Actual - Real Estate

After all the hard work in putting your house up for sale and in attracting/accommodating potenti

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

al buyers (with the help of a realtor, at the most), an offer or a series of offers finally comes

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

Examples of combination products may in

in.

This is the time when your decision making will be put into real test as this portion of the

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

sale process is the most mentally tough on almost all sellers. Unlike the earlier stages wherein

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

it is more physically stressful, deciding on offers will determine the success of a real estate t

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

Combination pro

ansaction and more importantly, the future of the seller and his/her family.

If you are deciding

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

on multiple offers, it is elementary to compare these offers thoroughly and select the best one.

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

More often than not, the highest bids win, but it is advised to have a backup buyer in case a fal

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

ing out ensues during the negotiation with the original buyer. Moreover, it is recommended that y

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

ou use whatever legitimate leverage you have (e.g. sweetening the deal by throwing in furniture a

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

d appliances that are already in the house) to entice buyers to agree on a higher price during ne

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

Following aspects would a

otiations.

But even before negotiations, always be sure to check a buyer’s profile first so that

dd to the challenges in developing combination products:

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

you can avoid wasting time on fraudulent or unworthy transactions. Among the buyer information t

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

at should be investigated are his/her debt and credit history, cash position, employment status,

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

urrent income, and other related financial information. Consulting a tax consultant beforehand 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

ll also be advantageous because you will be able to identify the tax-related costs attached to th

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

Professional from academic institutions, pharmaceutical industries, health care indust

sale of your property, which you can incorporate in your asking price.

During the negotiation a

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

d subsequent agreement, it is best to be represented by an attorney who has had substantial exper

.

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

ience in handling real estate transactions. The presence of a seasoned attorney will make sure th

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

Companies that provide selfless information through particip

t all terms, conditions, and penalties (if ever there are) are in writing to avoid future mix-ups

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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