VariZIG has been available on a patient-specific basis under an FDA-approved Expanded Access Protocol since March 2006. A cost recovery of $128.34 per 125 IU vial has been approved by the FDA. Now FFF is pleased to announce that VariZIG may be prepositioned at qualified sites.

A maximum of 5 vials (625 IU) can be prepositioned at each site. This amount is the maximum dose for one adult patient, or can be used to treat several pediatric patients @ 125 IU/10 KG or a minimum dose of 125 IU regardless of weight.

Each preposition shipment will include 5 vials of VariZIG 125 IU and one patient-specific binder containing all study-related materials: Expanded Access Study Protocol, Investigators Brochure, Case Report Forms, etc.

Each patient must qualify as a candidate based on the completed Release Form, which must be faxed to FFF Enterprises at 951-296-2570 for review of the inclusion and exclusion criteria, physician eligibility, and time since exposure. Once the patient is qualified, FFF will assign a subject number and contact the site to approve administration of the product. Under no circumstances should the product be administered to a patient without approval from FFF.

One physician (the Principal Investigator) will be responsible for the conduct of this Expanded Access Protocol at each site. If a physician other than the Principal Investigator needs to use the prepositioned VariZIG at the site, there are two options:

1. The physician becomes a Subinvestigator to the Principal Investigator, provided the Principal Investigator agrees to this arrangement. Section 6 of Form 1572 must be updated accordingly.

2. The physician who is treating the patient must become a Principal Investigator.

In both scenarios, the procedure for obtaining approval from FFF is the same.

The following documents must be completed and received at FFF before VariZIG is sent to the sites:

Protocol Signatory Page
Financial Disclosure Form
FDA Form 1572
Local IRB approval letter

The above four forms must be faxed to FFF Enterprises to Urs Aeberli at
951-296-2570 before prepositioned product can be released.

Then follow-up the fax by mailing the first three forms with original signatures to:

FFF Enterprises
Attn: Urs Aeberli
41093 County Center Dr
Temecula, CA 92591

Any questions regarding VariZIG can be directed to Urs Aeberli at
800-843-7477 x1195.