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You've heard all the lawyer jokes (How do you make a lawyer smile for a wedding photograph – ask them to say "Feeeeeeeees") and read the bad press ("Compensation wiped out by legal fees"), BUT a good lawy

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

er can help save you money, and money carefully spent on his or her legal fees is well spent.

• Is my first appointment free? Some lawyers provide the first appointment or initial consultation for free.

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

Examples of combination products may in

Ask about this when you make an appointment. You certainly shouldn't have to pay for an initial consultation, although some lawyers will try charging a fraction of their hourly billing rate. Don't even

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

consider a lawyer who wants to charge you his or her full rate for an initial consultation.

• Understand the law firm's fee system before you hire a lawyer. Understanding what and how you are to be charg

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

d is obviously important. Billing procedures and rates are a common point of disagreement between lawyers and clients. The more you know ahead of time, the better off you'll be. Again, this is another one

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

Combination pro

of those questions designed to eliminate disagreements later on. Too often clients find themselves on the hook for hidden costs they knew nothing about.

Ask about the account management process – i.e. h

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

ow often will you get to speak to the lawyer about how your matter is progressing and be given an update and breakdown of costs? If you have a tight budget, let them know and see if they will agree to a 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

ixed price for the work – if it's a straightforward piece of work, this shouldn't be out of the question.

• Check for hidden extras. Ask what additional charges there are likely to be (often referred to

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

by the lawyer as "disbursements") such as searches, stamp duty, bank charges etc. Although it should have been made very clear, make sure whether the figure you have been quoted includes or excludes VAT.

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

• What do you estimate as the total cost to me? Don't be concerned if the lawyer resists answering this question. So much of the cost of a case depends on the degree of conflict between you and the othe

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

r party, and you know that better than the lawyer. You may learn a lot from the lawyer's answer, however, so it's helpful to ask. If your fee arrangement is to be hourly, you should also ask your lawyer t

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

Following aspects would a

o notify you when he or she realizes that the estimate is likely to be exceeded.

• What can I do to reduce the charges? Ask if there are any tasks you can do yourself to cut down on the amount you will b

dd to the challenges in developing combination products:

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

charged.

• Conditional Fees (No Win, No Fee). This means that if you lose your case, you don't have to pay your lawyer, but you may have to pay the legal fees of the winning party. However, if you win,

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

you might have to pay a higher fee. This type of arrangement is most often seen in cases relating to accident/personal injury, human rights cases and insolvency. Increasingly, forward thinking commercia

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

l lawyers are prepared to share the risk of other types of commercial transaction with the client. Expect the fee to be higher for a win than it would have been had it been a fixed fee, as long as you pa

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

y less or nothing for a “loss” or aborted transaction.

• Please confirm this in writing. In most cases your lawyer must advise you in writing how much the work will cost or, if that is not possible, how

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

Professional from academic institutions, pharmaceutical industries, health care indust

costs will be calculated. Don't sign any agreement about fees unless you understand it and are happy with it and don't even consider a lawyer who won't give cost details.

• When do I have to pay? In most

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

cases your lawyer must advise you in advance and in writing how and when you will have to pay. You are entitled to receive a detailed bill before you pay. Some lawyers will agree to wait until the matter

.

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

ends before you pay them. Remember how and when you pay can always be negotiated.

• Negotiate! Fee and billing schedules aren't set in stone, and the market place is competitive. So if you think the pri

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

Companies that provide selfless information through particip

ce is too high, or that you'll need more time to pay the bill, try negotiating with the lawyer. ..preferably up front. Shop around but also remember cost should not the only factor in choosing your lawyer

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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