Cases - Business

"What's in a name? That which we call a rose by any other name would smell as sweet." --Romeo & Juliet, Act II, Scene II

Well, a rose by any other name may smell just as sweet to Shakespea

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

re, but don't try to call the tax collector to ask a property appraisal question. Not knowing which office to call may simply get you an exasperated employee who is unable to assist you.

If

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

Examples of combination products may in

you are not sure exactly which department to call about your property tax question, try finding out if your local government has a "311" type of service. This is the concept of "411 telephon

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

directory information”writ small to address only phone numbers in your municipal or county government. If the number to use is not actually 311, there may be another number which is a gener

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

l information number staffed by persons whose job it is to steer you in the right direction. Find that number and you will be off to a flying start.

To give you a head-start on the nomencla

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

Combination pro

ure and division-of-labor issue, use the following as a primer:

Who does what

Several entities determine the outcome of your annual property tax bill. While the names of these entities var

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

from state to state and from time to time, the names used in Florida generally exemplify the roles of the various entities in determining your property tax bill.

The property appraiser

Ju

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

t as the name implies, your county property appraiser assesses the value of property. He or she also makes exemption and classification decisions. In many jurisdictions, this position is cal

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

ed tax assessor. In fact, the position was called tax assessor in Florida until 1980. At that time it was changed to property appraiser to try to provide a more descriptive name of the funct

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

ons of the office, and to demarcate it more clearly from that of the tax collector.

But woe be unto those who don't keep their lingo up-to-date. A recent straw ballot on whether the propert

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

appraiser should be elected in Miami-Dade County, Florida, rather than appointed by the County Manager, as is presently done, was (properly) stricken from the ballot by a circuit judge on t

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

Following aspects would a

he ground that it was not clear whether the ballot question referred to the property appraiser or tax collector. So much for a rose by any other name smelling just as sweet!

The tax collect

dd to the challenges in developing combination products:

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

r

The tax collector, as the name implies, acts as collection agency and accountant, adding up the various taxes, billing property owners and collecting property taxes and other charges bill

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

d on the tax bill. The tax collector sells tax certificates to enforce unpaid and delinquent taxes on real estate and enforces tangible personal property taxes through warrants and seizure,

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

s provided by state statute.

The taxing authorities

Taxing authorities, cities, counties, community development districts, water management districts, etc., determine local millage rates a

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

d special assessments. And while we're talking about millage, a mill is simply a tenth of a per cent, and is a measure that makes it easier to discuss tax rates. Millage is synonymous with t

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

Professional from academic institutions, pharmaceutical industries, health care indust

x rate, expressed in terms of tenths of a per cent.

Value adjustment board

The Value Adjustment Board hears and rules on property owners complaints about assessed valuation of real estate

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

nd tangible personal property, exemption denials and disapprovals of special classification, such as greenbelt or agricultural.

Outside Florida, this function may be served by an entity kno

.

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

n as the property appraisal adjustment board, tax equalization board, tax adjustment board, or some similar name.

As with any other question regarding property tax rights and obligations in

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

Companies that provide selfless information through particip

your jurisdiction, confer with a local property tax consultant. He or she will be familiar with the regulations which govern in your area.

There, now, don't you feel better informed already

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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Naming a product tis the sort of thing that sounds like fun until you've had to do it. In many industries, the best names are already taken and there are a lot of legal hurdles to overcome in the search for the perfect name. Alas, there may be no perfect name. But here are some tips for your organization to at least find some serviceable names.

These social and destructive insects live off wood, decay and dead leaf and plants. Although there are over three thousand species of termites, there are three main groups called the subterranean, Formosan and drywood termites. These groups of termites have many different varieties and live in different parts of the country.

For many of you who are businessman and businesswomen, traveling becomes second nature. As you jump from city to city, it gets to the point where people ask you what you do for a living and you have to refrain from saying, “I’m a Nomad, what about you?” Traveling for business can certainly be a pain in the bags, but with a few simple changes, you may find the transition from home to away to be easier than assumed.

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