W911QY-15-R-0023-0001.pdf

W911QY-15-R-0023

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 is to extend the proposal due date and to add Questions and Answ ers into Section A.

1. CONTRACT ID CODE PAGE OF PAGES

S 1 24

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

16C. DATE SIGNED

BY 17-Jul-2015

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 W911QY-15-R-0023

X 9B. DATED (SEE ITEM 11)

26-Jun-2015

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 X is extended, 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 1 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

17-Jul-2015

CODE

W6QK ACC-APG NATICK

110 THOMAS JOHNSON DR SUITE #240

FREDERICK MD 21702

W911QY 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION A - SOLICITATION/CONTRACT FORM

The required response date/time has changed from 27-Jul-2015 03:00 PM to 29-Jul-

2015 12:00 PM.

The following have been added by full text:

Questions from Industry 17 July 2015

1. The RFP lists the estimated award date as September 4, 2015, but does not provide a period of performance (PO). Can the Government provide the POP for CLINS 0001-0015 and CLIN 0016?

The period of performance was not listed in the solicitation because this requirement is a completion-type effort dependent upon milestones that are not readily defined and are prone to schedule delays, such as clinical trial progress and FDA approvals. For estimation purposes, performance should be completed within 48 months, although offerors are invited to propose their own schedule to complete the work.

2. Can the Government clarify the difference between the Net Amount that needs to be listed for CLINS 0004- 0015 and the Estimated Cost we need to list for CLINS 0002-0003?

CLINs 0004-0015 are the contract deliverables and have been changed to Not Separately Priced. Estimated cost refers to the cost that which is proposed by the offeror and accepted by the Government, reflected in the Travel and ODC CLINs 0002 and 0003, respectively, which are priced at Cost, as well as the Labor CLINs 0001 and 0016 which are priced on a Cost-Plus-Fixed-Fee basis (i.e., estimated cost plus a negotiated fixed fee for profit or management).

3. Is IND sponsorship a mandatory requirement for the contractor?

Yes, IND sponsorship is a mandatory requirement.

4. Will the study drug be supplied by the Government or will the contractor be expected to secure a supplier?

Yes, the study drug has been synthesized by a CRO under GMP guidelines and will be provided in bulk to the performer. Awardee will need to have the bulk drug packaged in unit doses under sterile conditions prior to use.

5. It is understood that the awardee is expected to serve as sponsor for regulatory document submission.

However, in other projects with DoD, some units (e.g. USAMMDA) have taken eCTD publication upon themselves.

For the purposes of this project, would eCTD publishing and U.S. Agency be the responsibility of the Awardee?

The offeror must plan to do this, but other options may be available later depending on what is in the best interest of the Government.

6. Since the protocols have not been written it is difficult to identify the kinds of laboratory assessments required to support the BA/PK requirement. Can any assumptions be provided as further guidance?

Pre-clinical results are not yet available. The offerors, based on what they know about the drug, hemorrhage, standard requirements for phase I clinical studies, and relevant military or other considerations, can collect and use published information for relevant scientific studies to write their initial protocol, until such time pre-clinical data are available post award.

7. Can the Government provide guidance on the estimated number of sites and participants for phases 1a and 1b?

The Government anticipates that a single site study should be adequate to accomplish the objectives. This effort is essentially a two-pronged Phase 1 effort split into two stages, hence the 1a and 1b designations.

Participation is estimated at Phase 1a (n=20) and Phase 1b (n=60) for a total study population of 80.

8. The study drug appears not be a biologic product or derivative of a biologic product, yet the RFP states in several places that support for a Biologics License Application (BLA) will be required. Can the government provide clarification on this point?

The compound will be considered a drug and is expected to be regulated by the Center for Drug Evaluation and Research (CDER) of FDA. Offerors should plan to support an NDA rather than a BLA.

9. Section L.6.5 (Administrative Volume Content) specifies that “small businesses are not required to submit CPA audited or reviewed financials” as part of Volume I, Section V (Administrative Volume, Financial Documentation). However, section L.10.2.8 (Company Financial Statements) states that “offerors shall provide copies of their annual financial statements for the last three years” as part of Volume IV (Contract Cost). Please clarify whether small business offerors are required to submit financial statements for the last three years as part of Volume IV.

Section L.6.5 is a requirement as part of the Administrative Volume and Section 10.2.8 is a requirement as part of the Cost Proposal.

10. Section L.10.1.3 (General Information) references a cost element summary template that is provided in Section J, Attachment 0002. However, there is no Attachment 0002 to the RFP. Please indicate whether Attachment 0002 should be added or whether this clause was included in error.

Attachment 0002 has been added into Section J.

11. We request that the proposal deadline be extended.

The proposal due date has been extended to: 1200EST (noon) on 29 July 2015.

12. Section L.10.2.7 (Accounting System) references a Pre-Award Survey that shall be submitted with the proposal of any offeror that does not have an approved cost accounting system at the time of proposal submission. Please indicate how offerors can access this survey as it was not included as an attachment to the RFP.

Section L.10.2.7 has been changed.

13. Are costs for the purchase of clinical trial insurance allowable as direct costs in the budget?

The Government considers insurance to be included as part of the offeror’s indirect costs.

14. Is the contractor responsible for central laboratory services?

The contractor is responsible for central laboratory services.

15. Is the contractor responsible for services related to the investigational product, e.g., repackaging, labeling, distribution?

Yes, for the IND application the contractor will be responsible for services related to the investigational product. Awardee will need to have the bulk drug packaged in unit doses under sterile conditions prior to use.

16. Section B – Supplies or Services and Prices, Item 0001 requests a CPFF bid for “personnel, space and all other instruments necessary to meet the requirements of Phase 1a of this solicitation, including, but not limited to, Section C.” CLINs 0005 through 0015 request FFP bids for a number of deliverables that are essential parts of the work required by Section C of the RFP. Please clarify how the offerors are to segregate costs for these items from the CPFF bid required for CLIN 0001, particularly with regard to CLINs 0012 to 0015 where specific deliverables may be difficult to define and extract from the overall performance of the work.

CLINs 0004-0015 are contract deliverables and have been changed to Not Separately Priced.

17. Section B – Supplies or Services and Prices, Item 0016 requests a CPFF bid for “personnel, space and all other instruments necessary to meet the requirements of Phase 1b of this solicitation, including, but not limited to, Section C.” This CLIN is the only one that references the Phase 1b trial; unlike for the Phase 1a trial, no other CLINs are included for cost only or FFP items. Please clarify if the budget structure for the Phase 1b trial is to mimic that for the Phase 1a trial and provide the additional instructions.

Travel (0017) and ODC (0018) CLINS have been added for Phase 1b.

18. The instructions in section L.5.3 regarding exemptions from the page limitations do not reference appendix documents in support of the technical approach. Will the Government exclude such appendices from the Technical Volume page limitation?

Yes, appendices will be excluded from the total page count for this Volume.

19. Section F requires that drafts of the IMS, CWBS, and QMP be included with the proposal. Please confirm if these are to be included as part of the Technical Volume. If they are to be included in the Technical Volume, please confirm that they will be exempted from the page limitation for that volume.

Yes, these will be excluded from the total page count for this Volume.

20. In our experience, section L often includes a subsection for each volume that is devoted to instructions for compilation of that volume. However, only the administrative volume is addressed this way in the RFP (see Section L.6, titled ADMINISTRATIVE VOLUME CONTENT). Please confirm if additional sections are to be added to the RFP or if the offeror is meant to rely on the content regarding Factors To Be Evaluated that is presented in Sections L.8 through L.11.

There will be no additional sections added to the RFP. The offeror’s proposal shall address those elements as currently stated in Section L.

21. The RFP references Microsoft Word 2010 and/or the Microsoft Office 2010 Suite in 2 separate places. In L.5.2.1, the text states that “the offeror’s written proposal submission shall be submitted in Microsoft Word 2010 format (or comparable software).” In L.5.3, the text states that “the CD submission for each volume shall contain one copy of the respective proposal volume in Microsoft (MS) Office 2010 Suite (MS Word 2010, MS Excel 2010).” In the first instance, “comparable software” is allowed, but the second instance does not contain this option.

Please clarify the Government’s specific needs regarding the version of the Microsoft software to be used and, if applicable, what “comparable software” means, e.g., a file that may be accurately read by a user with 2010.

Documents must be compatible and viewable with Microsoft 2010.

22. Section L.5.3 states that Volume III for Past Performance is limited to 2 pages per contract reference for up to 10 pages. This allotment only accounts for past performance information for the prime offeror. May additional references be included for teaming partners/subcontractors? If so, please confirm how many references are allowed for each partner/subcontractor and the number of pages allowed for each of those references.

The Offeror can submit information regarding their teaming partners/subcontractors, however this shall be counted as part of the 10 pages limit for this Volume.

23. Please provide guidance regarding the projected trial durations and specific periods of performance to be used in budget submissions for both the Phase 1a and Phase 1b trials.

The Government does not anticipate prescribed trial durations, rather emphasize appropriate enrollment targets and historical enrollment rates for previously conducted trials of a similar nature by the proposer.

The period of performance was not listed in the solicitation because this requirement is a completion-type effort dependent upon milestones that are not readily defined and are prone to schedule delays, such as clinical trial progress and FDA approvals. For estimation purposes, performance should be completed within 48 months, although offerors are invited to propose their own schedule to complete the work.

24. As an interested party for this solicitation, I wish to pose a question with respect to the requirement on page 19 of 81 that the Investigator’s Brochure is a deliverable "Upon Award". I am not sure when the award will be made, but studies that generate the data to be included in the Investigator's Brochure take time to accomplish, thus it is likely that the Investigator's Brochure will be available post-award although before the clinical trials.

Is this acceptable?

Yes, this is acceptable. In addition, a draft brochure is already prepared and could be available for use by the contractor upon award.

25. Does the Government have their own laboratories they wish to use for sample storage and analysis or should the offeror be prepared to provide these services?

The offeror shall be prepared to provide these services.

26. Does the Government prefer that we submit all suggested study sites for both the Phase 1a and Phase 1b study with the initial proposal? Or just for the Phase 1a study, since the Phase 1b study is an option?

Yes, the Government anticipates this effort to be a single site study.

The following have been modified:

SUPPLEMENTAL INFORMATION

A-1 The U.S. Army Contracting Command, Aberdeen Proving Ground (ACC-APG), Natick Contracting Division (NCD) has a requirement to provide full solution clinical research support to guide 17α-ethynylestradiol-3-sulfate, sodium salt (EE-3-SO4) through Federal Drug Administration (FDA) Investigational New Drug (IND) submission and Good Clinical Practice (GCP) compliant Phase 1a and potentially 1b clinical trials for an indication as a viable infusion therapy for the treatment of critical patients with significant blood loss. Support may also be required to conduct additional preclinical work as required to facilitate the Phase 1a and potentially 1b clinical trials. The Contractor shall assume sponsorship for FDA IND submission.

A-2 The Government anticipates that this will result in one (1) Cost Plus Fixed Fee (CPFF) completion-type contract, however, the Government reserves the right to award more or none as a result of this Request for Proposals (RFP).

A-3 This acquisition is on a Full and Open competitive basis. The North American Industry Classification System (NAICS) code is 541712 and the size standard is 500 employees.

A-4 In accordance with Section M, award will be made on a tradeoff (best value) basis, wherein evaluation factors are weighted in order of importance to the requirement. That is, the Technical Factor is the most important of all the factors and is more important than the Past Performance Factor. The Past Performance Factor is more important than the Contract Cost Factor, which is more important than the Small Business Participation Factor.

The Small Business Participation Factor is not weighted, however must be rated as acceptable for award.

(Technical Factor > Past Performance Factor > Contract Cost Factor > Small Business Participation Factor).

A-5 This solicitation and any resultant contracts are subject to the availability of funds. Proposals shall be valid for at least 180 days. Please annotate the last day the proposal will be valid on page 1 of the RFP, SF 33 Block 12. Firms will not be reimbursed for any costs associated with their proposal preparation.

A-6 In accordance with Section L of this solicitation, proposals shall be delivered to:

US Army Contracting Command – Aberdeen Proving Ground Natick Contracting Division (CCAP-SCN) ATTN: Matthew Buchanan, Contract Specialist Solicitation #: W911QY-15-R-0023 Kansas Street, Building 1, 3rd Floor Natick, MA 01760

A-7 Questions shall be submitted to matthew.r.buchanan6.civ@mail.mil no later than 15 days prior to the closing date of the solicitation. Questions will not be accepted by telephone and must be submitted by e-mail. Questions received later than the deadline may not be answered prior to proposal submission.

A-8 Proposals are due by 12:00 PM EST (noon) on 29 July 2015.

SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0005

The contract type has changed from FFP to CPFF.

The unit of issue Each has been added.

The cost constraint NSP has been added.

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0005 Each CDRL A001 - Integrated Master Schedule

CPFF

Reference Section J, Exhibit A FOB: Destination

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

CLIN 0006

0006 Each

CDRL A002 - (CWBS)

CPFF

Contractor Work Breakdown Structure - Reference Section J, Exhibit B

CLIN 0007

0007 Each CDRL A003 - Status Report

CPFF

Reerence Section J, Exhibit C

CLIN 0008

0008 Each CDRL A004 - Scientific & Tech Reports

CPFF

Reference Section J, Exhibit D

CLIN 0009

0009 Each CDRL A005 - Quality Management Plan QMP

CPFF

Reference Section J, Exhibit E

CLIN 0010

0010 Each CDRL A006 - Interim Progress Review

CPFF

Reference Section J, Exhibit F

CLIN 0011

0011 Each CDRL A007 - Investigator's Brochure

CPFF

Reference Section J, Exhibit G

CLIN 0012

0012 Each CDRL A008 - IND Application

CPFF

Investigational New Drug Application - Reference Section J, Exhibit H

CLIN 0013

0013 Each CDRL A009 - Clinical Trial Monitoring

CPFF

Deliverables - Reference Section J, Exhibit I

CLIN 0014

0014 Each CDRL A010 - Data Management Deliverables

CPFF

Reference Section J, Exhibit J

CLIN 0015

0015 Each CDRL A011 - Biostatistical Support

CPFF

Deliverables - Reference Section J, Exhibit K

CLIN 0017 is added as follows:

OPTION Travel

COST

Travel associated with Phase 1b. Travel shall be in accordance with Section C.6 & H.13.

CLIN 0018 is added as follows:

OPTION Other Direct Costs (ODC)

COST

ODCs associated with Phase 1b. The Offeror shall propose the ODCs needed to perform this clinical research effort. The Offeror shall provide a list of all the additional costs that are associated with these ODCs.

SECTION E - INSPECTION AND ACCEPTANCE

The following Acceptance/Inspection Schedule was added for CLIN 0017:

INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

Destination Government Destination Government

The following Acceptance/Inspection Schedule was added for CLIN 0018:

INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

Destination Government Destination Government

SECTION J - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

Table of Contents

Attachment/Exhibit Title # of Pages Date

Exhibit A CDRL A001 - Integrated Master Schedule 03 15 April 2015 Exhibit B CDRL A002 - Contractor Work Breakdown Structure (CWBS) 03 15 April 2015 Exhibit C CDRL A003 - Status Report 03 15 April 2015 Exhibit D CDRL A004 - Scientific and Technical Reports 03 15 April 2015 Exhibit E CDRL A005 - Quality Management Plan (QMP) 03 15 April 2015 Exhibit F CDRL A006 - Interim Progress Review 03 15 April 2015 Exhibit G CDRL A007 - Investigator's Brochure 03 15 April 2015 Exhibit H CDRL A008 - Investigational New Drug (IND) Application/Clearance 03 15 April 2015 Exhibit I CDRL A009 - Clinical Trial Monitoring Deliverables 03 15 April 2015 Exhibit J CDRL A010 - Data Management Deliverables 03 15 April 2015 Exhibit K CDRL A011 - Biostatistical Support Deliverables 03 15 April 2015 Attachment 0001 Quality Assurance Surveillance Plan (QASP) Attachment 0002 Cost Element Summary Template 01 17 July 2015

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

L.1 PROPOSAL SUBMISISON

L.1.1 SOLICITATION QUESTIONS

Interested parties shall submit questions regarding this solicitation by electronic mail to matthew.r.buchanan6.civ@mail.mil with the solicitation number in the subject line. The Government will answer all questions through the issuance of a solicitation amendment prior to the deadline for final proposal submissions, provided it receives those questions no later than 14 calendar days prior to the closing date of the solicitation. Questions received after the deadline may not be answered prior to proposal submission. The Government does not anticipate extending the closing date for receipt of offers.

L.1.2 PERIOD FOR ACCEPTANCE OF OFFERS

The period for acceptance of offers is one hundred eighty (180) days after the closing date of the solicitation.

L.1.3 PRE-CONTRACT COST

The Contractor will not be reimbursed for any costs incurred prior to the effective date of the contract.

L.1.4 Information contained in the successful or unsuccessful Offeror's technical/management or price proposal must be released under the Freedom of Information Act (5 U.S.C. 552) upon request from the public after contract award except to the extent it contains trade secrets and privileged or confidential commercial or financial information. If the Offeror's proposal contains material meeting this description which is customarily maintained in confidence in the course of the Offeror's business and is not otherwise publicly available, and if the Offeror does and is not otherwise publicly available, and if the Offeror does not want it disclosed to the public, he shall mark the title page with the legend that follows.

"This proposal, furnished in response to Solicitation No. W911QY-15-R-0023 contains trade secrets and/or privileged or confidential commercial or financial information. This information is maintained in confidence in the course of the Offeror's business and is not otherwise publicly available. The Offeror submits this information to the Government in confidence and understands that it is received with that intent. This information shall not be released or disclosed outside the Government under the Freedom of Information Act (5 U.S.C. 552) or under any other circumstances."

Proposals so marked will be accepted by the Government in confidence and will not be released provided that the Offeror and/or the Government can show, upon request under the Freedom of Information Act, that disclosure would either (1) impair the Government's ability to obtain necessary information in the future or (2) cause substantial harm to the competitive position of the Offeror.

L.2 CONTRACT AWARD

L.2.1 TYPE OF SOLICITATION

This solicitation is being issued as a full and open competition under which all contractors eligible for Federal contracts are encouraged to participate.

L.2.2 PROPOSAL LIMITS

Offerors are only authorized to submit one proposal as a prime offeror.

L.2.3 AWARD ON INITIAL OFFER

The Department of Defense's preference is to engage offerors in discussion after the receipt of proposals.

However, the Government may decide in certain cases to award a contract without discussions with offerors (except clarifications as described in FAR 15.306(a)). Therefore, the offeror’s initial proposal should contain the best terms from a cost and technical standpoint as there may not be an opportunity to revise the proposal through the discussion process. The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary (FAR 52.215-1(f)(4)).

L.3 INSTRUCTIONS TO OFFERORS

L.3.1 Offerors are invited to submit a proposal in accordance with Paragraph L.7, Proposal Preparation

Instructions, to arrive at the office specified in Subparagraph L.3.3 below no later than the proposal due date for this solicitation. Hand delivery of proposals is not authorized. The Government does not authorize submission of telegraphic or facsimile offers for this solicitation.

L.3.2 The proposal due date is 12:00PM Eastern Standard Time (noon) on 29 July 2015.

L.3.3 All proposals delivered in response to this solicitation shall reflect the solicitation number on the address label and all proposal documents must be delivered to:

US Army Contracting Command – Aberdeen Proving Ground Natick Contracting Division (CCAP-SCN) ATTN: Matthew Buchanan, Contract Specialist Solicitation # W911QY-15-R-0023 Kansas Street, Building 1, 3rd Floor Natick, MA 01760

L.3.4 A company with multiple Divisions (and each division registered separately in CCR/SAM) is permitted to submit a separate proposal by Division for consideration. However, offerors are cautioned that if one company submits separate proposals from multiple Divisions, each Division’s proposal should address the full RFP requirements uniquely based on their particular Division’s capabilities. For example, technical, small business participation plans, and/or past performance submissions of a different Division may not be used in support of another Division submitting a proposal. The proposal must be specific to the Division submitting the proposal. Each Division shall have its own CAGE code.

L.4 PROPOSAL PREPARATION INSTRUCTIONS

L.4.1 INTRODUCTION AND PURPOSE

This section specifies the format and content that offerors shall use in responding to this Request for Proposal (RFP). The intent is not to restrict the offerors in the manner in which they will perform their work but rather to ensure a certain degree of uniformity in the format of the responses for evaluation purposes. Offerors must submit a proposal that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided should be concise, factual, and complete. Any proposal which does not provide, at a minimum, that which is required in this solicitation, may be determined to be incomplete and unacceptable.

L.4.2 Award Date: The anticipated award for this requirement is September 4, 2015.

L.4.3 All acceptable proposals must demonstrate the Offeror has an understanding of the requirements and associated risks. The Government considers statements that the prospective Offeror understands, can or will comply with the specifications, and/or statements paraphrasing the requirements or parts thereof to be inadequate and unsatisfactory. The Government further considers mere reiteration of the requirement or standard reference material to also be inadequate and unsatisfactory.

L.4.4 Any data previously submitted in response to another solicitation, whether submitted to the DoD or another agency, should be assumed to be unavailable during this proposal evaluation and source selection process.

Proposal data shall not be incorporated into the proposal by referring to another proposal or other source.

L.4.5 Elaborate brochures or other presentations beyond what is sufficient to present a complete and effective proposal, are neither necessary nor desired.

L.4.6 If a discrepancy exists between the original paper copy of the proposal and the CD copy required to be submitted, the original paper copy will take precedence.

L.4.7 The Government reserves the right to request additional information after receipt of Offeror’s response to the RFP.

L.4.8 The proposal shall be valid for not less than 180 calendar days from the proposal due date. The Offeror shall make a clear statement that the proposal is valid until such date in the Administrative Volume of the proposal and in Block 12 of the SF33

L.4.9 Proposal files shall not contain classified information.

L.4.10 Offerors are cautioned that in order for their proposal to be eligible for award, the proposal shall be in compliance with all of the terms and conditions set forth in the RFP.

L.5 PROPOSAL STRUCTURE

L.5.1 If the Offeror hand carries the proposal and/or any final proposal revision (as applicable), the Offeror shall notify the POC listed above in paragrap L.3.3 by email 72 hours in advance of the intent to hand deliver the proposal. The email must include the name of the Offeror’s organization, along with the name and phone number of the individual delivering the proposal and an intended delivery time.

L.5.2 PROPOSAL FILES

L.5.2.1 Format - Written. The offeror’s written proposal submission shall be submitted in Microsoft Word 2010 format (or comparable software), clearly indexed, and logically assembled. Each volume shall be clearly identified and shall begin at the top of a page. All pages of each volume shall be appropriately numbered and identified by the complete company name, date and solicitation number in the header and/or footer. A Table of Contents should be created. MS Word (.doc) files shall use the following page setup parameters:

Margins – Top, Bottom, Left, Right - 1” Gutter – 0” From Edge – Header, Footer - 0.5” Page Size, Width – 8.5” Page Size, Height – 11” Printed on Single Side Orientation – Portrait

The following additional restrictions apply:

Pages shall be single-spaced and each paragraph shall be separated by at least one blank line. The Offeror will use a standard, 12-point minimum font size in Times New Roman font. The Offeror may use a reduced font size, not less than 8-point, and landscape orientation for Tables and illustrations. Foldout sheets are not allowed. Align all text in “Align Left.” Do not “Justify” text. Use a single column (vice double column) text format.

All printed pages shall contain the phrase: “SOURCE SELECTION INFORMATION" (printed or stamped), in addition to referencing the FAR 3.104 proprietary data notice provided, on the front/cover page.

L.5.2.2 File Packaging - Offerors shall submit all volumes in standard size 3-ring binders that will facilitate the insertion of change pages and additional information the Offeror may be required to provide during the source selection process.

L.5.3 PROPOSAL VOLUMES: The proposal must consist of Volumes I through V, as set forth in the below table.

Volume Volume Title Page Limitations Copies I Administrative: Sec I: 5 limit 2 CDs and 2 hard

Section I: Executive Summary

Section II: Solicitation Documents Section III: DCMA POCs, CAGE, DUNs and TIN.

Section IV: Representations & Certifications Section V: Financial Documentation Section VI: Signed Teaming Agreements (if applicable)

Sec II: No page limit Sec III: No page limit Sec IV: No page limit Sec V: No page limit Sec VI: 10 page limit copies

II Factor I: Technical 30 pages 4 CDs and 4 hard copies

III Factor II: Past Performance Section A: Contract Description Section B: Contract Performance

Limit 2 pages per contract reference for up to 10 pages total.

4 CDs and 4 hard copies

IV Factor III: Contract Cost No page limit 2 CDs and 4 hard copies

V Factor IV: Small Business Participation Section A: Small Business Participation Plan Section B:

Small Business Subcontracting Plan (Large Business only)

No page limit 2 CDs and 2 hard copies

Information shall be confined to the appropriate volume to facilitate independent evaluation. The proposals shall be clear and concise, logically assembled (with all pages appropriately numbered), as wells as indexed and cross-indexed to the applicable parts of the Request for Proposal (RFP) as appropriate. Pages over the maximum page limitation for any volume, evaluation factor, or evaluation sub-factor will be excluded from evaluation. Exceptions to the page limitations are, if required: cover pages, indices/tables of contents, and divider pages.

The Offeror shall write each volume on a stand-alone basis so that the Government can evaluate its contents without cross-referencing to other volumes of the proposal. The Government will consider information it requires for proposal evaluation not found in its designated volume as the Offeror having omitted it from the proposal.

The CD submission for each volume shall contain one copy of the respective proposal volume in Microsoft (MS) Office 2010 Suite (MS Word 2010, MS Excel 2010) and one copy in Adobe Acrobat “.pdf” format. Security permissions on the “.xls,” and “.doc” files shall be set to allow the Government to select, cut, paste, and print text and graphics without the need for a password. If a discrepancy exists between the original paper copy of the proposal and the disk copy, the original paper copy will take precedence.

L.6 ADMINISTRATIVE VOLUME CONTENT

L.6.1 Section I: Executive Summary: A letter shall include:

L.6.1.1 Master Index. A master index that identifies the location of all major topics provided in each volume.

L.6.1.2 Statement of Compliance. Each offer shall include a statement indicating complete compliance with the solicitation in the Administrative volume, or detailed analysis of any objections, exceptions, contingencies, or additions.

L.6.1.3 Security Clearance. Each Offeror shall provide, if applicable, disclosure of the level of its Facility Security Clearance (personnel and facility) and its cognizant DSS office (address, name, phone, e-mail).

L.6.1.4 Authorized Negotiators. Offerors shall provide a list of authorized negotiators with their position title and their phone/email contact information.

L.6.2 Section II: Solicitation Documents. Each Offeror shall complete blank lines and provide signatures for the contract sections indicated below without modification to the files. An authorized official of the firm shall sign the Standard Form 33, amendments and all certifications requiring original signature. An Adobe Acrobat file, “.pdf” shall be created to capture the signatures for submission in the Administrative volume. Originating RFP section:

L.6.2.1 A signed and completed Solicitation/Contract Form and any subsequent amendments.

L.6.3 Section III: DCMA POCs, CAGE, DUNs and TIN for Prime and subcontractors. In this section of the Administrative volume, the offeror shall provide the Prime and subcontractor’s cognizant DCMA POC information for each of the respective offices. Also, in offeror format, this section shall list the Prime and subcontractor’s CAGE, DUNs and TIN.

L.6.4 Section IV: Representations and Certifications. Online Representations and Certifications Application (ORCA). Using ORCA, the Offeror shall enter the NAICS code for this effort and complete the Representations and Certifications information appropriately. Then print the ORCA documentation for the volume. Offerors must be registered in the System for Award Management (SAM) and ORCA under NAICS 541712, to be determined responsive and responsible at time of proposal submission. Please refer to the websites: https://orca.bpn.gov and www.sam.gov.

L.6.5 Section V Financial Documentation. In order for the Government to determine Financial Responsibility, offerors will submit the Prime Contractor’s past fiscal year and current reporting period, as of the date of the proposal financial statements to include a Balance Sheet; Income Statement; Cash Flow Statement; and Statement of Retained Earnings. Also, a certified copy of the Prime’s Line of Credit and its current status at the time of proposal submission shall be provided. Prior to submission, a company officer or CPA will certify the statements. Small businesses are not required to submit CPA audited or reviewed financials, but shall have their CFO sign off on their financials.

L.6.6 Section VI Teaming Agreements. If applicable, the offeror shall provide a copy of all pages within signed teaming agreements with subcontractors. The agreement should outline the type of work, complexity and approximate percentage level of work assigned to the subcontractor. Also, it must identify which socio-economic categories the sub-contractor qualifies for under NAICS code 541712; as well as the subcontractor’s POC with the address, phone, email and CAGE for verification-if necessary.

L.7 FACTORS TO BE EVALUATED

L.7.1 The evaluation factors include four (4) factors: Technical, Past Performance, Contract Cost, and Small Business Participation. The relative order of importance is as follows: the Technical factor is more important than the Past Performance factor, which is more important than the Contract Cost factor, which is more important than the Small Business Participation factor. All non-cost factors when combined are significantly more important than Cost.

L.8 FACTOR I – TECHNICAL: The Offeror shall describe in detail and demonstrate its thorough understanding and technical approach to meet the Government’s requirement in Section C, specifically Sections C.3 through C.5, for development of EE-3-S04 as an infusion therapy for severe hemorrhage and the conduct and management of Phase 1a and 1b (option) clinical trials. The Offeror shall provide as much detail as needed to adequately illustrate the methods or practices that will be used to perform the work.

L.8.1 The proposal shall identify the facilities and personnel required to successfully complete the tasks in the SOW and describe the quality and suitability of the facilities and personnel.

L.8.2 The Offeror shall provide the personnel and resources necessary to manage the full solution FDA clinical development efforts and research tasks. The Offeror must identify its proposed mix of labor categories (skill sets) with anticipated staffing levels described in anticipated number of hours required to perform this requirement. An

Offeror’s proposed staffing plan must provide support for all required functions for this effort. This includes direct and indirect labor that is either necessitated by the SOW requirements or implied in order to successfully complete this effort (e.g. management, quality assurance, etc.)

L.8.3 The Offeror shall provide a detailed program management approach as part of the proposal. The Offeror shall provide information detailing experience with FDA processes with respect to FDA IND submission and licensure; current products under development expected to achieve FDA licensure, including explanation of product type and current stage of development; experience conducting clinical trials and animal studies in accordance with Department of the Navy (DON) Human Research Protections Program (HRPP), and 21 CFR 314 Subpart I or 601 Subpart H (i.e., the Animal Rule) protocols; and experience conducting the following types of research and development studies: efficacy studies, genetic and reproduction toxicology studies, short-term and long-term toxicology studies, range- finding toxicology, toxicokinetic/pharmacokinetic studies, absorption, distribution, metabolism and excretion (ADME) studies, safety pharmacology analysis, and mechanism of action studies. The Offeror shall clearly demonstrate that it has the personnel and corporate knowledge to meet or exceed the requirements of this solicitation, including demonstration of a clear working knowledge of procedures related to FDA clinical development, successful completion of an FDA-compliant clinical study, document management, safety reporting, and other procedures completed in support of an IND application. The Offeror shall describe its capability and experience in working with drugs designed to mitigate the effects of hemorrhage and prevent or reduce the onset of hemorrhagic shock. Offerors shall describe the conduct of studies in accordance with FDA Good Laboratory Practice (GLP) guidelines.

L.8.4 The Offeror shall provide resumes of key personnel. The resumes should, at a minimum, discuss each person’s education/certifications and work experience relevant to the tasks identified in the SOW in a clear and relevant manner. Offerors shall provide information related to their retention plans for key personnel and shall address continuity of key personnel qualifications throughout contract performance. Examples may include but are not limited to information on whetehr the Offeror has more than one qualified person employed or detailed information regarding a plant to cross-train key personnel.

L.8.5 The Offeror shall provide an approach to communicate effectively between the Offeror and the Government. The Offeror shall identify a reporting cycle to include timelines for all required written deliverables and shall identify primary and secondary leads for documentation for all identified deliverables.

L.9 FACTOR II – PAST PERFORMANCE: IAW FAR 15.305(2)(iv), Offerors without a record of relevant past performance or for whom past performance is not available; the offeror may not be evaluated favorably or unfavorably.

L.9.1 Offerors shall submit a list of up to five (5) Government contracts (prime and major sub-contracts) performed or awarded during the past three years, which are relevant to the efforts required by this solicitation. Past performance of proposed major subcontractors may also be provided if it is relevant.

This volume shall be organized into the following sections:

L.9.1.1 Section A - Contract Descriptions: For each Government contract identified in this section include the following information:

L.9.1.1.1 Contractor/Subcontractor place of performance, CAGE Code and DUNS Number. If the work was performed as a subcontractor, also provide the name of the prime contractor and Point of Contact (POC) within the prime contractor organization (name, and current address, e-mail address, and telephone and fax numbers).

L.9.1.1.2 Government contracting activity, current address, Procuring Contracting Officer's name, email address, telephone and fax numbers.

L.9.1.1.3 Government’s technical representative/COR, current e-mail address, telephone and fax numbers.

L.9.1.1.4 Government contract administration activity, the Administrative Contracting Officer's name, current e-mail address, telephone and fax numbers.

L.9.1.1.5 Contract Number (in the case of Indefinite Delivery type contracts, GSA contracts, and Blanket Purchase Agreements, include Delivery/Task Order Numbers).

L.9.1.1.6 Contract Type (specified type, such as Fixed Price (FP), Cost Reimbursement (CR), Time & Materials (T&M), etc.) In the case of Indefinite Delivery contracts, indicate specific type (Requirements, Definite Quantity, or Indefinite Quantity) and secondary contract type (FP, CR, T&M, etc.).

L.9.1.1.7 Award contract price.

L.9.1.1.8 Final or projected final price.

L.9.1.1.9 Original delivery schedule, including dates of start and completion of work.

L.9.1.1.10 Final or projected final, delivery schedule, including dates of start and completion of work.

L.9.1.2 Section B – Performance: Offerors shall provide a narrative explanation of each contract listed in Section A. This narrative shall describe the objectives achieved and detail how the effort is relevant to the requirements of this solicitation. Offerors shall include all performance aspects of schedule, performance and supportability, including the offeror’s record of: 1) conforming to contract specifications to include the timely supply of personnel resources; 2) maintaining program execution within proposed Price; 3) adherence to contract schedules; 4) ability to resolve technical problems quickly and effectively; 5) professional concern for the interest of its customers; and 6) establishing and maintaining adequate management of subcontractors.

L.9.1.2.1 For any contracts that did not/do not meet original schedule or technical performance requirements, offerors are to provide a brief explanation of the reason(s) for the shortcomings and any corrective action(s) taken to avoid recurrence. Offerors shall list each time the delivery schedule was revised and provide an explanation of why the revision was necessary. Also, the offerors shall provide a copy of any Cure Notice or Show Cause Letter received on each contract listed and a description of any corrective action implemented by the offeror or proposed subcontractor. Additionally, the offerors shall indicate if any of the contracts listed were terminated and the type and reasons for the termination.

L.9.1.2.2 Additional past performance information may be obtained, at the discretion of the Contracting Officer, from any other sources available to the Government, to include, but not limited to, the Past Performance Information Retrieval System (PPIRS), Federal Awardee Performance and Integrity Information System (FAPIIS), Electronic Subcontract Reporting System (eSRS), or other databases; interviews with Program Managers, Contracting Officers and Fee Determining Officials; and the Defense Contract Management Agency (DCMA).

L.10 FACTOR III – CONTRACT COST:

L.10.1 General Information

L.10.1.1 Certified cost or pricing data are not required as a result of this solicitation. (“Cost or pricing data” are data requiring certification IAW 15.406-2. “Cost or pricing data” are factual, not judgmental, and are verifiable). These instructions are to assist you in submitting information other than cost or pricing data that is required to evaluate the reasonableness of your proposed cost/price. Compliance with these instructions is mandatory and failure to comply may result in rejection of your proposal. Note that unrealistically low or high proposed costs or prices, initially or subsequently, may be grounds for eliminating a proposal from competition either on the basis that the Offeror does not understand the requirement or has made an unrealistic proposal. Proposals should be sufficiently detailed to demonstrate their reasonableness. The burden of proof for credibility of proposed costs/prices rests with the Offeror.

IAW FAR 15.403-1(b) and 15.403-3(a), information other than cost or pricing data is required to support price reasonableness. Information shall be provided IAW FAR 15.403-5. If, after receipt of proposals, the Contracting Officer determines that there is insufficient information available to determine price reasonableness and none of the exceptions in FAR 15.403-1 apply, the Offeror shall be required to submit cost or pricing data.

L.10.1.2 The Cost/Price Proposal shall be an integrated and comprehensive estimate with descriptions of estimating techniques and allocation methods that correlate in sufficient depth with the SOW and CLINs when applicable. Estimating technique(s) used to create the proposal shall be clearly identified. When responding to the Cost/Price Proposal requirements in the solicitation, the Offeror and associated Subcontractors may use any generally accepted estimating technique, including contemporary estimating methods, commercially available parametric cost models, in-house developed parametric cost models, etc., to develop their estimates.

L.10.1.3 The Cost/Price Proposal shall be prepared in the Offeror’s format addressing the areas identified below, with a summary of each individual cost element and a total proposed cost. A template for use of the cost element summary is provided in Section J, Attachment 0002. The summary cost proposal shall be adequately supported in a clear and rationale approach.

L.10.1.4 The Cost/Price Proposal shall include any necessary equipment to be purchased/leased or minor facility modifications necessary to execute the proposed efforts.

L.10.2 Cost Elements

L.10.2.1 The Offeror shall address the following cost elements in sufficient detail to demonstrate reasonableness of the proposed costs.

L.10.2.1.1 Direct Labor. Provide estimated hours to complete the requirement by labor category and fully burdened labor rate. Explain the method used to determine the estimated hours necessary for each effort.

Indicate if the proposed loaded rates are based on actual or projected rates for current employees. Indicate the escalation factor used and first month(s) for each Government fiscal year that the escalation factor is applied.

Level of effort activities shall be expressed in man-hours. Define the number of man-hours that equal a man-year. Total labor costs/hours should track to summary spreadsheet. Add columns for additional years as required.

L.10.2.1.2 Subcontractor and Consultant Costs. “Subcontractor” means any supplier, distributor, vendor, or firm that furnishes supplies or services to or for a prime contractor or another subcontractor. Provide a complete description of all Subcontractor costs, including any Teaming Arrangements/Agreements. Submit proposals for major Subcontractors, which are those with subcontract values exceeding $250,000 (“Major Subcontractors”). Total subcontractor costs should track to the summary spreadsheet. The Offeror shall provide the basis of selection of the subcontractor and their analysis conducted to determine price reasonableness and the steps planned for compliance with the Competition in Subcontracting clause (FAR 52.244-5 ). Numerous sources of these potential subcontract functions are or may become available for competition. Offerors shall include Subcontractor letters of commitment.

Offers shall justify the requirement for consultant services. List proposed Consultants by name, if known.