Answers - Real Estate

How many times have we found ourselves trying to sell a building and we are confronted with a tenant who does not cooperate.

The tenant

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

does not want to let you in. You know you have the right to show but want to be sure that you do this exactly according to procedure. 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 tenant is already unhappy about having to move and you don't want to be be sued and besides your priority is to show it not have a leg

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

l fight.

The best approach in any potential dispute is to talk it out. There may be circumstances in your tenants life that you could 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

ccommodate and avoid a fight. Try to sit down and find out why or what you can do in a compromise that would allow you to show and accom

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

Combination pro

odate the tenant. Going to war is always the last thing you do. Good communications (in writing) and some understanding as to how disrup

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

ive to the tenants life along with a working knowledge of proper procedure should minimize friction.

What is Proper Procedure?

OK, you

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

've tried to be nice and still you are dealing with a rude and uncooperative tenant. Here is where you must proceed according to law so

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

hat you avoid a legal argument. Now you have to assume the tenant would love you be slip up. You should talk to your real estate attorne

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

, property manager or apartment association and follow the rules exactly and always document! All conversation should be in writing and

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

f its really heating up use certified mail, that will put the tenant on notice that you are serious and ready to apply the law.

First y

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

Following aspects would a

ou must give proper notice.
1. Do this in writing and give the approimate time, date and reason for your visit.
2. Hand deli

dd to the challenges in developing combination products:

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

er at least 24 hours before you intend to show the unit.
3. Your showings should be during business hours, whenever possible. This

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

will leave the tenant little reason to complain its too late.
4. If you intend to mail, give them one week's notice and send it ce

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

rtified if you have a problem tenant. You should check with local law to see how much notice you need when notifying by mail.

Now you 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

e within your rights to enter. However, never force your way in and don't argue if they still wont allow entry. The law is on your side

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

Professional from academic institutions, pharmaceutical industries, health care indust

o don't do anything silly like changing locks or getting angry. Try one more time to see if you can make suitable arrangements such as b

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

est times for entry or how many showings per week is reasonable. Its possible to negotiate a reasonable schedule with the tenant to avoi

.

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

fiction. If its still a problem send a certified letter indicating that the law allows you to show and that you have may take legal ac

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

Companies that provide selfless information through particip

ion. You can terminate a lease if a tenant does not allow a lawful entry. Please consult with an attorney before taking any legal action

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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