N02RC71023-75_AMD_1.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION

NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO.

IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

NSN 7540-01-152-8070

Previous edition unusable

Jame Chang, Contracting Officer

National Cancer Institute Office of Acquisitions 9609 Medical Center Drive Bethesda, MD 20892-9705

To All Potential Offerors

N02RC71023-75

02/16/2018

02/01/2018

02/16/2018

The purpose of this amendment is to: (1) Provide responses to questions received; 2) Add increased capacity options to the structure within the RFP; 3) Revise Article B.2., F.3., Section J - Attachment 1 and Attachment 3, Section L.1.d. "Level of Effort", Section L.2.a.11.a. "Past Performance", Section L "Technical Discussions - Additional Personnel", Section L.2.c.15 "Additional Business Proposal Instructions", and Section M "Mandatory Qualification Criteria - 3.a.".

Due Date for Additional Questions: February 21, 2018, 4:00PM Eastern (Changed) Proposal Due Date: March 5, 2018; 3:00PM Eastern (Unchanged)

The changes referenced above are attached.

RFP No: N02RC71023-75 Amendment 0001

RFP: N02RC71023-75

Amendment 0001

I. Questions and Answers:

Q1: Please confirm that proposals are to be submitted by electronic submission only and that no hardcopy submission is expected.

A1: Yes, proposals are to be submitted by electronic submission only. We will NOT accept hardcopies.

Q.2: Please confirm that offerors are to provide a list of the last 3 contracts completed or currently in progress that are similar in nature to the solicitation scope of work.

A.2: Yes, offerors are to provide a list of the last 3 contracts completed or currently in progress that are similar in nature to the solicitation scope of work. See the revised language below.

Past Performance information on page 44 of the RFP N02RC71023-75 has been modified, please see below:

A list of the last 3 contracts completed during the past Three years or currently being performed that are similar in nature to the solicitation workscope. Contracts listed may include those entered into by the

Federal Government, agencies of state and local governments and commercial concerns. Offerors may also submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition. For the purposes of this solicitation, a "major subcontract" is defined as $25,000 or more.

Q3: Will the government accept past performance references for contracts completed or in progress within the past 5 years?

A3: No, please see response above (A.2.) The Government will accept the last 3 contracts completed during the past Three years or currently being performed that are similar in nature to the solicitation workscope.

Q4: Section L – Additional Technical Proposal Instructions (page 48 in RFP), instructs offerors to limit the total number of pages for the entire proposal to 150 pages. Attachment 1 states that the Total Page

Count of the Technical proposal shall not exceed 200 pages.

Will the Government please confirm that the technical proposal shall not exceed 200 pages?

A4: Attachment 1 has been revised and is attached to RFP N02RC71023-75, amendment 001. It shall not exceed 150 pages.

Q5: Section L – Additional Technical Proposal Instructions (page 48 in RFP), states that total page count does not include PI/key personnel CVs while Attachment 1 states that total page count does include PI

CVs. Will the Government please confirm that CVs for PIs and key personnel are excluded from page count?

A5: Yes, CVs for PIs and key personnel are excluded from page count.

Q6: Given the value that the Government has placed on personnel for this contract, will the Government please increase the page limit for CVs for all non-key Personnel to 2-3 pages?

A6: The page limit for CVs for all non-key Personnel has been increased to 2-3 pages.

Q7: Will the government accept additional years of experience in lieu of a Ph.D., M.D., or Master’s degree?

A7: Yes, the Government will accept additional years of experience in lieu of a Ph.D., M.D., or Master’s degree. See revised language for Section L – Section 3 Technical Discussions, A.2. Additional Personnel

(page 50):

Additional Personnel: Offerors staff should include experienced key personnel and additional staff that can support and complement key personnel in achieving the project goals and areas.

Section Heads should have a Ph.D., M.D., or Master’s degree in an appropriate scientific area and particular experience in a given scientific area. However, the Government will accept additional years of experience in lieu of a Ph.D., M.D., or Master’s degree. The Section Heads will work with one or more support staff in performing the statement of work, will ensure the quality and accuracy of the work performed, and train new staff as appropriate. The Section Head will need to have at least 10 years of experience.

The technical staff should in general have a B.S. degree in an appropriate scientific area and perform the scientific activities needed to fulfill the statement of work.

The Administrative support position should be filled by an experienced manager who will maintain a log of scheduled activities, arrange pick-up and deliveries, make sure that electronic data are sent to the

Government, be a point of contact with the COR when the PI is not available, and fulfill other administrative duties as needed.

Other support will perform a variety of duties in fulfilling the statement of work (e.g., deliveries;

packaging materials; lab maintenance.)

Q8: Will the government accept an Executive Summary limited to 2-3 pages? If so, please confirm that this executive summary is excluded from page count.

A8: This will be up to the offeror to decide how many pages the offeror wants to include in an optional

Executive Summary. However, the Executive Summary information will be INCLUDED in the page count.

Q9: The outline/order provided for Technical Discussions is inconsistent with other sections of the RFP.

Will the Government allow offerors to use this as a general guidance and organize the response as needed? If not, will the government please provide the table of contents/format for the technical proposal?

A9: The outline/order should be in accordance with page 46 of the RFP entitled technical proposal instructions. Please disregard the layout/order specified under Additional Technical Proposal

Instructions starting on page 49 under “Section 3 Technical Discussions”. However, please address all of the items specified within “Section 3 Technical Discussions” in the technical proposal.

Q10: The offeror is required to provide an attesting letter signed by an authorized individual who has binding authority for the organization and certify that the facility is Biosafety level 2 (BSL2) with

Biosafety level 3 (BSL3).

Please confirm that the government is requesting that the facility is Biosafety level 2 (BSL2) with

Biosafety level 3 (BSL3) practices.

A10: Yes, that is correct. The Government is requesting that the facility is Biosafety level 2 (BSL2) with

Biosafety level 3 (BSL3) practices.

Q11: The amounts of each protein requested in the SOW differ from the instructions provided in the Cost

Assumptions for several proteins (5-15 mg vs. 4 mg SIVmac251, 3-7 mg vs. 2 mg SIV p27).

3-7 mg SIV nef was requested in the SOW but not included in the Cost Assumptions. Please clarify proteins and amounts requested to be included in the cost proposal.

A11: Please refer to the revised SOW (Attachment 3) and Additional Business Instructions (pages 65 –

67) in the RFP. The amounts of protein requested should now be consistent in the two documents, with exception of the purified proteins section of the SOW and additional business instructions. The

Government acknowledges there is a discrepancy between the two documents, as the potential offerors will need to address the entire range specified in the SOW in the technical proposal, but for cost estimation purposes, the offerors should use the cost assumptions in the additional business instructions for the business proposal.

Q12: The SOW and Uniform Cost Assumptions indicate two different methodologies for providing monoclonal antibodies. Could you confirm that request for monoclonal antibodies is as specified in SOW

B.4. “Provide purified monoclonal antibodies by expressing antibody genes provided by the Government in 293 T-cells by transfection or by producing stable CHO cell lines and purifying the antibody in quantities up to 2 grams.”

A12: Yes, the request for monoclonal antibodies methodologies is as specified in SOW B.4. Please refer to the revised SOW (Attachment 3) and Additional Business Instructions (pages 65 – 67) in the RFP, which addresses this discrepancy.

Q13: SOW B.6 states 500-1,500 blood samples can be expected per year for CD4/CD8 and B cell counts.

The Cost Assumptions B.6. specifies 1650 samples for CD4/CD8 and 300 samples for B cell counts.

Please clarify the numbers of samples to be included in cost proposals.

A13: The number of samples to be included in the cost proposals is what is stated in SOW B.6

Please refer to the revised SOW (Attachment 3) and Additional Business Instructions (pages 65 – 67) in the RFP, which addresses this discrepancy.

II. Revisions to Sections of the RFP including adding increased capacity options

ARTICLE B.2. ESTIMATED COST – OPTION, paragraph d. has been deleted in its entirety and replaced as follows:

Estimated Cost ($) Fixed Fee ($) Estimated Cost Plus

Fixed Fee ($)

Option A: Transition-In (1 month)

TBD TBD TBD

Base Period (12 months)

Increased Capacity Option -Base Period

(12 months)

Option Period 1 (12 months)

Increased Capacity Option – Option Period

1 (12 months)

TBD TBD TBD

Option Period 2 (12 months) TBD TBD TBD

Increased Capacity Option – Option Period

2 (12 months)

TBD TBD TBD

Option Period 3 (12 months) TBD TBD TBD

Increased Capacity Option – Option Period

3 (12 months)

TBD TBD TBD

Option Period 4 (12 months) TBD TBD TBD

Increased Capacity Option – Option Period

4 (12 months)

TBD TBD TBD

Option B: Transition Out (2 months) TBD TBD TBD

Option to Extend Services

(6 months)

Total (Base Period and Options) TBD TBD TBD

ARTICLE F.3 LEVEL OF EFFORT, paragraph a. has been modified to add “Increased Capacity

Options” table as follows:

Labor

Category

Option A:

Transition-

In

Base Option 1 Option 2 Option 3 Option 4 Option B:

Transition-

Out

Option to

Extend

Services

Professional

Other

Support

TOTAL

Labor Category Increased

Capacity

Option –

Base

Increased

Capacity

Option –

Option 1

Increased

Capacity

Option –

Option 2

Increased

Capacity Option

– Option 3

Increased

Capacity

Option –

Option 4

Professional

Other

Support

TOTAL

Section J – List of Attachments

Attachment 1: Packaging and Delivery of Proposal (Non R & D) is hereby deleted in its entirely and replaced in this amendment

Attachment 3: Statement of Work is hereby deleted in entirely and replaced in this amendment

Section L- Instructions, Conditions, and Notices to Offerors, paragraph 1.d. (Level of Effort –

pg. 39) has been deleted in its entirety and replaced as follows:

Labor Category Base

Period

Option 1

Period

Option 2

Period

Option 3

Period

Option 4

Period

TOTAL

Option A: Transition

In – Direct Labor

29 29

Base Work – Direct

Labor

3,800 3,800 3,800 3,800 3,800 19,000

Increased Capacity

Options

760 760 760 760 760 3,800

Option B: Transition

Out – Direct Labor

49 49

Option to Extend

Services – Direct

Labor

1,900

TOTAL

HOURS/YEAR

4,589 4,560 4,560 4,560 4,609 22,878

Section L - Past Performance information, paragraph 2.a.11.a (page 44) has been modified as follows:

Offerors shall submit the following information as part of their Business proposal.

A list of the last 3 contracts completed during the past Three years or currently being performed that are similar in nature to the solicitation workscope. Contracts listed may include those entered into by the

Federal Government, agencies of state and local governments and commercial concerns. Offerors may also submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition. For the purposes of this solicitation, a "major subcontract" is defined as $25,000 or more.

Include the following information for each contract or subcontract listed:

1. Name of Contracting Organization

2. Contract Number (for subcontracts, provide the prime contract number and the subcontract number)

3. Contract Type

4. Total Contract Value

5. Description of Requirement

6. Contracting Officer’s Name and Telephone Number

7. Program Manager’s Name and Telephone Number

8. North American Industry Classification System (NAICS) Code

The offeror may provide information on problems encountered on the identified contracts and the offeror’s corrective actions.

Section L – Section 3: Technical Discussions (page 50) paragraph A.2. entitled “Additional

Personnel” has been modified as follows:

Additional Personnel: Offerors staff should include experienced key personnel and additional staff that can support and complement key personnel in achieving the project goals and areas.

Section Heads should have a Ph.D., M.D., or Master’s degree in an appropriate scientific area and particular experience in a given scientific area. However, the Government will accept additional years of experience in lieu of a Ph.D., M.D., or Master’s degree. The Section Heads will work with one or more support staff in performing the statement of work, will ensure the quality and accuracy of the work performed, and train new staff as appropriate. The Section Head will need to have at least 10 years of experience.

The technical staff should in general have a B.S. degree in an appropriate scientific area and perform the scientific activities needed to fulfill the statement of work.

The Administrative support position should be filled by an experienced manager who will maintain a log of scheduled activities, arrange pick-up and deliveries, make sure that electronic data are sent to the

Government, be a point of contact with the COR when the PI is not available, and fulfill other administrative duties as needed.

Other support will perform a variety of duties in fulfilling the statement of work (e.g., deliveries;

packaging materials; lab maintenance.)

Section L- Instructions, Conditions, and Notices to Offerors, paragraph 2.c.15 (Additional

Business Proposal Instructions – pg. 65-67) is hereby deleted in its entirely and replaced in this amendment:

SECTION 1 – PROPOSAL COVERSHEET – Form NIH-2403 – PROPOSAL SUMMARY AND

DATA RECORD

SECTION 2 – COST OR PRICE SUPPORT

All related documentation should be included in the proposal in a clearly marked section. Cost and

Pricing support should be provided for all proposed subcontractors.

Uniform Cost Assumptions

I. Option A - Transition In: assume the Transition In will take approximately 2 weeks. The offeror will be responsible for moving/transferring all of the biological material under appropriate storage temperatures. Assume samples contained in 25 cubic feet of minus 180 degree Celsius storage maintained by liquid nitrogen, 185 cubic feet of minus 80 degrees Celsius storage, and 75 cubic feet of minus 20 degrees Celsius storage will need to be transferred.

II. Core work:

A. Pick-up and delivery of specimens: assume two (2) pick-ups and two (2) deliveries each week. Pick up locations and deliveries will be at NIH Campus (9000 Rockville

Pike, Bethesda, MD 20892-1360) or NCI Fort Detrick (810 Schreider Street #1, Frederick, MD 21702). The Contractor shall also arrange shipment of specimens or reagents to investigators outside the Government as requested by the COR. The

Contractor shall package biological speciments according to U.S. Department of

Transportation regulations www.who.int/csr/emc97_3.pdf_ which describes the packaging and transportation. The packing materials must be of good quality and strong enough to withstand leakage, pressure, vibration, temperature changes, conveyor and mechanical conditions.

B. Immunological assays and reagent preparation

1. Serologic assays: assume 1000 ELISAs to detect antibodies or antibody isotypes to either HIV, SIV, or HTLV-1/2 proteins, and pepscan analysis of 100 serum samples with anti-HIV envelope activity shall be performed in the first year. Assume similar quantities will be required in subsequent years.

2. Purified proteins: assume that 4 mg of native SIV gp120, and 2 mg of SIV p27 will be purified and supplied in the first contract year. Assume 55 mg of HIV or SIV recombinant envelope protein will be provided during the first year. Assume similar quantities will be required in subsequent years.

3. Peptides: assume that 3 sets of overlapping peptides, 5 mg each peptide, representing

HIV or SIV gp160, Pol, Gag, or Ad5 fiber protein, will be provided in the first year.

Assume similar quantities will be required in subsequent years.

4. Monoclonal antibody: provide purified monoclonal antibodies by expressing antibody genes provided by the Government in 293T-cells by transfection or by producing stable CHO cell lines and purifying the antibody in quantities up to 2 grams.

http://www.who.int/csr/emc97_3.pdf_

5. Virus reduction assay: assume 100 virus reduction assays will be conducted during the first year. Assume similar quantities will be required in subsequent years.

6. CD4/CD8 and B cell counts: assume 500-1,500 samples will be tested for CD4 and

CD8 counts and for B cell counts the first year. Assume similar quantities will be required in subsequent years.

C. Viral Stock preparation and Virological Assays

1. Poxvirus stock: assume that three (3) purified stocks of recombinant poxvirus, each approximately 10 ml with a titer of 109 to 1010 TCID50/ml, will be produced the first year. Assume similar quantities will be required in subsequent years.

2. Field isolate stocks: assume that two (2) titered field isolate stocks consisting of 100 one (1) ml aliquots each, and 1 TCLA HIV or SIV stock of 100 aliquots each, will be provided the first year. Assume similar quantities will be required in subsequent years.

3. Adenovirus stock: assume that 2-3 replication-competent Adenovirus stocks will be provided during the first year. Assume similar quantities will be required in subsequent years.

4. Real time PCR assays: assume that 4250 real time PCR assays for SIV gag in plasma and 200 for SIV gag in tissues shall be performed during the first year. Assume similar quantities will be required in subsequent years.

5. Proviral DNA: assume that 200 assays to quantitate viral DNA levels will be conducted during the first year. Assume similar quantities will be required in subsequent years.

D. General molecular assays and reagent preparation

1. Codon-optimized genes: assume that 5 mg of one (1) codon-optimized HIV primary isolate gp160 will be designed, synthesized and purified during the first year. Assume

2. Plasmid DNA: assume that one plasmid DNA preparation (50 mg of DNA encoding

SIV or HIV envelope or SIV gag-pro) will be provided during the first year. Assume

E. Storage of Biological materials - storage capacity and temperature requirements:

25 cubic feet of minus 180 degree Celsius storage maintained by liquid nitrogen, 185 cubic feet of minus 80 degrees Celsius storage, and

75 cubic feet of minus 20 degrees Celsius storage.

III. Increased Capacity Options: Include a budget for the increased capacity options which each represent up to a 20% increase over the Core Work (Base Period and Option Periods 1 through 4).

IV. Option B - Transition out: Assume the new contractor will be responsible for moving/transferring all the biological materials.

V. Option to Extend Services: In the event that the Government exercises 52.217-8 Option to

Extend Services for up to six (6) months, the Offerors shall include a budget for the additional 6 months for the core/base work only. In accordance with 52.217-8, the six (6) month budget shall not include any escalation.

Cost and Price information:

Please separate each task out separately. Option A (Transition in), Core Work, Increased

Capacity Options, Option B (Transition Out), and Option to Extend Services. In addition, please price out each task separately for the base and options below as follows:

• Base Period: June 1, 2018 – May 31, 2019

• Option Period 1: June 1, 2019 – May 31, 2020

• Option Period 2: June 1, 2020 – May 31, 2021

• Option Period 3: June 1, 2021 – May 31, 2022

• Option Period 4: June 1, 2022 – May 31, 2023

• Option to Extend Services: June 1, 2023 – November 30, 2023

Base

Period

(12 months)

Option

Period 1

(12 months)

Option

Period 2

(12 months)

Option

Period 3

(12 months)

Option

Period 4

(12 months)

Option to

Extend

Services

(6 months)

Total

Option A

(Transition In)

N/A N/A N/A N/A N/A

Core Work

Increased Capacity

Options

N/A

Option B

(Transition Out)

N/A N/A N/A N/A N/A

Option to Extend

Services

N/A N/A N/A N/A N/A

Section M – Evaluation Factors for Award (Mandatory Qualification Criteria), paragraph

3.a. has been modified as follows:

Offerors must have biocontainment facilities with Biosafety level 2 (BSL2) with Biosafety level 3 (BSL3) practices to conduct work with human retroviruses and non-human primate retroviruses (HIV, SIV, SHIV, HTLV-1/2), adenovirus, and poxviruses. The offeror is required to provide an attesting letter signed by an authorized individual who has binding authority for the organization and certify that the facility is Biosafety level 2 (BSL2) with Biosafety level 3 (BSL3) practices.

Attachment 1 Page 1 of 2

RFP No: N02RC71023-75

Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal,” in accordance with

HHSAR 352.215-70, Late Proposals and Revisions (December 18, 2015).

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.

2. Create one PDF file of your Business Proposal, including all attachments:

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Business Proposal PDF file.

Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel

Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of

Proposed Estimated Costs (plus Fee) with Excel Spreadsheet”

(http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

4. Each of the proposals, Technical and Business, must be separate and complete in itself.

Do not reference one proposal in another.

https://ecps.nih.gov/ https://ecps.nih.gov/home/howto http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

Attachment 1 Page 2 of 2

5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf

Business Proposal: XYZ Company_NIHAI2012001_Business.pdf

Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals

1. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

2. Font size must be 10 to 12 points.

3. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

4. Margins must be at least one-inch on all sides.

5. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

B. Page limitations:

1. The TOTAL PAGE COUNT of the Technical proposal shall not exceed 150 pages.

Pages in excess of this limitation will be removed from the proposal and will not be read, considered, or evaluated.

2. TOTAL PAGE COUNT DOES NOT INCLUDE (some of which may be added as appendices): Cover Sheet; Table of Contents; Section Dividers that do not contain information other than title of Section; Principal Investigator’s (PI’s) Resume/Curriculum

Vitae (CV), with highlights of any items that are directly related to the subject project, indicated by preceding them with a double asterisk (**); Resumes/CVs of other key personnel (same information and format as used for the PI); certificates and licensures, examples of protocols, Standard Operating Procedures (SOP), Health and Safety Manual, letters of commitment by proposed consultants and subcontractors.

Attachment 3 - Statement of Work

Revised February 16, 2018 1

Statement of Work

The contractor shall provide services in areas including cell culture and virology, immunology, protein biochemistry, molecular biology, storage of biological material and pick up/delivery of specimens for the Vaccine Branch, Center for Cancer Research, of the National Cancer Institute, Bethesda, Maryland.

The contractor shall have biocontainment facilities with Biosafety level (BSL) 2 with Biosafety level (BSL3) practices to conduct work with human retroviruses and non-human primate retroviruses (HIV, SIV, SHIV, HTLV-1/2), adenovirus, and poxviruses.

In performance of this work, the Contractor shall conduct the following:

I. Option A: Transition In (If applicable)

One (1) month from the start of the award, the successor Contractor shall ensure a smooth transition between the incumbent and the new award.

Phase-in plan shall include the following:

a) Describe the strategy for taking over work from the incumbent Contractor to ensure continuity of the current contract (Support for Research on Retroviral Pathogenesis, Treatment, and Prevention.)

The plan shall address the transfer of relevant files, records, materials (such as film for Weston blot and actual samples), data and transition of all activities, and electronic documents from the incumbent Contractor to a secure server space.

The plan shall also address how they plan to ensure an orderly, secure, efficient, and expedient transition of all contract activities with no break in service. The plan should also address communication and mitigation of any problems/concerns that are anticipated, or any that may arise.

b) Use an appropriately bonded moving agent, experienced in secure transfer of biological materials under appropriate storage temperatures, to safely move all materials maintained under the current contract to the successor Contractor or the Government, without any interruption of services. The Contractor shall package biological specimens according to U.S. Department of Transportation regulations www.who.int/csr/emc97_3.pdf_ which describes the packaging and transportation. The packing materials must be of good quality and strong enough to withstand leakage, pressure, vibration, temperature changes, conveyor and mechanical conditions.

Revised February 16, 2018 2

c) Ensure that adequate computer services are available, such as a software that combines scientific graphing, curve fitting, biostatistics and data organization; a spreadsheet program used to retrieve and store numerical data in grid format;

and a software package used for analyzing flow cytometry data. These are just a few of the computer applications that the Contractor will have to ensure that they have present. The Contractor shall ensure that data storage is available for receiving and maintaining data records.

II. Core work

A. Pickup and delivery of Biological specimens

The Contractor shall supply fresh, viable cells and biologically active purified proteins to the Government within one hour after harvest or preparation.

The Contractor shall arrange for pick-up and delivery of specimens, Monday through Friday, except Government holidays, between the Contractor’s site and laboratories on the NIH main campus (9000 Rockville Pike, Bethesda, MD 20892-

1360) or NCI Fort Detrick campus (810 Schreider Street #1, Frederick, MD

21702). Pick-up/delivery times shall be specified by the COR or other NCI

Investigators and will be approximately between 8:00 AM and 4:30 PM local time. Possession of specimens/items will be handled before and after normal hours via a telephone call to the necessary investigator or investigator’s lab designee. This will only occur if there is an emergency or inclement weather and the time allocated in the contract SOW doesn’t work.

The Contractor shall also arrange shipment of specimens or reagents to investigators outside the Government as requested by the COR. The Contractor shall package biological specimens according to U.S. Department of

Transportation regulations www.who.int/csr/emc97_3.pdf_ which describes the packaging and transportation. The packing materials must be of good quality and strong enough to withstand leakage, pressure, vibration, temperature changes, conveyor and mechanical conditions.

Shipping and Packing: The Contractor is responsible for shipping and packing of the materials after work at their site has been performed. The NCI Investigator’s lab will supply their own packing materials when items are ready to be sent from their laboratory to the Contractor. Packing materials such as Styrofoam boxes, freezer storage cardboard boxes, or Saf-T-Pak shipping boxes are acceptable

Revised February 16, 2018 3 containers for the Contractor to use for delivery of materials. The shipping items shall be saved for reuse to cut down on cost.

B. Immunological assays and reagent preparation

1. Conduct serological assays of human or animal samples supplied by NIH.

Approximately one hundred (100) serum or plasma samples provided annually by the Government shall be tested for the presence of antibodies to human and other mammalian viral proteins or peptides (HIV, SIV, HTLV-1/2) using such techniques as 1000 ELISAs, Western blots, and antigen capture assays. Pepscan assays shall be conducted to determine specific antibody epitopes recognized and ELISAs shall be conducted to determine antibody titers and isotypes. The Contractor shall, upon completion of assays, document the results achieved and report data in sufficient detail as required in the data report.

2. Provide purified, biochemically characterized and biologically active (where appropriate) native viral proteins from infected cells or conditioned media and from bacterial or mammalian expression systems. Provide recombinant viral proteins which could include but is not limited to, regulatory, enzymatic or structural proteins. Recombinant vectors expressing the proteins or peptides shall be supplied by the government. Purified proteins shall meet a predetermined level of purity as agreed to between the COR and the

Contractor. The Contractor shall also furnish data to the COR confirming that the proteins are of the quantity and meet the specifications of purity and biological activity agreed to between the COR and the Contractor before work was started on the product. In performance of this task, the Contractor shall provide:

i. Up to 100mg recombinant SIV and/or HIV envelope proteins,

ii. Between 4 and 8mg of SIV native gp120, and/or native HIV gp120,

iii. Between 2 and 4mg of SIV p27,

iv. Between 2 and 4mg of SIV Nef

3. Provide approximately three (3) sets of overlapping peptides, representing proteins from the HIV, SIV, or adenovirus genomes annually. These shall be

15-mers overlapping by 11 amino acids unless otherwise specified by the

COR. The produced peptides shall be delivered to the specific investigator, as requested.

Revised February 16, 2018 4

4. Provide purified monoclonal antibodies by expressing antibody genes provided by the Government in 293 T-cells by transfection or by producing stable CHO cell lines and purifying the antibody in quantities up to 2 grams.

5. Carry out assays measuring the ability of sera or purified antibody to inhibit virus propagation by virus reduction assay.

6. Provide CD4/CD8 and B cell counts (percentages and absolute numbers) from

500 to 1,500 blood samples per year from non-human primates.

7. The Contractor shall document in sufficient detail each step taken in performing the tasks 1 through 6 above and provide data collected to the specific NCI investigator, as requested.

C. Viral stock preparation and virological assays

1. Provide approximately three (3) purified and titered stocks of attenuated recombinant poxviruses or recombinant TK- vaccinia with titers of 109 to

1010TCID50/ml annually and as requested by the COR. The TK- vaccinia recombinants shall be expanded under BL2 conditions. Quality control for the expression of heterologous HIV/SIV genes shall be provided by Western Blot.

The initial viral inocula shall be provided by the Government. The stocks of recombinant viruses shall be stored until requested by the COR. The Contractor shall deliver viral stocks to the specific NCI investigator, as requested.

2. Provide approximately two (2) titered stocks of aliquots of field isolates for in vitro use from virus-infected humans and non-human primates at low passage number on human or non-human primate PBMC annually. The stocks shall be of sufficient titer for in-vitro experimentation (104 to 105 TCID50/ml). Determine titer by plaque assay and provide aliquots of high-titered T-cell-line-adapted

(TCLA) stocks of HIV or SIV for in vitro use. This work shall be conducted in

BSL2/BSL3 laboratories. The viral stocks shall be maintained in liquid nitrogen storage until requested by the COR. The Contractor shall deliver viral stocks to the specific NCI investigator, as requested.

3. Expand and purify replication-competent Adenovirus stocks provided by the

Government, to 2 to 3 ml with a titer of 1010 – 1011 plaque forming units/ml.

Titers shall be determined by OD and by plaque assay. For the purified

Adenovirus stock, the ratio of the OD titer to the titer by plaque assay shall be no more than 30. Work shall be performed under BSL2 conditions.

Revised February 16, 2018 5

4. Conduct real time PCR assays for approximately 4,250 SIV gag in plasma and

200 for SIV gag in tissues annually. Purify and quantitate mRNA in plasma or tissue samples of animals or humans by real time PCR. Quantitate viral RNAs, including HIV and SIV as requested by the COR. The real time PCR for viral RNAs shall be sensitive to 15 copies/ml plasma or less. The Contractor shall conduct real time PCR assays weekly over 5 to 15 weeks on 30 to 60 plasma samples per week associated with repeated low-dose SIV or SHIV challenges with a turn-around time of five (5) days for the weekly assays. The Contractor shall document in sufficient detail each step taken in performing the tasks delineated in this section and provide data collected to the specific NCI investigator, as requested.

5. Conduct approximately 200 assays annually to quantitate viral DNA levels by real time PCR for SIV from cells of non-human primates. The Contractor shall provide the results of the proviral DNA assays in a report to the specific NCI investigator, as requested.

D. General molecular assays and reagent preparation

1. Synthesize and purify codon-optimized genes encoding cellular or viral proteins designed by the Government for eukaryotic or prokaryotic expression. For the individual genes produced, the Contractor shall provide up to 2-50 mg of DNA. Examples include HIV or SIV primary isolate envelopes (gp160). Deliver the synthesized gene and/or the purified expressed protein to the specific NCI investigator, as requested.

2. Provide pre-clinical grade plasmid DNA (up to 50 mg per preparation) containing minimal levels of endotoxin and encoding HIV or SIV genes. The

Government shall provide the material to be expanded. The Contractor shall deliver the plasmid DNAs upon completion to the specific NCI investigator, as requested.

E. Storage of biological materials

1. Provide storage and electronic inventory for viable cell lines, titered field isolates, viral challenge stocks and viable cell specimens from inoculated and immunized animals as requested by the COR. The Contractor shall maintain

Revised February 16, 2018 6 a backup system capable of maintaining materials stored at the required temperatures. The storage capacities and temperature requirements are:

a) 25 cubic feet of minus 180 degrees Celsius storage maintained by liquid nitrogen,

b) 185 cubic feet of minus 80 degrees Celsius storage, and

c) 75 cubic feet of minus 20 degrees Celsius storage.

F. Increased Capacity Options

NCI includes increased capacity options to supplement the base contract to allow for additional support to cover an expansion of work in the major task areas mentioned at the beginning of the SOW that include: pickup and delivery of

Biological specimens, immunological assays and reagent preparation, viral stock preparation and virological assays, general molecular assays and reagent preparation, and storage of biological materials. The increased capacity options represent up to a 20% increase over the base work.

G. Option B: Transition Out

The Contractor shall:

1. Ensure there is no break in provision of services. The final transition shall be fully implemented before the expiration date of the contract.

2. Plan and coordinate an orderly, secure, and efficient transition of all activities, materials, data, and other documents to the successor Contractor or the Government. A description of transition activities and timelines shall be provided in a Draft and Final Transition Plan, which shall be reviewed and approved by the COR and Contracting Officer.

a) Draft Transition Out Plan: Two (2) months prior to the completion date of the contract, the Draft Transition Plan shall be submitted for review and comments by the COR and Contracting Officer. Elements to be addressed are:

1) A digital inventory of samples, materials, and products to be transferred.

Revised February 16, 2018 7

2) Clear labeling and identification of vials and sample containers to be transferred

3) If there is Government-owned property to be transferred and equipment maintenance records.

4) Materials that will be under production at the end of the contract which shall need to be transferred together with appropriate SOPs for completion of the production.

5) Electronic files of all data and labeled and inventoried paper files to be transferred.

6) Transition activities, timelines, and staff needed to implement the transfer to the Successor Contractor.

b) Final Transition Out Plan: One (1) month prior to the completion date of the contract, the Final Transition Out Plan shall be submitted for review and approval by the COR and the Contracting Officer. The Final Transition Plan shall present a comprehensive logistical analysis for the orderly and safe transition of all services to a Successor Contractor. This plan shall include:

i. The tasks associated with secure transfer of stored materials, reagents, all related data, and any Government-furnished property.

ii. A timeline for the complete, timely, and effective transfer of data and materials held by any subcontractor(s) to the Successor Contractor, and performance of all necessary transition, transfer and closeout functions on each subcontract.

iii. A timeline for delivery to the Successor Contractor and/or the

Government, the following additional items:

a. A computerized inventory of samples, materials, and products being transferred.

b. Lists of all materials still under production with any relevant SOPs for completing the production

c. Electronic files of all data

d. Labeled and inventoried paper files

e. Listings of all Government-owned property and equipment maintenance records.

iii. The Contractor shall organize and prepare all materials, data, documents, files, reagents and any government furnished property. The Successor

Revised February 16, 2018 8

Contractor shall be responsible for actual transfer and cost of moving the materials.

H. Section 508

• Any electronically-submitted documents submitted shall be conformant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at HHS Section 508: under "Making Files Accessible”. Checklists to ensure appropriate formatting can be found at HHS Section 508 Accessibility Checklists https://www.hhs.gov/web/section-508/making-files-accessible/checklist/index.html. Document or document-type specific testing shall serve in lieu of the Section 508 Annual Report for Vendors, which is located on the HHS Section 508 Evaluation Template Product Accessibility Template (PAT).

• In addition, we refer the contract holder to the following two GSA Section 508 pages for guidance on developing electronic documents for accessibility and Section 508-conformance:

▪ GSA Section508.gov. Best Practices. https://www.section508.gov/best-practices

▪ GSA Section508.gov. Create Accessible Electronic Documents https://www.section508.gov/content/build/create-accessible-documents

• This contract holder shall use the relevant or respective checklist as a Section 508 report for each document it submits all one per file type (e.g., Microsoft Word, Microsoft Excel, PDF, etc.) at the end of the year, in lieu of the Section 508 Annual Report for Vendors.

https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/making-files-accessible/index.html https://www.hhs.gov/web/section-508/making-files-accessible/checklist/index.html https://www.hhs.gov/web/section-508/making-files-accessible/checklist/index.html https://www.hhs.gov/web/section-508/making-files-accessible/checklist/index.html https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://www.hhs.gov/web/section-508/contracting/technology-products/product-accessiblity-template/index.html https://www.hhs.gov/web/section-508/contracting/technology-products/product-accessiblity-template/index.html https://www.section508.gov/best-practices https://www.section508.gov/best-practices https://www.section508.gov/content/build/create-accessible-documents https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc

Revised February 16, 2018 9

Statement of Work Appendix

Definitions

HIV Human immunodeficiency virus

SIV Simian immunodeficiency virus

BSL2/BSL3 Biosafety level 2/Biosafety level 3

PBMC Peripheral blood mononuclear cells

SHIV Chimeric simian/human immunodeficiency virus

Ad5 Adenovirus type 5

DNA Deoxyribonucleic acid mRNA Messenger ribonucleic acid

PCR Polymerase chain reaction

RNAs Ribonucleic Acids

HTLV Human T cell leukemia lymphoma virus

ELISA Enzyme linked immunosorbent assay

TCID50 50% tissue culture infectious dose

MHC Major histocompatibility complex