RFP_W81XWH-19-R-0036-0001.pdf

CODE

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until 03:00 PM local time 24 Jun 2019

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79 - 88 H 89 - 96 toloria.s.duvall.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 96

(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 submission only) conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME (NO COLLECT CALLS)

TOLORIA S DUVALL 301-619-2836

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

1 - 2 3 - 6

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT X

PACKAGING AND MARKING

7 - 14 J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

16 - 24

X K

REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA 25 - 27 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

28 - 68

PART II - CONTRACT CLAUSES

USA MED RESEARCH ACQ ACTIVITY

1504 PORTER STREET

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

24 May 2019

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

W81XWH19R0036

Section A - Solicitation/Contract Form

GENERAL INFORMATION

Project Title: Extracorporeal Life Support (ECLS) Reduced Dialysate

This is a Request for Proposal (RFP)/solicitation for a Research & Development (R&D) requirement. This RFP/solicitation is a total 100% small business set-aside.

The Government anticipates that any resulting award from the RFP/solicitation will be a Cost-Plus-Fixed-Fee (CPFF) contract.

The anticipated base period of performance (POP) will be thirty-sixty (36) months.

North American Industry Classification System (NAICS) Code: 541715—Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Product Service Code: AJ53—R&D-General Science/Technology: Life Sciences (Advanced Development)

Points of Contact (POCs): The primary point of contact (POC) for this solicitation is Toloria DuVall, Contract Specialist, toloria.s.duvall.civ@mail.mil. The alternate POC for this solicitation is Monica Ven Douern, Procurement Technician, monica.c.vendouern.civ@mail.mil. All inquiries regarding this requirement must be submitted via electronic mail (e-mail) to the Contract Specialist. Please carbon copy (cc) the Procurement Technician on all correspondence.

Solicitation Questions: Questions concerning this solicitation shall be submitted in writing to the primary POC (cc the alternate POC) via e-mail no later than 03 June 2019 at 8:00 AM Eastern Time. The e-mail must have a subject title of “W81XWH-19-R-0036 Solicitation Questions”. Any questions submitted after this date and time will not be accepted or answered. Answers to Contractor submitted questions will be provided to all Offerors through a solicitation amendment. Telephone inquiries will NOT be accepted at any time.

Proposal Submission: Proposals shall only be electronically submitted to the primary POC via e-mail. The e-mail must have a subject title of “W81XWH-19-R-0036 Proposal Submission”. The Offeror is responsible for verifying receipt by the POC. One electronic copy shall be submitted for each proposal volume. Each proposal volume should be a separate attachment.

Proposal Due Date: No later than 24 June 2019 at 3:00 PM Eastern Time. Any proposals received after this date and time may not be considered for evaluation. Offeror proposals shall remain open for a minimum of 150 calendar days from the date of submission.

Alternate Proposals: Only one proposal from each Offeror will be evaluated by the Government.

The Government anticipates that this solicitation will result in one (1) contract award.

This invitation to submit a proposal does not assure that a contract will be awarded.

The Offeror’s proposal will be incorporated by reference into a resulting contract. The Offeror’s Statement of Work (SOW) will be incorporated in full text into any resulting contract.

(End of general information)

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Job ECLS Device Development

CPFF

The Contractor shall develop a small, lightweight, rugged Extracorporeal Life Support device that provides renal support to critically injured patients in accordance with the Government's Statement of Objectives (SOO) and the Contractor's Statement of Work (SOW).

FOB: Destination

PSC CD: AJ53

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

0002 1 Job Exhibit A, Data Item No. A001

COST

Contract Data Requirements List (CDRL), Exhibit A, Data Item No. A001, FDA Interactions.

0003 1 Job Exhibit B, Data Item No. A002

COST

Contract Data Requirements List (CDRL), Exhibit B, Data Item No. A002, Product Development Planning Documents.

0004 1 Job Exhibit C, Data Item No. A003

COST

Contract Data Requirements List (CDRL), Exhibit C, Data Item No. A003, Pre-clinical Testing and Trials Data.

0005 1 Job Exhibit D, Data Item No. A004

COST

Contract Data Requirements List (CDRL), Exhibit D, Data Item No. A004, Clinical Trials Data.

0006 1 Job Exhibit E, Data Item No. A005

COST

Contract Data Requirements List (CDRL), Exhibit E, Data Item No. A005, Manufacturing Data.

0007 1 Job Exhibit F, Data Item No. A006

COST

Contract Data Requirements List (CDRL), Exhibit F, Data Item No. A006, System Engineering Data.

0008 1 Job Exhibit G, Data Item No. A007

COST

Contract Data Requirements List (CDRL), Exhibit G, Data Item No. A007, Quality Assurance Data.

0009 1 Job Exhibit H, Data Item No. A008

COST

Contract Data Requirements List (CDRL), Exhibit H, Data Item No. A008, Scientific and Technical Reports: Test Reports.

0010 1 Job Contractor Manpower Reporting (CMR)

COST

Contractor shall input information in accordance with requirement "Contractor Manpower Reporting (CMR)" in Section C. If the Offeror proposes CMR as "Not Separately Priced (NSP)" this CLIN will be removed (the contract writing system does not allow NSP or $0.00 CLINs); however the Contractor will still be required to complete and verify CMR.

CMR Due NLT 31 October of each year of contract performance, beginning with 2020.

Section C - Descriptions and Specifications

STATEMENT OF OBJECTIVES (SOO)

Extracorporeal Life Support (ECLS) Reduced Dialysate

1.0 Background and Overview

The US Army Medical Materiel Development Activity’s (USAMMDA’s) mission is to develop and deliver quality medical capabilities to protect, treat, and sustain the health of our Service Members and the Joint Program Committee-6’s (JPC-6’s) mission seeks to drive medical innovation through the development of knowledge and materiel solutions for the acute and early management of combat-related trauma.

Extracorporeal life support (ECLS) is administered to critically ill patients suffering from life-threatening renal injuries. For the purposes of this requirement extracorporeal life support is defined as any system that pulls blood out of the body and performs an action on the blood replacing the function of a critically injured organ. In this sense, it can be applicable to the lungs, heart, kidneys, or liver. This requirement is specifically for reducing dialysate required to run continuous renal replacement therapy (CRRT) for kidney support when treating patients with acute kidney injury (AKI).

Although ECLS is a life-saving intervention, current technology is limited by the immense logistical footprint required to support these devices. Current standard of care ECLS devices that provide support to the kidneys require ~70L of replacement fluid per patient per day. This is an immense logistical burden in the far forward environment where supply lines are limited or non-existent making the support of these devices infeasible. Therefore, the aim of this effort is to reduce the amount of replacement fluid required to support these patients in a logistically constrained environment.

2.0 Scope of Work

2.1 Scope

USAMMDA & JPC-6 anticipate the need for the following activities to be performed during the contract period:

Phase I:

2.1.1 Task #1: Food and Drug Administration (FDA) pre-submission meeting(s).

2.1.2 Task #2 (if required): Risk based assessment of the biocompatibility tests required for Investigational Device Exemption (IDE) acceptance.

2.1.3 Task #3: IDE preparation and submission.

2.1.4 Task #4 (if required): Performance, physical, & chemical property assessments of the device.

2.1.5 Task #5 (if required): Preclinical animal testing: testing ex vivo Good Laboratory Practices (GLP) safety and efficacy testing on uninjured and injured large animals with human like physiology in an Acute Kidney Injury (AKI) model. All testing shall be conducted following approval from an Institutional Animal Care and Use Committee (IACUC) and the US Army Medical Research and Materiel Command’s (USAMRMC’s) Animal Care and Use Review Office (ACURO) (https://mrmc.amedd.army.mil/index.cfm?pageid=Research_Protections.acuro_Animalappendix)

2.1.6 Task #6: Clinical animal testing: testing ex vivo GLP safety and efficacy testing on uninjured and injured large animals with human like physiology in an Acute Kidney Injury (AKI) model. All testing shall be conducted following approval from an IACUC and USAMRMC’s ACURO (https://mrmc.amedd.army.mil/index.cfm?pageid=Research_Protections.acuro_Animalappendix)

Phase II:

2.1.7 Task #1 (if required): Human feasibility studies as required by FDA. The device(s) will demonstrate proof of concept safety and efficacy in sustaining critically ill patients with AKI using less than or equal to 0.5L of replacement fluids per day for a minimum of 72 hours of support. All testing shall be conducted following approval from an Institutional Review Board (IRB) and USAMRMC’s Human Research Protection Office (HRPO) (https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.hrpo)

2.1.8 Task #2: Prototype finalization and lock down based on the Department of Defense (DoD) specifications.

Prototypes must be developed in compliance with Title 21 Code of Federal Regulations Part 820 (21 CFR 820) requirements. Design control and Quality Management System (QMS) documentation shall be available for assessment by the Government.

2.1.9 Task #3: Finalized product design freeze as per 21 CFR 820 compliant QMS.

2.1.10 Task #4: Delivery of two (2) Good Manufacturing Practices (GMP) (ISO 9001 and/or ISO 13485 compliant) representative devices to the Government (including 2 sets of consumables per device) following product design freeze.

2.1.11 Task #5 (if required): Human pivotal study. The device will be demonstrated to be safe and effective in sustaining critically ill patients with AKI using less than or equal to 0.5L of replacement fluids per day for a minimum of 72 hours of support. All testing shall be conducted following approval from an IRB and USAMRMC’s HRPO (https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.hrpo)

2.1.12 Task #6: FDA Submission.

2.1.13 Task #7: Delivery of six (6) FDA market authorized devices to the Government (including 2 sets of consumables per device).

3.0 Product Characteristics

The USAMMDA’s & JPC-6’s objective is to develop a small, lightweight, rugged ECLS device that provides renal support to critically injured patients. The following performance thresholds (minimum acceptable value) and objectives (desired value) have been developed for this requirement. Upon completion of the contract the device must meet the thresholds and will ideally meet the objectives.

Table 1. Product Performance Requirements

Parameter Threshold Objective

Regulatory Status FDA market authorized to provide renal support for treatment of AKI patients T=O

Catheter/Cannula Insertion Lengths

15cm & 24cm 15cm, 24cm, & 50cm

Weight* ≤20lbs ≤10lbs

Power 110/220Volt alternate current (AC) and/or 11-28Volt direct current (DC)

T=O

Battery Type Rechargeable T=O Battery Life 8 Hours 16 Hours

Hot Swappable Battery(ies) Device remains in operation while battery(ies) is/are swapped out T=O

Replacement Fluid ≤3.0L of renal replacement fluid per patient per day ≤0.5L of renal replacement fluid per patient per day

Ruggedization Suitable for military use according to the JECETS** T=O

*The weight requirement includes the device itself and new dialysate reduction technology even if the new technology is a consumable. The weight requirement does not include other standard consumables used for CRRT (e.g. dialysate, dialyzer, tubing, catheters, etc.). In other words, the solution shall not swap out 25lbs.

of dialysate for 25lbs. of a different consumable that is meant to reduce the dialysate.

**Joint Enroute Care Equipment Standard (JECETS) (Solicitation Attachment 1).

4.0 Period of Performance

The period of performance shall be up to 36 months from contract award.

(End of Statement of Objectives)

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 Army 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.

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 asks 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 Requirement)

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:

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

(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.

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 (Solicitation Attachment 6) 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 the Extracorporeal Life Support (ECLS) Reduced Dialysate Device (ECLS Device or the “Technology”). 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.

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

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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.

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 Destination Government Destination Government 0002 Destination Government Destination Government 0003 Destination Government Destination Government 0004 Destination Government Destination Government 0005 Destination Government Destination Government 0006 Destination Government Destination Government 0007 Destination Government Destination Government 0008 Destination Government Destination Government 0009 Destination Government Destination Government 0010 Destination Government Destination Government

CLAUSES INCORPORATED BY REFERENCE

52.246-8 Inspection Of Research And Development Cost

Reimbursement

MAY 2001

Section F - Deliveries or Performance

DELIVERABLES

1.0. General Deliverable Information

Delivery Address: All deliverables shall be submitted to the Contracting Officer’s Representative (COR) and Alternate Contracting Officer’s Representative (ACOR) designated in the COR/ACOR appointment letters.

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/ACOR. Electronic submission shall be made via email, unless otherwise agreed to by the COR/ACOR. This method of delivery also applies to Contract Data Requirement List (CDRL) deliveries.

Shipping: The Contractor shall use appropriate shipping methods for all 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/ACOR 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/ACOR 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 will be deemed approved if the Government has not rejected it in thirty (30) calendar days.

The COR/ACOR 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/ACOR 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:

NOTE: For this requirement “deliver” means that the Government COR/ACOR is in possession of the deliverable.

A summary of deliverables follows. The Contractor shall provide copies to the Government officials indicated in electronic file unless otherwise stated. Contract Data Requirements Lists (CDRL) will be incorporated into the contract in CDRL (DD1423) format. If a deliverable due date falls on Saturday, Sunday, or federal holiday, the Contractor shall submit the deliverable on the next business day.

Deliverable Chart

Item

SOW

Reference Title

Distribute To

Initial Subsequent

Deliverable

TBD Contract Kickoff Meeting Agenda and Minutes

COR/

ACOR/

CS

Meeting conducted NLT fifteen (15) calendar days after contract award.

Agenda provided NLT three (3) business days prior to meeting.

Minutes provided NLT three (3) business days after the meeting.

N/A

Deliverable

TBD

FDA Pre- Submission Package(s)

COR/

ACOR

NLT 45 calendar days after contract award.

NLT ten (10) business days prior to additional meetings requested by the FDA.

Deliverable

TBD

FDA Pre- Submission Meeting Minutes

COR/

ACOR

Meeting conducted NLT 90 calendar days after contract award.

Minutes provided NLT ten (10) calendar days after the meeting.

Additional meetings conducted as needed.

Minutes provided NLT ten (10) calendar days after the meeting.

Deliverable

TBD

Regulatory Strategy & Regulatory Plan

Initial:

CS

Subsequent:

COR/

ACOR

As part of the proposal.

NLT 30 calendar days after contract award; updated as needed but annually (at a minimum) through the end of contract performance.

Deliverable

TBD

Monthly Progress Report

COR/

ACOR

NLT 30 business days after contract award.

NLT the 10th calendar day of every month for the previous month during the period of performance.

SOW

Reference Title

Distribute To

Initial Subsequent

Deliverable

TBD

Biweekly Teleconference Agenda(s) and Minutes

COR/

ACOR

Meeting conducted within five (5) business days after the first monthly report is submitted and/or as requested by the COR/ACOR. Agenda provided NLT one (1) business day prior to teleconference.

Minutes provided NLT three (3) business days after the teleconference.

Meeting conducted within five (5) business days after the monthly reports are submitted and/or as requested by the

COR/ACOR.

Agenda provided NLT one (1) business day prior to teleconference.

Minutes provided NLT three (3) business days after the teleconference.

Deliverable

TBD

FDA Meeting Package Submissions, Communications , Formal Meeting Minutes, and FDA Finalized Meeting Minutes

COR/

ACOR

Meeting package submissions provided NLT ten (10) business days prior to FDA meetings; Copies of all communications NLT five (5) business days after receipt from the FDA; Formal meeting minutes provided NLT nine (9) calendar days after FDA meetings;

FDA finalized meeting minutes NLT five (5) calendar days after receipt from the FDA.

Meeting package submissions, communications, formal meeting minutes, and FDA finalized meeting minutes generated prior to award shall be provided NLT 30 calendar days after contract award.

Meeting package submissions provided NLT ten

(10) business days prior to FDA meetings; Copies of all communications NLT five (5) business days after receipt from the FDA; Formal meeting minutes provided NLT nine

(9) calendar days after FDA meetings;

FDA finalized meeting minutes NLT five (5) calendar days after receipt from the

FDA.

Deliverable 08 (Exhibit

A, CDRL

A001)

TBD

FDA Interactions Documentation

COR/

ACOR

NLT 180 calendar days after contract award.

Annually from date of contract award (at a minimum) and within 15 business days of request by the Government.

SOW

Reference Title

Distribute To

Initial Subsequent

Deliverable 09 (Exhibit

B, CDRL

A002)

TBD

Product Development Planning Documents

COR/

ACOR

NLT 180 calendar days after contract award.

Annually from date of contract award (at a minimum) and within 15 business days of request by the Government.

Deliverable 10 (Exhibit

C, CDRL

A003)

TBD

Pre-clinical Testing and Trials Data

COR/

ACOR

NLT 180 calendar days after contract award.

Annually from date of contract award (at a minimum) and within 15 business days of request by the Government.

Deliverable 11 (Exhibit

D, CDRL

A004)

TBD

Clinical Trials Data

COR/

ACOR

NLT 180 calendar days after contract award.

Annually from date of contract award (at a minimum) and within 15 business days of request by the Government.

Deliverable 12 (Exhibit

E, CDRL

A005)

TBD

Manufacturing Data

COR/

ACOR

NLT 180 calendar days after contract award.

Annually from date of contract award (at a minimum) and within 15 business days of request by the Government.

Deliverable 13 (Exhibit

F, CDRL

A006)

TBD

Systems Engineering Data

COR/

ACOR

NLT 180 calendar days after contract award.

Annually from date of contract award (at a minimum) and within 15 business days of request by the Government.

Deliverable 14 (Exhibit

G, CDRL

A007)

TBD

Quality Assurance Data

COR/

ACOR

NLT 180 calendar days after contract award.

Annually from date of contract award (at a minimum) and within 15 business days of request by the Government.

Deliverable

TBD

Contractor Recommended Surveillance

Initial:

CS

Subsequent:

COR/

ACOR/

CS

As part of the proposal.

Update as needed through the end of contract performance.

SOW

Reference Title

Distribute To

Initial Subsequent

Deliverable

TBD

Two (2) GMP representative, test ready devices (including 2 sets of consumables per device) following product design freeze

COR/

ACOR

Upon completion of product design freeze.

N/A

Deliverable

TBD

Six (6) FDA market authorized devices (including 2 sets of consumables per device)

COR/

ACOR

NLT 45 calendar days after receipt of FDA market authorization.

N/A

Deliverable 18 (Exhibit

H, CDRL

A008)

TBD

Test Reports showing

JECETS

compliance

COR/

ACOR

Prior to finalized product design freeze as per 21 CFR 820 compliant QMS.

N/A

Deliverable

TBD

Risk Management Framework

(RMF)

Questionnaire

COR/

ACOR

NLT 90 calendar days after contract award.

N/A

Deliverable

TBD

Verification of Contractor Manpower Reporting

(CMR)

Submission

COR/

ACOR/

CS

NLT 31 Oct 2019.

Annually, NLT 31 Oct.

Deliverable

TBD

Issue Summary Report (ISR)

COR/

ACOR/

CS

As required, within three (3) business days of issue identification.

As required, within three (3) business days of issue identification.

Deliverable

TBD

Non-Disclosure / Non-Use Agreement

COR/

ACOR/

CS

Within five (5) business days after contract award.

Additional agreements to be executed as needed.

3.0 Deliverable Descriptions

Deliverable 01: Contract Kickoff Meeting Agenda and Minutes. The contractor shall conduct a contract kickoff meeting with the identified Contracting Officer (KO), Contract Specialist (CS), COR, and ACOR. The Contractor shall meet with the Government to present an overview of their approach and establish schedules, procedures, and points of contact necessary to conduct the tasks outlined herein. This meeting should not exceed two (2) hours in length. The primary outcome of this meeting is to come to an understanding regarding contract expectations and goals. The kickoff meeting may be held in-person at Fort Detrick, MD or via teleconference. The contractor shall conduct the kickoff meeting no later than fifteen (15) calendar days after contract award. The Contractor shall provide the Government with a kickoff meeting agenda no later than three (3) business days prior to the meeting.

The Contractor shall provide the Government with kickoff meeting minutes no later than three (3) business days after the meeting.

Deliverable 02: FDA Pre-Submission Package(s). The contractor shall provide an FDA pre-submission package for COR/ACOR review and comment no later than 45 calendar days after contract award and subsequently, no later than ten (10) business days prior to additional meetings requested by the FDA.

Deliverable 03: FDA Pre-Submission Meeting Minutes. The contractor shall conduct an FDA pre-submission meeting no later than 90 calendar days after contract award with subsequent meetings conducted as needed. The contractor shall include the COR and ACOR or his/her designee in the FDA pre-submission meeting(s). The contractor shall provide meeting minutes no later than ten (10) calendar days after the initial and subsequent meetings.

Deliverable 04: Regulatory Strategy & Regulatory Plan. The contractor shall provide an FDA focused regulatory strategy and regulatory plan as part of the proposal and, subsequently, no later than 30 calendar days after contract award. The contractor shall update the FDA focused regulatory strategy and regulatory plan as needed but annually (at a minimum) through the end of contract performance. The Government will have five (5) business days to accept or reject the proposed changes to the regulatory strategy. Large changes requiring contract modifications affecting Cost, Schedule, or Performance would need USAMRMC approval and could take up to a year for approval; if the Government decides not to approve changes but contractor decides to proceed with the plan, such decisions from contractor could lead to termination of the contract.

Deliverable 05: Monthly Progress Reports. The contractor shall provide the COR and ACOR with an initial monthly progress report no later than 30 business days after contract award, and subsequent monthly progress reports no later than the 10th calendar day of every month for the previous month during the period of performance.

The report shall include, but not be limited to:

1. A summary of activities conducted during the month being reported.

2. An up to date status summary on all activities being conducted under the contract.

3. A Gantt chart provided in a separate Microsoft Project file that provides status on all activities being conducted under the contract with the actual percentage completed (XX%) shown for each task, critical path identified, any schedule slippage identified, and any impacts to the critical path.

4. An up to date spend plan that provides a monthly breakout of actual past expenses and anticipated future expenses.

5. A summary of activities that are planned for the next reporting period.

6. Any identified risks or issues and corresponding mitigation strategies.

7. A quad chart using template provided by COR/ACOR as a summary snapshot and snapshot of contract’s progress.

Deliverable 06: Biweekly Teleconference Agenda and Minutes. The contractor shall conduct biweekly teleconference meetings with the COR and ACOR within five (5) business days after the monthly reports are submitted and/or as requested by the COR/ACOR. The Contractor shall provide the COR/ACOR with an agenda no later than one (1) business day prior to the teleconference. The Contractor shall provide the COR/ACOR with meeting minutes no later than three (3) business days after the teleconference.

Deliverable 07: FDA Meeting Package Submissions, Communications, Formal Meeting Minutes, and FDA Finalized Meeting Minutes. The contractor shall include the COR and ACOR or his/her designee in all meetings (both formal and informal) with the FDA. The Contractor shall provide copies of meeting package submissions for both formal and informal meetings with the FDA to the COR/ACOR no later than ten (10) business days prior to the FDA meetings. The Government will review and provide recommendations on these documents within five (5) business days of receiving them. The contractor shall provide copies of all communications, to include emails and letters, to and from the FDA to the Government no later than five (5) business days after receipt from the FDA. The contractor shall provide formal meeting minutes to the Government no later than nine (9) calendar days after the meeting. Government attendees will provide input to the meeting minutes within three (3) calendar days of receipt in order to accommodate FDA-mandated timeline of fifteen (15) calendar days to submit meeting minutes. The contractor shall provide the FDA finalized meeting minutes to the Government no later than five (5) calendar days after receipt from FDA.