The Book of Jargon® – Healthcare & Life Sciences

An interactive glossary of healthcare and life sciences acronyms, slang, and terminology.

The Book of Jargon® – Healthcare & Life Sciences is one in a series of practice area and industry-specific glossaries published by Latham & Watkins.

The definitions provide an introduction to each term and may raise complex legal issues on which specific legal advice is required. The terms are also subject to change as applicable laws and customary practice evolve.

This glossary is intended to be a useful tool for recent law and business school graduates as well as other professionals seeking initiation into the industry, while also serving as a resource for seasoned executives.

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The information contained herein is not legal advice and should not be construed as such.

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  • AAC:
    acronym for Average Acquisition Cost.
    Abbreviated Biologics License Application (aBLA):
    an application to the FDA, requesting approval for a Biosimilar. The application does not have to contain full clinical trial Data to establish safety and efficacy — as is the case with BLAs. Instead, the aBLA must contain Data, including human clinical Data, demonstrating that the Biosimilar is “highly similar” to the innovator Biological Product (Biologic) (notwithstanding minor differences in clinically inactive components) and demonstrating no clinically significant differences between the two in terms of safety, purity and potency. See BPCIA.
    Abbreviated New Drug Application (ANDA):
    an application to the FDA, requesting approval for a generic Drug product. Section 505(j) of the Federal Food, Drug, and Cosmetic Act establishes an abbreviated approval process for generic versions of approved Drug products through the submission of an ANDA. An ANDA provides for marketing of a Drug product that has the same active ingredients in the same strengths and Dosage Form as the Reference Listed Drug and has been shown to be bioequivalent to the reference listed Drug. ANDA applicants are required to conduct bioequivalence testing to confirm chemical and therapeutic equivalence to the branded reference Drug. The application does not need to contain full Pre-Clinical and clinical Data to establish safety and efficacy — as is the case with NDAs. Instead, the ANDA must contain Data demonstrating that the Generic Drug is bioequivalent to the innovator Drug. See Hatch-Waxman.
    acronym for Abbreviated Biologics License Application.
    the surgical removal of body tissue. Cardiac Ablation is a procedure used to scar small areas of the heart that may be related to heart rhythm problems. This Ablation is usually done by inserting Catheters through a vein in a patient’s groin and threading them to the patient’s heart to correct structural problems that cause Arrhythmia. Endometrial Ablation is a procedure that destroys the uterine lining, or endometrium, to treat abnormal uterine bleeding. The endometrium heals by scarring, which usually reduces or prevents uterine bleeding.
    acronym for Affordable Care Act.
    Accelerated Approval:
    the FDA may approve an application for a Drug or Biologic for a serious or life-threatening disease or condition upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. The evidence to support that an endpoint is reasonably likely to predict clinical benefit may include epidemiological, pathophysiological, therapeutic, pharmacologic or other evidence developed using Biomarkers, for example, or other scientific methods or tools. Accelerated Approval may be subject to a requirement that the sponsor conduct appropriate post-approval studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit, and/or that the sponsor submit copies of all Promotional Materials during the pre-approval review period and, following approval and for a period that the FDA determines to be appropriate, at least 30 days prior to dissemination of the materials.
    an article which — although not technically a Device — is intended specifically by its Manufacturer to be used together with a Device to enable the article to be used in accordance with the use of the Device intended by the Manufacturer of the Device (Art. 1 para. 2 lit. b) Directive 93/42/EEC).
    Accountable Care Organization (ACO):
    groups of doctors, hospitals, and other healthcare Providers, who voluntarily participate in a payment and care delivery model that ties Reimbursement for services rendered to quality metrics with the goal of reducing the total cost of care for assigned populations of patients. As a concept, ACOs share three core principles: (1) provider-led organizations with a primary care focus that are collectively accountable for quality and total per capita costs across the full continuum of care for a defined population of patients; (2) Reimbursement and payments are tied to quality improvements that also reduce overall costs; and (3) subject to performance measurements to support improvement and provide confidence that savings are achieved through improvements in care.
    Under the Medicare program, an ACO is defined as an organization of healthcare Providers that agrees to be accountable for the quality, cost and overall care of Medicare beneficiaries enrolled in the traditional Fee-For-Service program and assigned to the particular ACO. CMS offers several ACO programs, including the Medicare Shared Savings Program, Advance Payment Initiative and Pioneer ACO Model.
    a process of review that healthcare organizations participate in to determine their ability to meet predetermined criteria and standards of Accreditation established by the Accreditation organization. Providers and Suppliers accredited by an approved national Accreditation organization (AO) are exempt from routine surveys by state survey agencies to determine compliance with Medicare conditions.
    acronym for Angiotensin-Converting Enzyme.
    ACE Inhibitors:
    ACE Inhibitors are compounds that block angiotensin, with potential utility in lowering blood pressure.
    acronym for Accountable Care Organization.
    Active Implantable Medical Devices (AIMDs):
    the Directive 90/385/EEC* defines Active Implantable Medical Devices as Medical Devices intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.
    Reference: Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable Medical Devices.
    Active Moiety:
    portion of Molecule responsible for causing a Drug to act the way it does. Active Moiety does not include appended portions of a Molecule that cause the Drug to be an ester, salt or other noncovalent derivative of the Molecule.
    Active Pharmaceutical Ingredient (API):
    the chemically active ingredient in a Drug intended to cause the desired effect in the body, as opposed to the inactive ingredients in a Drug, sometimes referred to as expedients.
    Active Substance Master File (ASMF):
    according to the EMA, the main objective of the ASMF is to allow valuable confidential active substance Manufacturer Intellectual Property or Know-How to be protected, while at the same time allowing the applicant or marketing authorisation holder to take full responsibility for the medicinal product and the active substance’s quality and quality control. National Competent Authorities and EMA thus have access to the complete information necessary to evaluate the active substance’s suitability in the medicinal product.
    Acute Lymphocytic Leukemia (ALL):
    also known as acute lymphoblastic leukemia (ALL), a cancer of the blood and marrow that is the most common form of childhood cancer. The term “acute” means that the Leukemia progresses rapidly and creates immature blood Cells. The term “lymphocytic” refers to the white blood Cells called lymphocytes, which ALL affects. Acute leukemia tends to respond well to treatment, especially in children.
    Acute Myeloid Leukemia (AML):
    also known as acute myelogenous leukemia, acute myeloblastic leukemia, acute granulocytic leukemia and acute nonlymphocytic leukemia, a cancer of the blood and bone marrow which is most common in older people. The word “acute” means the Leukemia progresses rapidly. The word “myeloid” refers to a group of white blood Cells called myeloid Cells, which AML affects.
    Adequate and Well-Controlled Clinical Trial:
    a study in humans typically characterized by: a clear statement of objective and study protocol, a study design allowing for valid comparison with a control to assess efficacy, a proper method of subject selection to minimize biases, well-defined and reliable methods of assessment, and proper analysis of the study results. The FDA typically requires Data from at least two Adequate and Well-Controlled Clinical Trials to support a claim of effectiveness for a Drug.
    acronym for “absorption, distribution, metabolism, and elimination,” the process of administering a drug Molecule throughout a human or animal body.
    an acronym for Adverse Drug Reaction.
    Adulterated Product:
    an FDA-regulated product that fails to conform to standards of quality, strength or purity. Drugs and Devices that are not manufactured, processed, packed or held in conformance with current good manufacturing practice are deemed adulterated as a matter of law.
    abbreviation for Advanced Medical Technology Association.
    AdvaMed Code:
    abbreviation for AdvaMed Code of Ethics on Interactions with Health Care Professionals.
    AdvaMed Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code):
    a code of ethics which AdvaMed developed that provides guidance to Medical Device companies on ethical interactions with healthcare professionals. The AdvaMed Code supports the adoption of effective compliance programs and sets forth guidance on such interactions to foster transparency and compliance with applicable laws, regulations and government guidance issuances. The AdvaMed Code addresses subjects including: sales, marketing and promotional activities, and financial arrangements with healthcare professionals. Adherence to the AdvaMed Code is voluntary; however, certain states have based regulations on the provisions of the AdvaMed Code or adopted the AdvaMed Code in its entirety by reference.
    Advanced Medical Technology Association (AdvaMed):
    a voluntary trade organization primarily for organizations that develop, produce, manufacture and market medical products, technologies, and related services and therapies. AdvaMed advocates on behalf of its global membership to facilitate faster product approvals, appropriate Reimbursement, and access to international markets. AdvaMed has more than 300 members. The organization developed the Code of Ethics on Interactions with Health Care Professionals (known as the AdvaMed Code) that serves as a guide for the Medical Device industry on ethical interactions with healthcare professionals.
    Advanced Therapy Medicinal Products (ATMPs):
    Advanced Therapy Medicinal Products (ATMPs) are biological medicinal products based on Genes or Cells and intended for human use.
    ATMPs can be classified into four main groups:
    - Gene-therapy medicines
    - Somatic-cell therapy medicines
    - Tissue-engineered medicines
    - Combined ATMPs
    Adverse Drug Reaction (ADR):
    see Adverse Event (AE).
    Adverse Event (AE):
    US: the FDA defines an Adverse Event as any untoward medical occurrence associated with the use of a Drug in humans, whether or not considered drug related.
    EU: defined by the Clinical Trials Regulation* as any untoward medical occurrence in a subject to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment.
    *Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on Clinical Trials on medicinal products for human use, and repealing Directive 2001/20/EC.
    See Adverse Drug Reaction (ADR).
    an advertisement for an FDA-regulated product that appears in print materials (published journals, magazines, other periodicals, newspapers) or that is broadcast through media (radio, television or telephone communication systems).
    Advisory Committee:
    a group that advises the FDA on whether to approve a Drug.
    Advisory Opinion:
    a legal opinion which the OIG issues to one or more requesting parties about how the OIG will apply its Fraud and Abuse authorities, principally the AKS, to the requesting party’s existing or proposed business arrangement. An OIG Advisory Opinion is legally binding on the Department of Health & Human Services and the requesting party or parties. It is not binding on any other governmental department or agency. A party that receives a favorable Advisory Opinion is protected from OIG administrative sanctions, so long as the arrangement at issue is conducted in accordance with the facts submitted to the OIG. No person or entity can rely on an Advisory Opinion issued to someone else. CMS also has a similar Advisory Opinion process addressing the Stark Law.
    acronym for Adverse Event.
    acronym for Spanish Agency for Medicines and Health Products or Agencia Española de Medicamentos y Productos Sanitarios.
    Affordable Care Act (ACA):

    also known as the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (and colloquially referred to as “Obamacare”), a US statute enacted on March 23, 2010, that substantially changed the US healthcare system to increase the quality and affordability of health insurance, to lower the uninsured rate by expanding access to and enrollment in insurance Coverage, and to reduce the cost of healthcare for all stakeholders, by transforming the provision of healthcare in the United States. Among the ACA’s healthcare reform provisions are:

    • The prohibition on denial of Coverage due to pre-existing conditions
    • Minimum standards for health insurance policies
    • A mandate that all individuals not otherwise covered by an employer-sponsored health plan or a public health insurance program (such as MedicareMedicaid or TRICARE) obtain an approved private-health insurance policy or pay a penalty
    • The creation of health insurance exchanges to foster a market through which such individuals may compare and purchase health insurance

    The ACA also included numerous provisions designed to assist the government to fight fraud, waste and abuse in the federal healthcare programs, including provisions amending the FCA’s public disclosure bar for certain whistleblower/Relator complaints, reducing the intent standard necessary to prove a violation of the AKS to permit the government to take action against persons for violating the law, even if that person did not have actual knowledge of the law or the specific intent to violate it; and imposed a requirement obligating Providers and Suppliers to report and return Overpayments to the government within 60 days of identifying the Overpayment or face potential liability under the FCA for retaining the Overpayment.

    Age-Related Macular Degeneration (AMD):
    the leading cause of vision loss among Americans aged 50 and older, AMD involves the degeneration of the macula, a small spot near the center of the retina responsible for the sharp, central vision needed to see objects that are straight ahead. Macular degeneration is defined as either dry (non-neovascular) or wet (neovascular). Neovascular refers to the growth of new blood vessels in an area where they are not supposed to be. Dry macular degeneration is more common and wet macular degeneration usually leads to more serious vision loss. AMD can only be detected by a comprehensive dilated eye exam.
    acronym for Italian Medicines Agency or Agenzia Italiana del Farmaco (the Italian drug agency).
    acronym for Anti-Kickback Statute.
    acronym for Acute Lymphocytic Leukemia.
    one of a number of alternative forms of the same Gene. Humans are called diploid organisms because they have two Alleles at each genetic locus, with one Allele inherited from each parent. In the case of genetically inherited disease, a person inheriting two or sometimes just one of a disease-causing Allele, that person may or may not get the disease, but the individual is a carrier. Genetic testing companies will screen for many disease Alleles and CRISPR technology eventually may be able to edit out bad Alleles in humans. Research is currently underway to edit out Alleles during In Vitro fertilization to eliminate inheritance of particularly bad Alleles (where there are no cures). Examples include Alleles for breast cancer (BRCA1 and BRCA2) and Leukemia (BCR-ABL).
    relating to or involving tissues or Cells that are genetically dissimilar and hence immunologically incompatible, even though they come from individuals of the same species.
    Ambulatory Payment Classification (APC):
    the APC system is the Coding system which the CMS designed and maintains to reimburse hospitals for outpatient services provided to Medicare beneficiaries. This bundled payment system groups covered outpatient services, identified by HCPCS Codes, that are comparable clinically and with respect to cost. APCs form the basis for payment rates under the Medicare Hospital Outpatient Prospective Payment System, with services assigned to specific APCs and bundled payment amounts calculated for the APC group.
    Ambulatory Surgery Center (ASC):
    a licensed healthcare facility that is dedicated to performing surgical procedures on an outpatient basis; that is, patients are admitted and discharged on the same day. ASCs may be either free-standing facilities or a dedicated part of a hospital. They may be owned by physicians, hospitals, publicly owned companies or various combinations of the foregoing. Also sometimes referred to as “outpatient surgery centers,” “same day surgery” or similar variations.
    Amino Acid:
    organic compounds that combine to form Proteins. The human body uses Amino Acids to make Proteins to help the body break down food, grow, repair body tissue and perform other bodily functions. There are 20 natural Amino Acids, and scientists are also making unnatural Amino Acids to create Molecules that are Protein-like, but with unique properties. Amino Acids are tethered to tRNA and are bound together with ribosomes as the tRNA reads the mRNA sequence during the Protein synthesis process.
    an increase in the frequency of a Gene or chromosomal region as a result of duplicating a DNA segment by an In Vivo or In Vitro process, such as gene duplication or PCR. Gene duplication refers to the duplication or replication of a portion of genetic material resulting in multiple copies of a region of DNA.
    Anatomical Therapeutic Chemical (ATC) Codes:
    the Anatomical Therapeutic Chemical Codes are two classification codes used to classify approved medicines into different levels.
    In the WHO (World Health Organization) classification system, the active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties. Drugs are classified in groups at five different levels. The Drugs are divided into 14 main groups (1st level), with pharmacological/therapeutic subgroups (2nd level). The 3rd and 4th levels are chemical/pharmacological/therapeutic subgroups and the 5th level is the chemical substance. The 2nd, 3rd and 4th levels are often used to identify pharmacological subgroups when that is considered more appropriate than therapeutic or chemical subgroups.
    In the EphMRA (European Pharmaceutical Market Research Association) classification system, the approved medicines are classified into four different levels, from the most general to the most specific. In its antitrust and merger control decisions the European Commission uses the third level (ATC3) of the EphMRA classification system as a starting point to define the relevant market in which to assess the effects on competition of investigated merger or conduct.
    acronym for Abbreviated New Drug Application.
    is a way to control pain during surgery or other procedures by using medicines called anesthetics. Local Anesthesia numbs a small part of the body during minor procedures while the patient remains conscious. Regional Anesthesia blocks pain to a larger part of the patient’s body. General Anesthesia affects the patient’s brain and the rest of the body and renders the patient unconscious.
    the physiological process through which new blood vessels form from pre-existing vessels. This process is distinct from vasculogenesis, which is the de novo formation of blood vessels. The first vessels in a developing embryo form through vasculogenesis, after which Angiogenesis is responsible for most blood vessel growth.
    Angiotensin-Converting Enzyme (ACE):
    an Enzyme which catalyzes the production of angiotensin, a hormone that causes narrowing of blood vessels.
    Animal and Plant Health Inspection Service (APHIS):
    an agency of the U.S. Department of Agriculture responsible for protecting animal health and welfare and plant health.
    acronym for National Agency for Medicine and Health Products Safety or Agence Nationale de Sécurité de Médicament et des Produits de Santé (the French Drugs and Medical Devices agency).
    anything that destroys or suppresses the growth of Bacteria or their ability to reproduce. Heat, certain chemicals and antibiotic Drugs have Antibacterial properties.
    Antibiotic and Antibiotic Resistance:
    antibiotics are natural or synthetic chemicals that kill Bacteria, but over- and misuse of Antibiotics has enabled some Bacteria to mutate their Genes in a way to resist the most common Drugs. As a result, super toxic alternatives must be used or no treatment is possible. More and more resistant Bacteria are showing up in society.
    Antibody Construct:
    the particular molecular structure of an Antibody, which typically consists of two large and two small subunits, each of which can vary in structure.
    Molecules the body makes in response to the detection of a foreign substance in order to target the foreign substance for destruction by the immune system. Antibodies can be used to diagnose a patient’s exposure to something.
    a reason for finding a Patent claim is not patentable based on the prior Invention or disclosure of the Invention claimed by another, or based on the inventor’s own disclosure of the claimed Invention by publication, prior sale or prior use. Anticipation requires that all claim elements appear in a single prior art reference.
    any substance (Bacteria, ProteinVirus or other harmful agent to which an Antibody binds) that causes an immune system to produce Antibodies against such substance.
    Anti-Kickback Statute (AKS):
    a federal law prohibiting persons and entities from knowingly and willfully soliciting, receiving, offering or providing remuneration, directly or indirectly, if one purpose of the Remuneration is to induce either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment may be made under a federal healthcare program, such as the Medicare and Medicaid programs. In this context, the term “induce” generally means the intent to gain influence over the reason or judgment of the person making a referral decision or recommendation. The definition of “remuneration” has been broadly interpreted to include anything of value, including for example gifts, Discounts, the furnishing of supplies or equipment, credit arrangements, payments of cash or cash equivalents, waivers of payments, ownership interests, and providing any item or service at an amount inconsistent with Fair Market Value. The penalties for violating the AKS include criminal penalties and civil sanctions, including fines, imprisonment and possible Exclusion from the Medicare and Medicaid programs.
    Antisense DNA:
    the non-coding strand of DNA that complements a coding strand in a segment of double-stranded DNA. During RNA synthesis, this strand serves as a template, and binds to RNA polymerase.
    Antisense RNA:
    the non-coding strand of RNA that complements a coding sequence of mRNA, in atypical circumstances when RNA forms a duplex. The presence of Antisense RNA impedes Translation because when RNA is in its duplex state, the ribosome cannot access the Nucleotides in the mRNA, or because the ribonucleases in the Cell quickly degrade the duplex RNA.
    Antitrust Statutes:
    federal and state laws designed to protect trade and commerce from illegal restraint, monopolies, price fixing and price discrimination. The primary federal antitrust acts are the Sherman Antitrust Act (1890), the Clayton Act (1914), the Federal Trade Commission Act (1914) and the Robinson-Patman Act (1936).
    a class of medications used to treat viral infections. Most Antivirals are used for specific viral infections, whereas a broad-spectrum Antiviral is effective against a wide range of Viruses. Antivirals do not destroy the Target pathogen, but instead inhibit its development.
    acronym for Ambulatory Payment Classification.
    acronym for Animal and Plant Health Inspection Service.
    acronym for Active Pharmaceutical Ingredient.
    Applicable GPO (Sunshine Act):
    Applicable Group Purchasing Organizations (see GPOs) under the Sunshine Act are those GPOs that operate in the United States, that purchase or arrange for purchase, or negotiate the purchase of a Prescription Drug, or a Device, or medical supply that requires premarket approval or notification from the FDA, for which federal Reimbursement is available, on behalf of GPO members. Applicable GPOs must annually disclose physician ownership through the open payments reporting system.
    Applicable Manufacturer (Sunshine Act):
    an entity with a physical location or which otherwise conducts activities within the United States, and engages in the production, preparation, propagation, compounding or conversion of Covered Drug, Device, Biological or Medical Supply, including entities under common ownership (5% ownership or more) that provide assistance or support with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale or distribution of a Covered Drug or Device for sale or distribution in the United States. Unless exempted or otherwise limited by the Act, an Applicable Manufacturer must report any payment or other transfer of value to a covered recipient, even if the payment is not related to a specific Covered Drug or Device.
    an irregular heartbeat. Tachycardia refers to the heart beating too fast and bradycardia refers to the heart is beating too slow. Arrhythmias result from many causes including coronary heart disease, high blood pressure, electrolyte imbalances in the blood and other medical conditions.
    the ultimate approval of a Pharmaceutical from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) in Germany. Such approval in particular requires Proof of Concept (Wirksamkeitsnachweis), appropriate Pharmaceutical quality as well as harmlessness of the Pharmaceutical.
    acronym for Ambulatory Surgery Center.
    acronym for Active Substance Master File.
    acronym for Average Sales Price.
    a generic term that refers to a method or experiment used to discover a new entity or to quantify the activity of a Molecule or organism.
    acronym for Advanced Therapy Medicinal Products.
    AUC / Area Under the Curve:
    Pharmacokinetic term denoting drug exposure over time and proportional to the total drug amount absorbed by the body. When plotting drug concentration in plasma against time, the quantification of the Area Under The Curve in such plot can then be used to describe the bioavailability of a given Drug.
    Authorized Representative:
    any natural or legal person who, explicitly designated by the Manufacturer, acts and may be addressed by authorities and bodies in the relevant country instead of the Manufacturer with regard to the latter's obligations.
    derived from the same individual; for example, incubated lymphoid Cells with Autologous tumor Cells.
    Average Acquisition Cost (AAC):
    an amount typically derived from the purchase prices retail community pharmacies pay to acquire Drug products. In the context of Medicaid, the AAC is used by some state agencies as a pricing benchmark to reimburse pharmacy Providers for covered outpatient Drugs dispensed to Medicaid beneficiaries.
    Average Manufacturer Price (AMP):
    the average price paid to the Manufacturer by wholesalers for Drugs distributed to retail community pharmacies, and by retail community pharmacies that purchase Drugs directly from the Manufacturer. AMP includes certain defined sales, nominal price sales, Discounts, Rebates, payments and other financial transactions. AMP may be used to calculate the Rebate amount Manufacturers must pay for Drugs under the Medicaid Drug Rebate Program (see, Medicaid Drug Rebate Program).
    Average Sales Price (ASP):
    a price calculated by dividing the value of a Manufacturer’s sales of a Drug to all purchasers in the United States in a calendar quarter by the total number of units of the Drug that the Manufacturer sold in that same quarter. The ASP is calculated net of price concessions, such as volume Discounts, prompt pay Discounts, cash Discounts, free goods contingent on purchase requirements, chargebacks and certain RebatesMedicare pays for most Drugs covered under Medicare Part B using a methodology based on ASP.
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