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Most states provide some free asset protection by state law in the form of Homestead Exemption. This state sanctioned creditor protection provides a fixed amount of equity protection for your primary r

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

esidence.

Only five states offer complete protection for the full value of your home. If you are fortunate to live in one of those states you can rest easy that your home is protected (unless you are

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

facing a challenge in a federal court).

For those of you who live in the other 45 states, it's in your best interest to do some simple math to determine how much of your home equity is exposed. To cal

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

culate this, take your home equity and subtract out your state's homestead exemption. (If you are unsure of the amount of your state's homestead exemption send an email to info@apcg.net with 'Exemption

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

' in the subject line and the state of your residence, you will receive a response back via email with that information).

If you have over $25,000 in equity exposed then it is time for you to consider

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

taking action to protect your home.

Why is it so important to protect your home equity? Equity in real estate is one of your greatest liabilities because if you own real estate and someone is looking

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

to sue you they know if they get a judgment they will absolutely collect. Why? Well, you can't very easily stuff your home equity under a mattress in the event of a lawsuit.

The good news is protecti

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

g the equity in your home or other real estate is not difficult.

One remarkably simple way to protect the equity in your home is to strip the equity from your home through the use of 2nd or 3rd mortga

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ges. For example, if your first mortgage is presently held by Chase and you are sued, Chase will never be affected by any judgment brought against you. Their investment in your home mortgage will alway

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

s be intact, no matter what happens to you or your finances. The same holds true for second mortgage holders and subsequent liens.

So should you run down to the bank and get a second mortgage and with

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

draw all your exposed equity? Not at all. Although this would encumber the equity in your home you would now have another asset exposed, cash.

A better solution is to place what is called a "friendly

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

lien" or "friendly mortgage" on your home to protect the exposed equity. It is a simple process that can be completed in a couple days and will act as a powerful deterrent to lawsuits.

The first step

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

is to choose your "friendly lien" holder. For the lien to be considered valid it has to be held by a third-party. Although this third party can be a friend or relative, it is not recommended because yo

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ur relationship to this person would be easily discovered if they were ever called into court to defend the lien. Ideally you want to engage a totally unrelated third party and preferably one that you

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

an control.

For this reason a private corporation, that you own and control while the ownership cannot be traced back to you, is the perfect vehicle to act in this capacity.

The second step is to cre

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ate a debt between you and the corporation, the lien-holder, for an amount that meets or exceeds the exposed equity in your home. This is documented by a Promissory Note between you and your corporatio

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

n.

Your final step is to record that debt as a Mortgage or a Deed of Trust on the property. The Mortgage or a Deed of Trust document is filed with your County Recorder’s office, perfecting the lien an

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

d making it a matter of public record that there is no equity in your property.

Voila! You have now made the equity of your home vanish. This private mortgage or "friendly lien" as we like to call it,

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

is just as valid as a mortgage by Chase with the exception that you don't have to make payments and you can have it completely removed at the time of your choosing. Don't you wish you had that kind of

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

control over your bank mortgage?

At some point, you may want to sell the property or refinance. At that time it will be simply a matter of drafting another document to have the friendly lien released

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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