DHS PIADC RFI for Tech Licensing FMD IP Licensing Partner (Classification Code 65)

UNITED STATES DEPARTMENT OF HOMELAND SECURITY DIRECTORATE OF SCIENCE AND TECHNOLOGY PLUM ISLAND ANIMAL DISEASE CENTER REQUEST FOR INFORMATION Note: This RFI has been posted twice. Once under Classification Code 87 for Agricultural Supplies and again here under Classification Code 65 for Medical, Dental, and Veterinary Equipment and Supplies. SUMMARY This is a Request for Information (RFI). The United States Department of Homeland Security (DHS) Directorate of Science and Technology (S&T) Plum Island Animal Disease Center (PIADC) is seeking information on the capabilities of United States (US)-based animal health companies ("Offeror") to develop, license, manufacture and distribute United States Department of Agriculture (USDA)-licensed veterinary livestock vaccines. Specifically, PIADC is seeking a global company with which it can establish a commercial licensing agreement including United States Government (USG) owned and pending intellectual property rights to manufacture, distribute, and sell Foot-and-Mouth Disease (FMD) recombinant subunit vaccines that incorporate the "FMDV 3C Protease L127P Patent Estate." [Note: USPTO 15/259,409; 16/368,146; 16/368,327; 16/369,177. PCT/US2017/048828] This RFI is subject to the provisions of Federal Acquisition Regulation (FAR) 52.215-3, Request for Information or Solicitation for Planning Purposes (Oct 1997), and is issued solely for information/planning purposes. This RFI does not constitute a solicitation for proposals, a commitment to issue a solicitation for proposals, or the authority to enter into negotiations to award a contract. This RFI shall not be considered as an obligation by the Government to acquire any products or services. The Government does not intend to award a contract on the basis of this RFI. There is no entitlement to payment of direct or indirect costs or charges by the Government as a result of a Contractor submission of responses to this RFI or the Government's use of such information. The Government reserves the right to reject, in whole or in part, any Contractor's input submitted in response to the RFI. Responses to the RFI will not be returned. The Government recognizes that proprietary information and data may be part of this effort and, if so included, such data should be clearly marked. Responders whose submissions are deemed worthy of further consideration given the information expressed herein may be asked to provide additional information. If you have any technical questions or require any additional technical information, please contact Dr. John Neilan, DHS S&T PIADC Director of Science, either via e-mail at John.Neilan@st.dhs.gov or by telephone at (631) 323-3025. If you have any technology transfer questions or require any additional technology transfer information, please contact Ms. Megan Mahle, DHS S&T Program Manager, either via e-mail at Megan.Mahle@hq.dhs.gov or by telephone at (202) 254-2245. Responses to this RFI shall be e-mailed to Dr. John Neilan at John.Neilan@st.dhs.gov on or before 11:59 p.m. Eastern Time (ET) on August 9, 2019. SUPPLEMENTARY INFORMATION 1. The FMD recombinant subunit vaccine platform will ideally: a. Meet the USDA Center for Veterinary Biologics (CVB) requirements for a production platform (Veterinary Services (VS) Memo 800.213; https://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo_800_213.pdf) b. Be utilized in new, recombinant-based FMD licensed vaccine products, a 3C protease mutant (see Journal of Virology. 2017. 91(22): doi 10.1128/JVI.00924-17: "Foot-and-Mouth Disease (FMD) Virus 3C Protease Mutant L127P: Implications for FMD vaccine development"). c. Be previously shown to be immunogenic in FMD susceptible domestic livestock species, including swine. d. Be previously shown to be efficacious in FMD susceptible domestic livestock species, including swine. e. Meet the USDA CVB requirements for safety, purity, potency and efficacy. f. Have a reasonable probability of and at least 3-year shelf-life at -20oC. g. Have a reasonable probability of application for the six FMDV major, circulating serotypes. 2. The Offeror must have proprietary rights to one or more vaccine production platforms that may meet the USDA CVB requirements for a production platform (VS Memo 800.213). 3. The Offeror must use reasonable business efforts to obtain new, recombinant FMD vaccine product USDA regulatory licenses using the vaccine production platform. 4. The Offeror must be willing to enter into a milestone-based licensing agreement in which failure to meet one or more milestones would constitute termination of the licensing agreement and reversion of intellectual property rights back to the USG. 5. The Offeror must have an established in-house record of accomplishment and/or use of outside legal counsel in the successful filing, prosecution and validation of patent applications, and maintenance of issued patents, through the United States Patent and Trademark Office (USPTO), the international Patent Cooperation Treaty, and national country phases. 6. The Offeror must be willing to agree to pay fully for all USPTO, European Patent Office, and National Country Patent Office-related future costs associated with the USG "FMDV 3C Protease L127P Patent Estate", including ongoing patent applications in several, specific countries (United Kingdom, Germany, Netherlands, and South Korea). 7. The Offeror must be willing to pay fully for all FMD subunit vaccine platform future Research and Development (R&D) costs, including clinical, analytical and manufacturing components of the regulatory development program. 8. PIADC shall provide livestock testing facilities for all clinical studies associated with the regulatory development program. SPECIAL NOTICE While only federal employees will participate in the potential final selection process, Government support contractors may review and provide support during the response evaluation process. All participants involved in the evaluation process, including those in support roles, will sign Non-Disclosure Agreements (NDAs) prior to such involvement. Submission in response to this notice constitutes approval to release the application package to the evaluation team that may include Government support contractors. CONFIDENTAL BUSINESS INFORMATION Pursuant to 10 Code of Federal Regulations (CFR) 1004.11, Handling Information of a Private Business, Foreign Government, or an International Organization, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit (via e-mail) two (2) well-marked copies as follows: 1. Submit one copy of the document marked "business confidential" or "proprietary information" that includes all the information believed to be confidential or proprietary; and 2. One copy of the document marked "non-confidential" with the information believed to be confidential deleted. DHS will make its own determination about the confidential status of the information and treat it according to its determination. Factors of interest to DHS when evaluating requests to treat submitted information as confidential include: 1. A description of the items; 2. Whether and why such items are customarily treated as confidential within the industry; 3. Whether the information is generally known by or available from other sources; 4. Whether the information has previously been made available to others without obligation concerning its confidentiality; 5. An explanation of the competitive injury to the submitting person that would result from public disclosure; 6. When such information might lose its confidential character due to the passage of time; and 7. Why disclosure of the information would be contrary to the public interest. This RFI is also included as a *.pdf document as an attachment to this posting. Thank you for your interest and we are looking forward to your responses.