Actual - Legal

If you take down a lease for a business, the lease agreement will shock you. It is the size of a small phone book, and the most important

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

page is usually buried in the back.

Assume you have a business. Assume further that you wisely decided to form a business entity. For t

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

Examples of combination products may in

e purposes of this article, we will assume it is a corporation, but it could be a limited liability company as well. At some point, you a

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

re going to need an office or retail space. This means you need to find a location and then sign a lease.

Most businesses fail. Sorry to

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

be blunt, but it is the brutal truth. The magic line in the sand is two years. Between 70 and 80 percent of all businesses fail in the fi

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

Combination pro

st two years. This is why banks will not touch you during this period. If you can make it past the two year mark, suddenly everyone wants

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 talk to you, lend you money and so on. This is true even if you are barely getting buy.

Commercial landlords know about the 2 year f

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

ilure information. In the case of retail landlords for malls and such, they don’t care about the two year rule. They just assume your bus

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

ness will fail. Why should you care what they think? Well, they put a nasty little thing in your lease that can really cause you a lot of

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

problems – a personal guarantee.

A personal guarantee is exactly what it sounds like. You are personally guaranteeing the obligation in

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

the agreement in question. In this case, you are personally guaranteeing that you will pay the monthly rent for the entire term of the le

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

Following aspects would a

se. If the business fails, you are on the hook.

Ah, but what about your business entity. Doesn’t it protect you from such business evils

dd to the challenges in developing combination products:

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

? No! If you personally guarantee something, you essentially are opening a door in the wall of corporate protection and letting the landl

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

rd through. Perhaps a simple example will explain things.

Think about the first time you purchased a car or a home. For many of us, we a

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

ranged financial help through the Bank of Mom and Dad. In some cases, they would lose their mind and actually co-sign our loan documents.

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

In doing so, they were personally guaranteeing the repayment of the debt. If we totaled the car or defaulted on the mortgage, they were

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

Professional from academic institutions, pharmaceutical industries, health care indust

oing to have to pay it.

A corporation provides you with protection from personal liability because of a legal fiction. That fiction says

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

the corporation will be treated as its own “person” under law. When you personally guarantee a corporate debt, you are essentially doing

.

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

what mom and dad did for you. The only difference is you can’t beat a corporation within an inch of its life if it doesn’t pay the bills!

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

Companies that provide selfless information through particip

If your business is functioning as a corporation or limited liability company, never personally guarantee any debt of the business. EVER

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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This is the third in a series of articles about the internationally collected sculptor, Nina Winters.

New galleries and their quest for a team of artists and vice versa must be done artfully. Artists and galleries need to think things through before making requests or shipping out art.

When you are self employed you have to think about more than your salary and how well you can afford to pay the bills. You have to think about income distribution and quarterly tax filings. You also have to think about filing paperwork for independent contractors and anyone that you may employ other than yourself.

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