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Generating income is the primary goal of any entrepreneur. Equally important to businessmen and investors is the desire to avoid personal financial liability for the obligations of

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

the business. The invention of the traditional corporation and more modern business entities such as the Limited Liability Company, have created a risk barrier which encourages busi

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

Examples of combination products may in

ness ventures yet shields the owners’ personal assets from seizure.

As a landlord, you are subject to virtually unlimited financial liability and exposure arising out of the operat

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

ion of your rental property. Large lawsuit judgments against landlords are becoming increasingly common. Without the protection of a Limited Liability Company (LLC), your home, vehi

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

cles, bank accounts, and other personal assets can be swept away.

Reorganizing your rental property into a LLC can eliminate this risk to your personal assets. A properly formed LL

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

Combination pro

C is a separate and distinct business entity with its own taxpayer identification number. The LLC, rather than the landlord, becomes the owner of the individual rental property. In

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

much the same way as shareholders of a corporation are protected from liability, a LLC will provide limited liability to its owner(s) and shield their personal assets. Should the ow

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

er(s) wish to manage the LLC’s daily operations, either in full or in part, they will be legally classified as employees of the LLC. Therefore, the maximum financial exposure to the

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

owner(s) of the LLC, including exposure from acts of its employees, is limited to the individual property held in the LLC, and nothing else.

Once your attorney completes and files

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 array of legal documents required for the initial formation of your LLC, you will no longer be personally liable for any debts or judgments against the LLC. Utilizing the LLC e

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

liminates the double taxation and extensive formalities associated with a traditional corporation. Perhaps the most obvious changes are that lease agreements are between the LLC and

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

Following aspects would a

the tenant, rent checks are made payable to the LLC, and when evictions are instituted, it is the LLC that is evicting the tenant, thus eliminating the appearance that you are pers

dd to the challenges in developing combination products:

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

onally seeking the eviction.

The State of California requires the LLC to pay an annual $800 franchise tax fee, the same as a regular corporation or limited partnership. This fee, h

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

owever, can be viewed as a yearly "insurance" premium, which provides vastly more protection than private insurance with an equivalent premium amount. The beneficial result is that

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

he maximum financial exposure to the owner(s) of the LLC, including liability from acts of its employees, is limited to the individual property held in the LLC, and nothing else.

I

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

n today’s legal environment, successful tenant lawsuits against landlords are becoming more frequent. Additionally, insurance no longer provides adequate protection to the property

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

Professional from academic institutions, pharmaceutical industries, health care indust

owner(s). Most insurance policies contain exclusions for mold, discrimination claims, and lead-based paint. Even with insurance, a building fire or balcony collapse resulting in num

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

erous claims could create a liability far exceeding your policy amount. Without the protection of a LLC, your personal assets can be taken from you, potentially leaving you destitut

.

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 and bankrupt. Given all of the advantages of the LLC, not to mention the piece of mind it brings to its owner(s), it is foolish to not utilize this most valuable business inventio

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

Companies that provide selfless information through particip

n. A typical LLC can be organized by an LLC specialist attorney for a very modest cost, bringing you, your family or your investors the protection you and they so rightfully deserve

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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