Technology Transfer Experience with the National Institutes of Health

1985 – Negotiated License Agreement between Immuno US and the National Technical Information Service (NTIS). Subsequently [1993] NTIS transferred license to the Office of Technology Transfer (OTT), Public Health Service NIH. The license was for US patent applications – continuations and foreign applications respecting “pox viruses as vectors for the expression of foreign genes.” Dr. Bernard Moss, inventor.

1986 to present – Negotiated and drafted various material transfer agreements, commercial evaluation license agreements and detailed applications for licenses to PHS inventions.

1988 – Negotiated CRADA between NCI and NIAID on the one hand and Immuno US on the other hand to develop one or more vaccines through use of chimeric virus strains for prevention of AIDS. Dr. Robert Gallo of NCI and Dr. Bernard Moss of NIAID were Principal Investigators.

1992 – Guest lecturer, Division of AIDS of NIAID respecting legal issues relevant to clinical trials.

1995 – Negotiated CRADA between Immuno AG and NHLBI (Dr. Neal Young Principal Investigator). The purpose was development of recombinant B19 parvovirus capsids.

1996 – Negotiated with OTT/NIH patent license agreement between Immuno US and OTT/NIH for several worldwide patent applications pertaining to the development of vaccines against the Heptatitis A virus.

1990 to 1997 – Negotiated several amendments to the "pox virus as a vector" license agreement with OTT. NIH General Counsel, also participated in 1995 amendment negotiations. The 1995 amendment granted the licensee the broadest enforcement rights ever granted by NIH at that time for a non-exclusive licensee pursuant to 35 USC § 207 (a)(2).

• Negotiated various agreements in connection with the pox virus as a vector license and the 1988 CRADA to develop an AIDS vaccine for pre-clinical and clinical trials with the NIAID Clinical Evaluation Group and subsequently with the Division of AIDS, NIAID. Clinical trials included use of Immuno’s GP160 III B or MN strains in AIDS vaccine trials and studies performed by AVEG/ACTG at various sites in the US.

• Participated in many of the early clinical trials and strategy sessions at the Division of AIDS for the various GP160 Studies pursuant to CRADA (these were amongst the earliest AIDS studies undertaken by NIAID and NCI).

• Lead counsel on behalf of Immuno US in connection with the strategy employed in the patent prosecution in both US and Europe respecting the NIAID pox virus as a vector patent application (inventor Dr. Bernard Moss). In this role Mr. Fersko worked closely with representatives of the OTT and on some occasions the General Counsel Office at NIH. The work included the settlement of an Interference at USPTO and an opposition proceeding at the oppositions branch of the EPO inclusing a hearing on appeal at the EPO.

2000 – Negotiated a CRADA between NCI and Biotech Inflection Point S.A. (Dr. Toby Hecht – principal investigator). CRADA was for pre-clinical development of recombinant Human Inerleukin-7. In connection with this CRADA also negotiated an SAIC Frederick Guest Researcher Agreement.

2001 – Negotiated with OTT for patent license from NIDCR pertaining to “Formation of Human Bone in Vivo Using Ceramic Powder and Human Marrow Stromal Fibroblasts” on behalf of Bio-Products and Bio-Engineering AG.

2002 – Lectured on International Technology Transfer at the Foundation for the Advanced Education in the Sciences (NIH Graduate School).

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