Q AsRFP11100SOL00020.pdf

No. Question Response Solicitation Revision

SECTION B – Supplies or Services and Pricing/Costs, page 2 – Section B.2 - Contract Line Item Numbers

1. No minimum ordering quantities are indicated in CLINs 0008-0012. What are the minimum ordering quantities for the CLINs 0008-0012?

Schedule B.2 has been modified Yes

SECTION B – Supplies or Services and Pricing/Costs, page 2 – Section B.2 - Contract Line Item Numbers Under the max quantity column header in Section B.2 CLIN Table, pgs 2-5 In each of the Tables, do the Maximum Quantities refer to the total quantity that could be ordered during that Period or per Task Order? In the Base Period Table the quantities covering a 36-month time period are the same as the Option Period Tables covering a 12-month time period.

What is HHS’ intention?

The max quantity refers to maximun quantities that can be ordered during the Base period (36) months. The maximum quantity for the life of the contract is equal to the maximum quantity for the Base Period plus the maximum quantity of Option period 1 and 2.

Yes

Solicitation 11-100-SOL-00020

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

What is HHS intention?

SECTION B – Supplies or Services and Pricing/Costs, page 3 – Section B.2 - Contract Line Item Numbers

4. In CLIN 0013, there is no mention of single-dose vial (SDV) in the UNIT column. Is this accurate?

Added SDV Yes

SECTION B – Supplies or Services and Pricing/Costs, page 3 – Section B.2 - Contract Line Item Numbers

5. Specific to CLINs 0014A&B, is the contractor supposed to provide one blended rate or three separate rates as described on pg. 11 – Section C.2 Detailed Description?

For the purpose of providing costs for CLINs 0014A and B offerors should provide three separate rates.

SECTION C – Statement of Work, pg. 6 – Section C.1 - Statement of Work/Background “Contractor without adjuvant programs will not be required to provide CLIN 0005 and 0007B”

6. Does this apply to the other adjuvanted CLINs 0011 and 0012 (on pg. 10)?

See Section C.1 Summary of CLINS. Yes

Questions and Answers

RFP No. 11-100-SOL-00020

Solicitation 11-100-SOL-00020

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

SECTION C - Statement of Work, page 7, – Section C.2 - Detailed Description of CLINs CLIN 0001 “under item 0001, “the Contractor shall provide optimized master and working seed lots…”

7. We request that HHS revise the Solicitation as necessary to confirm that the optimized master and working seed produced under CLIN 0001 will not become Government Property after acceptance by the Government, but will remain the property of the Contractor.

The master and working seed produced under the contract and accepted by HHS will become Government property.

Yes

SECTION C - Statement of Work, page 7, – Section C.2 - Detailed Description of CLINs CLIN 0001, bullet 3 “Submit seed samples to the FDA for testing and approval for use in vaccine production”

FDA/CBER must confirm the antigenic identity and approve all seeds used for licensed vaccine production in the United States. FDA/CBER does not test or approve No

8. Would HHS find it acceptable to submit seed samples to any appropriate governing agency for testing and approval for use in vaccine production?

seeds under IND; the opportunity to use another appropriate agency is acceptable in this case.

SECTION C – Statement of Work, pg. 8 – Section C.2 - Detailed Description of CLINs CLIN 0004, Bullet 1 “…or when required by HHS.”

9. Could this requirement be restricted to declarations of pandemic influenza or other such public health emergency as declared under applicable U.S. law?

This requirement will be likely required in a public health emergency. No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

SECTION C - Statement of Work, page 8, – Section C.2 - Detailed Description of CLINs CLIN 0002, bullet 4 “Provide Certificates of Analysis for the manufactured lot.”

10. Since non-cGMP pilot lots are not quality managed and no official Certificate of Analysis would be prepared, would a summary of assay results be acceptable?

CLIN 0002, bullet 5 “Stability testing shall be performed applying FDA cGMP guidelines.”

11. Since the non-cGMP pilot lot is not required to be prepared under cGMP conditions and not acceptable as cGMP starting material, could the contractor perform a non-quality controlled stability study following procedures and protocols similar to cGMP guidelines for stability

Summary of assays is acceptable; non cGMP stability study following procedures/protocols for cGMP is acceptable

No p g y programs? If no, please provide a non-cGMP alternative.

SECTION C - Statement of Work, page 8, – Section C.2 - Detailed Description of CLINs CLIN 0002, bullet 5 - CLIN 0003, bullet 8 - & CLIN 0003, bullet 7 “Execute a stability program for thirty-six (36) months.”

12. Because reagents may not be available for earlier time points, does HHS accept the fact that stability testing will not be possible until certified reagents are available? If no, please clarify.

Yes. Finished product cannot be formulated until calibrated reagents are available so the stability program will start when reagents are available. Potency testing using alternative (crossreactive) reagents could be initially requested by HHS in agreement with CBER if reagents production is delayed.

No

SECTION C – Statement of Work, pg. 9 – Section C.2 - Detailed Description of CLINs CLIN 0006, Bullet 3, “The government reserves the right to review the security system in place and request updates as needed”

13. If security system updates are requested by HHS, will HHS provide reimbursement for such updates?

No, HHS will not provide reimbursement for such updates. It is the manufacturer's responsibility to be able to store products according to the described CLIN 0006;

A pre-award security site visit can occur as described in L.3.8.

No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

SECTION C – Statement of Work, pg. 11 – Section C.2 - Detailed Description of CLINs

14. Are the shipping locations referenced in CLIN 0014A&B, geographic place holders? If yes, please stipulate the specific locations, as shipping costs vary from location to location.

For the purpose of evaluation of costs for CLINs 0014 A and B offerors should provide shipping costs to city/airport listed in the CLINs

No

SECTION C – Statement of Work, pg. 11 – Section C.2 - Detailed Description of CLINs

15. CLIN 0014B - When shipping internationally, is the destination considered the clinic, or the consignee at the designated airport?

See Section C CLIN 0014B Yes

SECTION C – Statement of Work, pg. 11 – Section C.2 - Detailed Description of CLINs CLIN 0014B, Bullet 4, “Address all applicable import/export permitting and pp p p p g regulations”

16. Because product registration lead time is long and variable, does HHS require the contractor to register their product in every country globally in order to address the applicable import permits and regulations for human-use of their vaccines or will a WHO pre-qualification certification suffice?

Offerors will not be required to register their product in order to respond and perform CLIN 14B No

SECTION C – Statement of Work, page 12, Section C.2 - Detailed Description of CLINs

17. CLIN 0017 - Should filling of the clinical lots and associated stability testing costs be captured under CLIN 0017?

Formulation and filling activities for clinical lots will be performed according to CLINs 0008-0012 No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

SECTION C – Statement of Work, page 12, Section C.3 - Additional Requirements “The contractor shall allow HHS personal, including BARDA staff to perform onsite auditing…”

18. What is the definition of an onsite audit and inspection?

What is the intended use of audit reports and inspection findings?

Please review FAR clauses 52.215-2, 52.246-1, 52.246-2 and 52.246-16 No

SECTION C – Statement of Work, page 12, Section C.3 - Additional Requirements “The contractor must submit a detailed production and delivery schedule for bulk vaccine, bulk adjuvant, and final container within 24 hours after delivery order is received.”

19. Because specific situations in case of a future pandemic event cannot be predicted, contractor may not be able to

The requirement will not be changed. The 24 hour submission of delivery schedule after receipt of a delivery order will be a result of an on-going discussion between the Contractor and HHS and the Contractor No p , y commit to submitting a delivery schedule within 24 hours after receiving a delivery order. Examples of unknown situations include: seed availability, productivity and other public health demands, etc. Please change requirement of “24 hours” to “a mutually agreeable timeframe.”

should be ready to submit a delivery schedule within 24 hours after delivery order is recieved.

SECTION C – Statement of Work, page 12, Section C.3 - Additional Requirements “In case of a pandemic event”…

20. Who is responsible for declaring a pandemic event?

A "pandemic event" occurs when the US Secretary of Health and Human Services or the President of the United States declares a public health emergency in reponse to a disease outbreak (see National Response Framework, January 2008).

No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

SECTION C – Statement of Work, page 13, Section C.3 - Additional Requirements “one year after award the contractor must prepare a pre-

EUA…”

21. Why would a contractor submit such a document one year later if no services have been performed? Under which CLIN should the contractor propose the cost for the preparation of the Pre-EUA document?

Contractors shall provide documentation to HHS to support a pre-EUA document preparation. This information will include i.e. summaries of safety and efficacy data and investigator's brochure.

Yes

SECTION F Deliveries or Performance, page 16

22. In past RFPs, there has been a table for “Dates of Delivery or Performance”, but it is not included in this RFP.

What are the dates for Delivery or Performance for each

CLIN?

The Ordering Period and/or Delivery or Performance for this contract is listed in Section F.1 and applies to all CLINs, unless otherwise stated in the RFP.

No

SECTION F Deliveries or Performance, page 16, Section

, p g , F.2 -b - Place and Method of Delivery of Items Under this Contract “The place of delivery should be provided to the contractor no less than 24 hours prior to shipping.”

23. Because shipping resources, especially to international destinations, must be scheduled in advance, could the requirement be rephrased to state “within a reasonable timeframe”?

See Section F.2.b. Yes

SECTION F Deliveries or Performance, page 17, F.4 Contract Deliverables & Distribution. Section F.4 provides that “delivery will be required as set forth in FAR 52.247- 35 F.O.B Destination, Within Consignee's Premises (APR 1984). Section F.5 incorporates by reference FAR 52.247- 34 F.O.B. Destination”. 4. Which provision is controlling, FAR 52.247-35 or FAR 52.247-34?

FAR 52.247-35 Yes

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

Section H Special Contract Requirements, page 24, Section H.14 - Manufacturing Standards requires that “Contractor shall comply with cGMP in the manufacturing, processing of packaging of all products under the contract”. 25.

However, CLIN 0002 seeks production of non-GMP Influenza Vaccine. Please clarify this discrepancy.

The discrepancy in Section H.14 has been corrected. Yes

Can you clarify that 'cGMP Influenza Vaccine Bulk Lot' refers to a monovalent influenza antigen concentrate (often described by manufacturers as 'Monovalent Pooled Harvest') produced from a seed strain specified by HHS?

Yes No

CLIN 0005: cGMP Adjuvant: Bulk Lot(s) – is 'classical' Aluminum adjuvant to be considered under this CLIN, or is this restricted to the newer, more novel adjuvants (e.g.

ASO3, MF59)? Both Aluminum Phosphate and Aluminum

If the contractor is proposing to provide Aluminum adjuvant to respond to CLIN 005 should also provide supporting data which demonstrate immunogenicity of the adj anted accine satisf ing CHMP and CBER

No) p Hydroxide adjuvants have, I believe, been used in existing H5N1 vaccines.

the adjuvanted vaccine satisfying CHMP and CBER criteria.

Does HHS/BARDA believe that the transfer of 'a qualified virus reference strain as designated by HHS' to a manufacturer, as specified under CLIN 0001, and the subsequent use of this virus strain in manufacturing activities may trigger the provisions of the World Health Organization Pandemic Influenza Preparedness Framework? In particular, does BARDA consider that a manufacturer may be considered a 'recipient' under the provisions of the SMTA2 for transfers of materials outside of the GISRS, and therefore need to respond in some way to the obligations under Article 4 of the SMTA2 (i.e set aside 10% of production, donate vaccine into a stockpile etc.)?

While the full framework and interpretation of the WHO PIP Framework are not fully defined at this point, it is reasonable to expect that any materials, reagents, seed viruses, vaccine strains, sequences, etc that are deemed PIP Biological Material will be regulated by the WHO PIP Framework SMTA provisions. Specifically, any materials that enter into the WHO GISRS network that then move outside the network, such as to any manufacturer, will be expected to follow provisions of SMTA2. The method of satisfying options within SMTA2 is to be negotiated between the WHO and Manufacturer.

No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

Given the complex nature of the RFP and the information required for a compliant proposal, will HHS consider extending the proposal submission date to May or June of 2012?

No. The due date for proposals is as indicated in RFP Amendment 0001 posted on March 9 2012. No

Will HHS consider proposals from contractors that desire to participate in a limited number of CLINs? If so, does HHS have minimum criteria as far as which CLINs must be priced in a proposal in order for it to be compliant?

Section C.1 Summary of CLINS. No

In the Tables that span from Pages 2 to 5, can HHS explain what is required under the “Extended” column? In the same tables, is the information requested under the “Total Price” column, the price to the government if the maximum quantity of product is procured under each CLIN?

The Total Extended Price is equal to the Maximum quantity multiplied by the Unit Price. No

Page 25 indicates that “Contractors will not be required to Y i d t i th i i d t g q propose on all TORs.” Are there any minimum response criteria for the successful offeror? Could a successful offeror theoretically not respond to any TORs at all?

Yes, in order to receive the minimum order guarantee as listed in Section B.3, successful offerors must respond to at least one (1) TOR.

No

31 Can HHS clarify its position with regards to indemnification of pandemic and/or prepandemic vaccines manufactured through this initiative?

HHS is currently reviewing its policy regarding liability relief including the PREP Act and cannot at this time provide contract specific information regarding indemnification. If future guidance is provided prior to the close or the RFP, information will be provided by amendment.

No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

Page 5, B.3, 1. Delivery Order and Task Order Type indicates that the task orders issued under this contract will be firm-fixed price. Will the firm-fixed price contracting mechanism be used for CLIN0016 and CLIN0017 as well?

Based on the fact that protocols will be provided by HHS prior to execution of the TOR, would it be more appropriate for these CLINs to be cost reimbursable since the scope of work for is not yet fixed? Pricing these CLINs at firm fixed seems to be put the offeror at great risk given their amorphous nature.

For purposes of costing CLINs 0016 and 00017 the offeror should price these CLINs according to the described activities. A more detailed description has been added to the section C.2 in the amended solicitation.

Yes

Page 5, B.3, 2. Minimum and Maximum Quantity indicates that the minimum guarantee under the contract is one (1) lot of CLIN0001. Given the level of commitment required to respond to the RFP and the subsequent task orders, will Minimum order guarantee is set as defined in B.3.2 Nop q HHS consider increasing the minimum order that will be procured under this contract?

Could HHS provide rationale for requiring CLIN0016 and CLIN0017? HHS requires licensure or a complete Phase III CSR as a prerequisite for contract award however these CLINs are for additional clinical and preclinical studies.

Are these CLINs in anticipation of a potential regulatory requirement to conduct studies prior to product use in response to a pandemic event?

Task orders for CLIN 0016 and CLIN 0017 can be issued anytime after award not only during a pandemic event. Additional preclinical and/or clinical studies may be warranted for newly emerged influenza viruses that pose a pandemic threat. Offeror must include costs for CLINs 0016 & 0017.

No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

On page 25, Task Order Procedures, the RFP details the information that must be provided by the contractor in response to a task order which includes substantial pricing justification. Given, that the contractor is providing pricing information as part of the initial proposal response, can HHS clarify why this level of detail and additional information is required at the time of TOR issuance? Can an offeror quote a different price in response to a TOR than what was included in the original proposal response for a specific CLIN? Requiring a second level proposal process seems to conflict with the theoretical advantages offered by the IDIQ mechanism.

The instruction provided in the RFP and resulting contract will be modified, as needed, at the time task orders are issued. The list of requirements will be specified in the TOR.

No

On Page 9, for CLIN007A and CLIN007B the contractor requirements include transfer and storage of pre-pandemic Only contractors with stored vaccine and adjuvants from q g p p influenza bulk vaccine. Can an offeror that manufactures its product overseas and plans on storing product within the US price into these CLINs, expected shipping and permitting costs?

y j previous contracts will provide costs for CLINS 0007A and 0007B. The products are already stored in the US, no shipping and permitting costs are expected

No

Will a contractor that submits a proposal without pricing CLIN0010 and CLIN0012 be considered compliant? Some offerors may have products that are not licensed and/or suitable for use in multi dose vials based on regulatory guidance.

See Section C.1 Summary of CLINS. Yes

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

CLIN0018 Section C3 indicates that Contractors with an unlicensed influenza vaccine shall prepare all activities (described in the following CLINS) using the same processes and testing as those described in the BLA document in preparation. In the event that minor manufacturing process differences exist, due to FDA guidance, between the offeror’s seasonal and pre-/pandemic vaccines, please confirm that a seasonal vaccine with a finalized Phase 3 CSR and a BLA in preparation fulfills the RFP’s technology requirements.

Proposals which meet the mandatory criteria for eligibility (M.2.) will be evaluated according to Section M.

No

On Page 26, the RFP states that contractors are required to propose hourly rates for each labor classification to each TOR with cost reimbursable contract line items proposed for other elements of cost. Will the TORs be cost S t Q ti b 35 N39 reimbursable in nature? Does this conflict with the fact that Page 5 indicates this opportunity is “firm-fixed price” and the per unit pricing structure required in the tables on pages 2 through 5?

See response to Question number 35. No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

The RFP Mandatory Criteria states "To be eligible for award, the offeror shall produce vaccines against influenza and influenza strains with pandemic potential; shall demonstrate a successful experience in the manufacturing of influenza vaccine by:

• Holding a US influenza vaccine license OR

• Have developed an influenza vaccine as evidenced by a final clinical study report from a Phase 3 clinical study conducted under a FDA Investigational New Drug application sponsored by the Offeror."

Please confirm if a vaccine would meet the Mandatory Criteria if it is unlicensed, but has had a BLA submitted for the seasonal version of the vaccine.

Yes, however the proposal will be evaluated for mandatory criteria for elegibility. If the vaccine is not licensed the final CSR shall be submitted for evaluation together with any information of BLA submission.

No

CLINS 0002 (Non-GMP Influenza Vaccine: Pilot Lot(s)), 0003 (cGMP Influenza Vaccine: Clinical Lot (s)), 0004 (cGMP Influenza Vaccine: Bulk Lot(s)) and 0005 (cGMP Adjuvant: Bulk Lot(s)):

a. If Offeror is to determine lot size, how will USG compare competing offers and Task Order bids?

b. Can Offerors propose tiered pricing based on numbers of lots to be purchased?

A) The offeror in the proposal should indicate the lot size. B) Yes No

Under CLIN 0004 (cGMP Influenza Vaccine: Bulk Lot(s)) the RFP states the contractor shall "provide a master stability program for thirtysix (36) months to HHS" and additionally "ensure that sufficient samples are included to extend the stability program up to one-hundred and twenty

(120) months." Please confirm that the total maximum period for storage/stability is 120 months.

The total duration (base plus option periods) of the contract will be 60 months. No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

Under CLIN 0006 (Storage of Bulk Lot(s) of Vaccine and/or Adjuvant) the RFP states that storage of material shall be at an FDA-licensed facility. Would it be possible to storage material at a non-FDA licensed facility, as long as the facility is approved by HHS and material is stored under FDA cGMP guidelines (as per similar past HHS RFPs)?

Yes, as long as the facility is locally licensed. No

CLIN 0006 (Storage of Bulk Lot(s) of Vaccine and/or Adjuvant) and CLIN 0007A/B (Storage of Bulk Lots of Vaccine and/or Adjuvant from Prior Contracts):

a. Is the contractor responsible for any loss of material (with the exception of loss due to discretionary movement) post 60 months from date of manufacture?

b. Are there specific requirements regarding physical

A) Yes B) Products must be segregated in dedicated locked storage locations or locked cages. C) see response to Q estion n mber 11

Nop q g g p y segregation of batches?

c. If HHS requests additional physical segregation or security improvements which exceed typical GMP regulations, will HHS reimburse for improvements?

to Question number 11.

Under CLIN 0006 (Storage of Bulk Lot(s) of Vaccine and/or Adjuvant) the RFP states "The Contractor is responsible for all costs (including replacement of lost materials) associated with their discretionary movement of the materials storage site." Please confirm that the USG will be responsible for all costs, including replacement of lost materials for USG-directed moves.

If necessary, at the time of a USG-directed move, the terms of the move will be negotiated with the contractor. No

CLIN 0007 addresses storage of Bulk Lots of Vaccine or Adjuvant from other contracts. Please confirm that "other contracts" refers only to other contracts received by the Offeror.

Other contracts means previous contracts awarded to the Offeror from HHS/ASPR/BARDA. No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

CLIN 0007A/B (Storage of Bulk Lots of Vaccine and/or Adjuvant from Prior Contracts):

a. Continue stability for 60 months – is this from original date of manufacture, or from date of any award resulting from this RFP?

60 months from any award resulting from this RFP. No

CLIN 0014A (Domestic Shipping of CLINS 0008-0012) / CLIN0014B (International Shipping of CLINS 0008-0012):

a. What assumptions should be made regarding quantities to be shipped per location?

b. Does USG accept material upon delivery to final destination?

c. Will USG reimburse Offerors for transport insurance?

A) 10 pallet per location. B) Delivery is per FAR 52.247-

35. C) Transport insurance should be included in transportation costs

No p

For animal studies under CLIN 0016 (Influenza Vaccine and/or Adjuvant Animal Testing) please clarify what contract provision will provide for study material.

At the direction of HHS, study materials may be withdrawn from the stored product of one of the CLIN of the contract.

No

Please clarify if the animal testing under CLIN 0016 (Influenza Vaccine and/or Adjuvant Animal Testing) is to be performed in accordance with GLP.

Pre clinical testing shall adhere to GLP standards of quality as defined in 21CFR58. No

CLIN 0016 (Influenza Vaccine and/or Adjuvant Animal Testing) states that safety, stability and immunogenicity will be monitored. What parameters are intended to monitor safety? (for example: abnormal toxicity/general safety testing, routine observations of viability, body weights)

When a TOR is issued, these parameters will be-redifined to suit the targeted endpoit of safety. For purposes of costing CLIN 0016, an example protocol for animal immunogenicity is provided (pg 11)

Yes

For animal testing under CLIN 0016 (Influenza Vaccine and/or Adjuvant Animal Testing) will 2 intramuscular doses of test/control article be administered to mice?

See response to Question number 51; for costing purposes, an example protocol is provided in the RFP. Yes

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

For animal testing under CLIN 0016 (Influenza Vaccine and/or Adjuvant Animal Testing) will 3 bleeds be performed for immunogenicity testing (pre-study, 2 weeks post-first dose, and 2 weeks post-second dose)?

See response to Question number 51; for costing purposes, an example protocol is provided in the RFP. No

For animal testing under CLIN 0016 (Influenza Vaccine and/or Adjuvant Animal Testing) will both hemagglutination inhibition (HI) and microneutralization (MN) assays be required?

See response to Question number 51; for costing purposes, an example protocol is provided in the RFP. No

For animal testing under CLIN 0016 (Influenza Vaccine and/or Adjuvant Animal Testing) is validation of the HI and MN assays required and funded?

The validation of these assays is required, but funding for such activities is not provided. No

For animal testing under CLIN 0016 (Influenza Vaccine and/or Adjuvant Animal Testing) what interval between studies is anticipated for CLIN 0016?

This is yet to be defined and to be discussed with contractors as needed. For costing purposes of this RFP, refer to question 51.

No p q

For animal testing under CLIN 0016 (Influenza Vaccine and/or Adjuvant Animal Testing) how many studies per year are anticipated?

This is yet to be defined and to be discussed with contractors as needed. For costing purposes of this RFP, refer to question 51.

No

For animal testing under CLIN 0016 (Influenza Vaccine and/or Adjuvant Animal Testing) is it the government’s intent to award individual task orders or one overall task order to address the efforts included in CLIN 0016?

Individual task orders will be issued as needed. No

CLIN 0017 (Influenza Vaccine and/or Adjuvant Clinical Testing): Safety, immunogenicity and dose-ranging studies may have a different variety of prices, driven by number of subjects, number of visits, country, and follow-up duration.

Without additional detail for the requirements of these studies, it will be difficult to provide a cost for this CLIN.

Please provide additional guidelines to the extent possible.

For the purpose of providing a cost for CLIN 00017, a sample protocol is provided; the study will include 6 arms (50 subject/arm), two vaccinations, three bleedings (one pre and two post each vaccination), a six month follow-up and the study should be conducted in the US.

Yes

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

Would HHS consider the use of SRID reagents from authorities other than CBER? (e.g. TGA, NIBSC)

FDA/CBER reagents must be used for vaccine licensed in the US unless otherwise directed by FDA/CBER.

HHS would consider using reagents from appopriately qualified authorities other than CBER for vaccines begin evaluated under IND.

No

In section C.3 Additional Requirements the RFP states "One year after award, Contractors must prepare a pre-EUA document which shall be reviewed and submitted to HHS for subsequent submission to FDA." Please indicate what content is required in this document.

See response to Question number 19. No

The current RFP does not provide for the Liability Protection or Authorization and Consent language. Please clarify how and when these issues will be addressed.

See response to Question number 31. No

The RFP does not contain any provision addressing y p g delivery timing. Please provide delivery timing requirements for each CLIN.

Delivery timing will be specified in the TOR No

In section B.3.2 Minimum and Maximum Quantity the RFP states that "The minimum ordering limitation and Government guarantee under this contract is 1 lot of CLIN 0001 at a total value of $TBD." Section B.5 Multiple Award Ordering states "All contractors may receive orders for CLINs 0001 up to the minimum guaranteed amount."

a. Please confirm that all contractors will be guaranteed a minimum order of 1 lot of CLIN 0001.

b. Does the minimum order limitation apply only to the Base Period, or to the Base Period and the Option Periods?

A. Yes. B. The minimum guarantee applies to the life of the contract. No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

In section C.3 Additional Requirements the RFP states "In case of a pandemic event the contractor must submit a detailed production and delivery schedule for bulk vaccine, bulk adjuvant, final containers within 24 hrs after delivery order is received." Twenty-four hours to provide a delivery schedule after receipt of an order is insufficient time. Will the USG consider 1 week?

See response to Question number 21. No

Please confirm that RFP sections F.1.a. and F.1.b.

pertaining to Ordering Period and Period of Performance is related to the Base Period only.

Please review section F.1.c. No

In section F.2 Place and Method of Delivery of Items Under this Contract the RFP states "the place of delivery shall be provided to the Contractor no less than 24 hours prior to shipping." Will USG consider 7 days notice?

See response to Question number 21. No pp g y

In section G.6.b (Payment Conditions) the RFP states "Accepted product which falls into any of the following categories shall be replaced by the contractor at no cost to the USG.

1. If product does not meet any criterion outlined in this contract."

Does this mean that if the government discovers non-compliance at any time post-acceptance it can demand replacement? Please clearly define non-compliance. Is there any limit on timing for determination of non-compliance, given that material changes over time? How is this non-compliance protection different than protections for latent defects in the FAR?

Please see FAR 52.246-2 No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

In section H.18. Method of Ordering / Task Order Procedures the RFP states that "When the Government elects to fill a requirement that is estimated to exceed $3,000, the CO shall provide a TOR to the awardees that received contracts for the particular Part for which responses are being solicited." Task Order Procedures also states, "A TOR shall, at a minimum, include a Statement of Work, evaluation factors, specific reporting requirements, deliverables and delivery schedule, the relevant importance of technical and cost factors, and any special instructions," which seems to suggest that contractors will need to submit Task Order proposals in order to be eligible to receive such orders. Please clarify to the extent that the USG will place

See response to Question 35. No y p orders based on costs negotiated in the Base contract vs. any activity which will require offerors to submit Task Order proposals. Is it possible that TORs could be used on all or only certain CLINs?

In section H.18. Method of Ordering the RFP states all awardees are to be given the right to compete for task orders over $3000 unless a FASA statutory exemption applies.

Please clarify exactly when the USG will use Task Orders and exactly how the process will work.

See response to Question 35. No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

In section I.3.g.c (52.217-9 Option to Extend the Term of the Contract (MAR 2000)) the RFP states "The total duration of this contract, including the exercise of any options under this clause, shall not exceed eighty four (84) (months)." A total duration of 84 months would seem inconsistent with the possibility of the USG making bulk purchases in Option Period I or II, and if the USG then requests storage under CLIN 0006 for 60 months. Please clarify.

Section I.3.g.c has been amended. Yes

L.1.b (FAR 52.216-1 Type of Contract (Apr 1984) the RFP states "The Government contemplates award of a firm-fixed price indefinite delivery/indefinite quantity type contract resulting from this solicitation with two option periods."

Firm Fixed price awards would seem inconsistent with the See response to Question 35. Nop need for detailed cost information required for TOR. Please clarify what type of awards are to result from TOR (FFP or Cost-reimbursement).

Is the unit pricing binding throughout the contract term, or will contractors be able to negotiate price on a task order by task order basis in order to account for changes in market condition and technical assumptions?

Unit pricing is binding as listed at time of award for the base period and each option period. No

CLIN 0001: Will BARDA or another agency on BARDA’s behalf provide the pre-master seed? Will the pre-master seed be provided to a contractor in a manner and form suitable for BSL2+ handling?

If pre-master seed means a vaccine candidate, yes the vaccine candidate will be provided to the contractor by CDC or other WHO collaborating center in a manner and form suitable for BSL2+ handling.

No

CLIN 0002-0003: A) Is the requested preparation of purified influenza immunogen to be done using bromelain cleavage of purified HA? B) Is there a standard protocol to be followed?

A) Yes. Whenever technically feasible. B) Yes. But the protocol might require minor modifications No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

CLINs 0001-0004 refer to vaccine. Does BARDA intend these CLINs to be for antigen only, or are these CLINs referring to final vaccine product, which in some cases could be a mix of antigen plus adjuvant?

CLINs 0002-0004 refers to antigen only No

CLIN 0007 refers to storage of materials from prior contracts. However, CLINs 0008-0012 do not clarify what materials are to be formulated and filled. Does BARDA contemplate issuing task orders under this contract to formulate and fill materials delivered under prior contracts also?

Yes, this possibility exists. No

It may not be possible for a contractor to respond to all CLINs due to circumstances outside the contractor’s control. Would BARDA permit offerors to propose on only some of the CLINs? For example:

p

CLIN 0008: If the product is licensed only as a MDV presentation, must the proposal respond to CLIN 0008?

CLIN 0009/0011: If the product is an adjuvanted vaccine with separately-vialed antigen and adjuvant that must be mixed before administration, must the proposal respond to CLINs 0009 and 0011?

See Section C.1 Summary of CLINS. Yes

CLIN 0016: If the non-clinical immune protocol will be provided by HHS, does HHS wish the offeror to price the example experiment described as part of CLIN 0016? Is the choice of immuno readout left to the offeror?

See response to Question number 51. No

CLIN 0017: : If the clinical immune protocol will be provided by HHS, does HHS wish the offeror to price the example experiment described as part of CLIN 0017? Is the choice of immuno readout left to the offeror?

Please include HAI and MN analysis Yes

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

Section C.3 states, “In case of a pandemic event the contractor must submit a detailed production and delivery schedule for bulk vaccine, bulk adjuvant, final containers within 24 hrs after delivery order is received. It will be very difficult, if not impossible, for contractors to provide such detailed information within 24 hours. Would BARDA remove this Additional Requirement, or at least require the contractor to provide the information “as soon as reasonably possible given the circumstances” instead of within 24 hours?

See response to Question number 17. No

The RFP does not include any indemnification or limitation of liability of the contractor providing products (such as the PREP Act, for example). Many (if not most or all) contractors will not deliver vaccine or vaccine-related

82 products that may be introduced to a large portion of the population without such coverage, especially if this contract is used by BARDA to procure various pandemic strains.

Does BARDA plan to include some form of indemnity for contractors performing this contract, including potential use of products overseas?

See response to Question number 31. No

Does BARDA believe it is possible that contractors may be required to provide Limited Rights Data such that FAR 52.227-14 Alternate II should be included?

FAR 52.227-14 with Alternate II has been added to the RFP. Yes

Given the likely value of the contract and individual task orders and the possibility of products being produced outside of the United States, would BARDA consider adding FAR clause 52.225-5, “Trade Agreements”?

No, this clause does not apply to this requirement. No

Will there be the opportunity to ask another round of questions, especially if answers to the questions submitted by March 9, 2012 lead to additional questions (in light of the extension of the proposal due date to April 20)?

See Amendment 0002 to the RFP for instructions on additional instructions Yes

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

CLIN 0001 requires delivery of optimized master and working seed lots. For highly pathogenic viruses such as H5 and H7 strains, should contractor assume that HHS will provide a reassortant virus carrying backbone genes and the appropriate HA and NA genes from wild type virus or viral RNA to be handled in BSL2 facilities, or would contractor be required to conduct or have conducted: 1) generation of the 6:2 reassortants in a BSL3 facility, 2) in vitro and in vivo confirmation of vaccine phenotype, and 3) avian virulence testing performed by the USDA? Regarding USDA's avian virulence testing, can HHS comment on what coordination between HHS and USDA regarding conducting this testing, and what timing the contractor

Contractors will receive the materials needed to produce optimized master and working seed lots that can be handled in BSL2+ facilities. Generation of reassortants is not required. BARDA will facilitate coordination between industry and federal agencies.

No g g g should assume for completion and final release by USDA.

If the interest of HHS is to obtain the most rapid possible delivery of the largest quantities of vaccine, contractors would need to stockpile or otherwise pre-position selected long-lead components and materials. Can HHS provide guidance on how rapidly and in what quantities deliveries would be required, and whether HHS envisions providing for stockpiling and/or prepositioning of long-lead components and materials, and if so under which CLIN(s)?

See response to Question number 35. No

88 What influenza vaccine strains does HHS intend to procure under CLIN 0001 through 0004, and in what quantities?

Strains with pandemic potential or pandemic strains if a pandemic is declared. Quantities will depend on the needs.

No

Regarding the bulk and/or filled product produced under CLINs 0004 and 0008 through 0012, should the inventory required expired during the term of this agreement, would the contractors be required to replenish as part of this submittal or would this be a secondary award?

The bulk vaccines and filled vaccine will likely be unlicensed with no expiration date. This contract does not cover any replenishment for expiration reasons.

No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

Can HHS confirm that shipment to storage locations of bulk and/or filled vaccine in excess of current storage capacities at the contractor's currently owned facilities would be deemed (as described in CLIN 0006) to be non-discretionary?

No. No

For international distribution of vaccine under CLIN 0014B, will these shipments be to US military bases which are coverd by the US license or will manufacturers be expected to submit and/or seek in-country or toher (e.g.

WHO pre-qualification) approval for license applications, GMO documentation, and any other applicable regulatory filings in each of the 3 countries identified?

International distribution will likely be requested for donation purposes following WHO requests and manufacturer will be expected to manage appropriate requirements for such distribution of vaccine as needed.

No

CLIN 0016 states that animal studies may be requested to monitor safety, stability and immunogenicity of the vaccine. Specific preclinical testing will be discussed as needed y, y g y Does HHS envsion that wild-type virus challenge studies in ferrets requiring isolation in BSL3 facilities will need to be conducted for highly pathogenic strains, or will HHS perform any required wild-type virus challenge studies which would require isolation in BSL3 facilities?

p p g with specific virus strains as appropriate. CLIN 0016 does not include wild-type virus challenge studies and for costing purposes the sample protocol provided in the RFP should serve as sufficient guidance for response.

No

CLIN 0016 and 0017 state that study protocols will be provided by HHS. Will these protocols be approved in advance by FDA and in accordance with the contractor's license, or will the contractor subsequently be required to see FDA approval for use of these products?

The contractor will hold the IND to perform the studies, it could be an amendement to a current IND or a new IND and the potential need for further review by the FDA may be warranted at the appropriate time.

No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

The size and setting of clinical studies that can be conducted under CLIN 0017 with live attenuated influenza vaccine depends on whether the studies are conducted before a pandemic outbreak is declared or after an outbreak has been declared. Studies of potential pre-pandemic vaccines have been limited to smaller inpatient adult studies while studies conducted after the declaration of a pandemic have included both adult and children and havebeen conducted on an outpatient basis. Given the implication for the size, design and costs of the clinical studies, does HHS anticipate that studies will be conducted prior to the declaration of a pandemic influenza outbreak or once an outbreak has been declared?

Under CLIN 0017 the USG can request contractors to perform clinical studies pre or post pandemic declaration No

The study design givne as example under CLIN 0017 y g g p references a study population of 300 subjects or more, however, under Section B.2 of the RFP the maximum number of subjects per clinical study appears to be limited to 150 people. Can HHS clarify the upper limit of subjects per clinical study?

The number in Section B.2 was corrected to 300 Yes

As the Sponsor of any clinical studies that would be conducted under CLIN 0017, contractors would have ultimate responsibility for the safety of subjects enrolled. In light of this is it correct to assume that contractors and HHS will agree on the final clinical protocols?

Yes the contractor will have the chance to discuss and agree the proposed protocol. No

CLIN 0018 and Section C.4 require submission of monthly technical progress reports, inventory reports, and other documents. Can HHS confirm this requirement will take effect only once an active task order has been initiated? If not, how are contractors expected to recover costs associated with these requirements?

CLIN 0018 requires submission of reports (eg monthly reports) after the first task order and for the entire life of the contracts. Costs for reports are not separately priced under this RFP and any resulting contract.

No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

One year after award, Contractors must prepare a pre-EUA document. There is no CLIN listed for pricing of this element. Should the offeors creat an additional CLIN for this item?

No and See response to Question number 19. No

One year after award, Contractors must prepare a pre-EUA document which shall be reviewed and submitted to HHS for subsequent submission to FDA. Could HHS please clarify what must be requested/applied for in the pre-EUA document? Given the anticipated award date for the contract and the need for task orders to be issued and responded to, it is likely that clinical study activities to support an EUA filing will not be complete one year after award - can HHS clarify expected timing requirements?

See Response to Question number 19. No

Section D.2 requires Freeze Watch Indicators or equivalent q q temperature indicating devices to be packed in each container containing the influenza vaccine. In the vaccine is shipped using validated shipping configurations would the temperature indicating devices still be required for shipment of vaccines?

Yes, qualified freeze indicators or approved temperature monitoring devices will be required for vaccine shipment.

No

Several statements concerning the duration of the contract seem inconsistent: F.1 states that the base period of th contract will be 36 months, followed by two 12-month option periods. I.3.g states that the term of the contract shall not exceed 84 months. Selected CLINs contain requirements for stability testing for periods of 36, 60, and 120 months. Over what time period is the contractor required to perform?

See response to Question number 20 and 71. No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

As written, the Key Personnel clause (G.3) requires the contractor to obtain HHS consent for the movement of identified key personnel to other positions not assocated with this contract. Such restrictions could potentially have the effect of limiting career mobility for an emploee to be placed on the key personnel list for this contract. Further, this requirement does not seem consistent with the firm-fixed price, product delivery nature of the contract. Is HHS willing to offer a contract structure under which HHS consent is not required for diversion or replacement of personnel?

No. No

H.2 Salary Rate Limitation, HHSAR 352.231-70 (January 2010) - According to HHS.GOV this clause is inserted per HHSAR 331.101-70 which states that this should be inserted for NIH, SAMSHA, and AHRQ solicitations and contracts and that it should be for cost-reimbursement, FP, LOE, T&M, or labor hour contracts. Since this is proposed to be a firm fixed price contract with competitive task order awards, what is the need for such information if competition can determine price reasonableness? There should not be any need for this if the competition is based on price reasonableness.

HHSAR 352.231-70 has been deleted from the RFP. Yes

Section M.4.D of the RFP states that the review and analysis of other than cost and pricing date will be part of the basis of evaluation, however the Task Order Procedures section H.18 states that Contractors must submit an itemization of all costs, both direct and indirect, (i.e.

personnel, fringe benefits, equipment, travel, supplies, other direct costs, overhead, etc.) necessary to complete the work.

Is it not the intent of the Government to award these orders based on Commercial Pricing or competition?

See response to Question number 35. No

Questions and Answers

Questions and Responses Acquisition of MCMs for Pandemic Influenza Preparedness and Response

The cover letter of the RFP states Past Performance questionaires are due 4/13/12, but Attachment 4 shows a due date of 4/3/12. Please confirm the 4/13/12 date.

Past Performance questionaires are due 4/20/12. The same date as the amended due date for proposals. Yes

How long after a Task Order is issued by HHS will responses to the Task Order be due?