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One of the strategies that franchises often employ to maintain the integrity of the franchise system and insure control and consistency throughout the franchise company is to use a standardized confidential operations manual. Yet, we all know that the only thing that

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

is constant use change. This is why the confidential operations manual in any franchisor company must be constantly updated. But, how do you know if all the franchisees have been diligent in updating their manual, so that everyone is doing everything the same way?

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

Examples of combination products may in

Many franchisors today put the manuals online in a company intranet system and the company itself makes the changes. This is a good strategy, however opens the door to downloadable theft of proprietary information. In our company we decided to use paper manuals,

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

in binders, which were extremely hard to copy. To insure that our franchisees updated their manual, we decided to add a clause into our franchise agreements and make them agree prior to the commencement of their franchise to above all else keep the confidential oper

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

tions manual up-to-date;

3.12 Confidential Operations Manual

3.12.1 Updating Manual And System

Franchisee acknowledges that the Service Marks, Confidential Operations Manual, and System, including any future amendments or modifications to them, have substantial va

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

Combination pro

lue, and that the conditions, restrictions, covenants not to compete, and other limitations imposed by this Agreement are necessary, equitable, and reasonable for the general benefit of Franchisee, Franchisor, and others enjoying any lawful economic interest in the S

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

ervice Marks, Confidential Operations Manual, and System.

Franchisor may change or modify any part of the Service Marks, Confidential Operations Manual, or System from time to time at its sole discretion. Franchisee will accept, use, and protect, for the purposes of

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

this Franchise Agreement, all changes and modifications as if they were a part of the Service Marks, Confidential Operations Manual, and System at the time this Franchise Agreement is executed. Franchisee will bear all costs and expenses which may be reasonably ne

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

essary as a result of such changes or modifications. Under no circumstances will Franchisor be liable to Franchisee for any damages, costs, losses, or detriments related to of these changes or modifications.

Complete and detailed uniformity of the Service Marks, Con

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

fidential Operations Manual, and System under the varying conditions to be experienced by our Franchisees may not be possible or practicable. Therefore Franchisor reserves the right, at its discretion, to accommodate Franchisees special needs, or those of any other o

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

f our franchisees. These needs may result from the peculiarities of a particular site or location, density of population, business potential, populations of trade area, existing business practices, requirements of local law or local customers, zoning requirements, da

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

Following aspects would a

ytime population, landlord requirements or any other condition which Franchisor deems to be important to the successful operation of the franchisee's business. From time to time, Franchisor may allow certain franchisees to depart from normal system standards and rout

dd to the challenges in developing combination products:

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

nes to experiment with or test new products, equipment, designs, and procedures. In no event will any variance or testing be deemed a waiver of any of the Franchisor’s rights, or an excuse for Franchisee to not perform any of their duties under this Franchise Agreeme

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

nt. Franchisor may require Franchisee at any time to commence full compliance with the Confidential Operations Manual and the System. Franchisor will not be required to grant any variance to Franchisee under any circumstances.

In order to protect the reputation and

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

the goodwill associated with the Franchisor’s trademarks and to maintain the Franchisor’s uniform standards of quality and operations, Franchisee must conduct their Franchised Business in strict accordance with the Confidential Operations Manual, as amended. Franchis

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

ee will update their manual via the Franchisee Forum intranet system, electronic mail, diskettes, CD-ROM’s, zip disks or other medium for their computer immediately upon receipt or insert new pages in their loaned copy of the Confidential Operations Manual. Any subse

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

Professional from academic institutions, pharmaceutical industries, health care indust

uently revised pages or old diskettes must be returned to Franchisor or completely shredded, burned up or destroyed immediately to insure confidentiality. Franchisor will advise Franchisee of what to do after each revision.

Franchisor may, at its sole discretion, re

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

vise any or all contents of the Confidential Operations Manual to convey to Franchisee any advancements and new developments in sales, marketing, operational techniques and other items and procedures relevant to the operation of the Franchised Business. There will be

.

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

no additional costs associated with updating Franchisee’s loaned copy of the Confidential Operations Manual. This remains a service funded by Franchisee’s on-going royalty fees.

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Each franchisor will need to determine the best strategy, whi

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

Companies that provide selfless information through particip

ch will work best for their company. It is well advised to talk to franchise attorney about the legal ways to go about this. There is more than one strategy and each franchise company will need to determine what makes the best sense for them. 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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There are often a lot of articles around the web with tips on how to get more attention with business card designs. It often has a lot of marketing gimmickry and made-up stories to get attention. But having to get a maximized business card design does not need too much trouble.

Computer training and integrated learning are two different concepts, often associated but very different. Integrated Learning is an alternative to other methods, such as computer training classes, which consider that learning only may occur in separation from other activities.

Are you finding it difficult to keep up with your many daily tasks and business demands? This is a problem that befalls most business owners whether you are a solopreneur or a small business owner operating with a few employees. You may be interested in outsourcing a few of your daily tasks but don't have the money or the patience to deal with hiring employees, I don’t blame you as this could become quite costly not to mention the benefits you are required to provide and the employment laws that you need to follow.

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