75N95022R00013_QandA Document.pdf

Q1: The pre-solicitation announcement for the subject opportunity states that “the NINDS anticipates awarding multiple IDIQ type contracts to support these programs with an eight-year ordering period---".

It further states “it is anticipated that the IDIQ award will be made in the third quarter of FY2022”. In numerous other places it refers to “the contractor”.

Our interpretation from this collectively is that NIH/NINDS intends to award an umbrella IDIQ contract to one contractor, but there will be multiple task order contracts under the umbrella IDIQ contracts. Is this correct, or does the government contemplate awarding multiple umbrella IDIQ contracts in FY22?

A1: The pre-sol notice uses “Contractor” in the singular as it is addressed to each individual offeror that will potentially prepare a proposal, however, the Government intends to award multiple IDIQ contracts as a result of the RFP. The awardees would then compete for individual competitive task order RFPs as the need arises.

Q2: Is the NIH looking for a CMO who can not only manufacture Drug Substance Oligonucleotides and also perform the corresponding laboratory in/ex vivo studies or is this posting is more a ‘catch all’ of everything you are trying to get Proposals for?

A2: It’s anticipated that no one company will be able to provide all of the required services. At a minimum, it is expected that offerors will need to partner with either a CMO or CRO to fulfill the full scope of the SOW. It is also permitted for more specialized CMOs/CROs, that only provide a specific manufacturing or nonclinical modality and are unable to fulfill the project management requirements, to enter into a subcontract with a prime contractor.

Q3: Does the Gov’t has a ROM ceiling value in mind for the IDIQ that the awardees would collectively have access to?

A3: The Government is still in the process of finalizing the IDIQ maximum quantity so I’m unable to reveal that information at this time, however, the value will be clearly stated in the RFP.

Q4: Based on our experience with other government subcontracts we may not meet a wide variety of government requirements for being a contractor/subcontractor (i.e. no open book. No value invoicing etc.) and we will not be able to change our organizational practices to align with those requirements.

Please let me know if this will be an issue.

A4: While I cannot identify at this time the exact terms and conditions will be included in the RFP, if it is determined they are applicable to this acquisition, then prime contractors must accept them before entering into a contract with the Government. Likewise, subcontractors will be required to accept any “flow-down” provisions/clauses before entering into a subcontract with the prime. All contractual terms

QUESTIONS AND ANSWERS

75N95022R00013

“Manufacturing and Nonclinical Studies Support for the

Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders” and conditions will be expressly identified in the RFP and you will have an opportunity to review them as soon as it is posted.

Q5: Would the Government consider revising the RFP to allow for a complete Commercial Items bid so that a Commercial Items company could respond to the entirety?

A5: The Government does not intend to reclassify this as a commercial acquisition, however, partnering with other companies to propose the full scope of required services is acceptable.

Q6: Is there is a spot that I can go online to perform a search for SAM registrations?

A6: You can search for registrations online by using the search bar at www.sam.gov. Please note that you need to be logged into SAM for any registrations to appear, however. You can also reach out to the “Federal Service Desk” for assistance at www.fsd.gov.

http://www.fsd.gov/