RFP 12-100-SOL-0026- anthrax therapeutics - final.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

PAGES

(Date) (Hour)

SEC. PAGE(S) SEC. PAGE(S)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

15A. NAME

AND

ADDRESS

OF

OFFEROR

(Type or Print)

RPSAUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 85

2. CONTRACT NO.

N/A

3. SOLICITATION NO.

RFP-12-100-SOL-00026

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

6/29/12

6. REQUISITION/PURCHASE

NO.

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

HHS/OS/ASPR/AMCG

330 Independence Ave, SW, RM G-644 Washington, DC 20201

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and 5 copies 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 07/30/2012

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.

10. FOR INFORMATION

CALL:

A. NAME

Jason Bell

a. TELEPHONE (NO COLLECT CALLS)

(202) 260-1457

b. E-MAIL ADDRESS jason.bell@hhs.gov

11. TABLE OF CONTENTS

((x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 30

X B SUPPLIES OR SERVICES AND PRICES/COSTS 3 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 8 X J LIST OF ATTACHMENTS 34

X D PACKAGING AND MARKING 9 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 10 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 11 X K OTHER STATEMENTS OF OFFERORS 71

X G CONTRACT ADMINISTRATION DATA 21 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 73

X H SPECIAL CONTRACT REQUIREMENTS 25 X M EVALUATION FACTORS FOR AWARD 81

OFFER (Must be fully completed by offeror) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) 23. SUBMIT INVOICES TO ADDRESS SHOWN IN (4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

FAR (48 CFR) 53.214©

K mailto:jason.bell@hhs.gov�

TABLE OF CONTENTS

Part I – The Schedule Page #

Section A –Solicitation Form

Section B – Supplies or Services and Price/Costs

Section C – Statement of Objectives

Section D – Packaging and Marking

Section E – Inspection and Acceptance

Section F – Deliveries or Performance

Section G – Contract Administration

Section H – Special Contract Requirements

Part II – Contract Clauses

Section I – Contract Clauses

Part III – Attachments

Section J – List of Documents, Exhibits, and Other Attachments

Part IV – Representations and Instructions

Section K – Representations, Certifications and Other Statements of Offerors

Section L – Instructions, Conditions, and Notices to Offerors

Section M – Evaluation Factors for Award

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

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 objectives:

• Objective 0001: Manufacture and deliver 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.

• Objective 0002: 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.

• Objective 0003: 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 documentation establishing compliance with cGMP and ICH requirements shall be provided.

• Objective 0004: 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 documentation establishing compliance with cGMP and ICH requirements shall be provided. The banks shall be suitable for the cGMP production of Anthrax Antitoxin Bulk Drug Substance.

B.2. Specific Technical Requirements

The Offeror shall provide the necessary qualified personnel, facilities, material, equipment (except Government property), and services to produce, test, formulate, fill, package, store, and deliver the anthrax immunotherapeutic. The manufacture, formulation, filling, and testing of the anthrax therapeutic shall be done in accordance with the Offeror’s Standard Operating Procedures, and all federal statutory and regulatory requirements.

B. 3. Contract Type

This is an Indefinite-delivery, indefinite-quantity (IDIQ) contract for the acquisition of anthrax antitoxins.

During the ordering period of the Contract, the contracting officer assigned to the contract may order, and the Offeror shall provide, supplies and services at the unit prices listed below.

B. 3.1 Task/Delivery Order Type.

The contemplated business arrangement for this effort is a Multiple Award IDIQ task/delivery ordering arrangement. Task/Delivery orders issued under this contract will be firm-fixed price. Ordering instructions will be found in Section H. Special Contract Requirements.

Pursuant to FAR 16.505(c) and 10 U.S.C. 2304b, the total ordering period of this contract, shall not exceed five years. The period of performance for individual task/delivery order shall be specified in each awarded task/delivery order.

B. 3.2. Minimum and Maximum Quantity.

B.3.2.1 Task/Delivery Order Minimum and Maximum Ordering Amount. The Government guarantee minimum is $100,000 (see Section B.3.2.4) and the minimum ordering amount is listed in Section B.4. below.

B.3.2.2 Maximum Ordering Amount Estimate. The Maximum Ordering Amount for this contract per task/delivery order is $300 Million.

B.3.2.4 If the Government fails to award task/delivery orders in the amount of $100,000.00 during the term of the Contract, the Contractor may invoice for the balance of this guaranteed minimum. This amount can only be claimed at the end of the contract period if the Contractor takes advantages of fair opportunity, as described in FAR 16.505, by proposing on at least one task/delivery order.

B.4. Price Schedule

CLI

N Item Name Unit of Issue

Minimum

QTY

Maximum

QTY

Unit Price Extended

Price

0001 Final Drug Product: mAb Dose 10,000 176,000

0002 Final Drug Product: pAb Dose 10,000 44,000

0003 FDP Delivery Each 1 20

0004 Immune Plasma Liter 10,000 202,400

0005 Bulk Drug Substance: mAb FDP Dose Equivalent

10,000 176,000

0006 Bulk Drug Substance: pAb FDP Dose Equivalent 10,000 44,000

0007 BDS Storage Year $100,000 $60 million

0008 Master Cell Bank Each 1 6

B.4.1. Maximum Prices

B.4.1.1 Unit prices are the maximum prices offerors can expect to be awarded under task or delivery orders . 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.

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 cost 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 costs proposed as necessary for performing the task/delivery? Task/Delivery Orders proposals shall generally be limited to twenty (20) pages, included attachments.

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 cost 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 cost 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.

B.6. Advanced Understandings

B. 6.1 Reserved

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 75,000 doses of a monoclonal antibody anthrax antitoxin or 10,000 doses of a polyclonal antibody anthrax antitoxin, at commercial scale. Additionally, the anthrax therapeutic FDP will be delivered to the Strategic National Stockpile (SNS).

C.2.2. Collection of 46,000 L 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 75,000 doses of a monoclonal antibody anthrax antitoxin or 10,000 doses of 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).

SECTION D – PACKAGING, MARKING AND SHIPPING

D.1. PACKAGING OF PRODUCT

Packaging shall be consistent with the FDA-approved labeling and packaging for this product at the time of manufacture. Appropriate packaging and labeling changes may be required for product delivered under the IND (for possible pre-approval use under provisions of EUA), and following product FDA marketing approval.

D.2. MARKING

Marking shall be in accordance with FDA-approved labeling direction to be provided at the time the government places an order.

D.3. SHIPPING

Shipping shall be in accordance with written authorization by the contracting officer for each shipment.

All shipping will be coordinated with HHS and, for products delivered to the Strategic National Stockpile, DSNS. The details of all shipments will be established through the negotiations for each Task Order. Before any shipment of FDP to the SNS can take place a Quality Agreement will be negotiated with BARDA and CDC.

D.4. DISPOSITON OF PRODUCT INVENTORY

The contractor cannot reclaim title to product upon acceptance by the Government. Upon expiration or termination (including partial termination) of this contract, the USG may affect final disposition of any BDS or FDP remaining at the Contractor’s facility by any one or combination of the following methods:

1. The USG may elect to direct the Contractor to ship within five (5) calendar days prior to the contract termination date, to a cosignee(s) by the USG, all BDS or FDP remaining in storage at the Contractor’s facility.

2. The USG may offer the BDS or FDP to be repurchased by the Contractor at the original purchase price.

3. The USG may elect to handle disposition of expired FDP by the following method:

a. The USG may elect to direct the Contractor to ship all expired FDP and FDP scheduled to expire within 180 calendar days to the USG to the location specified by the USG.

SECTION E – INSPECTION AND ACCEPTANCE

This contract incorporates one or more solicitation clauses by reference, with the same force and effect as if they were given full text. Upon request, the CO will make their full text available. Also the full text of a clause may be access electronically at https:www.acquisiton.gov/far/

FAR Source Title and Date

52.246-1 Contractor Inspection Requirement (Apr 1984) 52.246-2 Inspection of Supplies – Fixed Price (Aug 1996) 52.246-4 Inspection of Services – Fixed Price (Aug 1996) 52.246-16 Responsibilities for Supplies (Apr 1984)

E.1. INSPECTION AND ACCEPTANCE

Inspection and acceptance of the product, services, and documentation called for herein shall be accomplished by the Contracting Officer or a duly authorized representative at the destination of the product, services or documents.

At the discretion of the Government and independent of testing conducted by the contractor, the Government reserves the right to conduct site visits and collect samples of products held and stored by the contractor.

SECTION F – DELIVERIES AND PERFORMANCE

FAR Source Title and Date 52.211-17 Delivery of Excess Quantities (Sep 1989) 52.242-15 Stop Work Order (Aug 1989) 52.242-15, Alt 1 Stop Work Order (Aug 84) 52.242-17 Government Delay of Work (Apr 1984) 52.247-34 FOB Destination (Nov 1991) 52.249-14 Excusable Delays (Apr 1984)

F.1. PERIOD OF PERFORMANCE

The period of contract performance of this contract is anticipated to be SIXTY months from date of award.

F.2. PLACE AND METHOD OF DELIVERY

F.2.1. Delivery of drug product and other deliverables shall be in accordance with FAR 52.247-34 entitled F.O.B. DESTINATION.

F.2.2 Place of Delivery: The product shall be delivered as requested by the CO prior to time of delivery.

F.2.3 A method (e.g., TempTales) for determining shipping temperatures during transport will be included at appropriate locations with proximity to the product during transit. Data from temperature recording devices will have the capability of being “down-loaded” and read by designated HHS/ASPR personnel prior to off-loading of the product at destination.

F.2.4 Product determined to be out of compliance for shipping temperature specifications will not be accepted or off-loaded from the Offeror’s own or subcontracted conveyance, but will be immediately returned to the manufacturer by the same transport used for delivery.

F.3. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.3.1. Submission of Contract Deliverables

Documents should be delivered electronically to the CO and the Contracting Officer’s Representative (COR) and hard copies shall be sent through the US Mail or other postal services to the CO.

Unless otherwise specified by the CO all deliverables and reports furnished to the government under the resultant contract (including invoices) shall be addressed as follows:

Contracting Officer

HHS/ASPR/AMCG

330 Independence Avenue, S.W.

Room G644 Washington, DC 20201

Contracting Officer Representative

HHS/ASPR/BARDA

330 Independence Avenue, S.W.

Room G644 Washington, DC 20201

Email: To be identified at the time of award of contract Email: To be identified at the time of award of contract

F.3.2. Reporting Requirements

I. Reports

These reports are subject to the technical inspection and requests for clarification by the Contracting Officer Representative. All reports required herein shall be submitted in electronic format. In addition, two (2) hardcopy of each report shall be submitted to the Contracting Officer, unless otherwise specified.

a. Technical Task/Delivery Order Progress Reports

The contractor shall be required to submit a Task/Delivery Order Progress Report. The frequency will be specified in Task/Delivery Order Reporting Requirements during the issuance of a Task/Delivery Order Request. The Contractor shall submit to the Contracting Officer and Contracting Officer Representative, technical task/delivery order reports covering the work accomplished during each reporting period. The report shall detail the planned progress and actual progress during the period covered, explaining why any differences between the two occurred, and if behind schedule, what corrective steps and actions are planned. These reports shall be prepared in accordance with the format described below, and in accordance with the DELIVERIES ARTICLE in SECTION F below.

b. Annual Report

The contractor shall be required to submit an annual technical progress report within 15 days after the anniversary of the contract award date. This report is to include a summation of the work performed, and the results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved for the base contract and each Task/Delivery Order. Additional elements to be included in the Annual Report will be discussed, and approved by the Contracting Officer and/or the Contracting Officer Representative. An annual report will not be required for the period when the final report is due.

c. Final Report

The contractor shall be required to submit a final report upon final completion of the contract (with a requirement for a draft final report). This report is to include summation of work performed, and the results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. Additional elements to be included in the Annual Report will be discussed, and approved by the Contracting Officer and/or the Contracting Officer Representative.

d. Milestone Reporting

Milestones will be identified for each Task/Delivery Order and progress toward each Milestone will be reported as part of the Technical Progress Report. Separate Milestone reporting is not required.

II. Meetings/Teleconferences and Site Visits/Audits

a. Contract Initiation Meeting

The contractor should complete a Kickoff meeting within a month of task/delivery order award.

b. Monthly Meetings/Teleconferences (or as needed)

The following types of meetings should be expected, and the frequency will be specified in the Task/Delivery Order Statement of Work.

The Contractor shall perform the following tasks:

1. Within 30 calendar days of the effective date of each Task/Delivery Order award, participate in a Task/Delivery Order Initiation Meeting with the Contracting Officer Representative, the Contracting Officer, and other HHS/BARDA personnel designated by the Contracting Officer Representative to be held at a location determined by the PO. The purpose of the Task/Delivery Order Initiation Meeting will be to orient the Contractor to HHS/BARDA task/delivery order procedures, review contract requirements, and to plan implementation of initial task/delivery order activities.

2. Plan and conduct meetings of the Contractor’s Program Director, Program Team, Contracting

Officer Representative and Contracting Officer. This will include other BARDA personnel deemed appropriate by the Contracting Officer Representative, at a minimum of monthly intervals, either in person or via teleconference, to review protocols, the status of approved work assignments, discuss any matters relevant to the scientific and financial administration of the contract and future activities. The schedule for those meetings will be established by the Contracting Officer Representative and Contracting Officer after contract award. The Contractor shall prepare and distribute the agenda as well as meeting/teleconference materials to all participants, provide a summary of all meetings, and teleconferences in the Annual Progress Reports.

c. Annual Meeting

BARDA shall meet with the contractor once a year to discuss the contract. The meetings shall take place within 30 days of the anniversary of the contract award date. The Contractor shall arrange and may conduct annual site visits for BARDA contract and program staff to review and discuss the following items: project progress; problems, obstacles, and approaches to overcoming identified problems and obstacles; recommendations for modifications in project timelines, objectives, and research approaches/methodologies based on outcomes to date; and future plans. These site visits shall be attended by the Principal Investigator, the Contractor’s business representative, and all key personnel. The Contractor shall be responsible for the following activities:

1. Planning and submitting the agenda to the Contracting Officer Representative for approval.

2. Developing written and oral presentation materials of all task/delivery orders.

3. Present summary of all active task/delivery orders.

4. Discuss timelines related to active and future task/delivery orders.

5. Discuss methodologies and approaches.

d. Periodic Site Visits

The Contractor shall accommodate periodic site visits by BARDA on an ad hoc basis, to include, if applicable, subcontractor facilities.

e. Security and Quality Systems Audits

BARDA shall perform a pre-award security and QA audit, in addition to periodic security, and QA audits during the performance of the contract on an ad hoc basis. A summary of these audits will be provided within 25 business days to the contractor. The Contractor shall take the necessary corrective action within a timely manner.

Satisfactory performance of the final contract shall be deemed to occur upon HHS/ASPR acceptance of the supply or service described in the Statement of Objectives in SECTION C of this contract, and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the deliverables in accordance with the stated delivery schedule specify under Section F.3.3. below

F.3.3. Deliveriables

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 (Final IPDP revision to be submitted per Deliverable8.0). Program Review Meetings shall occur at least annually during contract period of performance.

2.0

Biweekly Teleconference

The Contractor shall participate in biweekly teleconferences with BARDA to discuss the performance of the contract. The Contractor shall record, maintain and provide draft meeting minutes to the Contracting Officer Representative for approval within three days after teleconference.

The Contracting Officer Representative will approve the draft version. The Contractor shall distribute the final approved version duly marked as final

Biweekly or as negotiated by all parties.

within 3 business days after receipt of BARDA approval.

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, 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

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.

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 and the cumulative costs incurred 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 or did not incur any costs in the previous month, then a statement to this effect should be included in this report for those respective subcontractors.

4.0

Technical Documents

The contractor shall provide complete technical documents for BARDA review and approval. All documents shall be duly marked as either 'Draft' or 'Final'. These technical documents shall include, but shall not be limited to, the following:

Manufacturing

1. Draft and Final Documents for development study plans and reports (with all data included).

2. Draft and Final Validation Protocols and Reports (with all data included)

3. Draft and Final Documentation of deviations and investigations

4. Draft and Final Documentation

Draft documents shall be submitted to BARDA for review and comment.

BARDA will provide feedback within 10 business days. Contractor shall submit all final technical documents within 10 business days of contract completion or as mutually agreed to during the program execution with the Contracting Officer Representative.

of production and QC data from all scales of production.

5. Draft and Final production and QC documents (e.g. batch records, SOPs, material & product specifications, test methods).

Stability Studies

1. Draft and Final Stability Plans.

2. Draft and Final Stability Test Reports.

Milestone Reports

1. Milestone status report with projected completion dates.

2. Final versions of key project documentation, after the completion of each Milestone.

5.1

Draft Final Contract Report

A Draft Final Contract Report containing a summation of the work performed and the results obtained for the entire contract period of performance. The draft report shall be duly marked as 'Draft'.

Due 90 days prior to the completion date of the contract.

5.2

Final Contract Report

The Final Contract Report incorporating the feedback received from BARDA and containing a summation of the work performed and the results obtained for the entire contract period of performance. The final report shall be duly marked as 'Final'. The Contractor shall submit one (1) copy of a comprehensive final report to the Contracting Officer and two (2) copies (one electronically on a CD) to the Contracting Officer Representative. This final report shall detail, document and summarize the results of the entire contract work for the period covered. This report shall be in sufficient detail to explain comprehensively the results achieved under all milestones.

Due on/before the completion of the contract.

6.0

Standard Operating Procedures

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

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

7.1

FDA

Correspondence and Mtgs Summaries

The contractor shall forward initial contractor and CBER/CDER-issued draft minutes and final minutes of any meeting with the FDA to BARDA. All documents shall be duly marked as either 'Draft' or 'Final'.

Within 5 business days of each meeting for contractor's minutes and upon receipt of minutes from

CBER/CDER.

7.2

FDA Meetings

The contractor shall forward the dates and times of any meeting with the FDA to BARDA and make arrangements for appropriate BARDA staff to attend the FDA meetings. BARDA staff shall include up to a maximum of four people (Contracting Officer Representative, Contracting Officer, and up to 2 subject matter experts).

This is to be scheduled during the contract period of performance.

7.3

FDA Submissions

The Contractor shall provide BARDA the opportunity to review and comment; upon all draft regulatory documents before submission to the FDA. The Contractor shall provide BARDA with an electronic copy of the final FDA submission. All documents shall be duly marked as either 'Draft' or 'Final'.

BARDA shall provide comment within 5 business days after receipt.

BARDA reserves the right to request more than 5 business days for review of any regulatory submission that is more than 50 pages. The contractor shall inform BARDA of the anticipated submission length so BARDA can make a determination if more than 10 business days will be needed to complete its review of the document.

Final FDA submissions shall be submitted to BARDA concurrently or no later than 1 calendar day of its submission to CBER/CDER.

7.4

FDA Audits

The Contractor shall notify the Contracting Officer Representative and Contracting Officer within 24 hours of all FDA's arrival to conduct site visits/audits by any regulatory agency. In the event of an FDA inspection which occurs as a result of this contract and for the product, or for any other FDA inspection that has the reasonable potential to impact the performance of this contract. The Contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483, and the Establishment Inspection Report (EIR). The contractor shall provide the Contracting Officer Representative and Contracting Officer copies of the plan for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines as identified in the audit report, status updates during the plans execution, and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. The contractor shall make arrangements for BARDA representative(s) to be present during the final debrief by the regulatory inspector.

The Contractor shall notify the Contracting Officer Representative and Contracting Officer within 24 hours of receipt of any interaction from the FDA or Subcontractor.

8.0

Subcontractor Audit/Site Visits

The contractor shall inform the Contracting Officer Representative and Contracting Officer in advance of upcoming audits/site visits of subcontractors as part of the bi-weekly communications, including goals and agenda. Upon completion of the audit/site visit the contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor.

If action is requested of the subcontractor, details and concerns for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.

The Contractor shall inform the Contracting Officer Representative and Contracting Officer within 5 business days of report completion and provide BARDA with a copy of the report.

9.0

Publications

Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to BARDA for review prior to publication.

Within 30 calendar days for manuscripts and 15 calendar days for abstracts.

10.0

Press Releases

The contractor agrees to accurately and factually represent the work conducted under this contract in all press releases.

The contractor shall ensure that the Contracting Officer has received, and approved an advanced copy of any press release to this contract; not less than 5 business days prior to the issuance of the press release.

11.0

Security Reporting

The contractor shall report to the government any activity; or incident that is in violation of established security standards; or indicates the loss or theft of government products.

The contractor shall report within 24 hours after occurrence of activity or incident.

SECTION G – CONTRACT ADMINISTRATION

G.1. CONTRACTING OFFICER

1. The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions or other stipulations of this contract.

2. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract;

(5) obligate or deobligate funds into the contract; or (6) otherwise change any terms and conditions of this contract.

3. No information, other than that which may be contained in an authorized modification to this contract duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The Government's COR is:

To be identified at the time of award of contract.

As delegated by the CO, the COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) assisting the CO in interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

G.3. CONTRACTOR’S POINTS OF CONTACT

The contractor shall provide primary and secondary points of contact that will be available 24 hours per day, 7 days per week, to be notified in case of a public health emergency.

G.4. ORDERING PROCEDURES

G.4.1. Method of Ordering

The Contracting Officer will sign all orders (including written confirmation of oral/telephonic orders) involving requests for supplies and/or services under this contract. Each delivery shall be accompanied by a packing slip or other evidence of delivery/performance.

G.4.2. Delivery Order and Task Order Type

Delivery orders and/or task orders issued under this contract will be firm-fixed price.

G.4.3. Ordering Official

The Contracting Officer is the designated Ordering Official for the contract.

G.5. PAYMENT BY ELECTRONIC FUNDS TRANSFER

The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer–Central Contractor Registration, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

G.6. INVOICE SUBMISSION

(a) The Contractor shall submit invoices to the Contracting Officer at the address provided in SECTION F.3. Unless otherwise specified by the Contracting Officer, two hard copies of the invoice shall be delivered by first class mail to the CO with a courtesy copy to be sent by electronic mail. The invoice shall be deemed as ‘received’ upon receipt of the hard copy of the invoice at the address provided. A sample invoice form is provided in SECTION J – Attachment 7.

(b) The Contractor agrees to include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Contract Number

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Total Amount of Invoice

(10) Name, title and telephone number of person to be notified in the event of a defective invoice

(11) Payment Address, if different from the information in (b) (1).

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 2007.

G.8. GOVERNMENT PROPERTY

The government does not intend to acquire, purchase or provide property relating to this RFP.

However, if this RFP will result in the acquisition or use of Government Property provided by the contracting agency, or if the Contracting Officer authorizes, in the pre-award negotiation process, the acquisition of property (other than real property), the contractor shall follow FAR Clause 52.245-1 Government Property. See also HHS Publication, entitled, "Contractor's Guide for Control of Government Property."

G.9. CONTRACT COMMUNICATIONS/CORRESPONDENCE

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

G.10. EVALUATION OF OFFEROR PERFORMANCE

(a) Purpose: In accordance with FAR 42.1502 - Policy, the contractor’s performance will be periodically evaluated by the government in order to provide current information for source selection purposes. These evaluations will therefore be marked “Source Selection Information.”

(b) Performance Evaluation Period: The contractor’s performance will be evaluated at least annually.

In addition, the Government will review the contractor’s performance under any Task/Delivery Order.

(c) Evaluators: The performance evaluation will be completed jointly by the COR and the Contracting Officer.

(d) Performance Evaluation Factors: The contractor’s performance will be evaluated in accordance with the attachment listed in SECTION J titled Contractor Performance Evaluation Report.

(e) Contractor Review: A copy of the evaluation will be provided to the contractor as soon as practicable after completion of the evaluation. The contractor shall submit comments, rebutting statements, or additional information to the Contracting Officer within 30 calendar days after receipt of the evaluation.

(f) Resolving Disagreements between the Government and the Contractor: Disagreements between the parties regarding the evaluation will be reviewed at a level above the Contracting Officer. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, Offeror's response, and review comments, if any, will be retained as part of the evaluation.

(g) Release of Contractor Performance Evaluation Information: The completed evaluation will not be released to other than Government personnel and the Offeror whose performance is being evaluated.

Disclosure of such information could cause harm both to the commercial interest of the Government and to the competitive position of the Offeror being evaluated, as well as impede the efficiency of Government operations.

(h) Source Selection Information: Departments and agencies may share past performance information with other Government departments and agencies when requested to support future award decisions.

The information may be provided through interview and/or by sending the evaluation and comment document to the requesting source selection official.

(i) Retention Period: The agency will retain past performance information for a maximum period of 3 years after completion of contract performance for the purpose of providing source selection information for future contract awards.

G.11. KEY PERSONNEL, HHSAR 352.242-70 (January 2006) The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1. ANTI-LOBBYING

The contractor is hereby notified of the restrictions on the use of Department of Health and Human Service’s funding for lobbying of Federal, State and Local legislative bodies.

Section 1352 of Title 10, United States Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient (and their subcontractors) of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency,…