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Nevada is considered a haven for business owners who want to create a new corporation or a lim

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

ited liability company or LLC. The state of Nevada offers complete protection to the officials

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

Examples of combination products may in

, agents and members of the LLC, in case of a lawsuit filed against them. In order to operate

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

a limited liability company in Nevada, an operative agreement is necessary. The operating agre

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

ment defines the nature of business, general operation and conduct of the affairs, of the comp

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

Combination pro

any. This agreement also outlines the voting powers of each member and the buy-sell requireme

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

nts that govern the stand taken by the company in case of members want to sell their interest.

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

An LLC operating agreement enables the business owners to constitute their financial and prof

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

essional relationships with their partners and employees. The operating agreement establishes

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

the percentage of ownership of each partner in the LLC and the distribution of profit, along w

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

th the responsibilities assigned to each one of them. It is good to have the operating agreeme

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

Following aspects would a

nt properly documented and signed by all members. This helps in avoiding confusion and misunde

dd to the challenges in developing combination products:

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

rstanding, as it specifies the limited liability status clearly. The operating agreement also

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

addresses the line of action in the case of a partner's death, disability or exit from the com

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

any.

The main rationale behind creating an operating agreement is that, it enables the busine

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

ss owners to prove their limited personal liability status in a court of law. A formal, writte

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

Professional from academic institutions, pharmaceutical industries, health care indust

n operating agreement lends credibility to the existence of a limited liability company.

Busi

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

ess owners can obtain the services of a professional attorney to draft the operating agreement

.

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

. They can take a look at sample agreements and model their own operating agreement on those,

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

Companies that provide selfless information through particip

in accordance with the laws of the state. Software is available to draw an operating agreement

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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