SF_33_Amendment_0001.pdf

0011195799

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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.

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

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment (i.e. 0001) is to post Vendor questions and Government responses as w ell as incorporate revisions to Attachment 1 - PWS (rev), Attachment 5 - Labor Categories (rev), Attachment 6 - Pricing Sheet (rev), Attachment 7 - Past Performance Questionniare (rev), and Attachment 13 - WRAIR Org Chart.

Updates/changes/revisions to the SF 33 and the associated attachments have been highlighted in yellow .

1. CONTRACT ID CODE PAGE OF PAGES

S 1 23

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

16C. DATE SIGNED

BY 10-May-2019

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81XWH19R0011

X 9B. DATED (SEE ITEM 11)

23-Apr-2019

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

Offer 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 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

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 you 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.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

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

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)

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

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

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

10-May-2019

CODE

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

W81XWH 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81XWH19R0011

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION B - SUPPLIES OR SERVICES AND PRICES

The following have been modified:

CONTRACT STRUCTURE

The contract shall be a non-commercial Single Award Indefinite-Delivery Indefinite-Quantity (SA IDIQ) contract.

Task orders for services will be Firm Fixed Price (FFP) or Cost-Plus-Fixed-Fee (CPFF). Task orders may have cost reimbursement Contract Line Item Numbers (CLINs) for Other Direct Costs (ODCs).

MINIMUM GUARANTEE AND MAXIMUM CEILING

The minimum guarantee is $150,000.00 over the life of the contract. The anticipated maximum ceiling amount for the entire ordering period is $77,000,000.00. The Government is not obligated to issue task orders up to the maximum amount of the award under this contract.

MINIMUM AND MAXIMUM TASK ORDER AWARD

The minimum task order award value is $150,000.00.

The maximum task order award value is $77,000,000.00.

ISSUANCE OF TASK ORDERS

The base contract is not funded. All services to be performed under this contract shall be set forth in individual task orders. It is anticipated that each clinical trial will be issued as a single task order. However, the first task order to be issued, after award, is anticipated to be for Administrative/Business Infrastructure support services. Individual task orders issued for clinical trial support services will follow thereafter. All task orders will be issued in accordance with (IAW) the provisions of Section C, Section H, and all clauses listed in Section I. Clauses DFARS 252.216-7006 Ordering, FAR 52.216-19 Order Limitation, FAR 52.216-22 Indefinite Quantity, and FAR 52.219-14 Limitations on Subcontracting shall be applicable to each task order.

Task Order performance may occur in places other than the National Capital Area. It is anticipated that wage determinations shall be added as needed at the base award level.

The unit of issue for each FFP CLIN issued on each task order under this contract shall be “Job.” Multiple payments are authorized against each “Job” unit of issue. “Job” is equal to twelve (12) monthly invoices/payments.

Each invoice/payment, however, shall not exceed the maximum amount as stated in each CLIN description of the task order issued under this contract.

TASK ORDERS PROPOSAL REQUESTS (TOPRs) Task Order Proposal Requests (TOPR) will be used by the Government to request formal task order proposals from the Contractor. Task order proposals shall be submitted in two (2) parts: Part 1 – a non price/cost proposal and Part 2 a price/cost proposal. Both parts shall be submitted electronically in MS Office format via email to the Contract Specialist assigned to the requirement as identified in the TOPR issued for the individual task order.

Part 1 NonPrice/Cost Proposal. Specific requirements for submission of noncost/price proposals will be described in the TOPR issued for the individual task order.

Part 2 Price Proposal. For FFP task orders, the Contractor shall propose fully burden rates no higher than those in the base contract for the labor categories required by the TOPR. The Contractor shall not propose a labor rate or labor category not included in the base contract.

Part 2 - Cost Proposal. When submitting an offer in response to a cost-type TOPR under this contract, the Contractor shall submit a cost proposal that reflects an in-depth, detailed presentation of each cost element proposed. The specific rate details of the fully burdened labor rate and other direct costs shall be disclosed with sufficient detail to review each item of the rate separately. For example, indirect rates shall include all the necessary supporting data including, details of the rate, budgets, actuals, rate calculations, etc. This data shall be disclosed at a sufficient level for proposal evaluation purposes. CPFF indirect rates will not be allowed to be discounted at the task order level.

TASK ORDER TYPES

The Contracting Officer will specify the order type (i.e. FFP or CPFF) based upon whether the conditions of FAR 16.3012, Cost Reimbursement Contracts are present and FAR 16.306(b) Cost Plus Fixed Fee or nonseverable Research and Development services under FAR Part 35. If these conditions are determined NOT to exist, FFP pricing will be requested from the Contractor, reference FAR 16.2 Fixed Priced Contracts. Task orders issued under this contract may be:

FirmFixedPrice (FFP) – NonCommercial CostPlusFixedFee (CPFF) – NonCommercial

INDIRECT RATES FOR CPFF LABOR CATEGORIES

The costs of CPFF task orders include indirect rates that were submitted with the Contractor’s final cost/price proposal on XXXXX 2019. The parties agree that these are capped rates for fringe benefits, labor overhead, G&A, and overhead that shall not be exceeded. The final rates for these cost categories will be determined by Defense Contract Audit Agency (DCAA). If actual rates are lower than those set forth in the Contractor’s proposal, the Contractor shall bill, and the Government will reimburse at the lower, actual rates.

NOTE: For the term of this contract, indirect rates shall have ceilings established. The indirect ceiling rates for option year one (1) and two (2) may be re-negotiated prior to exercising option year one, if the Contractor and Government concur that such a redetermination is necessary and in the best interest of both parties.

FFP & COST PLUS FIXED FEE TASK ORDER LABOR RATES

No task order shall be awarded with rates higher than those approved under the base contract. Rates approved in the base contract and option year(s) are the maximum rates the Government will allow on task orders.

NOTE: All FFP labor rates submitted with the Contractor’s final cost/price proposal on XXXXX 2019 are considered maximum ceiling rates for each labor category. These maximum ceiling rates are not renegotiable unless there is a price adjustment in accordance with FAR 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts) or another reason to renegotiate these rates is mutually agreed upon by the Contractor and the Government.

SECTION I - CONTRACT CLAUSES

The following have been added by full text:

52.237-7 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (JAN 1997)

(a) It is expressly agreed and understood that this is a nonpersonal services contract, as defined in Federal Acquisition Regulation (FAR) 37.101, under which the professional services rendered by the Contractor are rendered in its capacity as an independent contractor. The Government may evaluate the quality of professional and administrative services provided, but retains no control over professional aspects of the services rendered, including by example, the Contractor's professional medical judgment, diagnosis, or specific medical treatments. The Contractor shall be solely liable for and expressly agrees to indemnify the Government with respect to any liability producing acts or omissions by it or by its employees or agents. The Contractor shall maintain during the term of this contract liability insurance issued by a responsible insurance carrier of not less than the following amount(s) per specialty per occurrence:* .

(b) An apparently successful offeror, upon request by the Contracting Officer, shall furnish prior to contract award evidence of its insurability concerning the medical liability insurance required by paragraph (a) of this clause.

(c) Liability insurance may be on either an occurrences basis or on a claims-made basis. If the policy is on a claims-made basis, an extended reporting endorsement (tail) for a period of not less than 3 years after the end of the contract term must also be provided.

(d) Evidence of insurance documenting the required coverage for each health care provider who will perform under this contract shall be provided to the Contracting Officer prior to the commencement of services under this contract.

If the insurance is on a claims-made basis and evidence of an extended reporting endorsement is not provided prior to the commencement of services, evidence of such endorsement shall be provided to the Contracting Officer prior to the expiration of this contract. Final payment under this contract shall be withheld until evidence of the extended reporting endorsement is provided to the Contracting Officer.

(e) The policies evidencing required insurance shall also contain an endorsement to the effect that any cancellation or material change adversely affecting the Government's interest shall not be effective until 30 days after the insurer or the Contractor gives written notice to the Contracting Officer. If, during the performance period of the contract the Contractor changes insurance providers, the Contractor must provide evidence that the Government will be indemnified to the limits specified in paragraph (a) of this clause, for the entire period of the contract, either under the new policy, or a combination of old and new policies.

(f) The Contractor shall insert the substance of this clause, including this paragraph (f), in all subcontracts under this contract for health care services and shall require such subcontractors to provide evidence of and maintain insurance in accordance with paragraph (a) of this clause. At least 5 days before the commencement of work by any subcontractor, the Contractor shall furnish to the Contracting Officer evidence of such insurance.

Contracting Officer insert the dollar value(s) of standard coverage(s) prevailing within the local community as to the specific medical specialty, or specialties, concerned, or such higher amount as the Contracting Officer deems necessary to protect the Government's interests.

(End of clause)

SECTION J - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

The Table of Contents has changed from:

Exhibit/Attachment Table of Contents

DOCUMENT TYPE DESCRIPTION PAGES DATE

Attachment 1 Attachment 1 - PWS Attachment 10 Attachment 10 - WRAIR

Telework Program Command Memo

Attachment 11 Attachment 11 - PII, PHI, and Federal Information Requiremen

Attachment 12 Attachment 12 - SF 1408 Attachment 13 Attachment 13 -

WRAIR's CTC Org Chart Attachment 14 Attachment 14 - Wage

Determination Attachment 2 Attachment - QASP Attachment 3 Attachment 3 - GFP Attachment 4 Attachment 4 - OCI Attachment 5 Attachment 5 - Labor

Categories Attachment 6 Attachment 6 - Pricing

Sheet Attachment 7 Attachment 7 - Past

Performance Questionnaire

Attachment 8 Attachment 8 - Employee Participation Agreeement

Attachment 9 Attachment 9 - WRAIR VPN Policy to:

Exhibit/Attachment Table of Contents

DOCUMENT TYPE DESCRIPTION PAGES DATE

Attachment 1 Attachment 1 - PWS (rev) Attachment 10 Attachment 10 - WRAIR

Telework Program Command Memo

Attachment 11 Attachment 11 - PII, PHI, and Federal Information Requiremen

Attachment 12 Attachment 12 - SF 1408 Attachment 13 Attachment 13 - WRAIR

CTC org chart Attachment 14 Attachment 14 - Wage

Determination Attachment 2 Attachment - QASP

Attachment 3 Attachment 3 - GFP Attachment 4 Attachment 4 - OCI Attachment 5 Attachment 5 - Labor

Categories (rev) Attachment 6 Attachment 6 - Pricing

Sheet (rev) Attachment 7 Attachment 7 - Past

Performance Questionnaire (rev)

Attachment 8 Attachment 8 - Employee Participation Agreeement

Attachment 9 Attachment 9 - WRAIR VPN Policy

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

The following have been modified:

INSTRUCTIONS TO OFFEORS

1.0 GENERAL INSTRUCTIONS

This section provides general guidance for preparation of proposals as well as specific instructions on the format and content of the proposal. The Offeror’s proposal MUST include all data and information requested and MUST be submitted in accordance with these instructions. The proposal shall be compliant with requirements as stated in the Government’s Performance Work Statement (PWS). Any data previously submitted in response to another solicitation to USAMRAA or another agency will NOT be considered if not included in the proposal submitted in response to the soliciation. Proposal data shall not be incorporated into this proposal by referring to another proposal or other source. THE GOVERNMENT WILL NOT REIMBURSE OFFERORS FOR COSTS INCURRED

AS A RESULT OF PREPARATION AND SUBMISSION OF A PROPOSAL IN RESPONSE TO THIS

SOLICITATION.

This acquisition is a set aside for small business only under NAICS 541715 (size standard 1,000 employees). The Government intends to award a Single Award Indefinite-Delivery Indefinite-Quantity (SA ID/IQ) contract to the Offeror who represents the best value as determined by the Government. This SA-IDIQ CONTRACT will utilize firm-fixed-price (FFP) and cost-plus-fixed-fee (CPFF) task orders and non-severable Research and Development under FAR Part 35 based upon whether the conditions of FAR 16.301-2, Cost Reimbursement Contracts are present and FAR 16.306(b) Cost Plus Fixed Fee or non-severable Research and Development services under FAR Part 35.

If these conditions are determined NOT to exist, FFP pricing will be requested from the Contractor, reference FAR

16.2 Fixed Priced. Task orders issued under this contract may be of the following types:

Firm-Fixed-Price (FFP) – Non-Commercial Cost-Plus-Fixed-Fee (CPFF) – Non-Commercial

QUESTIONS DUE: 10:00am eastern, Thursday, 02 May 2019

Julie L. Burns, USAMRAA Contract Specialist julia.l.burns3.civ@mail.mil

Offerors shall submit one set of questions only; multiple emails shall not be accepted. No telephone calls will be accepted. Questions received after the due date will NOT be addressed. An amendment to the solicitation will be posted via www.fbo.gov. providing the answers.

NOTE: If an Offeror believes that the requirements in these instructions contain an error, omission, or are otherwise unsound; the Offeror shall immediately notify the Contract Specialist listed above in writing with supporting rationale. The Government reserves the right to award this effort based on the initial proposal, as received, without discussion.

PROPOSAL DUE DATE: 10:00am eastern, Thursday 23 May 2019

PROPOSAL SUBMISSION: Julie L. Burns at julia.l.burns3.civ@mail.mil

You MUST request confirmation that I have received your proposal.

The Government will evaluate ONLY one (1) proposal from each prime Offeror. The Government will NOT accept alternate proposals. The proposal shall be clear, concise, and shall include sufficient detail for effective evaluation and for substantiating the validity of stated claims. The proposal should not simply rephrase or restate the Government’s requirements, but rather shall provide convincing rationale to address how the Offeror intends to meet these requirements. The Offeror shall assume that the Government has no prior knowledge of the Offeror’s facilities and experience. The Government will base its evaluation on the information presented in the Offeror’s proposal.

Elaborate brochures or documentation, binding, detailed art work, or other embellishments are unnecessary and not desired.

Offerors are prohibited from modifying any documents, printed or electronic, associated with this solicitation and any amendments in any way, shape or form, unless specifically authorized to do so. The electronic solicitation documents posted on http://www.fbo.gov shall be the official documents for this solicitation.

All proposal information is subject to verification by the Government. Falsification of any proposal submission, documents, or statements may subject the Offeror to civil or criminal prosecution under Section 1001 of Title 18 of the United States Code.

DISCUSSIONS - The Government intends to award without discussions. Therefore, the Offeror’s proposal is presumed to represent the Offeror’s best effort in response to the Solicitation. If discussions are required, they will be conducted with Offerors in the competitive range to the extent deemed necessary by the Contracting Officer in accordance with FAR 15.306, Exchanges with Offerors After Receipt of Proposals. Discussions will be conducted on the content of the proposal and, if discussions have been conducted, a Final Proposal Revision (FPR) will be solicited from those Offerors within the competitive range. A common cut-off date will be established for receipt of all FPRs.

NOTE: Any request for “Change Pages” by the Government shall be submitted by the Offeror using highlighted text to identify changes made from the original proposal with a revision date affixed to the subject page.

ACCEPTANCE PERIOD - The proposal acceptance period SHALL be 120 calendar days minimum, after the solicitation closing date (block 9 on Standard Form 33) and shall be specified in block 12 of the Standard Form 33.

The Offeror may specify a longer acceptance period than the Government’s 120 calendar day minimum, but shall not specify a shorter period.

SYSTEM FOR AWARD MANAGEMENT (www.sam.org) - All Offerors must comply with FAR 52.204-7 System for Award Management and DFARS 252.204-7004, alternate A, System for Award Management. In complying with these provisions, the Offeror must ensure that ALL representations and certifications contained in Solicitation Section K are completed and uploaded to its SAM record at http://www.sam.gov by the date specified for receipt of proposals. Any Offeror that does not have an active SAM record or has a record that does not include all representations and certifications required in Section K may be found ineligible for award.

NOTE: The Government may conduct a pre-award survey during the Government evaluation period (prior to contract award). The pre-award survey may examine the Offeror’s record of integrity and business ethics, data management system, financial capability, and accounting systems.

TEAMING ARRANGEMENTS - The use of contractor teaming arrangements (as defined in FAR 9.601(1)) and subcontractor relationships is acceptable. Any subcontracting/teaming arrangements contemplated by the Offeror must be presented in detail. The details should disclose those portions of the task which will be subcontracted and the anticipated organizations with which subcontracting or teaming arrangements are planned. Since there is a direct relationship between the Cost/Price proposal and the Non-Cost/Price proposal, the Offeror shall include enough information on subcontracting/teaming arrangements to allow for a thorough proposal review from a technical and management perspective. The Offeror shall include evidence (e.g., signed teaming agreement letters) of all subcontractor teaming arrangements (with both large and small businesses) in the Volume I. Although this evidence shall be submitted in Volume I, only information presented in Volume II (Technical Approach, Experience, and Quality Management Approach, and Past Performance) will be considered when evaluating.

NOTE: The Offeror may submit a proposal as a prime contractor and also be included as a subcontractor to another prime contractor's proposal, since only one contract will ultimately be awarded.

2.0 ORGANIZATION OF PROPOSALS, NUMBER OF COPIES, PAGE LIMITS

The Offeror shall prepare the proposal as set forth in the Proposal Organization table below (Table 1). The titles and contents of the volumes shall be as defined in this table, all of which shall be within the required page limits as specified in Table 1. Failure to submit all documents and in accordance with these instructions, may render a proposal unacceptable. The Government will NOT consider pages submitted in access of the stated page limits.

There should be three (3) separate and distinct volumes:

Volume I - Documentation Volume;

Volume II - Technical Volume; and Volume III - Cost/Price Volume.

NOTE: Do not include cost/price information in the Volume I or II.

Table 1: Proposal Organization

Volume Section Volume Title/Section Title Page Limit

I I Documentation Volume/Cover Page 1 I II Documentation Volume/Table of Contents (TOC) No Limit I III Documentation Volume/Executed RFP/SF 33

- Page 1 of the SF 33 (blocks 12 – 18)

- Filled out FAR/DFARS clauses and provisions

No Limit

I IV Documentation Volume

- Attachment 4, OCI statement of intent to enter into a teaming agreement

No Limit

II I Technical Volume/Cover Page 1 II II Technical Volume/Technical Approach

II III Technical Volume/Experience

- Key Personnel resumes (not counted against the Technical volume page limit)

- Key Personnel signed letters of commitment (not counted against the Technical Volume page limit)

- Signed subcontractor teaming letters (not counted against the Technical Volume page limit)

II IV Technical Volume/Quality Management Approach

- Deliverable 5, Quality Control Plan

II V Technical Volume/Past Performance

- Past Performance references

- Attachment 7, Past Performance Questionnaire (received from Client only) (not counted against the Technical Volume page limit exempt from page limit)

III I Cost/Price Volume/Cover Page 1

- Attachment 6, Government Pricing Sheet

- Attachment 12, SF 1408;

- Forward Pricing Rate Agreement OR

- 3-year historical financial trend

- The name, address, and telephone number of the DCAA or DCMA Government Agency’s Point of Contact and a copy of the most recent/current audits, pricing or rate agreements issued by the cognizant agency, if applicable

- Estimating System documentation, if applicable

- Purchasing System documentation, if applicable

- Accounting System documentation

- POC who can obligate your company contractually

No Limit

2.1 VOLUME CONTENT

Each volume shall be written on a stand-alone basis. Pages shall be numbered sequentially within each volume.

Information required for proposal evaluation which is not found in its designated volume or section will be assumed to have been omitted from the proposal. Each volume shall contain a cover page with identifying RFP number, Offeror name and mailing address, CAGE Code, Business Manager’s name, and contact information.

All sections of the Offeror’s proposal shall make direct reference to the corresponding PWS specification paragraph numbers. Proposed approach and methods shall be presented in a clear and logical order. Statements such as “will comply,” “meets the intent of,” or “we intend to meet the requirements” and the like will not suffice for evaluation purposes.

The information in each volume should be specific and complete. Legibility, clarity, and coherence are very important. Your responses will be evaluated against the factors defined in Section M, Evaluation Criteria. Using the instructions provided herein, provide as specifically as possible, the actual methodology you would use for accomplishing/satisfying the requirement. All of the information specified in the solicitation is mandatory. By your proposal submission, you are representing that your firm will be responsible for meeting the requirements specified in the solicitation. Do not merely reiterate the objectives or reformulate the requirements specified in the solicitation.

2.2 COST/PRICE INFORMATION

All cost information shall be addressed ONLY in the Cost/Price Volume. Do not address cost/price in the Technical, Experience, Quality Management Approach, or Past Performance. Cost/Price trade-off information, labor hours, and quantities may be used in other sections only as appropriate for presenting rationale for alternative positions or design and trade-off decisions, if applicable.

2.3 PAGE LIMITATION

Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the proposal.

Page limitations exclude:

- SF 33

- Table of Content

- Attachment 4, OCI

- Key Personnel’s Curriculum Vitae/Resume

- Key Personnel’s Letters of commitment tatement of intent to enter into a teaming agreement Attachment 7, Past Performance Questionnaire (received from Offeror’s Client only)

- Attachment 6, Government Pricing Sheet

- Forward Pricing Rate Agreement

- 3-year historical financial trend

- The name, address, and telephone number of the DCAA and DCMA Government Agency’s Point of Contact and a copy of the most recent/current audits, pricing or rate agreements issued by the cognizant agency, if applicable.

- Tab indexing

- Attachment 12, SF 1408

2.4 PAGE SIZE AND FORMAT

A single side of a sheet display printed material shall be considered one (1) page. Page size shall be 8.5 x 11 inches, not including foldouts (See Table, Charts, Graphs, and Figures below). Pages shall be SINGLE-sided and single spaced. Use at least 1 inch margins on the top and bottom and ¾-inch side margins. Pages shall be numbered sequentially within each volume. Except for the reproduced sections of the solicitation document, the text size shall be “Times New Roman,” with 12 point size font.

2.5 TABLES, CHARTS, GRAPHS, AND FIGURES

Legible tables, charts, graphs, and figures shall be used wherever practical to depict organizations, systems and layout, implementation schedules, plans, etc. These displays shall be uncomplicated, legible, and shall not exceed 11 x 17 inches in size. Foldout pages shall fold entirely within the volume, and count as a single page. Foldout pages may only be used for large tables, charts, graphs, diagrams and schematics, not for pages of text. For tables, charts, graphs and figures, the text shall be “Times New Roman” with 10 point size font.

2.6 CROSS-REFERENCING

To the greatest extent possible, each section of the proposal shall be written on a standalone basis, so that its content may be evaluated with a minimum of cross-referencing to other sections of the proposal. Information required for proposal evaluation, which is not found in its designated section, will be assumed to have been omitted from the proposal.

2.7 INDEXING

Each volume shall contain a more detailed table of contents (TOC) to delineate the subparagraphs within that volume. Tab indexing shall be used to identify sections. Indices do not count against the page limitations for their respective volumes.

3.0 VOLUME I/SECTION I – DOCUMENTATION VOLUME/Cover Page

The Offeror shall include Cover Page.

3.1 VOLUME I/SECTION II – TABLE OF CONTENTS (TOC)

The Offeror shall include Table of Contents.

3.2 VOLUMNE I/SECTION III - DOCUMENTATION VOLUME/EXECUTED REQUEST FOR

PROPOSAL (RFP)/SF 33

The Offeror shall complete Page 1 of the Standard Form (SF) 33, Solicitation, Offer and Award. The Offeror shall fill out blocks 12 through 18 accordingly:

The Government requires a minimum acceptance period of not less than 120 calendar days. The Offeror shall complete Block 12 with full cognizance of the minimum acceptance period of 120 calendar days. “Acceptance Period” means the number of calendar days available to the Government for awarding a contract from the date specified in this solicitation for receipt of an offer. The offer may specify a longer acceptance period than the Government’s minimum requirement but shall not specify a shorter period.

If any amendments to the solicitation are issued, the Offeror must acknowledge each amendment number and date in Block 14 of the SF 33. Failure to acknowledge all solicitation amendments may render the Offeror ineligible for award.

The Offeror’s legal name and address in Block 15A on the SF33 must match the information for the Offeror in SAM at http://www.sam.gov including the corresponding Commercial and Government Entity (CAGE) code and Data Universal Numbering System (DUNS) number. The address listed in Block 15A will be the official mailing address used by the Government for letter correspondence, if necessary.

The name, title, signature and date identified in Block 16, 17, and 18 must be an authorized representative with authority to commit the Offeror to contractual obligation.

The Offeror shall submit a fully executed copy of the RFP/SF33. This submission shall be signed/dated and all clauses and provisions requiring a “fill-in” and signature shall be completed. They are:

FAR 52.219-28, Utilization of Small Business Concern FAR 52.204-8, Annual Representation and Certifications FAR 52.204-17, Ownership or Control of Offeror FAR 52.204-20, Predecessor of Offeror FAR 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations - Representations FAR 52.209-5, Certification Regarding Responsibility Matters FAR 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law FAR 52.209-12, Certification Regarding Tax Matters FAR 52.219-1 Alt I, Small Business Program Representation FAR 52.223-22, Public Disclosure of Greenhouse Gas Emission and Reduction Goals - Representation FAR 52.230-1 DEV, Cost Accounting Standards Notices and Certifications DFARS 252.204-7007, Alt A Annual Representations and Certifications DFARS 252.235-7010, Acknowledgement of Support and Disclaimer

3.3 VOLUME I/SECTION IV –DOCUMENTATION VOLUME/ATTACHMENT 4, ORGANIZATIONAL

CONFLICT OF INTEREST (OCI) and ATTACHMENT 15, SMALL BUSINESS PARTICIPATION The Offeror shall submit Attachment 4, OCI and s statement of intent to enter into a teaming agreement

The Federal Acquisition Regulation (FAR) Part 9.5 provides guidance for Contracting Activities with regards to Organizational conflict of Interest. OCI is characterized by a) biased judgment on the part of the contractor or b) unfair competitive advantage in a procurement. The FAR encourages mitigation of a conflict if at all possible. The Contracting Officer has significant discretion as to the acceptability of any mitigation plan offered.

The United States Army Medical Research Materiel Command (MRMC) has categorized its services requirements into two (2) broad categories, as defined in Attachment 4, for purposes of identifying, avoiding or militating against OCI in accordance with FAR Subpart 9.5.

The use of contractor teaming arrangements (as defined in FAR 9.601(1)) and subcontractor relationships is acceptable. Any subcontracting/teaming arrangements contemplated by the Offeror must be presented in detail.

The details should disclose those portions of the task which will be subcontracted and the anticipated organizations with which subcontracting or teaming arrangements are planned. Since there is a direct relationship between the Cost/Price proposal and the Non-Cost/Price proposal, the Offeror shall include enough information on subcontracting/teaming arrangements to allow for a thorough proposal review from a technical and management perspective. The Offeror shall include evidence (e.g., signed statement of intent to enter into a teaming agreement) of all subcontractor teaming arrangements (with both large and small businesses) in the Volume I. Although this evidence shall be submitted in Volume I, only information presented in Volume II (Technical Approach, Experience, and Quality Management Approach, and Past Performance) will be considered when evaluating.

4.0 VOLUME II/SECTION I –TECHNICAL VOLUME/COVER LETTER

The Offeror shall include Cover Page volume I.

4.1 VOLUME II/SECTION II – TECHNICAL APPROACH (FACTOR 1)

The Offeror shall provide written information as to a technical approach which demonstrates

(a) A clear working knowledge and understanding of Phases 1 and 2 clinical trial research studies, with vaccine and drug products, under the application of the principles of current Good Clinical Practice (cGCP), Good Laboratory Practice (cGLP), and Good Manufacturing Practice (cGMP);

(b) A clear working knowledge and understanding of the development platform and independent standards that aid interoperability with healthcare information systems that meet Clinical Data Interchange Standards Consortium (SCISC) standards; and

(c) A clear working knowledge and understanding of clinical trial automation technology and how this process eliminates data discrepancies and reduces data reconciliation activities.

Note: The Technical Approach shall not contain any reference to cost or price; however, information concerning labor hours and categories, if applicable, subcontractor(s) shall be contained in the Technical Volume in sufficient detail so that the Government may adequately evaluate the Offeror’s understanding of the requirements.

4.2 VOLUME II/SECTION II – EXPERIENCE (FACTOR 2)

The Offeror shall submit Key Personnel resumes, Key Personnel signed letters of Commitment, and signed subcontractor teaming letters.

The Offeror’s proposal shall demonstrate experience identical to, similar to, or related to, performing services contained within the PWS. The Offeror shall demonstrate the amount of relevant corporate experience the Offeror possesses and demonstrate the amount of relevant experience possessed by supporting subcontractors, consultants, and business partners, and proposed Key Personnel. The proposal shall demonstrate the Offeror’s experience (for this purpose, experience refers to what an Offeror has done, not how well it was accomplished) in performing clinical trial processes and procedures.

At a minimum, the Offeror’s experience shall demonstrate that the organization has:

(a) Experience conducting Phases 1 and 2 clinical trial research studies with vaccine and drug products under the principles of current Good Clinical Practice (cGCP), Good Laboratory Practice (cGLP), and Good Manufacturing Practice (cGMP);

(b) Experience identifying/recruiting, screening, and enrolling volunteer subjects and experience recruiting and retaining experienced/trained employees for clinical trial support services;

(c) Experience developing platform independent standards that aid interoperability of healthcare information systems that meet Clinical Data Interchange Standards Consortium (CDISC) standards;

(d) Experience conducting multiple different types of clinical trials/research protocols simultaneously and experience providing scientific status and financial status; and

(e) Proposed Key Personnel with relevant experience, including the appropriate mix and balance of education and training that is identical to, similar to, or related to, performing services contained within the PWS.

4.3 VOLUME II/SECTION III – QUALITY MANAGEMENT APPROACH (FACTOR 3)

The Offeror shall submit Deliverable 5, Quality Control Plan

At a minimum, the Offeror’s proposal shall demonstrate Quality Management Approach demonstrates:

(a) The Offeror’s organizational structure and chain of command practices that will contribute, in a positive manner, to ensure completion of all tasks to include individuals’ authority, roles, responsibilities, internal reporting relationships and positions within the organization. If the Offeror’s proposal includes subcontracting or teaming, those relationships must be clearly defined and explained;

(b) The Offeror’s methods for staffing, recruitment, and retention (e.g. including clinical trial volunteers and medical personnel) as well as training and maintaining licensure/certifications, managing subcontractors, managing individual task orders (i.e. clinical trials), including, but not limited to, mix of resources, teaming agreements, managing priorities, task monitoring, and decision making processes;

(c) The Offeror’s process and tools for managing cost, schedules, records, GFP, and clinical monitoring across all phases of multi-functional clinical trials under the application of current Good Laboratory Practice (cGCP) monitoring of non-investigational new drug (IND) protocols, including the need for reporting cost, having and maintaining a Clinical Monitoring Plan (reference deliverable 3), Program Management Plan (reference deliverable 6), Task Order Management Plan (reference deliverable 7), Contingency Operations Plan (reference deliverable 8), and Medical liability Insurance (reference deliverable 20); and

(d) The Offeror’s Quality Control Plan includes (a) self-inspection plan, (b) an outline of the procedures that will be used to maintain quality, timeliness, deliverable timelines, responsiveness, and customer satisfaction and (c) how a quality control approach identifies processes, procedures, and metrics.

4.4 VOLUME II/SECTION IV – PAST PERFORMANCE (FACTOR 4)

The Offeror shall submit NO MORE THAN three (3) past performance references for itself as the prime, NO MORE THEN two (2) references for each subcontractor proposed, and Attachment 7, Past Performance Questionnaire (received from Offeror’s Client/Customer).

The Offeror, shall submit NO MORE THAN three (3) past performance references for itself as the prime contractor of relevant contracts in scope, magnitude of effort, and complexities with this requirement. The Offeror shall also submit NO MORE THAN two (2) references for each subcontractor proposed. The contracts must reflect recent performance or current as long as the recent performance did not end more than three (3) years prior to the due date for the submission of the Offeror’s proposal. The referenced contracts may have been with Federal, State, or City agencies and/or commercial customers. In addition to the above, Past Performance references shall contain the following:

- Customer’s Full Name, Address, and contact information

- Contract number, contract type (FFP, CPFF, T&M, etc), and total contract value (base + all options)

- Service provided (It is not sufficient to state that it is comparable in magnitude and scope. Rationale must be provided to demonstrate that it is comparable as set forth above)

- Problems encountered on the identified contracts, if any, and the offeror’s corrective action(s)

- Method of acquisition (competitive or direct award/sole source)

- Number of FTEs

Offerors are reminded the Government may elect to consider data obtained from other sources. Other sources available to the Government include, but are not limited to, the Past Performance Information Retrieval System (PPIRS), Federal Awardee Performance and Integrity Information System (FAPIIS), and Contractor Performance Assessment Reporting System (CPARS).

The burden of demonstrating relevancy of the past performance rests with the Offeror.

The Past Performance Evaluation Questionnaire Form (Attachment 7) shall be forwarded by the Offeror to NO MORE THAN three (3) customers for the prime contractor and NO MORE THAN two (2) customers for each subcontractor within the last three (3) years for performance relevant in scope, magnitude of effort, and complexities with this requirement. Completed past performance questionnaires shall by received by proposal due date directly from Offeror’s Client/Customer or they will NOT be considered.

5.0 VOLUME III/SECTION – COST/PRICE VOLUME

The Offeror shall submit Attachment 6, Government Pricing Sheet, Attachment 12, SF 1408, Forward Pricing Rate Agreement OR 3-year historical financial trend, the name, address, and telephone number of the DCAA OR DCMA Government Agency’s Point of Contact and a copy of the most recent/current audits, pricing or rate agreements issued by the cognizant agency, if applicable, Estimating System documentation, if applicable, Purchasing System documentation, if applicable, Accounting System documentation, and POC who can obligate your company contractually.

5.1 COST/PRICE - BASE CONTRACT

The Offeror shall submit a cost/price proposal with a breakout of all labor categories by completing the Government provided worksheet in Attachment 6, Pricing Sheet. This template shall be used in place of the Section B of the SF

33. All labor categories are included on the pricing spreadsheet and should correlate to the prevailing locale, which supports the Offeror’s approach to the Clinical Trial Support Services requirement.

By submitting a proposal for the base contract, the Offeror agrees to pay the prevailing labor rates in accordance with the Department of Labor (DOL) Wage Determinations in the areas where services will be provided. For purposes of base contract proposal evaluation, the Offeror shall use the DOL wage determination for Montgomery County, Maryland in developing the labor rate ranges. The Offeror shall asterisk those labor categories determined to be Service Contract Labor Standards positions. These specific positions will be subject to change in Task Orders depending on the location of the work and the prevailing DOL Wage Determination.

Offerors must propose labor rates for all labor categories listed in Attachment 5, Labor Categories. The Offeror must provide a rate for each labor category it proposes OR if the Offeror chooses not to propose a labor category that is included in the template, it shall state “N/A” in corresponding fields for that position. If an Offeror elects not to propose rates for certain labor categories, the Offeror shall provide an explanation. The Offeror shall not delete any lines from the spreadsheet or leave any fields blank.

Additional labor categories - If the Offeror intends to propose additional labor categories which are not included in Attachment 5 - Labor Categories, it shall do so by adding the position, a description of skills/ tasks/experiences expected in that specific position, and corresponding rates for the base period and all option periods designated in the spreadsheet by creating Position Number 34 and adding as many rows as necessary with subsequent position numbers until all additional labor categories have been proposed for the base and all option periods for each geographical location. Any rows added to the spreadsheet for the purposes of proposing additional labor categories must be Font type: Times New Roman, size 12.

Subcontractors - If the Offeror intends to propose subcontractor labor categories, it shall do so by adding the position and corresponding rates for the base and all options periods designed in the spreadsheet by creating Position Number 40 and adding as many rows as necessary with subsequent position numbers until all additional subcontractor labor categories have been proposed for the base and all options periods for each geographical location. Any rows added to the spreadsheet for the purposes of proposing additional labor categories must be Font type: Times New Roman, size 12.

The Offeror shall provide cost build up data for loaded labor rates beginning with the unloaded labor rate through application of indirect and profit and/or fee. The Offeror shall not propose labor rates that are derived from blending two or more separate Contractors or Subcontractors. The Government prefer Time & Material (T&M) contracts between the prime and the subcontractor.

The Offeror shall refer to Attachment 5 - Labor Categories, for definitions of the labor categories contained in Attachment 6 - Pricing Sheet. If the Offeror intends to propose any labor category it feels are consistent in duties with a description in Attachment 5 - Labor Categories, but differently titled, in accordance with its cost accounting procedures, the Offeror must cross map the description/title of its proposed labor category to the Government’s PWS to ensure its proposal receives a proper evaluation

At award, a ceiling amount will be set forth in the base contract. This ceiling amount will serve as the cumulative ceiling for all task orders issued under this contract. The actual labor mix and number of hours for each requirement (i.e. Task Order) will be determined at the task order level.

Any Offeror who submits a Cost/Price Proposal utilizing an altered version of the Cost/Price Template in Attachment 6, Pricing Sheet (except for the addition of rows for purposes of adding labor categories) or submits a spreadsheet of its own in place of the completed template provided in Attachment 6, Pricing Sheet WILL NOT be considered for award. Only cost/price proposals which utilize the template provided in Attachment 6, Pricing Sheet will be evaluated.

All percentages and rates shall be rounded to two decimal places (i.e. XX%). The Offeror shall ensure mathematical computations are correct. Errors in addition or multiplication may be considered nonresponsive to this RFP.

5.2 COST/PRICE – Cost Breakdown

The Offeror shall address the following cost elements in sufficient detail to demonstrate the reasonableness of the proposed costs, which shall include build up of cost/price for both FFP and CPFF:

Direct Labor. The loaded and unloaded labor rates awarded in the prime contract shall be used by the prime contractor when proposing on task orders issued under this contract. Indicate if the proposed loaded rates are based on actual or projected rates for current employees. The rate for each labor category shall not exceed the negotiated approved rates awarded in the prime contract. Indicate the escalation factor used and first month(s) for each

Government contract year in which escalation factor is applied. For task orders, loaded rates shall be used for FFP contract line items (on-site and off-site) and unloaded rates shall be used for CPFF contract line items (on-site and off-site). All Subcontractors proposed must satisfy the requirements of FAR Part 44. Labor rates shall be proposed for Government On-Site and Off-site in accordance with the descriptions provided in Attachment 5, Labor Categories. The Offeror shall show cost data in support of all labor rates. Discounted rates shall be offered at this time, if available, however these are the maximum rates the Government will allow on task orders.

- Loaded Hourly Labor Rate. The rate shall include direct labor cost, indirect costs, and profit.

- Unloaded Hourly Labor Rates. The rate is direct labor cost and shall not include any other direct costs, indirect costs, or fee.

“On-site” / “Off-site” Labor. The Government on-site labor rates will be used when Contractor performance will primarily occur in Government-owned or operated facilities. Unless otherwise indicated, the Government will provide: space, office equipment, utilities, computer (and necessary computer accessories), basic office supplies, telephone and internet capabilities (if required). Since the Government provides these items, the cost of these items should not be included in the Contractors’ rates. In developing Government on-site labor rates, the Contractor should include: salary, benefits, indirect costs not covered above and any allowable profit/fees.

When Contractor performance will primarily occur off-site, the Contractor shall propose “off-site” rates.

Other Direct Costs (ODCs). ODCs will not be evaluated as part of the contract award. The Government has provided plug numbers for ODCs in Attachment 6, Pricing Sheet (see last tab). ODCs will be determined at the task order level.

Surge. Surge will not be evaluated as part of the contract award. Surge will be determined at the task order level.

Subcontractor Costs. Provide a complete description of all subcontractor costs.