Mosaic ImmunoEngineering is a nanotechnology-based immunotherapy company developing therapeutics and vaccines to positively impact the lives of patients and their families.

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Message: NDA 's compliance with SEC rules...

Please read Regulation FD.

 

As to the NDA, it is not just part of the settlement terms, it encompasses in totality the settlement, it is non-public.

 

Substantiating Confidential Treatment

If an FOIA request is made for materials for which confidential treatment has been requested, and no other grounds appear that would justify withholding such materials, the SEC’s FOIA officer will contact the issuer to substantiate the request for confidential treatment. Failure to submit written substantiation within 10 calendar days from the time of notification may be deemed a waiver of the confidential treatment request and the right to appeal an initial decision denying confidential treatment.

To substantiate the confidential treatment request, the issuer will need to provide the following regarding the request:

  • the reasons why the information should be withheld under the FOIA and the specific exemptive provisions of the FOIA relied on (e.g., a trade secret);
  • the applicability of any specific statutory or regulatory provisions that may govern the treatment of the information;
  • the existence and applicability of any prior determinations by the SEC, other Federal agencies, or a court concerning the confidential treatment of the information;
  • the adverse consequences to a business, financial or otherwise, that would result from disclosure of confidential commercial or financial information, including on the issuer’s competitive position;
  • the measures taken by the issuer to protect the confidentiality of the information in question, and of similar information, prior to and after its submission to the SEC;
  • the ease or difficulty of a competitor’s obtaining or compiling the commercial or financial information;
  • whether the commercial or financial information was voluntarily submitted to the SEC and, if so, whether and how disclosure of the information would tend to impede the availability of similar information to the SEC; and
  • such additional facts and such legal and other authorities as the requesting person may consider appropriate.

http://www.jonesday.com/pubs/pubs_detail.aspx?pubID=732

Be well

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