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  • Digg It - Consistency of Equipment and Supplies in Franchise Companies

    It is extremely important to a franchise company to maintain consistency throughout each franchise outlet.
    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
    That consistency should include all equipment and supplies, which are to be used or sold at the franchisee
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    level. Without such consistency you will dilute your brand-name and confuse your customer, thus you will l
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    se one of the major benefits of franchising.

    It is for this reason that I had determined that our company
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    eeded to add a clause in the franchise agreement to address is very issue before the commencement or signin
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    of the franchise or disclosure documents. Also this information was backed up in our confidential operati
    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
    ns manuals. Below is a clause in our franchise agreement that I came up with;

    3.14 Equipment and Supplies
    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

    Franchisee will display, sell and use only such equipment and supply items of independent suppliers whic
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    have been approved by Franchisor in accordance with Section 4.6 hereof. In the event Franchisee desires Fr
    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
    nchisor approval of a particular supplier, equipment or supply item, Franchisee will provide the documentat
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    on contemplated by Section 4.6 at its sole expense and will reimburse Franchisor for costs of further testi
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    g as contemplated by Section 4.6. Franchisee may not enter into or renew any agreement with a third-party v
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ndor of services, supplies or equipment if such agreement requires that Franchisee disclose information reg
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    rding the identity of its customers or the Services performed by Franchisee for any of its customers. If, a
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    of the date of this Agreement, Franchisee is already a party to an agreement of the sort described in the
    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
    receding sentence, Franchisee will not be deemed to be in violation of any of the provisions of this Agreem
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    nt by virtue thereof for the remainder of the current term of such agreement.

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

    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    t would behoove serious franchisors to consult a knowledgeable and experienced franchise attorney to help t
    .

    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
    em strategize on ways to control the consistency of their franchise system and how best to address this iss
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    e in the franchise agreement and the confidential operations manual. 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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