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When you own a copyright to a photograph, you have complete and exclusive control of how i

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

t is reproduced, displayed and distributed. These rights may be assigned, sold, transferre

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

Examples of combination products may in

or given away. If you decide to authorize others to use your copyright, also known as lic

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

nsing, you may want to consider the following items:

a) Who are you giving the rights to?

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

b) What specific rights are you granting?

c) Are you authorizing print and/or electronic

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

Combination pro

rights?

d) If you grant electronic rights, what kind? CD? Web?

e) For what time are you

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

ranting the rights?

f) Will the rights be exclusive?

g) How will the rights be used? Wha

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

market or industry?

h) What territory is covered by the rights? North America? English-s

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

eaking countries? Worldwide?

i) Are there any work-for-hire implications?

j) How will yo

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

be paid? By a flat fee? By royalties?

k) If paid by royalties, how will the royalties be

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

calculated?

l) When will you be paid?

m) Will you allow certain alterations of the work

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

Following aspects would a

in the use?

n) Will you require certain items with the usage? Copyright notice? Photo cre

dd to the challenges in developing combination products:

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

it?

o) Who is responsible for loss, damage or theft of the work?

p) Do you want samples

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

f the use?

q) Specifically retain all other rights to your copyrights - you never know wh

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

t future usage technology will bring.

r) Make the license subject to being paid in full.

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

While licensing rights like those referenced above can be done verbally, it is best to put

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

Professional from academic institutions, pharmaceutical industries, health care indust

them in writing. You will minimize confusion, and you will have something concrete to rely

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

upon if a dispute arises. To be sure that every important aspect of licensing is addressed

.

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

ask an attorney who is familiar with these issues to review the license.

Take my advice;

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

Companies that provide selfless information through particip

get professional help. PhotoAttorney

Copyright 2005 Carolyn E. Wright All Rights Reserve

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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