Advice You - Business

Once you have several products or services that are selling quite well, your customer will begin to ask if you will permit others to use your product as the

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

basis for training that they are doing. Or, if you are doing training or consulting, you may be asked if you'll train others to be a trainer using your syst

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

Examples of combination products may in

em.

This is the perfect opportunity for you to consider licensing your content or program. You've only got so many hours in the day, and if you have others

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

delivering your content and/or requiring the purchase of your materials, your business will grow exponentially as a result.

Here are some issues to think ab

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

out as you consider licensing your content to others:

1. What will you charge for a licensing fee? Will it be a one-time fee or something that has to be r

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

Combination pro

newed periodically, like on an annual basis? Or, do you base it on a percentage of sales?

2. Will you charge a royalty for each product sold or per partici

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

pant in a training session? What systems do you need to put into place to ensure that you are being compensated appropriately for each sale? Does the fee i

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

ncrease when the sales volume hits a certain level?

3. Is the licensing exclusive, i.e. pertinent to a particular project only, or can it be used at the li

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

ensee's discretion?

4. How will you ensure that your content is being delivered appropriately? Do you require each licensee to go through training? Is th

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

at an additional fee that you charge, or is that a part of the initial licensing package?

5. What are the requirements for your licensees to purchase any m

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

terials for a licensed training (CD programs, ebooks, etc.) through you, or if the materials are available through other sales outlets, can the materials be

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

Following aspects would a

purchased elsewhere? Do you offer the materials to them at a discounted rate?

6. Can your licensees modify or alter your program or content in any way to f

dd to the challenges in developing combination products:

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

it the needs of various target markets? If so, what are the parameters for doing so? Does the modification need your approval?

7. Can your licensees adop

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

any part of the name of your licensed product into their business name in any way, or into a domain name for a website?

8. In what ways do your licensees

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

have to display your logo, trademark info, or contact information for any products or training they license from you? What are the standards for usage of su

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

h information?

9. What are the grounds for terminating a licensing agreement?

10. What actions must be taken by both you and the licensee in the event a

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

Professional from academic institutions, pharmaceutical industries, health care indust

license is terminated?

In the process of drafting your licensing agreement, I would strongly encourage you to hire an intellectual property attorney who has

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

experience in licensing products or programs. S/he will tell you where the holes are in your agreement, and make suggestions for other issues you need to co

.

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

sider.

Licensing your programs or products is a great way to get the word out about what you do, and have others (your licensees) pay you for the privilege

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

Companies that provide selfless information through particip

of distributing your info around the globe. Take a look at your products and services with a discerning eye. Which of them could you license to others today

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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