Amendment 0002 to RFP-12-100-SOL-00026.pdf

RFP-12-100-SOL-00026 Page 2 Amendment #2

(Date) (Hour)

FORM SF28

The following section is hereby modified to the following:

9. Sealed offers in 2 original and 5 copies, along with 2 copies on compact disc (CD) for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in See Block 7 until 2:00 PM local time 8/13/12.

(Hour) (Date)

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214- 7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

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SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

The following sections are hereby modified to the following:

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

B.1.1 The U.S. Department of Health and Human Services (HHS) is charged with the responsibility of developing, licensing, procuring, and maintaining a definitive supply of medical countermeasures (MCM) for use in national medical emergencies. This acquisition will provide the USG with a key MCM essential for an effective medical response to an anthrax attack. Resultant contract(s) will not only provide anthrax antitoxin MCM, but also new valuable capabilities such as storage and/or manufacture of intermediate products.

Although much progress has been made on anthrax MCM preparedness over the past ten years, it is critical to continue development, manufacturing, and acquisition of MCMs for anthrax. In order to maintain a capability to respond to an anthrax attack, the USG needs to continue investment in the manufacturing, testing, and delivery of new doses of anthrax antitoxins. This will be done in a way that not only sustains the current stockpile, but also establishes surge and replenishment capacities augmenting the response to a public health or national emergency. This solicitation calls for an ID/IQ (Indefinite Delivery/Indefinite Quantity), five-year base contract, with multiple awardees, for requirements that will satisfy the needs of manufacturing, testing, and storage of these antitoxins. The details of each potential Offeror’s plan of action and implementation will be required in their proposal. This Request for Proposals (RFP) solicits proposals for the following below:

General

• Collection and storage of human immune plasma for the manufacture of Polyclonal Anthrax Antitoxins as Contractor Managed Inventory. The plasma shall be tested and characterized, and documentation establishing compliance with cGMP and ICH requirements shall be provided.

The plasma shall be suitable for the cGMP manufacture of Anthrax Antitoxin BDS.

• Manufacture and storage with stability testing of Anthrax Antitoxin Bulk Drug Substance (BDS).

The BDS shall be manufactured in compliance with cGMPs, tested and characterized in approved Product Specifications, and documentation establishing compliance with cGMP and ICH requirements shall be provided. The BDS shall be suitable for the cGMP manufacture of Anthrax Antitoxin FDP. The BDS shall be stored and shipped under validated conditions, and

Delivery

• Manufacture and Delivery to the SNS anthrax antitoxin Final Drug Product (FDP). The FDP shall be tested and characterized, and documentation establishing compliance with cGMP and ICH requirements shall be provided. The FDP shall be delivered in a controlled and validated way, and documentation establishing compliance with cGMP and ICH requirements shall be provided. The FDP shall be suitable for use in humans in a declared emergency or as an FDA-approved product.

• Manufacture and Delivery of Master Cell Banks for the production of Monoclonal Antibody

Anthrax Antitoxins to the USG. These cell banks shall be tested and characterized, and

RFP-12-100-SOL-00026 Page 4

The banks shall be suitable for the cGMP production of Anthrax Antitoxin Bulk Drug Substance.

B.5. Placing and Processing of Orders

B.5.1. Multiple Award Ordering. Under the Indefinite Quantity Clause, orders will be issued to all contractors awarded a contract under this solicitation. Each prime contract awardee will be guaranteed at least one task/delivery order award or a minimum guarantee amount. Fair opportunity will be provided to all prime contract awardees for each task/delivery order unless one of the circumstances described in Federal Acquisition Regulation (FAR) 16.505(b)(2)(i)(A) through (C) applies to the order or a statute expressly authorizes or requires that the purchase be made from a specified source. Task/Delivery Order competitions will utilize best value with “trade-off” analyses.

B.5.2. Method of Ordering. The Federal Acquisition Streamline Act (FASA) requires that each awardee under a multiple award contract, be given a fair opportunity to be considered for each order in excess of $3,000, unless a statuary exception applies. All awardees will be given an opportunity to compete for task orders in excess of $3,000. Any Offeror submitting a proposal must clearly demonstrate capability to perform the activities as required by each objective.

Each Task/Delivery Order Request issued by HHS will include a Statement of Work, Evaluation Factors for Award of the Task/Delivery Order, Reporting Requirements and Deliverables, required components of the offer to be submitted, format for submission, and any other issues pertinent to the Task/Delivery Order, including information on whether it is anticipated that the Task/Delivery Order will be awarded with or without discussions. Contractors will not be required to propose on all Task/Delivery Orders. Those eligible offerors that decide not to submit must notify the Contracting Officer in writing of their intention not to submit a proposal on or before the closing date and time established for the Task/Delivery Order.

An election not to propose on a given Task/Delivery Order will not negatively affect or prohibit a Contractor from competing on future Task/Delivery Order.

In providing services under this contract, the following procedures shall apply to the award of Task/Delivery. All work required under this contract shall be authorized through execution of an agreement, “Task/Delivery Order,” signed by the Offeror and Contracting Officer. The Task/Delivery Order may be awarded at any time within the contract period.

When the Government elects to fill a requirement that is estimated to exceed $3,000, the Contracting Officer shall provide a Task/Delivery Order request to the awardees that receive contracts for the particular part for which responses are being solicited. A Task/Delivery Order request shall, at a minimum include a Statement of Work, evaluation factors, specific reporting requirements, deliverables and delivery schedule, the relevant importance of technical and price factors, and any special instructions.

If necessary, the contracting officer shall arrange a meeting between offerors and the contracting officer to discuss the proposed Task/Delivery Order prior to submitting Task/Delivery Order proposals (technical and business). Business proposals shall include appropriate support of all prices proposed as necessary for performing the task/delivery? Task/Delivery Orders proposals shall generally be limited to twenty (20) pages, included attachments.

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Within the time allowed for proposals preparation (time allowed for proposal preparation and submission will vary depending on the task and will be designated in each Task/Delivery Order), Offerors shall submit their proposals in response to a Task/Delivery Orders, which shall include, but not necessarily limited to the following information:

1. Statement that the contractor has a clear understanding of the task requirement.

2. Statement of technical and managerial resources and expertise the contractor can provide to satisfy the requirement;

3. A schedule of performance identify major milestones, deliverables and delivery date, and task completion; and

4. A price schedule necessary to complete the work

The Government will evaluate proposals and conduct negotiations as necessary. Task/Delivery Orders will be awarded to the contractor whose proposals is determined to be the most advantageous to the Government based on the technical and price factors specified in the Task/Delivery Order. The Government reserves the right to make an award on the most favorable initials proposal without discussions.

The contracting officer is the only individual authorized to issue a Task/Delivery Order under this contract. Unless specifically authorized by the contracting officer, the contractor shall not commence work on a requirement until a fully executed Task/Delivery Order has been awarded.

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SECTION C – STATEMENT OF OBJECTIVES (SOO)

Independently, and not as an agent of the US Government, the Offeror shall furnish all the necessary services, qualified personnel, materials, supplies, equipment, facilities, transportation, and travel not otherwise provided by the USG, as required to fulfill the programmatic objectives. Contracts awarded in response to the solicitation must meet the objectives specified under Sections C.1.1 – C.1.5 and C.2- C.2.4.

C.1. General Objectives

C.1.1. Validated facilities, systems, equipment, and manufactured processes for cGMP manufacturing of antitoxin products.

C.1.2. Validated and approved assays and equipment for lot release of anthrax antitoxin product, FDP, and stability studies.

C.1.3. Validated facilities, systems, equipment suitable for cGMP storage of BDS, and FDP products.

C.1.4. Systems to retain all records, samples, etc. as indicated under GLP, and cGMP guidelines for US Government inspection during site visits of the manufacturing facilities.

C.1.5. Notification provided to the USG, prior to any disposal of material, records, documentation, and/or reports for consultation and disposition.

C.2. Delivery Objectives:

The Contractor shall provide the following items for manufacturing, testing, packaging, delivery, storage and disposal of anthrax antitoxin products:

C.2.1. Manufacture of an anthrax antitoxin therapeutic final drug product (FDP) either a monoclonal antibody anthrax antitoxin or a polyclonal antibody anthrax antitoxin, as shown in B.4. Price Schedule. Additionally, the anthrax therapeutic FDP will be delivered to the Strategic National Stockpile (SNS).

C.2.2. Collection of immune human plasma, delivery, and storage as Offeror managed inventory for conversion into a BDS and FDP anthrax therapeutic product.

C.2.3. Manufacture of an anthrax antitoxin therapeutic bulk drug substance (BDS) either in sufficient quantity to produce a monoclonal antibody anthrax antitoxin or a polyclonal antibody anthrax antitoxin. Additionally the Offeror will provide for the delivery, storage, and stability testing of the anthrax antitoxin therapeutic bulk drug substance (BDS) in Offeror managed inventory.

C.2.4. Manufacture and delivery of a Master Cell Bank for an anthrax antitoxin to the USG, which is used for the production of a Final Drug Product that is, at a minimum, TRL 6B (active IND and has demonstrated safety in a Phase 1 clinical trial).

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SECTION F – DELIVERIES AND PERFORMANCE

The following section is hereby modified to the following:

F.3.3. Deliverables

The items specified below in the REPORTING REQUIREMENTS Article in Attachment II of this contract will be required to be delivered FOB Destination as set forth in FAR 52.247-35, FOB DESTINATION WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below:

Deliverable Description Due Date

1.0

Kickoff Meeting/Status Update Meetings

The contractor shall complete a Kickoff meeting after contract award and shall hold recurring Program Review Meetings.

Within a month of contract award, but after submission of a draft IPDP, for Kick Off meeting Program Review Meetings shall occur at least annually during contract period of performance.

3.0

Annual Task/Delivery Order Technical Progress Report

The Annual Task/Delivery Order Technical Progress report shall address each of the below items and be cross-referenced to the WBS in the Gantt chart and IPDP.

1. An Executive Summary in MS PowerPoint format, highlighting the progress, issues, and relevant activities in manufacturing, non-clinical, clinical, and regulatory.

The Executive Summary should be limited to a few slides, and also highlight only critical issues for that reporting period and resolution approach.

2. Progress in meeting contract milestones - broken out by subtasks within each milestone, overall project assessment, problems encountered and recommended solutions. The reports shall detail the planned progress and actual progress during the period covered, Reports shall be submitted on the 15th day of each month for the previous calendar month with an Annual Report submitted on the 15th day of the final month of each contract year for the previous twelve calendar months. Progress reports are not required for the periods when the Annual Report(s) and Final Report are due.

RFP-12-100-SOL-00026 Page 8 explaining occurrences of any differences between the two, and the corrective steps and actions are planned, if behind schedule.

3. The reports shall also include a three month rolling forecast of key planned activities, referencing the

WBS/IPDP.

4. A tracking log of progress on regulatory submissions with the FDA submission number, description of submission, date of submission, status of submission, and next steps.

5. Estimated and Actual Expenses

a. This report shall also contain a narrative statement as to whether there is any discrepancy at this time between the % of work completed to date. This section of the report shall also contain estimates for the Subcontractors' expenses from the previous month if the Subcontractor did not submit a bill in the previous month.

These expenses shall be listed for each subcontractor.

b. If the subcontractor(s) was not working then a statement to this effect should be included in this report for those respective subcontractors.

6.0

Standard Operating Procedures

The contractor shall make internal and subcontractor Standard Operating Procedures (SOPs) available for review.

Upon request from the Contracting Officer Representative and/Contracting Officer.

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SECTION G – CONTRACT ADMINISTRATION

The following section is hereby modified to the following:

G.7. PAYMENT CONDITIONS

G.7.1. The contractor shall not submit an invoice prior to delivery of product or services.

G.7.2. 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 any contract awarded in response to this solicitation or any subsequent task order

2. If product is deemed to be recalled for any reason, as outlined in the Product Recalls, Including Removal and corrections published by U.S. Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs; or based upon Chapter 7 of the Regulatory Procedures Manual of March 2011.

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SECTION I - CONTRACT CLAUSES

I.1. Federal Acquisition Regulation (FAR) (48 Chapter 1) Clauses

The following clause is hereby added to the solicitation:

Reg Clause Date Clause Title

FAR 52.246-24 Feb 1997 Limitation of Liability—High-Value Items

The following clauses are hereby removed from this solicitation

Reg Clause Date Clause Title FAR 52.225-1 Feb 2009 Buy American Act—Supplies FAR 52.232-20 Apr 1984 Limitation of Cost FAR 52.232-32 Apr 2012 Performance-Based Payments.

FAR 52.242-1 Apr 2012 Notice of Intent to Disallow Costs

FAR 52.242-15,

Alt 1 Apr 1984 Stop-Work Order

FAR 52.249-14 Apr 1984 Excusable Delays

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SECTION K – REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS

The following clause is hereby modified and updated to the following:

K.1. FAR 52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (MAY 2012)

(a)(1) The North American Industry Classification System (NAICS) code for this acquisition is __________________ [insert NAICS code].

(2) The small business size standard is _____________ [insert size standard].

(3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

(b)(1) If the clause at 52.204-7, Central Contractor Registration, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the clause at 52.204-7 is not included in this solicitation, and the offeror is currently registered in CCR, and has completed the ORCA electronically, the offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The offeror shall indicate which option applies by checking one of the following boxes:

[ ] (i) Paragraph (d) applies.

[ ] (ii) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c)(1) The following representations or certifications in ORCA are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless—

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions.

This provision applies to solicitations expected to exceed $150,000.

(iii) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the clause at 52.204-7, Central Contractor Registration.

(iv) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that—

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(v) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations—Representation. This provision applies to solicitations using funds appropriated in fiscal years 2008, 2009, 2010, or 2012.

(vi) 52.209-5, Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(vii) 52.214-14, Place of Performance—Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

https://www.acquisition.gov/far/current/html/52_200_206.html#wp1137850 https://www.acquisition.gov/far/current/html/52_200_206.html#wp1137850 https://www.acquisition.gov/far/current/html/52_200_206.html#wp1137583 https://www.acquisition.gov/far/current/html/FARTOCP13.html#wp271421 https://www.acquisition.gov/far/current/html/52_200_206.html#wp1137684 https://www.acquisition.gov/far/current/html/52_200_206.html#wp1137777 https://www.acquisition.gov/far/current/html/52_200_206.html#wp1137850 https://www.acquisition.gov/far/current/html/52_200_206.html#wp1137824 https://www.acquisition.gov/far/current/html/52_207_211.html#wp1144909 https://www.acquisition.gov/far/current/html/52_214.html#wp1129381

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(viii) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(ix) 52.219-1, Small Business Program Representations (Basic & Alternate I). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(x) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xi) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xii) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xiii) 52.222-38, Compliance with Veterans’ Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(xiv) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA–designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xv) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA–designated items.

(xvi) 52.225-2, Buy American Act Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xvii) 52.225-4, Buy American Act—Free Trade Agreements—Israeli Trade Act Certificate. (Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225-3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $77,494, the provision with its Alternate

II applies.

(D) If the acquisition value is $77,494 or more but is less than $100,000, the provision with its Alternate

III applies.

(xviii) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xix) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan—Certification. This provision applies to all solicitations.

(xx) 52.225-25, Prohibition on Contracting with Entities Engaging in Sanctioned Activities Relating to

Iran—Representation and Certification. This provision applies to all solicitations.

(xxi) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to—

(A) Solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions; and

(B) For DoD, NASA, and Coast Guard acquisitions, solicitations that contain the clause at 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns.

(2) The following certifications are applicable as indicated by the Contracting Officer:

https://www.acquisition.gov/far/current/html/52_215.html#wp1144523 https://www.acquisition.gov/far/current/html/52_217_221.html#wp1135900 https://www.acquisition.gov/far/current/html/52_217_221.html#wp1135943 https://www.acquisition.gov/far/current/html/52_222.html#wp1147663 https://www.acquisition.gov/far/current/html/52_222.html#wp1147711 https://www.acquisition.gov/far/current/html/52_222.html#wp1147704 https://www.acquisition.gov/far/current/html/52_222.html#wp1147711 https://www.acquisition.gov/far/current/html/52_222.html#wp1148142 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1168785 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1168786 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1168826 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1169013 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1168995 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1169071 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1169038 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1169193 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1169151 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1181379 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1188714 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1169667 https://www.acquisition.gov/far/current/html/52_217_221.html#wp1136333

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[Contracting Officer check as appropriate.] __ (i) 52.219-22, Small Disadvantaged Business Status.

__ (A) Basic.

__ (B) Alternate I.

__ (ii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

__ (iii) 52.222-48, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification.

__ (iv) 52.222-52, Exemption from Application of the Service Contract Act to Contracts for Certain

Services–Certification.

__ (v) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA–

Designated Products (Alternate I only).

__ (vi) 52.227-6, Royalty Information.

__ (A) Basic.

__(B) Alternate I.

__ (vii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The offeror has completed the annual representations and certifications electronically via the Online

Representations and Certifications Application (ORCA) website accessed through https://www.acquisition.gov.

After reviewing the ORCA database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR CLAUSE # TITLE DATE CHANGE

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on ORCA.

(End of provision) https://www.acquisition.gov/far/current/html/52_217_221.html#wp1143559 https://www.acquisition.gov/far/current/html/52_222.html#wp1147605 https://www.acquisition.gov/far/current/html/52_222.html#wp1152427 https://www.acquisition.gov/far/current/html/52_222.html#wp1155404 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1168892 https://www.acquisition.gov/far/current/html/52_227.html#wp1139116 https://www.acquisition.gov/far/current/html/52_227.html#wp1145584 https://www.acquisition.gov/ https://www.acquisition.gov/far/current/html/Subpart%204_12.html#wp1073667

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SECTION L – INSTRUCTIONS, CONDITIONS AND NOTICES TO

OFFERORS

The following sections are hereby modified to the following:

L.9. Authorized Official and Submission of Proposal

The proposal must be signed by an official authorized to bind the Offeror organization, and must stipulate that it is predicated upon all the terms and conditions of this RFP.

PACKAGING AND DELIVERY OF PROPOSAL: Proposals will be paginated, reproduced on letter size paper, and shall be legible in all required copies. In addition to the original signed copy, five (5) hard copies and two (2) electronic copies of the technical and business proposal are required. To expedite the proposal evaluation, all documents required for responding to the RFP should be placed in the following order:

I. COVER PAGE

Include RFP title, number, name of organization, DUNS No., identification of the proposal part, and indicate whether the proposal is an original or a copy.

II. TECHNICAL PROPOSAL

It is recommended that the technical proposal consist of a cover page, a table of contents, and the information requested in the SOO. Appendices may be provided with the technical proposal, with the appropriate tabs.

III. BUSINESS PROPOSAL

It is recommended that the business proposal consist of a cover page, a table of contents, and the information requested in the SOO associating cost with identified task.

Proposals should be submitted, no later than the date and time specified in the RFP. The two original and five hardcopies, in addition to at least two (2) complete copies on compact disc (CD) media as backup, of the technical proposal, plus appendices, should be delivered by courier services to the Contracting Officer’s address at 330 Independence Ave., SW Room G640, Washington, D.C. 20201; no later than August 13, 2012 – 2 pm EDT.

II. TECHNICAL PROPOSAL INSTRUCTIONS

General Comment: The technical proposal should be prepared and submitted in a format to facilitate proposal evaluation, in accordance with the criteria specified in Section M., i.e., the proposal should also contain a separate section addressing the Offeror’s ability to meet the mandatory criterion for eligibility (See M.1.). Offerors should prepare their technical proposal submissions in a format that directly corresponds to the requirements listed in Price Schedule (Section B.4), the SOO (Sections C.1 and C.2), the Evaluation Factors (Section M), and Proposal Instructions (Section L.1). Offerors should also provide an index that cross-links the proposal with the SOO and Evaluation Factors.

The technical proposal shall address the Offeror’s understanding of the SOO and propose a detailed technical approach for fulfilling the SOO, and include: a separate section addressing the Offeror’s

RFP-12-100-SOL-00026 Page 15 facilities and equipment; a separate section addressing the Offeror’s management plan and personnel; In addition, as tabbed appendices, the proposal shall include a separate section addressing the Offeror’s Gantt chart, risk mitigation plan, security plan, and certification of Select Agents (sections L.20-L.24 below).

Offerors shall identify tasks, among those described in this solicitation, for which they plan to utilize subcontractors. This approach is encouraged if it allows the Offeror to more efficiently perform the numerous responsibilities required by this project. Offerors should describe the activities to be subcontracted, the method and level of integration between the prime and any proposed subcontractor(s), and the expected advantages of such an approach. A plan for the management of all subcontractors shall be provided.

The work should follow the outline of the SOO. Offerors should adhere to the following required formats and limitations:

• Five (5) complete hard copies of the technical proposal, plus appendices, shall be submitted with at least two (2) complete copies on compact disc (CD) media as backup. Submit the hard-copy documents in three-ring binders with tabbed divider pages separating each section.

• The technical proposal shall contain an index that cross-links the proposal with the requirements in the SOO and with the Evaluation Factors, to facilitate proposal evaluation by the USG. The technical proposal may not exceed 75 pages with up to 100 additional pages of appendices. Pages shall be numbered consecutively starting with page 1. Blank tabbed divider pages do not count.

Pages shall be single-spaced, single-sided, 8.5 by 11 inch pages of 10 or 12-point font. Also, the technical proposal should provide specific information addressing the elements listed in the SOO and those specified below.

Proposals that merely offer to conduct a program in accordance with the Government’s SOO will not be eligible for award. The technical proposal should contain an explanation of the proposed technical approach, in conjunction with the tasks to be performed in achieving the project objectives.

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Anthrax Antitoxins for the Treatment of Inhalational Anthrax

RFP-12-100-SOL-00026

Questions and Answers

QUESTION:

B.3.2.2 states the maximum ordering amount for this contract per Task/ Delivery Order is $300 million.

Can you confirm you can have more than 1 Task/ Delivery Order per CLIN, so this means for a single CLIN is it possible to have multiple Task/ Delivery Orders in total that exceed $300 million?

RESPONSE:

Yes, there is a possibility for multiple CLINs on a single task order, and there may be multiple task orders for a single CLIN.

Can Task/Delivery Orders be issued by BARDA anytime during the five year contract period?

RESPONSE:

Yes

QUESTION:

In section B.4.1. Maximum Prices (page 5) it states discounted prices will be expected based on the magnitude of the order. Offeror shall provide pricing for CLINS 0001, 0002, 0004, 0005, 0006 based on increments of 10,000. In the Statement of Objectives (page 8 in C.2.1 & C.2.3) it states specific quantities of 75,000 doses of a monoclonal antibody. Is the RFP intent that the Offeror submit separate pricing for (1) increments of 10,000 up to 176,000 of FDP doses, (2) increments of 10,000 up to 176,000 BDS dose equivalents, and (3) pricing for 75,000 FDP doses and 75,000 BDS (dose equivalents)?

RESPONSE:

The offeror should submit pricing for the minimum amount requested up to the maximum amount requested. The Statement of Objectives has been modified, and is included in this amendment to the solicitation.

Is the intent of the incremental pricing structure to apply to single Task/Delivery Orders or “cumulative” Task/ Delivery Orders. For example, if Task/ Delivery Order #1 is for 20,000 doses at an incremental unit price of $10,000 per dose and then a year later Task/ Delivery Order #2 is issued for an additional 20,000 doses, does HHS expect the unit price to remain $10,000 or the unit price would be discounted to the 40,000 dose price tier?

RFP-12-100-SOL-00026 Page 17

No, this is not the intent. The USG is seeking pricing for the minimum and maximum amounts that may be needed over the duration of the proposed period of performance.

QUESTION:

Does BARDA intend to take Title to/ownership of BDS (i.e. intermediate product) when it is delivered to a 3rd party storage location or will the Contractor maintain Title of BDS while in storage?

Yes, BARDA will take Title to the BDS upon deliver. It may be stored at a location under the direct control of BARDA or storage may be through a subcontract via the IDIQ awardee.

QUESTION:

Does BARDA have precedence or experience with other Contractors that may be able to assist HGS in determining the appropriate accounting treatment (i.e. timing of revenue recognition) ?

No, however, in general, revenue cannot be recognized until it is deposited into the Contractor’s bank account.

Does BARDA have a suggestion on what the desired ratio is of FDP doses and BDS dose equivalents to be maintained in SNS inventory?

At this time a ratio is not established. However, Offerors should remember that this is an IDIQ contract. Award of the “master” IDIQ contract does not require this information. It may be provided in a subsequent Request for Task Order Response (RTOR) that will solicit proposals related to specific CLINs.

Would it be acceptable to propose for example 50,000 doses of FDP and 25,000 dose equivalents of frozen BDS in the 5 year contract period?

Again, proposals at this time will result in award of the IDIQ master contract. Task Orders for BDS and FDP manufacturing, storage, and delivery will be based on subsequent Request for Task Order Requests (RTORs).

RFP-12-100-SOL-00026 Page 18

The RFP states on page 73 that the Offeror can request up to a maximum of 8 years, subject to HHS approval. Is it acceptable for the Offeror to propose a base contract of 5 years with optional years 6, 7, and 8? Would such a proposal fall under an “alternative proposal” described in L10 on page 77?

RESPONSE:

Yes, the offeror may submit an alternative proposal in the manner described; however, as stated in Section B.1.1, the government is currently anticipating a five year base only.

It appears that FAR clauses 52.246-23, 52.246-24 and 52.246-25 (Limitation of Liability clauses) have been inadvertently omitted from the solicitation. We believe that these clauses are required pursuant to FAR 46-805 and request that you issue an amendment to the solicitation incorporating these provisions.

The omitted provisions are appropriate in contracts pursuant to which the U.S. government is seeking to purchase biopharmaceutical products that have not yet received FDA approval and are essential to a proper allocation of risk between the parties.

RESPONSE:

USG agrees that 52.246-24 should be included because this is an acquisition of a product. The USG does not agree that 52.246-23 and 52.246-25 should be included since these are not applicable to this acquisition.

QUESTION:

Please confirm that, pursuant to FAR 52.246-16, risk of loss for frozen BDS would transfer to the USG upon acceptance (at the same time title transfers) since BDS will never be physically delivered to the

USG.

If storage is at a site directly managed by BARDA, the risk of loss transfers to the USG. However if storage is arranged through a subcontractor of the prime contractor, it is the responsibility of the prime contractor to ensure that a Risk Plan is developed which identifies and mitigates risk to the stored materials. Insurance may be included in the plan that transfers risk to a third party.

Is it permissible to submit a response to only certain objectives (ie, could our response omit those objectives that we are not interested in bidding on, like human plasma and master cell bank delivery?)

The offeror is encouraged to submit a response to any of the CLINs it believes it can successful perform and/or deliver. Offerors do not have to respond to every CLIN in order to be considered for award of the master IDIQ contract.

RFP-12-100-SOL-00026 Page 19

Please clarify what materials/documents General Objective C.1.5 is referring to. It is our understanding that this contract will not involve any government furnished or contractor acquired property.

GFE is not part of this contract. However many documents related manufacturing, testing, release, and storage of anthrax antitoxins will be retained by the Contractor. Retention and stability samples will be stored by the Contractor. Before these documents or materials are moved or destroyed the USG must be informed and may elect to take delivery of the materials for storage by the USG.

Offeror believes there can only be one Master Cell Bank. Offeror has a Master Cell Bank that may be used to generate Manufacturing Cell Banks (or Working Cell Banks). A new Manufacturing Cell Bank could be tested to the standard of a Master Cell Bank. Will BARDA accept an offeror’s proposal of a Manufacturing Cell Bank which is made from the Master Cell Bank for Objective 0004 in lieu of a proposal of a Master Cell Bank (CLIN 0008)?

RESPONSE:

Yes.

QUESTION:

Does BARDA intend to use the cell bank from CLIN 0008 to produce product with a different manufacturer than the offeror that provided the cell bank?

RESPONSE:

At this time BARDA intends only to procure cell banks to mitigate their loss after, in some cases, significant investment of taxpayer funds. However if, in the future, the USG wants the product produced by the call bank, and the Contractor is unable to provide that service (e.g., is no longer in business or no longer interested in responding to a RTOR), the cell banks may be used in USG Advanced Development Manufacturing (ADM) facilities.

QUESTION:

The RFP does not specifically state how offerors that receive awards for Objective 4 but then subsequently qualify for Objectives 1 and 3 can then bid on Task Orders for Objectives 1 and 3. If an offeror meets the criteria of Objective 4 but does not currently meet the mandatory criteria for Objectives 1 and 3 at the time the proposals are due, can an offeror that is awarded a contract for Objective 4 be included to bid on Task Orders for Objectives 1 and 3 once an offeror meets the criteria for Objectives 1 and 3?

RFP-12-100-SOL-00026 Page 20

Any and all work on the CLINs identified in this RFP will be performed through Task Orders.

Award of these Task Orders will be based on proposals submitted in response to specific RTORs.

Only those Offers which are successful in receiving the mother IDIQ contract will receive a RTOR and Task Order award. RTORs can be issued at any time and for any CLIN during the five year Period of Performance of the mother IDIQ contract.

QUESTION:

The following statement from page 5 of the RFP is made, “When the Government elects to fill a requirement that is estimated to exceed $3,000, the Contracting Officer shall provide a Task/Delivery Order request to the awardees that receive contracts for the particular part for which responses are being solicited”. This statement suggests that awardees may only bid on task orders related to the awarded objective. Is this a correct interpretation?

RESPONSE:

No, what is being stated is that awardees of this contract will have the opportunity to bid on upcoming Task Order/Delivery Orders. No Task/Delivery Orders will be awarded under this contract.

QUESTION:

If an offeror meets the criteria for some Objectives, but not others at the time of proposal submission, what is the mechanism to become eligible to bid on Task Orders that the offeror is not currently eligible for but expects to meet the mandatory eligibility criteria within the contract time period?

RESPONSE:

Any and all work on the CLINs identified in this RFP will be performed through Task Orders.

Award of these Task Orders will be based on proposals submitted in response to specific RTORs.

Only those Offers which are successful in receiving the master IDIQ contract will receive a RTOR and Task Order award. RTORs can be issued at any time and for any CLIN during the five year Period of Performance of the mother IDIQ contract.

QUESTION:

Is it the USG’s intention to expand the level of the anthrax anti‐toxin inventory in the SNS, or do they expect to maintain the SNS at existing levels?

RESPONSE:

The USG will not discuss policy or plans regarding current or future target SNS inventories.

QUESTION:

Will the contract award(s) under this RFP be for a term of 5 years or a term of 1 year with 4 option periods of 1 year each, for a total of 5 years? The RFP appears to imply the former; the Small Business Subcontracting Plan appears to imply the latter alternative.

RFP-12-100-SOL-00026 Page 21

This contract is for a base period of five years with no options.

QUESTION:

Please clarify the "Extended Price" column in the table of section B.4: are offerors to provide extensions of their unit price for the minimum quantity or the maximum quantity?

RESPONSE:

This should be listed for both minimum quantities and maximum quantities.

QUESTION:

Section B.4.1.1 requires pricing in increments of 10,000. Are offerors to develop their own additional tables to supplement the table in B.4, showing presumably lower unit pricing for incrementally increasing quantity of items in 10,000‐quantity groupings, particularly with respect to CLINs 0001, 0002, and 0004 through 0006? Alternatively, will BARDA provide a standard spreadsheet/table for all offerors to use?

RESPONSE:

Yes, offerors are to develop their own tables to supplement the table in B.4 showing their unit pricing in increments of 10,000.

QUESTION:

Section K.1 ‐‐ which is FAR provision 52.204‐8 ‐‐ in section (b) indicates that, if FAR clause 52.204‐7, "CCR," is in the solicitation [which it is], then section (c) of 52.204‐8 applies. However, there is no section (c) in the text of the clause contained on page 71 of the RFP. Please clarify this section (c) requirement, in as much as our research in the FAR, we found that provision 52.204‐8 has been updated, and the text of this provision is significantly different than contained in the RFP.

RESPONSE:

This is modified and included in this solicitation amendment.

QUESTION:

Section L.3 indicates that this acquisition is a partial small business set‐aside. We found no designation of the portion that would be set‐aside for small business and the balance that would be non‐set‐aside portion, using the distinction as indicated in FAR 19.502‐3. Please advise how the total number of CLINs and/or quantities under each CLIN would be divided between small businesses under the set‐aside portion and other than‐small businesses under the non‐set‐aside portion.

RFP-12-100-SOL-00026 Page 22

Our market research indicates that they are two or more small businesses who may have the capability to successful perform one or more CLINs for this IDIQ contract. The government intends to award an IDIQ master contract to atleast two small businesses, which entitles them to the guaranteed minimum as stated in Section B. 3.2. of the RFP. No set-aside has been determined for any of the potential CLINs.

QUESTION:

Section L.10 permits alternate proposals. If an offeror submits a proposal for one specific Objective only can it submit an alternative proposal for a different Objective not included in its basic proposal?

RESPONSE:

An offeror may submit an alternative proposal in any manner it feels may benefit the USG to pursue.

QUESTION:

The offeror has limited control over when and how the CDC will prepare a pre‐EUA package for the FDA to review on behalf of the offeror. As such, would BARDA consider revising the Mandatory Criteria for Eligibility in M.1, altering the pre‐EUA requirement to allow for offerors who will qualify for Objectives 0001 and 0003 with a pre‐EUA to be obtained prior to BDS or FDP shipment, during the 5‐year contract period, giving the USG greater competition and possibly more favorable pricing?

RESPONSE:

Data requirements for the pre-EUA package must be discussed with the FDA. However the actual package will be prepared by the USG using CMC, clinical safety, and nonclinical efficacy data provided by the Contractor.

QUESTION:

If an offeror does not submit a response to the current RFP, because they do not meet the Mandatory Criteria for Eligibility in M.1, but will meet the Mandatory Criteria in the near future (Q3 of 2013), is there a mechanism for the offeror to be included as a qualified bidder on Task Orders that are issued under Objectives 0001 and 0003?

RESPONSE:

Any and all work on the CLINs identified in this RFP will be performed through Task Orders.

Award of these Task Orders will be based on proposals submitted in response to specific RTORs.

Only those Offers which are successful in receiving the master IDIQ contract will receive a RTOR and Task Order award. RTORs can be issued at any time and for any CLIN during the five year Period of Performance of the master IDIQ contract.

Should offerors submit pricing for the quantities in Schedule B.4 or Section C.2?

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Offerors should submit pricing for the quantities in Schedule B.4

QUESTION:

If CLIN 0002 includes delivery for FDP, is CLIN 0003 (FDP Delivery) necessary?

RESPONSE:

As indicated, FDP deliveries will be arranged through a CLIN separate from that for manufacturing.

QUESTION:

Please clarify if plasma storage is intended to be included in CLIN 0007 (BDS Storage) or CLIN 0004 (Immune Plasma)?

RESPONSE:

Plasma storage is included in CLIN 0004.

QUESTION:

If plasma storage is intended to be included in CLIN 0007 or CLIN 0004, how long should offerors anticipate storage should be?

RESPONSE:

The actual length of storage will be identified in a subsequent RTOR. For the master IDIQ contract proposal, the Offeror should propose a period of time based on their knowledge and experience and use it to provide the requested cost information.

QUESTION:

What is the anticipated duration for BDS storage under CLIN 0007?

RESPONSE:

The actual length of storage will be identified in a subsequent RTOR. For the mother IDIQ contract proposal, the Offeror should propose a period of time based on their knowledge and experience and use it to provide the requested cost information.

QUESTION:

Will the government consider pricing based on minimum and maximum quantities for each CLIN if an independent order is placed for each option which will reduce the number of pricing variations required to a reasonable amount?

RFP-12-100-SOL-00026 Page 24

For the main IDIQ contract proposal, please provide information for minimum and maximum amounts identified in the RFP.

QUESTION:

Alternatively, will the government consider requiring pricing on a hypothetical delivery order with more than one CLIN being required in addition to minimum and maximum quantities?

RESPONSE:

Yes.

QUESTION:

Page 75, Section L.2, Business Proposal Instructions, provides that:

[1] For purposes of proposing shipping prices, the Offeror shall use a uniform cost assumption of shipping from its manufacturing facility to a destination approximately 1200 miles away. [2] The shipping costs shall be included in the total cost of the contract; however it shall be submitted in a separate line item for evaluation and discussion. This requirement is unclear. Please confirm that this requirement applies to CLIN 0003, FDP Delivery.

RESPONSE:

Yes, this applies to FDP delivery.

QUESTION:

Does this information need to be included in the proposal if the cost of shipping FDP or other product is included in other CLINs? e.g., CLIN 0002, 0004 and 0006 include delivery.

RESPONSE:

Shipping of plasma and BDS will be arranged as part of the relevant CLIN. FDP deliveries to the SNS will be arranged under CLIN 0003.

QUESTION:

Is this information just for evaluation purposes because delivery costs will depend on the actual destination?

RESPONSE:

This information is for evaluation purposes only.