A07-W81XWH-18-R-0058-Solicitation-.docx

W81XWH18R0058

Section A - Solicitation/Contract Form

GENERAL INFORMATION

Project Title: Temporary Corneal Repair

This is a Research & Development (R&D) requirement.

The Government anticipates that any resulting award from this Request for Proposal (RFP) will be a Cost Plus Fixed Fee contract.

North American Industry Classification System (NAICS) Code: 541690

Points of Contact (POCs): The primary point of contact (POC) for this solicitation is Jamie Diggs, Contract Specialist, jamie.l.diggs.civ@mail.mil. All inquiries regarding this requirement must be submitted via electronic mail (e-mail) to the Contract Specialist.

Solicitation Questions: Questions concerning this solicitation shall be submitted in writing to the POC via e-mail no later than 21 June 2018 at 9:00 AM Eastern Time. The e-mail must have a subject title of “W81XWH-18-R-0058 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-18-R-0058 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 12 July 2018 at 9:00 AM Eastern Time. Any proposals received after this date and time may not be considered for evaluation. Offerors’ proposals shall remain open for a minimum of 120 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 up to (but not greater than) three (3) contract awards.

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

Phase 1 FDA Pre-Submission GLP Protocol

CPFF

Phase 1: FDA Pre-Submission of GLP Protocol- See Statement of Objectives for details

FOB: Destination

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

Phase 2: Animal Study

Phase 2: Animal Study-See Statement of Objectives for details

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

Phase 3: IDE Pre-submission

Phase 3: IDE Pre-submission-See Statement of Objectives for details

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

FFP

Segment 1 Option-See Statement of Objectives for details

NET AMT

Materials/Equipment

COST

Materials/Equipment

ESTIMATED COST

Travel

COST

Travel

ESTIMATED COST

CDRL-A0001

CDRL-A0001-Regulatory Strategy

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

CDRL-A0002

CDRL-A0002-Technical Specifications of Product

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

CDRL-A0003

CDRL-A0003-FDA Communication (including FDA feedback on pre-submissions)

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

Section C - Descriptions and Specifications

STATEMENT OF OBJECTIVE

Statement of Objectives

1.0 Purpose

This effort is aligned with the MRMC Temporary Corneal Repair (TCR) program, and will support Food and Drug Administration (FDA) clearance/approval of a temporary, non-surgical solution to close open globe, full thickness corneal wounds. This specific contract action is for potential developers to engage the FDA, conduct GLP Animal Studies, and deliver prototype devices to the government.

2.0 Background

2.1. Ocular injuries are common occurrences among warfighters, occurring disproportionately compared to injuries affecting more protected areas of the body. The U.S Army Aeromedical Research Laboratory in 2013 estimated that, from 2002 to 2011, over 3,222 ocular injuries occurred in 1,732 warfighters participating in Operation Iraqi Freedom, Operation Enduring Freedom, and other military operations. Of these injuries, more than 1,500 were classified as open wounds including eye penetration, eye laceration, and eye rupture. These injuries, diagnosed as open globe or full-thickness (through the corneal epithelium, stroma, and endothelium) wounds, require immediate closure to prevent loss of intraocular fluids, low intraocular pressure, prolapse of ocular structures, and expulsive choroidal hemorrhage.

In contrast to civilian ocular trauma, in which patients generally have relatively little co-morbidity, ocular trauma in a combat theater of operations (TO) is usually associated with multiple injuries to a patient’s extremities, head, and/or trunk.

Delayed treatment of open eye injuries can significantly increase the likelihood of poor visual outcomes for patients. These outcomes are life-changing for the patient and incur long-term costs to society in terms of loss of potential income, increased burden on healthcare systems, and strains on family support systems.

The U.S. Army’s Initial Capabilities Document (ICD) for Clinical and Rehabilitative Medicine, ICD for Joint Force Health Protection, and ICD for Combat Casualty Care Medical Research and Development provide capability gaps for mitigating and treating traumatic war-related injuries and diseases to ocular structures and the visual system.

3.0 Program Objectives

The Government’s overall TCR program objective is to rapidly field a FDA cleared/approved device that will stabilize open globe, full thickness ocular wounds prior to definitive care. The device shall be a non-surgical solution which forms a water tight seal to maintain ocular tissue integrity. It is envisioned that the device will be initially used by trained ophthalmologists (Role of Care 3), and eventually other providers with the proper tools and training (Role of Care 2). For reference use only, the Roles of Care are defined by Emergency War Surgery, Chapter 2 (Attachment/Appendix).

The Government anticipates that future combat operations may require medical personnel to provide prolonged medical care in the pre-hospital environment for up to 72 hours prior to evacuation. To reduce blindness in wounded veterans associated with open globe injuries incurred on the battlefield, the objective device should support medical personnel in the pre-hospital management of patients for extended periods when casualty evacuation is delayed or unavailable.

The end state of the desired device

· Will form a water tight seal on ocular cornea tissue

· Provide the ability to view and assess intraocular structures following administration

· Compatible with common ocular medications or intraocular tamponades (e.g., silicone oil, and gasses).

· Compatible with trephine or other common instruments used to cut corneal tissue

· Be biocompatible with ocular tissue

· Easily and safely be applied, removed, and (if necessary) reapplied

· Not require any sutures and minimal surgical tools to apply

· Demonstrate safety and efficacy in a Good Laboratory Practices (GLP) Animal study to support FDA clearance/approval

· Demonstrate safety and efficacy in a clinical trial to support FDA clearance/approval

· Will be FDA cleared/approved

· Compliant with current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) per21 CFR Part 820

· Compliant with applicable International Organization for Standardization (ISO) requirements (e.g. 9001, 13485).

· Have a minimum 2 year shelf life

· Have minimal, if any, cold chain requirements

The Government realizes that the ideal goals stated above may not be obtainable within the period of performance of the contract. It is envisioned that the work to achieve the desired end state may be divided into three contracting actions:

Segment 1: GLP Animal Studies/ Pre-Clinical Studies Segment 2: Clinical Feasibility Trial Segment 3: Clinical Pivotal Trial.

This contracting action is specifically for Segment 1 and will seek offerors to engage the Food and Drug Administration, conduct GLP Animal Studies, and deliver prototype devices to the government. Preference for potential future work will be given to Contractors who are closest to achieving the programmatic goals.

4.0 Segment 1 Objectives

4.1. This contract is for activities to support development and eventual FDA clearance/approval of a temporary, non-surgical solution to close open globe, full thickness ocular wounds. The solution(s) should minimally be at a Technology Readiness Level (TRL) 4 or above. The contractor should submit a Statement of Work (SOW) in response to this Statement of Objectives (SOO).

4.2 The Contractor(s) shall develop the solution in accordance with (IAW) all applicable State laws, Federal laws, DoD regulations, and US Army regulations. The Government does not intend to provide equipment or facilities. The Government will not provide the Contractor with Government network access, building access badges, or common access cards during the duration of the contract.

4.3 The Contractor(s) shall submit a Program Management Plan (PMP) (Deliverable 1) with the proposal. The plan shall be used to manage, track and evaluate the Contractor’s performance along with the Contractor-provided Quality Assurance Surveillance Plan (QASP). See section L for specific submission details.

4.4 The Contractor shall provide a draft Quality Control Plan (QCP) with the proposal. A draft QCP shall be submitted with the Contractor’s proposal and should be updated 15 days after award Quality Control Plan (QCP) (Deliverable 2). The QCP should document how the Contractor will meet and comply with the quality standards established in their proposal. See section L for specific submission details.

4.5. The Contractor(s) shall be the FDA regulatory sponsor IAW Code of Federal Regulations (CFR) Title 21 Food and Drugs. The Contractor should submit a Regulatory Strategy (Deliverable 3) IAW MRMC DID DI-TCSP-82040 with the proposal and update as requested. The Regulatory Strategy should include a schedule with corresponding regulatory activities.

4.6. The Contractor should identify the intended Contract Research Organization (CRO) for Animal study (Deliverable 4) for the Phase I and Phase II activities, with the proposal. The CRO shall conduct these studies IAW all applicable State laws, Federal laws (e.g. 21 CFR Part 58), DoD regulations, US Army regulations, and DOD Directive 3216.1, “Use of Animals in DoD Programs” (http://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/321601p.pdf).

4.7. The Contractor(s) should complete the MRMC Quality Questionnaire Checklist and Quality Management Plan with the proposal Completion of Quality System Questionnaire and Quality Management Plan (Deliverable 5). Prior to the start of the GLP animal study described in the below phases, the Contractor should be actively working towards compliance with current Good Manufacturing Practices (cGMP) compliant Quality Management System (QMS), IAW 21 CFR Part 820. The Contractor’s compliance with applicable International Standards Organization (ISO) requirements should be noted (e.g. 9001, 13485). The quality management plan may include, but is not limited to the quality policy and objectives, management review, competencies and training, process document control, feedback, evaluation, corrective action and preventive action, process improvement, measurement, and data analysis processes. The framework is normally divided into infrastructure, senior management responsibility, resource management, lifecycle management, and quality management system evaluation.

4.8. This is a non-personal services Research and Development contract that will be divided into the following phases:

5.0 Segment 1, Phase 1: FDA Pre-Submission of GLP Protocol

5.1 The Contractor(s) shall provide a Spend Plan (Deliverable 6) that estimates the burn rate of Government funding in relation to the Contractor’s schedule and deliverables. The Spend Plan shall be submitted at time of award with a baseline, and subsequently updated with each invoice to show actual spending and any updated projections for spending.

5.2 The Contractor shall assist in a Kick-Off Meeting (Deliverable 7). The Government will provide notification of meetings and requested information by email or phone calls as appropriate. The Government will schedule the Kick-Off Meeting at Fort Detrick or the Contractor’s site within 15 working days after award of contract.

5.3 The Contractor shall at minimum hold Monthly Meetings (Deliverable 9), to discuss the Monthly Progress Reports (Deliverable 8). The Monthly Progress Report shall include the Integrated Master Schedule (IMS), describe the progress made within the reporting period, and inform the Government of existing or potential issues and problem areas.

5.4 The Contractor shall prepare a Pre-Submission package to the Food and Drug Administration for a Good Laboratory Practices (GLP) protocol, intended to support the clearance/approval of their product. The package at a minimum should include: protocol, questions for the FDA, applicable bench studies and data, as well as a validated animal model. The GLP protocol, and the facility executing the protocol, shall be in compliance with 21 CFR Part 58. The Pre-Submission packet shall be provided to MRMC for review, and the contractor shall make adjustments as necessary. This is know as the Pre-submission Package for GLP Animal Studies (Deliverable 10).

5.5. The Contractor(s) shall utilize the FDA Pre-Submission Program for GLP Animal Protocol (Deliverable 11) package described in 4.12. The Contractor(s) shall consider FDA feedback, make amendments as necessary, and finalize the GLP Animal Protocol (Deliverable 12).

5.6. The Contractor(s) shall include the USAMMA COR or his/her designee in all meetings both formal and informal with the FDA. It is the intention of the Government to be present (physically whenever possible or via Contractor provided teleconferences) for all meetings and discussions with the FDA. If the Government cannot attend, detailed notes will be provided. Copies of notes and regulatory communications from the FDA shall be sent to the COR within three (3) days of occurrence or receipt. The contractor shall provide copies of all communications, to include meeting minutes, emails, and letters, to the FDA within five (5) business days known as the FDA Communication and Supporting Documentation (Deliverable 13). If submissions have occurred prior to contract award, the contractor shall provide copies of any submissions, to date.

5.7 The Contractor shall provide verification of Contractor Manpower Reporting (CMR) submission (Deliverable 14) to the COR and the Contract Specialist via e-mail, initially, NLT 31 October and, subsequently, annually NLT 31 October.

5.8 The Contractor shall provide Point of Contact Information (Deliverable 15) to the COR and CS via e-mail, initially, NLT 10 calendar days after contract award and, subsequently, updated if representative changes. This representative shall participate in meetings via teleconference up to twice a month.

6.0 Segment 1, Phase 2: Animal Study

6.1 The Contractor(s) shall obtain an approval letter from the USAMRMC Animal Care and Use Review Office (ACURO) for their GLP animal study protocol IAW DoD 3216.0 known as the ACURO Approval Letter (Deliverable 16). The protocol shall be submitted to ACURO NLT 15 days after the start of Phase 2. Applicable regulations can be found at: http://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.acuro

6.2 The Contractor(s) shall conduct a GLP-compliant animal study (in accordance with 21 CFR Part 58), utilizing the protocol approved in 5.5. The Government shall be provided the study results first in a draft, then final report. This is known as the GLP Animal Study Report (Deliverable 17).

6.3. The Contractor(s) shall deliver 25 devices to a designated Point of Contact (POC) at the Institute of Surgical Research (ISR)60 days after initiation of Phase 2. The devices shall be the same design as the devices utilized in the GLP animal study. The Contractor(s) shall travel to the ISR in order to train users on the application and removal of the prototype (materials used in this training do not count toward the prototype devices to be delivered).It is anticipated that the training will take place over 2 days known as 25 Devices (Deliverable 18). The Contractor(s) shall be available via email or phone for any follow up questions. Please note that the Development Test & Evaluation DT&E/ Operational Test and Evaluation (OT&E) performed at the ISR is for Government internal informational purposes only. Resulting information shall not be reported to the FDA and is not designed to support FDA clearance/approval. The government is not obligated to share the results of this data with the Offeror.

6.4. The Contractor(s) shall develop a Manufacturing Plan that should align with their QMS. At minimum, the plan shall include: anticipated batch size, GMP strategy (e.g. subcontracting, internal manufacturing, assembly, etc.), design specifications, design history file, and lot release procedures known as Manufacturing Plan (Deliverable 19). The Government shall have the ability to assess the Contractor(s) facilities (over 2-3 days) and observe audits of any subcontractor facilities. The Contractor shall develop a mitigation plan in the event of a non-conformance.

6.5. The Contractor(s) shall develop a Business Plan that at minimum describes a commercialization strategy and relevance to civilian marketplace known as Business Plan (Deliverable 20).

6.6 The Contractor(s) shall assemble a draft Investigational Device Exemption (IDE) pre-submission package, including all relevant information for their product. The draft shall be provided to the Government for review. The Government will provide recommendations on these documents within 10 business days of receipt. The IDE pre-submission package shall take into consideration the requirements of 21 CFR Part 812.20. Known as Draft IDE Pre-submission Package (Deliverable 21).

7.0 Segment 1, Phase 3: IDE Pre-submission

7.1 The Contractor(s) shall request FDA feedback on their IDE package via the pre-submission process. If submissions have occurred prior to contract award, the contractor shall provide copies of any submissions, to date. The Contractor(s) shall provide all FDA feedback to the Government known as the Final IDE Pre-submission Packet (Deliverable 22).

8.0 Segment 1 Option

8.1 In the event that data from the GLP animal studies or feedback from the FDA requires additional studies/data, the Contractor(s) can propose the necessary work.

9.0 Period of Performance

Phases shall not run concurrently; the previous Phase must be completed prior to initiation of next Phase.

10.0 Deliverables

NOTE: For this requirement “deliver” means that the USAMMA COR is in receipt of the deliverable.

10.1 The SOW should include:

Table 1. Deliverables

Ref

To

CS

CS

CS

CS

CS

CS

CS

FDA

FDA

The Government shall be invited all meetings and discussions with the FDA.

Communication from the FDA to Contractor: NLT 3 days after occurrence.

Communication from Contractor to FDA: NLT 5 days after occurrence The Government shall be invited all meetings and discussions with the FDA.

Communication from the FDA to Contractor: NLT 3 days after occurrence.

Communication from Contractor to FDA: NLT 5 days after occurrence.

The Government shall have 10 business days to review any submissions to the FDA. If submissions have occurred prior to contract award, the contractor shall provide copies of any submissions, to date.

Deliverable 14

CS

Deliverable 15

CS

Deliverable 16 (Phase 2)

CS

Deliverable 17 (Phase 2)

CS

Deliverable 18 (Phase 2)

Contractor shall train ISR staff on proper application and removal of device

Deliverable 20 (Phase 2)

Deliverable 21 (Phase 2)

Deliverable 22 (Phase 3)

FDA

11.0 Contract Data Requirements List

11.1 The Contractor should submit a Regulatory Strategy IAW MRMC DID DI-TCSP-82040 (Deliverable 3, CDRL A0001), initially, with the proposal and, subsequently, update as requested by the government within 10 business days. The Regulatory strategy should include a schedule with corresponding regulatory activities. In accordance with Deliverable 3, after contract award, the Government will provide feedback as necessary. The format shall be IAW DID DI-TCSP-82040.

11.2 The Contractor shall provide the COR with a complete Technical Data Packet (TDP) IAW MIL-STD-31000 (CDRL A0002), initially, within 30 calendar days after the completion of Phase 2 and, subsequently, upon request by the Government within seven (7) business days. The Contractor shall prepare and maintain currency of a TDP that includes all necessary documentation and technical data and reports collected and prepared during the development effort funded by the Government. The TDP shall include all necessary technical data and documentation for the Government, or its designee, to continue the development and production of the product, including but not limited to the design history file, device master record, and device history record. The Contractor shall assist in the technical transfer as directed by the Government. The Contractor shall provide copies of TDP content as requested by Government and at contract expiration.

11.3 The Contractor shall include the USAMMA COR or his/her designee in all meetings both formal and informal with the FDA. It is the intention of the Government to be present (physically whenever possible or via Contractor provided teleconferences) for all meetings and discussions with the FDA. If the Government cannot attend, detailed notes will be provided. Copies of notes and regulatory communications from the FDA shall be sent to the COR within three (3) days of occurrence or receipt. The contractor shall provide copies of all communications, to include meeting minutes, emails, and letters, to the FDA within five (5) business days (Deliverable 1, CDRL A0003). If submissions have occurred prior to contract award, the contractor shall provide copies of any submissions, to date.

Table 2. Contract Data Requirements List (CDRL)

12.0 Deliverables Schedules Abbreviations

The following abbreviations are used in the deliverable schedules.

Table 3. Contracting Term Abbreviations

12.1 Delivery Address

All deliverables shall be delivered to the USAMMA COR designated in the COR appointment letter.

12.2 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), unless otherwise specified by the USAMMA COR. Electronic submission shall be made via email, unless otherwise agreed to by the USAMMA COR. The contractor shall make sure of commercial best practices in the packing and shipment of packages.

13.0 Travel & Other Direct Costs (ODCs)

ODCs shall be billed on a cost reimbursable basis. ODCs are defined as purchase price of materials or services plus applicable indirect costs and tax (if applicable), fee will not be paid on ODCs or travel.

Contractor will be authorized travel expenses consistent with the substantive provision of the Joint Travel Regulation (JTR) and the limitation of funds specified in the contract. All travel requires Government prior approval/authorization by the USAMMA COR.

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. Contractor shall submit travel requests with estimated costs to the COR NLT fifteen (15) calendar days prior to travel. Travel costs shall be incurred and billed in accordance with FAR Part 31 for up to 3 Contractor employees for each prototype demonstration event held at Fort Detrick, Maryland. Costs for these expenses will be reviewed, certified and approved by the USAMMA COR. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area results in reasonable charges to the government. The Government will not pay for business class or first-class travel. Lodging and meals shall be reimbursed in accordance with regulations defined in FAR Part 31.

Section E - Inspection and Acceptance

USAMRAA INSTRUCTION

REPORTS, MANUSCRIPTS AND PUBLIC RELEASES (June 2015) (USAMRAA)

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 Contracting Officer and Contracting Officer'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 Contracting Officer and COR, even though publication may be subsequent to the expiration of the contract.

c. The Contractor shall notify the Contracting Officer of planned news releases, planned publicity, 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 human use, the Contractor must include the following statement: "In the conduct of research where humans are the subjects, the investigator(s) adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects)."

5) 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."

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLAUSES INCORPORATED BY REFERENCE

Section F - Deliveries or Performance

REGULATORY RIGHTS IN EVENT OF PRODUCT DEVELOPMENT FAILURES (June 2015) (USAMRAA)

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 Temporary Corneal Repair for the 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 U.S. 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 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 TBD[insert “three (3)” or an appropriate timeframe] years after the FDA issues approval or clearance, the Contractor, upon the request of the Government:

(i) 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;

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

c. 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.

DELIVERY INFORMATION

01-FEB-2019

LEIGH ANNE ALEXANDER

693 NEIMAN STREET, 3W-218

FREDERICK MD 21702

W25MWY

01-OCT-2019

W25MWY

01-FEB-2020

W25MWY

01-FEB-2020

W25MWY

01-FEB-2020

W25MWY

01-FEB-2020

W25MWY

01-FEB-2020

W25MWY

01-FEB-2020

W25MWY

01-FEB-2020

W25MWY

Section G - Contract Administration Data

CLAUSES INCORPORATED BY FULL TEXT

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)

(a) Definitions. As used in this clause--

Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit, activity, or organization.

Document type means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

Local processing office (LPO) is the office responsible for payment certification when payment certification is done external to the entitlement system.

(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and receiving reports, as authorized by DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall--

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.acquisition.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this contract/order:

(1) Document type. The Contractor shall use the following document type(s).

Cost Voucher

(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting officer.

Not Applicable

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table* Field Name in WAWF Data to be entered in WAWF

(*Contracting Officer: Insert applicable DoDAAC information or “See schedule” if multiple ship to/acceptance locations apply, or “Not applicable.”)

(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in support of each payment request.

(5) WAWF email notifications. The Contractor shall enter the email address identified below in the “Send Additional Email Notifications” field of WAWF once a document is submitted in the system.

TBD at time of award

(g) WAWF point of contact. (1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

N/A

(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988.

(End of clause)

Section H - Special Contract Requirements

INVESTIGATING AND REPORTING POSSIBLE SCIENTIFIC MISCONDUCT (June 2015) (USAMRAA)

a. "Misconduct" or "Misconduct in Science" is defined as fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.

b. Contractors shall foster a research environment that prevents misconduct in all research and that deals forthrightly with possible misconduct associated with research for which U.S. Army Medical Research and Materiel Command funds have been provided or requested.

c. The contractor agrees to:

d. The contractor is responsible for notifying the ACO of appropriate action taken if at any stage of an inquiry or investigation any of the following conditions exist:

ORGANIZATIONAL AND CONSULTANT CONFLICTS OF INTEREST (OCOI) (June 2015) (USAMRAA)

1. It is recognized by the Government that the effort performed by the contractor under this contract is of a nature that it creates a potential organizational conflict of interest as is contemplated under the Federal Acquisition Regulation Subpart 9.5.

1. An organizational conflict of interest may result when factors create an actual or potential conflict of interest on a contract, or when the nature of work of the work to be performed on the contract creates an actual or potential conflict of interest on a future acquisition. Some restrictions on future activities of the contractor may be required.

1. In the performance of this contract, the contractor may have access to data which is procurement sensitive or is proprietary to other companies, Government consultants or advisors, or the Government. The contractor agrees that he will not utilize such procurement sensitive or proprietary data in performance of future competitive contracts, for studies in the same field, procured either through sealed bids or competitive negotiations unless authorized by the contracting officer.. The contractor further agrees not to act as a subcontractor or consultant to any other prime contractor or subcontractor seeking to utilize such data.

1. The contractor will include the provisions of paragraphs a and b in every first tier subcontract for performance of any portion of this requirement.

PROHIBITION OF USE OF LABORATORY ANIMALS (June 2015) (USAMRAA)

PROHIBITION – READ FURTHER FOR DETAILS

Notwithstanding any other terms and conditions contained in this award or incorporated by reference herein, the contractor is expressly forbidden to use or subcontract for the use of laboratory animals in any manner whatsoever without the express written approval of the USAMRMC, Animal Care and Use Review Office (ACURO). Written authorization to begin research under the applicable protocol(s) proposed for this award will be issued in the form of an approval letter from the USAMRMC ACURO to the contractor with a copy to the USAMRAA Contracting Office. Furthermore, modifications to already approved extramural protocols require approval by ACURO prior to implementation. Once approved, notification must be given immediately to USAMRAA contracting. For each fiscal year, the contractor shall maintain, and upon request from ACURO, submit animal usage information. Non-compliance with any of these terms and conditions may result in withholding of funds and/or the terminations of the award.

SAFEGUARDING PROPRIETARY INFORMATION (June 2015) (USAMRAA)

a. "Proprietary information" shall mean all information, whether disclosed orally, in writings, by drawings, or otherwise relating to the work to be performed under this contract, whether proprietary to the Government or one of its collaborating partners. Proprietary information includes, but is not limited to, information regarding properties, formulae, structures, manufacturing processes, and test results. Information ceases to be proprietary when it is generally available to the public or is available from sources other than the Department of the Army. All information submitted to the contractor under this contract shall be presumed to be proprietary to the Department of the Army or one of its collaborating partners until the Department of the Army announces to the contrary.

b. The contractor shall safeguard proprietary information both during and after the term of this contract, and shall neither appropriate, nor disclose, nor make unauthorized use of the proprietary information received under this contract. The requirements of this paragraph include, but are not limited to, the following:

1. Maintain a high degree of physical security over proprietary information at all times;

1. Discussion of proprietary information only among contractor's employees whose duties and responsibilities require knowledge of that information; and,

1. Elimination of proprietary information in open publications by the contractor and its personnel.

c. The contractor shall require all personnel who receive proprietary information to execute the statement in paragraph d below when this contract becomes effective or when first employed (if employed after the contract becomes effective). All statements executed pursuant to this paragraph shall be forwarded to the U.S. Army Medical Research Acquisition Activity Contracting Officer when this contract terminates, and/or when the employment ends, or and/or upon request of the Contracting Officer.

d. The following statements shall be executed pursuant to paragraph c above and when completed, placed in the official contract file:

I hereby acknowledge that I (insert contractor’s name here) have been informed that our duties may require that I have access to proprietary information. I /We understand this proprietary information which I/we will receive includes, but is not limited to, properties, formulae, structures, protocols, manufacturing processes, and test results.

I/we agree that I/we will neither appropriate, nor disclose, nor make unauthorized use of proprietary information both during and after my/our employment. I further agree that I/we will neither include nor draw upon proprietary information received under this contract in open publication. This agreement is executed with the intention that collaborating partners of the United States Government who have submitted information to the Government under non-disclosure obligations shall be third party beneficiary hereunder, and shall have the right to enforce the obligations undertaken herein.

Name:

Date:

Signature:

e. The contractor shall insert the substance of paragraphs a through d above in each subcontract hereunder. Compliance with the provisions of this clause shall be the responsibility of the contractor.

USE OF TECHNICAL REFERENCE FACILITY (June 2015) (USAMRAA)

The contractor agrees to use, to the extent practical, 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.

Section I - Contract Clauses