IRB. The Conducting Party shall be responsible for obtaining any necessary approvals from institutional review boards (each, an “IRB”) including, where ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. applicable, obtaining approval of all Clinical Trial protocols, informed consents, investigator brochures, subject recruitment materials or plans, authorization of disclosure of confidential subject information, and any alterations to or waivers of the same, prior to commencement of any study. The Conducting Party shall not modify the protocol or the informed consent without the prior written agreement of the IRB.
Appears in 1 contract
Sources: License and Collaboration Agreement (Theravance Biopharma, Inc.)
IRB. The Conducting Party shall be responsible for obtaining any necessary approvals from institutional review boards (each, an “"IRB”") including, where ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. applicable, obtaining approval of all Clinical Trial protocols, informed consents, investigator brochures, subject recruitment materials or plans, authorization of disclosure of confidential subject information, and any alterations to or waivers of the same, prior to commencement of any study. The Conducting Party shall not modify the protocol or the informed consent without the prior written agreement of the IRB.
Appears in 1 contract
Sources: License and Collaboration Agreement (Theravance Biopharma, Inc.)