CBD/HEMP Product Liability Application

Applicant Information

Applicant Name:

DBA (Doing business as):

Mailing Address:

City:

State:

Zip Code:

Location Address:

City:

State:

Zip Code:

Website:

Proposed Effective Date:

Email:

Phone Number:

Applicant is:

Please Specify:

1) Years in business under current and prior names:

(Please list all acquisitions of companies and operations in the past 5 years)

Your Operations

2) Description of operations/list products and goods:

3) Percentage of your gross sales generated by the following types of operations

a. Manufacturer:

b. Contractor-Manufacturer - Products sold under labels of others:

c. Wholesaler/Distributor – Products of others sold under label of others:

d. Importer:

Note: Products shipped directly to your customers without physical possession will not be considered as an acceptable form of business.

e. Retailer - Own Label:

f. Retailer - Products of others sold under label of others:

g. Direct to customers via internet:

h. Other:

Please also Describe.

4) Are you a manufacturer, contract-manufacturer or retailer - own label:

Yes

a. Have you or will you use ingredients imported from foreign suppliers?

Yes

b. Do you contract the manufacturing of your products to others?

Yes

Please provide the manufacturer's name and physical address:

5) Are you a Wholesaler/Distributor - Products of others sold under labels of others?

Yes

a. Please list manufacturers and their physical addresses:

b. Do your suppliers each provide you with a certificate of liability insurance?

Yes

c. Do your suppliers also each provide you with additional insured-vendors coverage?

Yes

6) Are you an importer?

Yes

Please list the countries of origin:

7) Are you a Contract-Manufacturer - Products sold under label of others?

Yes

a. What is the percentage of such products that are formulated entirely by the customer?

b. Percentage of overall sales that consist of products sold under the labels of your customers?

c. Do you have a written contract with each customer that includes hold harmless and indemnification agreements in your favor?

Yes

d. Do you exclusively use ingredients supplied by your customer?

Yes

8) Are you a Contract-Packager - For others?

Yes

a. Do you have a written contract with each customer that includes hold harmless and indemnification agreements in your favor?

Yes

Your Product Sales

Annual Gross Sales - Upcoming Year

Total:

United States:

Foreign:

Annual Gross Sales - Current Year:

Total:

United States:

Foreign:

Annual Gross Sales - First Prior Year:

Total:

United States:

Foreign:

Annual Gross Sales - Second Prior Year:

Total:

United States:

Foreign:

Annual Gross Sales - Third Prior Year:

Total:

United States:

Foreign:

Description of Major Products (i.e. lotions, soaps, etc):

Please list products you manufacture, distribute, and/or import. Please provide breakdown of sales for each product.

9) Percentage of total gross sales generated by the following types of products (if none, enter 0)

a. For use by children

Upcoming Year (Estimate):

Prior Year (Actual):

b. Caffeine exceeding 300 mg per serving (all sources)

Upcoming Year (Estimate):

Prior Year (Actual):

c. Animal & vet supplements

Upcoming Year (Estimate):

Prior Year (Actual):

d. Sports nutrition - bodybuilding, muscle enhancement supplements

Upcoming Year (Estimate):

Prior Year (Actual):

e. Weight loss supplements

Upcoming Year (Estimate):

Prior Year (Actual):

f. Sexual enhancement supplements

Upcoming Year (Estimate):

Prior Year (Actual):

g. Cannabidiol (CBD)/hemp products

Upcoming Year (Estimate):

Prior Year (Actual):

NOTE: Coverage will not apply to products containing ingredients banned by the FDA, including but not limited to Steroids, including any product, supplement, additive, substance, ingredient or compound controlled or banned by the Anabolic Steroid Control Act of 1990 including amendments thereto, or the Anabolic Steroid Control Act of 2005; DMAA (Dimethylamylamine) (1,3 - Dimethylamylamine); Ephedra; Ephedrine Alkaloids; or Fenfluramine (N-Nitroso-Fenfluramine).

YOUR QUALITY CONTROL AND REGULATORY COMPLIANCE

10) Product Withdrawal/Product Recall:

a. Do you have a formal written product recall procedure?

Yes

b. Have you voluntarily or involuntarily recalled or withdrawn, or are you considering recalling or withdrawing any products for any reason?

Yes

Please provide details:

11) Current practices or your specified industry equivalent:

a. Are you fully compliant with FDA Current Good Manufacturing Practices (cGMP)?

Yes

b. Are you compliant with Food, Drug & Cosmetic Act 21 CFR 111?

Yes

12) Quality Assurance Program (QAP)/Quality Control Program (QCP):

a. Have you attained ISO 9000, QS 9000 or similar third party certification for your quality systems?

Yes

b. Do you have a formal written QAP/QCP, including written SOP's that control your operations?

Yes

c. Please provide name, title and contact information (email/phone) for QAP/QCP manager:

13) Are all facilities used to manufacture, process, pack, hold or store your products registered with the FDA?

Yes

14) If you are making or selling any Cannabidiol (CBD) products, are they tested and certified by a third party laboratory?

Yes

N/A

a. Do you have batch records on file that document production details for each lot of finished product?

Yes

b. Are your products certified to contain no more than 0.3% THC and is it listed on the label?

Yes

15) Labels:

a. Has outside legal counsel reviewed your labeling and confirmed it is in compliance with the regulations established by the FDA and FTC?

Yes

b. Do all of your labels include a disclaimer that the FDA has not evaluated the claims on your labels and that your products are not intended to diagnose, treat, cure or prevent any disease?

Yes

c. Are you making any structure/function claims for your products on labels, websites or other marketing materials?

Yes

d. Do you maintain documentation that substantiates each claim you make?

Yes

e. Have you conducted, or are you planning to conduct, human clinical trials to substantiate your product claims?

Yes

Regulatory Events

16) In the past five years, have you submitted a Serious Adverse Event Report (SAER) to the FDA or has the FDA notified you of an SAER submitted directly by a health care provider, firm or consumer?

Yes

Please attach a comprehensive list of all Serious Adverse Events, along with copies of all reports and relevant documents.

17) Do you have an SOP detailing how to identify and handle an SAER/SAE?

Yes

18) Are you aware of any complaint or notice filed in the last three years with any governmental agency or industry regulatory body, including but not limited to the FDA or FTC, concerning your product?

Yes

Please provide a detailed explanation:

19) Have you been inspected by the FDA?

Yes

a. Did the FDA issue a Form 483 Notice of Inspection?

Yes

Please provide a copy:

b. Are you aware of any study, analysis or trial conducted by the FDA or any industry regulatory body, to examine the safety of your products?

Yes

c. Has FDA Form 483 been responded to with an FDA closeout letter?

Yes

20) Do you comply with Prop 65 labeling requirements?

Yes

Optional Coverage Enhancements

21) Hired & Non-Owned Auto

Applicant would like to be considered for Hired & Non-Owned Auto Liability (HNOA) coverage

No, Applicant has separate Auto Policy

N/A

a. Do you own any auto that is used in your business and is registered to your Company?

Yes

If yes, HNOA coverage is unavailable.

b. Does the Applicant have more than five employees using their personal auto for business use?

Yes

If yes, HNOA coverage is unavailable.

c. Will any vehicle be operated beyond a 50 mile radius of the business location address on a weekly basis?

Yes

d. Will any vehicle be used for product delivery?

Yes

If yes, HNOA coverage is unavailable.

Your Claims, Losses, Demands for Damages and Similar Experience

22) Have there been any losses in the past 5 years by the insured?

Yes

23) Are you aware of any incident, condition, circumstance, lawsuit, legal action or suspected defect in any product or work, which has resulted or may result in a demand for damages or claims against you that are not listed in the 5 year carrier loss his

Yes

Please provide a detailed explanation:

24) Do you currently have CBD/Hemp Product Liability Insurance?

Yes

Current Carrier:

Is current carrier offering renewal?

Yes

Coverage Form:

Occurrence

Claims-Made

If claims-made, Retroactive Date:

Limits:

Deductible:

Premium:

Rate:

25) Desired Limits:

Desired Deductible:

Please Initial:

I/We declare that I/We have reviewed this Application for accuracy before signing it, that the above statements and representations are true and correct, and that no facts have been suppressed or misstated. I/We understand that this is an application for insurance only and that the completion and submission of this Application does not bind the Company to sell nor the applicant to purchase this insurance. I/We nevertheless acknowledge that any contract of insurance issued by the Company in response to this Application will be in full reliance upon the statements and representations made in this Application.

Any person who knowingly and with intent to defraud any insurance company or other person, files an application for insurance, or statement of claim containing any materially false information or conceals for the purpose of misleading, information concerning any material fact, commits a fraudulent insurance act, which is a crime and may also be subject to civil penalty.

Please Initial:

I/We hereby declare that the above statements and particulars are true and I/We agree that this Application shall be the basis for any contract of insurance issued by the Company in response to it.

Electronic Signature of Applicant or Authorized Representative:

Title:

Date:

Certain terms are abbreviated in this application. Here are a few:

FDA means the United States Food and Drug Administration
FDCA-21CFR Part 11 means Food Drug and Cosmetic Act
FTC means the United States Federal Trade Commission
QAP / QCP means Quality Assurance Program / Quality Control Program
SOP means Standard Operating Procedure
cGMP / GMP means Current Good Manufacturing Practices / Good Manufacturing Practices
Cannabidiol (CBD) is a nonpsychoactive ingredient found in plant species cannabis sativa Prop 65 refers to the Safe Drinking Water and Toxic Enforcement Act of 1986

For detailed information on regulatory requirements and definitions, you may find useful references at www.fda.gov and www.ftc.gov.

Please provide any additional details in the space provided:

I agree to the Terms & Conditions