Exhibit 10.1


 


	AWARD/CONTRACT	1.      THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)	RATING	PAGE OF PAGES
	1	30
	
        2.     
        CONTRACT (Pros. Inst. Ident.) NO

        W911SR2030004
	
        3.     
        EFFECTIVE DATE

        01 Jul 2020
	
        4.     
        REQUISITION/PURCHASE REQUEST/PROJECT NO.

        0011506626-0001

	5.      ISSUED BY	CODE	W911SR	6.      ADMINISTERED BY (If other than Item 5)	CODE	S4402A
	
        US ARMY RDECOM CONTRACTING CMD

        APG, EDGEWOOD CONTRACTING DIVISION

        E4455 LEITZAN ROAD

        ABERDEEN PROVING GROUND MD 21010-5401

         
	
        DCMA DALLAS – S4402A

        600 NORTH PEARL STREET

        SUITE 1630

        DALLAS TX 75201-2843

	
        7.     
        NAME AND ADDRESS OF CONTRACTOR (No., street, city, county, state and zip code)

        RETRACTABLE TECHNOLOGIES, INC.

        511 LOBO LN

        LITTLE ELM TX 75068-5295

         

         
	
        8.     
        DELIVERY

        [ ] FOB ORIGIN       [ ] OTHER (See
        below)

	
        9. DISCOUNT FOR PROMPT PAYMENT

        Net 30 Days

	
        10. SUBMIT INVOICES

        (4 copies unless otherwise specified)

        TO THE ADDRESS
	ITEM
	CODE         1BFK3	FACILITY CODE	SHOWN IN:	 
	11.  SHIP TO/MARK FOR:	CODE	W56XNH	12.   PAYMENT WILL BE MADE BY	CODE	HQ0339
	
        BIOMEDICAL ADVANCED RESEARCH DEVELOPMENT

        [JOSEPH
        FIGLIO]

        ROOM 23E07

        O’NEILL HOUSE OFFICE BUILDING

        WASHINGTON DC 20515

         
	
        DFAS-COLUMBUS CENTER

        DFAS-COM/EST ENTITLEMENT OPERATIONS

        P.O. BOX 182381

        COLUMBUS OH 43218-2381

         

	
        13.  
        AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

        [ ] 10 U.S.C. 2304(c)( ) [ ] 41 U.S.C.
        253(c)( )
	
        14.  
        ACCOUNTING AND APPROPRIATION DATA

        See Schedule

	15A.  ITEM NO.	15B.  SUPPLIES/SERVICES	15C.  QUANTITY	15D.  UNIT	15E.  UNIT PRICE	15F.  AMOUNT
	
         

         

         

         

         
	
         

         

        SEE SCHEDULE
	 	 	 	 
	15G.	TOTAL AMOUNT OF CONTRACT	$53,664,286.00
	16.  TABLE OF CONTENTS
	(X)	SEC.	DESCRIPTION	PAGE(S)	(X)	SEC.	DESCRIPTION	PAGE(S)
	PART I – THE SCHEDULE	PART II – CONTRACT CLAUSES
	X	A	SOLICITATION/CONTRACT FORM	1	X	1	CONTRACT CLAUSES	15-30
	X	B	SUPPLIES OR SERVICES AND PRICES/C0STS	2	PART III – LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH
	 	C	DESCRIPTION/SPECS/WORK STATEMENT	 	 	J	LIST OF ATTACHMENTS	 
	 	D	PACKAGING AND MARKING	 	PART IV – REPRESENTATIONS AND INSTRUCTIONS
	X	E	INSPECTION AND ACCEPTANCE	3	 	K	REPRESENTATIONS, CERTIFICATIONS AND	 
	X	F	DELIVERIES OR PERFORMANCE	4-5	 	 	OTHER STATEMENTS OF OFFERORS	 
	X	G	CONTRACT ADMINISTRATION DATA	6	 	L	INSTRS., CONDS., AND NOTICES TO OFFERORS	 
	X	H	SPECIAL CONTRACT REQUIREMENTS	7-14	 	M	EVALUATION FACTORS FOR AWARD	 
	CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR 18 (SEALED-BID PROCUREMENT) AS APPLICABLE
	
        17 [ ] CONTRACTOR’S
        NEGOTIATED AGREEMENT. Contractor is required to sign this document and return ______ copies
        to issuing office. Contractor agrees to furnish and deliver all items or perform all the
        services set forth or otherwise identified above and on any continuation sheets for the consideration stated herein. The rights
        and obligations of the parties to this contract shall be subject to and governed by the following documents: (a) this award contract,
        (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications as are attached or incorporated
        by reference herein.

        (Attachments are listed herein.)
	
        18. [ ] SEALED-BID
        AWARD (Contractor is not required to sign this document.)

         

        Your bid on Solicitation Number ____________________

         

        Including the additions or changes made by
        you which additions or changes are set forth in full above, is hereby accepted as to the terms listed above and on any continuation
        sheets. This award consummates the contract which consists of the following documents: (a) the Government’s solicitation
        and our bid, and (b) this award contract. No further contractual document is necessary. (Block 18 should be checked only when awarding
        a sealed-bid contract.)

	
        19A. NAME AND TITLE OF SIGNER (Type or print)

         

        [THOMAS
        J. SHAW]
	
        20A. NAME OF CONTRACTING OFFICER[

        [[John
        Conlin, Agreements Officer]

        TEL: [508-206-2064]
        EMAIL: [john.conlin3.civ@mail.mil]

	
        19B. NAME OF CONTRACTOR

         

         

        By:_[/s/Thomas
        J. Shaw]____________________

        (Signature of person authorized to sign)
	
        19C. DATE SIGNED

         

         

        7/1/2020
	
        20B. UNITED STATES OF AMERICA

         

         

        By: [/s/
        JC]__________________________________

        (Signature of Contracting Officer)
	
        20C. DATE SIGNED

         

        1 July 2020

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 




    	 	 	 



     


    

 


Section B – Supplies or Services
and Prices


 


 


	ITEM NO.	SUPPLIES/SERVICES	QUANTITY	UNIT	UNIT PRICE	AMOUNT	 
	0001	 	 	[Job]	 	$53,664,286.00 NTE
	 	TECHNOLOGY INVESTMENT AGREEMENT	 	 
	 	COST	 	 
	 	 	 	 
	 	Technology Investment Agreement (TIA) for Expanding Domestic Production of Needles & Syringes IAW vendor project plan dated [18 JUN 20.]	 	 
	 	 	 	 
	 	FOB:  Destination	 	 
	 	PURCHASE REQUEST NUMBER:  [0011506626-0001]	 	 
	 	PSC CD:  [6515]	 	 
	 	 	 	 	ESTIMATED COST	$53,664,286.00	 
	 	ACRN AA	 	 	 	[$53,664,286.00]	 
	 	CIN:  [GFEBS001150662600001]	 	 	 	 
	 	 	 	 
	 	 	 	 	 	 	 	 


 




    	 	 	 



     


    

 


Section E – Inspection and Acceptance


 


 


INSPECTION AND ACCEPTANCE OF TERMS


 


Supplies/services will be inspected/accepted
at:


 


	CLIN	INSPECT AT	INSPECT BY	ACCEPT AT	ACCEPT BY
	0001	Destination	Government	Destination	Government


 




    	 	 	 



     


    

 


Section F – Deliveries or Performance


 


 


F.1  Supply
Chain Resiliency Plan


 


F.2  The
contractor shall develop and submit at the time of agreement award, a comprehensive Supply Chain Resiliency Program that provides
identification and reporting of critical components associated with the secure supply of drug substance, drug product, and work-in-process
through to finished goods.


		a)	A critical component is defined as any material that is essential to the product or the manufacturing
process associated with that product. Included in the definition are consumables and disposables associated with manufacturing.
NOT included in the definition are facility and capital equipment.



 


F.3  Consideration
of critical components includes the evaluation and potential impact of raw materials, excipients, active ingredients, substances,
pieces, parts, software, firmware, labeling, assembly, testing, analytical and environmental componentry, reagents, or utility
materials which are used in the manufacturing of a drug, cell banks, seed stocks, devices and key processing components and equipment.
A clear example of a critical component is one where a sole supplier is utilized.


 


F.4  The
contractor shall identify key equipment suppliers, their locations, local resources, and the associated control processes at the
time of award. This document shall address planning and scheduling for active pharmaceutical ingredients, upstream, downstream,
component assembly, finished drug product and delivery events as necessary for the delivery of product.


		a)	Communication for these requirements shall be updated as part of an annual
review, or as necessary, as part of regular contractual communications.



		b)	For upstream and downstream processing, both single-use and re-usable in-place
processing equipment, and manufacturing disposables also shall be addressed. For finished goods, the inspection, labeling, packaging,
and associated machinery shall be addressed taking into account capacity capabilities.



		c)	The focus on the aspects of resiliency shall be on critical components and
aspects of complying with the contractual delivery schedule. Delivery methods shall be addressed, inclusive of items that are foreign-sourced,
both high and low volume, which would significantly affect throughput and adherence to the contractually agreed deliveries.



 


F.5  The
contractor shall articulate in the plan, the methodology for inventory control, production planning, scheduling processes and ordering
mechanisms, as part of those agreed deliveries.


		a)	Production rates and lead times shall be understood and communicated to
the HHS/ASPR/BARDA Agreements Officer (AO) or the Agreements Officer’s Representative (AOR) as necessary.



		b)	Production throughput critical constraints should be well understood by
activity and by design, and communicated to contractual personnel. As necessary, communication should focus on identification,
exploitation, elevation, and secondary constraints of throughput, as appropriate.



 


F.6  Reports
for critical items should include the following information:


		a)	Critical Material



		b)	Vendor



		c)	Supplier, Manufacturing / Distribution Location



		d)	Supplier Lead Time



		e)	Shelf Life



		f)	Transportation / Shipping restrictions



 


F.7  The
AO and AOR reserve the right to request un-redacted copies of technical documents, during the period of performance, for distribution
within the Government Documents shall be provided within ten (10) days after AO issues the request. The Contractor may arrange
for additional time if deemed necessary, and agreed to by the AO.


 




    	 	 	 



     


    

 


DELIVERY INFORMATION


 


 


	CLIN	DELIVERY DATE	QUANTITY	SHIP TO ADDRESS	
        DODAAC/

        CAGE

	0001	
        POP 01-JUL-2020 TO

        30-JUN-2030
	[N/A]	
        [BIOMEDICAL
        ADVANCED RESEARCH

        DEVELOPMENT

        JOSEPH
        FIGLIO

        ROOM
        23E07

        O’NEILL
        HOUSE OFFICE BUILDING

        WASHINGTON
        DC 20515]

        FOB: Destination
	W56XNH
	 	 	 	 	 	 


 




    	 	 	 



     


    

 


Section G – Contract Administration
Data


 


 


ACCOUNTING AND APPROPRIATION
DATA


 


 


AA: [0212020202120400000664643255S.0074658.5.16100.9000021001]


COST CODE: [A5XAH]


AMOUNT: $53,664,286.00


 


 


	ACRN	CLIN/SIN	CIN	AMOUNT
	 	 	 	 
	AA	0001	[GFEBS001150662600001]	$53,664,286.00


 




    	 	 	 



     


    

 


Section H – Special Contract
Requirements


 


 


H.1         Key
Personnel


 


H.1.1       Pursuant
to HHSAR 352.237-75 (Dec. 2015), Key Personnel, any key personnel specified in this agreement are considered to be essential to
work performance. At least thirty (30) calendar days prior to the Contractor voluntarily diverting any of the specified individuals
to other programs or agreements the Contractor shall notify the Agreements Office and shall submit a justification for the diversion
or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation
of how the replacement's skills, experience, and credentials meet or exceed the requirements of the agreement (including, when
applicable, Human Subjects Testing requirements). If the employee of the Contractor is terminated for cause or separates from the
Contractor voluntarily with less than thirty (30) calendar-day notice, the Contractor shall provide the maximum notice practicable
under the circumstances. The Contractor shall not divert, replace. or announce any such change to key personnel without the written
consent of the Agreements Officer. The agreement will be modified to add or delete key personnel as necessary to reflect the agreement
of the parties. The following individuals are determined to be key personnel.


 


H.1.2       Substitution
of Key Personnel


 


H.1.2.1   The
Contractor agrees to assign to the agreement those persons whose resumes/CVs were submitted with the proposal who are necessary
to fill the requirements of the agreement. No substitutions shall be made except in accordance with this clause.


 


H.1.2.2   All
requests for substitution must provide a detailed explanation of the circumstance necessitating the proposed substitution, a complete
resume for the proposed substitute and any other information requested by the Agreements Officer to approve or disapprove the proposed
substitution. All proposed substitutes must have qualifications that are equal to or higher than the qualifications of the person
to be replaced. The Agreements Officer or authorized representative will evaluate such requests and promptly notify the Contractor
of his approval or disapproval thereof.


 


H.1.2.3   The
Contractor further agrees to include the substance of this clause in any subcontract, which may be awarded under this agreement.


 


H.2         Disclosure
of Information


 


H.2.1      Performance
under this agreement may require the Contractor to access non-public data and information proprietary to a Government agency, another
Government Contractor or of such nature that its dissemination or use other than as specified in the work statement would be adverse
to the interests of the Government or others. Neither the Contractor, nor Contractor personnel, shall divulge nor release data
nor information developed or obtained under performance of this agreement, except authorized by Government personnel or upon written
approval of the CO. The Contractor shall not use, disclose, or reproduce proprietary data that bears a restrictive legend, other
than as specified in this agreement or any information at all regarding this agency.


 


H.2.2      Consistent
with HHS Directive 1139, the Contractor shall comply with HHS requirements for protection of non-public information. Unauthorized
disclosure of nonpublic information is prohibited by the HHS’s rules. Unauthorized disclosure may result in termination of
the agreement, replacement of a Contractor employee, or other appropriate redress. Neither the Contractor nor the Contractor’s
employees shall disclose or cause to be disseminated, any information concerning the operations of the activity, which could result
in, or increase the likelihood of, the possibility of a breach of the activity’s security or interrupt the continuity of
its operations.


 


H.2.3       No
information related to data obtained under this agreement shall be released or publicized without the prior written consent of
the COR, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that no such consent is required
to comply with any law, rule, regulation, court ruling or similar order; for submission to any government entity, for submission
to any securities exchange on which the Contractor’s (or its parent corporation’s) securities may be listed for trading;
or to third parties relating to securing, seeking, establishing or


 






    	 	 	 



     


    

 


maintaining regulatory or other legal approvals or compliance,
financing and capital raising activities, or mergers, acquisitions, or other business transactions.


 


H.3         Confidentiality
of Information


 


a.                  Confidential information, as used in this article, means information or data of a personal
nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.


 


b.                 The Agreements Officer and the Contractor may, by mutual consent, identify elsewhere in this
agreement specific information and/or categories of information which the Government will furnish to the Contractor or that the
Contractor is expected to generate which is confidential. Similarly, the Agreements Officer and the Contractor may, by mutual consent,
identify such confidential information from time to time during the performance of the agreement. Failure to agree will be settled
pursuant to the “Disputes” clause.


 


c.                  If it is established elsewhere in this agreement that information to be utilized under this
agreement, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure
set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records
determined to be subject to the Privacy Act.


 


d.                  Confidential information, as defined in paragraph (a) of this article, shall not be disclosed
without the prior written consent of the individual, institution, or organization.


 


e.                   Whenever the Contractor is uncertain with regard to the proper handling of material under
the agreement, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions
of this article, the Contractor shall obtain a written determination from the Agreements Officer prior to any release, disclosure,
dissemination, or publication.


 


f.                   Agreements Officer Determinations will reflect the result of internal coordination with appropriate
program and legal officials.


 


g.                 The provision of paragraph (d) of this article shall not apply to conflicting or overlapping
provisions in other Federal, State or local laws.


 


All above requirements MUST be passed to
all sub-contractors.


 


H.4         Organizational
Conflicts of Interest


 


H.4.1      Performance
under this agreement may create an actual or potential organizational conflict of interest such as are contemplated by FAR Part
9.505-General Rules. The Contractor shall not engage in any other contractual or other activities which could create an organizational
conflict of interest (OCI). This provision shall apply to the prime Contractor and all sub-Contractors. This provision shall have
effect throughout the period of performance of this agreement, any extensions thereto by change order or supplemental agreement,
and for two (2) years thereafter. The Government may pursue such remedies as may be permitted by law or this agreement, upon determination
that an OCI has occurred.


 


H.4.2      The
work performed under this agreement may create a significant potential for certain conflicts of interest, as set forth in FAR Parts
9.505-1, 9.505-2, 9.505-3, and 9.505-4. It is the intention of the parties hereto to prevent both the potential for bias in connection
with the Contractor’s performance of this agreement, as well as the creation of any unfair competitive advantage as a result
of knowledge gained through access to any non-public data or third party proprietary information.


 


H.4.3      The
Contractor shall notify the Agreements Officer immediately whenever it becomes aware that such access or participation may result
in any actual or potential OCI. Furthermore, the Contractor shall promptly submit a plan to the Agreements Officer to either avoid
or mitigate any such OCI. The Agreements Officer will have sole discretion in accepting the Contractor’s mitigation plan.
In the event the Agreements Officer unilaterally determines that any


 






    	 	 	 



     


    

 


such OCI cannot be satisfactorily avoided or mitigated, other
remedies may be taken to prohibit the Contractor from participating in agreement requirements related to OCI.


 


H.4.4       Whenever
performance of this agreement provides access to another Contractor’s proprietary information, the Contractor shall:


 


(1)                enter into a written agreement with the other entities involved, as appropriate, in order
to protect such proprietary information from unauthorized use or disclosure for as long as it remains proprietary; and refrain
from using such proprietary information other than as agreed to, for example to provide assistance during technical evaluation
of other Contractors’ offers or products under this agreement. An executed copy of all proprietary information agreements
by individual personnel or on a corporate basis shall be furnished to the CO within fifteen (15) calendar days of execution.


 


H.5         Operations
Security (OPSEC)


 


H.5.1       The
Contractor shall develop and submit an OPSEC Standing Operating Procedure (SOP) Plan within thirty (30) calendar days of agreement
award, to be reviewed and approved by the Government OPSEC lead for this effort. The final OPSEC plan must address the Government’s
identified Critical Information List (CIL).


		a)	All contractors supporting this effort must complete OPSEC Computer Based Training (CBT) that can
be accessed via the (Insert applicable website here).



 


H.6         Security


 


H.6.1      The
Contractor shall develop a comprehensive security program that provides overall protection of personnel, information, data, and
facilities associated with fulfilling the BARDA requirement. This plan shall establish security practices and procedures that demonstrate
how the Contractor will meet and adhere to the security requirements outlined below prior to the commencement of product manufacturing,
and shall be delivered to the Government within thirty (30) days of award. The Contractor shall also ensure all subcontractors,
consultants, researchers, etc. performing work on behalf of this effort, comply with all BARDA security requirements and prime
contractor security plans.


		a)	ASPR will review in detail and submit comments within ten (10) business days to the Agreements
Officer (CO) to be forwarded to the Contractor. The Contractor shall review the Draft Security Plan comments, and, submit a Final
Security Plan to the U.S. Government within thirty (30) calendar days after receipt of the comments.



		b)	The Security Plan shall include a timeline for compliance of all the required security measures
outlined by BARDA.



		c)	Upon completion of initiating all security measures, the Contractor shall supply to the Agreements
Office a letter certifying compliance to the elements outlined in the Final Security Plan.



 


H.6.2       At
a minimum, the Final Security Plan shall address the following items:


 


BARDA SECURITY REQUIREMENTS


	
1.  Facility
Security Plan


        Description: As part of the partner facility’s
        overall security program, the Contractor shall submit a written security plan with their proposal to BARDA for review and approval
        by BARDA security subject matter experts. The performance of work under the BARDA agreement will be in accordance with the approved
        security plan. The security plan will include the following processes and procedures at a minimum.

	Security Administration	
●  organization
chart and responsibilities


●  written
security risk assessment for site


●  threat
levels with identification matrix (High, Medium, or Low)


●  enhanced
security procedures during elevated threats


●  liaison
procedures with law enforcement


●  annual
employee security education and training program

	Personnel Security	
●  policies
and procedures


●  candidate
recruitment process


●  background
investigations process







 






    	 	 	 



     


    







 


	 	●  employment suitability policy


●  employee access determination


●  rules of behavior/conduct


●  termination procedures


●  non-disclosure agreements



	Physical Security Policies and Procedures	
●  internal/external
access control


●  protective
services


●  identification/badging


●  employee
and visitor access controls


●  parking
areas and access control


●  perimeter
fencing/barriers


●  product
shipping, receiving and transport security procedures


●  facility
security lighting


●  restricted
areas


●  signage


●  intrusion
detection systems


●  alarm
monitoring/response


●  closed
circuit television


●  product
storage security


●  other
control measures as identified

	Information Security	
●  identification
and marking of sensitive information


●  access
control


●  storage
of information


●  document
control procedures


●  retention/destruction
requirements

	Information

Technology/Cyber Security Policies and Procedures	
●  intrusion
detection and prevention systems


●  threat
identification


●  employee
training (initial and annual)


●  encryption
systems


●  identification
of sensitive information/media


●  password
policy (max days 90)


●  lock
screen time out policy (minimum time 20 minutes)


●  removable
media policy


●  laptop
policy


●  removal
of IT assets for domestic/foreign travel


●  access
control and determination


●  VPN procedures


●  Wi-Fi
and Bluetooth disabled when not in use


●  system
document control


●  system
backup


●  system
disaster recovery


●  incident
response


●  system
audit procedures


●  property
accountability

	
2.  Site Security
Master Plan


        Description: The partner facility shall
        provide a site schematic for security systems which includes: main access points; security camera;, electronic access points; IT
        Server Room; Product Storage Freezer/Room; and bio-containment laboratories.

	 	 
	
3.  Site Threat/Vulnerability/Risk
Assessment


        Description: The partner facility shall
        provide a written risk assessment for the facility addressing: criminal threat, including crime data; foreign/domestic terrorist
        threat; industrial espionage; insider threats; natural disasters; and 




 






    	 	 	 



     


    




 


	potential loss of critical infrastructure (power/water/natural
        gas, etc.). This assessment shall include recent data obtained from local law enforcement agencies. This assessment should be updated
        annually.
	 	 
	
4.  Physical
Security


        Description:

	Closed Circuit Television (CCTV) Monitoring	
        a)      
        Layered (internal/external) CCTV coverage with time-lapse video recording for buildings and
        areas where critical assets are processed or stored.

        b)     
        CCTV coverage must include entry and exits to critical facilities, perimeters, and areas within
        the facility deemed critical to the execution of the agreement.

        c)     
        Video recordings must be maintained for a minimum of 30 days.

        d)     
        CCTV surveillance system must be on emergency power backup.

        e)     
        CCTV coverage must include entry and exits to critical facilities, perimeters, and areas within
        the facility deemed critical to the execution of the agreement.

        f)      
        Video recordings must be maintained for a minimum of 30 days.

        g)     
        CCTV surveillance system must be on emergency power backup.

	Facility Lighting	
        a)     
        Lighting must cover facility perimeter, parking areas, critical infrastructure, and entrances
        and exits to buildings.

        b)     
        Lighting must have emergency power backup.

        c)    
         Lighting must be sufficient for the effective operation of the CCTV
        surveillance system during hours of darkness.

	Shipping and Receiving	
        a)     
        Must have CCTV coverage and an electronic access control system.

        b)     
        Must have procedures in place to control access and movement of drivers picking up or delivering
        shipments.

        c)     
        Must identify drivers picking up BARDA products by government issued photo identification.

	Access Control	
        a)     
        Must have an electronic intrusion detection system with centralized monitoring.

        b)     
        Responses to alarms must be immediate and documented in writing.

        c)     
        Employ an electronic system (i.e., card key) to control access to areas where assets critical
        to the agreement are located (facilities, laboratories, clean rooms, production facilities, warehouses, server rooms, records storage,
        etc.)

        d)    
        The electronic access control should signal an alarm notification of unauthorized attempts
        to access restricted areas.

        e)     
        Must have a system that provides a historical log of all key access transactions and kept on record for a minimum of 12
        months.

        f)     
        Must have procedures in place to track issuance of access cards to employees and the ability
        to deactivate cards when they are lost or an employee leaves the company.

        g)      Response
        to electronic access control alarms must be immediate and documented in writing and kept on record for a minimum of 12
        months.

        h)    
        Should have written procedures to prevent employee piggybacking access.

        i)      
        to critical infrastructure (generators, air handlers, fuel storage, etc.) should be controlled
        and limited to those with a legitimate need for access.

        j)      
        Must have a written manual key accountability and inventory process.

        k)    
        Physical access controls should present a layered approach to critical assets within the facility.

	
        Employee/Visitor

        Identification
	
        a)     
        Should issue company photo identification to all employees.

        b)   
        Photo identification should be displayed above the waist anytime the employee is on company
        property.

        













 



    	 	 	 



     


    




 


	 	c)     Visitors should be sponsored by an employee and must present government issued photo identification to enter the property. 


d)     Visitors should be logged in and out of the facility and should be escorted by an employee while on the premises at all times.



	Security Fencing	Requirements for security fencing will be determined by the criticality of the program, review of the security plan, threat assessment, and onsite security assessment.
	Protective Security Forces	Requirements for security offices will be determined by the criticality of the program, review of the security plan, threat assessment, and onsite security assessment.
	Protective Security Forces Operations	
        a)     
        Must have in-service training program.

        b)     
        Must have Use of Force Continuum.

        c)     
        Must have communication systems available (i.e., landline on post, cell phones, handheld radio,
        and desktop computer).

        d)     
        Must have standing Post Orders.

        e)     
        Must wear distinct uniform identifying them as security officers.

	
5.  Security
Operations


        Description:

	Information Sharing	
        a)     
        Establish formal liaison with law enforcement.

        b)    
        Meet in person at a minimum annually. Document meeting notes and keep them on file for a minimum
        of 12 months. POC information for LE Officer that attended the meeting must be documented.

        c)     
        Implement procedures for receiving and disseminating threat information.

	Training	
        a)     
        Conduct new employee security awareness training.

        b)     
        Conduct and maintain records of annual security awareness training.

	Security Management	
        a)     
        Designate a knowledgeable security professional to manage the security of the facility.

        b)     
        Ensure subcontractor compliance with all BARDA security requirements.

	
6.  Personnel
Security


        Description:

	Records Check	Verification of social security number, date of birth, citizenship, education credentials, five-year previous employment history, five-year previous residence history, FDA disbarment, sex offender registry, credit check based upon position within the company; motor vehicle records check as appropriate; and local/national criminal history search.
	
        Hiring and Retention

        Standards
	
        a)     
        Detailed policies and procedures concerning hiring and retention of employees, employee conduct,
        and off boarding procedures.

        b)    
        Off Boarding procedures should be accomplished within 24 hours of employee leaving the company.
        This includes termination of all network access.

	
7.  Information
Security


        Description:

	Physical Document Control	
        a)     
        Applicable documents shall be identified and marked as procurement sensitive, proprietary,
        or with appropriate government markings.

        b)   
        Sensitive, proprietary, and government documents should be maintained in a lockable filing
        cabinet/desk or other storage device and not be left unattended.

        c)    
        Access to sensitive information should be restricted to those with a need to know.

	Document Destruction	Documents must be destroyed using approved destruction measures (i.e., shredders/approved third party vendors/pulverizing/incinerating).
	
8.  Information
Technology & Cybersecurity


        Description:




 






    	 	 	 



     


    

 


	Identity Management	
        a)     
        Physical devices and systems within the organization are inventoried and accounted for annually.

        b)     
        Organizational cybersecurity policy is established and communicated.

        c)     
        Asset vulnerabilities are identified and documented.

        d)     
        Cyber threat intelligence is received from information sharing forums and sources.

        e)     
        Threats, vulnerabilities, likelihoods, and impacts are used to determine risk.

        f)      
        Identities and credentials are issued, managed, verified, revoked, and audited for authorized
        devices, users and processes.

        g)    
        Users, devices, and other assets are authenticated (e.g., single-factor, multifactor) commensurate
        with the risk of the transaction (e.g., individuals’ security and privacy risks and other organizational risks).

	Access Control	
        a)    
        Limit information system access to authorized users.

        b)    
        Identify information system users, processes acting on behalf of users, or devices and authenticate
        identities before allowing access.

        c)    
        Limit physical access to information systems, equipment, and server rooms with electronic
        access controls.

        d)    
        Limit access to/verify access to use of external information systems.

	Training	a)     Ensure that personnel are trained and are made aware of the security risks associated with their activities and of the applicable laws, policies, standards, regulations, or procedures related to information technology systems.
	Audit and Accountability	
        a)    
        Create, protect, and retain information system audit records to the extent needed to enable
        the monitoring, analysis, investigation, and reporting of unlawful, unauthorized, or inappropriate system activity. Records must
        be kept for minimum must be kept for 12 months.

        b)     
        Ensure the actions of individual information system users can be uniquely traced to those
        users.

        c)     
        Update malicious code mechanisms when new releases are available.

        d)     
        Perform periodic scans of the information system and real time scans of files from external
        sources as files are downloaded, opened, or executed.

	Configuration Management	
        a)     
        Establish and enforce security configuration settings.

        b)     
        Implement sub networks for publicly accessible system components that are physically or logically
        separate from internal networks.

	Contingency Planning	a)     Establish, implement, and maintain plans for emergency response, backup operations, and post-disaster recovery for information systems to ensure the availability of critical information resources at all times.
	Incident Response	a)     Establish an operational incident handling capability for information systems that includes adequate preparation, detection, analysis, containment, and recovery of cybersecurity incidents.  Exercise this capability annually.
	Media and Information Protection	
        a)     
        Protect information system media, both paper and digital.

        b)     
        Limit access to information on information systems media to authorized users.

        c)     
        Sanitize and destroy media no longer in use.

        d)     
        Control the use of removable media through technology or policy.

	Physical and Environmental Protection	
        a)    
        Limit access to information systems, equipment, and the respective operating environments
        to authorized individuals.

        b)     
        Intrusion detection and prevention system employed on IT networks.

        c)     
        Protect the physical and support infrastructure for all information systems.

        d)     
        Protect information systems against environmental hazards.

        e)     
        Escort visitors and monitor visitor activity.




 






    	 	 	 



     


    

 


	Network Protection	Employ intrusion prevention and detection technology with immediate analysis capabilities.
	
9.  Transportation
Security


        Description: Adequate security controls
        must be implemented to protect materials while in transit from theft, destruction, manipulation, or damage.

	Drivers	
        a)     
        Drivers must be vetted in accordance with BARDA Personnel Security Requirements.

        b)     
        Drivers must be trained on specific security and emergency procedures.

        c)     
        Drivers must be equipped with backup communications.

        d)     
        Driver identity must be 100 percent confirmed before the pick-up of any BARDA product.

        e)     
        Drivers must never leave BARDA products unattended, and two drivers may be required for longer
        transport routes or critical products during times of emergency.

        f)      
        Truck pickup and deliveries must be logged and kept on record for a minimum of 12 months.

	Transport Routes	
        a)     
        Transport routes should be pre-planned and never deviated from except when approved or in
        the event of an emergency.

        b)    
        Transport routes should be continuously evaluated based upon new threats, significant planned
        events, weather, and other situations that may delay or disrupt transport.

	Product Security	
        a)     
        BARDA products must be secured with tamper resistant seals during transport, and the transport
        trailer must be locked and sealed.

        ·     
        Tamper resistant seals must be verified as “secure” after the product is placed
        in the transport vehicle.

        b)     
        BARDA products should be continually monitored by GPS technology while in transport, and any
        deviations from planned routes should be investigated and documented.

        c)     
        Contingency plans should be in place to keep the product secure during emergencies such as
        accidents and transport vehicle breakdowns.

	
10.  Security
Reporting Requirements


        Description: The partner facility shall
        notify the BARDA Security Team within 24 hours of any activity or incident that is in violation of established security standards
        or indicates the loss or theft of government products. The facts and circumstances associated with these incidents will be documented
        in writing for government review.

	 	 
	
11.  Security
Audits


        Description: The partner facility agrees
        to formal security audits conducted at the discretion of the government. Security audits may include both prime and subcontractor.

	 	 


 




    	 	 	 



     


    

 


Section 1 – Contract Clauses


 


TERMS & CONDITIONS


 


TECHNOLOGY INVESTMENT AGREEMENT


 


between


 


Retractable Technologies, Inc.(RTI)


 


and


 


Department of Defense,


U.S. Army Contracting Command –
Aberdeen Proving Ground,


Natick Contracting Division & Edgewood
Contracting Division


(ACC-APG, NCD & ECD)


 


on behalf of


 


Biomedical Advanced Research and Development
Authority (BARDA)


 


for


 


Expanding Domestic Production of Needles
 & Syringes


 


 


 


Agreement No.: W911SR2030004


Total Amount of Government Funding for the
Agreement: $53,644,286


Total Cost Share for the Agreement: [$53,644,286]


Total Estimated Value of the Agreement: [$107,328,572]


Effective Date: 01 JUL 2020





 




    	 	 	 



     


    

 


TECHNOLOGY INVESTMENT AGREEMENT TERMS
AND CONDITIONS


 


 


ARTICLES


		1.	Scope of Agreement



		2.	Term of Agreement



		3.	Order of Precedence



		4.	Program/Administrative Management



		5.	Financial Management & Payment



		6.	Accounting & Audit



		7.	Purchasing & Title



		8.	Cost Sharing



		9.	Government Preference



		10.	Records Retention & Government Access



		11.	Intellectual Property & Patent Rights



		12.	Data Rights



		13.	FDA Regulatory Requirements



		14.	Termination



		15.	Disputes



		16.	Reports & Distribution



		17.	Modification



		18.	Miscellaneous



 


 


 


[ATTACHMENTS


 


		A.	Recipient’s Proposal (Final Project Plan
dated 18 JUN 2020)



 


		B.	Collaboration Plan (Statement of Objectives
[SOO] dated 22 JUN 2020) ]






 




    	 	 	 



     


    

 


RECITALS


 


This Agreement is entered
into between the United States of America, Department of Defense, represented by ACC-APG, NCD & ECD ("Government")
and Retractable Technologies, Inc. (RTI), ("Recipient"), collectively referred to as the "Parties,'' pursuant to
and under the statutory authority at 10 U.S.C. §2371 and/or 10 U.S.C. §2358.


 


The Recipient, a for-profit
firm, submitted a basic, applied, or advanced research proposal to the Government in response to the publicly disseminated Medical
Countermeasures System (MCS) Broad Agency Announcement (BAA) 17-01. The proposal was identified within the MCS BAA scope of: Advanced
Development & Manufacturing Capabilities (ADMC), to develop a national capability and capacity to develop and produce medical
countermeasures rapidly to counter known or unknown chemical, biological, radioactive, and nuclear (CBRN) threats, including novel
and previously unrecognized, naturally-occurring emerging infectious diseases such as the COVID-19 virus. The specific MCS BAA
Area of Interest is Mission Area I, Medical Biological Prophylaxis.


 


The Government awards
this Technology Investment Agreement (TIA) to fund the Recipient proposal subject to the following terms and conditions and other
statutory requirements. The Parties desire to enter into this Agreement to establish said terms and conditions under which they
plan to carry out the research and other activities as described below.


 


THEREFORE, THE PARTIES AGREE:


 


		1.	Scope of Agreement



 


		1.1	Governing Authority



 


This Technology Investment
Agreement (TIA) is an assistance transaction other than a grant or cooperative agreement and is awarded pursuant to 10 USC §2371
and/or 10 USC §2358, as applicable, as implemented by 32 Code of Federal Regulations (CFR) Part 37, and Parts 22 and 34 where
specifically referenced. The following are also incorporated in full: Definitions at Subpart J of 32 CFR Part 37; National Policies
at Appendix B, 32 CFR Part 22; Audits at Appendix C of 32 CFR Part 37. This TIA is subject to good manufacturing practices (cGMPS)
at 21 CFR 210 and 211, as applicable. The Federal Acquisition Regulation (FAR), Defense Federal Acquisition Regulation Supplement
(DFARS), DoD Grant and Agreement Regulations (DoDGARs), or other regulatory and statutory requirements apply as specifically referenced
herein. If this instrument is awarded under the authority at 10 USC §2358, the Bayh-Dole Act, 35 U.S.C. §§200-212
applies, as applicable.


 


		1.2	Principal Purpose



 


The Government and
the Recipient agree that the principal purpose of this Agreement is for Government investment into the development/expansion of
Recipient's manufacturing capacity for hypodermic safety needles and corresponding syringes in response to the worldwide Coronavirus
(COVID-19) global pandemic [as described in RTI's proposal entitled "Increasing U.S.
Manufacturing Capacity of Essential Healthcare Supplies'', dated 18 JUNE 2020, hereinafter, the "Plan" or "Project".
This effort shall be carried out as set forth in the Recipient's Plan and subsequent revisions, which are hereby incorporated in
their entirety]. This Agreement is not intended to be, nor shall it be construed as, by implication or otherwise, a partnership,
a corporation, or other business organization.


 




    	 	 	 



     


    

 


		2.	Term of Agreement



 


This Agreement shall
commence upon the effective date listed on page 1, after execution of the Agreement by both parties, for a period of 10 years,
the “term” of the Agreement or “Period of Performance.” Period of performance means the time during
which a recipient or sub-recipient may incur new obligations to carry out the work authorized under an award or sub-award, respectively.


 


		3.	Order of Precedence



 


This Agreement is subject
to the laws and regulations of the United States. In the event of a conflict or inconsistency in the terms and conditions or attachments
specified in this Agreement, the conflict or inconsistency shall be resolved according to the following order of precedence: (a)
the Federal statute authorizing this award, or any other Federal statutes directly affecting performance of this Agreement, including
attachments where applicable; (b) Federal regulations specifically referenced;(c) the terms and conditions contained within the
Agreement, including any documents incorporated; (d) programmatic requirements.


 


		4.	Program/Administrative Management



 


4.1              
Program Management


 


The Recipient has full
responsibility for the project/activity supported by this Agreement, in accordance with the Recipient's proposal and proposal revisions/appendices,
and the terms and conditions specified in this Agreement. The Government will have continuous and/or substantial involvement with
the Recipient pursuant to a Collaboration Plan as incorporated. The Recipient must consult the Program Office/Technical Representative
through the Agreements Officer before deviating from the objectives or overall program of the research originally proposed. Non-compliance
with any award provision of this clause may result in the withholding of funds and or the termination of the award.


 


4.2              
Government Representatives:


 


Agreements Officer (AO)


[John
Conlin


ACC-APG,
NCD


1
General Greene Avenue


Natick,
MA 01760


508-206-2064


john.conlin3.civ@usa.army.mil]


 


Agreements Specialist (AS)


[Mackenzie
Martz]


ACC-APG, ECD


8456 Brigade Street


Building E4215


Aberdeen Proving Ground, MC 21010


[301-619-8518


mackenzie.t.martz.civ@mail.mil]


 




    	 	 	 



     


    

 


Administrative Grants Officer (AGO)


DCMA DALLAS -S4402A


4211 Cedar Springs Road


Dallas, TX 75219


[214-670-9201


dcma.lee.hq.list.s4402a-casd@mail.mil]


 


Biomedical Advanced Research and
Development Authority (BARDA) Program

Manager (PM)


[Joseph
Figlio


Assistant
Secretary for Preparedness and Response (ASPR)/BARDA


Room
23E07 – O’Neill House Office Building


Washington,
DC 20515


202-480-0145


joseph.figlio@hhs.gov]


 


4.3              
Recipient’s Representatives


 


[Kathryn
Duesman


Registered
Nurse (RN), Vice President of Clinical Affairs


RTI


511
Lobo Lane


Little
Elm, TX 75068


972-294-1010


RTIclinical@vanishpoint.com


 


Larry
Salerno


Director
of Operations


RTI


511
Lobo Lane


Little
Elm, TX 75068


972-294-1010


RTIops@vanishpoint.com]


 


		5.	Financial Management & Payment



 


5.1              
Expenditure-Based.


 


This Agreement is an
expenditure type TIA as described in 32 CFR §37.1285. Expenditure is defined in 32 CFR §37.1290. The charges may
be reported on a cash or accrual basis, as long as the methodology is disclosed and is consistently applied. In accordance with
32 CFR 37.300(a): "For an expenditure-based TIA, the amounts of interim payments or the total amount ultimately paid to the
Recipient are based on the amounts the Recipient expends on project costs. If a Recipient completes the project specified at the
time of award before it expends all of the agreed-upon Federal funding and Recipient cost sharing, the Federal Government may recover
its share of the unexpended balance or, by mutual agreement with the Recipient, amend the agreement to expand the scope of the
research project. An expenditure-based TIA therefore is analogous to a cost-type procurement contract or grant.”


 


Payments shall be made
on a monthly basis for expenditures incurred up to the agreed upon project ceiling & Government investment funding amount,
for the duration of the Period of Performance.


 






    	 	 	 



     


    

 


5.2              
Obligation


 


In no case shall the
Government’s financial obligation exceed the amount obligated on this Agreement or by amendment to the Agreement. The Government
is not obligated to reimburse the Recipient for expenditures in excess of the amount of obligated funds allotted by the Government.


 


5.3              
Wide Area Workflow. The following guidance is provided for invoicing processed under this
Agreement through WAWF:


 


5.3.1         
Acceptance within the WAWF system shall be performed by the AGO upon receipt of a confirmation
email, or other form of transmittal, from the BARDA PM.


 


5.3.2         
The Recipient shall send an email notice to the BARDA PM and upload the BARDA PM approval
as an attachment upon submission of an invoice in WAWF (this can be done from within WAWF).


 


5.3.3         
Payments shall be made by the Defense Finance and Accounting services (DFAS) office indicated
below within thirty (30) calendar days of an accepted invoice in WAWF.


 


5.3.4         
WAWF Provision:


 


(a)        Definitions.
As used in this clause –


 


Department of Defense Activity
Address Code (DoDAAC) is a six-position code that uniquely identified 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 Recipient shall (i) have a designated electronic business point of contact in the System for Award
Management at https://www.acquisition.gov; and (ii) be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step
procedures for self-registration available at this website.


 


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


 






    	 	 	 



     


    

 


(1)                
Document type. The Recipient shall use the following document type: Invoice and Receiving
Report (Combo).


 


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


 


(3)                
Document routing. The Recipient 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 WA
	Pay Official DoDAAC	HQ0339
	Issue by DoDAAC	W911SR
	Admin DoDAAC	S4402A
	Inspect by DodAAC	W56XNH
	Ship to Code	W56XNH


 


Payee Information: As identified
at the System for Award Management.


 


		·	RTI



		·	Cage Code: 1BFK3



		·	DUNS: 838024255



 


(4)                
Payment request and supporting documentation. The Recipient 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 in support of each payment request.


 


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


 


(g)       WAWF
point of contact.


 


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


 


Administrative
Grants Officer (AGO)


DCMA DALLAS
-S4402A


4211 Cedar Springs Road


Dallas, TX 75219


214-670-9201


[dcma.lee.hq.list.s4402a-casd@mail.mil]


 




    	 	 	 



     


    

 


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


 


		6.	Accounting & Audit



 


6.1              
Accounting System.


 


6.1.1.       
The Recipient's systems must demonstrate effective control of all funds. Control systems must
be adequate to ensure that costs charged to Federal funds and those counted as the Recipient's cost share or match are consistent
with requirements for cost reasonableness, allowability, and allocability as set forth in 32 CFR §37.625(b) and in the terms
and conditions of the award. The Recipient must be able to provide accurate, current and complete records that document for work
funded wholly or in part with Federal funds, the source and application of the Federal funds and the Recipient has required cost
share or match.


 


6.1.2.    
The Recipient's cost accounting system shall be in compliance with Generally Accepted Accounting
Principles (GAAP) in accordance with 32 CFR §37.615. The system must effectively control all Project funds, including Federal
funds and any required cost share. The system must have complete, accurate, and current records that document the sources of funds
and the purposes for which they are disbursed. It also must have procedures for ensuring that Project funds are used only for purposes
permitted by the agreement (§37.625).


 


6.2   
Annual Audit Requirement.


 


The Recipient shall
have an annual audit performed by the Defense Contract Audit Agency (DCAA), or, an independent auditor, in accordance with 32 CFR
 §37.650. It is preferable that DCAA conduct the audit if the Recipient will grant DCAA access to information and records required
to complete the audit. The Recipient shall provide a copy of the auditor's report to the AO within 60-days after audit.


 


6.3              
Program Income. Program income derived during the initial Period of Performance from Government
funding shall be allocated to finance the non-Federal share of the Project (including the amounts described in Section 8.1) in
accordance with 32 CFR §34.14(d)(2). As contemplated by 32 CFR §34.14(b)(2), Recipient will have no obligation to the
Government for program income generated after the end of the Period of Performance, and no recover of funds is contemplated under
32 CFR §37.580.


 


		7.	Purchasing & Title



 


7.1        Title
to Property Acquired under Agreement. Title to real property, equipment, and supplies or intangible property that are acquired
by the Recipient (whether by purchase, construction or fabrication, development, or otherwise) with Government funding vests in
the Recipient conditionally as described at 32 CFR 37.685.


 


7.2              
Disposition. Any Federal interest in the real property or equipment remaining after the term
will be addressed at the time of property disposition. Disposition will be in accordance with 32 CFR 34.21.


 


7.3             
Purchasing System. If the Recipient currently performs under DoD assistance instruments subject
to the purchasing standards in 32 CFR 34.31, then that Part applies. Otherwise, the Recipient may use the existing purchasing systems,
as long as applicable requirements are flowed down (37.705).


 




    	 	 	 



     


    

 


		8.	Cost Sharing



 


8.1       To
the maximum extent practicable, the recipient must provide at least [half] of the
costs of the project, in accordance with §37.215. Total value of the TIA means the total amount of costs that are currently
expected to be charged to the award over its life, which includes amounts for the Federal share and any non-Federal cost sharing
or matching required under the award; and any options, even if not yet exercised, for which the costs have been established in
the award.


 


8.2        
The Government funding is estimated to represent approximately [50%]
of the overall amount necessary to accomplish the scope of work cited in the proposal (inclusive of all proposal revisions and
appendices). The Recipient agrees to provide the resources in the manner shown in their proposal. Recipient's cost sharing contribution
will occur within the term of the agreement but may not coincide with the Government's expenditure payments.


 


8.3        
Failure of either Party to provide its respective total contribution may result in a unilateral
modification to this Agreement by the AO to reflect proportional reduction in funding for the other Party.


 


		9.	Government Preference



 


[9.1       Pricing.
For a period of three (3) years following construction, installation and startup of commercial production for VanishPoint 1 mL,
VanishPoint 3 mL syringes and EasyPoint needles made by Recipient on machines funded by the U.S. Government ("Products")
Recipient agrees not to knowingly offer or sell such Products to any other U.S. purchaser for a unit price less than that offered
to the U.S. Government by Recipient with the exception of sales under contractual price agreements executed prior to the effective
date of this Agreement. In the event that Recipient, without prior written agreement by the Agreements Officer, makes a material
sale of Products to another U.S. purchaser at a unit price lower than that offered by Recipient to the U.S. Government, Recipient
shall promptly notify the Agreements Officer of the lower unit price of Products sold. Recipient shall also promptly apply the
difference in unit price against the unit price quoted to the U.S. Government for Products then on order or subsequently ordered
from Recipient within the three-year period. For a period of 10 years following construction, installation and startup of commercial
production for VanishPoint 1 mL, VanishPoint 3 mL syringes and EasyPoint needles should any other public health emergency be declared,
the aforementioned preferred pricing shall be in effect for up to three (3) years upon declaration of public health emergency.]


 


9.2       Precedence.
Recipient agrees that upon Presidential Declaration of a Public Health Emergency, that Government orders will be provided precedence
for completion on machines funded by the U.S. Government over and above any other orders. This requirement applies regardless of
a DO or DX rating under the Defense Production Act.


 


9.3       Maintenance
of equipment and availability of capacity. Recipient agrees that for a period of 10 years following the commissioning of equipment
funded by this Agreement, that it shall maintain the equipment in such a way as to ensure that, should the rights established under
9.1 and 9.2 be in effect, there is capacity equal to that which was available at time of commissioning. Further, the Recipient
agrees that should the equipment funded by this agreement be unavailable during a period in which the rights under 9.l and 9.2
are in effect, the Recipient will make available to the Government equivalent capacity from equipment not funded under this agreement.


 


9.4.      Inspection
of equipment. The Recipient grants the Government the right to inspect at any time, upon provision of reasonable advance notice,
the equipment funded by this agreement. This right shall be in effect for l 0 years following commissioning of the equipment.


 






    	 	 	 



     


    

 


		10.	Records Retention & Government Access



 


The DoD, Comptroller
General of the United States, or any of their duly authorized representatives, have the right of timely and unrestricted access
to any books, documents, papers, or other records of the Recipient that are pertinent solely to the Recipient's technical performance
under this Agreement, in order to make examinations, excerpts, transcripts and copies of such documents. This right also includes
timely and reasonable access to the Recipient's personnel for the purpose of interview and discussion related to such records.
Such access shall be performed during business hours on business days upon written notice and shall be subject to the security
requirements of the audited Party to the extent such security requirements do not conflict with the rights of access otherwise
granted by this paragraph. The rights of access in this paragraph shall last as long as records are retained. The rights of access
in this paragraph do not extend to the Recipient's financial records.


 


		11.	Intellectual Property & Patent Rights



 


11.1          
Background IP and Materials. The Recipient and the Government each retain any intellectual
property (IP) rights to their own materials, data, technology, information, documents, or know-how – or potential rights,
such as issued patents, patent applications, invention disclosures, or other written documentation – that exist prior to
execution of this Agreement or are developed outside the scope of this Agreement (Background IP).


 


11.2          
Authorization and Consent for Non-commercial Products. The Government authorizes and consents
to all use and manufacture, in performance of this Agreement, of any invention described in and covered by a United States patent,
except for deliverables under this Agreement that are commercially available to the public by the Recipient.


 


11.3          
Ownership. Ownership of any invention, regardless of whether it is not patentable, held as
a trade secret or is patentable under U.S. patent law that is conceived or first reduced to practice under this Agreement will
follow inventorship in accordance with U.S. patent law. The Parties represent and warrant that each inventor will assign his or
her rights in any such inventions to his or her employing organization.


 


11.4          
Patent Applications. Irrespective of any Disclosure of Information clauses in this Agreement
the Parties will respectively have the option to file a patent application claiming any Invention made solely by their respective
employees. The Parties will consult with each other regarding the options for filing a patent application claiming a joint Invention.
Within two (2) months of being notified of the discovery of an invention or filing a patent application covering an Invention,
each Party will provide notice of such discovery or filing to the other Party. The Parties will reasonably cooperate with each
other in the preparation, filing, and prosecution of any patent application claiming an Invention. Any Party filing a patent application
will bear expenses associated with filing and prosecuting the application, as well as maintaining any patents that issue from the
application, unless otherwise agreed by the Parties.


 


11.5          
Licenses. Upon the Recipient's request, the Government agrees to enter into good faith negotiations
regarding a non-exclusive commercialization license covering the Government's interest in any Invention made in whole or in part
by a Government employee. Any Invention made by a Recipient employee is subject to a nonexclusive, nontransferable, irrevocable,
paid-up license for the Government to practice and have practiced the Invention.


 


11.6          
Executive Order No. 9424 of 18 February 1944 requires all executive Departments and agencies
of the Government to forward through appropriate channels to the Commissioner of Patents and Trademarks, for recording, all Government
interests in patents or applications for patents. Should any of these provisions be inconsistent with the Bayh-Dole Act, the statute
takes precedence.


 






    	 	 	 



     


    

 


		12.	Data Rights



 


12.1          
All data generated in connection with the performance of the studies under this Agreement,
or that arises out of the use of any materials or enabling technology provided or used by the Recipient in the performance of this
Agreement, other materials or confidential information, whether conducted by the Government or the Recipient (collectively, the
 "Study Data"), shall be owned by the Recipient. The Government shall have the right to use, modify, reproduce, release,
perform, display, or disclose data first produced in the performance of this Agreement within the Government and otherwise including
use for Government procurement of the items covered by the data. The Government may, under a separate agreement or by modification
to this agreement, obtain any rights to use or disclose the material or data to the extent that such material or data was produced
outside the scope of the Agreement. Notwithstanding the above, as a result of this Agreement, the Government shall obtain “Unlimited
rights,” as that term is defined in DFARS 252.227-7013(a)(16) in any data generated under this agreement.


 


12.2       Marking
of Data: The Recipient is responsible for affixing appropriate markings indicating the rights of the Recipient on all data and
technical data delivered under this Agreement. Any rights that the Awardee or the Government may have in data delivered under this
Agreement, whether arising under this Agreement or otherwise, will not be affected by Awardee's failure to mark data pursuant to
this Article. Any distribution markings shall be established by the GPM and incorporated prior to distribution.


 


12.3        
Any Software (as that term is defined in DFARS 252.227-7014) developed under this agreement
shall be owned by the Recipient subject to "Unlimited Rights" (as that term is defined in DFARS 252.227-7014) held by
the Government. The Recipient shall deliver source and object code for each instance of Software developed under the agreement
in accordance with the requirements of the other deliverables under this Agreement. Use of any open source code in any Software
required to be delivered to the Government shall be subject to approval of the Government.


 


12.4       
Any Technica1 Data and Software (each term as defined under DFARS 252.227-7013) which shall
be delivered under this agreement with less than unlimited rights shall be identified in reasonable specificity and particular
rights granted (Government Purpose, Limited or Restricted (all as defined in DFARS 252.227-7013)) prior to entering into the agreement.
All other Technical Data and Software developed under funding of this agreement shall be delivered with unlimited rights as provided
for within this Article.


 


		13.	U.S. Food and Drug Administration (FDA) Regulatory Compliance



 


13.1       Good
Manufacturing Practices (GMP) Compliance. To the extent required under the Federal Food, Drug, and Cosmetic Act, the Recipient
will ensure that the manufacturing capability established under this Agreement complies with current good manufacturing practices
(cGMPs) under 21 CFR 210 and 211. The Recipient will notify the Government of any written cGMP inspection findings from the FDA
pertinent to the manufacturing capability established under this Agreement.


 


13.2       FDA
Communications. The Recipient will provide the Government with summaries of any Recipient formal meetings with the FDA and future
correspondence between Recipient and the FDA regarding the manufacturing contemplated under this Agreement and ensure that Government
representatives are invited to participate in any Recipient formal meetings with the FDA regarding topics that are material to
Recipient's compliance with the terms of this Agreement.


 




    	 	 	 



     


    

 


		14.	Termination



 


Termination and Enforcement
procedures are in accordance with 32 CFR §34.51 through §34.52.


 


		15.	Disputes



 


For any disagreement,
claim, or dispute arising under this Agreement, the parties shall communicate with one another in good faith and in a timely and
cooperative manner. Whenever disputes, disagreements, or misunderstandings arise, the parties shall attempt to resolve the issue
by discussion and mutual agreement as soon as practicable. Failing resolution by mutual agreement, the aggrieved party shall request
a resolution in writing from the AO. The AO will review the matter and render a decision in writing. Any such decision is final
and binding. In the event of a decision, within 60-calendar days of the referral for review (or such other period as agreed upon
by the parties), either party may pursue any right or remedy provided by law in a court of competent jurisdiction as authorized
by 28 U.S.C. 1491. Alternately, the parties may agree to explore and establish any Alternate Disputes Resolution procedure to resolve
this dispute


 


		16.	Reports & Distributions



 


16.1          
Monthly Progress Reports. Submitted monthly no later than the 10th of the month.
Recipient format acceptable. Electronic submission acceptable in MS Office or PDF format. Financial information shall be MS Excel
format. Monthly reports shall NOT be marked proprietary and shall have Distribution Statement C (U.S. Government and their contractors).
Each monthly report shall, at a minimum, contain the following:


 


		a.	Summary of monthly progress for the Recipient’s facilities/capabilities
associated with this effort;



		b.	Summary of progress towards established milestones for each facility/capability;



		c.	Identification of any milestone that is slipping or missed, and discussion
of path forward to bring milestone back to schedule, and impact on other milestones;



		d.	Summary of risks, discussion of potential impacts and efforts to
mitigate;



		e.	Summary of overall schedule and changes from previous month;



		f.	Financial summary of Recipient costs incurred by month to date, vouchers
submitted, and Government payments made.



 


16.2    
Quarterly-In-Process Reviews. Scheduled as needed, generally not more frequently than
quarterly, at the Recipient's facilities. Duration: eight (8) hours max. Face-to-face review of previous quarter’s activities.
Informative in nature to keep BARDA apprised of project progress and to discuss issues that may require joint resolution, such
as milestone changes, political impacts on objectives, schedule, funding.


 


16.3    
Annual Financial Status Report. (37.880)


 


16.4    
Final Report. Final Report shall not be marked proprietary, and shall have Distribution Statement
C. Final report summarizing stated objectives and the progress that was achieved in meeting those objectives; summary of risks
incurred, impacts and mitigation; quantitative discussion of needle & syringe production throughput improvements achieved;
financial summary of project; schedule summary for project, comparing original schedule to final schedule; recommendations for
path forward as applicable.


 






    	 	 	 



     


    

 


		17.	Modification of the Agreement



 


17.1       Limitation.
In no event shall any understanding or agreement, modification, change order, or other matter in deviation from the terms of this
agreement between the Recipient and a person other than the AO be effective or binding upon the Government. All such actions must
be formalized by a proper contractual document executed by the AO. The only method by which this Agreement can be modified is by
a formal, written modification signed by the AO. No other communications, whether oral or in writing, shall modify this Agreement.


 


17.2       Recommendation.
Modifications to this Agreement may be proposed by either Party. Recipient recommendations for any modifications to this Agreement,
including justifications to support any changes to the proposal (inclusive of proposal revisions, proposal appendices, and the
collaboration plan), as incorporated by reference, shall be submitted in writing to the Government PM with a copy to the AO. The
Recipient shall detail the technical, chronological, and financial impact of the proposed modification to the program. Changes
are effective only after this Agreement has been modified. The AO is responsible for the review and verification of any recommendations.


 


17.3       Unilateral
or Minor. The AO may unilaterally issue administrative Agreement modifications (e.g., changes in the paying office or appropriation
data, or changes to Government personnel identified in this Agreement, etc.). All other modifications shall be the result of bilateral
agreement of the Parties. The Government may make minor or administrative Agreement modifications unilaterally.


 


		18.	Miscellaneous



 


18.1       Security.
The Recipient shall not develop and/or handle classified information in the performance of this Agreement. No DD254 is currently
required for this Agreement.


 


18.2       Entire
Agreement. This Agreement, inclusive of the proposal, proposal revision, proposal appendices, and collaboration plan(s), constitutes
the entire Agreement between the Parties concerning the subject matter hereof and supersedes any prior understandings or written
or oral Agreement relative to said matter. In the event of a conflict between the terms of this Agreement, the terms of this Agreement
shall govern.


 


18.3       Waiver
of Rights. Any waiver of any requirement contained in this Agreement shall be by mutual agreement of the Parties hereto. Any waiver
shall be reduced to a signed writing and a copy of the waiver shall be provided to each Party. Failure to insist upon strict performance
of any of the terms and conditions hereof, or failure or delay to exercise any rights provided herein or by law, shall not be deemed
a waiver of any rights of any Party hereto.


 


18.4       Liability.
No Party to this Agreement shall be liable to the other Party for any property consumed, damaged, or destroyed in the performance
of this Agreement, unless it is due to the negligence or willful misconduct of the Party or an employee or agent of the Party.
In no event shall either Party be liable for special, incidental, or consequential damages arising from or connected with this
Agreement.


 


18.5       Non-Assignment.
This Agreement may not be assigned by any Party except by operation of law resulting from the merger of a Party into or with another
corporate entity.


 


18.6       Severability.
If any clause, provision or section of this Agreement shall be held illegal or invalid by any court, the invalidity of such clause,
provision, or section shall not affect any of the remaining clauses, provisions, or sections herein, and this Agreement shall be
construed and enforced as if such illegal or invalid clause, provision, or section had not been contained herein.


 


18.7       Force
Majeure. Neither Party shall be in breach of this Agreement for any failure of


 






    	 	 	 



     


    

 


performance caused by any event beyond its reasonable
control and not caused by the fault or negligence of that Party. If such a force majeure event occurs, the Party unable to perform
shall promptly notify the other Party and shall in good faith maintain such partial performance as is reasonably possible and shall
resume full performance as soon as is reasonably possible.





 


		18.8	Foreign Access to Technology & Domestic Manufacturing.



 


18.8.1     
Activities Abroad. The Recipient shall assure that project activities carried on outside the
United States are coordinated as necessary with appropriate Government authorities and that appropriate licenses, permits, or approvals
are obtained prior to undertaking proposed activities. The awarding agency does not assume responsibility for Recipient compliance
with the laws and regulations of the country in which the activities are to be conducted.


 


18.8.2     
Export. The Parties understand that information and materials provided pursuant to or resulting
from this Agreement may be export controlled, sensitive, for official use only, or otherwise protected by law, executive order,
or regulation. The Recipient is responsible for compliance with all applicable laws and regulations. Nothing in this Agreement
shall be construed to permit any disclosure in violation of those restrictions.


 


18.8.3    Exclusive
right to use or sell the technology in the United States must, unless the Government grants a waiver, require that products embodying
the technology or produced through the use of the technology will be manufactured substantially in the United States (37.875).


 


18.9       Publicity.
During the term of this Agreement, each Party will obtain the consent of the other Parties and the Government Program Manager before
making any press releases or public statement pertaining to the Program or to this Agreement. This consent will not be unreasonably
withheld. In addition, each Party will provide the other Parties 60-days in which to review and comment on proposed scholarly publications
or presentations. The publishing Party shall take into account any comments received, and shall remove any other Party's Confidential
Information that appears in the publication.


 


 


IN WITNESS WHEREOF, each Party has
executed this Agreement by signature of its authorized representative.


 


SIGNATURES:


 


	Recipient	 	Government
	 	 	 
	 	 	 
	[/s/ Thomas J. Shaw]	 	[/s/John Conlin]
	Signature	 	Signature
	 	 	 
	[THOMAS J. SHAW]	 	[John Conlin]
	Printed Name	 	Printed Name
	 	 	 
	[CEO]	 	Agreements Officer
	Title	 	Title
	 	 	 
	7/1/2020	 	 
	Date	 	Date