W81XWH19R0033_RFP_CPP_28June2019.pdf

CODE

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until 10:00 AM local time 29 Jul 2019

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51 - 60 H 61 - 67 douglas.a.medcalf.civ@mail.mil

RATING PAGE OF PAGES

7. ISSUED BY

(Date)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

Previous Edition is Unusable 33-134 STANDARD FORM 33 (REV. 9-97)

Prescribed by GSA FAR (48 CFR) 53.214(c)

1 67

(If other than Item 7)

15A. NAME 16. NAME AND TITLE OF PERSON AUTHORIZED TO

AND

ADDRESS

SIGN OFFER (Type or print)

OF

OFFEROR

AMENDMENT NO. DATE

15B. TELEPHONE NO (Include area code) 17. SIGNATURE15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

18. OFFER DATE

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

2. CONTRACT NO.

W81XWH 8. ADDRESS OFFER TO

See Item 7

9. Sealed offers in original and 1 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and electronic copies only conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME (NO COLLECT CALLS)

DOUGLAS A. MEDCALF, JR. (301) 619-2394

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

2 - 5

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT X

PACKAGING AND MARKING

6 - 17 J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

19 - 23

X K

REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA 24 - 26 X

SPECIAL CONTRACT REQUIREMENTS

OFFER (Must be fully completed by offeror) X M

L INSTRS., CONDS., AND NOTICES TO OFFERORS

EVALUATION FACTORS FOR AWARD

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments

AMENDMENT NO. DATE

to the SOLICITATION for offerors and related documents numbered and dated):

FACILITY

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period

SOLICITATION, OFFER AND AWARD

X

(X) SEC. DESCRIPTION (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE

26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE

EMAIL:TEL: (Signature of Contracting Officer)

CODE CODE

B. TELEPHONE (Include area code) C. E-MAIL ADDRESS

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) (4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

PART IV - REPRESENTATIONS AND INSTRUCTIONS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

27 - 40

PART II - CONTRACT CLAUSES

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

FAX:

TEL:

FAX:

TEL:

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

6. REQUISITION/PURCHASE NO.5. DATE ISSUED

28 Jun 2019

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

W81XWH19R0033

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Job Phase II Clinical Trial

CPFF

FOB: Destination

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

0002 1 Job Contractor Manpower Reporting

FFP

NET AMT

0003 1 Job OPTION Phase III Clinical Trial

CPFF

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

0004 1 Job OPTION Contractor Manpower Reporting

0005 1 Job CDRL A001 - CPP Technical Documents

0006 1 Job CDRL A002 - Technical Data Package

0007 500 Unit

OPTION LRIP 1

FFP

The Contractor shall supply the Government 500 units of Cryopreserved Platelets in accordance with the contract terms and conditions. This CLIN may only be exercised after FDA licensure.

0008 1 Job OPTION Contractor Manpower Reporting

0009 500 Unit

OPTION LRIP 2

FFP

The Contractor shall supply the Government 500 units of Cryopreserved Platelets in accordance with the contract terms and conditions. This CLIN may only be

0010 1 Job OPTION Contractor Manpower Reporting

0011 500 Unit

OPTION LRIP 3

FFP

The Contractor shall supply the Government 500 units of Cryopreserved Platelets in accordance with the contract terms and conditions. This CLIN may only be

0012 1 Job OPTION Contractor Manpower Reporting

Section C - Descriptions and Specifications

CPARS

CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS)

A CPARS assesses a contractor's performance and provides a record, both positive and negative, on a given contractor during a specific period of time. Each assessment is based on objective facts and supported by program and contract management data, such as cost performance reports, customer comments, quality reviews, technical interchange meetings, financial solvency assessments, construction/production management reviews, contractor operations reviews, functional performance evaluations, and earned contract incentives. Performance evaluations are transmitted into the Past Performance Information Retrieval System (PPIRS) which is used by government agencies to assess contractor past performance for future acquisitions. The contractor shall appoint a Contractor Representative (CR) and provide this information to the KO (KO) within 10 calendar days of award. The contractor POC shall have the authority to comment on the CPAR assessment on behalf of their company and within the timeframes established.

A CPARS assessment must be completed within 120 calendar days after the evaluation. Evaluations are sent to PPIRS within 14 calendar days after the government Assessing Official (AO) has submitted the rating. If the CR has not concurred/non- concurred with the rating; PPIRS will show the government evaluation as “Contractor Comment Pending Review”. The CR has a total of 60 calendar days to concur/non- concur with the assessment.

After 60 days, the CR can either concur/non-cur. The CR has the authority to: access the Government evaluation;

review/comment/concur or non-concur with the assessment within 60 calendar days after notification of the government’s assessment. The CR has the right to request a meeting (in writing) with the government within 7 calendar days of notification of an assessment. Once the government and the CR complete the evaluation; an automatic update will be sent to PPIRS and visible for Source Selection. If the CR fails to respond within 60 days, the assessment will be finalized. Training for CPARS can be found on the CPARS website:

https://www.cpars.gov/index.htm.

To access CPARS, the contractor must have a Public Key Infrastructure (PKI). It is suggested an ECA certificate of Medium Assurance should be purchased. This should be a Department of Defense identity certificate, not an e-mail certificate.

(End of Requirement)

CONTRACTOR MANPOWER REPORTING

CONTRACTOR MANPOWER REPORTING (CMR)

The contractor shall report ALL contractor labor hours (including subcontractor labor) required for performance of services provided under this contract for the U.S. Army Medical Materiel Development Activity via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: www.ecmra.mil. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013.

The four Service components user accounts and system data were merged and transferred to the new consolidated Enterprise Contractor Manpower Reporting Application (ECMRA) effective 1 October 2017 at www.ecmra.mil .

Contractors may direct questions to the new ECMRA Support Desk at dod.ecmra.support.desk@mail.mil or obtain detailed instructions from the CMR Contractor Manpower Reporting User Guide available on the new eCMRA website www.ecmra.mil.

The Order Data tab on the CMRA Contractor Data Entry website will ask for the “Requiring Activity Unit Identification Code” (UIC). This is the UIC of the USAMRMC or other USAMRAA Supported activity or organization (such as DHS), the Requiring Activity that would be performing the mission if not for the contractor.

This is not necessarily the Contracting Office, Contracting Administrative Office, or Funding Source. The UIC is not the same as the Department of Defense Activity Address Code (DODAAC).

The UIC of the Requiring Activity for this contract is W4QFAA.

(End of Instruction)

KEY PERSONNEL

KEY PERSONNEL

a. Solicitation Requirement:

(1) The Government has identified the following positions to be filled by Key Personnel. The offeror may propose alternate and/or additional positions as Key personnel.

Position Titles:

Program Manager Regulatory Affairs Manager Clinical Research Manager Manufacturing Operations Manager Blood Research Subject Matter Expert

(2) For all Key Personnel positions, provide an attachment naming the individuals proposed to fill Key Personnel positions along with a description of the portion of the solicitation’s Performance Work Statement that each individual is being proposed to perform.

(3) A resume is required for all individuals proposed to fill Key Personnel positions. Do not submit resumes for all labor proposed, only for those Key Personnel identified above. A signed a letter of intent is required for those individuals proposed as Key Personnel who are not current employees of the prime contractor responding to this requirement. This includes letters of intent for key personnel proposed by subcontractors, teaming partners and consultants. A letter of intent is not required for individuals proposed as key personnel who are current employees of the prime contractor.

(4) The resumes must provide thorough and detailed documentation of the experience, abilities, and background for proposed Key Personnel or equivalent statements of qualifications. Such documentation shall include but not be limited to: name, curriculum vitae, type and description of experience.

b. Contract Requirement:

(1) The following positions have been identified to be filled by Key Personnel proposed for this award.

Position Title: _________________________________

(2) The approved Personnel identified to fill the Key Personnel positions shall be utilized as necessary to fulfill the requirements of this contract.

(3) The contractor agrees that during the contract performance period substitution for Key Personnel shall not be permitted unless such substitution is necessitated by sudden illness, death, or change in employment conditions (e.g.

termination, change in position, etc.). In any of these events, the contractor shall promptly notify the KO in writing and provide the information required by paragraph 5 below.

(4) All requests for substitutions must provide a detailed explanation of the circumstances necessitating the proposed substitution(s), a complete resume for the proposed substitute(s), and any other information requested by the KO needed to approve or disapprove the proposed substitution(s). Any proposed substitute or replacement key personnel shall have qualifications comparable to the individual being replaced, taking into account the requirements of the PWS. The KO or his authorized representative will evaluate such requests and promptly notify the contractor of his approval or disapproval thereof.

(5) If any of the listed Key Personnel are subcontractor personnel, the contractor shall flow down the substance of this instruction in any subcontract which is awarded in support of this contract.

CONFLICTS OF INTEREST

ORGANIZATIONAL AND CONSULTANT CONFLICTS OF INTEREST (OCI)

The FAR Part 9.5 prescribes responsibilities, general rules, and procedures for identifying, evaluating, and resolving Organizational Conflict of Interest (OCI), provides examples to assist Contracting Officers in applying these rules and procedures to individual contracting situations; and implements section 8141 of the 1989 Department of Defense Appropriation Act. The two (2) underlying principles which the FAR seeks to avoid are preventing the existence of conflicting roles that might bias a Contractor's judgment and preventing unfair competitive advantage.

An unfair competitive advantage exists where a Contractor competing for award of any Federal contract possesses --

(1) Proprietary information that was obtained from a Government official without proper authorization; or

(2) Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that Contractor in obtaining the contract.

The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

It is the Contractor’s responsibility to notify the Contracting Officer of any potential OCI. In the event that an OCI exists the Contractor shall propose a Mitigation Plan that shall be reviewed and accepted by the Contracting Officer prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the Contracting Officer, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

Contractors shall sign a Non-Disclosure Agreement (Attachment XX) at the start of their performance on the contract.

If, under this contract, the Contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the Contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

If, under this contract, the Contractor will prepare and furnish complete specifications covering non-developmental items, to be used in a competitive acquisition, the Contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer. This rule shall not apply to Contractors who furnish specifications or data at Government request or to situations in which Contractors act as Government representatives to help Government agencies prepare, refine or coordinate specifications, provided this assistance is supervised and controlled by Government representatives.

If, under this contract, the Contractor will prepare or assist in preparing a work statement to be used in competitively acquiring a system or services, the Contractor shall not supply the system, its major components, or the service unless the Contractor is the sole source, the Contractor has participated in the development and design work, or more than one Contractor has been involved in preparing the work statement. The term of this prohibition shall endure for the length of this contract.

If, under this contract, the Contractor will provide technical evaluation of products or advisory and assistance services, the Contractor shall not provide such services if the services relate to the Contractor's own or a competitor's products or services unless proper safeguards are established to ensure objectivity.

If, under this contract, the Contractor gains access to proprietary or source selection information of other companies in performing advisory assistance services for the Government, the Contractor agrees to protect this information from unauthorized use or disclosure and to refrain from using the information for any purpose other than that for which it was furnished. A separate agreement shall be entered into between the Contractor and the company whose proprietary information is the subject of this restriction. A copy of this agreement shall be provided to the Contracting Officer.

The Contracting Officer has significant discretion as to the acceptability of any mitigation plan offered.

Contractors are encouraged to present their best strategy for mitigation of any potential OCI under this contract.

Contractors shall submit a mitigation plan at the Contract level and update it as often as necessary throughout the life of the Contract.

The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan, in accordance with the requirements of FAR Subpart 9.5 (Organizational Conflict of Interest) to determine whether award to that Offeror would be consistent with those requirements and review as necessary throughout the life of the contract. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Avoidance or Mitigation Plan adequately protects the interests of the government in the event of award to that Offeror, the Offeror will be determined eligible for award. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or avoidance/mitigation plan, or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

If the Offeror/Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI status and submit the certification with its proposal and any later award, if awarded the contract. The Contractor shall also obtain a similar certification of OCI status from all sub-Contractors, teaming partners or consultants prior to tasking any such party under this contract.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

Prior to a contract modification involving a change to the Performance Work Statement, or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable organizational conflict of interest disclosure or an update of the previously submitted disclosure or representation.

REGULATORY RIGHTS

REGULATORY RIGHTS IN EVENT OF PRODUCT DEVELOPMENT FAILURES

This contract includes research with an investigational drug, biologic or medical device that is regulated by the U.S.

Food and Drug Administration (FDA) and requires FDA pre-market approval or clearance before commercial marketing may begin. It is expected that this contract will result in the FDA clearance and commercialization of Cryopreserved Platelets. The Contractor is the sponsor of the Regulatory Application (an investigational new drug application (IND), investigational device exemption (IDE), new drug application (NDA), biologics license application (BLA), premarket approval application (PMA), or 510(k) pre-market notification filing (510(k)) or another regulatory filing submitted to FDA) that controls the research under this contract. As the sponsor of the Regulatory Application to FDA (as the terms “sponsor” and “applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20), the Contractor has certain standing before the FDA that entitles it to exclusive communications related to the Regulatory Application. This provision protects the return on research and development investment made by the Army Medical Research and Materiel Command (USAMRMC) in the event of certain regulatory product development failures related to the Technology.

The Contractor agrees to the following:

a. Contractor will, within three (3) business days of receipt, provide USAMRMC with all communications and summaries thereof, both formal and informal, to or from FDA regarding the Technology and ensure that USAMRMC representatives are given advance notice of and are invited to participate with at least two (2) representatives in any formal or informal sponsor meetings with the FDA;

b. If contract is to be terminated or is about to expire prior to the time the Contractor obtains FDA approval or clearance; or the Contractor fails to commercially market the regulated technology within three (3) years after the FDA issues approval or clearance, the Contractor, upon the request of the Government:

(1) shall transfer possession, ownership and sponsorship or holder ship of any Regulatory Application (including any associated expedited review designation, priority review voucher, or marketing exclusivity eligibility or award), regulatory correspondence, and supporting regulatory information related to the Technology to USAMRMC or its designee;

(2) shall inform FDA of the transfer of sponsorship or holder ship of the Regulatory Application transferred under section (c)(i) above.

(a) The terms of this provision and its derivative obligations:

(i) will be included in any license, sale or transfer by the Contractor to a third party of any intellectual property covered by section (b) above;

(ii) will survive the acquisition or merger of the Contractor by or with any third party;

(iii) will be included in any subcontracts relating to the development of the Technology;

(iv) will survive the expiration of this contract.

REPORTS, MANUSCRIPTS, RELEASES

REPORTS, MANUSCRIPTS AND PUBLIC RELEASES

a. Contractors are encouraged to publish results of research supported by the US Army Medical Research and Materiel Command (USAMRMC) in appropriate media forum. Any publication, report or public release, which may create a statutory bar to the issuance of a patent on any subject invention, shall be coordinated with appropriate patent counsel.

b. Manuscripts intended for publication in any media shall be submitted to the KO and KO's Representative (COR), simultaneously with submission for publication. Review of such manuscripts is for comment to the Principal Investigator, not for approval or disapproval. Courtesy copies of the reprint shall be forwarded to the KO and COR, even though publication may be subsequent to the expiration of the contract.

c. The Contractor shall notify the KO of planned news releases, planned publicity and advertising material concerning contract work, and planned presentations to scientific meetings, prior to public release. This is not intended to restrict dissemination of research information but to allow USAMRMC advance notice in order to adequately respond to inquiries.

d. Manuscripts, reports, public releases and abstracts, which appear in professional journals, media and programs, shall include the following statements:

(l) “This work is supported by the US Army Medical Research and Materiel Command under Contract No.

TBD.”

(2) "The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation."

(3) As applicable, if the research involves the use of animals, the Contractor must include the following statement: “In conducting research using animals, the investigator(s) adhered to the Animal Welfare Act Regulations and other Federal statutes relating to animals and experiments involving animals and the principles set forth in the current version of the Guide for Care and Use of Laboratory Animals, National Research Council.”

(4) As applicable, if the research involves the use of recombinant DNA, the Contractor must include the following statement: “In conducting work involving the use of recombinant DNA the investigator(s) adhered to the current version of the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules.”

e. Contractors are encouraged to publish results of research supported by the US Army Medical Research and Materiel Command (USAMRMC) in appropriate media forum. Any publication, report or public release, which may create a statutory bar to the issuance of a patent on any subject invention, shall be coordinated with appropriate patent counsel.

f. Manuscripts intended for publication in any media shall be submitted to the KO and KO's Representative (COR), simultaneously with submission for publication. Review of such manuscripts is for comment to the Principal Investigator, not for approval or disapproval. Courtesy copies of the reprint shall be forwarded to the KO and COR, even though publication may be subsequent to the expiration of the contract.

g. The Contractor shall notify the KO of planned news releases, planned publicity and advertising material concerning contract work, and planned presentations to scientific meetings, prior to public release. This is not intended to restrict dissemination of research information but to allow USAMRMC advance notice in order to adequately respond to inquiries.

TECHNICAL REFERENCE FACILITY

USE OF TECHNICAL REFERENCE FACILITY

To the extent practical the Contractor shall utilize the technical reference facilities of the Defense Technical Information Center (DTIC) for the purpose of surveying existing knowledge and avoiding needless duplication of scientific and engineering effort and the expenditure thereby represented. The DTIC headquarters office is located at 8725 John J. Kingman Road, Fort Belvoir, VA 22060-6218. Information can also be obtained via the Internet at http://www.dtic.mil or via the toll-free number for the DTIC help desk, 1-800-225-3842. To the extent practical, all other sources, whether or not Government controlled, should be consulted for the same purpose.

RESEARCH INVOLVING HUMANS

RESEARCH INVOLVING HUMAN ANATOMICAL SUBSTANCES, HUMAN SUBJECTS, OR HUMAN

CADAVERS

READ FURTHER FOR DETAILS

All DoD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO), prior to research implementation. This administrative review requirement is in addition to the local Institutional Review Board (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Additional time for regulatory reviews may be needed for clinical studies taking place in international settings. When possible, protocols should be written for research with human subjects and/or human anatomical substances that are specific to the DoD-supported effort outlined in the submitted application as a stand-alone study. Submission to HRPO of protocols involving more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol (DoD and non-DoD funded). DoD human subjects protection requirements may be applied to non-DoD funded work and necessitate extensive revisions to the protocol. Refer to the General Application Instructions, Appendix 1, and the Human Subject Resource Document available on the electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information.

A clinical trial is defined as a prospective accrual of patients (human subjects) in whom an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the subject of that intervention or interaction.

RESEARCH INVOLVING ANIMALS

RESEARCH INVOLVING ANIMALS

READ FURTHER FOR DETAILS

All DoD-funded research involving new and ongoing research with animals must be reviewed and approved by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP) Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Specific documents relating to the use of animals in the proposed research will be requested if the application is selected for funding. The ACURO must review and approve all animal use prior to the start of working with animals, including amendments to ongoing projects. PIs must submit the institutional animal use protocol, IACUC approval of that protocol, and a version of the animal use appendix titled, “Research Involving Animals.” Allow at least 2 to 3 months for ACURO regulatory review and approval processes for animal studies.

STATEMENT OF OBJECTIVES

Title: Cryopreserved Platelet (CPP) Development for US FDA Licensure

Requiring Activity/Agency Name: U.S. Army Medical Materiel Development Activity (USAMMDA)

Program Name: Cryopreserved Platelet (CPP)

1. PURPOSE/OBJECTIVE

Work under this SOO is intended to result in a single award, Research and Development (R&D) contract for the purpose of conducting all activities necessary to successfully develop an U.S. Food and Drug Administration (FDA) licensed dimethyl sulfoxide (DMSO) Cryopreserved Platelets (CPP) product, conforming to the requirements shown in Table 1. Hence forward, this candidate will be referred to as CPP.

Successful development of CPP will enable long-term storage of platelets in the battlefield, sustaining supply and thus enabling field medical personnel to curtail hemorrhage and save the lives of injured Service Members.

Development of CPP is in direct support of the USAMMDA’s line of effort to enhance battlefield management of severe hemorrhage due to combat trauma.

Market research has shown that there will be both a military and civilian market for CPP. Specifically, the market research has shown that the ability to stockpile platelets, which can be used for surgery as well as for trauma and mass casualty situations, will curtail shortages and enable a more dependable supply of platelets in a market that is currently supplied with platelet products that have a shelf life of only a few days.

Program Objective:

The successful Offeror is expected to perform all research, development, manufacturing, and regulatory activities, as necessary, to achieve a U.S. Food and Drug Administration (FDA) licensed dimethyl sulfoxide (DMSO) Cryopreserved Platelet (CPP) product that meets or exceeds U.S. Military requirements (see Table 1) and is commercially sustainable.

2. BACKGROUND

Management of severe hemorrhage in the battlefield/theater requires the contemporaneous replacement of large volumes of blood products, including platelets. Platelets are a normal component of blood and a key initiating factor in hemostasis (blood clotting). Current standard of care in both civilian and military settings consists of walking donor, room-temperature stored (20 - 24C) under gentle agitation, apheresis platelets (i.e., liquid stored platelets), which only have a shelf-life of 5-7 days with decreasing efficacy during this period of storage. Platelet supply in an unsettled military theater of operations is inherently limited due to the inability to store current platelet products for more than 5-7 days. In the event of in-theater trauma, surgical repair of damaged organs and tissues, and/or mass casualty situations, the supply of walking donor apheresis platelets will not meet demand; compromising the ability (and capacity) of U.S. Army field medical teams to curtail bleeding and stabilize patients. Such conditions create a significant constraint to conventional, walking donor platelets due to the inherent shelf life limitations.

Additionally, Liquid Stored Platelets are available only via walking donor; i.e., they cannot be shipped due to their short shelf-life.

Leading technology candidate:

The Government has conducted extensive analysis of alternatives and has determined that the leading candidate for a long-term stored platelet product, by virtue of technological maturity and risk, is DMSO CPP. CPP is a frozen platelet product (regulated as a biologic by the U.S. FDA) composed of γ-irradiated [2500 centi-gray (cGy)] leukocyte reduced apheresis platelets stored in plasma and anticoagulant citrate dextrose solution A (for up to 57 hours after apheresis), concentrated, and frozen in approximately 6% DMSO at -80°C and stored at ≤ -65°C.

The Government has developed CPP through a Phase 1 dose escalation study. All data to date with the current product development effort will be available to the successful Offeror. A developmental summary and Investigators Brochure is provided in Appendix A. Offerors are expected to leverage past Government effort to the greatest degree possible in order to achieve the program objective in the shortest amount of time possible.

Table 1: CPP Product Specifications [Threshold = minimum acceptance level; Objective = desired level]

Parameter Threshold (T) Objective (O)

FDA Licensure Approval T = O

Efficacy 75% as efficacious as liquid-stored platelets

99% as efficacious as liquid-stored platelets

Duration of Presence in Blood

Recovery greater than 50% of fresh platelets with 1 day survival

Recovery of greater than 50% of fresh platelets with 7 day survival

Storage Temperature ≤ -65˚C ≤ -30˚C

Shelf-Life Greater than 1 year when stored at ≤ -65°C

Greater than 1 year when stored at ≤ - 30˚C [Note: achievement of this objective will enable storage in existing equipment]

Preparation Time Ready to use in 30 minutes or less

Ready to use in 10 minutes or less

Universality 25% of product must be transfusable to all patients (universal donor)

100% of product must be transfusable to all patients

3. SCOPE OF EFFORT

The objective of this program is to achieve an FDA licensed, commercially viable CPP product. As such, Offerors are expected to conduct all development, test and evaluation, manufacturing, and regulatory activities to achieve a FDA-licensed CPP product that is suitable for both civilian and military use. In doing so, Offerors are urged to explore development strategies that will enable rapid licensure and availability of CPP. As such, viable incremental development strategies should be presented. Anticipated activities include (but are not limited to):

1) Design and development of a CPP manufacturing process that is compliant with FDA regulations and applicable guidance for current good manufacturing practices; to include manufacture of products as necessary, to complete the objective.

2) Design, development, and validation of processes (inclusive of any necessary materials, equipment, and tests/assays) to enable storage and shipment of CPP for U.S. Military use.

3) Performance of all necessary non-clinical (in-vitro) studies and clinical trials (conducted in accordance with Good Clinical Practices).

4) Sponsorship and execution of all activities commensurate with serving as the Investigational New Drug (IND) application # 14047 holder and regulatory sponsor in accordance with 21 Code of Federal Regulations 312 subpart D, including all regulatory submissions and continuation through submission of the Biological License Application.

5) Development and maintenance of various management, risk, project, and quality plans/reports (as necessary) to provide documented evidence that the development effort is being effectively managed in accordance with the risk profile.

6) Optional Task: Low Rate Initial Production (LRIP): Production and shipment of licensed CPP (shelf-life to be determined) for U.S. Army LRIP. The Offeror shall produce, release, and ship to the Government three separate lots of CPP. The total LRIP requirement will be 1500 units broken down into three (3) one-year options of 500 units per year. The prices will be re-negotiated at time of the award of the optional tasks. The prices shall not exceed the estimated prices established at time of the original award of the contract.

Note: Government experience thus far has shown that the CPP product will be regulated by the U.S. FDA as a Biologic product, but the product is manufactured according to blood establishment regulations.

4. PLACE AND DELIVERY SCHEDULE

The final product (FDA approved CPP) is estimated be delivered in no longer than 5 years (7 Years if a Phase 3 Clinical Trial is required). Offerors are expected to leverage past Government effort to the greatest degree possible in order to achieve the program objective in the shortest amount of time possible.

Upon FDA approval of the CPP, 500 units will be provided to the Government each year for up to three (3) years.

Place of Performance is anticipated to be within the Continental United States. However, the Offeror is to determine the place of performance and present within their proposal and Statement of Work.

5. CONSTRAINTS

Non-Disclosure/Non-Use Agreement: The Contractor shall sign and submit a Non-Disclosure Statement (Attachment 4) on behalf of the company, and shall also ensure that all staff assigned to, including all subcontractors and consultants, or performing on this task order execute and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other contractors. Assignment of staff who have not executed this statement or failure to adhere to this statement may constitute default on the part of the Contractor.

Offerors should take note of the following materials and information that will be provided by the Government. Items 1-3 will be provided to the successful Offeror as part of the contract award and Items 4-8 will be provided as attachments to this RFP for the purpose of proposal preparation:

GOVERNMENT FURNISHED INFORMATION (GFI) TABLE AND OTHER TRANSFERRED ITEMS

Item Number

Originator Title Description/Contents Label

1 United States Army Medical Research and Development Command

(USAMRDC)

IND #14047 Transfer of the current Office of the Surgeon General held IND

N/A

2 USAMRDC N/A Clinical grade lots of

CPP

N/A

3 Developed under contract W81XWH- 13-C-0167

CPP Mock Shipment Study

Document No. 17MI- 0001.01-SR.01, January

Unlimited Rights

4 USAMRDC CPP

Development Summary

Unclassified

5 USAMRDC Phase 2 clinical protocol

Unclassified

6 Developed under contract W81XWH- 13-C-0167

TMRL 0026 Source Document for Closed System Preparation and Freezing of Apheresis Platelets

Unlimited Rights

7 Developed under contract W81XWH- 13-C-0167

TMRL 805 Current Specifications for Manufacturing of Cryopreserved Platelets

Unlimited Rights

8 Developed under contract W81XWH- 13-C-0167

TMRL 806 Weight of DSMO to add for Freezing Platelets

Unlimited Rights

Notes:

If the contract is to be terminated or is about to expire prior to the time the Contractor obtains FDA approval or clearance; or the Contractor fails to commercially market the regulated technology within three (3) years after the FDA issues approval or clearance, the Contractor, upon the request of the Government, shall transfer back to the Government possession, ownership and sponsorship or holder ship of all items and/or GFI identified in the above table.

6. ACCESS AND COMMUNICATIONS

The Contractor shall allow the Government or its designee, to audit the contractor and/or its subcontractor(s) for regulatory compliance and quality assurance purposes. The Contractor shall allow access to records, files, and other data derived from this work for the purposes of audit by the FDA and/or other Government entities.

Public Law 115-92 was enacted in December 2017, and it gives DoD the ability to work collaboratively with FDA to expedite the review and approval of DoD medical priority products. Please see this website for background on the public law: https://mrdc.amedd.army.mil/index.cfm/about/jag/pl_115-92. The link at the bottom of the page (Public Law 115-92: A New Era of Collaboration between DoD and FDA) may be of particular interest.

In order for DoD and the sponsor of a DoD medical priority product to realize the full benefits of the expedited review and approval process available under the Public Law, the FDA requires sponsors to authorize the FDA to share information concerning DoD priority products with DoD. The form of this authorization is contained as Exhibit B to the DoD-FDA Memorandum of Understanding implementing the public law, available at this link:

https://mrdc.amedd.army.mil/assets/docs/jag/Final_Signed_DoD_FDA_MOU_Implementing_PL_115_92_dated_11 -2-18.pdf. A Word version of the sponsor authorization letter is provided with the RFP. The successful Offeror shall submit an executed authorization letter (Deliverable 10) to the COR NLT 5 business days after contract award.

The authorization letter enables FDA to share information with "DoD Partners" and their "contractors." The term "DoD Partners" is defined by the footnote in the letter, and includes agencies within DoD that are involved with medical research and development. The term "contractors," as used in Section V of the MOU and in the authorization letter, refers to government support personnel that assist DoD military and civilian employees. This authorization letter is not intended to, and does not, authorize the FDA to disclose information to other pharmaceutical or biotech companies that have contracts with DoD.

The authorization letter provides information about how the Government expects to engage with the FDA and the Awardee under Public Law 115-92. To the maximum extent practicable, the Government intends to include the Awardee in any and all Public Law 115-92 discussions with FDA focused on this product; and in fact, it is expected that most (if not all) discussions will include the Awardee, DoD, and the FDA. If the Government has any engagements with FDA where it is not possible to include the Awardee (for example, at a quarterly or semi-annual meeting between FDA and DoD conducted under the Public Law), the Government will provide a summary of the discussion within 10 business days.

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 N/A N/A N/A Government 0002 N/A N/A N/A Government 0003 N/A N/A N/A Government 0004 N/A N/A N/A Government 0005 N/A N/A N/A Government 0006 N/A N/A N/A Government 0007 N/A N/A N/A Government 0008 N/A N/A N/A Government 0009 N/A N/A N/A Government 0010 N/A N/A N/A Government 0011 N/A N/A N/A Government 0012 N/A N/A N/A Government

CLAUSES INCORPORATED BY REFERENCE

52.246-8 Inspection Of Research And Development Cost

Reimbursement

MAY 2001

Section F - Deliveries or Performance

CONTRACT DELIVERABLES

DELIVERABLES/CONTRACT DATA REQUIREMENTS LISTS (CDRLS)

Title: CRYOPRESERVED PLATELET (CPP) DEVELOPEMNT FOR U.S. FOOD AND DRUG

ADMINISTRATION LICENSURE

1.0. General Deliverable Information

Delivery Address: All deliverables shall be submitted to the Contract Officer Representative (COR) designated in the COR appointment letter.

Method of Delivery: Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format) or in Adobe PDF format, unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR.

Shipping: The Contractor shall use appropriate shipping methods for all other materials, equipment, and hard copy documents. In the United States, the contractor shall use the US Postal Service standard delivery for delivery of all such shipments.

Government Acceptance Period: The COR will have ten (10) business days to review draft deliverables and make comments. The Contractor shall have five (5) business days to make corrections. Upon receipt of the final deliverables, the COR will have two (2) business days for final review prior to acceptance or providing documented reasons for non-acceptance. Should the Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten (10) business days the Government notifies the Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in 30 calendar days.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted proposal. In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) business days to correct the rejected deliverable and return it per delivery instructions.

2.0. Deliverable/Delivery Schedule:

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E) unless otherwise stated.

Deliverable/CDRLS Chart

Item Title Distribute To Initial Subsequent Comments

Deliverable

Provide Monthly Task Status Report

COR

NLT 30 calendar days after contract award

NLT 5 business days after months end

None

Deliverable

Spend Plan COR Draft – Due with Proposal Submission

Updated quarterly every three (3) months to show task progress, % completion, and schedule slippage.

None

Deliverable

Project Plan & Integrated Master Schedule

COR

Draft – Due with Proposal Submission

Updated quarterly every three (3) months to show task progress, % completion, and schedule slippage.

None

Deliverable

CDRL

A002

Technical Data Package

COR

NLT three (3) months after FDA licensure or due immediately if the contract is to be terminated or is about to expire prior to the time the Contractor obtains FDA approval or clearance.

As required

None

DI-TCSP-82040

Deliverable

Quality Management Plan

COR

Draft – Due with Proposal Submission

Annually (at minimum) or more frequently if required (ex: new subcontractor).

None

Deliverable

Monthly Meeting Minutes

COR

NLT 5 business days after monthly meeting

NLT 5 business days after monthly meeting

None

Deliverable

Risk Management Plan

COR

NLT 30 calendar days after contract award

Updated quarterly every three (3) months or as needed

None

Deliverable

CDRL

A001

Technical Documents

COR

Draft within 5 business days of Government request.

Final within 5 business days of receiving Government feedback.

None

DI-TCSP-82040

Deliverable

Market Sustainment Plan

COR

Draft – Due with Proposal Submission

Annually (at minimum) or more frequently if required

Deliverable

Model Authorization for FDA To Share Non- Public Information With the Department of Defense

COR

NLT 5 calendar days after contract award

N/A

3.0 Deliverable Descriptions

Deliverable 1: Monthly Task Status Report. The contractor shall submit the report for this requirement to the COR that highlights major events in the reporting period. The report shall include details outlining the expenditures and billings to date, projected expenditures and billings, progress, status, and any problems/issues encountered. The contractor shall require and incorporate input from subcontractors where there are critical or significant tasks related to the task. Critical or significant tasks shall be defined by mutual agreement between the Government and contractor. The format for the report shall be agreed upon by the Government and contractor.

Deliverable 2: Spend Plan. The contractor shall provide a Spend Plan which details how the Offeror expects to incur and invoice for costs against tasks. The Spend Plan shall detail costs to be incurred monthly by fiscal year (1 0ctober – 30 September), starting with the first month of the period of performance. The Spend Plan total shall match with the total costs proposed for the entire task in the Cost/Pricing Sheet. The Spend Plan shall be updated quarterly. The contractor shall report actual progress against the Spend Plan in the Monthly Task Status Report.

Deliverable 3: Project Plan & Integrated Master Schedule (IMS). The Project Plan & IMS shall be submitted with the proposal Statement of Work (SOW) and updated (minimum) quarterly thereafter to show task progress, percent completion, schedule slippage. Prior Government approval is required for any major changes. Any issues and questions shall be discussed with the COR. The Project Plan & IMS shall be structured to correlate with the Statement of Work; it shall contain planned events and milestones, accomplishments, and activities from contract award to the completion of the contract as well planned costs that should correlate with the spend plan (Deliverable #2).