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Digital Commodities Inc. — Regulatory Filings 2021
Sep 30, 2021
43345_rns_2021-09-29_a1714be2-4979-4f25-8ebd-880f0423332b.pdf
Regulatory Filings
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QUALITY AGREEMENT
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In Witness Whereof, the Parties hereto have caused this Quality Agreement to be executed by their authorized representatives as of the effective date and year of this Agreement.
Quality Agreement
for
Manufacturing, Packaging and Transport of Cannabis Products
Between
Contract Owner
BevCanna Enterprises Inc. 6401 Sidley Mountain Rd. Bridesville, BC V0H 1B0
and
Contract Acceptor
The BC Bud Co. (“Client”)
[redacted: personal address]
Vancouver, BC
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Quality Agreement between BevCanna Enterprises Inc. and Client
Document Ref: QKAQP-ZEQHN-VOXZZ-CERQQ
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Table of Contents
Contents
| 1. | Purpose and Scope...................................................................................4 |
|---|---|
| 2. | Term of Agreement ..................................................................................4 |
| 3. | Confidentiality .........................................................................................5 |
| 4. | Representations and Warranties.................................................................5 |
| 5. | Termination.............................................................................................6 |
| 6. | Regulatory Responsibilities ........................................................................6 |
| 7. | Facilities and Equipment ...........................................................................6 |
| 8. | Raw Materials..........................................................................................7 |
| 9. | Packaging and Labelling Materials ..............................................................7 |
| 10. | Manufacturing Instructions and Records ...................................................8 |
| 11. | Finished Product Testing.........................................................................8 |
| 12. | Risk Management (Preventive Control Plan) – PCP and Prohibited Substances9 |
| 13. | Reprocess and Batch Adjustments/Rework/Retest......................................9 |
| 14. | Technical Transfer, Promotions, and Assistance .......................................10 |
| 15. | Deviation and Non-Conformance............................................................10 |
| 16. | Certification and Disposition of Product...................................................10 |
| 17. | Documentation Requirements................................................................11 |
| 18. | Storage Requirements..........................................................................11 |
| 19. | Transportation Requirements ................................................................12 |
| 20. | Complaint and Adverse Event Handling...................................................12 |
| 21. | Returns..............................................................................................12 |
| 22. | Document and Reserve Sample Retention...............................................13 |
| 23. | Change Control ...................................................................................13 |
| 24. | Recalls ...............................................................................................13 |
| 25. | Regulatory Interactions and Inspections .................................................14 |
| 26. | Client Audits/Visits...............................................................................14 |
| 27. | Sub-Contractors ..................................................................................15 |
| 28. | General Provisions ...............................................................................15 |
| 29. | Final Approval .....................................................................................15 |
| ANNEX A: Contact Details.......................................................................17 |
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ANNEX B: List of Products ......................................................................18 ANNEX C: Table of Responsibilities .........................................................19 ANNEX D: Batch Numbering and Expiry Date System .............................24 ANNEX E: Sub-Contractors .....................................................................25 ANNEX F: History of Changes .................................................................26
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QUALITY AGREEMENT
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Table of Annexes
Annexes to this Quality Agreement are permissible for detailing/listing required information such as the list of products, product specifications, contacts, subcontractors list, etc. Revisions to the Annex information may be approved separately from the Main Agreement.
Annex A: Contact Details Annex B: List of Products Annex C: Table of Responsibilities Annex D: Batch Numbering and Expiry Date System Annex E: Sub-Contractors Annex F: History of Changes
1. Purpose and Scope
This Quality Agreement, (hereafter “Agreement”) is between:
BevCanna Enterprises Inc. (“BevCanna”) with corporate office located at 6401 Sidley Mountain Rd., Bridesville, B.C. V0H 1B0, Canada and Mailing Address: PO Box 33957 Vancouver D CSC, Vancouver, B.C. V6J 4L7
AND
The BC Bud Co. (“Client”) located 151 W. 2[nd] Ave. Vancouver, BC V5Y 0L8
BevCanna and Client are sometimes referred to herein individually as a ‘Party’ and collectively as the ‘Parties’.
This Agreement defines the expectations and responsibilities of BevCanna as an approved supplier of the products listed in Annex B (“Products”) to Client.
The scope, operation and requirements of the Quality Agreement is in relation to the Co-packing agreement entered into between the Parties (“Co-packing Agreement”) and shall be interpreted in a manner that is consistent with the terms and conditions of the Co-packing Agreement. In the event of any conflicts or inconsistencies between the Co-packing Agreement and this Agreement, this Agreement shall prevail with respect to any quality and compliance provisions. In the event that the Quality Agreement is silent, the Copacking Agreement shall apply, and specifically, the indemnity/limitation of liability, insurance, governing law and dispute resolution provisions of the Co-packing Agreement shall apply to the Quality Agreement.
This Agreement, and the Co-Packing Agreement, contain the entire agreement and understanding of the Parties with respect to manufacturing of products by BevCanna, and there are no other promises or conditions in any other agreement whether oral or written which form a part of the relationship of the Parties hereto. This Agreement supersedes any prior written or oral agreements between the Parties related to Quality. This Agreement may be modified or amended if the amendment is made in writing and is signed by both Parties.
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2. Term of Agreement
This Agreement shall enter into full force and effect on the date all Parties have signed the Agreement, and shall continue in effect until the termination, expiration or cancellation of the Co-packing Agreement. The responsibilities set forth in this Quality Agreement and all related definitions shall survive the completion of performance, expiration or termination of this Quality Agreement.
The Quality Agreement may be amended or renewed at any time by written agreement between all Parties. Annexes to this Agreement may be revised separately, as required. The History of Changes (Annex G) will document revision to the Agreement and the Annexes. Approval of the History of Changes by both Parties will indicate approval of any updates to the Annexes to this Agreement.
3. Confidentiality
The Parties acknowledge that manufacturing procedures, technical specifications of the Products and all other information provided by one Party to the other for the purpose of this Agreement constitute Confidential Information for the purposes of the Co-packing Agreement.
BevCanna and the Client shall commit each other to the strict secrecy of their mutual know-how. This provision shall survive termination of this Agreement or a separate Non-Disclosure Agreement (NDA).
Upon termination of this Agreement, the Parties shall, upon request, immediately return to each other the documents, studies and other written information provided, with the exception of data which the Party who received the request is obliged to retain pursuant to requirements under the Cannabis Act and Regulations.
4. Representations and Warranties
BevCanna agrees to implement and maintain a Quality Management System (QMS) in connection with performance of the obligations under this Agreement.
BevCanna represents, warrants and covenants that BevCanna:
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is a licensed processor of certain cannabis products pursuant to the Cannabis Act (Canada) under Licence No. LIC-XPWWN7429O-2021 from its site located at 6401 Sidney Mountain Road, Bridesville, BC V0H 1B0 (“License”).
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will provide a copy of the Licence to the Client. The Product(s) will only be produced at the location defined in this Agreement. Any change of location for production of the Product(s), including within the limits of the Licence, needs the pre-approval of the Client. BevCanna will inform Client immediately of all restrictions or updates concerning the Licence for the Product(s).
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has appropriate knowledge of, and will comply with all laws, regulations and regulatory guidelines applicable to its obligations under this Agreement, including but not limited to the GPP requirements under the Cannabis Act .
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will test all Product(s) under this Agreement prior to shipment to Client to ensure that they conform to their specifications and are otherwise of good quality and suitable for the purposes for which they are intended to be used.
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- has reasonable evidence and capability to conclusively determine whether or not the Product(s) conform to agreed upon specifications and to the standards required by regulatory authorities.
5. Termination
Termination of this Agreement does not relieve either party of their joint and/or individual responsibilities under Good Production Practices (GPP) for Products in distribution for commercial use or sale and that were manufactured in accordance with this Agreement.
Any termination must be affected by notice to the other Party in accordance with the notice provisions set out in the Co-packing Agreement.
6. Regulatory Responsibilities
BevCanna’s Licensed Sales Partner is responsible for maintenance of the product regulatory notifications, (Notice of New Cannabis Product, NNCP) and reports to Regulatory Agencies. BevCanna shall provide Client advance notification in writing of new or supplemental regulatory requirements that directly impact Client.
Based on the agreed upon timelines with BevCanna, Client shall be responsible for:
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(i) providing the documents required for drafting of the relevant regulatory submission/notification/report (hereafter referred to as ‘regulatory submissions’),
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(ii) review of regulatory submissions and to submit proposed revisions back to BevCanna, (iii) support BevCanna in answering questions from Regulatory Agencies relating to the facility and processes provided to Client. Upon submission to Regulatory Agencies, Client will be provided with a copy of the relevant section(s) of the regulatory submissions.
BevCanna will advise Client of any changes or updates to the regulatory submissions that pertain to Client’sproducts. BevCanna shall inform Client in writing of any reporting requirements that may impact Client. BevCanna will ensure that manufacturing, packaging, testing and supply of Product(s) are in strict accordance with the Submission on file with the Regulatory Agency.
BevCanna will ensure that Client is fully aware of any known risks/problems associated with the product, work or tests that might compromise or pose a hazard to products. BevCanna will within five (5) business days, inform Client of any such risks/problems as they arise during the tenure of supply.
7. Facilities and Equipment
Unless otherwise authorized by Client, all activities performed as per this Agreement will occur at the following facility: 6401 Sidney Mountain Road, Bridesville, BC V0H 1B0, Canada.
BevCanna must ensure that the Good Production Practices (GPP) manufacturing facilities are used, controlled and maintained in accordance with GPP and applicable laws and regulation. BevCanna shall not subcontract out any of their responsibilities without prior written consent from Client. Formulation and Analytical testing, such as pesticide testing, that cannot be performed by BevCanna will be contracted to an appropriate and approved subcontractor (at the Client’s expense). Information on any third-party service providers will be made available to Client and will be part of this Agreement as Annex F.
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BevCanna is responsible for ensuring that equipment for the manufacture and testing of Client’s Product(s) is calibrated, operated and maintained according to BevCanna’s internal Standard Operating Procedures (SOP) and GPP requirements.
8. Raw Materials
The manufacturing responsibility for the cannabis, ingredients, and the materials used in processing lies with BevCanna. This includes the responsibility for supplier qualification and, if necessary, regular audits of such suppliers as deemed to be critical in the manufacturing process.
The specifications of the cannabis products are agreed between BevCanna and Client and are set out in this Agreement in accordance with the Cannabis Act and Cannabis Regulations . Changes to Annexes B and F shall require the prior written consent of each Party. In the case of consent, the Parties will maintain the amended specifications in an updated Annex which is then part of this Agreement.
The Party responsible for procuring the materials specified in Annexes B and C is responsible for obtaining the relevant documentation related to compliance of the materials (for example, ingredient/packaging specifications and keeping records specified in the Cannabis Regulations.
Packaging and Labelling Materials
BevCanna shall be responsible for ensuring the proper quality of packaging and labelling materials procured by them and used in the manufacture of Product(s) for Client. The packaging materials will be checked by BevCanna and approved according to the defined specifications.
BevCanna is responsible for review and approval of all incoming receipts of packaging and labelling materials. Such materials must be purchased from vendors that are qualified and approved in accordance with established procedures.
Client is responsible for approval of packaging specifications and labelling designs provided by BevCanna. BevCanna shall inform Client in writing of any changes to packaging and labelling materials and supply revised specifications, final approved artwork, standards for text, copy, layout, etc. Effective controls shall be in place to ensure that revised packaging and labelling materials are clearly differentiated from prior versions and that obsolete and rejected materials are adequately separated and properly dispositioned.
9. Manufacturing Instructions and Records
BevCanna shall manufacture Client’s Product(s) according to written manufacturing Instructions (Master Batch Record) specific to each Product. A written manufacturing record, in compliance with GPPs, shall be completed for each batch manufactured. BevCanna shall create a manufacturing instruction, which contains the in-process controls with specifications to be performed. BevCanna shall inform Client of any other changes that have or could have an effect on the manufacturing procedure and the product quality prior to implementation.
BevCanna shall confirm to Client the proper production of each batch and provide Client with the corresponding documentation – Certificate of Compliance/Manufacture (as described in Annex D).
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10. Finished Product Testing
BevCanna shall establish appropriate specifications and test procedures for Client’s Product(s), which are consistent with the Cannabis Regulations. Specifications must be approved by Client.
BevCanna shall perform or have performed finished product testing using only approved and validated analytical methods. Any compendial method shall be verified prior to use. All testing methods must be validated as stated in part 5 Good Production Practices (GPP) for all Client’s Product(s) under this quality agreement.
BevCanna shall inform Client of any changes in the test methods that have or may have an impact on the test results prior to implementation.
Third party laboratories must be qualified as per BevCanna’s SOP and GPP requirements. Third party Laboratories are listed in Annex F.
11. Risk Management (Preventive Control Plan) – PCP and Prohibited Substances
A Preventive Control Plan compliant to s. 88.94 of the Cannabis Regulations will be developed by BevCanna for each edible Cannabis and Cannabis extract product manufactured for Client. BevCanna will ensure that Risk Management principles are applied prior to acceptance of new material into the GPP facilities to prevent cross-contamination. Under BevCanna’s procedures, under no circumstances should any other products which may present a potential hazard to Client’s Product(s) be permitted into the GPP facilities without a suitable containment plan.
The following substances are strictly prohibited from BevCanna’s GPP facility:
Pesticides listed in Health Canada’s Mandatory cannabis testing for pesticide active ingredients – List and limits
(https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/drugs-healthproducts/cannabis-testing-pesticide-list-limits/Mandatory-Cannabis-Testing-List-and-limits.pdf)
Substances other than those described above which pose a specific risk to the product should be communicated within this agreement along with pertinent information as to the specific mode of interaction with the product or packaging material.
12. Reprocess and Batch Adjustments/Rework/Retest
BevCanna must have procedures for batch adjustments and reprocessing, if applicable.
Reprocessing is defined as introducing an intermediate or raw material, including one that does not conform to standards or specifications, back into the process and repeating appropriate chemical or physical manipulation steps that are part of the manufacturing process.
Rework is defined as subjecting an intermediate or raw material that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain an acceptable quality.
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BevCanna must have a protocol for Product(s) requiring rework that describes the rationale and justification for rework for approved rework processes, if applicable.
BevCanna shall inform the Client of any batches that require re-testing and provide retest result documentation to Client upon request.
13. Technical Transfer, Promotions, and Assistance
BevCanna shall provide Client with technical information and assistance to prepare regulatory submissions, if applicable, and assist in preparation of regulatory notifications, health professional publications, notification to customers, monographs, leaflets and other publications.
Client shall use only promotional materials that are approved by BevCanna (e.g. website content, promotional decks, social media posts). BevCanna’s approval of promotional materials shall include both content of the promotion (e.g. logos, images, promotional claims) and method of distribution (e.g. television, radio, print ad, social media etc.) Client is responsible for providing promotional material to BevCanna for approval.
Client is responsible for providing BevCanna with assistance in responding to any communication from regulatory bodies that is received in response to promotional material associated with Client’s product
14. Deviation and Non-Conformance
BevCanna must notify Client within five (5) business days of becoming aware of any manufacturing process event which is likely to impact the safety or regulatory status of a Product.
BevCanna must notify Client within five (5) business days of the occurrence of any out-of-specification (OOS) results that impacts the lots of Product(s) in the market, unless the OOS result is invalidated within this time frame. Upon discovery of an OOS, BevCanna’s laboratories shall perform initial lab investigation with a target completion of seven (7) business days to rule out laboratory or known error and will notify BevCanna immediately upon confirmation of an OOS result. Parties shall agree upon appropriate corrective steps to be taken. If the confirmed OOS could reasonably be expected to result in a recall, BevCanna must require a 24-hour notification for those laboratories and Client will be notified within two (3) business days.
BevCanna shall ensure that any deviation, OOS and non-conformance related to manufacturing, packaging/labelling, testing, release and distribution processes related to product(s) are investigated. Where applicable, this includes the identification of the root cause, a risk analysis (including the risk to other lots and impact to other test results), and the actions taken for correction of the problem, prevention of future occurrence and the formal conclusion by BevCanna’s Quality Assurance department. If an investigation reveals that there is no impact on the Product(s) in the market, BevCanna shall inform Client within three (3) business days.
15. Certification and Disposition of Product
BevCanna shall issue a Certificate of Compliance/Manufacture to cover all stages of manufacture and a Certificate of Analysis for each batch of Product. This documentation shall be supplied to the Client with
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each production lot. The Certificate of Compliance/Manufacture must comply with Client’s requirements and the Cannabis Act and Regulations.
BevCanna will provide a Certificate of Analysis (COA) for every lot/batch of product supplied. The certificate will as a minimum:
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Identify BevCanna as the organization issuing it, be signed and dated by the Quality Assurance Person.
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Include the name of the material to which it refers and identification by a lot number.
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Include the date of manufacture of the product.
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Document the results obtained for quantitative analysis.
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Document that the results showed compliance to the stated specification for qualitative analysis.
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State the specification(s) and current method(s) against which, and by which, the analysis was performed.
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State the storage conditions.
16. Documentation Requirements
BevCanna must have a QMS that conforms to the requirements found in Part 5 (Good Production Practices (GPP)) and Part 6 (Cannabis Products) of the Cannabis Regulations. Moreover, BevCanna will provide Client with a copy of the master batch records used for the manufacture, packaging, labeling and testing of the product. Master documents must be approved prior to execution.
BevCanna will provide a list of raw materials and components (Bill of Material) used for the formulation, filling, labelling and packaging. The list shall include at a minimum the grade and source of raw materials and components.
BevCanna will provide a copy of executed and QA reviewed documents within a maximum of 30 days following the last production activity, test results and raw data to Client. Record retention will be as per BevCanna’s internal SOPs and for at least 2 years following the date the record is prepared to be in line with the Cannabis Regulations . The records must be legible and retrievable for the entire period of storage.
BevCanna will maintain a document control system for specifications and test methods, including: raw materials, Product labeling, packaging materials and other materials that would likely affect product quality.
Any changes to the master batch production record, labeling and packaging procedures for the manufacture of Client’s products shall go through BevCanna’s change control system.
17. Storage Requirements
BevCanna shall notify Client’s of deviations from specified Product storage conditions.
BevCanna shall ensure that storage conditions prevent alterations of the potency, purity or physical characteristics of the Product(s). BevCanna will store and maintain the Product(s) in appropriate environmental conditions and otherwise safeguard them from any loss, damage, contamination or degradation during storage.
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BevCanna shall store rejected materials (starting raw materials, intermediates, finished products and packaging components) in segregated, identified storage areas prior to disposition. Disposition of any excess expired or rejected materials shall be in accordance with internal procedures.
18. Transportation Requirements
BevCanna is responsible for ensuring that arrangements for shipping and distribution of Product(s) are made with appropriate licenced parties in the supply chain.
BevCanna shall select appropriate transportation carriers for the Product(s).
BevCanna or Client, as applicable, shall maintain records of transportation to demonstrate that the transportation services met the appropriate shipping requirements for the Product(s).
19. Complaint and Adverse Event Handling
BevCanna must have written procedures in place to document and investigate all quality related complaints and assist in investigations as requested by Client for product quality complaints. The complaint investigation records shall be retained as per BevCanna’s site SOP on document retention and immediate corrective actions shall be implemented as necessary.
Client is responsible for establishing a process for handling complaints received by Client. Client shall promptly inform BevCanna of any particular event, finding and/or complaint which may have a bearing on product safety or quality, then supply all necessary information and cooperation for the investigation of such events.
20. Returns
BevCanna ensures storage conditions of the returned Client’s Product(s) are maintained during storage until a decision has been made regarding the product in question.
BevCanna performs redistribution of returned goods only when approved by Client.
21. Document and Reserve Sample Retention
BevCanna shall retain the complete documentation for the manufacturing and testing of the Product(s) for a minimum time allowed for by Health Canada Regulations. BevCanna shall inform the Client immediately about a possible change to BevCanna’s business that may affect this obligation such that Client can fulfill its documentation obligations by taking over these documents.
BevCanna shall retain retention samples of the Product(s) at minimum one year after release of finished product produced, except in cases where the shelf life is shorter. The amount of sample retained must be sufficient to perform at least two full analyses.
For unprinted primary packaging, appropriate retention samples shall be stored, as applicable.
The retention samples shall be stored in such a way that their quality is not adversely affected.
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22. Change Control
BevCanna shall establish and maintain procedures ensuring that changes to Product(s), materials and process are approved in writing before they are introduced. Changes to the Product(s) require Client’s involvement/approval.
Changes to process or specifications proposed by BevCanna, must include proper justification, shall be given in writing and must be agreed upon with Clien’s . BevCanna shall implement the changes according to their site change control procedures. If changes are rejected, the reasons for the rejection shall be discussed with Client.
Other changes (e.g. facility changes) must be managed through BevCanna’s change control program, but do not require CO’s involvement unless they are significant or impact Client Product(s).
23. Recalls
If any Regulatory Authority or other governmental agency issues or requests a recall or takes similar action in connection with the Product in the Territory or if either Party reasonably determines after consultation with the other Party that an event has occurred which may result in the need for a recall or market withdrawal of the Product, then the Party notified or willing to implement such a recall or similar action shall, within one (1) business day, inform the other party thereof. The Parties shall promptly discuss and work together to affect an appropriate course of action to implement any recall provided that neither Party shall be prohibited from unilaterally taking any action which determines in good faith it is required to take to minimize risk to public health and safety or to comply with applicable laws.
Client and BevCanna shall provide reasonable assistance to each other in dealing with regulatory matters related to the recall.
BevCanna will reconcile, and immediately place in a quarantine area, all products subject to a stop distribution notification, upon Client request.
24. Regulatory Interactions and Inspections
BevCanna will notify Client of any Regulatory inspection as soon as the inspection directly involves Client products. BevCanna is responsible for managing the inspection and determining appropriate Client interaction.
BevCanna will notify Client within Seven (7) business days of the receipt of a Regulatory Authority inspection report, deficiency letter or written regulatory compliance observation, which contains any critical (or warning) findings that relate to Client’s products or the facilities used to produce, test or warehouse the product.
25. Client Audits/Visits
Client shall have access to BevCanna’s facilities associated with the Product(s).
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Client Cannabis facility visits shall be permitted in accordance with a mutually agreed upon schedule to periodically review the facilities, equipment, process and records associated with the Product(s) at a maximum of 2 per year.
BevCanna shall promptly respond to any written audit observations provided by Client and shall commit to appropriate corrective measures in a timely manner indicated by such observations. Client audits are to be treated as confidential and audit reports are not to be shared with other organizations without prior written consent both Parties.
When audited by a third party, BevCanna shall ensure that the audit team is subject to confidentiality requirements relating to Client activities being part of the business with BevCanna.
26. Sub-Contractors
BevCanna shall not engage third parties to provide services under this Agreement without the prior written consent of Client (see Annex F). In addition, BevCanna must enter into a written agreement with any engaged third party, which imposes the obligations incumbent on BevCanna under this Agreement in a corresponding manner to the third party.
In the case of a contract to third parties, BevCanna has the sole responsibility in relation to Client for the fulfillment of all contractual obligations.
BevCanna agrees that Client may carry out audits in connection with the production and testing of the Product(s) together with BevCanna at the third parties after the prior agreement of the relevant third party.
27. General Provisions
In the event of any individual provisions of this Agreement are held to be invalid or unenforceable or the Agreement contains a gap, this shall not affect the validity of the remaining provisions. Ineffective or unenforceable provisions shall be replaced by those effective provisions which come as close as possible to the economic intentions of the Parties. The same applies to any gaps in the Agreement.
The Parties agree that they shall in good faith work towards implementation of this Agreement and any dispute arising out of or in relation to this Agreement shall be first attempted to be resolved amicably by mutual negotiations.
The Agreement may be executed electronically by facsimile or PDF, in any number of counterparts, each of which will be deemed to be an original and all of which taken together will be deemed to constitute one and the same document.
This Quality Agreement may be amended by the written consent of both parties. Any notice, amendment or supplement of this Quality Agreement shall be made in writing to the address and contacts provided in Annex A.
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28. Final Approval
| 28. Final Approval | 28. Final Approval |
|---|---|
| Client | |
| Date July 28, 2021 |
Josh Taylor, Director "Signed" |
| BevCanna Enterprises Inc. | |
| Date July 28, 2021 |
Japheth Noah, Quality Assurance Manager "Signed" |
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ANNEX A: Contact Details
| Client | Client | Client |
|---|---|---|
| Name | Title/Role | Contact Information |
| Josh Taylor | Director | [redacted: Personal Email] |
| BevCanna Enterprises Inc. | BevCanna Enterprises Inc. | BevCanna Enterprises Inc. |
|---|---|---|
| Name | Title/Role | Contact Information |
| Marcello Leone | CEO | redacted: Personal Email |
| Japheth Noah | Head ofQualityAssurance | redacted: Personal Email |
| Japheth Noah | Complaint,Recall & Return | redacted: Personal Email |
| Duane Harfman | Head of Production | redacted: Personal Email |
| Duane Harfman | Head of SupplyChain | redacted: Personal Email |
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ANNEX B: List of Products
| Product Description | Material Code |
Shelf-Life |
|---|---|---|
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ANNEX C: Table of Responsibilities
| Subject | Client | BevCanna |
|---|---|---|
| General | ||
| License for processing of product according to_Cannabis Act_and Cannabis Regulations |
X | X |
| Storage and transport according to Canadian GPP requirements | X | |
| Maintain a Quality System according to regulatory requirements stated above |
X | |
| Personnel training according to regulatory requirements stated above |
X | |
| Specification approval for product | X | |
| Starting materials | ||
| Selection of suitable materials for Edible/Extract Processing | X | |
| Release of suitable materials for Edible/Extract Processing | X | |
| Specifications of other starting materials | X | |
| Supplier qualification | X | |
| Purchasing | X | X |
| Sampling and Quality testing | X | |
| Storage | X | |
| Release for processing | X | |
| Retained sample storage | X | |
| Packaging materials (for bulk packaging) | ||
| Specifications | X | |
| Supplier qualification | X | |
| Purchasing | X | X |
| Sampling and Quality testing | X | |
| Storage | X |
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| Subject | Client | BevCanna |
|---|---|---|
| Release for processing | X | |
| Retained sample storage | X | |
| Manufacturing | ||
| Method of manufacture (process description) | X | |
| Creation of manufacturing instruction (Master batch record) | X | |
| Determination of batch number | X | |
| Perform manufacturing according to defined instructions | X | |
| Document in Batch Production Record (BPR) | X | |
| Document and investigate deviations, if applicable | X | |
| Sampling for quality testing | X | |
| Forward samples to third party for quality testing | X | |
| Storage of retention samples | X | |
| Quality Testing of product before shipment | ||
| Test methods for quality testing (if available in pharmacopoeia) | X | |
| Test methods for quality testing (if not available in pharmacopoeia) (third party) |
X | |
| Qualify third party for quality testing | X | |
| Validation / Verification of test methods (third party) | X | |
| Creation of testing instruction (third party) | X | |
| Perform bulk analysis (third party) | X | |
| Create Certificate of Analysis / CoA (third party) | X | |
| Document and investigate OOS, if applicable | X | |
| Inform Client about product release | X | |
| Forward documentation as agreed to Client before product shipment |
X | |
| Storage and Transport |
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| Subject | Client | BevCanna |
|---|---|---|
| Intermediate storage of product according to Good Distribution Practices (GDP) and defined conditions |
X | |
| Packaging and labelling for transport | X | |
| Prepare documentation based on permission for transport | X | |
| Verification of service provider at pick-up place | ||
| Transport validation (if applicable) | X | |
| Information to Client about pick-up | X | |
| Others | ||
| Archiving manufacturing, testing and shipping documentation according to legal requirements |
X | |
| Complaint management | X | X |
| Mutual information about complaints, possible adverse reactions, quality defects, recalls etc. |
X | X |
| Support for investigation of complaints etc. | X | |
| Decision about recalls | X | X |
| Organization and execution of recalls | X | |
| Information to Health Canada authorities | X | |
| Forwarding analytical test results to Client | X | |
| Definition of shelf-life for finished product | X | |
| Information to Client about inspections by Regulatory Authority | X | |
| Information to Client about Regulatory Inspection findings which could have impact on product quality |
X | |
| Qualification of subcontractors | X | |
| Release of subcontractors | X | |
| Change Management process for introduction of new product/material |
X | |
| Change approval for introduction of new product/material | X | |
| Maintain a system to ensure evaluation of returned goods and subsequent redistribution or rejection |
X |
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| Subject | Client | BevCanna |
|---|---|---|
| Maintain procedures for batch adjustments, reprocessing and rework |
X | |
| Notify Client of any reprocessing/rework activity and get prior approval |
X | |
| Maintain a Preventive Control Plan (PCP) for each product manufactured at site |
X |
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ANNEX D: Batch Numbering and Expiry Date System
-
Batch Numbering Method: Includes Year and Month of Manufacture.
-
Expiry Date: To be described
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ANNEX F: Sub-Contractors
Company Name Activity Facility Address
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ANNEX G: History of Changes
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----- Start of picture text -----
Document Version Reason for Change Date
Part
----- End of picture text -----
| Client | |
| Date July 28, 2021 |
Josh Taylor, Director Signed" |
| BevCanna Enterprises Inc. | |
| Date July28,2021 |
Japheth Aetermed, Quality Assurance Person "Signed" |
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