Advice You - Business

When a franchisee company offers for sale of their method of doing business to the public

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

and use of their brand-name they must list the information in a concise format in the fr

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

Examples of combination products may in

nchise agreement. Additionally when a franchisor wishes to expand their franchise system

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

through the use of master franchises, they will need to further describe how the master f

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

anchise is expected to go about the selling of additional franchises and give an overview

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

Combination pro

of exactly what is expected in the agreements.

Below you will find an excerpt from my co

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

pany's franchise agreement that dealt with the grant of right to sell franchises under my

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

brand-name. This may give you some good ideas of how such things are done;

1.1.1 Grant

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

f Right to Sell Franchises

Once Franchisee Core Services operating franchise has been es

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

ablished and operating for a period of ninety (90) calendar days, Franchisor grants to Fr

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

nchisee the right to sell to other parties franchises of The Car Wash Guys or Wash Guys S

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

Following aspects would a

stems (the right to become a “Master Franchise”) within the boundaries of Franchisee desi

dd to the challenges in developing combination products:

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

nated Marketing Area only. If Franchisee has not established and have operational the Cor

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

Services franchise within one hundred eighty (180) calendar days of delivery of Franchis

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

e’s initial car wash truck/unit, this right may be terminated by Franchisor.

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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

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Of course if you are a franchisor and are considering master franchises as

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

Professional from academic institutions, pharmaceutical industries, health care indust

method of expanding your business model you should also realize that it is not as easy a

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

it looks. In fact it is quite a litigious industry and therefore you'll need to seek le

.

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

al counsel and find your self a competent, knowledgeable and an experienced franchise att

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

Companies that provide selfless information through particip

rney who is capable of drawing up these master franchise agreements. Consider us 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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Advice You - Franchising Agreements and the Grant of Right to Sell Franchises

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