ITN-2025-00130 Scope of Work.pdf

INVITATION TO NEGOTIATE

E-ITN-2025-00130

FOR

Establishment of a Cyclotron Facility: Installation, Build-Out, and Operation of Cyclotrons at the Modesto Maidique Campus (MMC) Innovation Complex to Support Clinical, Educational, and Research Efforts in FIU’s Academic Health Center

ITN-2025-00130 Page 2 of 5

Statement of Objective This competitive solicitation is an invitation to negotiate (ITN) with The Florida International University Board of Trustees (“FIU”) to establish a cyclotron facility, which will include designing and constructing improvements to the space and installation, operation and ownership of two

(2) cyclotrons, all privately financed, within a recently completed academic building in FIU’s Modesto Maidique Campus (MMC). Once operational, the cyclotron(s) will support FIU’s needs for clinical, research and training purposes, and will also support the successful respondent’s business operations. See more information about FIU at https://www.fiu.edu/

FIU’s objective in entering into this collaboration is to partner with a radiopharmaceutical solutions provider, dedicated to nuclear medicine and radiopharmaceutical production, to support FIU’s strategic plans and its partnership with Baptist Health South Florida and other FIU collaborators in areas of physician training, research, and patient care for the benefit of the South Florida community.

The expectation is that the successful respondent will operate the cyclotrons for its pharmaceutical and health care clients and will also produce radiopharmaceuticals for FIU’s clinical and research efforts, including a Positron Emission Tomography (PET) Scanner that will be located in a building adjacent to the location of the two (2) cyclotrons.

The successful respondent will have a track record of building cyclotron facilities, obtaining FDA operational approval for cyclotrons, and managing cyclotron facilities in the private sector and in collaboration with academic research institutions to the highest standards of safety, quality, and performance.

FIU’s Experience Impact 2030 has three strategic focus areas: (1) Environment and Environmental Resilience, (2) Health, and (3) Technology and Innovation. FIU’s aspiration is that the cyclotrons (and the PET/CT) will support treatment and research in chronic diseases such as cancer, cardiovascular and neurological diseases by:

• Providing core facilities and resources supportive of FIU’s clinical, research and educational programs and initiatives

• Growing and enhancing FIU’s clinical trials opportunities and collaboration with pharma

• Leveraging the cyclotron and PET/CT facilities for the recruitment of physician scientists and researchers

• Developing radio pharmaceutical training programs

Scope of Work and Deliverables Basic Description: The successful respondent is expected to design and build out, staff and operate a Cyclotron Facility at FIU’s recently completed Innovation Complex located in the MMC. The available space is located on the ground floor and can accommodate the necessary changes and improvements required for a Cyclotron Facility. The successful respondent will be https://www.fiu.edu/

ITN-2025-00130 Page 3 of 5 responsible for all construction of improvements, all equipment purchases, and obtaining all necessary permits (including FDA) for the operation of the Cyclotron Facility.

Location: The Cyclotron Facility will occupy approximately 6,000 to 10,000 square feet on the ground floor, with additional office spaces. The facility will be located at FIU’s recently completed Innovation Complex at the MMC located at 11200 SW 8th St, Miami, FL 33199.

The successful respondent will collaborate with FIU’s Facilities Management Department for the smooth integration of the Cyclotron Facility with the operation of the building. As part of the design and build-out of the Cyclotron Facility the successful respondent will be responsible for any necessary enhancement to the building systems such as mechanical, electrical, plumbing (MEP) and other infrastructure required for the operation of the facility.

Ownership: All equipment in the Cyclotron Facility will be owned by the successful respondent.

Successful respondent will be obligated to remove all equipment, including the cyclotrons, upon the termination or expiration of the relationship with FIU.

Timing: The Cyclotron Facility is expected to be operational within 26 months of the signing of all necessary agreements with the successful respondent (which agreements must be negotiated and signed within four months of the award of this solicitation, as such timeline may be extended upon the mutual agreement of the parties).

Design: The Cyclotron Facility must be designed in accordance with FIU’s Campus Master Plan, FIU’s Facilities Management Department’s planning processes, FIU design guidelines posted at https://facilities.fiu.edu/Planning/Documents/FormsAndStandards/FIU_Building_Standards_20 23_FINAL_6-16-23.pdf and all other applicable federal, state and local laws. The Cyclotron Facility design must also be responsive to feedback from key university stakeholders for consistency with FIU’s Master Plan and technical standards, impact on FIU’s utilities, water, sewer, master storm water, and traffic infrastructure, compliance with applicable Building Code, and general design characteristics.

Respondents shall include floor plans from recently completed cyclotron facilities as part of its response to this ITN.

Construction: Build-out of the Cyclotron Facility must be timely done in accordance with all Federal, State, local laws and FIU’s design guidelines.

Note: FIU is the building codes permitting official for construction projects on MMC.

Financing: Respondents are expected to be able to provide their own financing for the design, build-out, and furnishing of the Cyclotron Facility, and well as the operational costs once constructed.

Neither the State of Florida nor FIU will participate in the financing of the newly developed facility in any way, including but not limited to guarantees of revenue.

https://facilities.fiu.edu/Planning/Documents/FormsAndStandards/FIU_Building_Standards_2023_FINAL_6-16-23.pdf https://facilities.fiu.edu/Planning/Documents/FormsAndStandards/FIU_Building_Standards_2023_FINAL_6-16-23.pdf

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Management Options: The Facility will be managed solely by the successful respondent, including obtaining FDA approval for operations.

Project Costs: All costs of the Facility including but not limited to financing, design, buildout and operation are the responsibility of the successful respondent. The lease of space for the Cyclotron Facility will be a triple net lease, with all costs associated with the lease, including ad valorem taxes, insurance, maintenance, utilities and operational costs borne by the successful respondent. The successful respondent will be responsible for paying rent in an amount at least equal to the appraised fair market value rental rate of the leased space on which the facility is operated. Credit against the rental for in-kind contributions of significant value to FIU may be offered, but acceptance by FIU is not guaranteed. Examples are discounted use of the Facility by FIU researchers and/or revenue sharing for FIU-related referrals.

University Priorities: FIU seeks collaboration with an organization that shares FIU’s priorities in areas pertaining to research, education and innovation in health. As such, FIU prefers and will give additional weight to proposals that enrich the academic, clinical and research at FIU.

Examples include, but are not limited to:

• Support for engagement with pharma industry

• Support for establishment of radio pharmaceutical programs at FIU

• Support for FIU clinical and research use of the cyclotrons

• Revenue share to support research programs

Evaluation Criteria

• Design and construction – A clear picture that the design intent and project planning will deliver a facility of outstanding design, built to high standards and in a timely manner. Assurance that the respondent understands: (a) the University’s mission;

and (b) the objectives of the ITN

• Experience – Evidence that the respondent has successfully developed and managed projects of similar scope suitable for our campus with preference for higher education and research experience. Ability to secure FDA and all other required approvals for operation of the facility.

• Team - Evidence that the team has the qualifications and experience to timely and properly execute the proposed development in keeping with the requirements contained herein and successfully operate and maintain a dual use facility focusing on clinical and research operations.

• Financials - Evidence that the proposed team has the financial strength and sufficient working capital to meet the procurement requirements. Clear indication that the respondent intends to generate revenues to cover debt service (if applicable), maintenance, and operations such that benefits to FIU are maximized.

• Benefit to FIU Research, Clinical and Education – Evidence of respondent’s commitment to the creation of radio pharmaceutical programs at FIU, fostering

ITN-2025-00130 Page 5 of 5 relationships between FIU and the pharma industry, and support for FIU research and education.

Please be aware that depending on the final legal structure and deal documents negotiated between FIU and the successful respondent, the transaction may be subject to the prior approval of the State University System Board of Governors, FIU’s Board of Trustees, and/or the Board of Trustees of the Internal Improvement Trust Fund of the State of Florida.

Submittals

• Hard copies are not accepted.

• Respondents must submit their solicitation via the electronic sourcing platform and upload all pertinent information as required.

• The "FIU Procurement Portal" refers to the FIU Procurement Services Department’s website at https://controller.fiu.edu/departments/procurement/procure/competitive-solicitations/.

• Please review the Addenda for any additional amendments, refer to the important dates within the Calendar of Events, and use the Q&A Board within the electronic sourcing platform for inquiries.

END OF SCOPE OF WORK

https://controller.fiu.edu/departments/procurement/procure/competitive-solicitations/ https://controller.fiu.edu/departments/procurement/procure/competitive-solicitations/