Advice You - Business

In order to maintain the quality and consistency of a franchised outlet it becomes

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

necessary to inspect the facilities and franchise operations to make sure they ar

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

Examples of combination products may in

in compliance with confidential operations manual at all times. Franchisors must

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

therefore have the right of inspection to check the books, audit the company and

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

nsure that image is maintained. In our franchise company I inserted a special cla

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

Combination pro

se into the franchise agreements, which address this issue, you will find it below

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

;

3.17.2 Right of Inspection

Franchisor has the right, upon a minimum of forty-e

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

ght (48) hours notice, to inspect and audit Franchisee’s books, records, ledgers,

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

journals, bank statements, sales tax reports, income tax returns, cash control sys

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

ems and other accounting records pertaining to the Franchised Business. If any aud

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

t shows that the Franchisee has underpaid any royalties or other amounts due to Fr

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

Following aspects would a

anchisor, Franchisee must immediately make payment to Franchisor to correct the un

dd to the challenges in developing combination products:

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

erpayment. If the underpayment exceeds two percent (2%) of the total royalties, Pr

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

omotional Fund contributions or other amounts due in any twelve (12) month period,

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

which includes the date when the underpayment occurred, Franchisee must also pay o

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

reimburse Franchisor for the costs of conducting the audit, in addition to any La

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

Professional from academic institutions, pharmaceutical industries, health care indust

te Payment owed to Franchisor.

--- --- --- ---

The franchising company would be

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

ell advised to discuss this with a franchised attorney, who is both knowledgeable

.

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

and experienced. Indeed, without inspections it would be almost impossible to mai

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

Companies that provide selfless information through particip

tain the integrity of the franchise system. I hope you will 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 methodology allows you to define in a quantifiable manner the compliance tasks involved in your company. All of the companies which use a type of Sarbanes Oxley software have the same financial data collection and their reporting needs are not really one and the same...

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Advice You - Franchisors, Franchising Agreements and the Right of Inspection

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