Exhibit 10.2


 





 






     

     


    

 





	 	Quality
                                         Agreement








 





 



 


Approvals


 


The
signatures below certify that this document has been reviewed and accepted, and demonstrates that the signatories are aware of
all the requirements contained herein and are committed to ensuring their provision.


 


	 	Name	Signature	Position	Date
	Pocono
    Coated Products, LLC	Michael
                                         Myer



	/s/
    Michael Myer	CQO	07/19/2016
	Nutriband,
    Inc.	Gareth
                                         Sheridan




	/s/
    Gareth Sheridan	CEO	07/19/2016


 


Amendment
Record


 


This
Quality Agreement is reviewed to ensure its continuing relevance to the systems and processes that it describes. A record of contextual
additions or omissions is given below:


 


	Page
    No.	Context	Revision	Date
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	 	 


 


Document
Control


 


The
electronic version of this document is the latest revision. It is the responsibility of the individual to ensure that any paper
material is the current revision. The printed version of this manual is uncontrolled, except when provided with a document number
in the field below:


 


	Document
    No	Pocono-Nutriband-QA	 	 
	 	 	 	 
	Uncontrolled
    Copy	 ☐	 	Controlled
    Copy	☒	 	Date	07/19/2016





 



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Contents


 


	CONTENTS	 
	 	 	 	 	 
	QUALITY AGREEMENT	3
	 	 	 	 	 
	 	1.	Administrative
    Elements	4
	 	 	1.1	Scope	4
	 	 	1.2	Parties
    to the Agreement and Their Responsibilities	4
	 	 	1.2.1	Responsibilities
    – CUSTOMER	4
	 	 	1.2.2	Responsibilities
    – POCONO	5
	 	 	1.3	Devices
    Covered by This Agreement	6
	 	 	1.4	Site(s)
    Involved	6
	 	 	1.5	Quality
    Management Systems	6
	 	 	1.6	Term
    of Agreement	6
	 	 	1.7	Assignment	6
	 	2.	Compliance	7
	 	 	2.1	Specification
    Changes	7
	 	 	2.2	Activity
    by Regulators, Notified Bodies, or Certification Bodies	7
	 	 	2.3	Third-Party
    Quality Agreements	7
	 	3.	Change
    Control	8
	 	 	3.1	Change
    Requests	8
	 	 	3.2	Deviations	8
	 	 	3.3	Other
    Changes	8
	 	4.	Non-Conformance,
    CAPA, and
    Complaints	9
	 	 	4.1	Non-Conformances	9
	 	 	4.2	Corrective
    Action	9
	 	 	4.2.1	POCONO
    Initiated Corrective Action	9
	 	 	4.2.2	CUSTOMER
    Initiated Corrective Action	9
	 	 	4.3	Complaints	9
	 	 	4.3.1	POCONO
    Received Complaints	9
	 	 	4.3.2	CUSTOMER
    Received Complaints	10
	 	5.	Audits	11
	 	6.	Debarment	12




 






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Quality
Agreement


 


	1.	Administrative
    Elements




 


	1.1	Scope




 


This
Quality Agreement is a comprehensive written agreement that defines and establishes the obligations and responsibilities of the
Quality Units of each party involved in the contract manufacturing of transdermal patches subject to cGMP. This Quality Agreement
clarifies which of the cGMP activities are to be carried out by each party. This agreement is not a commercial or business agreement;
it does not cover issues such as general business terms and conditions, confidentiality, pricing or cost issues, delivery terms,
or liquidated damages.


 


This
agreement, solely, defines the Quality Agreement between the parties identified below. It defines the commitment the parties make
to ensure their respective processes and services satisfy the quality and regulatory requirements called out in this agreement.
Each party agrees to cooperate in the success of this agreement.


 


Pocono
Coated Products, LLC does not participate in any marketing claims made by the customer. Furthermore, Pocono Coated Products, LLC
prohibits the use of the Facility Establishment Identifier (FEI) for which Pocono Coated Products, LLC is registered too to be
used without prior written consent.


 


	1.2	Parties to the
    Agreement and Their Responsibilities




 


This
Quality Agreement is executed between Pocono Coated Products, LLC with business address at 100 Sweetree Street, Cherryville, NC
28021, hereafter referred to as ‘POCONO’ and Nutriband, Inc with business address at 309 Celtic Court, Oviedo, FL,
32765 hereafter referred to as ‘CUSTOMER’.


 


All
parties, collectively herein referred to as ‘the parties’, agree to provide the goods or services defined below in
full conformance with the requirements of this agreement.


 


Quality
Unit Responsibilities


 


The
Quality Unit of each party is responsible for the process or service it performs. The assignment of particular responsibilities
to either party does not relieve any party from compliance with cGMP requirements that are not specifically set forth in this
agreement. The CUSTOMER is ultimately responsible for approving or rejecting product(s) mentioned in section 1.3 of this agreement,
manufactured, processed, packed, or held under contract by POCONO. Although the Quality Unit of POCONO is responsible for release
of the device from the operations it performs, final device release of finished goods for distribution must be carried out by
the CUSTOMER and the responsibility cannot be delegated to another party under the cGMP regulations or any terms of the Quality
Agreement. All parties will comply with cGMP’s and applicable local (state and national) authorities as agreed by the parties.


 


Points
of Contact at CUSTOMER:


 


	Gareth
    Sheridan	phone:
    (887) 616-0959	email:
    gareth@nutriband.com


 


Points
of Contact at POCONO:


 


	Rick
    Myer	phone:
    (704) 445-7891	email:
    rgmyer@poconoctd.com
	 	 	 
	Mike
    Myer	phone:
    (980) 202-0429	email:
    mrmyer@poconoctd.com


 


	1.2.1	Responsibilities
    – CUSTOMER



 



		●	Final
                                         approval of any/all final product change request(s);
	 	 	 
		●	Final
                                         product formulation percentage approval;
	 	 	 
		●	Ultimately
                                         responsible for approving or rejecting devices manufactured, processed, packed, or held
                                         under contract by another company;






 









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		●	Final
                                         product approval and release of finished goods for distribution;
	 	 	 
		●	Maintenance
                                         of regulatory status, and communication of any changes;
	 	 	 
		●	Determining
                                         suitability for warehousing device, and performance and documentation of due diligence;
	 	 	 
		●	Approve
                                         all CAPAs;
	 	 	 
		●	Approve
                                         master labels and/or artwork;
	 	 	 
		●	Responsible
                                         for complaints, communications with the regulatory authorities and product recalls;
	 	 	 
		●	Ensure
                                         personnel participate in on-going training to facilitate conformance through their required
                                         activities;
	 	 	 
		●	All
                                         required documentation pertinent to their activities.



 


	1.2.2	Responsibilities
    – POCONO




 


		●	Procurement
                                         of primary packaging;
	 	 	 
		●	Procurement
                                         of secondary labelling and packaging;
	 	 	 
		●	Procurement
                                         of all materials needed for the manufacturing, packaging, and shipping of device(s) covered
                                         in this Quality Agreement, excluding materials for which CUSTOMER is responsible to procure.
	 	 	 
		●	Final
                                         product inspection;
	 	 	 
		●	Receiving,
                                         inspecting/approval of use, and storage of incoming raw materials for use in manufacturing
                                         processes;
	 	 	 
		●	Receiving,
                                         inspecting/approval of use, and storage of incoming raw materials for use in order fulfilment,
                                         packaging;
	 	 	 
		●	Ensure
                                         personnel participate in on-going training to facilitate conformance through their required
                                         activities.



 


Facilities
and Equipment


 


		●	Maintaining
                                         a facility free of infestation;
	 	 	 
		●	Maintaining
                                         programs to ensure required equipment is calibrated and maintained properly;
	 	 	 
		●	Maintain
                                         environmental conditions free from extreme climate change.



 


Materials
Management


 


		●	Sourcing
                                         of required material(s) and vendor due diligence;
	 	 	 
		●	Receiving,
                                         inventory control, product labelling, and storage to prevent mix-ups and cross-contamination;
	 	 	 
		●	Sampling,
                                         and approving or rejecting all incoming receivables used in any aspect of the device
                                         manufacture, or packaging.



 


Sampling
Controls


 


		●	Maintain
                                         trained personnel necessary for proper sample testing;
	 	 	 
		●	Ensure
                                         all monitoring and measuring equipment are calibrated and maintained properly.



 


Documentation


 





		●	Ensure
                                         all required documentation pertaining to the quality management systems, training, manufacture
                                         process, packaging process are written and followed.





 









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	1.3	Devices Covered
    by This Agreement




 


This
agreement pertains to the device(s) listed in the table below.


 


	Device	Description
	Slimline
    Patch	Die-cut,
    individually sealed, and boxed in 5 packs and 30 packs
	Vitamin
    Patch	Die-cut,
    individually sealed, and boxed in 5 packs and 30 packs
	Energy
    Patch	Die-cut,
    individually sealed, and boxed in 5 packs and 30 packs




 


	1.4	Site(s) Involved




 


Laboratory
testing is conducted at the site(s) listed below.


 





	Testing
    Facility	Site
    address
	None
    listed	None
    listed




 


Third
Party logistics and storage is conducted at the site(s) listed below.


 





	Warehousing
    Facility	Site
    address
	None
    listed	None
    listed




 


	1.5	Quality Management
    Systems




 


CUSTOMER
should maintain a Quality Management System (QMS) that minimally conforms to the requirements of their activities outlined in
section 1.2.1 of this Quality Agreement and ensures full traceability.


 


POCONO
shall maintain a Quality Management System (QMS) that minimally conforms to the requirements of their activities outlined in section
1.2.2 of this Quality Agreement and ensures full traceability.


 


	1.6	Term of Agreement




 


This
Agreement shall become effective and binding upon the date of the final signature and shall remain in effect for 2 years after
the last delivery of any product by POCONO and CUSTOMER, unless either party specifically requests an extension of the Agreement.
Either party may terminate the Agreement by giving 6 months written notice to the other parties.


 


	1.7	Assignment




 


None
of the parties shall have the right to assign any or all of its rights or obligations under this agreement without the other parties’
prior written consent, which shall not unreasonably be withheld. The foregoing notwithstanding, prior to written consent shall
not be required in connection with a merger, consolidation, or a sale of all or substantially all of a party’s assets to
a third party, except if such merger, consolidation or sale is with a competitor of the other parties.


 









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	2.	Compliance




 


	2.1	Specification
    Changes




 


Changes
to specifications are made and documented by mutual agreement between the parties. In addition to agreement of the change POCONO
and CUSTOMER will determine the date when the change becomes effective. When the specifications include references to brand names
POCONO and CUSTOMER will mutually agree on the implementation of any changes made in the brand device. The changes will be documented,
signed, and dated by representatives of both parties.


 


	2.2	Activity by Regulators,
    Notified Bodies, or Certification Bodies




 


Any
audited party shall promptly notify the other party of any inspections, audits, formal visits, etc. of any regulator, notified
body, or certification body acting in a formal capacity. In the US this includes, but is not limited to the Food and Drug Administration,
the Environmental Protection Agency, the Occupational Safety and Health Administration, and the Drug Enforcement Agency. It also
includes corresponding State Agencies. Upon written request from either party, the audited party shall disclose the results of
any regulatory inspections or audits and the associated cause and corrective action. The audited party shall promptly notify the
other parties of any inspection or audit findings that affect the safety, effectiveness, conformity, or availability of device(s)
provided.


 


This
section does not extend the results of internal audits, or audits conducted by other clients of audited parties.


 


	2.3	Third-Party Quality
    Agreements




 


All
parties utilizing Third Party Suppliers must instate a Quality Agreement with those suppliers used for production, packaging,
testing, processing, or release. Upon written request a copy of the Quality Agreement must promptly be presented.


 









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	3.	Change Control




 


	3.1	Change Requests




 


Changes
may be requested by either party, for any reason, but must go through the appropriate initiation and approval/rejection process.
Any party requesting a change must fill out a change request form, and submit it for review. The request shall include the specific
change, the reason for the change, the benefit from approving the request, the loss incurred from disapproving the request, and
the anticipated lead-time before the change is reflected in the product. All parties must approve change requests prior to implementation,
then work in collaboration to develop a plan of implementation. Either party can use their own change request forms.


 


The
receiving party shall promptly acknowledge receipt of each change request.


 


	3.2	Deviations




 


If
any party needs to deviate from a document, specification, drawing, etc. under another party’s control, that party will
document the deviation request including the specific deviation, the reason for the deviation, and the period (time, lots, etc.)
the deviation will be in effect.


 


	3.3	Other Changes




 


POCONO
will promptly notify CUSTOMER of changes in the product or service so the CUSTOMER may determine whether the changes may affect
the quality of the finished product.


 









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	4.	Non-Conformance,
    CAPA, and Complaints




 


	4.1	Non-Conformances




 


The
parties must have standard operating procedures (SOPs) on how to handle all Non-Conformances. POCONO is authorized to make rework
and scrap dispositions without authorization from CUSTOMER. Concession or repair dispositions require CUSTOMER written authorization.


 


If
POCONO requests authorization for a repair or concession disposition, POCONO will document the disposition request including the
inspection or test conducted, the actual results, and, if applicable, the proposed repair using a Non-Conformance Report (NCR).


 


Any
non-conformance found outside of POCONO activities warrants an initiation of a NCR to the third party with which the activity
pertains. This, depending on material(s) disposition, may initiate a Corrective Action Report (CAR).


 


	4.2	Corrective Action




 


	4.2.1	POCONO Initiated
    Corrective Action




 


Corrective
Action shall include the following steps.


 


		1.	Determine
                                         the cause(s) of nonconformity
	 	 	 
		2.	Evaluate
                                         the need for action to ensure the nonconformity doesn’t recur
	 	 	 
		3.	Determine
                                         the action needed to prevent recurrence
	 	 	 
		4.	Implement
                                         the action needed to prevent recurrence
	 	 	 
		5.	Review
                                         the effectiveness of the corrective action



 


The
receiving party must report the results of the corrective action to the initiating party within 15 working days of initiation.
When the Corrective Action is not completed within 15 days, the receiving party will provide a status report every 5 working days
until the corrective action is completed. The receiving party must document this information regarding these activities and provide
availability upon written request.


 


	4.2.2	CUSTOMER Initiated
    Corrective Action




 


CUSTOMER
may initiate corrective action for POCONO when non-conformances are identified after receipt of POCONO product. POCONO will investigate
a corrective action upon receipt of the request. POCONO corrective action will include the same steps mentioned in subsection
4.2.1 of this agreement. POCONO will report the results of the corrective action to the initiating party within 15 working days
of initiation. When the corrective action is not completed within 15 days, POCONO will provide a status report every 5 working
days until the corrective action is completed. POCONO keeps documented information regarding these activities and will provide
availability to CUSTOMER upon written request.


 


	4.3	Complaints




 


Whichever
party is listed on the product labelling will make record all serious, unexpected adverse experiences associated with the use
of the. These concerning experiences are defined and explained in 21 CFR 310.305.


 


	4.3.1	POCONO Received
    Complaints




 


If
POCONO receives a complaint related to the product supplied to the CUSTOMER, POCONO will promptly forward those complaints to
CUSTOMER, enter the complaint into the Customer Complaint Management System and review and evaluate the complaint. CUSTOMER will
notify POCONO of the result of the review and evaluation. If CUSTOMER requires POCONO assistance in the investigation, CUSTOMER
will follow the steps for CUSTOMER initiated corrective action described above in subsection 4.2.2.


 









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	4.3.2	CUSTOMER Received
    Complaints




 


If
CUSTOMER receives a complaint related to the product supplied, the receiving party will enter the complaint into the Customer
Complaint Management System, review and evaluate the complaint and notify POCONO in writing. If the receiving party requires POCONO
assistance in the investigation, the receiving party will follow the steps for CUSTOMER initiated corrective action described
above in subsection 4.2.2.


 









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	5.	Audits




 


This
agreement provides the parties with the opportunity, at their expense, to evaluate and/or audit the other party to ensure cGMP
compliance for manufacturing processes occurring at the audited site(s). If objectionable conditions are found through conducting
an audit, the Quality department of the audited party must send an audit report to the audited party. The auditing party must
submit an Audit Report within 30 calendar days. The auditing/audited parties must follow the guidelines of section 4.


 









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	6.	Debarment




 


All
parties are required to follow all laws and regulations set in place by the Generic Drug Enforcement act of 1992


 


		●	All
                                         parties will not employ persons that have been convicted of a crime for which they could
                                         be debarred.
	 	 	 
		●	All
                                         parties will not use in any capacity the services of any person, or entity, that has
                                         been or can be debarred under the Generic Drug Enforcement Act of 1992.



 


 


  


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