Answers - Real Estate

Arizona has been hot in more ways than one. Not only has the temperature always been high, in recent years real estate has been hot as well. For several decades demand for housing has increased at a ste

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

ady rate because of the significant influx of people moving there. Over the last two years investors discovered the Phoenix metropolitan area and prices, like so many places in the country went through 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 roof. Traditionally, around 18% of the transactions may have involved an investor. In recent history that number has been closer to 40%. A corollary is that these investors were from other states. L

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

cal investors and many move-up buyers were sidelined because of the bidding wars that were occurring in that hot market.

The good news is the market has cooled and now could be a great time to consider b

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

ying in the Phoenix area. There is an excessive inventory and prices have been moderating for the past 6 months. Sellers are more negotiable and yet, from a long-term perspective, Arizona still has grow

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

Combination pro

h potential that has supported real estate appreciation that was - and will be significantly higher than other parts of the country in coming years.

If your purchase is a resale home rather than a new on

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

, the Arizona Association of Realtors? (AAR) approved contract will be used as the agreement between yourself and the Seller. This document and several others have been drafted and modified over the year

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

s to provide built in protections for both parties. The AAR Residential Purchase Agreement includes the following to serve as safeguards both parties:

· 10 Day Inspection Period during which the Buyer m

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

y have numerous inspections performed by specialists;

· A 5 Day Response Time during which the Seller is given the opportunity to correct issues which may be discovered during the inspections;

· A 5 Day

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

period during which the Buyer can decide to continue with the transaction based on all the information collected during the inspection period and the Seller's 5 Day response time. The Buyer "at his sole

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

iscretion" may decide to cancel the contract based on information gained during the previous 20 days;

· A provision for the Seller to Provide the Buyer with a Seller’s Property Disclosure Statement (SPDS

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

Following aspects would a

to disclose “known” defects;

· The requirement of a property appraisals for financing;

· A provision that gives both parties the right to give the other a "3 Day Cure Notice" prior to declaring a breac

dd to the challenges in developing combination products:

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

of contract;

· The ability to cancel the contract if the other party is in breach or has not performed to the terms of the contract during the “cure” period;

· A provision for mediation of conflicts as

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

an option to legal action;

· A provision for a Final Walk-Through to allow the Buyer access to the home to verify the property is in substantially the same condition as when originally was viewed before

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

the original offer was made. The Buyer also can verify at that time everything the Seller may have agreed to do has been done.

A normal transaction in Arizona has other supporting documents that are use

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

routinely to ensure both parties are treated fairly:

The SPDS mentioned above;

A Preliminary Title Report describing the technicalities of the particular property;

An Agency Disclosure so that all par

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

Professional from academic institutions, pharmaceutical industries, health care indust

ies know who the agent is working for; The Buyers Advisory, a catch-all that informs the Buyer as to where additional information may be found.

The process in Arizona is one that makes every eff

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

rt to ensure the Buyer is receiving what he contracted for and the Seller is receiving in exchange what he expects. Unfortunately, Agreements are only as dependable as the parties making the agreement.

.

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

he sale and purchase of a home is distressful for both parties regardless of the safeguards. To minimize the distress, it is beneficial to use the AAR Residential Purchase Contract as the controlling doc

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

Companies that provide selfless information through particip

ment. It’s equally important to have someone who is competent and representing your interests to draft the agreement. It’s a good reason to call a REALTOR? to represent your interests in the transaction

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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