This Clinic Vendor Agreement (the "Agreement") is entered into as of the date of acceptance (the "Effective Date") by and between Pico IV Inc., a corporation located at 1601 R St. Ste 300, Sacramento, CA 95811 ("Pico"), and the undersigned clinic ("Clinic"), collectively referred to as the "Parties." Clinic agrees to be bound by the following terms and conditions for the purchase, sale, and intravenous administration of Pico IV's hemp-derived cannabidiol (CBD) products ("Products").
Pico is engaged in the manufacturing and sale of CBD-related products and possesses substantial proprietary and confidential technical, engineering, manufacturing, and business information related thereto. Clinic provides various products and services to its clients in the health and wellness space. Clinic desires to purchase Pico’s hemp-derived cannabidiol (CBD) products for use in its business upon the following terms and conditions.
1. General Terms. General terms regarding Product pricing, delivery, returns, and warranty are set forth in the Clinic Portal of Pico’s website.
2. Compliance with Laws and Regulations
2.1 Federal, State, and Local Laws. Clinic shall comply with all applicable federal, state, and local laws, regulations, and ordinances, including but not limited to the Federal Food, Drug, and Cosmetic Act (FD&C Act, 21 U.S.C. 301 et seq.), the Agriculture Improvement Act of 2018 (2018 Farm Bill), and regulations issued by the U.S. Food and Drug Administration (FDA). Clinic is solely responsible for understanding and adhering to all licensing, permitting, and operational requirements in its jurisdiction.
2.2 FDA Regulations. Clinic acknowledges that Pico IV's Products are hemp-derived (containing ≤ 0.3% delta-9-tetrahydrocannabinol) and are not FDA-approved drugs. Clinic shall not market, promote, or distribute the Products in a manner that implies they are intended to diagnose, treat, cure, mitigate, or prevent any disease or medical condition, including but not limited to pain, anxiety, seizures, cancer, inflammation, or neurodegenerative disorders, as such claims violate sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a), 331(d)) and 21 CFR 312.7.
2.3 Prohibited Claims. Clinic shall not make any claims, whether express or implied, in marketing materials, social media, websites, or patient communications, suggesting that the Products have therapeutic or medicinal benefits, affect the structure or function of the body, or are intended for use as a drug. Prohibited claims include, but are not limited to, statements about pain relief, anxiety reduction, anti-inflammatory effects, neuroprotection, or treatment of specific diseases. By signing this Agreement, Clinic certifies that all marketing materials comply with FDA regulations. Violation of this clause constitutes a material breach of this Agreement.
2.4 Health Insurance Portability and Accountability Act (HIPAA). Clinic shall comply with HIPAA (45 CFR Parts 160, 164) when handling any Protected Health Information (PHI) related to Product use, ensuring confidentiality and security of patient data.
3. Marketing and Promotional Responsibilities
3.1 Clinic Responsibility. Clinic is solely responsible for ensuring that all marketing and promotional materials related to Products (e.g., website content, social media posts, brochures, advertisements) comply with FDA regulations and do not make prohibited claims as outlined in Section 2.3. Clinic shall independently verify compliance with federal, state, and local laws prior to publication or distribution.
3.2 Compliance with FTC Guidelines. Clinic shall ensure all marketing materials comply with Federal Trade Commission (FTC) guidelines, including clear and conspicuous disclosure of any material connection to Pico IV, per 16 CFR Part 255.
3.3 Monitoring and Reporting. Clinic shall promptly report to Pico IV any complaints, or regulatory inquiries related to Products within 24 hours of receipt. Clinic shall cooperate with Pico IV to investigate and resolve any non-compliant materials or claims, including providing copies of all relevant materials upon request.
4. Authorized Use of Products
4.1 Authorized Use. Clinic shall use Products solely for administration by licensed healthcare providers in accordance with applicable laws and regulations. Products are intended for wellness support and shall not be used or promoted as drugs or for any unapproved medical purposes.
5. Indemnification
5.1 Clinic Indemnity. Clinic shall defend, indemnify, and hold harmless Pico IV from any losses, damages, liabilities, penalties, fines, costs, expenses (including reasonable attorney fees) arising from Clinic's (a) failure to comply with federal, state, or local laws, including FDA regulations; (b) unauthorized marketing claims about Products; (c) misuse or improper administration of Products; or (d) breach of this Agreement. Clinic shall promptly notify Pico IV of any potential claims and cooperate fully in any defense. Pico IV shall not be liable for any violations by Clinic, and Clinic agrees to report any known or suspected violations of this Agreement or applicable laws to Pico IV and relevant authorities, including the FDA, within 24 hours. This indemnification survives termination of the Agreement.
5.2 Pico Indemnity. Pico IV shall defend, indemnify, and hold harmless Clinic from any losses arising from Pico IV's breach of warranties regarding Product safety or quality, provided Clinic complies with storage, handling, and usage instructions.
6. Termination
6.1 Termination for Cause. Pico IV may terminate this Agreement immediately upon written notice if Clinic (a) violates FDA regulations or makes prohibited claims about Products; (b) fails to comply with applicable laws; (c) breaches any material term of this Agreement; or (d) becomes insolvent or subject to bankruptcy proceedings.
6.2 Effect of Termination. Upon termination, Clinic shall cease all use, distribution, and marketing of Products, return any unused Products to Pico IV, and destroy any promotional materials containing prohibited claims.
7. Confidentiality
7.1 Confidential Information. All non-public, confidential or proprietary information regarding, or belonging to, Pico, including, but not limited to, all forms and types of business, technical, scientific, engineering, specifications, samples, patterns, designs, plans, drawings, documents, data, systems, procedures, methods and techniques, inventions, ideas, discoveries, improvements, know-how, show-how, business operations, customer lists, pricing, discounts or rebates, disclosed by Pico to Clinic, whether disclosed orally or disclosed or accessed in written, electronic or other form or media, and whether or not marked, designated or otherwise identified as “confidential,” in connection with this Agreement is confidential, solely for the use of performing pursuant to this Agreement and may not be disclosed or copied unless authorized by Pico in writing. Upon Pico’s request, Clinic will promptly return all documents and other materials received from Pico. The Parties agree that Pico, in addition to any other available remedies, shall have the right to seek an immediate injunction and any other equitable relief enjoining any breach or threatened breach of this section, without the necessity of posting any bond or other security. Clinic agrees to notify Pico in writing immediately upon becoming aware of any such breach or threatened breach. This Section will not apply to information that is: (a) in the public domain; (b) known to Clinic at the time of disclosure; or (c) rightfully obtained by Clinic or a on a non-confidential basis from a third party.
8. Governing Law
8.1 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of California, without giving effect to the principles of conflict of laws. Any legal action which may be brought to enforce any provision of this Agreement, or which may arise from or be related to this Agreement, shall be brought in a state or federal court of competent jurisdiction in the State of California.
8.2 Mandatory Mediation. In the event of any dispute, controversy, or claim arising out of or relating to this Agreement, including its interpretation, performance, breach, termination, or validity, the parties agree to first attempt to resolve the matter through mediation prior to the filing of a lawsuit pursuant to section 8.1 of this agreement. The mediator shall be selected jointly by the Parties. If the Parties cannot agree on a mediator either Party may request the appointment of a mediator by the American Arbitration Association. The cost of mediation shall be split equally by the Parties.
9. Attorney’s Fees. Should any action be brought by either Party to enforce the provisions of this Agreement, the prevailing Party, whether by settlement, adjudication or arbitration, shall have the right to collect reasonable attorneys' fees, expenses and costs from the non-prevailing Party.
10. Severability. If any provision of this Agreement is deemed invalid or unenforceable, the remaining provisions shall remain in full force and effect.
11. Entire Agreement. This Agreement constitutes the entire understanding between the Parties and supersedes all prior agreements or understandings.
12. Amendment. No amendment to this Agreement shall be effective unless in writing and signed by both Parties.
13. Notices. All notices shall be in writing and delivered to Pico IV at 1601 R St. Ste 300, Sacramento, CA 95811, and to Clinic at the address provided during onboarding.