Cannabis practice 2019 - Allen & Overy

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Cannabis practice 2019 - Allen & Overy
Cannabis practice
                 2019

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Cannabis practice 2019 - Allen & Overy
2   Cannabis practice | 2019

    Cannabis markets
    According to UN estimates, the global cannabis market is currently
    worth approximately USD150 billion annually.
    At present, much of this market is illegal, but what is most interesting is the rate at which new products
    are being developed for the growing sections of the medicinal and recreational market that are legal
    (or anticipated to be authorised in the near future).
    Many companies, from industries as diverse as beverages, food, pharmaceuticals, cosmetics and
    tobacco, are actively investing in this market which, in recent research, Barclays suggests could almost
    double to USD272bn by 2028. For example, we recently advised.

       We advised Imperial Brands Ventures Ltd, a subsidiary of Imperial Brands PLC on its equity
       stake in Oxford Cannabinoid Technologies (OCT). OCT is a biopharmaceutical company
       focused on researching, developing, and licensing cannabinoid-based compounds and therapies.
       Its activities are licensed for operation by the UK Home Office. Imperial is just one of the
       companies making a mark in the sector by taking stakes in innovative companies. A number
       of joint venture and collaborations are also happening – for example Novartis’ strategic
       alliance between its subsidiary Sandoz and Tilray, a Canadian company developing
       cannabis-based medications.

    Allen & Overy LLP’s ‘top tier’ multidisciplinary team is ‘responsive, extremely
    knowledgeable about the healthcare industry, the client’s needs and the relevant technolog y’
    Legal 500 EMEA, Health and Life Sciences 2017

    Strong European offering with noted expertise in IP and patent litigation
    matters. Well regarded for its impressive client portfolio, which spans the
    pharmaceutical, biotechechnolog y, medtech, diagnostics and healthcare industries.
    Chambers Global guide 2018 Global-wide: Life Sciences

    Allen & Overy LLP covers the full spectrum of advice on
    governance, regulatory compliance and risk management issues
    Legal 500 UK 2019 Corporate Governance

    © Allen & Overy LLP 2019
3

Why the shift?

                              The main reason for greater activity in this market is the softening regulatory
                              environment worldwide.
                              Cannabis is now authorised for medicinal use in more than 25 countries, including Canada,
                              Israel, Germany and the UK.

                              Cannabis is proven to be effective in a number of areas of unmet clinical need including
                              the treatment of chronic pain – a market currently experiencing significant challenges as
                              governments, lawmakers and healthcare practitioners respond to the epidemic of abuse and
                              addiction associated with opioids. Another significant treatment area is anxiety, depression and
                              sleep disorders.

                              Cannabis-based products have also been used to treat the nausea and vomiting associated
                              with chemotherapy and a wide range of conditions associated with inflammation (eg eczema).
                              One of the most high profile areas is the treatment of epilepsy (indeed in June 2018, the FDA
                              approved GW Pharma’s Epidiolex – the first approved drug to contain CBD and one of a
                              category of antiepileptic drugs targeting early onset of the condition).

                              On 17 October 2018, Canada also became the first G7 country to legalise cannabis for
                              recreational use. Interestingly, few traditional players seem interested in exploring commercial
                              production of “joints” or cannabis cigarettes. The most active part of the market so far is for
                              edibles such as ice-cream, sweets, and cookies. There is also growing interest in the potential
                              for products which are infused with cannabis including beverages and beauty and skin-care.
                              Vaporisers are another active segment of the market.

Advises on many of the most significant transactions of the day. Draws on its international
footprint to handle work in multiple jurisdictions including the emerging markets.
Chambers UK Guide 2019: UK: Life Sciences

Heavyweight corporate and M&A practice that boasts an
exceptional coverage across Europe.
Chambers Europe-Wide 2018 Corporate/ M&A Department

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    Why does this matter?
    As the cannabis market opens up, it signals both opportunity and disruption for our clients – for example,
    if the recreational marijuana market liberalises, will this impact the size of the alcoholic beverage market?
    However, one of the key risks for new market entrants is the changing regulatory landscape.
    Our regulatory team is developing particular expertise in understanding the nuances of regulation in
    different markets and helping our clients to assess how their products may be affected. Our team is
    actively monitoring the changing status of regulations of cannabinoid-containing products around the
    globe and thinking about the impacts this will have on our clients’ businesses. Our experience includes
    advising key industry players, on:
    – national regulations related to hemp-based ingredients (such as cannabidiol/CBD), when included in
       regulated products such as food supplements, cosmetics, vaping and medicinal products;
    – agreements for the supply and licencing of cannabis for medical use;
    – sale of cannabis-based products on e-commerce platforms;
    – legal opinions to support investment strategy;
    – working with industry bodies and liaising with regulators to shape the definition of the law; and
    – securities and reporting requirements for companies involves in the manufacture, distribution or sale of
       cannabis-based products.
    Alongside our regulatory and compliance lawyers, we have built a multidisciplinary group focused on the
    cannabis market and offering expertise in key areas including investment, M&A and commercial alliances;
    intellectual property (brands, patents and trade secrets); distribution and licencing; marketing and
    advertising; and employment, among other areas. We can offer strategic and practical legal advice from
    practitioners who understand the specific sector and the particular challenges it may bring
    (including reputational issues).

           Tier 1: Pharmaceuticals
           and biotechnolog y                                      Tier 1: Commercial litigation
                                                                   Legal 500 UK 2019
           Legal 500 UK 2019

    Allen & Overy LLP is ‘top of the game’
    Legal 500 EMEA Healthcare and Life Sciences

    They are excellent; it was a proper partnership.
    Chambers Global, Life Sciences 2017

    Top multidisciplinary firm recognised for its expertise in life sciences.
    Chambers Europe, Life Sciences 2016

    © Allen & Overy LLP 2019
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Case study: Acquisition of HemPoland
by The Green Organic Dutchman
Allen & Overy advised Green Organic Dutchman Holdings                              Slovenia, Lithuania, and Estonia, and e-commerce
Ltd., a Canadian cannabis research & development company,                          platform and product sales in over 700 locations. In 2017,
(TGOD) on its USD 15.5 million acquisition of 100% of                              the company produced over 32,000 kgs of organic dried
shares in HemPoland sp. z o.o., (HemPoland), a leading                             flower and 310 kgs of organic CBD oils.
European manufacturer and marketer of premium organic
                                                                                   Our involvement in the transaction included the due
CBD oils. The acquisition provides access to HemPoland’s
                                                                                   diligence of the target, negotiations of the transaction
vast distribution network, premium Cannabigold brand,
                                                                                   documentation and the assessment of the regulatory regime
state-of-the-art hemp oil extraction technologies, and
                                                                                   in the EU and more than 13 EU jurisdictions governing
provides a strategic pathway into the European market
                                                                                   the production and sale of HemPoland’s products
for TGOD’s medical & recreational products and
                                                                                   (ie CBD-derived products) in the EU. The transaction
licensing deals.
                                                                                   was required to be cleared before the Toronto Stock
Founded in 2014, HemPoland was the first company in                                Exchange and the process included TGOD to
Poland to obtain a state licence allowing the company                              providing: (i) an overview of the regulatory framework;
to grow hemp and manufacture CBD oil products.                                     and (ii) opinions confirming the legality of marketing and
HemPoland’s management is comprised of experts in                                  distributing HemPoland’s products for each jurisdiction to
cultivation, oil extraction, and marketing of high-quality                         which HemPoland exports its products. We also advised
organic CBD oil. The company is vertically integrated,                             TGOD on the EU regulatory framework relating to sales
with over 1,250 acres of cultivation leveraging third parties,                     of CBD products across the EU, and our opinion was
multiple commercial scale extraction units, local distributors                     instrumental in having the deal cleared. Projects of this
in Poland, Austria, Netherlands, Germany, United Kingdom,                          nature demonstrate the unique strength and capabilities of
Italy, Switzerland, Portugal, Ireland, Czech Republic,                             our network; and the depth of our knowledge of this area.

    Definitions
    – Cannabis: a broad term used to describe organic products (eg cannabinoids, marijuana, hemp) derived from the
       Cannabis genus of plants.
    – Cannabinoids: a class of diverse chemical compounds that act on cannabinoid receptors in cells that alter
       neurotransmitter release in the brain, spinal cord and peripheral nerves. Cannabinoids can be naturally derived
      from the cannabis plant, or manufactured. Non–psychoactive examples include cannabinol and cannabidiols.

Source: Report reviewing the current evidence on of the medicinal benefits of cannabis–based products by the Chief Medical Advisor to the UK Government, June 2018

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    Other Relevant Expertise
     Licensing of cannabis for                         Patient access to CBD                             Review of regulatory
     medical use                                       based medicines                                   status CBD in EU
     We have assisted several pharmaceutical           We have provided general advice on issues         We have reviewed the regulatory status of
     companies with the drafting and negotiating       related to patient access to cannabis based       CBD in food, cosmetics and medicinal
     of supply and licence agreements for the          medicines, and the interpretation of ECHR         products in the EU and several EU MS.
     supply and licencing of cannabis for              case law in this respect.
     medical use.

                                                       Seizure of hemp products
     Advertising related to cannabis                                                                     Regulatory cannabis monitoring
                                                       (> 0.2% THC)
     We have provided a legal risk assessment          We have assisted a client with respect to the     We perform a regulatory monitoring
     on cannabis related advertising and claims        seizure of hemp tea (containing more than         of evolutions with respect to the
     (eg use of the slogan “keep calm and”             0.2% THC) by the customs authorities, and         regulations regarding cannabis based
     together with a cannabis leaf) as well as         the related potential classification of hemp as   products in Europe, the U.S., and Canada,
     sponsorship restrictions under EU member          narcotic under EU and local legislation and       for different clients.
     state law.                                        case law

     Sale and cultivation of hemp seeds                Legal highs monitoring

     We have advised on the legality of the sale       We perform a regulatory monitoring of
     of cannabis/hemp seeds for (i) food/feed          evolutions with respect to “legal highs”
     purposes and (ii) cultivation purposes; as well   for some of our clients.
     as the actual cultivation of those seeds in
     several EU jurisdictions.

    Global reach and cross-border approach
    We are one of the few firms able to put at our clients disposal a truly global and “one firm”
    cohesive network now spanning 44 offices in 31 countries from Europe, Asia Pacific, the Middle East
    and Africa to the Americas, as well as selecting a network of leading regulatory specialists in places where
    we do not currently have a physical presence or the specific expertise which our clients require. This unified
    approach enables us to offer a “one-stop-shop” mechanism, where our clients have one main point of contact
    able to coordinate regulatory advice across multiple jurisdictions.
    Our firm is regularly acknowledged as market leader for life sciences (eg in Chambers & Partners and Legal 500).

          550                         2,800                         5,500                                44                         31
             Partners                       Lawyers                       People                         Offices                    Countries

    © Allen & Overy LLP 2019
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                                                A&O Life Sciences Hub
                                                A blog where experts from Allen & Overy analyse the latest EU and
                                                national legal and regulatory developments in the life sciences sector.
                                                For relevant news, visit us here.

                                                Cannabis Legal & Regulatory Update
                                                Our monthly selection of handpicked news and legal developments.
                                                For relevant news, visit us here.
                                                Subscribe here to our dedicated Cannabis newsletter.

KEY CONTACTS

Cannabis Sector Lead                  M&A & Investments                    IP (Patents)                      IP (Brands)

Eveline Van Keymeulen                 Jeremy Parr                          Marc Doring                       David Stone
Head of the Life Sciences             Partner – Corporate                  Partner – IP                      Partner – Litigation/IP
Regulatory Practice                   Tel +44 20 3088 3383                 Tel +44 20 3088 4197              Tel +44 20 3088 2920
Tel +33 1 40 065 566                  jeremy.parr@allenovery.com           marc.doring@allenovery.com        david.stone@allenovery.com
eveline.vankeymeulen@allenovery.com

Commercial                            Disputes & Investigations            Trade & Regulatory

Jim Ford                              Hippolyte Marquetty                  Matthew Townsend                  Isabella Kelly
Partner – Corporate                   Partner – Litigation/Corporate       Partner – Corporate               Associate (adnitted in Victoria-Australia)
Tel +44 20 3088 4797                  Tel +33 1 40 06 53 98                Tel +44 20 3088 3174              – Corporate
jim.ford@allenovery.com               hippolyte.marquetty@allenovery.com   matthew.townsend@allenovery.com   Tel +44 20 3088 1717
                                                                                                             isabella.kelly@allenovery.com

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© Allen & Overy LLP 2019 | CS1811_CDD-53099_ADD-80776

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