Common use of Human Subject Protection Clause in Contracts

Human Subject Protection. The research to be conducted under this CRADA involves Human Subjects or human tissues within the meaning of 45 C.F.R. Part 46, and all research to be performed under this CRADA will conform to applicable federal laws and regulations. Additional information is available from the HHS Office for Human Research Protections (xxxx://xxx.xxx.xxx/ohrp/). The confidentiality of IPI of subjects enrolled in studies at NIH facilities is protected pursuant to the Privacy Act (5 U.S.C. 552a, implementing regulations 45 CFR Part 5b). Any disclosure to Collaborator will be done in accordance with applicable law and regulations. ICD will provide a copy of the informed consent template to Collaborator for its records. All informed consent forms used in clinical studies conducted under this CRADA must identify the existence of Collaborator and Collaborator’s right to access and use IPI contained in the Raw Data as provided in Paragraph 3.10.2 above. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

Human Subject Protection. The research to be conducted under this CRADA involves Human Subjects or human tissues within the meaning of 45 C.F.R. Part 46, and all research to be performed under this CRADA will conform to applicable federal laws and regulations. Additional information is available from the HHS Office for Human Research Protections (xxxx://xxx.xxx.xxx/ohrp/). The confidentiality of IPI of subjects enrolled in studies at NIH facilities is protected pursuant to the Privacy Act (5 U.S.C. 552a, implementing regulations 45 CFR Part 5b). Any disclosure to Collaborator will be done in accordance with applicable law and regulations. ICD will provide a copy of the informed consent template to Collaborator for its records. All informed consent forms used in clinical studies conducted under this CRADA must identify the existence of Collaborator and Collaborator’s right to access and use IPI contained in the Raw Data as provided in Paragraph 3.10.2 above. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended.