Advice Pool - Legal

In any franchise company there will be cases where one franchisee will wish to retire, cashed out of their business or s

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

ell it to someone who has offered them more than they can refuse. It is a fact of life in the modern franchise world.

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

Examples of combination products may in

hether it is for a master franchise or a single franchised outlet each franchisor generally has either a clause in their

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

franchise agreement for first right of refusal or first right of purchase. In my franchisee company, I could see that t

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

ere were times when I wanted both clauses in my franchise agreements.

There are cases where you'll want first right of

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

Combination pro

efusal, but there are also times when you want first right of purchase. In consideration of this you may wish to add 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

ight of first purchase in your franchise agreements. Most franchise attorneys who draw up franchise disclosure document

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 do use boilerplate clauses for first right of refusal. I decided in our franchise company that, that was not enough f

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

r me. Below is the additional clause that I added to our franchise agreements;

5.5 Right of First Purchase

Franchisor

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

requires Franchisee (or Master Franchisee) to give Franchisor the right of first purchase prior to soliciting offers fro

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

a third party if Franchisee chooses to sell their Franchised Business. Franchisee agrees to notify Franchisor in writin

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

Following aspects would a

if Franchisee desires to sell or transfer Franchisee’s interest in their Franchised Business. Franchisor must elect to

dd to the challenges in developing combination products:

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

xercise Franchisor’s option to purchase Franchisee’s Franchised Business within thirty (30) business days after Franchis

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

r’s receipt of Franchisee’s written notification. If Franchisor offers Franchisee an amount that Franchisee doesn’t agre

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

e to, Franchisee may try to sell to a third party. Franchisee is obligated before any transfer to a third party to make

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

ure that they meet all criteria set forth above under the heading “Transfer by Franchisee”.

- - - - - - - -

If you own

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

Professional from academic institutions, pharmaceutical industries, health care indust

a franchise company, you would be well advised to talk to an experienced franchisor attorney and ask them be a right of

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

irst purchase clause makes sense for your particular business and franchise model. It may or it may not there are sever

.

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

l reasons why. I hope this may help you in your search to consider adverse potential eventualities that could harm your

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

Companies that provide selfless information through particip

franchise company in advance so that you do not have to learn saying was the hard way like I did. Consider this in 2006

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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This is the story of two entrepreneurs we'll call Jack and Jill. Jill went up the hill and built a successful business. Jack went up the hill, failed and fell down the hill. Read on to discover how Jill succeeded and Jack failed.

Customer segmentation is all about understanding the people you sell to and who you would like to be your customers. Once you have an understanding of this then you can ensure that you build your products and services to meet the demands of these markets and become a market orientated company, which in turn should lead to greater profitability.

You have a great product or service… Now, how should you market it? You have to make others know about what you have to offer. There is no good in having a great idea if you don’t know how to sell i...

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