Advice You - Business

One of the things that a franchisor has to offer a potential franchisee is their brand name. A strong brand name means the built-in potential customers for the franchisee and his franchise outlet. Each franchisor must stipulate how their trademarks and proprietary information within the confidential operations manual will

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

be used during the term of the franchise. It is far better in my opinion to be upfront with this issue into address it in the franchise agreement prior to the signing or exchanging of any monies for the franchise business. It is for this reason that I developed a clause to put into our franchise agreement, which was a li

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

Examples of combination products may in

ttle different than most other franchisors. Below is a copy of that clause;

3.11.1 Proprietary Rights

Franchisee acknowledges the exclusive right, title and interest of Franchisor in and to the Marks. Franchisee agrees that the Service Marks, Confidential Operations Manual, and System are Franchisor’s sole and exclusive p

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

roperty. Nothing in this Agreement or any other agreement will give Franchisee or others any right, title, or interest whatsoever in or to the Service Marks, Confidential Operations Manual, or System as it exists or as it is developed. Franchisee’s license to use the Service Marks is non-exclusive. Franchisor, in its sole d

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

scretion, may operate under the Service Marks and may grant licenses to others to use the Service Marks on any terms and conditions Franchisor deems appropriate. Franchisor may make reasonable efforts to protect Franchisee’s rights to use the Service Marks. In those states and nations where applicable, Franchisee agrees to

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

Combination pro

execute on request all documents necessary to record Franchisee as a registered user of the Service Marks.

Franchisee will immediately notify Franchisor of any infringement of, or challenge to, their use of the Service Marks. Franchisor will have sole discretion to take or not to take action, as Franchisor deems appropriat

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. If Franchisor undertakes the defense or prosecution of any litigation involving Franchisee or any litigation involving the Service Marks, Franchisee agree to execute any and all documents and to do all acts and things, that in the opinion of Franchisor’s counsel are necessary or advisable to carry out the defense or pros

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

ecution. This may be done either in Franchisor’s name or in Franchisee’s name, as Franchisor will elect. Franchisee will modify or discontinue use of any franchise names or Service Marks, or will use one or more substitute names or marks, if Franchisor so directs in writing at any time.

Franchisor’s sole obligation in this

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

event will be to reimburse Franchisee for their tangible costs in complying with Franchisor’s direction (i.e., cost of changing signs, stationery, etc.). Under no circumstances will Franchisor be liable to Franchisee for any other damages, costs, losses, rights, or detriments related to any modification, discontinuance, or

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

substitution. All obligations or requirements imposed upon Franchisee relating to the Service Marks will apply with equal force to any modified or substituted names or marks.

Franchisee will not contest, directly or indirectly: Franchisor’s ownership, title, right, or interest in the Service Marks, the Confidential Operati

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

ons Manual, the Confidential Marketing Manuals or the System; or Franchisor’s exclusive right to register, use, or license others to use the Service Marks, Confidential Operations Manual, the Confidential Marketing Manuals and System. Franchisee will not advertise or use the Service Marks without following Franchisor’s then

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

Following aspects would a

current guidelines and requirements. These may include, but will not be limited to, the placement of appropriate (C) or (R) copyright and registration marks, or the designations TM or SM, where applicable.

Any and all goodwill associated with the Service Marks, as existing or as developed, including any goodwill that migh

dd to the challenges in developing combination products:

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

be deemed to have arisen through Franchisee’s activities, will accrue directly and exclusively to the Franchisor’s benefit, except as otherwise provided by applicable law. Franchisee appoints Franchisor as their agent and attorney-in-fact to amend or cancel any Registered User or Business Name filings obtained by Franchise

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

e or on Franchisee’s behalf that involve or pertain to the Service Marks.

Franchisee acknowledges and agrees at all times and in all respects that Franchisor’s trademarks, trade names, service marks, patents, copyrights and all goodwill (local, regional and national) are the Franchisor’s sole and exclusive property. Franch

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

isee also acknowledges that Franchisee has only a license to use such rights and marks according to the provisions of this Franchise Agreement and in strict accordance with the standards, specifications and procedures as outlined in the Confidential Operations Manual. Franchisee will not take any action contesting or impair

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 exclusive right, title and interest of the Franchisor’s in any trademarks, trade names, service marks, patents and copyrights. Franchisee will not represent that Franchisee has any ownership rights in the Marks and Franchisee acknowledges that use of the Marks will not create in its favor any right, title or interes

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

Professional from academic institutions, pharmaceutical industries, health care indust

in or to the Marks, but that all uses will inure to the benefit of the Franchisor. Neither Franchisee nor any officer, director, agent or employee of Franchisee shall in any way register or attempt to register the Marks, whether within or outside the Marketing Area, with any government or any other authority, nor dispute o

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

r impugn the validity of the Marks, any registration or application to register any of the Marks, Franchisor’s rights to the Marks, or Franchisor’s rights to use Marks or grant licenses to others to use the Marks.

Franchisee must affix and change trademark notices and indications of registration when and as instructed by F

.

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

ranchisor. Franchisee must assist Franchisor to the extent reasonable requested in obtaining or maintaining any registration of any of the Marks to the extent reasonably requested, including by providing advertising samples.

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

It behooves all franchisors to make an audit of their brand-name ended

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

Companies that provide selfless information through particip

their proprietary information and decide how best to protect its value. It is advised to discuss this at length, as it is money well spent with a competent, knowledgeable and experienced franchise attorney to best strategize ways to protect your franchisee company and its proprietary information. Do 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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Businesses routinely maintain copies of correspondence and memos. Far to often, however, they do not extend this practice to email correspondence. Email correspondence is no different then your normal paperwork. You must keep copies of all of it to protect your business in any litigation.

Advertising balloons are inflated with helium gas, which is a colorless odorless gas, lighter than air and is preferred over hydrogen because of its non-inflammability.

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