Advice You - Business

A non compete agreement or (no compete clause) is often used by employers to protect themselves against their sta

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

ff leaving their company to join another company (ie. a competitor).

The fear is that when leaving the company,

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

Examples of combination products may in

n employee could take assets with them to their new employer that would hurt their current employer.

Imagine for

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

example you sell plumbing equipment and have built up a significant customer base while working there and decide

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

o leave your employer to join a rival plumbing supplier in a similar sales role. If you took all of your business

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

Combination pro

from your current employer to your new company, it would certainly hurt your current employer very badly.

As a

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

onsequence, companies typically try to protect themselves from such things happening and a non compete agreement

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 one way of doing so.

Here are some examples of non compete agreements that I’ve seen included in job offers:

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

li>A non compete agreement that prevents the person from working for a direct competitor for a certain period of

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

time ie. one year.

A non compete agreement that prevents or limits the geographic area in which the pe

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

son works for a competitor.

A non compete agreement that limits the industry or trade that a person ca

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

Following aspects would a

work in for a period of time ie. one year.

What should you do when faced with a job offer that

dd to the challenges in developing combination products:

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

ontains a non compete agreement?

First and foremost, a non compete agreement is a legal clause so your best

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

bet is to consult a labor lawyer or someone else who is qualified to determine the validity of the clause and whe

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

her or not you should be concerned about agreeing to it.

Don’t assume you understand legalese (ie. lawyer langua

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) if you don’t!

If you’re already employed, are considering leaving your employer and are concerned about a non

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

Professional from academic institutions, pharmaceutical industries, health care indust

compete agreement that is already in place in your employment contract, you should again consider consulting some

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

one with professional experience in this area before doing anything.

The last thing you want to do is anythin

.

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

that could be construed by your current employer as being a breach of your employment contract with them. Ig

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

Companies that provide selfless information through particip

orance on your part (ie. “I didn’t know what I was signing”) is not a good excuse.

If in doubt, consult a lawyer

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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