RFP_18-100-SOL-00011_Q&A_1.pdf

RFP 18-100-SOL-00011 Questions and Answers

QUESTIONS AND ANSWERS

The following are answers to questions received from potential Offerors:

Q1: Is this procurement for just the IV formulation (as it's included in the title) or is this for IV and oral formulations?

A1: This procurement is intended to establish an inventory of parenteral (IV) formulated antiviral in the SNS (as indicated in the title) as well as to build upon the inventory of nonparenteral (oral) antiviral established in the SNS to ensure preparedness against smallpox as a threat.

Q2: In section L.5.1, the following language is contained therein: “CLIN-0005 through CLIN-0028

(Additional Procurement Phases): These CLINs may be utilized to support up to four additional procurement phases. Please propose pricing per CLIN that address the specifics of these procurement phases with respect to volume and type of product (BDS/API/FDP), destination (VMI or SNS). Within the Business Proposal, costs for these CLINs should rely upon “not to exceed” treatment course values. In addition, please provide volume discounts for CLINs 2, 5, 6, 11, 12, 17, 18, 23 and 24.” Can you clarify what the bolded sentence above from page 57 means? Does the bolded sentence mean that the Government may issue 4 additional procurement contracts in the future? In other words, could the government seek to purchase an additional aggregate number of 5mm courses spread out over 4 additional procurement contracts (i.e. CLINS -0005 through CLIN-0028 total 1,250,000 courses multiplied by 4 equals 5,000,000 courses)?

A2: CLINs 0005 – 0028 encompass the four additional procurement phases. The purpose of the highlighted sentence is to provide the government with maximum flexibility in maintaining preparedness against smallpox through the SNS stockpile. The RFP will not exceed the 1.7M treatment course ceiling as noted in question No. 1 above.

However, it was necessary to include a range of courses available for procurement in each option period. This does not change the government’s stated ceiling limit, but it does allow for the government to procure the appropriate number of treatment courses in an option year (e.g. due to limited funding and expiration of a limited number of treatment courses), and ensure that the government can procure sufficient treatment courses in later option periods to meet the stated ceiling procurement of 1.7M treatment courses should the need exist.

Q3: Has a contractor performed similar work to this for the government in the past? If available, please provide the incumbent contract number. If you are unable to provide a contract number, is it safe to assume this is a new requirement for the government?

A3: Previous relevant work to meet the need of preparedness against the smallpox threat has been done on the following contracts:

- HHSO100201100001C

- HHSO100201100013C

- HHSO100201100023C

IV Smallpox Antiviral

RFP-18-100-SOL-00011

Q4: In section L.5.1, the following language is contained therein: “CLIN-0005 through CLIN- 0028 (Additional Procurement Phases): These CLINs may be utilized to support up to four additional procurement phases. Please propose pricing per CLIN that address the specifics of these procurement phases with respect to volume and type of product (BDS/API/FDP), destination (VMI or SNS). Within the Business Proposal, costs for these CLINs should rely upon “not to exceed” treatment course values. In addition, please provide volume discounts for CLINs 2, 5, 6, 11, 12, 17, 18, 23 and 24.”

a. Does this language give BARDA the option (but not the obligation), to purchase an additional aggregate number of 5mm courses (assuming the Contractor offered to provide the maximum number courses within each CLIN numbered 0005- 0028)? In other words, 4 additional procurement phases would yield, by exercising CLIN-0005 through CLIN-0028, a total of 5,000,000 courses (1,250,000 courses multiplied by 4 equals 5,000,000)?

A4a: Please refer to the response to Question 2.

b. And if the Contractor offered the maximum number of courses in each CLIN referenced in the RFP, and BARDA accepted the business proposal by such Contractor, what would be the maximum number of courses that BARDA could elect to purchase under the terms of the RFP?

A4b: Please refer to the response to Question 2.

c. Does the 1,700,000 courses referenced in the RFP represent the maximum number of courses BARDA could buy under the RFP?

A4c: Please refer to the response to Question 2.

Q5: In section C.1.1. you state that the “objective of this RFP will be to procure up to

1.7 million treatment courses of the antiviral(s) against smallpox.” I struggle to tie the 1.7 million course number to the CLINs listed in the chart of section B. Do you have a targeted parenteral and nonparenteral amount that you would like to procure and store in the SNS? From the chart, I see 50k courses for the base contract (either parenteral or nonparenteral) and four separate options for 262.5k nonparenteral and 50k parenteral. This implies 1.3 million total courses (50k in the base contract and options for 1.25 million).

A5: The option CLINs allow for BARDA flexibility to respond to a yearly funding environment, expiration of doses stored in the SNS, and the appropriate mix of dosage formulations. The logic of building CLINs with a range of treatment courses that could be procured is to allow for the government to award a CLIN for a large procurement when funds are available, and to award CLINs for a limited procurement when in a limited funding environment.

BARDA will procure up to 1.7 million treatment courses. There is an error in the TC ceiling amounts for CLINs 0005, 0011, 0017, 0023. The number of units for each of the non-parenteral CLINS (0005, 0011, 0017, and 0023) should be 362,500 TCs not 262,500 TCs. The sum of CLIN 2 (50,000 TCs) + Non Parenteral (4 CLINs * 362,500 TCs) + Parenteral (4 CLINs * 50,000 TCs) = 1.7M TCs

CLIN 0002: 50,000

Nonparenteral (CLINs 0005, 0011, 0017, 0023): 4*362,500 = 1,450,000 Parenteral (CLINs 0006, 0012, 0018, 0024): 4*50,000 = 200,000 Total: 1,700,000

Q6: It seems clear that this RFP targets an ability for you to procure less than 1.7 million courses but does it also allow you the ability to procure more than 1.7 million courses? If so, will you direct me to the language in the RFP that would allow this?

Or even specifically with the targeted 1.7 million courses, how would the CLINs be utilized? I assume that you can utilize a specific CLIN more than once to allow you to get to the 1.7 million courses?

A6: BARDA intends to procure up to 1.7M treatment courses.

The CLIN ranges will allow BARDA to procure up to the 1.7M ceiling amount.

CLIN 0002: 50,000

Nonparenteral (CLINs 0005, 0011, 0017, 0023): 4*362,500 = 1,450,000 Parenteral (CLINs 0006, 0012, 0018, 0024): 4*50,000 = 200,000 Total: 1,700,000

Q7: In section C.1.1, you stated, “Utilizing Project BioShield, BARDA has established an inventory of smallpox antiviral therapeutics, however the drugs in the stockpile will soon begin expiring and it is necessary that the USG seek to procure additional treatment courses to maintain the preparedness posture already established.” Is it fair to assume that the cadence of the procurements will match with the expiry of the current antiviral stored in the SNS? Considering the current stockpile of 1.7 million antivirals is entirely nonparenteral, is there interest to expand beyond the 1.7 million treatment number when parenteral courses are included?

A7: The government does not intend to exceed the 1.7M treatment course ceiling as noted in question No. 1 above, however it was necessary to include a range of courses available for procurement in each option period. This does not change the government’s stated ceiling limit, but it does allow for the government to procure fewer treatment courses in an option year (e.g. due to limited funding), and ensure that the government can procure sufficient treatment courses in later option periods to meet the stated ceiling procurement of 1.7M treatment courses should the need exist.

Q8: IND and Safety Data Requirements - Section M.3.b states that “the Contractor must provide evidence of an active FDA IND or licensed product with completed phase I trials demonstrating safety of both candidate formulations.“ This appears to require (1) two active INDs for each of the parenteral and non-parenteral formulation and (2) separate phase 1 trials demonstrating safety for each formulation. Please confirm this is correct.

A8: That understanding is correct.

Q9: Pre-EUA Submission Requirements - Section M.3.d states that “the Contractor must be capable of meeting USG requirements for delivery to the SNS with at least one of the two formulations (e.g. product approval, pre-EUA IND filed) and demonstrate ability to ship (i.e.

validated shipping method). The Contractor shall demonstrate the eligibility of the products by providing us proof of approved status (e.g. provide a license number from the FDA for a commercial indication), or demonstrate through FDA correspondence that a pre-EUA IND is on file with the FDA”. We interpret this to require offerors to (1) have at least one IND on file with FDA for either the parenteral or non-parenteral formulation; and (2) have submitted to the FDA a “Pre-EUA” submission in accordance with the guidance in Section III.C of the FDA Guidance document titled “Emergency Use Authorization of Medical Products and Related Authorities” and dated January 2017. Please confirm.

A9: That understanding is correct.

Q10: Expiry Requirements - Section C.4.5.4 requires the contractor to do long term stability studies to establish an expiry period of at least 5 years, indicating that 5 year expiry dating is not required pending completion of these studies. However, Section C.4.1.5 states that “product shall have a minimum of 5 years stability at the intended storage temperature.”

Reading these sections together, we interpret them to require that at some point during the performance period of the contract, the contractor must establish at least 5 years of stability for both formulations. Thus, 5 years of stability data is NOT required for initial deliveries.

Please confirm.

A10: That understanding is correct.

Q11: Quantities - Section C.1.1 and other sections of the RFP state that the requirement is for procurement of “up to 1.7 million treatment courses of the antiviral(s) against smallpox.”

However, the contract line item number (“CLIN”) breakdown in Section B.2 indicated that BARDA will only procure up to 1.3 million treatment courses:

CLIN 2 (either parenteral or non-parenteral)= 50,000 Non-Parenteral: 4 CLINs (0005,0011,0017 and 0023)x 262,500=1,050,000 Parenteral: 4 CLINS (0006,0012,0018,0024) x 50,000=200,000 Total=1,300,000

C.1.1 states “The objective of this RFP will be to procure up to 1.7 million treatment course of the antiviral(s) against smallpox.” When all the maximum FDP courses are added up from the CLINs, however, it is 1.3M courses. Can you please clarify?

A11: Please refer to the response to Question 5.

Q12: Will responders be required to provide a CAS (Cost Accounting Standards) disclosure statement?

A12: Yes, Offerors will be required to provide a CAS disclosure statement per

FAR30.201-4(b).

Q13: Given the potential size of this contract is it anticipated that awards would include

FAR 52.234-4, Earned Value Management System?

A13: No EVMS reporting is required under this procurement.

Q14: The key personnel listed in section G.4 does not match the list in Evaluation Criteria 2

(page 67). Can BARDA please clarify the Key Personnel Required?

A14: The Key Personnel required are those listed in the Evaluation Criteria, also found below:

i. Program Director (PD)/Principle Investigator (PI)

ii. Chief Scientific/Medical Officer

iii. Clinical Development/Clinical Study Director

iv. Quality Assurance (QA)

v. Quality Control (QC)

vi. Manufacturing Lead

vii. Regulatory Affairs (Lead)

viii. Project Manager

ix. Pharmacovigilance (Lead)

Q15: Since the quantities in the optional fixed price CLINs (5-28) are unknown, how would BARDA like that addressed in the small business subcontracting plan?

A15: Please use the quantities proposed for each option CLIN in the calculation of the total dollar amounts and associated planned subcontracting categories.

Q16: The RFP requests “volume discounts for CLINs 2, 5, 6, 11, 12, 17, 18, 23 and 24.”

RFP page 57. Does BARDA contemplate that the discounts would be between or within these CLINs? In other words, is BARDA requesting that offerors propose range pricing within each of the cited CLINs (1-25,000= $X per unit, 25,001-50,000=$Y per unit)?

A16: BARDA prefers that a discount would apply across the total volume order under the entire contract. However, it is incumbent upon the Offeror to propose the pricing discounts per your business practices.

Q17: The RFP has conflicting guidance regarding when options may be exercised. Section B.2 of the RFP states that the “The options may be exercised within the base period of the contract, if needed.” However, the RFP also includes provisions indicating that options might be exercised at some later date. For example, Clause I.3.2, FAR 52.217-7 states the “Contracting Officer may exercise the option by written notice to the Contractor within 30 days,” but doesn’t say what the 30 days relates to. Please clarify.

A17: Option CLINs could be awarded at any point after award of the base period (the language above indicates that optional CLINs could be awarded while the base period is still active in the event that BARDA has available funding and is able to award optional CLINs for procurement of additional treatment courses). There is not benchmark or milestone driving the 30 day notice. The 30 day notice refers to the government’s responsibility to the contractor to notify 30 days in advance of any option award.

Q18: The CLIN schedule provides for multiple options to purchase from 1-50,000 and 1-

262,500 courses and requests unit pricing. RFP pages 4-5. Is it BARDA’s intent that, if an option is exercised at less than the maximum number of courses, BARDA will retain the ability to further exercise the option for the remaining number of courses? For instance, if BARDA exercised CLIN 0005 for 200,000 courses, would BARDA have the ability to exercise that option again for the remaining 62,500 courses?

A18: BARDA does not intend to partially obligate options. If an option is exercised at less than the maximum number of courses, BARDA will not retain the ability to further exercise the option for the remaining number of courses. Future options will be exercised should the need exist.

Q19: The RFP provides the following Mandatory Evaluation Criterion: “The Contractor shall provide evidence of efficacy in at least two animal models accepted by the FDA for the evaluation of efficacy of a smallpox MCM (Dec 14-15, 2011 FDA Antiviral Drugs Advisory Committee).” RFP page 66. This criterion is ambiguous. It could be read to mean that the animal models must be of a type that are accepted by the FDA. Alternatively, it could be read to mean that the evidence of efficacy must have been accepted by the FDA.

Please clarify BARDA’s intent.

A19: The FDA indicated that three animal models were acceptable for development and evaluation of countermeasures against smallpox: (1) the monkeypox intravenous challenge of nonhuman primates, (2) the intradermal challenge of rabbits with rabbitpox, and (3) the intranasal challenge of mice with ectromelia.

An Offeror is expected to show efficacy in at least two of these animal models.

At present, these are the only appropriate models which the FDA has stated can be used for establishing efficacy of a candidate to treat smallpox.

Q20: The RFP states BARDA will evaluate relevant past performance. RFP pages 68-69.

However, it does not define relevance. Please provide the criteria by which BARDA will determine relevance, such as size, scope or magnitude of the prior contracts.

A20: BARDA will follow standard evaluation procedures for past performance. We will evaluate the Offeror’s past experience with the government, specifically grants and contracts awarded by HHS and NIH. Available contractor performance assessment report system (CPARS) will be utilized to establish a past performance profile.

Q21: The RFP does not state how the evaluated price/cost for purposes of the best value trade off will be calculated. Please clarify how BARDA intends to calculate evaluated price/cost for purposes of the best value trade-off. Will BARDA sum the total pricing for each CLIN, utilize estimates of likely numbers of courses to be purchased, or some other method?

A21: The best value tradeoff will evaluate proposals against the factors identified in

Section M of the RFP. As mentioned in the RFP, all evaluation factors other than cost or price, when combined, are significantly more important than cost/price. However, the proposed cost/price will analyzed through a cost realism analysis as defined in FAR15.404-1(d). BARDA recognizes the economies of scale in terms of pricing and will work with our industry partners to get to a commercially sustainable price that represents best value to the government.