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  • Top Articles - UK Property Code is No Substitute For Expert Advice

    Businesses are being warned to avoid tempting but
    potentially costly shortcuts in commercial property leases.
    The advice comes following the publication o
    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
    f a new stronger
    code of practice that includes a step-by-step guide for
    tenants to negotiate a lease. Leading city law firm, Hegarty
    Solicitors, welc
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    omes the code of practice, but says it is
    not a substitute for expert legal advice that can often
    secure substantial savings for businesses and anticipate
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.


    issues that arise years after a lease is signed.

    New Government Backed Code

    The new ‘Code for Leasing Business Premises’ that was
    lau
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ched in March 2007 by Housing Minster Yvette Cooper, has
    been published to clarify the process and aims to assist new
    businesses that are new to negotiati
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ng leases for shops and
    offices.

    Commercial Property Partner Richard Hegarty says businesses
    might be tempted to try and handle negotiating the lease
    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
    >themselves, but it is their lack of experience that makes
    them more vulnerable, and they need to realise the
    importance of using experienced property law
    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
    yers.

    Richard explained, “The new code is not compulsory but is
    regarded more as a basis for negotiation rather than a
    blueprint for a lease.”

    “I would
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    trongly recommend that anyone entering into lease
    negotiations takes expert legal advice. The code is still
    quite complicated, and businesses should take
    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
    into
    consideration the time they want to spend trying to
    understand the lease, and what happens when something goes
    wrong at a later stage”

    “Also, th
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    e code is standardised but every property is
    different. A commercial property lawyer would able to
    provide specialist advice on each individual scenario a
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    nd
    know to look for anything unusual in the lease.”

    Negotiating Yourself; A False Economy

    He continued, “When people are starting up we kn
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    w that
    every penny counts, and they might think they will save
    money handling the lease themselves. A commercial property
    lawyer is really like an ins
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    urance policy. We are highly
    experienced at negotiating leases and can often obtain a
    better deal than they could themselves. The savings they
    could m
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ake can dwarf the legal costs involved, and they have
    peace of mind knowing they are fully aware of their rights
    and commitments in the lease.”

    The new c
    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
    ode suggests that landlords may not want to tie
    tenants in for lengthy periods. Richard says that when a
    company is unsure of it’s future, perhaps because
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    it is new
    or in an unstable market it can make sense to have a shorter
    lease period. However, many other businesses prefer to have
    the security of kno
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    wing they will not be looking for other
    premises or incurring moving costs in the near future.

    “When you are busy running a business the last thing you
    w
    .

    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
    ant to contend with is the pressure of having to find new
    premises. The length of a lease is very important, and a
    commercial property lawyer would be abl
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    e you help you make a
    decision to suit you and your business,” commented Richard.

    Details of the new code can be seen at
    www.leasingbusinesspremises.co.u


    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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