Revised_SCHEDULE_(OSP)-Amd_0001-Attachment_2.pdf
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- Solicitation number
- 15-100-SOL-00003
About this file
This document contains revised pricing tables for a federal contract solicitation seeking medical countermeasures for pandemic influenza preparedness and response. The pricing tables provide estimated maximum quantities, unit prices, and total estimated values for contract line items including cGMP influenza vaccine master and working seed lots, investigational vaccine lots, commercial scale bulk lots, adjuvant bulk lots, formulation and filling services, storage and stability services, shipping, candidate vaccine viruses, potency reagents and standards, analytical testing, non-clinical and clinical studies, disposal of product, BARDA tracking tools, and additional reporting. The solicitation will be issued by the Department of Health and Human Services seeking single or multiple awards for a three-year base period plus two one-year option periods to supply these products and services. Responses are due on February 20, 2015 with anticipated awards by July 2015. Eligible offerors must produce influenza vaccines or have an influenza vaccine license or completed Phase 3 clinical trials and be preparing a BLA.
Attachment 2 - Amd 0001 - CLIN and Pricing Schedule
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Revised B.2. CLINs and Pricing -Offer Submission Package:
Reference Offer Submission Package, pages 5-14.
B.2. Contract Line Item Numbers (CLINs) and Pricing is revised as follows:
a. Base Period: September 1, 2015 through August 31, 2018
CLIN Item Name Unit of Issue Estimated Maximum Quantity
Unit Price
Estimated Dollar Value Per 12-month
Total Estimated Dollar Value (36 Month Base Period)
0001 cGMP Influenza Vaccine Master and Working Seed Lot
Lot 15
0002 Influenza Vaccine Research Lot(s)
0003 cGMP Influenza Vaccine Investigational Lot(s)
0004 cGMP Influenza Vaccine Commercial Scale Bulk Lot(s)
Lot 300
0005 cGMP Adjuvant:
Clinical or
Lot 50
0006A Formulation and Filling:
Antigen--Single-dose vials
Each 10,000,000
0006B Formulation and Filling:
Antigen--Syringes or Sprayers
Each 100,000,000
Amendment 0001-Attachment 2 Page 1
0006C Formulation and Filling:
Antigen--Multi-
0006D Formulation and Filling:
Adjuvant—Single-
0006E Formulation and Filling:
Adjuvant--Multi-
0006F Formulation and Filling: Co-formulated Antigen and Adjuvant— Single-dose vials
0006G Formulation and Filling: Co-formulated Antigen and Adjuvant-- Syringes
0006H Formulation and Filling: Co-formulated Antigen
Multi-dose vials
0007A Storage and Stability:
Lots of Antigen
Lot 20
Per Lot Per month
Per lot/12 months
20 Lots/12 months
0007B Storage and
Commercial Scale Bulk Lots of Antigen
Lot 100
Per month
Per Lot/12 months
100 Lots/12 months
Amendment 0001-Attachment 2 Page 2
0007C Storage and Stability: Antigen in Final Container
Final Container
5,000,000
Per FC Per Month
Per FC/12 months
5,000,000 FC/12
months
0007D Storage and Stability: Clinical/ Commercial scale lots of Adjuvant
Lot 400
Per Lot/12 months
400 Lots/12 months
0007E Storage and Stability: Adjuvant in Final Container
Final Container
5,000,000
Per FC
Per FC/12 months
5,000,000 FC/12
months
0007F Storage and Stability: Licensed Product in Final Package
Package TBD
Per PG
Per PG/12 month
0008 Shipping
Each TBD
0009 Candidate Vaccine Virus (C V V)
Each 15
0010 Potency Reagent and Standards Manufacture and Testing
0011 Analytical Laboratory Testing/Assay
0012 Non-Clinical Studies
Study TBD
0013 Clinical Studies
0014 Disposal of Product
Amendment 0001-Attachment 2 Page 3
0015 BARDA Tracking Tool-Development and Testing of New Standard Data Reporting Formats
0016 Additional Reporting
Report N/A Not Separately Priced
(NSP)
0017A Prior Contracts:
Storage and Stability of Bulk Lots--Antigen
Lot 250
0017B Prior Contracts:
Storage and Stability in Final Container-- Antigen
Final Container
500,000
0017C Prior Contracts:
Storage and Stability of Bulk Lots--Adjuvant
Lot 250
0017D Prior Contracts:
Storage and Stability in Final Container-- Adjuvant
Final
500,000
Total Estimated Dollar Amount - Base Period (36 month Base Period)
b. Option Period One: September 1, 2018 through August 31, 2019
CLIN Item Name Unit of
Issue Estimated Maximum Quantity
Unit Price Total Estimated Dollar Value
0101 cGMP Influenza
Lot 5
0201 Influenza Vaccine
Amendment 0001-Attachment 2 Page 4
0301 cGMP Influenza
Vaccine
0401 cGMP Influenza Vaccine
0501 cGMP Adjuvant:
Clinical or
0601A Formulation and Filling:
Antigen—Singe-
0601B Formulation and
0601C Formulation and Filling:
0601D Formulation and Filling:
Adjuvant—Single-
0601E Formulation and Filling:
0601F Formulation and Filling: Co-formulated antigen and adjuvant-- Single dose vials
Amendment 0001-Attachment 2 Page 5
0601G Formulation and
Filling: Co-formulated antigen
0601H Formulation and Filling: Co-formulated antigen
0701A Storage and Stability:
Lot 7
0701B Storage and
Commercial Scale
Lot 30
0701C Storage and
5,000,000
0701D Storage and
0701E Storage and
5,000,000
0701F Storage and Stability: Licensed Product in Final Package
Package TBD
0801 Shipping
0901 Candidate Vaccine
Each 5
Amendment 0001-Attachment 2 Page 6
1001 Potency Reagent and Standards
Analytical
1201 Non-Clinical
1301 Clinical Studies
1401 Disposal of Product
1501 BARDA Tracking and Testing of New
1601 Additional
Report NSP
1701A Prior Contracts:
Storage and Stability of Bulk Lots—Antigen
Lot 250
1701B Prior Contracts:
Storage and Stability in Final Container—
500,000
1701C Prior Contracts:
Storage and
Lots—Adjuvant
1701D Prior Contracts:
Storage and Stability in Final Container-- Adjuvant
Final Container
Amendment 0001-Attachment 2 Page 7
Total Estimated Dollar Amount – Option Period One
c. Option Period Two: September 1, 2019 through August 31, 2020
CLIN Item Name Unit of
Issue Estimated Maximum Quantity
Unit Price Total Estimated Dollar Value (36 Month Base Period)
1701 cGMP Influenza
1801 Influenza Vaccine
1901 cGMP Influenza Vaccine
2001 cGMP Influenza Vaccine
2101 cGMP Adjuvant:
Clinical or
2201A Formulation and Filling:
Antigen--Single-
2201B Formulation and
Amendment 0001-Attachment 2 Page 8
2201C Formulation and
Filling:
2201D Formulation and
Adjuvant--Single
2201E Formulation and Filling:
2201F Formulation and Filling: Co-formulated Antigen
Single dose vials
2201G Formulation and Filling: Co-formulated Antigen
2201H Formulation and Filling: Co-formulated Antigen
2301A Storage and
Lot 7
2301B Storage and
Commercial Scale
Amendment 0001-Attachment 2 Page 9
2301C Storage and
5,000,000
2301D Storage and
2301E Storage and
5,000,000
2301F Storage and Stability: Licensed Product in Final Package
Package TBD
2401 Shipping
2501 Candidate Vaccine
Each 5
2601 Potency Reagent and Standards
2701 Analytical
2801 Non-Clinical
2901 Clinical Studies
3001 Disposal of Product
3101 BARDA Tracking and Testing of New
Amendment 0001-Attachment 2 Page 10
3201 Additional
Report N/A NSP
3301A Prior Contracts:
Storage and
Lots—Antigen
3301B Prior Contracts:
Storage and Stability in Final Container-- Antigen
Final Container
500,000
3301C Prior Contracts:
Storage and Stability of Bulk Lots--Adjuvant
Lot 250
3301D Prior Contracts:
Storage and Stability in Final Container-- Adjuvant
Final
Total Estimated Dollar Amount – Option Period Two
Amendment 0001-Attachment 2 Page 11
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