Advice You - Business

Franchisees must worry about employee lawsuits, as employment litigation has shot up dramatically in the last decade. A franchisor must also shield themselves from the potential lawsuits

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

of the franchisee's labor. One way to distance the franchising companies liabilities from the franchised outlets operations is to include a clause in the franchise agreement, which states

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

Examples of combination products may in

that all obligations and lawsuits regarding employment are the sole responsibility of the franchisee’s operation.

It is for this reason that I had expanded our franchise company’s sectio

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

n in the franchise agreement to address this very issue. Below you will find a copy of the inserted clause,

3.5 Employees

Franchisee must hire and train all employees who are necessary

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

for the operations of the Franchised Business. Franchisee will be solely responsible for the terms of employment of its personnel, including compensation, training, supervision and payroll

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

Combination pro

withholding. Franchisee will in no way obligate Franchisor for expenses incurred in the operation of the Franchised Business including labor costs.

Franchisee is required to hire and mai

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

ntain sufficient staff in order to handle customer volume at all times. Franchisee is required to pay their employees and staff the wage prevailing (or in some areas a wage high than the t

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

hen prevailing wage) in the Marketing Area for employees with similar labor skills, people skills and similar job responsibilities.

Franchisee is responsible for making sure their crews m

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

eet the standards, specifications and procedures outlined in the Confidential Operations Manual. Franchisee will hire only efficient, competent, sober and courteous employees for the condu

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

ct of the Franchised Business and will pay their wages, commissions, piece work and any other compensation justly due with no liability on our part.

Franchisee must take all steps necessa

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

y to preserve and protect proprietary information from publication, ommunication or other unauthorized disclosure or misuse. Franchisee must not disclose any of the proprietary or confiden

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

Following aspects would a

tial information, use it in any unauthorized way or assist any other person or entity to disclose or use it either during the term of this Franchise Agreement or at any time thereafter. In

dd to the challenges in developing combination products:

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

particular, Franchisee will require as a condition of the employment of any employee by the Franchisee in the management and operation of the Franchised Business that the employee similar

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

ly covenants to maintain and protect the confidential and proprietary information, including the signing of the Franchisee’s employee non-compete agreement. Franchisee will be responsible

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

for the compliance with such covenants by their employees, with such covenants being for the benefit of the Franchisor and enforceable by the Franchisor.

In the event Franchisee becomes a

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

ware of any actual or threatened violations of any such covenants by any of their employees, Franchisee will promptly and fully advise Franchisor in writing of all related facts known to F

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

Professional from academic institutions, pharmaceutical industries, health care indust

ranchisee. Franchisee will further cooperate with Franchisor in all ways reasonably requested by Franchisor to prevent or stop any such violation, including without limitation institution

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

or permitting to be instituted in the name of Franchisee any demand, suit or action that Franchisor determines is advisable, which demand, suit or action may be maintained and prosecuted b

.

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

y Franchisor and/or Franchisee at the Franchisee’s expense.

-------- -------- ---------

All franchisors would be well advised to also shield themselves from liability and speak to an exp

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

Companies that provide selfless information through particip

erienced franchise attorney on how best to protect themselves from lawsuits of the franchisee's business operations having to do with employment law. I hope you will consider this in 2006

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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I'm getting really nervous with the daily security threats that abound in the news. People forget that packaging has an important role to play in helping keep our products safe for consumption. Remember the Tylenol packaging incident? Many packaging applications, such as the tamper evident seal and the shrink wrap band, were invented as a result of that incident. Frighteningly, a major concern should be our food supply. One bio-terrorism incident in our food supply could be a thousand times more deadly than 9/11.

Profitable businesses often struggle with cash flow due to poor accounts receivable management strategies. Included in this article are some practices and advice which businesses may employ to maintain a healthy receivables portfolio and optimize their cash flow.

Business cards are a great way to market your business, even when you are a doctor and many assume that you don't need to market. Not only can you ensure that your business cards get around helping promote your business, your business cards can help you ensure that you keep existing clients.

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