Confidential
| 9. | Add in a new Article 8.9 (Certificate of Confidentiality) as follows: |
8.9 Certificate of Confidentiality. The CRADA Data collected under a Protocol conducted under this CRADA are covered under a Certificate of Confidentiality that has been issued by the NIH pursuant to Section 301(d) of the Public Health Service Act (42 U.S.C. 241(d)). Under this Certificate of Confidentiality, the Collaborator may not:
a) Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document, or biospecimen pertains; or
b) Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.
Provided that Collaborator will be permitted to disclose the information described in the points set forth above as follows:
a) If required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding;
b) If necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;
c) If made with the consent of the individual to whom the information, document, or biospecimen pertains; or
d) If made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of Human Subjects in research.
Prior to making any permitted disclosures, Collaborator will ensure that that any recipient of data protected by a Certificate of Confidentiality agrees to comply with the Certificate.
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