Advice You - Business

Executive management franchising teams in franchising companies must deci

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

de how they wish to handle disputes in the franchising agreement. More o

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

Examples of combination products may in

ten than not clauses are put into the franchising agreements, which stipu

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

late how disputes between franchise stores and franchisees will be handle

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

Generally the parties agree in advance to handle such disputes in a cer

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

Combination pro

tain way. One of the most common ways, which saves both the Franchisor 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

d the franchisee from extensive legal fees is to use an arbitration claus

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

e.

Generally these arbitration clauses serve the franchisee as well beca

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

se litigation is so very costly and generally when a franchisee has a dis

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

pute it is because the business is not succeeding and therefore they will

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

have little if any money to fight the Franchisor in court. The Franchisor

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

Following aspects would a

also benefits and it prevents excessive lawsuit litigation and very high

dd to the challenges in developing combination products:

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

awards from kangaroo courts with problematic juries.

Am I saying that ar

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

bitrator is usually rule in favor of franchisees? Yes, more often then no

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

, I have found this to be the case. In the end however, it saves time an

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

money USUALLY for both parties although it appears some franchise compani

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

Professional from academic institutions, pharmaceutical industries, health care indust

s have indeed found an exception.

Do I recommend arbitration clauses in

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

franchising agreements? Actually I do and we always had them in our fran

.

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

hising agreements, ask your attorney. But mediation and litigation are a

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

Companies that provide selfless information through particip

lso options to binding arbitration clauses. Please 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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Not having the correct amount of space in your office can seriously affect productivity. Find out the best ways to use the space you have.

Any time there is a change in management at the corporate level it can cause a conflict with productivity, efficiency and innovation. For those companies that rely on innovative spirit to propel their profits such decreases can spell disaster for the department or division. Consider if you will a project manager who is rapidly reassigned to another division or another important project.

Having been involved in business and politics and watched government attack us business folk and thus having been on all sides of this equation, it is readily apparent to me that the humans are just doing what humans do anyway.

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Advice You - Business Management Case Study; Arbitration, Mediation or Litigation in Franchising Agreements

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