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If you’ve taken the necessary steps to register your copyrighted works, you inevitably will have an opportunity to royalties off of them.

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

To take advantage of the opportunity, you will need to be familiar with copyright license agreements.

Copyright License Agreement

A co

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

Examples of combination products may in

pyright license agreement sets for the terms under which a third party can use your content. In legal language, you will the “licensor” w

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

th the other party being the “licensee.” The purpose of the agreement is to set forth the terms under which you, the licensor, will gran

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 the third party, licensee, the right to use, publish or reuse your copyrighted work in exchange for a royalty. Let’s take a closer look

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

Combination pro

at key components of the licensing agreement.

Specific Rights Granted

This may sound obvious, but the agreement needs to detail exactly

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

what copyrighted material can be used. If you have copyrighted articles, are you granting a right to use all of the articles or only cer

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

ain ones? It is highly recommended that the agreement contain a detailed description of the exact materials being covered.

Once you agre

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

e upon the exact materials, you need to determine any restrictions on how the material can be used. Can the material be used on the Inter

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

et or will it be restricted to a certain niche’ such as manuals or collections of materials?

An extremely important issue is whether the

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

agreement grants exclusive or non-exclusive rights. In English, this simply defines whether the licensor can grant similar rights to oth

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

Following aspects would a

er parties. The grant of exclusive licenses should require a much larger royalty rate since you are essentially betting the third party w

dd to the challenges in developing combination products:

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

ll be successful.

Licensing Royalties

In exchange for your copyrighted work, the third party is going to make royalty payments to you.

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

The particular amount of the royalty is dependent upon the nature of your work. Issues to consider include:

1) Will you be paid a flat a

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

ount or percentage of sales?

2) If a percentage, will it be figured from gross revenues or something less?

3) How often will you be pai

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

d?

4) What rights will you have to audit the books of the third party to determine you are getting the full royalty?

In some situations

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

Professional from academic institutions, pharmaceutical industries, health care indust

you may decide to forgo a royalty payment. This usually occurs when the third party will use the materials in manner that produces massi

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

ve publicity for you. For example, many professionals seek to right columns for publications as a marketing tool. Often, they will not ch

.

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

rge the publication for the material because the resulting publicity carries enough of a benefit.

In Closing

If you are considering lic

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

Companies that provide selfless information through particip

ensing copyrighted content, keep the above in mind. Since such agreements are difficult to break, hiring an attorney is worth the expense

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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You must trust your instincts as an entrepreneur and if you do you should be able to tell when someone is shopping you or a competitor is trying to get information from you. Then you have to ask yourself why, as that in itself will tell you a lot. Sometimes competitors will give them selves away and once you catch them they will ask; How did you know or why did you think that I was pretending?

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