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Digg It - International Franchise Agreements and Language Issues
When dealing with foreign investors and franchising in another country often langua
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
ge and interpretation of word meanings can get clouded. Additionally tenses or gend
; 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
er of words can change what a sentence says or means in an agreement. In franchisin
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
g Internationally this becomes a real issue because of the number of potential coun
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
tries an international US Based, Australian or European Based Franchisor might fran
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
hise in.
As we expanded our company into other markets we found this to be extreme
As we expanded our company into other markets we found this to be extreme
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
ly problematic due to the fact that a particular country may have different dialect
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
s and issues in their own language itself, not to mention the English versions of t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
he words and their meanings. One issue we immediately noticed when trying to deal i
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
n multiple languages is that even the topics in the table of contents were at issue
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
So, I addressed this issue by inserting this clause into our international contrac
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
ts for franchising our business model;
7.20 Headings and Table of Contents
The he
7.20 Headings and Table of Contents
The he
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
adings and Table of Contents used in this Franchise Agreement are for purposes of c
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
onvenience only and shall not be used in constructing the provisions hereof. As use
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 in this Franchise Agreement, the male gender shall include the female and neuter
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
enders, the singular shall include the plural and the plural, the singular.
- - -
- - -
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
- -- - - --
Although this did not solve all the issues it did in fact assist us
Although this did not solve all the issues it did in fact assist us
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
in some of the issues and helped us from causing ourselves litigation issues over
.
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
miss interpretations due to language barriers, mistakes or cultural differences in
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
basic word meanings and sentence structures. Perhaps 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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