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Registration of Clinical Trial Information and Disclosure of Results

a. Registration of our clinical trial information, and disclosure of results, to clinical trial registries

TPA will register and disclose information on publicly accessible clinical trial registries such as ClinicalTrials.gov regarding clinical trials that are being conducted or have been conducted.

b. Disclosure of clinical trial summary results

TPA will disclose the results from clinical trials in patients that form part of the submission package for products approved in the United States. Results will not be disclosed if TPA decides that disclosure may lead to identification of clinical trial participants. Results may not be disclosed under any of the following conditions:

• A third party, such as a company involved in joint development, has not agreed to disclosure.
• Disclosure may interfere with publication in medical journals.
• Disclosure may interfere with the protection of intellectual property rights.