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If you have been building your business with Resale Rights Products, or intend to, you’ve likely found th

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

at the terms of some Resale Rights licenses are not exactly crystal clear.

While most authors will expla

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

Examples of combination products may in

in the resale terms very clearly, so there is no chance of a misunderstanding, others are more inclined t

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

leave the terms and conditions to your imagination.

Here is a brief rundown on some of the more common

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

Resale Rights license conditions.

Personal Use
You do not have any Resale Rights.

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

Combination pro

his product is for your own use only.

Has Resale Rights
You can sell the product b

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

ut you cannot pass on the Resale Rights. In other words, your customer cannot resell the product. It is f

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

r your customer’s personal use only.

Has Master Resale Rights
You can sell the pro

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

duct and you can pass on the right to sell the product to your customer

Master Resale Rights can

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

ot be sold separately
This means you cannot sell the product without the Master Resale Righ

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

ts. The author wants everyone who buys this product to have the right to sell it.

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

Following aspects would a
strong>
You cannot give this product away. There has to be an exchange of money. Most authors will g
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
ve you a suggested price. Some will state unequivocally that the product must be sold for a specific pric
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
e.

The idea here is to maintain the value of the product. A purchaser of a Resale Rights product who int
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
nds to sell the product will not be happy if he or she sees the same product being given away on another
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
site.

Can be used as bonus
This is essentially a mitigation of the “Must be sold”
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
ule. It means you can give the product away after all, but only as a bonus for a product that has been so
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ld.

Can be bundled
This is really the same as using the product as a bonus. The di
.

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
ference is that the product is sold as part of the key product instead of as an add on or bonus.

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

Companies that provide selfless information through particip
three of this three part series we’ll look at how to deal with ambiguities in your Resale Rights license

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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