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As a franchisor often one will be presented with relatively simple transactions, which on paper have significance but in reality will not change the franchise relationship between the franchisor and the franchisee. Even so such changes could

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

be significant down the road. For instance, take the assignment of the franchise agreement, which is transferred into a newly formed corporation or LLC. A franchisee may do this, to limit its liability, for tax purposes or other legal reaso

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

Examples of combination products may in

s.

A franchisor must consider how this will effect his operations in dealing with the franchisee and making sure that the new corporation as the same partners and legal entities behind it, because a franchisee might be bringing in monies fro

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

a competitor, someone who has not signed the franchise agreement and is not bound by its stipulations or they might be trying to dodge tax laws, and thus jeopardizing the company brand-name if something wrong. It is for this reason that I m

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

dified our clauses in our franchise agreement regarding assignments of the franchise agreement to a corporation or LLC. Below is the clause that I came up with for our company;

5.3 Assignment to Corporation or Limited Liability Company

If

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

Combination pro

ranchisee is a partnership or individual and hereafter desires to conduct the Franchised Business in an incorporated or limited liability company form, Franchisor will not unreasonably withhold its consent to the transfer of this Agreement an

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

Franchisee’s interest herein to any corporation or limited liability company formed for that purpose; provided that Franchisee and such corporation or company must, prior to such transfer, satisfy such reasonable requirements as Franchisor s

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

all impose, which may include, without limitation, the following:

(a) Franchisee or its partners will at all times be the record and/or beneficial owner of, and will have, by law or by written agreement satisfactory to Franchisor, voting con

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

rol of, not less than fifty-one percent (51%) of the issued and outstanding shares or membership interests of each class of the capital stock or membership interests of such corporation or company;

(b) No other person or entity, except membe

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

s of Franchisee’s or its partners’ respective immediate families or trusts for the benefit of such family members, may own or have any right to acquire any capital stock, membership interests or other securities of such corporation or company

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

(c) The form and content of the articles or certificate of incorporation, organization or formation of such corporation or company and by-laws of any such corporation or operating agreement of any such company must contain provisions enforc

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

Following aspects would a

able under applicable law restricting the issuance and transfer of capital stock, membership interests or securities of the corporation or company to such extent as Franchisor shall reasonably require;

(d) Franchisor must have been furnished

dd to the challenges in developing combination products:

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

in writing the names and address of all existing or prospective shareholders or members of the corporation or company and Franchisee or its partners and (if requested by Franchisor) each such shareholder or member, or prospective shareholder

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

r member, must have guaranteed in writing (in form and substance satisfactory to Franchisor) the performance by the corporation or company of the obligations of the Franchisee under this Agreement; and

(e) Each shareholder or member must hav

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

executed and delivered to Franchisor a non-competition covenant in form and substance satisfactory to Franchisor, containing the covenants not to compete required by Section 3.20.3 hereof. After assignment of this Agreement to a corporatio

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

or limited liability company as above provided, or, if Franchisee is a corporation or limited liability company at the date of this Agreement, the sale, transfer, assignment or encumbrance or change in rights of any class or series of capita

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

Professional from academic institutions, pharmaceutical industries, health care indust

stock, membership interests or other securities of such corporation or company, whether by operation of law or otherwise, will be deemed a sale by Franchisee or (if a partnership) its partners or its or their interest(s) in this Agreement an

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

will in all respects be subject to the limitations set forth in this Section 5 on the sale of Franchisee’s interests in this Agreement. Any merger, consolidation or reorganization by any corporation or limited liability company having an int

.

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

rest in this Agreement will be deemed a sale of such interest and, unless the prior written consent of Franchisor has been obtained, will constitute a material breach hereof.

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

It is interesting how something so simple can

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

Companies that provide selfless information through particip

become so problematic. It is for this reason that I suggest that you consult an experienced and knowledgeable franchisee attorney and ask them how such a clause would best fit your franchise in company. 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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In recent years, one industry has grown as such an alarming rate that some of the companies involved in it have actually broken into the Fortune 500. That industry is recruitment. Temping industries provide people with a fantastic service because it has never been easier to explore job opportunities.

This article is loaded with stats and facts on the UK Magazine Industry. Whether you are thinking about entering the market or a huge player, this article is a must read.

Acquisitions let owners establish a base, such as: obtain a going concern in a particular location and establish a niche, i.e. bring in more business of a certain type in the market. Acquisitions also help to obtain entry into adjacent market areas and increase the prestige of the company. Mergers, in addition to these benefits, offer reduced work level and a way to cope with larger competitors.

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