Start and Duration. This Agreement is effective as of the date of execution and shall remain valid and in force until the CLINICAL TRIAL has been fully completed, without prejudice to the provisions of CLAUSE TEN. To such effect, the CLINICAL TRIAL shall only beconsidered as fully completed upon due execution by each Party of their respective obligations of this Agreement. The CLINICAL TRIAL shall not be initiated unless and until the mandatory permission of the Spanish Agency for Drugs and Health Products (‘Agencia Española de Medicamentos y ProductosSanitarios’) (hereinafter AEMPS) has been obtained in the terms provided by Royal Decree 1090/2015, and also until the authorisations of both the competent CREC, and any other, if any, required by the laws have been obtained. The effectiveness of this Agreement, with protocol version ……….... of date ………….. is subject to the authorisations above being obtained in due course. The Parties acknowledge that each of them is responsible for the execution of the CLINICAL TRIAL exactly as per the specifications contained in the PROTOCOL. The estimated duration of the CLINICAL TRIAL is …….... month(s), as specified in the PROTOCOL.
Appears in 1 contract
Sources: Clinical Trial Agreement
Start and Duration. This Agreement is effective as of the date of execution and shall remain valid and in force until the CLINICAL TRIAL has been fully completed, without prejudice to the provisions of CLAUSE TEN. To such effecteffects, the CLINICAL TRIAL shall only beconsidered been considered as fully completed upon due execution by each Party of their respective obligations of this Agreement. The CLINICAL TRIAL shall not be initiated unless and until the mandatory permission of the Spanish Agency for Drugs and Health Products (‘Agencia Española de Medicamentos y ProductosSanitariosProductos Sanitarios’) (hereinafter AEMPS) has been obtained in the terms provided by Royal Decree 1090/2015, and also until the authorisations authorizations of both the competent CREC, the HOSPITAL Management and any other, if any, required by the laws law have been obtained. The effectiveness of this Agreement, with protocol version ……….... of date ………….. is subject to the authorisations above being obtained in due course. The Parties acknowledge that each of them is responsible for the execution of the CLINICAL TRIAL exactly as per the specifications contained in the PROTOCOL. The estimated duration of the CLINICAL TRIAL is …….... month(s), as specified in the PROTOCOL.
Appears in 1 contract
Sources: Clinical Trial Agreement