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Advice Pool - Did You Read and Fully Understand the Franchise Agreement?
Modern Day Franchising can be an excellent way to extend your brand name rapidly, but there are many draw backs to franchising. On
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
e of the most serious considerations is the incredible litigation between franchisees and franchisors. The cost of protecting you
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ranchise Company from attorneys of disgruntled and/or non-performing franchisees can be very expensive indeed.
It was not long ag
It was not long ag
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
before my retirement that I ran a franchise company and even wrote our companies franchise agreements and international franchise
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
agreements; many over 180 to 200 pages of mandatory disclosure documents. One piece of boilerplate clauses I most remember was one
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
we always put at the end of our franchise agreements, which was titled “Questions Concerning This Franchise Agreement” and the bas
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
ic jist of it all was to make sure that the franchisee could not get out of the contract claiming he never read it or did not unde
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
stand a specific part of it, which indeed could easily happen in 200 pages of legal crap couldn’t it? In any case the clause went
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
omething like this:
“Franchisee understands the intent of each paragraph of the franchise agreement and Franchisee has asked all
“Franchisee understands the intent of each paragraph of the franchise agreement and Franchisee has asked all
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
uestions of anything they did not understand and have consulted competent advisors to help them determine the exact meaning of eve
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ything in this Franchise Agreement. Franchisee further considers them selves mentally competent and that nothing written in this F
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ranchise Agreement still seems ambiguous to Franchisee. There is nothing in this Franchise Agreement, which Franchisee did not und
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
rstand at the time Franchisee signed this Franchise Agreement. Franchisee has shown this Franchise Agreement to consultants and/or
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
advisors who they feel comfortable with and Franchisee’s advisors and Franchisor have gone over this Franchise Agreement and relat
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
d and attached agreements with Franchisee. Franchisee have written down questions and personally checked them off when Franchisee
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
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
elt they were answered adequately both by Franchisor and Franchisee’s advisors.”
Now on the surface you might think no big deal r
Now on the surface you might think no big deal r
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ight? Well without such clauses you could actually be sued and someone who failed to fulfill their side of the agreement could che
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t you out of money. It seems with all the over regulation and litigation that it is truly amazing after 200 pages of a legal docum
.
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
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
nt you have to have such a clause in the agreement. But with kangaroo courts and juries with their heads up their butts and libera
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
judges, go figure? This is only one of the reasons I retired early at age 40 from the franchising industry. 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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