Top Articles

How should you use a confidentiality agreement to protect your trade secrets and how effective are they anyway?

Many commercial

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

clients still regard a Confidentiality Agreement or Non-disclosure agreement (NDA) as routine documents that do not require det

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

Examples of combination products may in

iled consideration or legal advice. Are you one of them?

They are all the same aren’t they?

I must have seen and reviewed seve

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

al hundred Non-disclosure Agreements in my 11 years in commercial practice. NDAs vary from a half page statement through to a co

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

prehensive 8-10 page document. Usually a two to three pager, or possibly a concisely drafted and formatted one page document, wi

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

Combination pro

ll meet most needs. 80-90% of the clauses will be the same in all agreements and can be scanned quickly when you know what you a

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

e looking for; but the 10-20% unique clauses are the ones to watch out for. It is usually these that have the potential to catch

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

you out.

What type of information? For what purpose is it being disclosed. How sensitive is the information? What is the upside

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

What is the downside? What is the shelf-life of the confidential information? What practical methods are there of securing the

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

confidential nature of the information? Can the obligation be enforced on employees, advisers, holding companies or subsidiaries

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

Who bothers suing for breach of an Confidentiality Agreement? Aren’t they just symbolic?

There is a widely held belief (which

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

Following aspects would a

I have some sympathy for) is that the mere presentation of an NDA at the outset of a relationship is more important than the sig

dd to the challenges in developing combination products:

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

ature itself. Asking the other party to sign an Confidentiality Agreement is a good to way to set the mindset of the recipient.

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

Often this has the desired effect of putting the recipient on notice and reinforcing the duty of care that is then owed to keep

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

he information confidential.

The usual remedy for unauthorised disclosure is an injunction preventing the recipient from disclo

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

ing the confidential information. Admittedly the costs of obtaining an injunction may outweigh the benefit of securing one. Once

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

Professional from academic institutions, pharmaceutical industries, health care indust

the information is in the public domain it is difficult to persuade a judge to grant an injunction. The remedy then is damages.

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

I’ve got better things to spend my time on than negotiating or obtaining a written agreement?

To a practised eye a review of a

.

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

draft Confidentiality Agreement needn’t take that long. A good commercial lawyer should be able to identify the 10-20% and advis

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

Companies that provide selfless information through particip

of any tweaks that may be required. If your bargaining power is weak, you will at least sign with knowledge of the consequences

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.toparticles.org.ua/article/128896/toparticles-How-To-Protect-Your-Crown-Jewels-With-A-Confidentiality-Agreement.html">How To Protect Your Crown Jewels With A Confidentiality Agreement</a>

BB link (for phorums):
[url=http://www.toparticles.org.ua/article/128896/toparticles-How-To-Protect-Your-Crown-Jewels-With-A-Confidentiality-Agreement.html]How To Protect Your Crown Jewels With A Confidentiality Agreement[/url]

A successful video or web conference can really give a boost to your organization. Online conferencing is now connecting people in a way that was not possible in the pre-Internet era. However, as powerful a tool as online conferencing is, it works best when you prepare your conferences properly. Here are some steps that you can take to help guarantee that your next video or web conference is a great success.

What is a splog? You need to know more about them and what you can do to stop them.

If you are about to purchase web hosting, it is very likely that you will be using cPanel to manage your hosting. To get the most from your web hosting, you need to learn the workings of cPanel.

Tags

Links

Top Articles - How To Protect Your Crown Jewels With A Confidentiality Agreement

Related Articles: