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If you are going to be a landlord, I strongly advise having a well-prepared lease. A good lease will solidify the verbal agreement and important criteria between the landlord and the tenant. It

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

will also be your strongest ally should a dispute arise between you and your tenant. A properly entered lease will go farther in solving landlord/tenant disputes than any other document you ha

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

Examples of combination products may in

ve. In 99 percent of the cases, it is your first weapon in a courtroom battle.

Finding a lease.
So once you understand what a lease is, the next question becomes, “Where does one find a g

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

od rental lease?”

That’s an excellent question. One in fact, that I was having trouble solving for the scope of my book, How to Find That Quality Tenant. Fortunately, as I wrote the chapter on

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

leases, I was determined not to let the problem stop me from helping you find or develop a good lease. Therefore, let’s begin with me telling you how you go about finding a lease that best fit

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

Combination pro

s your needs. As far as I am concerned there are basically three ways. I’ll list each of them along with the advantages and disadvantages associated with each choice.

Draft your own. (Should y

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

u choose to do this, read my article on the contents of a lease available on the articles page at http://www.findthatqualitytenant.com to better understand what should be in a lease)

The advan

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

tage: it is cheap. The disadvantage: you could make some costly legal mistakes by not having enough information or the wrong information in your lease. If you choose to draft a lease yoursel

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

f, there are books you can purchase that will walk you through the process, although I cannot say how well they work, because I have personally never tried to draft my own lease.

You can pick

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

ne up at an office supply store.

Advantage: It is easy to do. Disadvantage: It could be too general to offer adequate protection. When you need a lease right now, these store-bought leases c

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

an do the trick since they are so easy to find. They are cheap and simple but will offer the least amount of protection out of the three lease options.

You could have a real estate lawyer draf

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

Following aspects would a

t you a lease.

Advantage: It is tailor fit, offering you the best overall protection. Disadvantage: It is more costly, although not nearly as costly as a poorly drafted lease followed by a t

dd to the challenges in developing combination products:

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

nant dispute.

As you can probably guess by that last comment, I recommend using a real estate lawyer to draft a lease. They know the laws for your state, county, and locale, and have a good id

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

ea which landlord/tenant disputes are most likely to trip you up. Let their expertise and past experiences work to your advantage.

In addition, when you are a landlord, you have at least some

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

financial net worth; definitely more than your tenants will have. This automatically makes you prone to frivolous lawsuits and unwarranted demands by those tenants.

A properly drafted lease wi

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

l offer maximum custom protection against many of the possible lawsuits and demands landlords are exposed to. Therefore, I would advise you to have a lawyer draft your lease and to do it from t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he time you put that first tenant in your first rental.

I know money can be extremely tight when you are first entering your landlording career, but I highly recommend using a lawyer from the

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

beginning for this reason. If you draft your own lease or use a store-bought one and you have reasonable success with it for a couple of tenants, you could be lulled into a false sense of secur

.

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

ty. When you reach this point, you will never pay a professional to draft a lease for you until you end up with a legal dispute, which may of course, be too late.

Take my recommendation and sp

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

Companies that provide selfless information through particip

end the money initially on a lawyer structured lease.

(I am not a lawyer; therefore, if you have any legal concerns with anything in this article, please contact the appropriate legal counsel)

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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The article outlines the basic points one should be aware of before going into any real estate transaction. It briefly discusses the various techniques on should undertake in order to avoid complications in a transaction. It also provides an overview of the assistance real estate agents can provide the buyers and sellers.

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