Advice You - Business

When setting up franchises and expanding a franchising company, you will often find that your franchise buyer

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

s will set up a variety of legal entities based on their financial needs, tax situations and advice of their

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

Examples of combination products may in

ersonal or corporate accountants and attorneys. This of course is to be expected, however as a franchisor you

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

also need to be sure that there is actually someone responsible for the ongoing viability of the franchise ou

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

let and the royalty fees you charge under the franchise agreement.

You need to understand and have knowledge

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

Combination pro

of who is behind the mask. As a franchisor you need to be sure that any new members or investors coming into

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

corporate entity are bound by the same terms and conditions as the other members of the team. It is for this

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

reason that I modified our franchise agreement to include this clause below;

5.2.3 Limited Partnership or Li

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

ited Liability Company

If Franchisee is a general or limited partnership or a limited liability company, the

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

the admission of a new partner of member, or the redemption, purchase, liquidation or transfer of a partners

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

ip or limited liability company membership interest or any disposition of the assets of the partnership or co

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

Following aspects would a

mpany, in one transaction or in a series of transactions which, in the aggregate, result in either

(i) more

dd to the challenges in developing combination products:

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

han a twenty-five percent (25%) change in the beneficial ownership of the corporation, or

(ii) a change in t

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

e voting control of the partnership or company, is a transfer which requires the consent of Franchisor. The p

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

rtnership agreement or limited liability company operating agreement must contain the following provision:

“

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

he transfer of a legal or beneficial interest in the (partnership) (limited liability company) is subject to

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

Professional from academic institutions, pharmaceutical industries, health care indust

he restrictive provisions of a Franchise Agreement with The Company. Reference is made to the Franchise Agree

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

ent for all particulars.”

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

It is advised that all franchisors consider the

.

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

e issues and ask their franchise attorneys what they can do to protect their companies in the event of transf

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

Companies that provide selfless information through particip

rs or additional investors buying into a franchised outlet of group of them. So, please think on 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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Corporate gift baskets have become de rigueur in doing business these days. If you do marketing, you know that corporate gift baskets are among the most popular thank you and holiday gifts sent out between businesses.

The choice between higher education and not, is also the choice, often, between a great job and a terrible one. If you have studied your way through University, and think that you are ready to take on the world, then there are graduate jobs in insurance waiting for you to take up the calling and prove your worth to the working world. You have a leg-up on the competition if you go to the job search with degree in hand, because there are many well paying jobs that will accept only graduate applicants. In the insurance field, for example, jobs range from advertising with the company to adjusting claims, and none of these jobs can be had without a degree in your hand.

Call centers were once seen as an extremely cost-heavy and commitment-engaging endeavor for businesses. One company set out to change all that. Freedom TeleWork created a virtual call center with all the bellsand whistles of a traditional call center; including predictive and progressive dialing, chat, IVR, skills-based routing and click to call but they added a very key element to their solution, manpower. What makes FT so unique is having created the first international community of TeleWorkers.

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Advice You - Franchising Agreements with LLC or Limited Partnership Franchisee and Transfers

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