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A majority of businesses have ownership groups of less than five individuals. While this provides for efficient and

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

effective management, difficulties arise when something happens to one of the owners.

If your business has multip

; 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 owners, ask yourself what happens if:

· The owners can’t get along?

· One of you is hospitalized for an extended

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

period?

· An owner gets divorced [and the spouse is awarded half the shares?]

· An owner stops coming to work?

·

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

ou want to sell stock to a third party?

· An owner passes away?

· One of you wants to retire?

Each of these events

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

Combination pro

an severely disrupt your business, particularly ownership disputes. If the owners can’t agree to a course of actio

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

, they often end up in court and a judge may get involved in the actual running of the business. Many businesses t

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

hat were otherwise successful have failed because of such disputes.

How can you avoid these problems?

The best sol

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

tion is to pursue an agreement between the parties before there are problems. This agreement, sometimes called a b

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

y-sell agreement, is a contract between the owners [and their spouses, if any]. The purpose of the document is to

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

ddress how disputes, ownership sales and other events will be addressed before they happen. These issues are much

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

Following aspects would a

asier to deal when emotions are not involved.

The most common issues addressed in the ownership agreement are whe

dd to the challenges in developing combination products:

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

and how equity interest will be bought back by the business or other owners. Common topics include:

· First Right

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

f Refusal if a shareholder tries to sell their stock;

· Right of owners to buy the stock from the estate of a dec

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

eased owner to avoid ownership by the children or spouse of the deceased owner. This is often combined with life i

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

surance products to supply a means for making payment;

· Right to buy back stock from an owner that files personal

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

Professional from academic institutions, pharmaceutical industries, health care indust

ankruptcy;

· Right to buy back stock from an owner that is found to be mentally incompetent [drug addictions, etc.]

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

· Right to buy back stock from an owner that fails to perform their assigned duties; and

A buy-sell agreement is

.

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

smart and effective means of short-circuiting ownership disputes before they occur. If your corporation consists

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

Companies that provide selfless information through particip

f two or more owners, you should seriously consider putting an agreement in writing to avoid debilitating disputes

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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