Advice You - Business

International Franchising is a tricky business and different cultures varying in their levels of integrity, yet as a franchi

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

sor it is important to extent brand name, collect royalties and to do so in as many parts of the world as possible. It makes

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

Examples of combination products may in

since therefore to take a few risks, knowing that issues will arise.

Since various nations have different laws governing f

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

anchising and business transactions and some countries have no laws it makes sense to have clauses in the franchise agreemen

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

t to address this and in doing so I suppose you will need to consult a professional parasite scum [attorney] to assist you t

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

Combination pro

ru this process.

We felt it necessary for our company to address the potential eventuality of non-compliance and injunction

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

s in our international agreement so I came up with this clause and stuck it in our franchise agreement;

7.18 Injunctions

N

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

thing contained in this Franchise Agreement shall bar The Company or Franchisee’s right to obtain specific performance of

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

the provisions of this Agreement and injunctive relief against threatened conduct that will cause Franchisee or Franchisor l

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

ss or damages under customary equity rules, including applicable rules for obtaining restraining orders and preliminary inju

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

nctions.

Franchisee recognizes the unique value and secondary meaning attached to the System, the trade names, service mark

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

Following aspects would a

s, trademarks, standards of operation and the trade practices and agrees that any noncompliance with the terms of this Agree

dd to the challenges in developing combination products:

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

ent or any unauthorized or improper use will cause irreparable damage to Franchisor and its Franchisees. Franchisee therefor

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

e agrees that if Franchisee engages in any such unauthorized or improper use, during or after the period of this franchise,

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

ranchisor will be entitled to both permanent and temporary injunctive relief from any court of competent jurisdiction in add

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

ition to any other remedies prescribed by laws.

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

You can see simply by reading this clause I cre

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

Professional from academic institutions, pharmaceutical industries, health care indust

ted for our international franchise agreements why it was necessary to include it. Just because you have a good and tight an

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

d fair franchise agreement does not mean your counterpart in the other country respects the written word or those promises t

.

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

ey make. In fact many cultures begin the negotiation process after the agreements are signed and it is a little tough to do

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

Companies that provide selfless information through particip

business in that way, but in the international world of business you kind of get use to it. Please consider all 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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