EBOLA_Therapeutics_Amendment__1.pdf

OMB No 0990-0115

11 . CONTRACT ID CODE IPAG~ OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A I 13

2. AMENDMENT/MODIFICATION NO. 13. EFFECTIVE DATE 4. REQUISITION/PURCHASE REO. NO.

PROJECT NO. (II applicable)

0001 See Block 16C N/A

6. ISSUED BY CODE I 7. ADMINISTERED BY (If other than Item 6) CODE I N/A

HHS/OS/ASPRIAMCG

200 C Street SW Washington, DC 20024

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) (tl) 9A. AMENDMENT OF SOLICITATION NO.

17-1 00-SOL -00014

9B. DATED (SEE ITEM 11)

May 8, 2017

TO ALL POTENTIAL OFFERORS 10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE I FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

t8J The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers 0 is extended, t8J is not extended.

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 Items 8 and 15, and returning one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAIL,URE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATA 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment. and is received prior to the opening hour and data specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

~ A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Spedfy authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor t8l is not, D is required to sign this document and return ___ copies to the issuing office.

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

PURPOSE:

1. Modify Attachment #12 to replace the Small Business Subcontracting Plan template (SBSP) with a new revised SBSP template.

2. Answer questions in response to the RFP.

3. Modify Section M.3.

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

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

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

NSN 7540·01·152·8070

PREVIOUS EDITION UNUSABLE

Jason Bell, Contracting Officer

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

May 24, 2017

BY

t:f (Signature of Contracting Officer)

30-105 STANDARD FORM 30 (REV. 10-83)

Computer Generated Prescribed by GSA

FAR (48 CFR) 53.243

ATTACHMENT #12

HHS SUBCONTRACTING PLAN TEMPLATE

A Subcontracting Plan is required if the estimated cost of the contract may exceed $700,000 ($1,500,000 for construction) Small businesses are excluded.

The following outline meets the minimum requirements of section 8(d) of the Small Business Act, as amended, and implemented by the Federal Acquisition Regulations (FAR) Subpart 19.7. The U.S. Department of Health and Human Services (HHS), Office of Small and Disadvantaged Business Utilization (OSDBU) recommends that offerors use the following format to submit proposed Individual Subcontracting Plans. It is not intended to replace any existing Corporate/Commercial Plan that is more extensive.

Questions should be forwarded to the Contracting Officer and/or Small Business Subcontracting Program Manager.

PROJECT INFORMATION

Solicitation/Contract No.: MOD No. (If applicable):

Title of Acquisition:

Contractor’s Name:

Period of Performance:

Total Contract Amount (including options, and any modifications if this submission is due to a modification):

Total Modification Amount: (if applicable) $ Base Period (if there are options): $

Option 1 (if applicable): $ Option 2 (if applicable): $

Option 3 (if applicable): $ Option 4 (if applicable): $

FAR 52.217-8 (if applicable): $

Contracting Officer/Specialist Name: Tel & Fax:

OPDIV/Division/Branch (including location): Email:

SUBCONTRACT PLAN REQUIREMENTS- Failure to include the essential information of FAR Subpart 19.7 may be cause for either a delay in acceptance or the rejection of a bid or offer when a subcontracting plan is required. “SUBCONTRACT,” as used in this clause, means any agreement (other than one involving an employer-employee relationship) entered into by a Federal Government prime contractor or subcontractor requesting supplies or services required for performance of the contract or subcontract.

If assistance is needed to locate small business sources, contact the Small Business Specialist (SBS) supporting the OPDIV. SBS contact information is located on the OSDBU website (http://www.hhs.gov/about/smallbusiness/osdbustaff.html) or you may contact the OSDBU headquarters at (202) 690-7300.

HHS currently has the following subcontracting goals for Fiscal Year 2017:

Type of Concern Goal (%) Small Business 33.00% Small Disadvantaged Business, including 8(a) Program Participants, Alaska Native Corporations (ANC) and Indian Tribes

5.00%

Women Owed Small Business 5.00% Service Disabled Veteran Owned Small Business 3.00% HUBZone 3.00%

For this procurement, or modification, HHS expects all proposed subcontracting plans to contain at a minimum the aforementioned percentages.

https://www.hhs.gov/grants/grants-business-contacts/small-business-staff/index.html

1. Type of Plan (check one):

Individual *Master (Addendum) *Commercial

*When Master is checked, Individual must also be checked and submission must include both.

*If Commercial is checked, please stop here and attach a copy of your commercial plan.

For Informational Purposes:

Individual plan - all elements developed specifically for this contract and applicable for the full term of this contract.

Master plan - goals developed for this contract, all other elements standardized and approved by a lead agency Federal Official; must be renewed every three years and contractor must provide copy of lead agency approval.

Commercial products/service plan - goals are negotiated with the initial agency on a company-wide basis rather than for individual contracts; this plan applies to the entire production of commercial service or items or a portion thereof. The contractor sells commercial products and services customarily used for non-government purposes. The plan is effective during the offeror’s fiscal year.

2. Subcontracting Goal Data: (FAR19.702(a)(1-3) & FAR 52.219-9(d)(1)) Below indicate the dollar and percentage goals for Small Business (SB), Small Disadvantaged (SDB) including Alaska Native Corporations and Indian Tribes, Women-owned and Economically Disadvantaged Women-Owned (WOSB), Historically Underutilized Business Zone (HUBZone), Veteran Owned Small Business (VOSB), Service-Disabled Veteran-Owned (SDVOSB) Small Businesses and “Other than Small Business” (Other) as subcontractors. Indicate the base year and each option year, as specified in FAR 19.704. If any contract has more than four options, please attach additional sheets which illustrate dollar amounts and percentages.

PLEASE NOTE: Zero dollars is not an acceptable goal for the SB, SDB, WOSB, HUBZone, VOSB or SDVOSB categories since this does not demonstrate a good faith effort throughout the period of performance of the contract.

% of Total Contract $ If required by CO

For Individual Plans complete a(1): (FAR 52.219-9(d)(2)(i)) a(1). Total dollars planned to be subcontracted under this contract is:

For Individual Plan

$ =2b+2h

If your contract includes options, please include the break down here:

Base Period: $ Option Period 3: $

Option Period 1: $ Option Period 4: $

Option Period 2: $

If options are applicable:

Base: %

OPT 1: %

OPT 2: %

OPT 3: %

OPT 4: %

b. Total dollars planned to be subcontracted to small business concerns (including ANC and Indian tribes)- [Percentage of 2a.]: (FAR 52.219-9(d)(2)(ii))

If your contract includes options, please include the break down here:

Base: $

OPT 1: $

OPT 2: $

OPT 3: $

OPT 4: $

and

Base: %

OPT 1: %

OPT 2: %

OPT 3: %

OPT 4: %

c. Total dollars planned to be subcontracted to veteran-owned small business concerns- [Percentage of 2.a.]:

(FAR 52.219-9(d)(2)(iii))

OPT 2: $

Base: %

OPT 1: %

OPT 2: %

OPT 3: %

OPT 4: %

d. Total dollars planned to be subcontracted to service-disabled veteran-owned small business - [Percentage of 2.a.]: (FAR 52.219-9(d)(2)(iv))

OPT 2: $

Base: %

OPT 1: %

OPT 2: %

OPT 3: %

OPT 4: %

e. Total dollars planned to be subcontracted to HUBZone small business concerns - [Percentage of 2.a.]:

(FAR 52.219-9(d)(2)(v))

OPT 2: $

Base: %

OPT 1: %

OPT 2: %

OPT 3: %

OPT 4: %

f. Total dollars planned to be subcontracted to small disadvantaged business concerns (including ANCs and Indian tribes) - [Percentage of 2.a.]: (FAR 52.219-9(d)(2)(vi))

If your contract includes options, please include the break down here:

OPT 2: $

Base: %

OPT 1: %

OPT 2: %

OPT 3: %

OPT 4: %

g. Total dollars planned to be subcontracted to women-owned small business concerns- [Percentage of 2.a.]:

(FAR 52.219-9(d)(2)(vii))

OPT 2: $

Base: %

OPT 1: %

OPT 2: %

OPT 3: %

OPT 4: %

h. Total Subcontracting Dollars & Percentage with “Other” than Small Businesses (i.e., large companies, non profits, etc.) [Percentage of 2.a.]: (HHS OSDBU)

OPT 2: $

Base: %

OPT 1: %

OPT 2: %

OPT 3: %

OPT 4: %

i. Subcontracting Opportunities (description of all principal products/services to be subcontracted to all types of concerns listed in 2.b.- 2.f.) (FAR 52.219-9(d)(3)):

Provide a description of ALL the products and/or services to be subcontracted under this contract, and indicate the size and type of business supplying them (include all that apply):

Products and/or Services

Other Small Business

SDB WOSB Hubz VOSB SDVOSB

j. Please describe the methodology used to develop goals & identify potential sources (e.g. historical trends, information on technical and competitive bidding, formula for calculating goals, etc.) (FAR 52.219-9(d)(4-5)):

k. Indirect costs have have not been included in the dollar and percentage subcontracting goals above (check one).

If indirect costs have been included in establishing subcontracting goals, please provide a description of the method used to determine the proportionate share of indirect costs to be incurred with all types of concerns listed in 2.b.-2.f. (FAR 52.219-9(d)(6)):

SUBCONTRACTING PLAN REQUIREMENTS (con’t)

3. Please enter the following information for the individual who will administer your Subcontracting Program: (FAR 52.219-9(d)(7)) Name: Title:

Address:

Telephone: Email:

Duties: Does the individual named above have general overall responsibility for the company’s subcontracting program, i.e., developing, preparing, and executing subcontracting plans and monitoring performance relative to the requirements of those subcontracting plans and perform the following duties? yes no

Additionally, please respond whether or not the individual who will administer you subcontracting program conducts the following:

1. Developing and promoting company-wide policy initiatives that demonstrate the company’s support for awarding contracts and subcontracts to SB, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns; and for assuring that these concerns are included on the source lists for solicitations for products and services they are capable of providing; yes no

2. Developing and maintaining bidder source lists of SB, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns from all possible sources; yes no

3. Ensuring periodic rotation of potential subcontractors on bidder’s lists; yes no

4. Assuring that SB, SDB, WOSB, HUBZone, VOSB and SDVOSB businesses are included on the bidders’ list for every subcontract solicitation for products and services that they are capable of providing. yes no

5. Ensuring that Requests for Proposals (RFPs) are designed to permit the maximum practicable participation of SB, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns. yes no

6. Reviewing subcontract solicitations to remove statements, clauses, etc., which might tend to restrict or prohibit small, 8(a), SDB, WOSB, HUBZone, VOSB and SDVOSB small business participation. yes no

7. Accessing various sources for the identification of SB, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns to include the

System for Award Management ( http://sam.gov ), local small business and minority associations, local chambers of commerce and Federal agencies’ Small Business Offices; yes no

8. Establishing and maintaining contract and subcontract award records; yes no

9. Participating in Business Opportunity Workshops, Minority Business Enterprise Seminars, Trade Fairs, Procurement

Conferences, etc; yes no

10. Ensuring that SB, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns are made aware of subcontracting opportunities and assisting concerns in preparing responsive bids to the company; yes no

11. Conducting or arranging for the conduct of training for purchasing personnel regarding the intent and impact of Section 8(d) of the Small Business Act, as amended; yes no

12. Monitoring the company’s subcontracting program performance and making any adjustments necessary to achieve the subcontract plan goals; yes no

13. Preparing and submitting timely, required subcontract reports; yes no

14. Conducting or arranging training for purchasing personnel regarding the intent and impact of 8(d) of the Small Business Act on purchasing procedures;and yes no

15. Coordinating the company’s activities during the conduct of compliance reviews by Federal agencies. yes no

(If NO is checked for any of the duties above, please provide who in the company performs those duties, or indicate why the duties are not performed in your company on a separate sheet of paper and submit with the proposed subcontracting plan.)

Additional duties of the individual:

http://sam.gov/

4. Please describe your efforts to ensure that Small Businesses (incl. SDB, WOSB, HUBZone, SDVOSB) have an equitable opportunity to compete for subcontracts: (FAR 52.219-9(d)(8))

These efforts include, but are not limited to, the following activities:

a. Outreach efforts to obtain sources: (1) Contact minority and small business trade associations; (2) contact business development organizations and local chambers of commerce; (3) attend SB, SDB, WOSB, HUBZone, VOSB and SDVOSB procurement conferences and trade fairs; (4) review sources from the System for Award Management ( http://www.sam.gov); (5) review sources from the Small Business Administration (SBA), Dynamic Small Business Search database (DSBS) http://dsbs.sba.gov/); (6) Consider using other sources such as the National Institutes of Health (NIH) e-Portals in Commerce, (e-PIC), (http://epic.od.nih.gov/)). The NIH e-PIC is not a mandatory source; however, it may be used at the offeror’s discretion; and (7) Utilize newspaper and magazine ads to encourage new sources.

b. Internal efforts to guide and encourage purchasing personnel: (1) Conduct workshops, seminars and training programs;

(2) Establish, maintain, and utilize SB, SDB, WOSB, HUBZone, VOSB and SDVOSB source lists, guides, and other data for soliciting subcontractors; and (3) Monitor activities to evaluate compliance with the subcontracting plan.

Efforts Described:

5. Flow Down Clause: (FAR 52.219-9(d)(8))

The contractor agrees to include the provisions under FAR 52.219‑8, “Utilization of Small Business Concerns,” in all acquisitions exceeding the simplified acquisition threshold that offers further subcontracting opportunities. All subcontractors, except small business concerns, that receive subcontracts in excess of $700,000 ($1,500,000 for construction) must adopt and comply with a plan similar to the plan required by FAR 52.219‑9, “Small Business Subcontracting Plan.” Note: In accordance with FAR 52.212-5(e) and 52.244-6(c)(2) the contractor is not required to include flow-down clause FAR 52.219.-9 if it is subcontracting commercial items.

6. Reporting and Cooperation: (FAR 52.219-9(d)(10)); (FAR 19.704(a)(10))

The contractor gives assurance of 1) cooperation in any studies or surveys that may be required; 2) submission of periodic reports which illustrate compliance with the subcontracting plan; 3) submission of its Individual Subcontracting Report (ISR) and Summary Subcontract Report (SSR); and 4) subcontractors submission of ISRs and SSRs. ISRs and SSRs shall be submitted via the Electronic Subcontracting Reporting System (eSRS) website https://esrs.symplicity.com/index?_tab=signin&cck=1

Please refer to FAR Part 19.7 or contact the Contracting Officer for regulatory reporting requirements and other obligations you are accepting as part of your signing of this document and acceptance of any subsequent contract award that may be granted.

7. Record keeping: (FAR 52.219-9(d)(11))

FAR 52.219-9(d)(11) requires a list of the types of records your company will maintain to demonstrate the procedures adopted to comply with the requirements and goals in the subcontracting plan.

Contractor acknowledges and agrees to record keeping obligation expressed at FAR 52.219-9(d)(11). yes no

8. Assurances of Good Faith Effort, and the submission of explanations when failing to acquire as stated in Good Faith Effort: (FAR 52.219-9(d)(12-13))

Contractor hereby makes the following assurances:

(1) that contractor will make a good faith effort to acquire articles, equipment, supplies, services, or materials, or obtain the performance of construction work from the small business concerns that it used in preparing the bid or proposal, in the same or greater scope, amount, and quality used in preparing and submitting the bid or proposal yes no ; and

(2) that the Contractor will provide the Contracting Officer with a written explanation if the Contractor fails to acquire articles, equipment, supplies, services or materials or obtain the performance of construction work within 30 days of contract completion and as required under FAR 19.7. yes no

9. Assurances that the Contractor will not prohibit a subcontractor from discussing with the Contracting Officer any material matter pertaining to payment to or utilization of a subcontractor: (FAR 52.219-9(d)(14))

Contractor hereby makes the assurance that the Contractor will not prohibit a subcontractor from discussing with the Contracting Officer any material matter pertaining to payment to or utilization of a subcontractor. yes no

10. Assurances of Timely Payments to Subcontractors: (FAR 52.219-9(d)(15))

FAR 19.702 requires your company to establish and use procedures to ensure the timely payment of amounts due pursuant to the terms of your subcontracts with SB concerns, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns.

Your company has established and use such procedures yes no . Additionally, Contractor makes an assurance that Contractor will pay its small business subcontractors on time and in accordance with the terms and conditions of the underlying subcontract, and notify https://esrs.symplicity.com/index?_tab=signin&cck=1 the contracting officer when the prime contractor makes either a reduced or an untimely payment to a small business subcontractor yes no .

Signature Page

1. Contractor makes the following representation: I have reviewed FAR Part 19.704 and FAR Clause 52.219-9, and this Subcontracting Plan is in compliance. yes no This Subcontracting Plan was submitted by:

Name: Title:

Signature:

Address:

Telephone: Email:

Questions and Answers to RFP-17-100-SOL-00014

(Answers are in Bold Text)

1. What is the role of the primary and secondary contacts referenced in section 3.1.2 and provided in attachment 1 of the RFP?

In case of a public health emergency, these individuals will need to act on behalf of the offeror and as a representative for the contract. They will need to coordinate with appropriate individuals in their organization regarding providing information that the USG may need, that may be related to but not limited to, Manufacturing, Regulatory, Safety, Efficacy, etc. In addition, these individuals may also need to assist in coordinating access to product that may be procured under the contract.

2. What are the differences in requirements and logistics between storage of material as Vendor Managed Inventory versus those of material delivered to the Strategic National Stockpile? The link to the site referenced in the RFP in Section 5 is not working. a. Must the Offeror store material delivered as Vendor-Managed Inventory or can it be stored by BARDA?

Vendor Managed Inventory requires the offeror to store and manage the product that is produced until shipment is requested by the USG. If delivered to the SNS, the offeror would be required to ship the product (only FDP would be accepted) under GMP conditions to a designated SNS site and is responsible for product until it is accepted at that site. BARDA will not provide government owned facility to store material. The link in section 5 is active:https://www.fda.gov/EmergencyPreparedness/Counterterrorism/ucm182568.htm.

3. We would like to request a waiver from the 75 page limit stipulated for the Technical Proposal.

We cannot accommodate this request. 75 pages should be sufficient for an adequate response.

4. When does BARDA anticipate providing a draft contract to begin negotiations?

We are anticipating July or August.

5. "Can the Government confirm that requirements and prices for optional CLINs 0008-0027 will be fixed at contract award and will not be subject to subsequent negotiation? If so, will the Government clarify the reference in Section L.4.1 to ""negotiate[ing] as needed"" ""[p]roduct type, volume, cost, destination and delivery schedule"" and the reference in Section L.5.1 to negotiating pricing ""during the exercise of these options""? If not, how does the Government intend to satisfy its obligations under FAR 17.207(f)?"

This will be discussed at time of negotiations and contract award if they are conducted.

6. "Does the Government expect to have title and risk of loss for materials included in VMI? If so, how does the Government intend to obtain title to material that is not identified as a contract deliverable and covered by a fixed-price CLIN? Does the Government expect to obtain title to bulk drug substance as well as final drug product? Will stored material be returned to the Government or destroyed at the end of contract performance?"

7. Are CLINs 0005 and 0006, and each corresponding optional CLIN, mutually exclusive in that the Government will be able to direct that all final drug product be stored through a VMI or delivered to the SNS, without allocating a portion of final drug product to each VMI and SNS CLIN?

8. Will the Government be required to exercise CLIN 0007 if the U.S. Food and Drug Administration requires post-marketing commitments?

Pending budget and Government needs will determine if CLIN007 will be exercised.

9. May a proposal exclusively address storage through a VMI under CLIN 0005 or delivery to the SNS under CLIN 0006, adopting a similar practice for each corresponding optional CLIN, without addressing both VMI and SNS CLINs? If so, will any unused VMI or SNS CLINs be removed from a resulting contract if they are not covered by an agreement regarding storage location prior to execution of the contract (e.g., if the parties agree to store base period final drug product through a VMI, will CLIN 0006 be removed)?

The Technical and Cost Proposals should address completion of all CLINs. However, it is possible that the initial procurement supported by these CLINs will not included all components. This will be determined in contract negotiations and the final CLIN structure will be adjusted as necessary.

10. Is the cost data identified in Section L.5.2 required for both cost-reimbursement and fixed-price CLINs?

No, the cost data is only required for the Cost-Reimbursement portion of the RFP.

11. "With respect to the reporting obligations identified in Section F.3.2, does the Government expect contractors to identify expenses incurred in performing work under fixed-price CLINs? Requiring contractors to track such costs imposes an additional burden that may result in an increase of the overall price to the Government."

Firm Fixed price CLINs should be budgeted as price per treatment courses. Therefore the cost of treatment course will include all components and identification/detailing of expenses will not be necessary.

12. "Will the Government agree that no materials produced under a contract resulting from the solicitation will be administered to human subjects absent a current declaration under the Public Readiness and Emergency Preparedness Act that covers any liability resulting from such administration or an alternative mechanism for liability protection to be agreed upon by a contractor and the Government?"

After a product is licensed, the government will have the right to utilize the product as desired. Prior to licensure, the contractor will need to consent to use. The authority to declare PREPA lies outside BARDA.

13. Will contracts resulting from the solicitation recognize that a contractor satisfies its obligations under CLIN 0001 by seeking an emergency use authorization and licensure even if the U.S. Food and Drug Administration refuses to issue an emergency use authorization or approve licensure?

It is the government's intention to procure product, pending the Pre-EUA status. Awardees will be expected to maintain a focused effort toward this goal; however, it is understood that products can be delayed or fail prior to reaching EUA or licensure.

14. "With respect to Sections G.5.e and I.3.1, can the Government confirm that (i) a certification regarding compliance with the HHS Salary Rate Limitation Provisions is not required to the extent that an invoice covers work performed under a fixed-price CLIN and (ii) HHSAR 352.231- 70 does not apply to work performed under a fixed-price CLIN?"

Yes, this is only required for the Cost-Reimbursement portion of the RFP.

15. With respect to Section F.3.2.F, can the Government confirm that earned value management requirements will only apply to the cost-reimbursement component of a contract resulting from the solicitation?

Yes, this is only required for the Cost-Reimbursement portion of the RFP.

16. With respect to Section F.3.2.E.f, will the Government consider identifying an exception to the requirement to provide press releases at least five business days' in advance of issuance for press releases that are issued to comply with an applicable legal requirement, related to health or safety concerns, or related to other significant developments that may be of interest to a contractor's investors?

This will be discussed at time of negotiations and contract award if they are conducted.

17. Can the Government confirm that FAR 52.222-41, FAR 52.222-43, and FAR 52.222-62 should not be included in the solicitation because awards resulting from the solicitation will not have a principal purpose of furnishing services performed by service employees as contemplated by the Service Contract Labor Standards statute?

18. "Can the Government confirm that FAR 52.227-3 should be removed from the contract? A patent indemnity is only appropriate for commercial-item contracts. See FAR 27.102, 27.201- 1(d), 27.201-2(c)(1)."

19. Can the Government confirm that the solicitation should include Alternate II to FAR 52.227-14 because a contract resulting from the solicitation will require a contractor to deliver limited rights data, rather than allow the contractor to withhold such data. See FAR 27.204-2(c)(1).

20. "Notwithstanding references in the solicitation to providing data in ""non-proprietary form,"" will all data provided to the Government under a contract resulting from the solicitation be both subject to FAR 52.227-14, Alternate II, and capable of being marked as limited rights data if appropriate as contemplated by this clause?"

21. "Can the Government confirm that FAR 52.215-10 and FAR 52.215-12 should be removed from the solicitation because the Government does not expect to request certified cost or pricing data in connection with awards based on the existence of adequate price competition?"

22. As contemplated by the FAR 46.304, FAR 46.305, and FAR 46.316, does the Government intend for both FAR 52.246-4 and FAR 52.246-16 to apply only to work performed under fixed-price CLINs and FAR 52.246-5 to apply only to work performed under cost-reimbursement CLINs?

This will be discussed at time of negotiations and contract award if they are conducted.

23. Can the Government confirm that FAR 52.217-9 should identify a total potential contract duration of ten years, rather than five years?

24. "As contemplated by FAR 44.204(a)(1), does the Government intend for FAR 52.244-2 to apply only to work performed under cost-reimbursement CLINs?"

25. "As contemplated by FAR 15.408(n)(1), does the Government intend for FAR 52.215-22 to apply only to work performed under cost-reimbursement CLINs?"

This will be discussed at time of negotiations and contract award if they are conducted.

26. "Notwithstanding Section E.1, will transfer of risk of loss of or damage to supplies under FAR 52.246-16 be deemed to occur upon delivery into a VMI, regardless of whether delivery occurs at a contractor's or subcontractor's facilities?"

27. Does the government intend to include FAR 52.203-18 in the solicitation in lieu of the deviation identified in Section I.3.2?

FAR 52.203-18 includes updated provisions.

28. "With respect to Section H.16, can the Government confirm that requirements imposed under Section 508 of the Rehabilitation Act of 1973 do not apply to the work contemplated by the solicitation? Section 508 requirements are only applicable to contracts in which electronic and information technology is developed, procured, maintained, or used, or in which a deliverable is “specifically intended for publication on, or delivery via, a federally owned or federally funded website.” Electronic and information technology that is ""incidental"" to performance, such as electronic and information technology used to produce a report, is not covered by Section 508 requirements. See 36 C.F.R. §§ 1194.2(c), 1194.3(b);

FAR 39.204(c); 66 Fed. Reg. 20,894, 20,895 (Apr. 25, 2001); see also 65 Fed. Reg. 80,500, 80,503 (Dec. 21, 2000) ([A] consulting firm that enters into a contract with a Federal agency to produce a report is not required to procure accessible computers and word processing software to produce the report regardless of whether those products were used exclusively for the government contract or used on both government and non-government related activities since the purpose of the contract was to procure a report."")."

29. Would BARDA trigger the first procurement CLINs (CLIN 2-6) at the point of BLA submission, or post-Process Validation, but during BLA review period?

Triggering the Options will depend on status of the product in development, government requirements and government available budget.

30. There is a request for 5 years of stability for DS and DP under CLIN 1, however the Base Period is targeted for 5 years, which would not accommodate all stability time-points after manufacture. Should the generation of the stability data be captured in CLIN 1 or CLIN 7?

The Offeror should propose the 5 years of stability as requested in the RFP for CLIN1. As noted in Section B.2. as well as other sections of the RFP the contract may have a period of performance of up to 10 years if all options all exercised.

31. For sub CLINs under CLIN 1, should they be costed and scheduled as unique items?

Yes, Sub-CLINs should be costed and scoped as unique individual packages.

32. "The Mandatory Criteria volume is described as a separate volume, however in section M3 Offerors are instructed to address these criteria as a section in the technical volume. Please clarify."

This has been updated and will be part of this Amendment to the RFP.

33. Attachment #6 is required in both the technical and business volume? Please confirm

Yes.

34. Confirming the EVM deliverables in the RFP: Integrated Master Schedule, Performance Measurement Baseline Review, CPRs (Format 1, 3, 5) are all that is required for EVM compliance under this contract.

35. "Can the offeror speak to a member of BARDA’s Program Protection Office (PPO) prior to the submission of the proposal? "

36. For an Offeror with multiple sites with varying scopes, auditing external security practices prior to award is not feasible. The Offeror plans to submit a security plan with assumptions based on the requirements in Attachment #14 which may evolve as vendors are onboarded. is this acceptable?

This will be discussed at time of negotiations and contract award if they are conducted.

37. The offeror assumes that sites with only staff (no critical assets stored) will have a reduced requirement for security. Is this correct?

END OF QUESTIONS AND ANSWERS

The following Section of the RFP is hereby amended to the following:

M3. MANDATORY EVALUATION CRITERIA

Listed below are the Mandatory Evaluation Criteria. The Offeror(s) shall provide a separate volume outside of the technical proposal that addresses the mandatory criteria for eligibility. The mandatory criteria for eligibility must be met at the time of receipt of proposal as determined by the Contracting Officer in order for any proposals to be considered for award. Any Offeror(s) who submit proposals that do not meet the Mandatory Evaluation Criteria for eligibility will not be considered for further evaluation. All proposals that satisfy the mandatory criteria for eligibility will be considered for a second phase (technical evaluation).

a. The Offeror shall have an active IND related to the intended operational use for the candidate and have already completed the demonstration of safety in a Phase I clinical trial with the intended formulation and route of administration expected for clinical use and licensure;

b. The Offeror shall have demonstrated protection against EBOV challenge in a delayed treatment non-human primate model using the formulation intended for the clinic;