Advice You - Business

Easier said than done. Negotiating is complicated. No one style is effective in every situation and it's important to stay focused on your objectives and remain flexib

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

le in finding ways to achieve them.

The other side will not necessarily play by your rules or behave in a reasonable way.

The ideal case situation is when both parties

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

Examples of combination products may in

are clear and collaborative and work towards a win-win solution.

Positive approaches include:

-Talking about interests

-Friendly discussion of issues

-Facts, data 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.

o support position

-Problem solving, looking for alternatives, tradeoffs

-Acknowledging the other party's point of view

-Asking questions, 'What if?'

Negative approa

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

hes include:

-Making demands

-Provocative and threatening statements

-Digging into a position

-Being adversarial

Take a break -- Walk Away

If the negotiation becom

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

Combination pro

es deadlocked, or the other party is unreasonable to deal with, you may need to walk away. You can't force the other party to be reasonable, and making too many concess

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

ions is not the basis for a healthy business relationship.

Involve an intermediary

Sometimes cultural or style differences make it advisable to involve an intermediary

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

Effective negotiation needs to be peer-to-peer. Involving an intermediary can help to bridge the differences and find the common ground or 'win-win' outcome. Be caref

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

ul in your choice of intermediary. You want a deal -- not a battle.

Dealing with Adversarial Lawyers

Not all lawyers are adversarial, but the sad truth is that lawyer

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

s make more money when there's a fight. Lawyers have an economic incentive to turn amicable business relationships into protracted negotiations and even adversarial out

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

omes.

Here are some warning signs: Lawyer is posturing and taking positions that are obviously one-sided and trigger protracted negotiations in order to get to a posi

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

Following aspects would a

tion of reasonable balance for all parties.

Lawyer demands last-minute concessions, price reductions or other major changes just before the deal is to be completed.

La

dd to the challenges in developing combination products:

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

wyer uses massive boilerplate documents, 80% of which are incomprehensible and 90% are irrelevant to the deal. Adversarial negotiations are unlikely to produce a good

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

deal and business relationship. The deal needs to be fair to all parties to work well. The party that feels unfairly treated usually finds a way to get even.

To avoid

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

aving your deal derailed by such lawyer tactics, I recommend that you keep adversarial lawyers out of the negotiations.

I recommend that:

The parties draft a term shee

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

t which is the essence of their agreement on one page. (Answer the questions: Who? What? Where? When? And how much?)

Each party reviews the term sheet with his/her

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

Professional from academic institutions, pharmaceutical industries, health care indust

respective advisor and revises the term sheet based on such input. (Basically, use your lawyer as a coach and do the negotiating yourself.)

The parties discuss the agr

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

ement and revise the term sheet. Then, instruct the lawyers to write up your agreement, without gobs of boilerplate, and include a provision to mediate any dispute. (On

.

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

e lawyer should draft and the other review.)

With this approach, you'll get a deal that is fair and workable and an agreement that you understand. The parties should b

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

Companies that provide selfless information through particip

e able to track from the term sheet to the agreement easily.

In conclusion, negotiating is situational. To get the outcome you want, you need to adapt to the situation

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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