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The limited liability company (aka L.L.C. or LLC) is the strongest asset protection devise for your business replacing the sub chapter "S" corporation. The LLC offers limited liability to the owners of a business and, additionally, the limited liability comp

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

any is approved in all 50 states.

The LLC is similar to a corporation and sometimes has been mistakenly referred as the limited liability corporation. In the LLC, the individuals are called members and the LLC is most advantageous to smaller companies with

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

Examples of combination products may in

a smaller number of members. In cases where the LLC has only one member the LLC may be regarded as a disregarded entity whereby the sole member is viewed as the entity performing the operations of the LLC. This contrasts a corporation owned by a single indiv

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

idual whereby the corporation is viewed as the entity performing the operations.

The limited liability company with multiple members avoids double taxation because the members are partners for taxation purposes. The IRS Form 1065 and Schedule SE (i.e. Self-

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

Employment Tax) are used with the LLC entity. For tax purposes, the LLC in a partnership formation reports its income and deductions via each members' income tax return.

WHY CHOOSE THE LLC FOR ASSET PROTECTION?

Courts and clever predators with their contin

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

Combination pro

gent-fee lawyers have significantly eroded the benefits and protection of corporate entities, allowing for little or no asset protection against employees, shareholders, officers, or directors. The limited liability company has become the "entity of choice"

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

for all new business structures. The sub chapter "S" corporation has now become the white elephant.

LIMITED LIABILITY COMPANY'S FINANCIAL BENEFIT

There is a significant financial benefit to establishing a limited liability company for your business. Your p

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

redatory creditor's sole remedy is the "charging order." Similar to partnerships, the charging order can only be against LLC member(s) and not the LLC. The charging order is obtained subsequent to your creditor obtaining a judgment against you for monetary d

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

amages and other frivolous charges. Your creditor cannot, and is precluded by law, to step into your shoes as an LLC member and take over the financial affairs of your LLC. This is, in and by itself, the limited liability company's most significant financial

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

benefit.

In all cases, after you plead with your creditor, "Please, please, please, do NOT place a charging order against me because it'll have the most detrimental affect on how I deal with my existing clients, banks and other businesses," your creditor w

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

ll turn around and slap you with a charging order. What you creditor does not realize is that he just gave you a major gift. Thanks in largely due to the drafters of the Uniform Limited Partnership Act.

The charging order means that your creditor has a righ

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

Following aspects would a

t to "all your capital distributions." So when will you have a capital distribution to pay your creditor? The answer is never. You are allowed to take a salary, to joint venture, to borrow money from the limited liability company but you will never take a ca

dd to the challenges in developing combination products:

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

pital distribution wherein you will pay your creditor. You have just become your creditor's and their contingent-fee, gold-digging lawyer's worst nightmare.

LIMITED LIABILITY COMPANY TAX ADVANTAGE

The LLC has a significant tax advantage. Someone must pay t

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

he taxes so the IRS declares. According to the IRS, in revenue ruling (77-137) it states that someone must pay the taxes. Since the person holding the charging order will receive the "K-1", he must pay the taxes on the income generated by the LLC even though

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

your creditor never receives any actual cash from the business.

The creditor saddled by the charging order is treated as a substituted limited partner for tax purposes, thanks to the IRS, and will suffer the tax consequences without capacity to force payme

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

nt, dissolution or distribution. Do you think that your creditor will want to settle? Please note the "K-1" is the yearly income tax statement to be included in recipient's taxable income for the year similar to your mutual fund's form 1099.

The shocking ne

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

Professional from academic institutions, pharmaceutical industries, health care indust

ws is that your creditor will be obligated to pay the taxes for you. Every 6 months, send your creditor a letter on how well your business is doing and that you want to make sure that he prepares himself to pay the taxes. At the end of the taxable year, you

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

send your creditor a copy of an additional letter along with the K-1, addressed to the IRS, requesting an audit of your creditor because you want to be tax compliant and that you want to make sure that all taxes have been timely paid and are up-to-date. Do y

.

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

ou still have doubts that your creditor will want to settle?

When you combine the limited liability company's tax benefit and the protection of the charging order with a surefire asset protection system of an irrevocable trust such as the Ultra Trust you wi

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

Companies that provide selfless information through particip

ll receive a financial asset protection fortress against your creditors and other contingent-fee based lawyers. So the next time there are any pending frivolous lawsuits you can relax and sleep soundly at night knowing your business assets are well protected

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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