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Just Answers - A Gift to Uncle Sam
We were three days from closing on a 45-day escrow. I was working with a first-time buyer who was becoming more and more anxious as the closing
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
date grew nearer. Then, I received a call from the listing agent. Her client, an “experienced” investor, wanted to perform a 1031 Tax-Deferred E
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
changed.
“What,” I asked her. “Now you tell us?”
To say the least, I was pretty disappointed with the agent because from the beginning, I brou
“What,” I asked her. “Now you tell us?”
To say the least, I was pretty disappointed with the agent because from the beginning, I brou
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ght the subject up and she continuously told me her client didn’t want to perform one.
“Is your client performing a 1031 Exchange,” I asked her
“Is your client performing a 1031 Exchange,” I asked her
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
on one occasion.
“Are you sure he’s not performing a 1031 Exchange,” I asker her on another. “He’s purchasing another property. He’s going to g
“Are you sure he’s not performing a 1031 Exchange,” I asker her on another. “He’s purchasing another property. He’s going to g
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t killed on taxes!”
Finally, I just came out and asked, “You did discuss an Exchange with your client, right?”
On each occasion, she assured m
Finally, I just came out and asked, “You did discuss an Exchange with your client, right?”
On each occasion, she assured m
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
e it had been discussed and he just didn’t want to perform one. She also made it clear that she had been in real estate for a number of years an
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
knew what she was doing. The case was closed for me! It’s in her hands now.
For those who may not know, a 1031 Tax-Deferred Exchange (also kn
For those who may not know, a 1031 Tax-Deferred Exchange (also kn
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
wn as a “1031” or “Exchange”) is the method for exchanging one investment property for another one, while deferring the possible capital gains t
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
ax. The financial gain you would realize can be deferred as long as you follow the rules set out by IRS Code 1031—where the name comes from—and
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ou use proper professionals who know and understand the process. They should also be able to explain the process to you and help you follow you
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
requirements under the code. This is important because if there are any mistakes made, you could be left holding the legal and financial bag. T
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
hat financial bag would be in the form of a healthy tax consequence levied by Uncle Sam! If used correctly, this a true wealth-preserving tool.
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Fortunately, we were working with an experienced escrow officer. Early in the escrow period, she looked at me and asked, “Why the hell is he not
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
doing a 1031? I know he’s purchasing another investment property!”
That was an answer I could not give her…until the call from the listing agen
That was an answer I could not give her…until the call from the listing agen
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
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
t.
It turned out her “experienced” investor didn’t even know what an Exchange was.
Because my escrow officer was experienced, she knew exactly
It turned out her “experienced” investor didn’t even know what an Exchange was.
Because my escrow officer was experienced, she knew exactly
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
what to do. In fact, it was as if she knew what was coming. She set up a Delayed Exchange and we only had to close a few days later than schedul
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
d, at no additional cost to my client. She was a lifesaver! If it weren’t for her, this situation could have turned out differently.
If an inve
If an inve
.
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
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
stor can only get one thing from this story it is this: If you do not perform a 1031 Tax-Deferred Exchange—or any other equivalent wealth-preser
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ing tool—you might as well place tens of thousands of dollars in a cute box, wrap it up nicely, put a pretty bow on it, and give it to Uncle Sam
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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