Amend_2_Body.pdf

Solicitation No. 13-100-SOL-00004 Amendment No. 0002

(Continuation of Block 14 of SF 30)

a. Under Section B, Paragraph B-4; Cost/Price Schedule; Cost Share CLIN 0001, is hereby deleted in its entirety and replaced with the following table:

Cost Share CLIN 0001

CLIN Item Description Contractor

Share (50%)

Gov’t Share (50%)

Total

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

b. Under Section L, Paragraph L-9: General Proposal Instructions; Proposal Formatting #3, is herby deleted in its entirety and replaced with the following:

3. Text shall be printed using a font size of 10 or 12 cpi.

c. Under Section L, Paragraph L-11: Technical Proposal Instructions; (c)(iv) Organizational Competency #7, is hereby deleted in its entirety.

d. Under Section M, Paragraph M-2: Mandatory Criteria for Eligibility #3, last line-- the phrase “and minimum doses should be 15 M doses” is hereby deleted.

e. Under Section M, Paragraph M-3: Evaluation Factor 2, is hereby deleted in its entirety and replaced with the following:

Evaluation Factor 2: Provide Pharmaceutical Fill and Finish Surge Capacity for Pandemic Influenza Vaccines and other Medical Countermeasures

(Sub-Factor 1 will be considered of higher importance than sub-factor 2, 3 and 4, which are of equal importance. Sub-elements under each sub-factor are of equal importance.).

Sub-Factor 1: Pandemic Influenza Tech Transfer/Licensing Plan

a. Pandemic Influenza Vaccine candidate description

b. Status of Contract/Agreement with bulk influenza vaccine manufacturer

Solicitation No. 13-100-SOL-00004 Amendment No. 0002

c. Technology Transfer Plan and Schedule

d. Licensing Plan and Schedule

e. Timeline to product availability (meets FDA requirements for use)

Sub-Factor 2: Pandemic Influenza Vaccine Surge Capacity

a. Quantity of packaged, internally released doses available within the 12 weeks allocated to completely fill & finish manufacturing of a pandemic influenza vaccine bulk material.

b. Integrated Master Schedule (IMS) of surge production plan to deliver the proposed doses.

Sub-Factor 3: Operating Plans

a. Surge Production Plan including but not limited to staffing, schedule, product release, and delivery

b. Readiness/Sustainability Plan (warm base) including, but not limited to, facility, staffing, training, and changeover strategies Sub-Factor 4: Organizational Competency

a. Experience of prime organization(s) and proposed prime subcontractors

b. Experience of key personnel that will support this effort

c. Subcontractor lines of accountability and relation to the Contractor

f. Under Section J, Attachment #9 Past Performance Questionnaire, return the Questionnaire via fax to the attention of Quintin Hackshaw