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Advice Pool - The Franchise Agreement and Failing On-Going Training
Training is a big part in any large company and nowhere is it more important than any franchise organization, there
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 a lot at stake. For instance, the brand name of the company, the consistency of the products and services, and
; 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
of course the success of each individual franchise outlet. A few non-performing franchisees can drag down an entire
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
franchise system in any given marketing region. This will in fact negatively impact other local franchisees.
To i
To i
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nsure that each franchise operates by the book; the confidential operations manual, training must be thorough and c
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
mprehensive. But what if a franchisee fails training or what if they fail ongoing training? This is a key conside
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
ation considering the need to protect the integrity of the franchise system and the profitability of all the other
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
franchisees. It is for this reason that the failing of ongoing training needs to be addressed in the franchise agre
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ments. Below is a copy of the clause we used in our franchise agreements;
3.6.4 Failing On-Going Training
From ti
3.6.4 Failing On-Going Training
From ti
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
e to time Franchisor may provide refresher training programs or seminars and may require that the Franchisee or the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
r managers and crew leaders attend and complete them to Franchisor’s exclusive satisfaction. These programs and sem
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
inars will be held at locations Franchisor designates. When Franchisor determines that it is in Franchisee’s best i
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
terest to take additional training courses, Franchisor will notify Franchisee either via the Franchisee Forum intra
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
et system, by e-mail or in writing. Franchisee will have up to six (6) months to schedule this required training. I
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
f Franchisee fails to schedule the required training, Franchisee will be notified that Franchisee is in default of
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
his Agreement. Franchisee will then have thirty (30) calendar days to cure this default. If Franchisee fails an on-
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
oing training course, Franchisee may be deemed in default and Franchisee will have thirty (30) calendar days to cur
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e this default by re-taking and passing the required course or courses.
-- -- --- --- -- --
All franchisee compan
-- -- --- --- -- --
All franchisee compan
.
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
es need to address this and the needy expert legal counsel and an experienced franchise attorney to help them strat
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
gize the best way to protect the franchise company in the event a franchisee fails training. 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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