WHOLESALE PRODUCT USE ACKNOWLEDGMENT AND RELEASE OF LIABILITY AGREEMENT
BIO Code USA LLC
Wholesale Distribution of Research and Wellness-Related Amino Acid Chain Compounds
This Acknowledgment, Assumption of Risk, and Release of Liability Agreement (“Agreement”) is entered into, on the date set forth in the signature block below (the “Effective Date”), by and between BIO Code USA LLC (“Supplier” or “BIO Code USA”) and the purchasing entity (“Purchaser,” “Business,” or “Clinic”).
For purposes of this Agreement, “Purchaser Parties” means Purchaser’s physicians, medical directors, practitioners, employees, agents, and affiliates, and any other individuals or entities acting on its behalf or under its direction or control, or otherwise accessing or using the Products through or on behalf of Purchaser, in each case in connection with the use, handling, or administration of the Products.
This Agreement governs the receipt, possession, handling, and use by Purchaser of any amino acid chain compounds and related materials supplied by Supplier to Purchaser in connection with the parties’ commercial transaction (collectively, the “Products”). Supplier acts solely as a wholesale supplier of materials. Supplier does not provide medical services, treatment recommendations, patient-specific guidance, compounding services, or regulatory advice. Purchaser acknowledges that Supplier is not engaged in the practice of medicine, pharmacy, or any licensed profession, and nothing in this Agreement shall be construed as creating any such relationship.
By purchasing, receiving, possessing, or utilizing any Products supplied by Supplier, Purchaser acknowledges that it has read, understood, and agrees to be legally bound by the following terms, and agrees that it is responsible for compliance with this Agreement in connection with the acts and omissions of the Purchaser Parties:
1. PRODUCT CLASSIFICATION
Purchaser acknowledges that the materials supplied by BIO Code USA consist of synthetic amino acid chain compounds intended solely for research, investigational, compounding, educational, or laboratory use.
These products are not marketed as pharmaceutical drugs, and BIO Code USA does not represent, warrant, or imply that the products have any therapeutic, diagnostic, or medical use or benefit, and expressly disclaims any such representations.
Purchaser acknowledges that any use of the Products in clinical, compounding, investigational, or research settings, if undertaken by Purchaser, shall be determined solely by Purchaser and at the sole discretion and responsibility of the Purchaser. Purchaser acknowledges that the Products are not marketed, labeled, or sold by Supplier as approved drugs, medical devices, or treatments for human use. Supplier does not represent or warrant that the Products are safe or effective for any therapeutic, diagnostic, or clinical purpose. Any compounding, formulation, repackaging, patient-specific preparation, or human administration of the Products, if undertaken by Purchaser, is outside Supplier’s intended use and is undertaken solely at Purchaser’s independent election and sole risk.
Purchaser shall not represent to any patient, regulator, payor, or third party that Supplier has recommended, approved, validated, endorsed, or authorized any use, protocol, dosage, indication, or outcome relating to the Products.
2. PROFESSIONAL RESPONSIBILITY
Purchaser represents and warrants that the purchasing entity is a licensed medical clinic, healthcare provider, research facility, or authorized compounding entity in good standing under all applicable laws and regulations; possesses the requisite medical training, knowledge, and professional licensure required to evaluate and utilize amino acid chain compounds in compliance with applicable laws, regulations, and professional standards of care; and that any clinical use, administration, formulation, dilution, or patient interaction involving the Products supplied shall be performed solely under the Purchaser’s professional judgment and responsibility and in accordance with all applicable laws, regulations, and accepted medical standards.
Supplier does not provide medical direction, prescribing authority, or treatment protocols, and shall have no involvement in, or responsibility for, any clinical or patient-related decisions or outcomes.
Purchaser acknowledges that any materials, documentation, communications, or information provided by BIO Code USA are supplied solely for educational, informational, or research purposes and are not intended to constitute, and shall not be construed as, medical advice, clinical guidance, dosing instructions, or treatment protocols.
BIO Code USA expressly disclaims any role in clinical decision-making, and Purchaser agrees that all such decisions, including patient eligibility, dosing, administration, and treatment protocols, are made independently and solely at the Purchaser’s discretion and responsibility.
3. CLINICAL USE ASSUMPTION OF RISK
Purchaser acknowledges that amino acid chain compounds may involve inherent biological variability and scientific uncertainty, including both known and unknown risks.
Purchaser expressly assumes any and all risks, whether known or unknown, foreseeable or unforeseeable, associated with compounding, reconstitution, dilution, clinical administration, storage conditions, handling or transportation, and patient outcomes or adverse events.
Purchaser further agrees that all patient screening, informed consent, dosing protocols, and monitoring remain the exclusive responsibility of the Purchaser and its medical director and shall be conducted in accordance with all applicable laws, regulations, and accepted medical standards.
4. INDEPENDENT CLINICAL DECISION MAKING
Purchaser acknowledges that BIO Code USA does not provide medical advice, treatment plans, dosing protocols, or patient management guidance and that Purchaser shall not rely on any information or materials provided by BIO Code USA as a substitute for its independent medical judgment.
All decisions regarding clinical use, compounding, dosing, administration, and patient eligibility are determined independently by the Purchaser.
5. REGULATORY COMPLIANCE
Purchaser agrees that it is solely responsible for ensuring that its and the Purchaser Parties’ use, handling, storage, compounding, and administration of the supplied compounds complies with all applicable laws, rules, and regulations, including without limitation all applicable federal regulations, state medical board regulations, pharmacy compounding standards, clinical practice laws, and FDA guidance where applicable.
Supplier makes no representation or warranty that Purchaser’s use or intended use complies with any applicable legal or regulatory requirements in Purchaser’s jurisdiction. Such compliance obligations include, without limitation, all applicable federal, state, and local laws relating to advertising, consumer protection, privacy, informed consent, patient records, medical board regulations, pharmacy board requirements, supervision and delegation rules, and any laws governing medspa operations or the corporate practice of medicine where applicable.
6. PRODUCT TESTING AND ACCEPTANCE
Purchaser acknowledges that it has had the opportunity to request Certificates of Analysis (COA), review product documentation, and independently verify product quality.
Purchaser shall inspect the Products promptly upon receipt and shall notify Supplier in writing within three (3) business days of any visible damage, shortage, or nonconformity reasonably discoverable upon inspection. Failure to provide such notice shall constitute acceptance of the Products with respect to such visible issues.
7. LIMITATION OF LIABILITY
To the maximum extent permitted by law, Purchaser agrees that BIO Code USA LLC and its affiliates shall not be liable for any damages arising from or related to the use of the Products, including patient injury, adverse reactions, clinical outcomes, improper dilution, storage errors, or misuse, including, without limitation, any indirect, incidental, consequential, special, or punitive damages, whether arising in contract, tort, strict liability, or otherwise.
Supplier’s total liability, if any, shall be limited strictly to the replacement of the Products or refund of the purchase price paid for such Products, at Supplier’s sole discretion.
8. INDEMNIFICATION
Purchaser shall defend, indemnify, and hold harmless Supplier, its officers, directors, employees, agents, affiliates, successors, and assigns from and against any and all claims, demands, actions, investigations, proceedings, damages, fines, penalties, losses, liabilities, judgments, settlements, costs, and expenses, including reasonable attorneys’ fees, arising out of or relating to: (a) Purchaser’s or any Purchaser Party’s storage, handling, transfer, compounding, formulation, relabeling, repackaging, marketing, sale, administration, or other use of the Products; (b) any patient claim, adverse event, malpractice claim, consumer claim, false advertising claim, informed consent claim, or professional discipline matter; (c) any actual or alleged violation of applicable law or regulation; (d) any representation or statement made by Purchaser regarding the Products; or (e) any breach of this Agreement.
9. NO WARRANTY
All products are provided “AS IS” and “AS AVAILABLE.” Supplier disclaims all express or implied warranties, including, without limitation, merchantability, fitness for a particular purpose, therapeutic efficacy, clinical performance, non-infringement, and any warranties arising from course of dealing or usage of trade.
10. GOVERNING LAW & DISPUTE RESOLUTION
This Agreement shall be governed by and construed in accordance with the laws of the State of Alabama, without regard to conflict of law principles.
Any dispute, claim, or controversy arising out of or relating to this Agreement, the purchase of products, or the relationship between the parties shall be resolved exclusively through final and binding arbitration administered by the American Arbitration Association (AAA) under its Commercial Arbitration Rules.
The arbitration shall take place in the State of Alabama, and the parties expressly waive any right to trial by jury or participation in any class action proceeding.
Any action to enforce an arbitration award or otherwise permitted under applicable law shall be brought exclusively in the state or federal courts located within Alabama, and each party irrevocably consents to the jurisdiction and venue of such courts.
11. ACKNOWLEDGMENT
By purchasing products from BIO Code USA, Purchaser acknowledges that it has read, understood, and voluntarily agrees to be legally bound by the terms of this Agreement, and represents and warrants that the individual accepting this Agreement has full authority to bind the Purchaser to its terms. Purchaser further acknowledges and agrees that it shall be responsible for any acts or omissions of the Purchaser Parties that, if taken by Purchaser, would constitute a breach of any obligation, representation, or warranty under this Agreement.
