Advice You - Business

Many franchise consultants shy away from such advice as securing master franchises as a plan for expansion with a new franchising company. This is because the legal issues and the litigation are tough to deal with and for that kind of l

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

iability there just is not enough money in it. Plus most franchisor later regret giving away that much of he pie or they have one or two master franchise failures which brings down the whole system due to bad PR and litigation costs.

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

e method considered for our company was to set up regional team partners and use existing franchisees already under the franchise agreement to assist in regional expansion. But we decided to make them managers rather than master franchi

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

ses, regional franchises, sub-franchisors or partners. It turned out we were right as we made the rapid expansion term of only 2-years to the regional team managers incase they under performed or failed to assist us in opening new units

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

Several underwhelmed us, yet as a whole the program worked and added many units each year in many different regions.

This is good as the goal of a franchisor is to expand. Below is the list of stipulations I put forth to insure that e

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

Combination pro

veryone had a fair chance in the agreement;

Regional team manager understands and acknowledges that the following requirements must be met in order to qualify as the regional team manager:

(A)The regional team manager must, at the tim

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

of such assignment, be financially responsible and economically capable of performing our objectives in this Agreement and in our business development plan.

(B) The regional team manager must expressly assume and agree to perform such

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

obligation and sign a binding agreement with us.

(C) The regional team manager must be trained and pass our special regional team manager training course.

(D) The regional team manager must be competent and subject to a thirty (30) t

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

sixty (60) day review by us before assignment as the regional team manager.

(E) The regional team manager must run their own The Company franchise for at least one month prior to assignment as the regional team manager.

(F) The regio

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

nal team manager must own and run a company store unit for the duration of their franchise in a specifically designated territory other than another franchisee’s territory but in their exclusive territory.

(G) The regional team manager

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

must be able to provide all on-going support items to the franchisees listed in the Franchise Agreement.

(H) The regional team manager must attend any formed franchisee organization, union or association meetings in their exclusive ter

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

Following aspects would a

itory, which have been officially recognized by us, providing that you want them to be there and of which you are a member.

(I) The regional team manager must maintain on hand at least one area representative and one loaner truck for e

dd to the challenges in developing combination products:

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

very twenty (20) franchisees in their exclusive territory.

(J) The regional team manager must sign a non-competition agreement with franchisees not to operate their company store in a franchisee’s exclusive territory unless they have b

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

en asked to by the franchisee in case of vacation or injury. For this Agreement to be in force the regional team manager must meet all ten (10) of the above requirements.

In addition to the termination provisions in the Franchise Agree

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

ment described in Section 7.1, 7.2 and 7.3, regional team manager will be in default of this Agreement and this Agreement will terminate if five (5) or more franchisees transfer or fail in the regional team member’s exclusive territory

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

ithin a twelve (12) month period.

This Agreement will remain in force until Franchisor and the regional team manager mutually agree to terminate this Agreement as long as the regional team manager is in good standing and has not violat

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

Professional from academic institutions, pharmaceutical industries, health care indust

ed their The Company Franchise Agreement in any way. Regional team manager will be in violation of this Agreement if they are sixty (60) days or more in arrears with any monies owed Franchisor.

If a franchisee from the regional team me

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

ber’s exclusive territory contacts The Company with service problems from the regional team manager, The Company will contact the regional team manager to help solve the problem. If The Company has to service the franchisee, the regiona

.

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 team manager will be billed for the service to their franchisee from The Company.

- - - -

Perhaps this might give you your own ideas of how best to rapidly expand your system without getting into the problems of master franchising.

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

Companies that provide selfless information through particip

f course I am not a professional parasite attorney so you will have to go pay one $300 per hour to look at such a scenario for you if you think this might be a potential expansion idea for you like it was us and so 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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A simple definition for accounting may be acceptable to an individual. That accounting definition however may not be as clear with regard to an ongoing business enterprise.

Accounting services is all the more important for any type of business, be it a big business house or a small venture. Accounting is one such aspect of every business that requires careful concentration, as it directly deals with cash and other transactions.

All franchised companies must have Territory Limitations to maintain the peace within their systems. Often the unspoken ethics of territory limitations are blurred with mobile, home based or online franchise companies. Territory limitations in fixed site franchises are fairly cut and dry.

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Advice You - Franchising with Regional Team Managers and Partners

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