SOLICITATION NOTICE
65 -- Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response
- Notice Date
- 8/24/2021 5:37:40 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- ASPR BARDA DIV CONTRACTS MGMT & ACQ Washington DC 20515 USA
- ZIP Code
- 20515
- Solicitation Number
- 75A50121R00013
- Response Due
- 9/13/2021 9:00:00 AM
- Archive Date
- 09/14/2021
- Point of Contact
- Wendell Conyers, Phone: 202-308-9247, Deitra Williams, Phone: 202-845-4483
- E-Mail Address
-
wendell.conyers@hhs.gov, deitra.williams@hhs.gov
(wendell.conyers@hhs.gov, deitra.williams@hhs.gov)
- Description
- 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.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/a6e640e6a0724295bd3d19c31e2f8a1f/view)
- Place of Performance
- Address: DC, USA
- Country: USA
- Country: USA
- Record
- SN06109390-F 20210826/210824230132 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |