Main Subject - Business

In modern-day franchising the franchisor will license his business model and operational strategies to folks who will run t

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

he franchised outlets. To ensure quality, consistency and customer service the franchisor will define in the confidential

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

Examples of combination products may in

perations manual be exact method of doing business. Often in these confidential operations manuals they will nearly addres

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

every single possible aspect of the franchised business model.

In doing so, the franchisor risks giving away secrets, whi

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

h might fall into the hands of competitors. Therefore protection of the confidential operations manual in franchising is e

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

Combination pro

sential. It is for this reason that I came up with additional clauses for our franchise agreements to protect our propriet

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

ry information in our franchise company. Below you will find a copy of that clause;

4.1.6 Confidential Operations Manual

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

Franchisor will lend Franchisee a copy of The Company’s Confidential Operations Manual (as it may be revised, the “Confide

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

tial Operations Manual”) or provide Franchisee with one password to access the loaned copy of the Confidential Operations M

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

nual on our Franchisee Forum intranet system to use during the term of this Agreement. Franchisor may revise the contents o

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

the Confidential Operations Manual to convey to Franchisee advancements and new developments in sales, marketing, operatio

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

Following aspects would a

al techniques and other items and procedures relevant to the operation of the Franchised Business. Franchisor will send new

dd to the challenges in developing combination products:

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

pages, diskettes or a completely revised Confidential Operations Manual to Franchisee, at no cost to Franchisee. Franchisee

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

shall bear the responsibility and the cost of translating the Confidential Operations Manual into any language other than E

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

nglish. Franchisee shall promptly arrange for any such translation and submit it to Franchisor for approval. All right, tit

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

e and interest in and to such translated materials and directives shall vest in Franchisor and Franchisee shall execute (an

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

Professional from academic institutions, pharmaceutical industries, health care indust

cause to be executed by the translator and/or Franchisee’s employees and agents) such documents as Franchisor may require

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

or this provision to be given full effect.

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

This is indeed a very important point for all franchisors who

.

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

franchise both domestically and internationally. If you are a franchise company you would be well advised to consult a fra

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

Companies that provide selfless information through particip

chising attorney on this issue. This way you can address it up front in the franchising agreements. 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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