Schedule of Fresh Clinics’ Liability Insurance Limitations and Exclusions*
This Exclusions Schedule is attached to and incorporated in the FC MSA. Capitalized terms in this Exclusions Schedule shall have the definitions set forth in the FC MSA.
Fresh Clinics maintains a global liability policy (“Fresh Liability Policy”) that includes professional liability and general liability coverages (insuring clauses). The scope of those coverages are determined by the terms, conditions, definitions, exclusions, endorsements, and other parts of the Fresh Liability Policy.
Using commercially reasonable efforts to secure broad coverage, there are nonetheless certain specific exclusions to the Fresh Liability Policy of which we want to ensure you are aware. This Exclusions Schedule summarizes those exclusions.
Medical Weight Loss Amendatory Clause
This clause:
- Applies to all insuring clauses, including Professional Liability and General Liability.
- Excludes coverage for claims directly or indirectly arising from the prescribing, dispensing, marketing, or distributing of certain medical weight loss products.
- And more specifically:
- Excludes the use of GLP-1 salt forms, such as semaglutide sodium and semaglutide acetate;
- Excludes coverage if treatments use active pharmaceutical ingredients lacking FDA approval for commercially manufactured drugs, or if prescribed dosages exceed the FDA-approved label.
- Precludes coverage for counterfeit drugs, imported compounded medications with ingredients formulated outside North America, or medications provided without a valid individual prescription from a licensed medical practitioner.
- Excludes GLP-1 ingredients compounded by a 503B pharmacy unless the ingredient was explicitly on the FDA bulks list or drug shortage list at the time of distribution.
Specified Activities Exclusion.
This exclusion:
- Applies universally to all insuring clauses within the policy, encompassing both professional and commercial liability.
- Excludes coverage for claims arising directly or indirectly from the prescription of any peptide products that lack approval from the relevant drug regulatory body.
- Explicitly retains coverage (meaning the exclusion does not apply) for the medical direction, clinical oversight, or prescribing of only the following specifically named treatments:
Testosterone, BPC-157, TB-500, GHK-Cu, MOTS-C, and Sermorelin.
- (Precludes coverage related to the prescription of any Schedule 4D or Schedule 8 drugs, as classified by The Poisons and Therapeutic Goods Regulation 2008 in Australia.)
Unapproved Compounded Versions of GLP-1 Drugs Exclusion Clause
This clause:
- Applies specifically to the policy’s Commercial General Liability coverage
- Excludes coverage for bodily injury or property damage caused by compounded versions of GLP-1 drugs, dual GLP/GLP-1 receptor agonists, or similar medications.
- Applies if the medication is not approved by the FDA in the specific form and manner in which it was manufactured, dispensed, or supplied.
* This Exclusions Schedule provides only a brief summary and certain specific exclusions and limitations under the Fresh Liability Policy. It is solely for the Licensed Professional’s convenience, and is not intended to be comprehensive or definitive, or to constitute any representations, warranties or covenants of Fresh Clinics or any of its Affiliates, or to bind the issuing insurance company or broker in any way. This Exclusions Schedule may be revised, with or without notice, whether or not the FC MSA has been revised, and should be reviewed regularly.
The Fresh Policy contains its own schedules, coverage grants, definitions, terms, conditions and exclusions, and controls over anything to the contrary herein or in the FC MSA.