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As far as the 1031 Exchange is concerned, it is the Qualified Intermediary who can be called the top “expert” who makes or breaks the deal. The role of the

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

QI is crucial to completing the exchange successfully. It is he who acts as the “glue” that binds the buyer and seller of the property together in the 1031

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

Examples of combination products may in

Exchange process.

Selecting the right QI is most important, otherwise it will be like going to a quack rather than a qualified doctor for treating some se

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

rious disease. That means, a taxpayer intending 1031 must be cautious about falling victim to a poor facilitator with disastrous results, as he may not do a

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

exchange at all or does not know how to structure it. And his deal will not pass the muster at IRS audit, leading to a loss of exchange funds due to poor i

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

Combination pro

nvesting or conscious deceit.

Care must be taken to ensure the credentials of a QI as a really experienced, knowledgeable professional who is clear in thou

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

ght and communication, and transparent in dealings. As the exchange process requires quick decision-making, only a learned facilitator can help and clearly

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

understand the situation and use the options rightly.

What makes a good or bad exchange QI is his level of depth in knowledge and resources. He must be wel

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

l-versed with all tax code changes and latest rulings. Since the 1031 code has many gray areas, only an experienced facilitator can apply them to situations

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

intelligently. To ensure safety for the money of the taxpayer, the QI ought to maintain a substantial fidelity bond for the benefit of their exchangers.

T

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

ere are no licensing requirements for Intermediaries. No federal regulations for 1031 Exchange Experts are in place, and only two states have mandated licen

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

Following aspects would a

sing and bonding requirements for them.

To practice, they only need not to be stay qualified as defined by the Internal Revenue Code. Under certain circums

dd to the challenges in developing combination products:

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

tances, the Code prohibits certain ‘agents’ of the taxpayer, such as accountants, attorneys and realtors who have served the taxpayer in their professional

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

capacities within the last two years, from becoming a Qualified Intermediary for the taxpayer in an exchange.

Once in the job, a QI, who is not the taxpaye

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

and not a disqualified person, takes up the assignment and enters into a written agreement called an Exchange Agreement with the taxpayer, acquires the rel

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

inquished property from the taxpayer, transfers the relinquished property, acquires the replacement property, and transfers the replacement property to the

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

Professional from academic institutions, pharmaceutical industries, health care indust

taxpayer. The whole process involves several time-consuming steps.

The written agreement between the taxpayer and intermediary arrogating the former’s righ

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

s to buy and sell, and hold the money or property to the latter, is to take advantage of the qualified intermediary “safe harbor” provision enshrined in 103

.

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

1.

Thus the main obligations of the this middle-man cum expert can be summed up as receiving the 45-day identification notice for replacement property and

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

Companies that provide selfless information through particip

delivering escrow funds for replacement property settlement and arranging for direct deeding of the properties and ultimately providing the final accounting

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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