have a written agreement for Provider to acquire the equipment. The Site understands and agrees that if Site has not enrolled at Sponsor’s expense, to least XXXX (X) Study Subject by the Key Enrollment Date then Quintiles or/and Sponsor may terminate this Agreement in accordance with Section 15 „Term & Termination„ Sponsor/CRO or a location designated by CRO or Sponsor. If Quintiles has the right to limit enrollment at any equipment is delivered to Institution, a separate loan agreement will be entered intotime.