00018-Q A.pdf

RFP 15-100-SOL-00018 Questions and Answers

Cell-Based Skin Substitutes for Definitive Care of Burn Injuries

15-100-SOL-00018

QUESTIONS AND ANSWERS

The following are answers to questions received from potential Offerors:

Q1: In section L.2., Mandatory Criteria is described as a separate section. In L.3. it is listed as a component of the technical proposal. Which is correct? Should the same information be repeated in both sections? If included in the technical proposal, would it count against the 75 page limit? If the information needs to be present in both sections, should it be repeated verbatim, or could the technical proposal include a condensed version?

A1: Mandatory Criteria shall be a separate section as described in section L.2. of the solicitation.

Q2: Do the title page, table of contents, and government instructions on handling proposals count towards the 75 page limit for the technical proposal?

A2: No, the above mentioned documents do not count towards the 75 page limit for the technical proposal.

Q3: Should the mandatory criteria section describe and support the status of the product or is it just a statement that the product meets the criteria?

A3: All Offerors shall clearly state if the product meets the mandatory criteria as described in

Section M of the solicitation as well as a narrative that supports this position to be no longer than 5 pages.

Q4: Can you make editable versions (Word or Excel, as appropriate) of attached forms and questionnaires available?

A4: Yes, an updated word version is now posted to FBO for this solicitation.

Q5: How should confidential information be handled in the proposal? Does it have to be specifically marked, or is the entire proposal handled as confidential?

A5: Please see FAR 215-1(e) for specific instructions regarding restriction on disclosure and data.

Q6: The solicitation lists 5 anticipated CLINs. How closely should proposals adhere to that example structure? Can additional CLINs be proposed if properly justified? Can existing CLINs be expanded to include additional, related tasks?

A6: All Offerors shall adhere to the CLIN structure in the above referenced solicitation. No separate additional CLINs shall be proposed. Please ensure proposed budgets and sections of work described in Section C of the solicitation are appropriately matched for each CLIN.

Q7: Is the 75 page limit for the business proposal just for the breakdown of proposed costs or does it also include all of the required forms (Points of Contact, Related Activities, Disclosure of Lobbying Activities, Past Performance Questionnaires, and Representations and Certifications)?

A7: There is no page limit for business proposals. The solicitation is amended to reflect this change.

Q8: Is it possible to modify the cost structure of a proposed CLIN? For example, can a CLIN listed as

FFP be changed to a CPFF structure?

A8: No, please see Section B of the solicitation for a complete breakdown of CLIN structures.

Q9: Is the same level of budget breakdown required for the firm fixed price CLINs? Specifically, for procurement, if the CLIN is set up for purchase of XX units at YY price per unit, what additional support should be supplied?

A9: Please provide supporting documentation for the price per unit for procurement CLINs and how it was derived.

Q10: Is it possible to loosely structure the FFP for procurement CLINs? Our product is not currently being sold commercially, so production costs are still projections. Can the FFP CLIN be set up to deliver up to a certain number of units at a total not to exceed cost, with the exact per unit price to be negotiated at the time of procurement?

A10: Please estimate a price per unit cost that will ultimately lead to a total not to exceed amount for CLINs that involve procurement.

Q11: Which indirect rate should be used for generating the cost proposal? The Company’s most recent provisional rate negotiated with HHS? The recently-submitted, but not yet negotiated rate?

A11: Please submit the most recent approved negotiated rate agreement with HHS.

Q12: Can you confirm that section L.4.3.5 is asking that proposed major subcontractors also complete

Past Performance Questionnaires covering the previous 3 years? What constitutes a “major” subcontractor?

A12: For the purposes of this solicitation, a major subcontractor is defined as one performing overall work with a value of $500,000 and above.

Q13: How will changes in the Company’s indirect rate be handled over the course of the contract? Will there be an opportunity for true-up?

A13: Indirect rate adjustments based on final negotiated rate agreements may be allowed during the life of the contract.

Q14: The solicitation mentions two different production levels that would be of interest to the USG: 680 m2 standard and 2,000 m2 for surge. Can you clarify the specifics behind these target volumes and the logistics for procurement?

A14: Per Section 4.3.1 of the SOO, the initial procurement under CLIN 0002 is for up to 680 m and the precise amount is at the sole discretion of the USG. The logistics are mentioned in Sections 4.3.4 and 4.4. If considered for award, the actual amount (unit increments to meet up to 680 m

) and specifics of VMI may be discussed during contract negotiations.

The additional procurement (Surge Capacity) for 2000 m is an Option (CLIN 0005) which may or may not be exercised at the sole discretion of the USG. All Offerors are required to provide information in a tabular format with cost and schedule for procurement in 100 m increments as mentioned in section 8.1 and see applicable conditions in section 4.3.

Q15: Are these referring to annual production capacity (i.e., the ability to manufacture the amount in a year) or to product availability (i.e., the amount of product that would be on-hand for immediate procurement)? The former depends completely on the manufacturing facility, workforce, and the length of the production process; the latter would also involve the product shelf-life.

A15: Please refer to section 4.3.1, which covers the initial procurement at the sole discretion of the USG, as product availability up to 680 m . The production capacity shall be calculated based on the information provided in section 4.3.2.

Q16: There are accompanying questions related to the time-frame necessary to achieve the capacity.

Are these questions directed at the time it would take to manufacture the target amount (e.g. 680 m2) of product? An example response could be “the requested product could be manufactured in 6 months of operating at full capacity”. Alternatively, is the question asking about how long it would take the company to reach an overall capacity of 680 m2 per year? Responses could be “we are currently at that capacity” or “it would take 1 year to scale-up to the requested annual capacity”

A16: Please refer to section 4.3.2, which requires a production plan and timeline under normal market conditions for product availability up to 680 m

If the current production capability is unable to meet the stated availability, then information (production plan and timeline) can be provided that would allow the Offeror to meet this overall requirement in a defined period of time.

Q17: Similarly, for procurement, is the USG looking to procure a total of 680 m2 over a set period of time? If so, what is the anticipated timeframe? Is the intent to procure and maintain an inventory of 680 m2 for the entirety of the 5 year contract, which depending on the product shelf-life could require procurement of a larger total volume to replace product lost to expiry?

A17: The USG is seeking product availability up to 680 m which meets either criteria 4.1 or 4.2.

The ‘timeframe’ would depend on the when the product becomes eligible under the criteria and the production capacity. Please note that procurement of products must be initiated within the 5 year period of performance.

The initial procurement (under VMI) negotiated during a potential contract award would be for a defined amount of product over a timeframe (driven by the production capacity).

Product expiring during this time-frame has must be replenished to maintain the inventory amount negotiated.

Q18: Section C.1 paragraph 4.3 encourages use of Vendor-Managed Inventory to minimize product expiry. Once FDA has approved the product for sale, if the volume of manufactured product for emergency use (up to 680 m2) exceeds the product volume that can reasonably be rotated into commercial sales channels, will the USG purchase the excess product? Or should the inventory be restricted to align with commercial demand so as to avoid product expiry? During the period prior to FDA product approval but after gaining pre-Emergency Use Authorization, is it the USG intent to purchase and maintain in inventory all unexpired product for use in an emergency?

A18: The reasonable expectation is that Offerors would at least have a defined production capacity to meet the commercial demand. The initial purchase (and VMI) would allow the Offeror to rotate the product through commercial channels, replenishing the inventory with fresh batches for use by USG (in an emergency). Only the excess, unsold units up to the negotiated procurement amount are paid for by the USG under CLIN 0002.

All Offerors are expected to provide a plan under section 4.3.2. and section 4.4. to include production capacity that balances inventory management, processes for commercial sales

(upon approval), assumptions for product stability, and a plan which minimizes or eliminates loss due to expiry.

Q19: With the goal of “stockpiling” the material, would we be able to supply the required amount over a period of time (ie. 6 months to 1 year)? This would give us time to ramp up production and our supply chain.

A19: Please refer to answers to questions 16 and 17.

Q20: Will this be a “sole provider” award or will the quantity be divided up among multiple companies?

A20: It is anticipated that one or more awards may be made from this solicitation. The

Government will ultimately make a final decision based on best overall value prior to award of any contract.

Q21: Is the intent to shut off production after the stock pile quantity is achieved? This would be shutting down the additional facilities/equipment that would be used for this production.

A21: No, the intent is not to shut off production after the stock pile quantity is achieved as the

USG cannot predict or comment on future procurement needs.As mentioned in section 4.3.1, initial procurement considered under CLIN 0002 is for up to 680 m

. Additional procurements may be considered under CLIN 0005 also at the sole discretion of the USG.

The expectation is that commercial use for one or more indications would allow for the product to be available in the market place enabling VMI in the future. All Offerors are advised to factor this in their proposal when establishing production capacities and projections.