Appendix A – HKA Product Compliance Addendum
This HKA Product Compliance Addendum (this “Compliance Addendum”), dated as of [_________] (the “Effective Date”) is incorporated into and made part of the Marketplace Retailer Participation Agreement (the “Agreement”) between Normalize LLC, a Colorado limited liability company, and Normalize Marketplace LLC, a Colorado limited liability company (collectively, “NM”) and Retailer. This Compliance Addendum is subject to all terms and conditions of the Agreement, and in the event of any conflict between this Compliance Addendum and the Agreement, the terms of the Agreement shall control. Capitalized terms used but not defined in this Compliance Addendum shall have the meanings set forth in the Agreement. For good and valuable consideration, the sufficiency and receipt of which is hereby acknowledged by the parties, NM and Retailer hereby agree as follows:
WHEREAS, the Retailer is in the business of manufacturing and selling HKA Products (as defined below);
WHEREAS, NM has been engaged by Retailer to provide NM Services to Retailer in connection with Retailer’s HKA; and
WHEREAS, the parties wish to supplement the Agreement to address certain regulatory considerations surrounding the manufacturing, processing, distribution, marketing, and sale of HKA Products.
NOW, THEREFORE, in consideration of the covenants and agreements hereinafter set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto incorporate the foregoing recitals and agree as follows:
- Definitions. For purposes of this Addendum, the following terms shall mean as follows:
- “2018 Farm Bill” means, Agriculture Improvement Act of 2018 , P.L. 115-334, §§ 10113-10114, 12619; 7 U.S.C § 1639o (1), as amended from time to time.
- “Applicable Law” means all federal, state, municipal and local laws, codes, ordinances, rules and regulations of governmental authorities, committees, associations, or other regulatory committees, agencies or governing bodies having jurisdiction over the production, marketing, and sale of HKA Products, including, but not limited to, the U.S. Controlled Substances Act of 1970 (21 USCS § 801, et seq.), as amended from time to time, the Dietary Supplement Health and Education Act of 1994, the Federal Food, Drug, and Cosmetic Act, and the Agricultural Marketing Act of 1946 (7 USCS § 1621, et seq.), as amended from time to time, and any similar state laws or regulations governing the production, marketing, and sale of HKA Products.
- “Amanita Muscaria” means the mushroom species Amanita muscaria and any products derived from, containing, or incorporating any part of such mushroom species.
- “Amanita Muscaria Products” means finished products that contain Amanita Muscaria that are intended for human use or consumption and contain any part of the Amanita Muscaria mushroom, including naturally occurring compounds, concentrates, extracts, isolates, or derivatives.
- “Hemp” has the meaning ascribed to such term pursuant to Section 1639o of the Agricultural Marketing Act of 1946 (7 USCS § 1639o), as amended from time to time.
- “Certificate of Analysis” or “COA” means a document issued by an independent third-party laboratory that is ISO/IEC 17025 accredited or similarly accredited, which provides detailed analytical results regarding the composition, purity, potency, and safety of HKA Products, including but not limited to testing for active compounds, contaminants, heavy metals, pesticides, residual solvents, and microbials as applicable to the specific HKA Product type.
- “HKA Products” means Hemp Products, Kratom Products, and Amanita Muscaria Products, collectively.
- “Hemp Product” means a finished product that contains Hemp that:
- is a cosmetic, a dietary supplement, a food or beverage, a food or beverage additive, or an herb;
- is intended for human use or consumption;
- contains any part of the Hemp plant, including naturally occurring cannabinoids, compounds, concentrates, extracts, isolates, or resins; and
- is produced from Hemp.
- “Kratom” means the plant Mitragyna speciosa and any products derived from, containing, or incorporating any part of such plant.
- “Kratom Products” means finished products that contain Kratom that are intended for human use or consumption and contain any part of the Kratom plant, including naturally occurring alkaloids, compounds, concentrates, extracts, isolates, or resins.
- Licensing and Regulatory Documentation. Retailer represents, warrants, and covenants that:
- Prior to listing any HKA Product on the Marketplace, Retailer shall provide NM with copies of all licenses, certifications, permits, and other regulatory approvals required for Retailer to lawfully manufacture, distribute, or sell HKA Products, including:
- Any state-issued hemp processor, distributor, or retailer licenses;
- Any applicable FDA facility registration or food facility permits;
- Any state or local business licenses required for HKA product sales; and
- Any third-party certifications (organic, GMP, etc.) claimed for products.
- All licensing documentation shall be current and valid, and Retailer shall immediately notify NM of any license suspension, revocation, or non-renewal; and
- Retailer shall provide updated licensing documentation upon renewal or as requested by NM.
- Prior to listing any HKA Product on the Marketplace, Retailer shall provide NM with copies of all licenses, certifications, permits, and other regulatory approvals required for Retailer to lawfully manufacture, distribute, or sell HKA Products, including:
- Certificate of Analysis Requirements. Retailer represents, warrants, and covenants that:
- For each batch or lot of HKA Products listed, offered, or sold through the Marketplace, Retailer shall obtain and maintain current Certificates of Analysis from independent third-party laboratories;
- Each Certificate of Analysis shall be dated within twelve (12) months of the Product Listing date and shall include testing appropriate to the specific HKA Product type, including but not limited to:
- For Hemp Products:
- Complete cannabinoid profile including verification that delta-9 THC content does not exceed 0.3% on a dry weight basis;
- Verification of Hemp source in compliance with 2018 Farm Bill statutory definitions;
- Pesticides, heavy metals, residual solvents, and microbials testing
- Potency verification for all claimed cannabinoid content
- For Kratom Products: alkaloid profile, heavy metals, pesticides, and microbials;
- For Amanita Muscaria Products: active compound analysis, heavy metals, pesticides, and microbials;
- For Hemp Products:
- Retailer shall provide copies of all Certificates of Analysis to NM upon request within forty-eight (48) hours;
- Retailer shall ensure that all HKA Products conform to the specifications and results set forth in the applicable Certificate of Analysis;
- Retailer shall immediately notify NM if any Certificate of Analysis reveals results that indicate the HKA Product may be unsafe, non-compliant with Applicable Law, or otherwise unsuitable for sale;
- All Certificates of Analysis must be issued by laboratories that maintain current ISO/IEC 17025 accreditation or equivalent third-party accreditation acceptable to NM; and
- Retailer shall maintain a complete chain of custody documentation linking each COA to the specific product batches sold through the Marketplace.
- Labeling And Marketing Compliance. Retailer represents and warrants that all HKA Products comply with applicable labeling requirements including:
- Accurate ingredient lists and nutritional panels;
- Appropriate warning statements as required by law;
- Compliance with FDA regulations regarding structure/function claims;
- Proper age restriction warnings; and
- Batch/lot identification for traceability purposes.
- Product Sample Requirements for Quality Assurance. Retailer represents, warrants, and covenants that:
- Upon NM’s written request, Retailer shall provide NM with representative samples of any HKA Products listed, offered, or sold through the Marketplace for quality assurance purposes, including but not limited to independent third-party testing, compliance verification, and product safety evaluation;
- Retailer shall provide such samples within seven (7) Business Days of NM’s written request, unless a different timeframe is specified by NM in its sole discretion;
- All samples provided shall be from the same batch or lot as the HKA Products being sold through the Marketplace and shall be representative of the Products available to Customers;
- Sample quantities requested by NM shall be reasonable and appropriate for the intended testing or quality assurance purposes, but shall not exceed two (2) units per Product per calendar quarter unless NM has reasonable cause to believe additional testing is necessary for compliance or safety purposes;
- All costs associated with providing samples (including product costs and shipping) shall be borne by Retailer;
- All costs associated with any independent testing conducted by NM shall be borne by NM, unless such testing reveals that the HKA Product fails to meet the specifications set forth in the applicable Certificate of Analysis, violates Applicable Law, or is otherwise non-compliant with this Agreement or the Retailer Policies, in which case all testing costs shall be reimbursed to NM by Retailer within thirty (30) days of receiving an invoice from NM;
- NM may, in its sole discretion, engage independent third-party laboratories to conduct additional testing on samples beyond what is reflected in Retailer’s Certificates of Analysis;
- If any sample testing conducted by or on behalf of NM reveals non-compliance with Applicable Law, safety concerns, or material discrepancies from the applicable Certificate of Analysis, Retailer shall immediately cease sales of the affected HKA Product(s) through the Marketplace and take all necessary corrective actions as directed by NM; and
- Retailer’s failure to provide requested samples within the specified timeframe or Retailer’s refusal to provide samples may result in immediate suspension of the affected Product Listings and/or termination of the Agreement at NM’s sole discretion.
- State-Specific Compliance and Shipping Restrictions. Retailer represents, warrants, and covenants that:
- Retailer shall conduct monthly reviews of all Applicable Laws in each of the fifty (50) U.S. states and the District of Columbia to identify any states where the sale, distribution, or shipment of Retailer’s HKA Products is prohibited, restricted, or regulated;
- By the fifth (5th) Business Day of each calendar month, Retailer shall provide NM with a written compliance report (via email) identifying:
- All U.S. states where each of Retailer’s HKA Product types (Hemp Products, Kratom Products, and Amanita Muscaria Products) are prohibited from sale, distribution, or shipment;
- All U.S. states where each of Retailer’s HKA Product types are subject to specific restrictions, age requirements, licensing requirements, or other regulatory limitations that may affect sales through the Marketplace;
- Any changes from the previous month’s report; and
- Citations to the specific laws, regulations, or legal authorities supporting such determinations.
- Retailer shall immediately (but in no event later than twenty-four (24) hours after becoming aware) notify NM in writing if Retailer learns of any change in Applicable Law in any U.S. state or the District of Columbia that:
- Newly prohibits, restricts, or regulates the sale, distribution, or shipment of any of Retailer’s HKA Products;
- Modifies existing restrictions or regulations applicable to any of Retailer’s HKA Products; or
- Otherwise affects Retailer’s ability to legally sell or ship any HKA Products to such jurisdiction.
- Retailer shall immediately update and notify NM of its Product Listings and shipping configurations to reflect any jurisdictions where HKA Products cannot be legally sold or shipped;
- Retailer acknowledges and agrees that NM may, in its sole discretion and without prior notice to Retailer:
- Remove or delist any HKA Product Listings from the Marketplace;
- Prevent or block sales of HKA Products to any U.S. state or jurisdiction;
- Cancel pending Customer Orders for HKA Products destined for any U.S. state or jurisdiction; and/or
- Suspend Retailer’s ability to list or sell HKA Products through the Marketplace if NM determines, after consultation with legal counsel or based on its own legal research, that the sale, distribution, or shipment of such HKA Products to any jurisdiction may violate Applicable Law.
- Retailer shall bear all costs and expenses associated with any Customer Order cancellations, refunds, or other remedial actions resulting from Retailer’s failure to properly identify jurisdictional restrictions or NM’s exercise of its rights under subsection (e) above;
- Retailer acknowledges that laws regarding HKA Products are subject to frequent changes and that Retailer bears sole responsibility for staying current with all Applicable Laws in all jurisdictions; and
- Retailer’s failure to provide timely monthly compliance reports or immediate notification of legal changes may result in suspension of HKA Product Listings and/or termination of the Agreement at NM’s sole discretion.
- Notification of Regulatory Enforcement. The Retailer agrees to promptly notify NM, at the Retailer’s sole cost and expense, of any regulatory enforcement actions, claims, demands, or proceedings that may impact the Retailer’s ability to manufacture, process, market, and/or sell HKA Products.
- Customer Service Contact Information. For all HKA Products, Retailer must provide and maintain at least two (2) forms of customer service contact information readily accessible to customers, including but not limited to:
- A monitored telephone number with live customer service during regular business hours;
- A monitored email address that responds to customer inquiries within 24 hours; and/or
- A physical business address where customers can direct inquiries or complaints.
- Product Recalls And Safety Alerts. If any HKA Product becomes subject to a voluntary or mandatory recall, safety alert, or regulatory warning, Retailer shall:
- Immediately cease all sales of the affected product through the Marketplace;
- Notify NM within two (2) hours of becoming aware of the recall or safety issue;
- Cooperate fully with NM in notifying affected customers;and
- Bear all costs associated with customer notifications, refunds, and product retrieval.
- NM Discretion on Shipments. NM shall have the sole discretion to deny fulfillment and shipments of HKA Products into any state which NM determines, after consultation with legal counsel, prohibits the sale of HKA Products produced or otherwise supplied by the Retailer to NM for performance of the services contemplated in the Agreement.
- Indemnification. The Retailer shall indemnify, defend, and hold harmless NM and its officers, directors, employees, agents, and affiliates from and against any and all losses, liabilities, damages, fines, penalties, costs, and expenses (including reasonable attorneys’ fees) arising out of, relating to, or resulting from any regulatory actions, claims, or proceedings directed at NM related to the HKA Products produced or otherwise supplied by the Retailer to NM for performance of the NM Services contemplated in the Agreement.
- Termination. NM may, in its sole discretion, terminate the Agreement in its entirety upon written notice to the Retailer if NM is notified of any regulatory action, claim, or proceeding against NM that is related to or arising from the shipment or storage of the HKA Products produced or otherwise supplied by the Retailer. In the event of such termination:
- The Retailer, at the Retailer’s sole expense, shall recover its HKA Products stored by NM within thirty (30) days from the date of termination notice.
- If the Retailer fails to recover its HKA Products within the specified thirty (30) day period, NM shall have the right to destroy the HKA Products.
- The Retailer hereby releases and holds harmless NM from any and all claims, liabilities, damages, or expenses arising from or related to the destruction of the HKA Products pursuant to this Section 12.
- Severability. If any term or provision of this Addendum is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Addendum. Such unenforceable term or provision is to be construed either by modifying it to the minimum extent necessary to make it enforceable (if permitted by law) or disregarding it (if not). If an unenforceable term or provision is modified or disregarded in accordance with this Section 13, the rest of this Addendum is to remain in effect as written and the unenforceable term or provision is to remain as written in any circumstances or jurisdictions other than those in which the provision is held to be unenforceable.
No Other Amendments. The terms of this Addendum shall modify and supplement the terms of the Agreement to the extent expressly modified and supplemented herein, but every other term and condition contained in the Agreement is hereby ratified, affirmed, remains in full force and effect and shall remain unchanged unless expressly amended or modified hereby or by another written instrument entered into by and between the parties hereto.