Common use of Obligations of the Sponsor Clause in Contracts

Obligations of the Sponsor. The Sponsor shall comply with all of the obligations established in RD 1090/2015, specifically those set out in Article 39 of this law. Likewise, the Sponsor agrees to provide the Principal Investigator with: Basic information on the medicinal Products of the Trial: Toxico-pharmacological and pharmacokinetic data, studies carried out prior to clinical trials on humans. Case-report forms and, if applicable, support services and computer hardware, including its repair. All the documents related to the Trial. Information on the evolution of the Trial, if it were multicentre, and the results obtained at the end of the Trial or when available, as well as the serious and unexpected adverse reactions detected in relation to the Product. New information obtained about the Product during the performance of the Trial The Sponsor agrees to provide for free: The Product, that, as defined by current legislation, is the drug under test or the one used as a reference, even as a placebo, in the Trial. The auxiliary medicine, that, as defined by current legislation, is understood as the medicine used for the needs of a clinical trial, as described in the Protocol, but not as a research drug. The Sponsor, through the Monitor, will be responsible for the relabelling and recounting of the Product and leftover auxiliary medication. The Sponsor agrees to carry out this activity in person and in coordination with the HUVH Pharmacy Service. The Sponsor agrees to provide the following equipment (hereinafter, the "Equipment") during the conduct of the Trial: Type of Equipment: [•] Model: [•] Series: [•] Units to be provided to HUVH / VHIR: [•] Price: [•] (VAT included) Temporality: During the Trial. The Sponsor agrees to: Assume the transportation costs related to the delivery and return of the Equipment. Take responsibility for preventive maintenance and repairs in the event of Equipment failure. In the event that the Equipment is computer equipment, the Sponsor will ensure that the Equipment includes the software necessary for its operation (operating system and applications) in compliance with current legal regulations regarding licenses. Collect the Equipment within a maximum period of sixty (60) days after the end of the Trial. In the event that this period has elapsed and the Sponsor has not proceeded to collect the Equipment, it will become part of the HUVH / VHIR's fixed assets and the Sponsor will not be entitled to financial compensation in exchange for this assignment.

Obligations of the Sponsor. The Sponsor shall comply with all of the obligations established in RD 1090/2015, specifically those set out in Article 39 of this law. Likewise, the Sponsor agrees to provide the Principal Investigator with: Basic information on the medicinal Products of the Trial: Toxico-pharmacological and pharmacokinetic data, studies carried out prior to clinical trials on humans. Case-report forms and, if applicable, support services and computer hardware, including its repair. All the documents related to the Trial. Information on the evolution of the Trial, if it were multicentre, and the results obtained at the end of the Trial or when available, as well as the serious and unexpected adverse reactions detected in relation to the Product. New information obtained about the Product during the performance of the Trial Trial. The Sponsor agrees to provide for free: The Product, that, as defined by current legislation, is the drug under test or the one used as a reference, even as a placebo, in the Trial. The auxiliary medicine, that, as defined by current legislation, is understood as the medicine used for the needs of a clinical trial, as described in the Protocol, but not as a research drug. The Sponsor, through the Monitor, will be responsible for the relabelling and recounting of the Product and leftover auxiliary medication. The Sponsor agrees to carry out this activity in person and in coordination with the HUVH VHIO Pharmacy Service. The Sponsor agrees to provide the following equipment (hereinafter, the "Equipment") during the conduct of the Trial: Type of Equipment: [•] Model: [•] Series: [•] Units to be provided to HUVH / VHIRVHIO: [•] Price: [•] (VAT included) Temporality: During the Trial. The Sponsor agrees to: Assume the transportation costs related to the delivery and return of the Equipment. Take responsibility for preventive maintenance and repairs in the event of Equipment failure. In the event that the Equipment is computer equipment, the Sponsor will ensure that the Equipment includes the software necessary for its operation (operating system and applications) in compliance with current legal regulations regarding licenses. Collect the Equipment within a maximum period of sixty (60) days after the end of the Trial. In the event that this period has elapsed and the Sponsor has not proceeded to collect the Equipment, it will become part of the HUVH / VHIRHUVH/VHIO's fixed assets and the Sponsor will not be entitled to financial compensation in exchange for this assignment.

Obligations of the Sponsor. The Sponsor shall comply with all of the obligations established in RD 1090/2015, specifically those set out in Article 39 of this law. Likewise, the Sponsor agrees to provide the Principal Investigator with: Basic information on the medicinal Products of the Trial: Toxico-pharmacological and pharmacokinetic data, studies carried out prior to clinical trials on humans. Case-report forms and, if applicable, support services and computer hardware, including its repair. All the documents related to the Trial. Information on the evolution of the Trial, if it were multicentre, and the results obtained at the end of the Trial or when available, as well as the serious and unexpected adverse reactions detected in relation to the Product. New information obtained about the Product during the performance of the Trial Trial. The Sponsor agrees to provide for free: The Product, that, as defined by current legislation, is the drug under test or the one used as a reference, even as a placebo, in the Trial. The auxiliary medicine, that, as defined by current legislation, is understood as the medicine used for the needs of a clinical trial, as described in the Protocol, but not as a research drug. The Sponsor, through the Monitor, will be responsible for the relabelling and recounting of the Product and leftover auxiliary medication. The Sponsor agrees to carry out this activity in person and in coordination with the HUVH VHIO Pharmacy Service. The Sponsor agrees to provide the following equipment (hereinafter, the "Equipment") during the conduct of the Trial: Type of Equipment: [•] Model: [•] Series: [•] Units to be provided to HUVH / VHIRVHIO: [•] Price: [•] (VAT included) Temporality: During the Trial. [Note to the Sponsor: For the formalization of any transfer of equipment, please contact Xxxxxx Xxxxx: xxxxxx@xxxx.xxx prior to signing this contract]. The Sponsor agrees to: Assume the transportation costs related to the delivery and return of the Equipment. Take responsibility for preventive maintenance and repairs in the event of Equipment failure. In the event that the Equipment is computer equipment, the Sponsor will ensure that the Equipment includes the software necessary for its operation (operating system and applications) in compliance with current legal regulations regarding licenses. Collect the Equipment within a maximum period of sixty (60) days after the end of the Trial. In the event that this period has elapsed and the Sponsor has not proceeded to collect the Equipment, it will become part of the HUVH / VHIRHUVH/VHIO's fixed assets and the Sponsor will not be entitled to financial compensation in exchange for this assignment.