Category Archive for: Products Liability

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Late 2019 saw a national outbreak in hospitalized cases of e-cigarette or vaping product use associated lung injury (EVALI). The United States Center for Disease Control (CDC) reported 2,807 cases from all 50 states, the District of Columbia, and two U.S. territories, including 68 EVALI-related deaths in 29 states and the District of Columbia. In response to this outbreak, Emerge Law Group and Greenbridge Corporate Counsel prepared a bulletin for its clients which is linked here entitled “Client Bulletin: Overview of State and Local Responses to EVALI” analyzing the responses of each state with legalized medical or recreational cannabis to the outbreak.

In November 2019, the CDC identified tocopheryl acetate, commonly known as vitamin E acetate, as a primary “chemical of concern” because 48 of 51 patients with EVALI tested had this chemical in fluid samples collected from their lungs. This chemical is sometimes used as a thickening agent or to dilute THC oil in vaping cartridges. The CDC reports that although vitamin E acetate appears to be associated with most of the cases, evidence is not sufficient to rule out the contributions of other chemicals of concern. However, due to continued declines in new EVALI cases in recent months and the CDC’s identification of vitamin E acetate as a primary cause of EVALI, the CDC stated that its February 18, 2020 update would be its final official update on the number of hospitalized EVALI cases and deaths nationally.

Today, March 6, 2020, JAMA Internal Medicine published an in-depth report on 160 EVALI cases in California. This report—the first to our knowledge to describe cases in a state with a legal adult-use cannabis market—appears to confirm patterns of clinical findings and vaping practices previously reported in other states and nationally. Although California has a legal adult-use cannabis market, the majority of affected patients (83% of those interviewed) reported using THC-containing products obtained from informal sources, such as friends, acquaintances, or unlicensed retailers. When asked specifically whether THC-containing products had been acquired at a licensed dispensary, patients answered affirmatively for only 25% of the THC-containing products. Of these products, only four products had a named purchase location verified as a state-licensed dispensary. In addition, 84% of THC-containing products tested contained vitamin E acetate, reinforcing the potential association between this chemical and EVALI. The report concluded that while use of THC-containing products and vitamin E acetate appear to be associated with the EVALI outbreak, additional investigation is needed to determine the cause or causes.

Both the CDC and the United States Food & Drug Administration (FDA) published recommendations to the public regarding EVALI and the risks of using vaping products, including warnings to stop using any vaping products containing THC. In response to EVALI and the CDC and FDA recommendations, several states with legalized medical and recreational cannabis products acted to address THC-infused vaping products, up to and including partial or complete bans on the manufacture, distribution and/or sale of vaping products.

The linked Greenbridge-Emerge Client Bulletin summarizes state actions undertaken (or proposed to be undertaken) regarding THC-infused vaping products as of March 2, 2020. A previous version of our client bulletin was cited in Marijuana Business Magazine’s February issue focusing on the vaping crisis. Our analysis was also incorporated into the NCIA Policy Council’s white paper on safe vaping entitled “The Key to Consumer Safety: Displacing the Illicit Cannabis Market – Recommendations for Safe Vaping,” which the NCIA has shared with key congressional committees.  Check out the Client Bulletin and get in touch to learn more about how your business can successfully navigate the latest legal and regulatory reactions to EVALI.

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There’s a lot of fear out there, but not a lot of information regarding the safety of e-cigarettes and cannabis vape pens in the face of widely publicized cases of a new “vape-related illness” affecting vape users across the country, including here in Oregon.  Many of our clients – mostly retailers (dispensaries) – are wondering what they should and should not say to customers who have questions about the safety of their products.

Our attorneys, including Josh DeCristo, an experienced products liability litigator, have been confronting this issue head-on and have put together recommendations for our clients on how to handle such questions, including providing hand-outs for customers and best practices for companies and their employees.  We continue to monitor this issue and can provide up-to-the-minute advice as news breaks.  Please let us know if you have any questions or concerns about how to proceed on this delicate issue and we’d be happy to advise based on your individual needs.

 

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Many people have been asking about what to do if their container is too small to fit all of the required label information. Think tinctures, single-serving shots, or small edibles. Fortunately, the OLCC and OHA heard these concerns and created special rules for small containers. If your container is too small to include all required label information, you may now use additional packaging for display purposes to include this required information.

Minimum Information on Small Container

The container actually holding the marijuana item must contain:

  • Information in a minimum 8-point font, Arial, Helvetica, or Times New Roman;
  • A principal display panel containing required information (product identity, universal symbol, net weight) if required for the type of marijuana item;
  • Business or trade name and licensee or registrant number;
  • For OLCC licensees, package unique identification number;
  • For OHA registrants, batch or process lot number;
  • Concentration of THC and CBD; and
  • Required warnings.

Additional Information

All other required information must be included on:

  • a leaflet or hangtag that will accompany the marijuana item; or
  • an outer package.

If an outer package is used, all required information must be listed on the outer packaging, even if some of it has been included on the inner container.  In other words, outer packaging must have a full label.

Check back next week for more updates, including details on the registration procedure for OHA processors, what to do with unsold dispensary inventory on October 1st, and more!

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If you are an Oregon marijuana business owner, you will need to ensure compliance with not only new labeling rules, but also new packaging rules. The general rule to remember is that all marijuana items must comply with these packaging rules at retail sale to the end consumer. This rule applies to OLCC licensees immediately, and OHA registrants on and after October 1, 2016.

OLCC retailers and OHA-registered dispensaries will want to pay particular attention to the new packaging rules as they are ultimately responsible for ensuring that marijuana items leaving their businesses are properly packaged. With that said, any marijuana business that wants its product to be sold to consumers in their own packaging – without first being placed in “exit packaging” (which is explained below) – will also need to ensure that their products are properly packaged.

Pre-Approval

All packaging must be “pre-approved” by the OLCC. Both OLCC licensees and OHA registrants can pursue packaging pre-approval through the OLCC’s licensing portal (this is the same method used to obtain labeling pre-approval).

The OLCC will publish a list of pre-approved packaging. Any OLCC licensee or OHA registrant may use pre-approved packaging without first seeking permission from the OLCC. If you plan to use a pre-approved package from this list, be aware that:

  • the OLCC has not yet published the list;
  • once the OLCC does publish the list, there is no guarantee that the packaging you plan to use will be on the list; and
  • if you plan to use pre-approved packaging, but of a different size or color than is specified on the list, you may not use that packaging without first obtaining pre-approval from the OLCC.

General Requirements for Packaging

The general rule is that packaging used in retail sales to end consumers must:

  • protect marijuana items from contamination or exposure to toxic and harmful substances;
  • not be attractive to minors; and
  • be child-resistant.

There are three types of child-resistant packaging:

      1. Single Use. This packaging loses its child-resistance once opened; it may be used for usable marijuana (dried flower), single-serving edibles, single-serving topicals, single-serving concentrates, and single-serving extracts. singleusepackage
      2. Continual Use. This packaging maintains its child-resistance throughout the life of the marijuana item within; it may be used for usable marijuana, edibles, topicals, concentrates and extracts. continualusepackage
      3. Exit Packaging. This packaging can be used at the point of sale to enclose non-child resistant packaging. Use of exit packaging ensures that the sale to the end consumer complies with the new packaging rules. exitpackaging

For a complete list of packaging requirements and restrictions, see Oregon Administrative Rules 845-025-7000 to 845-025-7060.

Exception to the Child-Resistance Rule

Packaging does not need to be child-resistant if the product being sold is a marijuana seed or immature marijuana plant. Regardless of this exception, all packaging – including non-child resistant packaging and exit packaging – must be pre-approved by the OLCC.

Transportation Packaging

An additional rule applies to all transfers of marijuana items among OLCC licensees. In short, these transfers must use shipping containers and must be labeled with a UID tag prior to transport. For a complete list of requirements and restrictions applicable to these transfers, see Oregon Administrative Rule 845-025-7700.

For more information, please visit the OLCC’s page for packaging and labeling pre-approval. There you will find links to guides, workshop presentations, and frequently asked questions. If you have further questions, please contact one of our compliance attorneys and we will be happy to assist you with your packaging or other needs.

Tune in tomorrow for information on how small packages (e.g., 5ml plastic screw top containers) can comply with the new packaging and labeling rules.

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Whether you are involved in the medical or recreational side of the Oregon cannabis industry, you will likely be required to comply with new labeling regulations on and after October 1, 2016. These regulations, contained in Oregon Administrative Rule 333-007-0010 to 333-007-0100, apply to all recreational licensees at all times during licensure, and most medical registrants. These labeling requirements do not apply to you if you are:

  • A grower providing usable marijuana or an immature plant to a patient who designated you as their grower or to the caregiver of a patient who designated you as their grower; or
  • A designated caregiver who is transferring a marijuana item to the patient who designated you as their caregiver

Generic Labels

A label that provides only the necessary information required by the rules, and no graphics, photographs, or logos, is considered a “generic” label and requires no pre-approval. You are not required to provide notice to OLCC that you will be using a generic label.

Pre-Approved Labels

All other labels require pre-approval from OLCC before they may be placed on a marijuana item. OLCC licensees and OHA registrants may submit labels for pre-approval through the OLCC’s licensing portal. Although not ideal, if you are unable to obtain pre-approval prior to October 1, 2016, you may use a generic label until you are pre-approved. Going forward, certain label information may be changed without the need for a new pre-approval. The OLCC has been working on detailing what label information this applies to (e.g. strain, net weight, test results, etc.). We will update you as we learn more.

General Requirements for Labels

A container holding a marijuana item must have a principal display panel (PDP) that provides:

  • The product’s identity;
  • The universal marijuana symbol at a minimum size of .48” x .35 inches; universalsymbol
  • If applicable, the medical grade symbol at a minimum diameter of .35 inches; and medicalsymbol
  • Net weight in US Customary and metric units.

Labels must:

Pictograms may be used in place of written label information where appropriate, such as for activation time.  activationpictogram

Specific Labeling Requirements by Product Type

Follow the links below to find administrative rules containing lists of labeling requirements for each different product type.

Prohibitions

A label may not contain any untruthful or misleading statements. These include:

  • Use of the term “organic” unless the product has been certified;
  • Claiming that the product is gluten-free, unless labeling follows FDA labeling requirements for gluten-free products; and
  • Health claims that have not been substantiated by the totality of publicly available scientific evidence, for which there is scientific agreement among experts.

A label must not be attractive to minors. This includes:

  • Brands or designs that resemble a product marketed to children;
  • Brands or designs typically marketed to children;
  • Cartoons; and
  • Images of minors.

For more information, please visit the OLCC’s page for packaging and labeling pre-approval. There you will find links to guides, workshop presentations, and frequently asked questions. If you have further questions, please contact one of our compliance attorneys and we will be happy to assist you with your labeling or other needs.

Tune in tomorrow for information on packaging requirements under the new rules.

 

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Is there such a thing as organic marijuana? Like most things in the industry, the answer isn’t simple. Many cultivators use organic techniques. So yes, organic cannabis exists. However, can flower, concentrates, oils or edibles be marketed as organic? That answer is NO.

Federal Regulation of the Word “Organic”

Use of the word “organic” on agricultural products is regulated by the U.S. Department of Agriculture (USDA) under the Organic Food Production Act of 1990 (OFPA). Only agricultural products certified by approved agencies may be marketed as “organic”. Marijuana is considered an agricultural product under the OFPA, but the USDA will not certify marijuana as organic because the substance remains illegal under federal law.

“Organic” Marijuana Products

So where does this leave marijuana producers? Can a business name include the word “organic”? How can “organic” products be described to discerning consumers or sensitive medical patients seeking such products? Here are a few thoughts:

  • Business Name – In August 2014, the USDA issued a statement to its various certifying agencies stating that business names containing the word “organic” do not inherently constitute a false or misleading statement. Therefore, technically you can use the word “organic” in a business name BUT it may not be practical to do so (see labelling below).
  • Labelling – Remember, the key issue is to protect consumers by preventing false advertising and providing uniformity. Consequently, the USDA regulates how you can use “organic” in labeling products. There are two main product label parts: (1) the principal display panel (PDP); and (2) the information panel. The PDP portion of the package is the front, what consumers most likely see at the time of purchase. The information panel includes the list of ingredients contained in a product and other product information. We do not recommend using the term “organic” on the PDP for marijuana products. Therefore, if a business name includes “organic” it should not appear on the PDP. You may consider an assumed business name or branding product lines. However the information panel can be used to identify ingredients used in the product that have been certified organic.
  • Alternative Terms – Businesses can use other words or phrases to describe their products. Alternative terms such as “clean”, “natural”, “local”, “whole” and “sustainable” are not regulated liked the word “organic”.
  • Alternative Certification Programs – Lastly, there are alternative certification programs for the marijuana industry equivalent to organic certification. Currently two private companies have been created, Clean Green Certified and Certified Kind. Alternative certification costs approximately $1,800 to $2,000 per year. But remember, even with alternative certification, you cannot market products as “organic”.

Prior to the OFPA, organic food was regulated by the states. There were substantial differences in organic farm regulations from state to state. For example, by 1990 three states operated their own organic certification programs, four states used independent certification organizations, and fifteen states defined organic techniques but did not require certification. Organic farmers found the patchwork of state regulation to be confusing to consumers and lobbied Congress to pass federal law to provide consistent and uniform information to consumers and promote fair trade practice. My prediction is that states at the forefront of marijuana legalization will begin self-regulating, similar to the food industry. In fact, Oregon passed the nation’s first organic certification law in 1973. Maybe Oregon will lead the way again by developing marijuana industry standards.

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FRANCHISE LAW

Franchisors

Franchise law is a heavily regulated area of law.  We help clients expand their businesses through franchising and other distribution methods. We have experience in many industries including, restaurants, health, and beauty, alcohol, and cannabis among others. Our representative services include the following:

Franchisees

We also help potential franchisees interested in buying a franchise. We are able to assist with evaluation of franchise opportunities with respect to:

Alternative Structures

However, not all businesses are suited to franchise. We are also experienced with helping clients structure alternative distribution methods to prevent classification as a franchise.

MERGERS AND ACQUISITIONS

Our M&A attorneys are highly experienced in counseling clients who are considering acquisitions or exit strategies.  We have many years of experience handling deals of various types and sizes, ranging from sales of small closely-held business, private companies, and publicly-traded corporations.  We have represented business owners, private equity firms and investment banks in a wide range of industries. 

We have a deep business bench, and Emerge attorneys have handled transactions of all shapes and sizes.  Whether your deal is valued at $100,000 or $100,000,000, our experienced attorneys will guide you through the deal process.

We understand the intensity, technical skill and judgment needed to get deals done, and we provide our clients with timely, practical and cost-effective legal advice.  We are highly capable in all aspects of M&A, including the following:

CANNABIS INDUSTRY

Emerge Law Group is highly experienced in the cannabis industry.  We have helped many clients obtain state licenses and local permits to operate cannabis businesses throughout California, Oregon, and Washington.

Emerge attorneys were instrumental in the drafting and passage of Oregon Measure 91, legalizing marijuana in the State of Oregon, and have represented cannabis businesses well before many law firms were willing to enter the cannabis industry. As a firm that has provided legal services in the cannabis space for many years, we are familiar with the unique and complex issues businesses and individuals face in an emerging and highly regulated industry.

We regularly help clients with:

Cannabis laws and rules are also regularly changing.  Members of our team are dedicated to attending legislative hearings, state agency and local city and county meetings to stay up-to-date on any new changes and how to adjust to any new changes.

See our Cannabis Industry page for more information.

PSYCHEDELICS

There is tremendous excitement about the potential for psychedelic drugs to benefit a wide variety of populations, including terminally ill patients suffering with anxiety and depression. Until recently, psychedelic substances have been accessible only in the illicit market and are illegal under federal and state to manufacture, distribute, or possess. These substances have, since 1970, been treated as having no legitimate medical use, and no commercial application. As such, no one invested in this area or required legal services, outside of the criminal context.

Today, researchers in a multitude of clinical studies are proving the medical safety and efficacy of these medicines, with the objective of changing the treatment of these substances under the Controlled Substances Act. Companies are now actively raising money to develop intellectual property and seize market opportunities associated with psychedelic drugs.

In addition, advocates at the state and local levels are not waiting for the rescheduling of these substances and are active in undertaking efforts to decriminalize these substances and/or make them affirmatively legal under state and/or municipal law. Decriminalization already has occurred in cities including Denver, Oakland, Santa Cruz, and Ann Arbor. Oregon is poised to be the first state to make psilocybin therapy affirmatively legal. Emerge Law Group is working with a wide array of clients pushing forward in this emerging area.

See our Psychedelics Practice Group page for more information.

TAXATION

CORPORATE AND PARTNERSHIP TAX

Businesses of all kinds benefit from a customized but systematic approach to structuring legal relationships. Emerge Law Group helps businesses and business owners with a variety of tax planning matters.

Representative client services include:

ESTATE PLANNING

Estate planning encompasses everything from a will and power of attorney to combined estate and business succession planning. In almost all cases, the purpose of the plan is to help the client protect those they care about most in the event they can no longer be there for them.

Emerge Law Group has experience with a wide range of tools used in estate planning, including wills, trusts, and family business entity planning.

TAX CONTROVERSIES

Emerge Law Group can assist with the resolution of difficult tax controversies. Our areas of emphasis and experience include:

REAL ESTATE TRANSACTIONS

Emerge Law Group assists clients with a wide range of real estate transactional matters.  We regularly help clients with:

LAND USE

Emerge Law Group also assists clients with all aspects of local government land use and development processes, ranging from preliminary property analyses and building permit issues to complex land use reviews and hearings. Our attorneys are experienced in obtaining land use entitlements and development permits for a wide range of uses.

We regularly help clients with:

Above all, we understand the value of working with cities and counties to enhance communities while developing the land to its potential. We strive to create solutions to land use issues that serve to better our clients and the communities in which they live and work.

LITIGATION AND ALTERNATIVE DISPUTE RESOLUTION

The attorneys in Emerge Law Group’s Litigation and Alternative Dispute Resolution practice group litigate commercial, intellectual property, and public interest matters in state and federal courts, as well as private mediation and arbitration proceedings.  Our lawyers have represented national and regional financial institutions, major media, entertainment and technology companies, and other Fortune 500 companies in a broad array of high-stakes disputes.  Our team of litigators has handled leading cases that have shaped the law in cutting-edge business, technology, free speech, and public interest impact lawsuits in trial and the courts of appeal.

We have particular expertise in handling civil litigation and regulatory enforcement matters in the cannabis and psychedelic industries.  While many firms claim expertise in the these industries, few have our depth of experience successfully litigating contract, trademark, partnership, shareholder, land use, and real estate disputes in court and arbitration.  Even fewer firms have our level of experience handling writ of mandate proceedings against the government regulators.

Our litigators practice in California, Oregon, and Washington, but have appeared in state and federal courts nationwide.  Our knowledge of our clients’ businesses, goals and concerns, and our experience litigating at the highest levels, give us unique insight into possible outcomes and pitfalls as we continuously confront issues of new impression.

No matter what the industry, we pride ourselves in achieving our clients’ objectives through efficient and creative solutions primarily designed to avoid disputes in the first place—which is always the best litigation strategy.  Many times, our clients obtain excellent outcomes before or at the earliest stages of litigation because our adversaries quickly recognize the challenges they will face in litigating against us.  When litigation is unavoidable, however, we work hard to provide our clients with both cost-efficient and “big firm” quality representation.

 

INTELLECTUAL PROPERTY

Your intellectual property (or “IP”) strategy can harness your most valuable information and intangible assets including your name, your brand, your designs, your content, your services, and your products — what makes your business stand apart in a competitive world.  We can help you evaluate and build your IP portfolio, then secure it, monetize it, and protect it.

IP encompasses multiple areas of law and different types of information or material.

Our Intellectual Property practice focuses on:

TRADEMARK

Trademarks include names, signs, logos, designs, phrases, slogans, expressions, and sometimes even colors, sounds, or smells that identify or distinguish one business compared to others.  Trademark protection is fundamental in securing your “brand.”

COPYRIGHT

Copyright covers original works of creative authorship fixed in a tangible medium of expression.  This includes literary, dramatic, musical, and artistic works, such as poetry, novels, designs, movies, songs, computer software, and architecture. Copyright does not protect facts, ideas, systems, or methods of operation, although it may protect the way these things are expressed.  Depending upon the type of work, “moral rights” (such as the right of attribution) may be implicated as well.

TRADE SECRET

Trade secret laws can vary somewhat between states, but generally trade secrets cover information, including drawings, cost data, customer lists, formulas, recipes, patterns, compilations, programs, devices, methods, techniques or processes that derive economic value from not being generally known and are the subject of efforts that are “reasonable under the circumstances” to maintain secrecy.

PRIVACY

Depending upon where you live or operate, there is a special patchwork of laws and regulations that protect and regulate personal information.  If you are handling or giving out personal or potentially sensitive information, you may be implicating privacy laws.

PUBLICITY

Publicity rights address the commercial use of an individual’s face, name, image, or likeness.  These rights vary state-to-state.  Marilyn Monroe, for example, lived in multiple states which created complex questions about her publicity rights.

Our Intellectual Property services include:

FINANCIAL INSTITUTIONS

In states where new cannabis banking opportunities exist, Emerge Law Group has the proven expertise in creating canna-banking programs to efficiently capitalize on those opportunities. Our Banking Practice Group specializes in working with banks and credit unions to develop regulatory compliant programs and operational best practices. We also train banking staff to become experts in canna-banking so they can effective understand and manage the risk affiliated with canna-banking.

We regularly help clients with:

EMPLOYMENT LAW

At Emerge Law Group, we recognize that employees are the heart and soul of any successful business.  Our Employment Law Practice Group works with employers to help them effectively manage their workforce, navigate the complex web of federal, state and local employment laws and, if necessary, defend against claims before administrative agencies and in court.

We regularly help clients with:

CORPORATE FINANCE AND SECURITIES

Our corporate finance and securities lawyers are experienced attorneys who have practiced at large law firms, worked as in-house counsel for public companies and investment banks, and owned and operated start-up companies. We work with clients to help achieve their financing goals while safely navigating the highly technical securities law landscape. 

In addition to representing issuers, we also routinely represent institutional and individual investors, including in connection with fund formation and investments.

Our expertise includes:

We have a deep understanding of the financing options available to businesses, including simple unsecured loans, asset-backed financing, convertible debt, common and preferred equity, crowdfunding and various other structures.  We work closely with our clients to understand their business and financing needs, ensure they are prepared to approach investors and choose the right partners, structure and negotiate terms, navigate the due diligence process and successfully close the deal.

COMPLIANCE AND LICENSING

ALCOHOL AND BEVERAGE INDUSTRY

Emerge attorneys have represented businesses in the alcohol and beverage industry, including wineries, breweries, distilleries, restaurants, bars, movie theaters, golf courses, and gas stations.  We can help you vet new locations, acquire existing locations, and apply for the appropriate liquor license.  We also provide training to comply with applicable rules and regulations, prepare operating procedures, submit renewals, and keep clients protected in the event of any potential violations or administrative hearings.

CANNABIS INDUSTRY

Emerge Law Group is highly experienced in the cannabis industry.  We have helped many clients obtain state licenses and local permits to operate cannabis businesses throughout California, Oregon, and Washington.  We regularly help clients with:

Cannabis laws and rules are also regularly changing.  Members of our team are dedicated to attending legislative hearings, state agency and local city and county meetings to stay up-to-date on any new changes and how to adjust to any new changes.

See our Cannabis Industry page for more information.

PSYCHEDELICS INDUSTRY

Emerge Law Group is a leader in the psychedelics industry.  There is tremendous excitement about the potential for psychedelic drugs to benefit a wide variety of populations, including veterans struggling with PTSD and terminally ill patients suffering with anxiety and depression.  Until recently, psychedelic substances have been accessible only in the underground; they are illegal under state and federal law to manufacture, distribute, or possess.  These substances have, since 1970, been treated as having no legitimate medical use, and no commercial application.  As such, businesses have not invested in this area or required legal services, outside of the criminal context.

Today, psychedelics are proceeding toward legalization on multiple paths.  Researchers in a multitude of clinical studies are proving the medical safety and efficacy of these medicines, with the objective of changing the treatment of these substances under the federal Controlled Substances Act, opening legal access to them.  Private and public companies are now actively raising money to develop intellectual property and capitalize on the market opportunities associated with psychedelic drugs.  Opportunities to be early actors in this new arena are tremendous.

See our Psychedelics Practice Group page for more information.

BUSINESS AND CORPORATE

Our business transactions team is made up of highly experienced transactional attorneys who have practiced at large law and accounting firms, worked as in-house counsel for public companies and investment banks, and owned and operated start-up companies. We understand complex legal matters and provide high quality legal services in a cost-effective manner.  Our clients value our experience, knowledge and judgment.

ENTITY FORMATION

Our team routinely advises clients regarding:

CORPORATE GOVERNANCE

Emerge attorneys also advise on-going concerns with: