Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

The FDA rejected the use of 52,088 on the grounds that the IND was an investigator-sponsored IND owned by Stony Brook University and canceled by FDA in 2014 after the death of the IND Principal Investigator, Professor Said). No other IND for aviptadil was in force in any jurisdiction and it was learned that the predecessor of Relief Therapeutics had applied for and not been granted an IND for human use of aviptadil on multiple other occasions.

With the agreement of Relief Therapeutics, NeuroRx submitted an FDA compliant IND 149,152 to FDA on March 24, 2020 and was issued a “Study May Proceed” letter by FDA on March 28, 2020.
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In addition, in September 2021, NeuroRx and Relief Therapeutics agreed to collaborate as separate companies under a structure where Relief Therapeutics had the right to fund all development costs related to aviptadil for respiratory diseases in exchange for a predetermined division of profits and NeuroRx had the right to continue its development program with other investor funds should Relief Therapeutics not provide funding. The agreement recognizes ownership by NRx of all intellectual property developed by or licensed by NRx with Relief Therapeutics advised its investors in various annual reports issued in 2020 and earlier that it had formulated aviptadil as a human drug and had “1 million doses” available to treat patients. In the course of development, NeuroRx learned that there was no stable formulation of aviptadil and began developing the intravenous formulation with manufacturing records submitted to and reviewed by FDA.

We reported to Relief Therapeutics in December 2020 that the formulation data provided by Relief Therapeutics could not be replicated and that a new formulation and manufacturing method was required. Moreover, we were warned by a former Relief Therapeutics declined to fund the costs of developing a stable formulation of aviptadil, which NRx proceeded to do with funding from other investors under the tradename ZYESAMI, named for Professor Sami Said. In May 2021, Relief Therapeutics advised its shareholders that Relief Therapeutics was aware of the stability problems with its formulation at the time it signed the September 2020 collaboration agreement.

ZYESAMI is not currently covered by any US or international patent. US Patent 8178489B2 and foreign counterparts does not apply to ZYESAMI because it covers only formulations of aviptadil that are formulated in a buffer. Laboratory evidence suggests that VIP (aviptadil) aggregates and may be inactivated by known buffers. We are engaged in a discovery process to extend the stability of ZYESAMI and has made certain discoveries that may lead to future patent filings and which may or may not lead to allowed patent claims. In the event that no patent protection is granted covering the formulation of ZYESAMI, if the drug is approved by FDA, it is anticipated to receive at least five (5) years of data exclusivity from the FDA under what is commonly known as “paragraph 4” protections. Should no patents be granted by the end of this data exclusivity period, competitors may be able to market generic versions of ZYESAMI.

https://content.equisolve.net/sec/0000950142-21-002866/eh210183152_ex9901.htm

I have read and re-read the C.A several times, and I continue to walk away with different “impressions” that re-shape my thoughts about it. Again, we do not know the contents of the N.D.A. nor the Development Agreement.

However, based on the strict reading of the language of the C.A., my OPINION is that this Agreement is very much Executory in it’s terms. You can look up what an Executory Contract means. Long and short, it means a contract that is unperformed and one where the parties have continuing obligations to each other. The obligations remain for both NRXP and Relief.

~ Bogo, Y@h00 RLFTF finance conversations

…E. “Dr. Javitt Seeks to Capitalize on Aviptadil's Early Success by Demanding that Relief Renegotiate the Terms of their Collaboration while Simultaneously Attempting to Circumvent Relief through a Secret Agreement with SUNY Stony Brook”
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From the CA:
“Relief assets to be utilized in the Collaboration include:
US and European Union Orphan Drug Designations Related to ARDS”….

And yet from the 9/15/2021 NRXP prospectus page 102:

“Moreover, the FDA awarded Orphan Drug Status to the State University of New York at Stony Brook for the use of RLF-100, a prior formulation of ZYESAMI, in ARDS in 2001.”

~Raven, Y@h00 RLFTF finance conversations

A certification that the proposed product will not infringe the already approved product’s listed patents or that such patents are invalid or unenforceable is called a Paragraph IV certification. We may seek Paragraph IV Certification for our product candidates. If the applicant does not challenge the listed patents or does not indicate that it is not seeking approval of a patented method of use, the ANDA or 505(b)(2) NDA application will not be approved until all the listed patents claiming the referenced product have expired.

If the ANDA or 505(b)(2) NDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once the application has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days after the receipt of notice of the Paragraph IV certification automatically prevents the FDA from approving the ANDA or 505(b)(2) NDA until the earlier of 30 months, expiration of the patent, settlement of the lawsuit, a decision in the infringement case that is favorable to the ANDA applicant or other period determined by a court.

https://www.sec.gov/Archives/edgar/data/1719406/000119312521208673/d175615ds1a.htm