75A50119R00028_Amendment_1_(9.25.2019)_FINAL_(signed).pdf

(x)

75A50119R00028 x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

ASPR-BARDA

Washington DC 20201 Room 640-G 200 Independence Ave., S.W.

ASPR-BARDA

09/25/2019

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

09/06/2019

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Amendment 1 to RFP 75A50119R00028. The RFP close date is extended to October 21, 2019 at 12 pm Eastern Time. Attachments to the Amendment include 1) Amendment modification body and 2)

Questions and Answers.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

JEFFREY E. BROWN

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

09/25/2019 jeffrey.brown Highlight jeffrey.brown Highlight jeffrey.brown Highlight jeffrey.brown Highlight

RFP 75A50119R00028: Amendment 1

G.11. Negotiated Indirect Rates and Ceiling, is modified as follows:

3. In the absence of an indirect rate agreement the Government may negotiate Rate Ceilings for each applicable indirect cost element. If established, any costs over and above the established cost ceiling shall not be reimbursed under this contract or any other Government contract, grant, or cooperative agreement.

4. If Rate Ceilings are established, the Government is not obligated to pay any additional amount, should the final indirect cost rates exceed the established ceiling rates of the contract. In the event that the final indirect cost rates are less than the negotiated ceiling rates, the Government's obligation shall be reduced to conform to the lower rate.

Indirect Cost Rate Ceiling NTE

Fringe TBD Overhead TBD

G&A TBD

L.2.1. Delivery of Proposals, is modified as follows:

Proposals shall be delivered no later than 12:00 Noon ET on Monday October 21, 2019.

Proposals shall remain valid for two hundred and seventy (270) calendar days after receipt by the Government. Please confirm this on the cover sheet of each, Volume I and Volume II.

L.4.3. Appendicies to Technical Proposal, is modified as follows:

Items below can be revised during negotiations with the successful Offeror and will be incorporated into the contract. The Appendices are in addition to the 50 page limit in the Technical Proposal (up to 90 page limit when including the response to both Sample RTORs). The Appendices shall not exceed 150 pages.

L.5.1. Business Proposal Instructions, is modified as follows:

The business proposal shall not exceed 50 pages (up to 80 pages when including response to both Sample RTORs). The proposal must be signed by an official authorized to bind the Offeror(s) organization and must stipulate that it is predicated upon all the terms and conditions of this RFP. In addition to the main proposal and RTOR proposals the offeror can provide attachments. Attachments shall not exceed 100 pages.

L.5.3.3. Section 6: Past Performance, is modified as follows:

Offerors shall submit the following information as part of their business proposal for both the Offeror and proposed major subcontractors (Attachment #8).

The Offeror shall provide a list of the last five (5) relevant contracts completed during the past three years and all relevant contracts currently in process. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial customers. Any previous activities with BARDA must all be included in the submitted past performance list. Offeror’s that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel.

Please Note: That all Offerors are responsible to provide an answer regarding shipping outside of the BSIP for testing in accordance with Q&A 44.

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED.

# Contractor Questions BARDA Answers Location in RFP

1 Will BARDA please advise where contractors should include our completed attachment #3?

Attachment 3 should be submitted as part of the Appendix. Where appropriate, the Attachment should be referenced within the body of the RFP.

Will BARDA consider removing the 50 page limit from the appendices?

The limit for appendices is revised to 150 pages.

3 SF33 and L.2.1 indicate the proposal should be valid for 120 days; L.6.1 indicates 270 days. Please clarify.

The proposal is valid for 270 days in order to allow for the Offeror's transfer cost quotations to be applied to transfer of legacy biological specimens to the BSIP after award. RFP SF33, L.2.1, L.6.1

For costing purposes, please confirm the Legacy materials will NOT be provided in freezers/LN2 tanks (GFP) and that the Contractor needs to provide them. Legacy materials will be provided to contractor in freezers/LN2 tanks (GFP) and the Contractor does not need to provide freezers/LN2 tanks (GFP) for shipping.

RFP L.4.2 Part 1

If the Legacy materials will NOT be provided in freezers/LN2 tanks, please clarify whether the Contractor or current guardian is responsible for transferring the specimens (to the Contractor's containers) for shipment. This may be a concern if there are security restrictions at the current guardian's facility.

The current guardian(s) will be responsible for transferring the specimens to the awardee contractor facility.

RFP L.4.2 Part 1

6 For costing purposes, please confirm none of the Legacy samples contain Select Agents. None of the current legacy specimens contain select agents

RFP L.4.2 Part 1

7 For costing purposes, are the Legacy Samples currently labeled with legible barcodes? All biological specimens in storage should be labeled appropriately with legible barcodes. Any specimen samples that are not legible will be quarantined and disposed of according to a plan put in place with BARDA.

RFP L.4.2 Part 1

8 For costing purposes, in what format will the data for the Legacy samples be provided?

The data format for the legacy samples has not yet been determined. Please include your capacity for common data transfer methods and formatting in your proposal. RFP L.4.2 Part 1

9 For costing purposes, what format are the Legacy samples in (for example- 2 mL tubes, cryoboxes)? Legacy samples are stored in 2 ml cryotubes and cryoboxes

RFP L.4.2 Part 1

Please confirm there are no current requirements to cost aliquoting of biological specimens, packaging or repackaging of investigational products, outbound sample retrieval/shipping, or sample destruction of the Legacy Samples. If there are requirements, please provide plug number for costing purposes.

We have no current requirements for aliquoting, packaging or repackaging of legacy specimens. We have no current requirements for destruction of legacy samples

RFP L.4.2 Part 1

The Draft RFP Q&A #56 indicates that a Gantt Chart and WBS are not necessary at the IDIQ level, only at the RTOR level. RFP Section L.4.3.3.f (Appendix-Project Management Plan) requests a "Gantt chart and Work Breakdown Structure (WBS)".

Please confirm whether the Government is requesting a Gantt Chart and WBS at the IDIQ level.

The Government is requesting a Gantt Chart and WBS at the IDIQ level. A Gantt Chart and WBS is requested for a realistic timeline to complete the required infrastructure outlined in the SOO to accept legacy specimens and new specimens under sample RTOR0001 and RTOR0002. This will include the COTS equipment, SOPs, and validations of protocols, equipment, and training.

RFP L.4.3.3.f

The Draft RFP Q&A #73 indicates the Security Plan and Continuity of Service Plan will be exempted from the 50 page Appendix limit. Is this still the Government's intention? We will not have exemptions as stated in the draft RFP. We will have a 150 page limit for appendices.

RFP L.4.3.5 and L.4.3.6

“The Offeror shall also provide all labor categories and all labor rates for all positions with any possible work under the prospective contract. The hourly rates proposed for each labor category shall be listed with a crosswalk chart listing out any indirect or overhead rates applicable for all positions.”

a. Does the Government require prime contractors to also include the labor categories and rates for subcontractors as part of this requirement? We note that some subcontractors may be unknown at this point as future task orders may require the inclusion of subcontractors who have not participated in this solicitation.

b. If the Gov’t requires subcontractor information related to labor categories/rates, please confirm the subcontractors can submit proprietary/confidential detailed pricing information directly to the Government?

a. The offeror, to the extent possible should include rates for any subcontractor that is included in the offeror's proposal. b. A subcontractor can submit proprietary/confidential detailed pricing directly to the Government. The subcontractor must directly reference the Prime Contractor and RFP number for whom the proposal is being submitted for.

RFP L.5.2.3 Labor Categories and Labor Rates (page 91)

“The business proposal shall include the business portion of the Offeror’s response” to the sample RTORs" Does the Government require subcontractor pricing for the sample RTORs to be detailed as described in the table of L.5.2.4? And if so, can subcontractor’s provide the proprietary/confidential detailed pricing information directly to the Government?

The Offeror must at a minimum provide sufficient details regarding overall cost of the subcontract in its proposal so that the cost can be evaluated. A subcontractor can submit proprietary/confidential detailed pricing directly to the Government. The subcontracor must directly reference the Prime Contractor for whom the proposal is being submitted. RFP L.5.2.4 Sample RTOR (page 93)

The Draft RFP Q&A #77 indicates "A Past Performance Questionnaires is not required for U.S. Government projects listed in the proposal, when a finalized CPARS record is available". Is this still the Government's intention?

If the CPARS Scores are available and the Offeror can provide reference numbers in the CPARS system, or actual copies of the CPARS scores to the CO, the Past Performance Questionnaire would not be required. It is not enough to say that there are CPARS

RFP L.5.3.3

BSIP 75A50119R00028- Q&As

16 Can the government provide position descriptions for each of the (minimum) six required Key Personnel?

The government does not maintain position descriptions for Key Personnel. The contractor should provide an Organizational Chart and the breakout of key personnel that it believes are required to fulfill this contract.

Describe the roles and responsibilities and the required number of key personnel required. Be sure that resumes are targeted to the positions on the BARDA contract.

M.5.3 and L.4.3.1

Please clarify the differences between the "Principal Investigator/Project Director" and "Project Manager (PM)" requested in L.4.3.1 and the "Chief Scientific Officer, Principal Investigator or Lead Scientist", "Program Director (PD)/Study Directors" and "Program Manager" roles requested in M.5.3

The use of these terms was not intended to denote differences and we suggest for clarity using the titles in M.5.3.The inclusion of Principal Investigator (L.4.3.1.) was an error and should be removed.

M.5.3

18 Is it acceptable for one person to fulfill more than one of the six required Key Personnel positions, assuming they are qualified for both positions?

Yes but you need to describe the roles and responsibilities and provide the percent effort. Also, fill out Attachment 9 for key personnel

L.4.3.1

Per the RACI, the CTP&E Contractor will hold all samples during the study. Please confirm the BSIP Contractor should expect one bulk shipment from each of the six US study sites, of both biological specimens and investigational products, at the conclusion of the study.

The contractor should assume one bulk shipment from the one CTPE central laboratory facility for long term storage of serum samples and another bulk shipment from the CTPE IP vendor.

Attachment #1

The Total Task Order Duration is 29 months, with the final CSR completed in Month

28. If the BSIP Contractor receives one bulk shipment each of biological specimens and investigational products at the conclusion of the study (Month 28 or 29), how should ongoing, long term storage of the samples be costed?

Plan the budget to extend for the duration of the first 5 years, or up to 60 months. Include start up costs for COTS equipment, SOPs, validations etc.

Attachment #1

If the Government's intention is that the long term storage of samples is performed/costed at the IDIQ level, please provide plug numbers for samples per year for cost estimating purposes.

Assume that funding for the legacy specimens will be received at the time of award. Refer to Question #11 for developing the timeline needed to prepare to receive legacy specimens. Budget up to 60 months (5 years) for storage of the legacy specimens based on your timeline. Use plug in numbers from sample RTORs, RTOR0001 and RTOR0002. Specimens are expected to be shipped to the BSIP at the end of each study. Specimens from sample RTOR0001 should be sent around the middle of the second year of the contract. Budget for samples from RTOR0002 at the beginning of the third year of the contract. Data for biological specimens and IP retains are found in the tables on pages 121 and 132 of the RFP. All cryovials should be assumed to be 2ml capacity. For budgeting and developing the timeline, the offeror should assume that: 1) the IDIQ base contract starts on the date of award, 2) Routine RTOR0001 will start 6 months following IDIQ award, and 3) Response RTOR0002 will start 12 months following IDIQ award.

Attachment #1

Please confirm there are no cost requirements for aliquoting of biological specimens, packaging or repackaging of investigational products, outbound sample retrieval/shipping, or sample destruction. If there are requirements, please provide plug number for cost estimating (for inclusion at either the RTOR or IDIQ level).

There are no cost requirements for aliquoting of biological specimens, packaging or repackaging of investigational products, outbound sample retrieval/shipping, or sample destruction..

Attachment #1

23 How is it expected that sample data will be transferred to the BSIP Contractor and in what format (for example- electronically via a portal, csv files)?

It is expected that the current guardian will provide a sample data format DVD. Please include your capacity for common data transfer methods and format to receive common data.

Attachment #1

It is understood that extensive coordination between entities is expected to ensure sample security, but for costing purposes, is the BSIP Contractor or the CTP&E Contractor responsible for packaging and shipping biological specimens and investigational products to the BSIP at the conclusion of the study?

For the legacy samples and for sample RTOR0001 and RTOR0002, assume that shipping costs will be the responsibility of the current guardians and central labs, respectively. For future RTORs, it is anticipated that shipping costs will be included in either the CTPE or BSIP budgets Attachment #1

Per the RACI, the CTP&E will hold all samples during the study. Please confirm the BSIP Contractor should expect one bulk shipment from each of the six US study sites, of both biological specimens and investigational products, at the conclusion of the study. See Question # 19

Attachment #2

The Total Task Order Duration is 12 months, with the final CSR completed in Month

11. If the BSIP Contractor receives one bulk shipment each of biological specimens and investigational products at the conclusion of the study (Month 11 or 12), how should ongoing, long-term storage of the samples be costed? Budget for up to 60 months based on your timeline. See Question 21

Attachment #2

If the Government's intention is that the long term storage of samples is performed at the IDIQ level, please provide plug numbers for samples per year for cost estimating purposes. See Question # 21

Attachment #2

Please confirm there are no requirements for costing aliquoting of biological specimens, packaging or repackaging of investigational products, outbound sample retrieval/shipping, or sample destruction. If there are requirements, please provide plug number for cost estimating (for inclusion at either the RTOR or IDIQ level).

See Question # 10 Also See Question # 22. For shipping biological samples, provide an answer in your proposal to Question # 44.

Attachment #2

29 How is it expected that sample data will be transferred to the BSIP Contractor and in what format (for example- electronically via a portal, csv files)? See Question #23

Attachment #2

It is understood that extensive coordination between entities is expected to ensure sample security, but for costing purposes, is the BSIP Contractor or the CTP&E Contractor responsible for the cost of packaging and shipping biological specimens and investigational products to the BSIP at the conclusion of the study? See Question #24

Attachment #2

Should Attachment 3 be submitted as part of the Appendix, Technical Volume or Other? Is it acceptable to reference the Section(s) within the RFP response where the information requested is located, in lieu of duplicating information within the RFP response? See Question # 1

Attachment #3

Based on the timeframe required to receive responses for the Acquisition Past Performance Questionnaire (Attachment 8), and the time required to evaluate the Government’s answers to questions asked, and to issue RFP Solicitations and evaluate vendor responses and address the pricing related thereto, we respectfully request a two (2) week proposal due date extension. We request the due date be changed from 1200 ET October 7, 2019 to 1200 ET October 23, 2019. This date would also provide us an additional weekend to prepare the proposal and receive internal approvals. The response period has been extended. Please see the SF 30 SF30

The RFP states that “The proposal must stipulate that it be predicated upon all the terms and conditions of this RFP. In addition, it must contain a statement to the effect that it is firm for a period of at least 270 days from the date of receipt by the Government.” 270 days is in conflict with the statement on page 84/107 and the SF33, both of which state that proposals shall remain valid for 120 calendar days after receipt by the Government. Please clarify. See Question #3

L.6 Other Administrative Data

Based on the answer to Question 2 above, and to ensure all bidders price to the same period of performance, please clarify what period of performance the pricing should be based upon. (i.e. if the proposal is due on October 1, 2019 and must be valid for 90 days…or till January 1, 2020-Generally the proposal would be based upon a period of performance starting on January 1, 2020).

The proposals are valid for 270 days, please use a period of performance start date of April 1, 2020.

L.6 Other Administrative Data

The RFP states that “There is a 50 page limit for the technical proposal.” Does this limit include such items as the Cross Reference Matrix, Table of Contents, Cover Letter, etc.?

The cover letter, cross reference matrix and table of contents are not included in page limit of 50 pages. The Appendicies shall not exceed 150 pages. L.2.2 Packaging of Proposals

The RFP states: “The Offeror shall provide a list of the last five (5) contracts completed during the past three years and all contracts currently in process.” Based on the number of contracts a large company (and hence bidders) are working on, we respectfully request that the statement be changed to read: “The Offeror shall provide a list of the last five (5) contracts completed during the past three years and any pertinent contracts, up to five (5) contracts currently in process to demonstrate on-going contractors work.” Would the Government modify this requirement to provide a listing of all contracts to reduce the administrative burden of listing all active contracts? The section is modified to read: "The Offeror shall provide a list of the last five (5) relevant contracts completed during the past three years and all relevant contracts currently in process." (L.5.2.6.). Section 6: Past Performance

The government states that the contractor shall receive shipments of biological specimens from domestic and international BARDA designated sites. Will the contractor be responsible for shipping costs?

For the legacy samples and for sample RTOR0001 and RTOR0002, assume that shipping costs will be the responsibility of the current guardians and central labs, respectively. For future RTORs, it is anticipated that shipping costs will be included in either the CTPE or BSIP budgets

Section C.3.1.1

The government states that the contractor shall receive shipments of biological specimens from domestic and international BARDA designated sites. For budgeting purposes, how many shipments will the contractor receive annually?

For budget purposes, you can use bulk shipments of biological specimens frrom the clinical contractor and IP retains from the vendor. Where needed shipments can be broken down into several shipments according to current best practices.

Section C.3.1.1

The government states that the contractor shall perform inspections at the vial level.

For budgeting purposes, how many vials will be received annually?

For estimating, use the numbers of specimens in the sample RTORs. Refer to the tables provided for biological specimen storage and IP retains on pages 121 and 132 of the RFP

Section C.3.1.1

The government states that the contractor shall store biological specimens at temperatures and conditions in validated units. For budgeting purposes, can we assume that samples will be provided in 2ml cryovials? If not, please provide sizes and quantities of each size.

Yes the contractor should assume that samples will be provided in 2ml cryovials

Section C.3.1.1

The government states that the contractor shall store biological specimens at temperatures and conditions in validated units. For budgeting purposes, how many samples can we expect to store annually in ambient? +4

? -20

? -80

, and LN2?

See Question #21

Section C.3.1.1

The government states that the contractor shall maintain the necessary clean rooms and equipment for aliquoting and labeling. Does the government anticipate the need for a clean room? Or is equipment such as a BSC for sterile aliquoting and handling sufficient?

BSC for sterile aliquoting is sufficient for routine purposes.

Section C.3.1.2

The government states that the contractor shall provide arrangements for testing biological specimens upon request. Will the contract serve only to make arrangements? Or will the contractor incur cost associated with testing? If the latter, what testing would BARDA require?

The type of testing will depend on the investigational product and clinical study. BARDA expects that most if not all specialized testing will be outsourced to specialized labs. In such cases, the role of the BSIP may be to perform aliquoting and shipping. The contractor will be making arrangements to coordinate and move specimens to required site. Section C.3.1.3

The government states that the contractor shall package and ship Biological Specimens. How many samples will be shipped annually and in how many shipments?

Undetermined at this time. TO BE ANSWERED BY OFFERORS: Once the BSIP and SDCC are established, future testing of biological specimens will become realistic. 1) Ship samples from RTOR0001 during the third year of the contract to a specialty laboratory located on the continental US. Using current best practices, provide an estimate for shipping nine hundred (900) 2ml cryotubes peripheral blood monocyte (PBMC) samples. The total number for shipment was derived from the five PBMC collection time points, ten aliquots per time point, times the forty eight (48) subjects on study. The specialty laboratory receives sample shipments Tuesday through Thursday weekly. 2) Use current best practices for RTOR0002 to ship specimens during the fourth contract year.

Provide an estimate to ship seven hundred (700) nasal swabs collected from one hundred subjects every day for seven days. In addition, ship one thousand (1000) plasma samples derived from one hundred (100) subjects taken twice daily, for five days. These are pre-treatment and post-treatment plasma samples. Both the nasal swabs and the plasma specimens will be shipped to the same Government test laboratory on the continental US for screening. Use best practices to inform BARDA on the number of shipments recommended. Include packing materials, supplies, and arrangement costs.

Section C.3.1.3

The government states that the contractor shall dispose of biological specimens. For budgeting purposes can the government provide a number of samples that will need to be disposed of annually?

We do not anticipate sample destruction being requested over the 5 year duration of the BSIP contract

Section C.3.1.5

The government states that the contractor shall store IP at temperatures and conditions specified by BARDA. For budgeting purposes can the government provide the size and quantities of containers the IP will be stored in and at what temperatures will be required?

No IP will be transferred for legacy specimens. Each reserve sample shall be stored under conditions consistent with product labeling. For budget purposes, please refer to the sample RTOR Tables for IP retains on pages 121 and 132 of the RFP.

Section C.3.2.3

The government states that the contractor shall provide all associated SOPS within ten days for validation. Please provide clarification on the time frame; within ten days of what?

We apologize for the typo. Please rephrase " the contractor shall provide all associated SOPs." We are removing the specific timeframe.

Section C.3.2.4

In the subsection titled “Facilities, Equipment and Other Resources”, the government asks for a description of the capacity needed for archiving specimens over the period of performance. Can the government provide estimates on the number of biological specimens and the amount of IP expected to be delivered annually that will require storage? Regarding the Legacy Specimens, will the specimens be delivered in the existing storage units? If yes, can the government provide information on the number of units, type, age and condition? If no, can the government provide the vial size of the different specimen types (all 2ml Cryovials?). In addition, if the specimens will not be delivered in the existing storage units, will the contractor be responsible for packaging and shipping the specimens to the contractor’s site?

No Legacy Specimen IP will be transferred from current storage conditions to the BSIP. The amount of IP is currently not known at this time. The information for the legacy biological samples is on page 87 (L.4.2.). For budgeting purposes of biological specimens and IP storage for sample RTOR0001 and RTOR0002, please refer to the appropriate tables on 121 and page 132 of the RFP. The specimens should arrive at the BSIP in existing storage units, ready for long-term storage. The current plan is for the clinical contractors to be responsible for shipments to the BSIP.

Page 87/107

Please provide the FAR reference that indicates that ceiling rates can be established for each indirect cost element that would be specific to a resultant contract. In accordance with FAR 42.703-1, a single agency shall be responsible to establish indirect rates that would be applicable to all contracts awarded to a contractor. If a Contractor already has provisional rates established with another agency, shouldn’t these rates be the rates that apply, including the final rates when they are determined?

The Section is modified to read: "In the absence of an indirect rate agreement the Government may negotiate Rate Ceilings for each applicable indirect cost element. If established, any costs over and above the established cost ceiling shall not be reimbursed under this contract or any other Government contract, grant, or cooperative agreement."

Section G.11 Negotiated Indirect Rates and Ceiling

With regard to the requirement for a COTS Inventory Management System, does the client require a single-tenant hosting environment for the COTS system or can a multi-tenant solution be utilized to satisfy this requirement?

Either one is acceptable to BARDA Section C.3.1.4. Tracking and Electronic Inventory Management of Biological Specimens

Please confirm that the BSIP contractor is only responsible for the following, found in both Sample Routine RTOR 0001 and Sample Response RTOR 0002: Long-term storage of IP retains; Long-term storage of Biological Specimens; Inventory Management of IP retains and biological specimens in long-term storage

For budgeting purposes, the BSIP contractor is responsible for legacy specimens (RFP page 87, Section L.4.2) as well as Sample RTOR0001 and RTOR0002. Please refer to the tables provided for biological specimen and IP retains for storage on pages 121 and 132 of the RFP. The contractor will be responsible for long term storage of biological specimens and IP retains and inventory management of IP retains and biological specimens in long term storage for a period of performance up to five years. offerors should assume that: 1) the IDIQ base contract will start on the date of award, 2) Routine RTOR0001 will start 6 months following IDIQ award, and 3) Response RTOR0002 will start 12 months following IDIQ award for budget purposes. See Question #21 Attachment #1 and

Attachment #2