Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

Reference Amendment 1

PERIOD OF PERFORMANCE
a. The base period of performance of this contract is anticipated for thirty-six (36) months from date of award. The period of performance may be extended up to 24 months with the exercise of option(s), structured as CLINs.
b. If the Government exercises its option(s), the period of performance will be increased as listed below:
Option I Twelve (12) Months (Year 4)
Option II Twelve (12) Months (Year 5)

The Statement of Work (SOW) delineates the specifics of the supplies or services to be furnished. The minimum guarantee is $50,000.00 for the duration of any resultant contract (base + options).
Provide firm-fixed prices for all CLINs, except those CLINs which have “TBD” or “N/A” in the Estimated Maximum Quantity column. Provide pricing based upon the CLIN, item name and description in the SOW contained in Section C for the three (3) year base period, and item name and description for the two 12-month option periods, as the numbers in SOW reflect base period numbering (SOW Numbering identified in SOW would be revised in conjunction with any resultant option award with description data
unchanged).
Price/Cost, e.g., Firm-fixed-price or cost reimbursable, for “TBD” CLINs, i.e., 0008, 0010, 0011, 0012, 0013, and 0014 will be determined as a result of the issuance of a Request for Task Order Response (RTOR) to any or all resultant contract awardee(s).

C.2.1. Detailed Description of Contract Line Item Numbers (CLINs): Reference attached RFP for additional detail
CLINs will differ for option periods with item name and scope unchanged.
CLIN 0001: cGMP Influenza Vaccine Master and Working Seed Lot
The Contractor shall provide yield optimized master and working seed lots for inactivated, live attenuated,or recombinant influenza vaccine product.

CLIN 0002: Influenza Vaccine Research Lot(s)
The Contractor shall provide an influenza vaccine small scale, research lot.

CLIN 0003: cGMP Influenza Vaccine: Investigational Lot(s)
The Contractor shall provide influenza vaccine investigational lot(s).

CLIN 0004: cGMP Influenza Vaccine: Commercial Scale Bulk Lot(s)
The Contractor shall provide influenza vaccine bulk product.

CLIN 0005: cGMP Adjuvant: Clinical or Commercial Scale Bulk Lot(s)
The contractor shall provide adjuvant bulk product suitable for formulation and fill-finishing for use in the clinic, including clinical trial or use during a public health emergency. Proposed adjuvant shall have completed Phase 2 development in combination with a pandemic influenza or pre-pandemic influenza or emerging pathogen antigen. Clinical evidence of antigen sparing and/or adjuvant benefit for the pandemic influenza or pre-pandemic influenza or emerging pathogen antigen is required.

CLIN 0006: Formulation and Filling
The unit for this item is each (vial, syringe and sprayer)

Submit standard data report according to instructions in ‘Reporting Requirements.’ Provide a final report including, at minimum, the information identified in the Final Report Requirements.
CLIN 0006A: Antigen: Single dose vials
CLIN 0006B: Antigen: Syringes or sprayers
CLIN 0006C: Antigen: Multi-dose vials
CLIN 0006D: Adjuvant: Single dose vials
CLIN 0006E: Adjuvant: Multi-dose vials
CLIN 0006F: Co-formulated antigen and adjuvant: Single dose vials
CLIN 0006G: Co-formulated antigen and adjuvant: Syringes
CLIN 0006H: Co-formulated antigen and adjuvant: Multi-dose vials

CLIN 0007: Storage and Stability

Submit standard data report according to instructions in ‘Reporting Requirements.’ Provide a final report including, at minimum, the information identified in the Final Report Requirements
CLIN 0007A: Storage and Stability of investigational lots of antigen. The unit for this item is a lot, which equals storage and stability for one (1) lot/month.
CLIN 0007B: Storage and Stability of commercial scale bulk lots of antigen. The unit for this item is a lot, which equals storage and stability for one (1) lot/month.
CLIN 0007C: Storage and Stability of antigen in final container. The unit for this item is a final container which equals storage and stability for a single (1) final container/month.
CLIN 0007D: Storage and Stability of clinical/commercial scale lots of adjuvant. The unit for this item is a lot which equals a single (1) month of storage and stability for a single (1) lot/month.
CLIN 0007E: Storage and Stability of adjuvant in final container. The unit for this item is a final container which equals storage and stability for a single (1) final container/month.

CLIN 0008: Shipping

CLIN 0009: Candidate Vaccine Virus (CVV)

CLIN 0010: Potency reagent and standards manufacture and testing .The Contractor shall provide influenza vaccine reagents and standards.

CLIN 0011: Analytical Laboratory Testing/Assay

CLIN 0012: Non-Clinical Studies
CLIN 0013: Clinical Studies

CLIN 0014: Disposal of product
CLIN 0015: Standard Data Reporting Requirements

CLIN 0016: Additional Reporting
CLIN 0017: Storage and Stability of Materials from Prior Contracts

CLIN 0017A: Storage and Stability of commercial scale bulk lots of antigen. The unit for this item is a lot, which equals storage and stability for one (1) lot/month.
CLIN 0017B: Storage and Stability of antigen in final container. The unit for this item is a final container which equals storage and stability for a single (1) final container/month.
CLIN 0017C: Storage and Stability of clinical/commercial scale lots of adjuvant. The unit for this item is a lot which equals a single (1) month of storage and stability for a single (1) lot/month.
CLIN 0017D: Storage and Stability of adjuvant in final container. The unit for this item is a final container which equals storage and stability for a single (1) final container/month.

CLIN 0018: Emerging Pathogen. The contractor shall perform activities as required by HHS and as specified in an RTOR.