13-100-SOL-00004_FFMN.pdf

13-100-SOL-00004

FFMN

February 8 2013

Dear Ladies and Gentlemen:

The Department of Health and Human Services (HHS) invites you to submit a proposal in accordance with the requirements of the enclosed solicitation # 13-100-SOL-00004, entitled, “Fill Finish Manufacturing Network.” The Government anticipates awarding an Indefinite Delivery Indefinite Quantity contract with cost reimbursement and firm-fixed price task or delivery orders. The period of performance is 10 years. The broad purpose of this contract is to provide filling and finishing capabilities for influenza vaccines and other public health emergency products to address national security and to augment public health needs on a cost-effective, reliable, and sustainable basis.

Read the entire solicitation carefully. Be sure to thoroughly answer all the Technical Evaluation Criteria in Section M in accordance with the instructions set forth in Section L to include Mandatory Evaluation Criteria and Technical proposals instructions. Additionally, take care to review and comply with the Representations and Certifications in Section K and the detailed Business Instructions in Section L. In order to be considered for award, the Contractor must meet the mandatory evaluation criteria in Section M-2 and respond to all other requirements of the RFP.

The attached questions and answers provided at the end of this Request for Proposals (RFP) stemmed from the BARDA-DRAFT-FFMN RFP which was posted to Federal Business Opportunities (FBO.gov) in November 2012 as market research for this RFP. BARDA’s answers to the questions posed provide a crosswalk to the pertinent section of this RFP to which the answers relate. While the answers provided by BARDA seek to clarify various matters within the RFP, they do not amend or affect the RFP in any way. This RFP and its amendments are the only official documents that proposals shall be based on.

This solicitation incorporates Federal Acquisition Regulation (FAR) clauses and provisions by reference, which must be fully understood by the Contractor. The full text of these clauses and provisions may be accessed from the following website: https://www.acquisition.gov/far.

HHS must receive your proposal in the contracting office (See Section G-1) no later than 2:00 p.m. local prevailing time on April 5, 2013.

Sincerely, //signed Quintin Hackshaw//

Quintin Hackshaw

Contract Specialist

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

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

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

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

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 82

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

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.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

H

G

F

E

D

C

B

A

SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

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

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

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

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

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 253 (c) ( 10 U.S.C. 2304 (c) (

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

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

X

HHS/OS/ASPR/BARDA

HHS/OS/ASPR/BARDA

330 Independence Ave., S.W.

Room 640-G Washington DC 20201

See Section L

1400 ET 04/05/2013

QUINTIN K HACKSHAW 202

Quintin.Hackshaw@hhs.gov

260-0453

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PAGE(S)

SALIM K. ROBERTS

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

1-3 4-8

9-14 17-19 20-24 25-33

34-41

43-44

45-74

75-82

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 82

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

13-100-SOL-00004

(A) (B) (C) (D) (E) (F)

FILL FINISH MANUFACTURING NETWORK REQUIREMENT

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

TABLE OF CONTENTS

SECTION A – SOLICITATION/CONTRACT FORM 1

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS 4

SECTION C – DESCRIPTION/SPECS/WORK STATEMENT 9

SECTION D – PACKAGING AND MARKING 15

SECTION E – INSPECTION AND ACCEPTANCE 16

SECTION F – DELIVERIES OR PERFORMANCE 17

SECTION G – CONTRACT ADMINISTRATION DATA 20

SECTION H – SPECIAL CONTRACT REQUIREMENTS 25

SECTION I – CONTRACT CLAUSES 34

SECTION J – LIST OF ATTACHMENTS 42

SECTION K – REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS 43

SECTION L – INSTRUCTIONS, CONDITIONS AND NOTICES

TO OFFERORS 45

SECTION M – EVALUATION FACTORS FOR AWARD 75

ATTACHMENTS 1 THROUGH 10

FOLLOWING PAGE 82 OF THE SOLICITATION

SECTION B

SUPPLIES OR SERVICES AND PRICES/COSTS

B-1 GENERAL DESCRIPTION OF SERVICES/TYPE OF CONTRACT

The United States Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) seek to establish a Fill and Finish Manufacturing Network (FFMN) that facilitates medical countermeasure (MCM) and ensures domestic pharmaceutical surge fill and finish capacity. These fill and finish U.S. based facilities are expected to provide filling and finishing capabilities for influenza vaccines and other public health emergency products to address national security and to augment public health needs on a cost- effective, reliable, and sustainable basis. HHS/BARDA requires the services of Contractor(s) to provide filling and finishing services to other commercial partners under contract to the U.S. Government (USG) for filling and finishing of influenza vaccines and possibly for pharmaceuticals against Chemical, Biological, Radiological and Nuclear (CBRN) threats or to support fill finishing for other drug shortages. The work performed at the FFMN will be coordinated and integrated by HHS/BARDA with programs from other USG agencies to provide long-term solutions that address the medical consequences of currently known and unknown threats.

B-2 TYPE OF CONTRACT

The Government anticipates that award(s) from this solicitation will be Indefinite Delivery Indefinite Quantity (IDIQ) contract(s) with COST REIMBURSEMENT or FIRM FIXED PRICE CLINs. The period of performance for this contract is 10 years. . In accordance with FAR

16.504 (c) it is anticipated that there will be multiple awards resulting from this solicitation.

B-3 CONTRACT LINE ITEM NUMBERS

The following Contract Line Item Number (CLIN) descriptions and tables represent the bid schedule that the Contractor shall use to develop their cost breakdown and deliverables.

Contractors are encouraged to propose sub-CLINs where necessary to delineate specific activities within the CLIN.

Task /Delivery Order Requests (T/DORs) for any of the services as described in the Statement of Work (SOW) may be issued. Each T/DOR will specify its own period of performance. T/DORs may be issued at any time during the contract but the T/DORs period of performance shall in no event exceed the contract period of performance.

B-4 COST/PRICE SCHEDULE

Cost Share CLIN 0001

CLIN Item Description Contractor Share (50%)

Gov’t Share (50%)

Total

0001 Establish Agreements with License Holder/Sponsor (FFP)

Firm Fixed Price CLINS (0005, 0007, 0008)

CLIN Item Description Unit Unit Price Extended Price

0005 Fill and Finish Services (FFP): TBN TBN To be Negotiated

0007 Contract Management (FFP) Sub-CLINs below:

0007A Regulatory and Clinical Bridging Study Plan Each

0007AA Facility Operation Feasibility Plan Each

0007AB Security Plan Each

0007AC Contactor Defined Milestones Each

0007AD Manufacturing Summary Report Each

0007AE Monthly Reports Each

0008 Shipping, Distribution and Storage (FFP):

TBN TBN To be

Negotiated

Cost Plus Fixed Fee CLINS (0002, 0003, 0004, 0006)

CLIN Item Description Cost Fixed Fee CPFF

0002 Product Technology Transfer (CPFF)

0003 Technology Transfer Reimbursement (CPFF)

0004 Maintaining a State of Readiness (CPFF)

0006 Tech Transfer of Alternate Configuration

(CPFF)

B-5 MINIMUM AND MAXIMUM ORDERING LIMITATIONS AND

CEILING LIMITATIONS

The minimum guarantee under this IDIQ contract is $ 5,000,000.

The maximum ordering limitation for a single item or combination of items shall be $100,000,000.00. The maximum ordering limitation for the base period is subject to negotiations.

The ceiling limitation for Cost Plus Fixed Fee (CPFF) portion of the contract will be determined during negotiations.

B-6 FAIR OPPORTUNITY ORDERING (for Fill and Finish Services, CLIN 0005 only)

In accordance with FAR 16.505, Ordering, the following procedures will be used to issue orders under the contract:

All work under this contract will be ordered through the issuance of written "Task Order(s)" and/or “Delivery Order(s)” on an Optional Form 347 executed by the Contracting Officer. The Contracting Officer is the only individual authorized to issue orders under this contract. The Contractor shall only commence work upon receipt of a properly awarded written order executed by the Contracting Officer.

For orders exceeding the micro-purchase threshold, see FAR 2.101, at the time of the order placement, and subject to the exceptions to the fair opportunity process, see FAR 16.505(b)(2), the Government will place an order with the Contractor that provides the greatest overall benefit to the Government upon consideration of factors pertinent to an individual order.

Orders over $5 million – FAR 16.505(b)(1)(iv) - For task or delivery orders in excess of $5 million, the requirement to provide all awardees a fair opportunity to be considered for each order shall include, at a minimum— (A) A notice of the task or delivery order that includes a clear statement of the agency’s requirements; (B) A reasonable response period; (C) Disclosure of the significant factors and sub-factors, including cost or price, that the agency expects to consider in evaluating proposals, and their relative importance; (D) Where award is made on a best value basis, a written statement documenting the basis for award and the relative importance of quality and price or cost factors; and (E) An opportunity for a post-award debriefing in accordance with paragraph (b)(4) of this section.

Fair opportunity to be considered for each order will be accomplished by the Contracting Officer issuing a T/DOR to establish an adequate basis for fair opportunity consideration of placement of that order. The Contracting Officer may issue a T/DOR to fewer than all contract-holders.

However, this will only occur if the other contract-holders have not obtained the proper validation/capability to fulfill the T/DOR. A T/DOR will be issued either in a written format that either has been executed by the Contracting Officer or sent via electronic mail directly from the Contracting Officer. A review pursuant to this subparagraph will be deemed adequate for fair opportunity consideration.

A T/DOR shall provide a Statement of Work, order-specific factors to be used in the selection decision, reporting requirements, deliverables and delivery schedule, and any special instructions or terms applicable to the order. Selection factors for award will be specific for each individual order.

A T/DOR will request a written proposal to be prepared and submitted by the contract-holders to the Contracting Officer. The T/DOR will set forth the specific requirements for the proposal.

Information that may be requested includes, but is not limited to, an approach to perform the work, technical (equipment, materials, staffing) and managerial resources, and schedule for performance identifying major milestones, conflict-of-interest certification, and price/cost itemized by price/cost elements. Contractors should also include a timeline for completing the task, risks associated with the task, and expected adverse impact on current commercial business.

Unless otherwise specified in a T/DOR, all contract-holders shall prepare and deliver a proposal within the timeframe stipulated in the T/DOR in order to receive consideration.

Orders placed hereunder will be executed on an OF 347 and will, at a minimum, contain the following information:

Date of order Contract number and order number Description of services, contract item number(s) and description, quantity, and price Delivery or performance schedule Place of delivery or performance (including consignee) Any packaging, packing, and shipping instructions Accounting and appropriation data Delegation of a Task Order COR, if applicable

Ombudsman: The name, address, telephone number, facsimile number and e-mail address of the agency task and delivery order ombudsman is available upon request to the Contracting Officer.

At the conclusion of each Task/Delivery Order the Contractor shall provide written documentation to the CO that the Task/Delivery Order is complete to include release of claims.

The CO will provide written approval that each Task/Delivery Order is complete. Each Task/Delivery Order shall provide the specific written documentation that is to be provided.

B-7 ITEMS UNALLOWABLE

Notwithstanding the clause "Allowable Cost and Payment" incorporated in this contract, unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:

(a) acquisition, by purchase or lease, of any interest in real property;

(b) purchase or lease of any item of general purpose office furniture or office equipment, regardless of dollar value (general purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.); and

(c) Foreign travel.

B-8 TRAVEL COSTS

The rates (per diem, personal vehicle mileage, etc.) at which the Government will reimburse the contractor for travel shall be no greater than those allowed by GSA Travel Regulations, current as of the time the travel occurs.

B-9 ADVANCED UNDERSTANDINGS

Priority Rating

HHS may assign a priority rating to any contract awarded under this solicitation. The Contracting Officer may unilaterally modify the task order(s) to add FAR Clause 52.211-15, Defense Priority and Allocation Requirements (Apr 2008) and assign a Health and Human Services priority rating under Defense Priorities and Systems Regulation (15 CFR 700).

Failure to Meet Requirements – CLIN 0001

Failure to meet the pandemic influenza vaccine candidate agreement requirements within the deadline specified under CLIN 0001 shall constitute grounds for termination of any Contract awarded in response to this Solicitation. The termination shall be at the sole discretion of the Contracting Officer. In the event that the Contractor fails to meet the 1 year period of performance deadline specified under CLIN 0001, and as a result, the Contractor incurs additional performance costs necessary to meet any requirement in the Contract, the Contractor will be responsible for those additional costs, and those incurred costs may not be charged to any CLIN under a Contract awarded in response to this Solicitation.

SECTION C

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C-1 INTRODUCTION AND BACKGROUND

In the last ten years, the U.S. has experienced the destructive effects of both acts of terrorism and infectious disease outbreaks. While limited in scope, the anthrax attacks of 2001 were highly disruptive and suggestive of the impact that large-scale acts of bioterrorism would have if carried out successfully. Similarly, concerns have escalated that terrorist groups might obtain and use chemical, radiological, and nuclear weapons against civilian populations. Events of the last decade – the SARS epidemic of 2003, the global spread of H5N1 avian influenza, and the 2009- H1N1 pandemic – have also highlighted the persistent threats of pandemic influenza and emerging infectious diseases.

The U.S. Government (USG) has mobilized in many ways to meet such threats. Among the most prominent of these have been the efforts to develop safe and effective MCMs against CBRN threats, pandemic influenza, and emerging infectious diseases. The need for MCMs to diagnose, prevent, mitigate, or treat the illness caused by such agents is clear, but their development has been hindered by the lack of viable markets for such products. The USG has addressed these market barriers by providing substantial support for the research, development, and procurement of MCMs. Many of the firms that have been attracted to biodefense efforts lack experience in the late stages of product development including filling and finishing their products.

The 2009 H1N1 influenza pandemic, and influenza vaccine shortages of 2004, illustrated the vulnerability that dependency on offshore manufacturing of pandemic influenza vaccines entails.

These events and trends prompted the President and the Secretary of Health and Human Services to call for a critical review of the civilian Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). This review, led by the U.S. Department of Health and Human Services’ (HHS) Assistant Secretary for Preparedness and Response, resulted in the August 2010 publication of a report, The Public Health Emergency Medical Countermeasures Review:

Transforming the Enterprise to Meet Long-Range National Needs, that articulated as a strategic imperative that “Current vaccine manufacturers lack the capacity to rapidly “fill and finish” sufficient quantities of pandemic vaccine for the Nation. HHS should immediately develop a network of existing facilities that are pre-qualified and under contract to fill and finish vaccine for U.S. Government-contracted vaccine manufacturers in a public health emergency. This proposed additional infrastructure for influenza could also provide needed capacity for other MCM products.” To meet this objective, adequate capacity to fill and finish MCM products will be created. The FFMN could support the additional products being developed through the Centers of Innovation in Advanced Development and Manufacturing (CIADM). The FFMN also provides a fill finish option for the emerging influenza-focused pharmaceutical companies who do not have fill finish capabilities already in-house, as well as potentially provide fill finish capacity to support remediation of drug shortage situations of national consequence.

C-2 STATEMENT OF WORK

The primary purpose of this contract is to establish the contractual relationships between the U.S.

Government (USG) and multiple Contractors that can be utilized during both pandemic and non-pandemic situations. The multiple Contractors who receive an award will be collectively referred to as the Fill Finish Manufacturing Network (FFMN). Specifically during a pandemic, the Network will allow faster execution of filling & finishing services, since the technology transfer and appropriate regulatory submissions would have already been executed, and will allow for sooner delivery of necessary product to the public. The necessary up front activities (e.g., formulation, technology transfer, alternate site licensure) will be coordinated and integrated with the FFMN.

For non- pandemic situations, task/delivery orders will be issued to all the Contractors within the network to execute tasks on other medical counter measure products, or drugs in shortage status.

These orders may complement or supplement existing BARDA contracts, or those of other USG agencies. All task/delivery orders will be competitive and require all Network Contractors to respond. Each independent task order must include a contractor submitted proposal describing the funding required to complete that task order. The funding for these future task/delivery orders is separate from the funding being allocated to establish this Fill Finish Manufacturing Network. The separate funding for the future task orders may include materials, spare parts, equipment, staffing, fees, etc. that are within the scope and necessary to complete the required task.

Establishing the FFMN with different capabilities and filling platforms (powders, liquid or lyophilized vials, single dose or multi-dose, prefilled syringes or sprayers, single packed dose or multi-packed doses) will allow for maximum flexibility and adaptability to respond to public health threats. It also develops that relationship that facilitates continuation of existing BARDA development contracts to the next stages of formulation, fill and finishing. It is anticipated that formulation, filling and finishing of Clinical trial materials will be needed to support existing BARDA projects/contracts and will be another requirement of the FFMN. New technologies such as disposable filling lines would provide desired agility and flexibility, and may also be considered in this solicitation. FFMN members are expected to provide formulation, fill and finish capabilities for influenza vaccines, other biologic products, pharmaceuticals or adjuvants to address national security, and to augment public health needs on a cost-effective, reliable, and sustainable basis as an element of critical national infrastructure. The FFMN will augment existing U.S.-based fill and finish capacity to deliver pandemic influenza vaccines and other public health emergency products at pilot and commercial scale during public health emergencies.

The envisioned result is an integrated, domestic infrastructure based on strategic partnerships with industry and/or academia with multi-purpose capabilities to fill and finish new pharmaceutical MCMs in a timely manner to protect the U.S. civilian population.

C-3 GENERAL TASKS

The Contractors, as independent organizations and not as agents of the Government, shall furnish all of the necessary services, qualified personnel, materials, equipment and facilities not otherwise provided by the Government to complete the following general requirements:

I - Augment Current US-based Fill and Finish Capacity:

The Contractors shall expand domestic pharmaceutical filling and finishing capacity for an influenza vaccine and other public health emergency products at pilot and commercial scale. Fulfillment of this requirement may include purchasing of change parts, additional equipment, and minor renovations to supplement and/or re-qualify an existing fill finish facility. Purchase of equipment for a new line that includes equipment that is in contact with product is acceptable for this solicitation. Examples of acceptable activities may include upgrading and re-qualifying a previously obsolete filling line, replacing equipment such as a 5-head filler with a 10-head filler in order to increase throughput, adding automated inspection to replace a manual inspection process, and purchase of spare parts or dedicated parts in order to reduce changeover time between products.

Construction of a new facility, a facility addition, or purchase and installation of new critical utilities systems is not within scope of this requirement. Requirement 1 will be fulfilled within the first 3 years of the contract.

The technology transfer, complete qualification (IQ,OQ,PQ), and all associated license requirements of an influenza vaccine shall be executed as part of this general task. The Contractor may pursue their own relationship to identify an FDA licensed or Phase 3 influenza vaccine candidate for use in their facility. Tasks associated with maintaining the active status of the filling facility on the existing or pending BLA are anticipated. If the contractor does not secure such a candidate, the USG may introduce a pandemic influenza candidate(s) to initiate an agreement between a pandemic influenza vaccine candidate and the Offeror to meet this Requirement. T/DORs may include the technology transfer of additional pandemic influenza candidates.

II - Provide Fill and Finish Services-Non-surge:

Contractors shall provide technology transfer (including products other than influenza), and fill and finish services that shall include the capability to process clinical investigational lots, engineering lots, process validation lots, and commercial-scale lots.

Services may include, but are not limited to: technology transfer, analytical testing, process optimization, process validation, formulation, filling, labeling and packaging, and distribution.

Services may be provided to support the fill and finish of pharmaceuticals including parenteral drug products, monoclonal antibodies, recombinant proteins, antitoxins, bacterial or viral vector-based products, and attenuated/killed virus vaccines. As per the USG requirement, these liquid, lyophilized, or powder drug products may be filled and finished as prefilled syringes or sprayers, single dose or multi-dose vials.

The funding for these future task orders is separate from the funding being allocated to create this Fill Finish Manufacturing Network. As the task orders are product specific, the separate funding for the future task orders may include materials, spare parts, equipment, staffing, fees, etc. that are within the task order scope and necessary to complete the required task.

III - Provide Fill and Finish Surge Capacity:

Once a public health emergency has been declared, the Contractor shall provide the minimum of the proposed doses (up to 50M doses) of Pandemic Influenza Vaccine in 10-dose vials (5 ml or 10 ml vials) in response to a USG T/DOR. The timeframe for a T/DOR requiring delivery of agreed upon doses of Pandemic Influenza Vaccine is ≤ 12 weeks post receipt of bulk material. The government estimates the FFMN Contractors will be given approximately 3 months notification that bulk pandemic influenza vaccine will need to be formulated and filled at the Contractors’ site. This estimate is dependent upon the bulk manufacturing schedule and potency assay/calculations which are needed before formulation and filling can occur.

Additionally, the USG anticipates that there may be other life saving products being produced for commercial needs at the selected Contractors’ facilities. The delivery schedule for pandemic influenza vaccine will be negotiated between the USG and the Contractors on a case by case basis to ensure supply of all priority life saving products is maintained at appropriate levels.

C-4 DELINEATION OF CONTRACTOR TASKS

In order to meet the SOW of this contract, the Contractor shall perform the following general scope of work through the issuance of specific delivery/task orders. In all of these activities, all decision making and program management authority shall remain with the US Government.

CLIN 0001 Establish Agreements with License Holder/Sponsor (Cost Share):

The Contractor shall establish master services, technology transfer and quality agreements with the product license holder/sponsor for influenza vaccine and other public health emergency products at commercial scale. The agreement between the sponsor and manufacturer shall be obtained within 1 year and shall be for the life of the contract (maximum 10 years). Activities required to complete this CLIN only shall be funded at a 50% Contractor/ 50% Government cost. Completion of this task is a precursor to technology transfer and demonstrates a mutual willingness on the part of the licensee and Contractor.

Note: The initial T/DOR for this task will be for a pandemic influenza candidate that shall meet the requirements as described in Requirement I above and Section M-2.

CLIN 0002 Product Technology Transfer (CPFF):

This task is contingent on successful completion of CLIN 0001. Perform technology transfer, license amendment and/or other activities related to augmenting current U.S.-based FFMN capacity. Activities associated CLIN 0002 shall be completed within (3) years after contract award.

The Contractor shall expand licensed domestic FFMN capacity for influenza vaccine and other public health emergency products at commercial scale. The technology transfer of an influenza vaccine shall be executed as part of this requirement. The Offeror may pursue their own relationship to identify an FDA licensed or Phase 3 influenza vaccine candidate for use in their facility. If the contractor does not secure such a candidate, the USG may introduce a pandemic influenza vaccine candidate(s) to the Offeror in order to encourage an agreement between the pandemic influenza candidate and the Contractor to meet this CLIN .

The Contractors shall complete the following within three (3) years after contract award:

• Purchase of change parts, additional equipment, and minor renovations to supplement and re-qualify an existing fill finish facility.

• Complete fill and finish technology transfer of an influenza vaccine product.

• Support all license requirements to include the Contractors’ facilities for the license application.

CLIN 0003 Technology Transfer Reimbursement to License Holder/Sponsor (CPFF):

This task represents the reimbursement of the expenses incurred by the License Holder/Sponsor for the technology transfer of the product. These expenses may include staffing resources as well as costs associated with preparation of license amendment(s) incurred by the License Holder/Sponsor (e.g. bulk vaccine manufacturer). This CLIN may include labor hours, administrative costs such as printing, collating, & office supplies, and travel expenses required for the License Holder/Sponsor to support the technology transfer activities included in CLIN 0002.

CLIN 0004 Maintaining a State of Warm Base (CPFF):

This CLIN may reimburse warm base activities related to maintaining the product license in good standing. This reimbursement is contingent on successful completion of CLIN 0002. After successful technology transfer and licensure approval of the influenza candidate, the Contractor is required to perform activities to meet all cGMP requirements to maintain the license or EUA in good standing. Commercial activities that maintain licensed fill/finish capability shall off-set warm based reimbursement under this task.

CLIN 0005 Fill and Finish Services (FFP):

CLIN 0005 shall include the capability to process clinical investigational lots, engineering lots, process validation lots, and commercial-scale lots. his CLIN is to support the fill and finish of influenza vaccines and other medical countermeasure products. Services may be provided to support the fill and finish of pharmaceuticals including parenteral drug products, monoclonal antibodies, recombinant proteins, antitoxins, bacterial or viral vector-based products, and attenuated/killed virus vaccines.

As per the USG requirement, these liquid, lyophilized, or powder drug products could be filled and finished as prefilled syringes or sprayers, single dose or multi-dose vials.

Contractors shall provide matrices of products, services, images, capacities and associated costs. These task/delivery orders could be executed at any time during the 10 year period of performance.

CLIN 0006- Additional Technology transfers (CPFF):

The Contactor may provide the capability to provide additional pandemic influenza vaccine doses that are of another configuration i.e. prefilled syringes, 5 dose vials, etc.

CLIN 0006 would provide for the technology transfer of this additional configuration into the CMO. In addition, at the request of the USG, the Contractor may perform the technology transfer of another product for public health emergency into the proposed facility. CLIN 0006 would provide for such a technology transfer for another product.

The Contractors shall:

• Complete fill and finish technology transfer of an influenza vaccine or other public health emergency product

• Support all license requirements to include the Contractors’ facilities for the license application.

CLIN 0007 Contract Management (FFP):

This task shall reimburse the cost for managing the contract in connection with the following deliverables: required project plans, tech transfer plans, contractor defined milestones, commissioning and validation reports, monthly and final reports.

Additionally, monthly meetings, periodic site visits and quarterly site visits shall be included.

CLIN 0008 Shipping, Distribution and Storage (FFP):

This task shall reimburse the cost of shipping the final finished products to distribution site(s) as directed by the USG. If applicable, this task may cover cost for potential storage of the product pending final release and/or approval to ship. Shipping or storage costs shall not begin until after product acceptance by the USG.

SECTION D

PACKAGING AND MARKING

D-1 METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, delivery of the items to be furnished to the Government under this contract (including invoices) shall be made by commercial carrier, first class mail, overnight carrier, or e-mail.

D-2 PACKAGING AND SHIPPING

Packaging

As required, packaging of biopharmaceuticals and samples shall be consistent with the FDA-approved labeling and packaging at the time of processing. Appropriate packaging and labeling changes may be required for product delivered under the Investigational New Drug (IND) and following product FDA marketing approval.

Shipping

Shipment of deliverables will be defined by each T/DOR.

D-3 REPORT DELIVERABLES

Unless otherwise specified by the Contracting Officer delivery of reports to be furnished to the Government under the resultant contract (including invoices), shall be addressed as follows:

Contracting Officer (CO) Contracting Officer’s Representative (COR)

HHS/OS/ASPR/AMCG HHS/OS/ASPR/BARDA

330 Independence Ave., SW 330 Independence Ave, SW Rm G640 Rm G640 Washington, DC 20201 Washington, DC 20201

SECTION E

INSPECTION AND ACCEPTANCE

E-1 52.252-2 CLAUSES INCORPORATED BY REFERENCE

This contract incorporates one or more Federal Acquisition Regulation (FAR) clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov http://farsite.hill.af.mil/vffar1.htm

The following FAR contract clause pertinent to Section E is hereby incorporated by reference:

CLAUSE TITLE DATE

52.246-2 52.246-3 52.246-4

Inspection of Supplies—Fixed-Price Inspection of Supplies—Cost-Reimbursement Inspection of Services-Fixed Price

Aug-96 May-01 Aug-96

52.246-5 Inspection of Services-Cost-Reimbursement Apr-84 52.246-16 Responsibility of Supplies Apr-84

E-2 INSPECTION AND ACCEPTANCE

(a) The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

(b) For the purpose of this section, To be filled-in at award, is the authorized representative of the Contracting Officer.

(c) Inspection and acceptance will be performed at the destination of the articles, services or documentation delivered for the performance of this contract.

E-3 AUDITS

The Contractor shall allow for and provide requested information to support security, quality, regulatory, and cGMP audits conducted by USG on an ad hoc basis. The estimated frequency of audits under this paragraph is annually, unless an audit for cause is determined necessary at the discretion of the Contracting Officer. If the USG finds non-compliances or deficiencies during its audit(s) on firm fixed price line items, the Contractor, at its sole expense, shall take all necessary corrective action within a timely manner. In addition, the Contractor shall provide all information requested by the USG, including the FDA, to facilitate a cGMP inspection at the time of production of vaccine lots.

http://www.acquisition.gov/

SECTION F

DELIVERIES OF PERFORMANCE

F-1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

http://www.acquisition.gov.

52.242-15 Stop-Work Order (AUG 1989), Alternate I Apr-84 52.242-17 Government Delay of Work Apr-84 52.247-35 F.O.B. Destination, Within Consignee’s Premises Apr-84

F-2 DELIVERY SCHEDULE

All work and services required hereunder including preparation and submission of all deliverables shall be completed within 10 years, of the effective date of the contract.

Period of Performance for Task/Delivery Orders

Task/delivery orders related to FFMN core services and warm-based influenza vaccine fill finishing will state their own deliverables and period of performance. The period of performance for individual task/delivery orders issued pursuant to this contract are anticipated to be no more than three (3) years.

CLIN Description Deliverable/format Approx. due date

0001 Copy of the created master services, technology transfer and quality agreements with the product license holder/sponsor

Original – CO 2 Copies – COR 1 Electronic Copy – Sent to C.O. and COR

Within one (1) year of contract award.

0002 Overall Technology Transfer Project Plan to complete the technology transfer of an influenza vaccine candidate.

Original – CO 2 Copies – COR 1 Electronic Copy – Sent to C.O. and COR

Within one (1) month after the T/DO has been issued.

0007 Regulatory and Clinical Bridging Study Plan

Original – CO.

2 Copies – COR 1 Electronic Copy – Sent to CO and COR

Within three (3) months after the T/DO has been issued.

http://www.acquisition.gov/

0007 Facility Operation Feasibility Plan Original – CO 2 Copies – COR 1 Electronic Copy – Sent to C.O. and COR

Within three (3) months after T/DO has been issued.

0007 Security Plan Original – CO 2 Copies – COR 1 Electronic Copy – Sent to C.O. and P.O.

Within three (3) months after T/DO has been issued.

0007 Contactor Defined Milestones Original – CO 2 Copies – COR 1 Electronic Copy – Sent to CO and COR

Within three (3) months after T/DO has been issued.

0007 Manufacturing Summary Report Original – CO Copy – COR

1 Electronic Copy – Sent to CO and COR

Within six (6) weeks after CO written approval of completion of each task/delivery order, a written report summarizing the campaign, cost of goods, and release documents must be submitted.

0003 Provide detailed list of Technology Transfer Reimbursement requirements for the influenza vaccine license holder/sponsor

Original – CO Copy – COR 1 Electronic Copy – Sent to CO and COR

Within 6 weeks after CO written approval of completion of the technology transfer and license activity complete.

0007 Monthly Reports (12 per year) Original – CO Copy – COR 1 Electronic Copy – Sent to CO and COR

The initial Technical Report due on/before TBD;

thereafter, due on/before the 15th of the month or milestone following each reporting period.

F-3 MEETINGS

Monthly Teleconferences

The Contractor shall participate in monthly teleconferences with USG to discuss the performance of the contract. The Contractor shall keep meeting minutes and forward a finalized copy to the Contracting Officer and COR for approval within three (3) business days after each teleconference, or as otherwise authorized by the Contracting Officer.

Periodic Site Visits

The Contractor shall accommodate for periodic site visits by USG on an ad hoc basis. The Contractor shall keep meeting minutes and forward a finalized copy to the Contracting Officer and COR for approval within 3 business days after each site visit, or as otherwise authorized by the Contracting Officer.

Quarterly Site Visits

The Contractor shall provide formal presentations summarizing all work accomplished in the previous calendar quarter at the Contractor’s site on a quarterly basis. The contractor shall keep meeting minutes and forward a finalized copy to the Contracting Officer and COR for approval within three (3) business days after each site visit, or as otherwise authorized by the Contracting Officer.

F-4 PLACE AND METHOD OF DELIVERY

Delivery of contract deliverables specified under Section F-2 shall be F.O.B. destination, within consignee’s premises.

Unless otherwise specified, deliveries shall be Monday through Friday (excluding Federal Holidays and other official Federal government closures) between the hours of 8:30 AM and 5:00 PM EST only. Contract deliverables scheduled for delivery on a Federal holiday shall be made the following business day.

Deliveries shall be made to the address(es) specified by the Contracting Officer.

SECTION G

CONTRACT ADMINISTRATION DATA

G-1 DESIGNATION OF GOVERNMENT CONTRACTING OFFICER AND

CONTRACT SPECIALIST

Kyle Roberts, Contracting Officer and Quintin Hackshaw, Contract Specialist, Office of Aquisitions Management Contracts & Grants (AMCG), have been assigned to administer the contractual aspects of this contract.

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.

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 any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

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.

The contractor shall submit all correspondence that in any way concerns the terms or conditions of this contract shall be submitted directly to the Contracting Specialist at the following address:

Office of Aquisitions Management Contracts & Grants (AMCG) Assistant Secretary for Preparedness and Response (ASPR) Department of Health and Human Services 330 Independence Ave, SW, RM G640 Washington, DC 20201

Telephone Number: 202-260-0747 (Kyle Roberts) Telephone Number: 202-260-0453 (Quintin Hackshaw) E-mail Address: kyle.roberts@hhs.gov E-mail Address: quintin.hackshaw@hhs.gov

G-2 DESIGNATION OF THE CONTRACTING OFFICER’S REPRESENTATIVE

(a) The individual(s) named below is hereby designated as the Contracting Officer’s Representative (COR). If an alternate COR is listed below, that person will serve in mailto:kyle.roberts@hhs.gov mailto:rosemary.mann@hhs.gov the COR’s stead when the COR is unavailable. The COR is responsible for the technical administration of this contract, [in accordance with the provisions of the clause included herein entitled, "Technical Direction” and the COR letter of delegation."]

NAME ADDRESS

TBD Biomedical Advanced Research Development Authority Assistant Secretary for Preparedness and Response

Department of Health and Human Services 330 Independence Ave, SW, RM G640 Washington, DC 20201

(b) The COR, or his/her authorized representative, shall be responsible for coordinating with the contractor the technical aspects of the contract. The COR is not authorized to make any changes, which affect the contract amount, terms or conditions. The contracting officer is the only person with the 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 any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

G-3 KEY PERSONNEL

The key personnel under this contract shall be:

Name Title Program Manager Principal Investigator Filling & Operations Manager Technical Operations Manager

G-4 SUBSTITUTION OF KEY PERSONNEL

(a) The Contractor agrees to assign to the contract those persons whose resumes were submitted with the proposal who are necessary to fill the requirements of the contract.

No substitutions shall be made except in accordance with this clause.

(b) All requests for substitution must provide a detailed explanation of the circumstance necessitating the proposed substitution, a complete resume for the proposed substitute and any other information requested by the contracting officer to approve or disapprove the proposed substitution. All proposed substitutes must have qualifications that are equal to or higher than the qualifications of the person to be replaced. The contracting officer or authorized representative will evaluate such requests and promptly notify the contractor of his approval or disapproval thereof.

(c) The contractor further agrees to include the substance of this clause in any subcontract, which may be awarded under this contract.

G-5 CONTRACT ADMINISTRATION

The contractor's representative responsible for handling contract administration is:

NAME TITLE TELEPHONE # ADDRESS

To Be Filled-In By Contractor

G-6 INVOICE SUBMISSION & PAYMENT RELATED INFORMATION

You must submit all invoices by regular mail, FedEx, UPS, etc, but not by hand or courier by the 15th of each month. Your invoice must include all of the elements of a proper invoice as defined in the invoice or payment clause used in this award as well as any other information required below or in the contract. No more than one invoice may be submitted per month.

Submit an original and one (1) copy of the invoice to:

Office of Aquisitions Management Contracts & Grants Assistant Secretary for Preparedness and Response Department of Health and Human Services 330 Independence Ave, SW, RM G640 Washington, DC 20201 Attn: Kyle Roberts

Submit an electronic copy to the following email addresses:

Kyle.Roberts@hhs.gov Quintin.Hackshaw@hhs.gov

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 and delivery/task order (if applicable)

(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 if different than number 1 above.

mailto:Kyle.Roberts@hhs.gov mailto:Quintin.Hackshaw@hhs.gov

(12) Any additional backup information required to justify the invoice.

SUBMISSION OF ELECTRONIC FUNDS TRANSFER (EFT) INFORMATION

AND REMITTANCE INFORMATION:

The Government shall make payment to the Contractor using the EFT information contained in the Central Contractor Registration (CCR) database. In the event that the EFT information changes, the Contractor shall be responsible for providing the updated information to the CCR database.

Remittance information associated with EFT payments is now available via the Payment Advice Internet Delivery (PAID) System on the Department of Treasury's Internet site at http://fms.treas.gov/paid/index.asp. This site provides an explanation of the system, how it works, security and access information, a user demonstration, and registration information. There is no charge to use the PAID system.

G-7 CONTRACTOR PERFORMANCE REPORT

Interim and final evaluations of contractor performance shall be conducted on this contract in accordance with FAR 42.15. The final performance evaluation shall be completed at the time of completion of work. Interim and final evaluations will be submitted to the Contractor as soon as practicable.